JP4977038B2 - Percutaneous spinal implant and method - Google Patents

Description

Cross-reference to related applications This application is based on US patent application Ser. No. 11 / 059,526, filed Feb. 17, 2005, “Devices and Methods for Treating Spinal Conditions”, Jul. US Provisional Application No. 60 / 695,836 “Percutaneous Spinal Implants and Methods”, US Patent Application No. 11 / 252,879, filed Oct. 19, 2005, “Percutaneous Spinal Implants” And US patent application Ser. No. 11 / 252,880, filed Oct. 19, 2005, “Percutaneous spinal implants and methods”.

  The present invention relates generally to the treatment of spinal conditions and, in particular, to the treatment of spinal compression using a percutaneous spinal implant to implant between adjacent spinous processes.

  The back condition that affects many individuals is spinal stenosis. Spine stenosis is a progressive stenosis of the spinal canal that compresses the spinal cord. The vertebrae in the spinal column have openings that extend through the vertebrae. These openings are vertically aligned to form the spinal canal. The spinal cord runs through the spinal canal. Because the spinal canal is narrow, the spinal cord and nerve roots that extend from the spinal cord and between adjacent vertebrae are compressed and inflamed. Spinal stenosis can cause pain, weakness, numbness, burning, tingling, particularly in severe cases, loss of bladder or bowel function, or paralysis. Legs, calves, and hips are most commonly affected by spinal stenosis, but the shoulders and arms are also affected.

  Mild spinal stenosis is treated with rest or limited activity, non-steroidal anti-inflammatory drugs (eg, aspirin), corticosteroids (epidural steroids), and / or physical therapy. Some patients have been found to help relieve pain by bending forward, sitting, or lying down. This is because bending forward creates more vertebral space and temporarily relieves nerve compression. Since spinal stenosis is a progressive disease, pain in the patient continues to increase and the pressure source must be surgically corrected (decompression laminectomy). Surgical procedures can remove bone or other tissue that strikes the spinal canal or applies pressure to the spinal cord. Two adjacent vertebrae may also be fused during a surgical procedure to prevent unstable areas, improper alignment or misalignment such as that caused by spinal spondylolisthesis. Surgical decompression can relieve pressure on the spinal cord or spinal nerves by welding the spinal canal to create more space. This procedure requires the patient to undergo general anesthesia in order to make an incision in the patient, access the spine, and remove the area causing the pressure. However, this procedure can result in blood loss, increased potential for significant complications, and generally longer hospital stays.

  A minimally invasive procedure has been developed to gain access to the space between adjacent spinous processes, without the need for major surgery. However, these known procedures are not suitable for situations where the spinous processes are significantly compressed. In addition, such procedures are generally relatively large or involve multiple incisions.

  Accordingly, there is a need for improved treatment of spinal conditions such as spinal stenosis.

  In one embodiment, the apparatus comprises an elongate member having a proximal portion configured to deform from a first configuration to a second configuration. The elongate member has a distal portion configured to deform from a first configuration to a second configuration. The non-expanding central portion is located between the proximal portion and the distal portion. The non-expanded central portion is configured to engage an adjacent spinous process.

  In another embodiment, the apparatus comprises a guide shaft, an expansion member coupled to the guide shaft, and an actuator. The expansion member is configured to apply a force from within the implant to deform the implant. The actuator is coupled to the expansion member and is configured to move the expansion member from the first position to the second position.

  In yet another embodiment, the apparatus comprises a first clamp having a first end and a second end. The second end of the first clamp is configured to engage the first spinous process. The second clamp has a first end and a second end. The second end of the second clamp is configured to engage a second spinous process spaced from the first spinous process. The connector is coupled to the first end of the first clamp and the first end of the second clamp.

  As used in this specification and the appended claims, the singular forms “indefinite” and “definite” include plural referents unless the context clearly dictates otherwise. Thus, for example, “a member” is intended to mean a single member, or a combination of members, and “a material” means one or more materials, or a combination thereof. I intend to. Further, the terms “proximal” and “distal” refer to an operator (eg, a medical device) that inserts a medical device into a patient, respectively, with the medical device tip (ie, the distal end) initially inserted into the patient's body. , Surgeon, doctor, nurse, technician, etc.) and away from the operator. Thus, for example, the end of the implant that was first inserted into the patient's body is the distal end of the implant, and the end of the implant that last enters the patient's body is the proximal end of the implant.

  In one embodiment, the apparatus comprises an elongate member having a proximal portion configured to deform from a first configuration to a second configuration, eg, by an axial load or a radial load. The elongate member has a distal portion configured to deform from the first configuration to the second configuration, for example, by an axial load or a radial load. The non-expanding central portion is located between the proximal portion and the distal portion. This non-expanded central portion is configured to engage an adjacent spinous process.

  According to an embodiment of the present invention, the elongated member may have a plurality of portions each moving from the first configuration to the second configuration simultaneously or sequentially. Furthermore, the device, or part of it, can be in many locations as it moves from the first configuration to the second configuration. For ease of reference, the entire device shows a state that exists in the first configuration or the second configuration.

  FIG. 1 is a schematic illustration of a medical device according to one embodiment of the present invention adjacent to two adjacent spinous processes. The medical device 10 includes a proximal portion 12, a distal portion 14, and a central portion 16. The medical device 10 has a first configuration that can be inserted between adjacent spinous processes S. The central portion 16 is configured to contact the spinous process S to prevent over-extension / compression of the spinous process S. In some embodiments, the central portion 16 does not distract the substantially adjacent spinous process S. In other embodiments, the central portion 16 does not distract adjacent spinous processes S.

  In the first configuration, the proximal portion 12, the distal portion 14, and the central portion 16 are coaxial (ie, share a common longitudinal axis). In some embodiments, the proximal portion 12, the distal portion 14, and the central portion 16 define a tube having a constant inner diameter. In other embodiments, the proximal portion 12, the distal portion 14, and the central portion 16 define a tube having a constant outer diameter and / or inner diameter.

  The medical device 10 can move from the first configuration to the second configuration as shown in FIG. In the second configuration, the proximal portion 12 and the distal portion 14 are disposed in positions that limit the lateral movement of the device 10 relative to the spinous process S. Proximal portion 12 and distal portion 14 are configured to engage the spinous process (ie, directly or through surrounding tissue) in the second configuration. For the sake of clarity, the tissue surrounding the spinous processes S is not shown.

  In some embodiments, the proximal portion 12, the distal portion 14, and the central portion 16 are integrally molded. In other embodiments, one or more of the proximal portion 12, the distal portion 14, and the central portion 16 are separate components that are coupled together to form the medical device 10. For example, the proximal portion 12 and the distal portion 14 can be integrally formed and the central portion can be a separate component coupled thereto.

  In use, the spinous process S can be distracted prior to inserting the medical device 10. The distraction of the spinous process is described below. If the spinous process is distracted, a trocar can be used to define the access path of the medical device 10. In some embodiments, the trocar can be used to define a passageway and distract the spinous process S. Once the access passage is defined, the medical device 10 is inserted percutaneously and the distal end 14 is first advanced between the spinous processes and the central portion 16 is positioned between the spinous processes S. After the medical device 10 is placed between the spinous processes, the proximal portion 12 and the distal portion 14 are moved to the second configuration sequentially or simultaneously.

  In some embodiments, the medical device 10 is inserted percutaneously (ie, through a skin opening) in a minimally invasive manner. For example, as described in detail herein, the size of the portion of the implant is expanded after the implant is inserted between the spinous processes. Once expanded, the size of the expanded portion of the implant is greater than the size of the opening. For example, the size of the opening / incision is 3 mm to 25 mm in length. In some embodiments, the size of the implant in the expanded configuration is 3-25 mm.

  FIG. 3 is a schematic illustration of a deformable element 18 representing, for example, characteristics of the distal portion 14 of the medical device 10 in a first configuration. The deformable member 18 includes notches A, B, C along its length, which is a weak point that allows the deformable member 18 to deform in a predetermined manner. Depending on the depth d of the notches A, B, and C and the width w of the throats T1, T2, and T3, the method by which the deformable member 18 is deformed by the applied load can be controlled and changed. Furthermore, the method by which the deformable member 18 deforms can be controlled and changed according to the length L between the notches A, B, and C (that is, the length of the material between the notches).

  4 is a schematic diagram of the expansion characteristics of the deformable member 18 shown in FIG. For example, when a load is applied in the direction indicated by the arrow X, the deformable member 18 is deformed by a method determined in advance based on the characteristics of the deformable member 18 as described above. As shown in FIG. 4, the deformable member 18 is most deformed in the notches B and C due to the configuration of the notch C and the distance between the notches B and C is short. In some embodiments, the deformable member 18 between the notches B and C is sized to fit adjacent to the spinous process.

  The deformable member 18 is relatively stiff at the notch A because the width of the notch A is narrow. As shown in FIG. 4, the smooth transition is defined by the deformable member 18 between the notches A and B. In this smooth transition, there is less stress on the tissue surrounding the spinous process than in the case of a relatively large transition between notches B and C. The dimensions and configuration of the deformable member 18 can also determine the time of deformation at various notches. A relatively fragile (ie, relatively deep and wide) notch deforms before a relatively strong (ie, relatively shallow and narrow) notch.

  5 and 6 show the spinal implant 100 in a first configuration and a second configuration, respectively. As shown in FIG. 5, the spinal implant 100 can be collapsed in a first configuration and inserted between adjacent spinous processes. The spinal implant 100 has a first expandable portion 110, a second expandable portion 120, and a central portion 150. The first expandable portion 110 has a first end 112 and a second end 1140. The second expandable portion 120 has a first end 122 and a second end 124. Center portion 150 is coupled between second end 1140 and first end 122. In some embodiments, spinal implant 100 is integrally formed.

  The first expandable portion 110, the second expandable portion 120, and the central portion 150 have a common longitudinal axis A along the length of the spinal implant 100. The central portion 150 has the same inner diameter as the first expandable portion 110 and the second expandable portion 120. In some embodiments, the outer diameter of the central portion 150 is smaller than the outer diameter of the first expandable portion 110 and the second expandable portion 120.

  In use, the spinal implant 100 is inserted between adjacent spinous processes percutaneously. The first expandable portion 110 is first inserted and passes through the spinous process, with the central portion 150 positioned between the spinous processes. The outer diameter of the central portion 150 may be slightly smaller than the space between the spinous processes, taking into account the surrounding ligaments and tissue. In some embodiments, the central portion is disposed between the spinous processes in direct contact with the spinous processes. In some embodiments, the central portion of spinal implant 100 is a fixed size and is not compressible or expandable.

  The first expandable portion 110 includes expansion members 115, 117 and 119. An opening 111 is defined between the expansion members 115, 117, and 119. As described above, the size and shape of the opening 111 affects the way in which the expansion members 115, 117, and 119 are deformed when an axial load is applied. Second expandable portion 120 includes expansion members 125, 127, and 129. An opening 121 is defined between the expansion members 125, 127, and 129. As described above, the size and shape of the opening 121 affects how the expansion members 125, 127, and 129 are deformed when an axial load is applied.

  When an axial load is applied to the spinal implant 100, the spinal implant 100 expands in the second configuration as shown in FIG. In the second configuration, the first end 112 and the second end 1140 of the first expandable portion 110 move in the direction of each other, and the expansion members 115, 117, 119 are substantially separated from the longitudinal axis A. Protruding sideways. Similarly, the first end 122 and the second end 124 of the second expandable portion 120 move in the direction of each other, and the expansion members 125, 127, 129 protrude laterally away from the longitudinal axis A. . The second configuration of expansion members 115, 117, 119, 125, 127, and 129 form protrusions that extend adjacent to the spinous processes, between which the spinal implant 100 is inserted. In the second configuration, the expansion members 115, 117, 119, 125, 127, 129 prevent lateral movement of the spinal implant 100, and the central portion 150 has a diameter of the central portion 150 as adjacent spinous processes move relative to each other. To prevent access closer than the distance defined by.

  A spinal implant 200 according to one embodiment of the present invention is shown in various configurations in FIGS. The spinal implant 200 is shown in a fully collapsed configuration in FIG. 7 and is inserted between adjacent spinous processes. The spinal implant 200 has a first expandable portion 210, a second expandable portion 220, and a central portion 250. The first expandable portion 210 has a first end 212 and a second end 214. The second expandable portion 220 has a first end 222 and a second end 224. Central portion 250 is coupled between second end 214 and first end 222.

  The first expandable portion 210, the second expandable portion 220, and the central portion 250 have a common longitudinal axis A along the length of the spinal implant 200. The central portion 250 can have the same inner diameter as the first expandable portion 210 and the second expandable portion 220. The outer diameter of the central portion 250 is greater than the outer diameter of the first expandable portion 210 and the second expandable portion 220. The central portion 250 can be integrally molded with the first expandable portion 210 and the second expandable portion 220, or can be molded separately and coupled to or on these portions.

  In use, the spinal implant 200 is inserted between adjacent spinous processes S percutaneously. The first expandable portion 210 passes through the spinous process S and the central portion 250 is disposed between the spinous processes S. The outer diameter of the central portion 250 may be slightly smaller than the space between the spinous processes S, taking into account the surrounding ligaments and tissue. In some embodiments, the central portion 250 is disposed between the spinous processes S in direct contact with the spinous processes S. In some embodiments, the central portion 250 of the spinal implant 200 is a fixed size and is not compressible or expandable. In other embodiments, the central portion 250 can be compressed to conform to the shape of the spinous process.

  The first expandable portion 210 includes expansion members 215, 217 and 219. An opening 211 is defined between the expansion members 215, 217, and 219. As described above, the size and shape of the opening 211 affect how the expansion members 215, 217, 219 are deformed when an axial load is applied. Each expansion member 215, 217, 219 of the first expandable portion 210 includes a tab 213 that extends into the opening 211 and an opposing mating slot 218. In some embodiments, the first end 212 of the first expandable portion 210 is circular to facilitate insertion of the spinal implant 200.

  The second expandable portion 220 includes expansion members 225, 227, and 229. An opening 221 is defined between the expansion members 225, 227, and 229. As described above, the opening 221 affects the way in which the expansion members 225, 227, 229 are deformed when an axial load is applied. Each of the expansion members 225, 227, 229 of the second expandable portion 220 includes a tab 223 that extends into the opening 221 and an opposing mating slot 228.

  When an axial load is applied to the spinal implant 200, the spinal implant moves to a partially expanded configuration as shown in FIG. In the partially expanded configuration, the first end 222 and the second end 224 of the second expandable portion 220 move in the direction of each other, and the expansion members 225, 227, 229 move laterally away from the longitudinal axis A. Protrusively. To prevent the second expandable portion 220 from expanding, the tab 223 engages the slot 228 and acts as a positive stop. If the axial load continues to be applied to the spinal implant 200 after the tab 223 engages the slot 228, the load is transmitted to the first expandable portion 210. Accordingly, the first end 212 and the second end 214 then move in the direction of each other and the tab 213 engages the slot 218 in the fully expanded configuration shown in FIG. In the second configuration, the expansion members 215, 217, 219 protrude laterally away from the longitudinal axis A. In some alternative embodiments, the first expandable portion and the second expandable portion expand as soon as an axial load is applied.

  The degree of expansion of the spinal implant 200 can be controlled by changing the size of the openings 211 and 221. For example, in the embodiment shown in FIGS. 7 to 9, the opening 221 is slightly larger than the opening 211. Accordingly, notch 226 is slightly larger than notch 216. Thus, as described above with respect to FIGS. 3 and 4, the second expandable portion 220 expands prior to the first expandable portion 210 when an axial load is applied.

  In the second configuration, the expansion members 215, 217, 219, 225, 227, 229 form a protrusion adjacent to the spinous process S. When in the second configuration, the expansion members 215, 217, 219, 225, 227, 229 prevent lateral movement of the spinal implant 200 and the central portion 250 is defined by adjacent spinous processes relative to each other by the diameter of the central portion 250. It will prevent you from moving closer than you can.

  Each portion P of the expansion member 215, 217, 219, 225, 227, 229 proximal to the spinous process S expands such that the portion P is substantially parallel to the spinous process S. Each portion D of the expansion member 215, 217, 219, 225, 227, 229 distal from the spinous process S is inclined so that little tension is applied to the surrounding tissue.

  In the second configuration, the expansion members 225, 227, 229 are separated from the axial image by about 120 ° as shown in FIG. Although three expansion members are shown, when multiple implants 200 are inserted between multiple adjacent spinous processes, two or more expansion members are used and arranged to overlap or alternate. be able to. Further, regardless of the number of expansion members provided, adjacent expansion members need not be separated by an equal angle or distance.

  The spinal implant 200 is deformed by a compressive force applied substantially along the longitudinal axis A of the spinal implant 200. The compressive force can be achieved, for example, by attaching a rod (not shown) to the first end 212 of the first expandable portion 210, pulling the rod along the longitudinal axis, and applying an opposing force to the second expandable portion 220 second. Added by adding to end 224. The opposing force creates a compressive force that results in the spinal implant 200 expanding as described above.

  A rod that is used to apply a compressive force to the spinal implant 200 is removably coupled to the spinal implant 200. For example, the spinal implant 200 can include a thread 208 at the first end 212 of the first expandable portion 210. Force against the force exerted by the rod can be applied using a push bar (not shown) removably coupled to the second end 224 of the second expandable portion 220. The push rod can be aligned with the spinal implant 200 by the alignment notch 206 at the second end 224. The spinal implant 200 can be deformed in a variety of other ways, examples of which are described in detail below.

  11-14 illustrate a spinal implant 300 according to one embodiment of the present invention. The spinal implant 300 is configured to be disposed between adjacent spinous processes S and includes an elongated tube 310 having a first end 312 and a second end 314. The elongated tube 310 has a longitudinal slot 311 defined at a predetermined location along its length. In the slot 311, each part of the elongated tube 310 extends outward to form a protrusion 317. Inflatable member 350 is disposed around the elongated tube and between adjacent sets of slots 311.

  The inflatable member 350 is configured to be disposed between adjacent spinous processes S as shown in FIGS. The inflatable member 350 is inserted between adjacent spinous processes and then inflated using a liquid and / or gas, such as a biocompatible material. Inflatable member 350 is inflated to maintain spinal implant 300 in place between spinous processes S. In some embodiments, the expandable member 350 is configured to at least partially distract the spinous process S when expanded. The inflatable member 350 is inflated to various dimensions, taking into account the various spacings between the spinous processes S.

  The inflatable member 350 can be inflated via an inflation tube 370 inserted through the spinal implant 300 after the spinal implant 300 is placed in place between the spinous processes S. The protrusion 317 is expanded before or after the expandable member 350 is expanded. To expand the protrusion 317, an axial force is applied to the spinal implant 300 using a pull bar 320 coupled to the first end 312 of the spinal implant 300.

  As the pull bar 320 is pulled, the axial load causes the protrusion 317 to buckle outward, thereby preventing the spinal implant from moving laterally relative to the spinous process S. FIG. 12 is a view of the spinal implant 300 during deformation, with only the protrusion 317 being partially formed. Although illustrated as deforming simultaneously, the slot 311 can be dimensioned by another method so that deformation occurs at different times as described above. When the spinal implant is in the expanded configuration (see FIG. 13), the pull bar 320 is removed from the elongated tube 310.

  The orientation of the spinal implant 300 need not be such that the two protrusions are substantially parallel to the axes of the adjacent spinal portions as shown in FIG. For example, spinal implant 300 can be oriented with each protrusion 317 at a 45 ° angle to the spinal axis.

  The spinal implant 100, 200, 300 can be deformed from its first configuration to its second configuration using a variety of expansion devices. For example, portions of spinal implants 100, 200, 300, and other types of implants I can be deformed using the following expansion devices. Although various types of implants I are shown, the various expansion devices described can be used with any of the implants described herein.

  FIGS. 15-17 illustrate one embodiment of an expansion device 1500. The expansion device 1500 includes a guide handle 1510, a knob assembly 1515, an upper housing 1517, a shaft 1520, and an implant support portion 1530. The expansion device 1500 is used to insert an implant (not shown) between adjacent spinous processes to expand the implant and hold it in place between the spinous processes as described above. Both the guide handle 1510 and the knob assembly 1515 can be gripped to manipulate the expansion device 1500 to insert the implant. For clarity, specific implants are not shown in FIGS. 15-17, but an implant such as, for example, implant 200 can be used with expansion device 1500 (see FIG. 7).

  Implant support portion 1530 slidably houses the implant on the surface of rod 1532. The implant slides on the rod 1532 and is received in the recess 1534 as best shown in FIG. 15B. The implant is screwed to the implant support portion 1530 using a threaded rod 1570. Threaded rod 1570 is coupled into actuator knob 1550 using thrust bearing 1552. The alignment protrusion 1536 is disposed within the recess 1534 and is configured to mate with a corresponding notch on the implant to ensure proper positioning of the implant.

  Upper housing 1517 slidably houses shaft 1520 as best shown in FIG. 15A. The upper housing includes an inner thread 1519 that fits into an outer thread 1521 on the shaft 1520. Actuator knob 1550 is coupled to upper housing 1517 so that when actuator knob 1550 rotates in the direction of arrow E, threaded rod 1570 acts as a pull bar to prevent the implant from moving in the distal direction. The shaft 1520 moves axially toward the distal end of the device 1500. That is, when the implant is inserted between adjacent spinous processes, the actuator knob 1515 rotates and the distal end of the shaft 1520 provides an axial force against the proximal end of the implant. At the same time, the threaded rod 1570 creates an opposing force in the proximal direction.

  The force exerted by the shaft 1520 and threaded rod 1570 causes the portion of the implant to expand into the transverse configuration and remain in place between the spinous processes as described above.

  When the implant is in place and fully expanded, the release knob 1560 can rotate in the direction indicated by arrow R to disengage the threaded rod 1570 from the implant. The expansion device can then be removed.

  FIG. 18 shows an expansion device 400 in a collapsed configuration. The expansion device 400 can be used to selectively form protrusions on the implant I (not shown in FIG. 18) at desired locations. The expansion device 400 includes a guide shaft 410 that can guide the expansion device 400 into the implant I, and a cam actuator 450 that is attached to the guide shaft 410 and can be placed in an eccentric position. The expansion device 400 has a longitudinal axis A, and the cam actuator 450 has a cam axis C that is laterally offset from the longitudinal axis A by a distance d. FIG. 19 shows the expansion device 400 in an expanded configuration with the cam actuator 450 rotated about the cam axis C. FIG.

  The expansion device 400 can be inserted into the implant I through the implant holder H shown in FIG. The implant holder H is coupled to the implant and is configured to hold the implant in place, and the expansion device 400 is manipulated to deform the implant I. When the implant I is sufficiently deformed, the implant holder H is separated from the implant I and can be removed from the patient, leaving the implant I behind.

  Referring to FIGS. 20 and 21, the expansion device 400 includes a handle 420 that is used to deploy the cam actuator 450. As the handle 420 rotates, the cam actuator 450 deploys and deforms the implant I. When the cam actuator 450 is fully deployed (eg, 180 ° from its original position) and locked in place, the entire expansion device 400 rotates and deforms the implant I around the implant I. The cam actuator 450 surrounds the trajectory of a plurality of points outside the original diameter of the implant I that forms the protrusion P (see FIG. 22). After the expansion device 400 is locked in place, it can grip the guide shaft 410 or be rotated using the handle 420.

  The expansion device 400 can be used to form a plurality of protrusions P. After the first protrusion P is formed, the cam actuator 450 rotates in the reverse direction to the first configuration, and the expansion device 400 can be advanced through the implant I to the second position. When the expansion device 400 is properly positioned, the cam actuator 450 is deployed again and the expansion device 400 rotates to form the second protrusion P (see FIG. 23). In some embodiments, the implant I is disposed between adjacent spinous processes and the protrusions P are formed on both sides of the spinous process to prevent the implant I from being displaced laterally (ie, axially). .

  An alternative expansion device 500 is shown in FIGS. FIG. 24 shows the expansion device 500 in the first configuration, and FIG. 25 shows the expansion device 500 in the second configuration. The expansion device 500 includes a guide shaft 510 that is inserted into the implant I. The axial camshaft actuator 520 is slidably disposed within the guide shaft 520. The axial camshaft actuator 520 has an inclined recess 530 for receiving a movable object 550. As the camshaft actuator 520 moves, the movable object 550 is displaced along the inclined recess 530 and protrudes through the opening 540 in the guide shaft 510.

  The movable object 550 is configured to displace a portion of the implant I to form the protrusion P. A plurality of movable objects 550 can be used around the guide shaft 510 to form a protrusion P extending radially around the implant I. Further, the protrusions can be formed at a plurality of positions along the length of the implant I by advancing the expansion device 500 to the second position along the length of the implant as described above. Alternatively, the expansion device can have a plurality of recesses that displace other collections of movable objects.

  In an alternative embodiment, the expansion device also serves as an implant. For example, the expansion device 500 can be inserted between adjacent spinous processes S, a movable object moves from the opening 540, and the expansion device 500 is left behind in the body. In such an embodiment, the movable object prevents the expansion device 500 from moving laterally relative to the spinous process S.

  In another alternative embodiment, rather than having an opening 540 in the expansion device 500, the movable object 550 is placed in a relatively fragile (thin) portion of the wall of the expansion device, and the expansion device 500 such portions can be moved to the protruding configuration.

  Another alternative expansion device 600 is shown in FIGS. FIG. 26 shows an expansion device 600 having a first configuration, and FIG. 28 shows an expansion device having a second configuration. The expansion device 600 includes a guide shaft 610 that is inserted into the implant I. The guide shaft 610 has an opening 640 defined therein. An axial camshaft actuator 620 is rotatably coupled within the guide shaft 610. The displaceable object 650 is disposed in the guide shaft 610 and is configured to protrude from an opening 640 in the guide shaft 610. As the camshaft actuator 620 rotates approximately 90 °, the movable object 650 moves through the opening 640 and deforms the implant I to form the protrusion P. Alternatively, the expansion device can have multiple cams that displace other collections of movable objects.

  A plurality of movable objects 650 can be used around the guide shaft 610 to form a protrusion P extending radially around the implant I. Further, the protrusions can be formed at a plurality of positions along the length of the implant I by advancing the expansion device 600 to the second position along the length of the implant I as described above.

  An implant expansion device 700 is shown in FIGS. Implant expansion device 700 is configured for insertion into implant I. The implant 700 includes a guide shaft 710 that is coupled to the housing 770. The cam actuator 720 includes an arm 790 that is rotatably mounted in the housing 770 and extends in a direction facing each other. Cam actuator 720 is rotated using rod 722.

  As cam actuator 720 rotates, arm 790 engages movable object 750. The movable object 750 is configured to protrude from the housing 770 when the cam actuator rotates clockwise. When the movable object 750 is fully extended, it engages the implant I and the expansion device 700 makes one complete rotation to form a protrusion in the implant I.

  After the protrusion is formed, the rod 722 can rotate counterclockwise to disengage the movable object 750 from the implant I. After disengagement, the expansion device 700 can be advanced to another position within the implant I as described above.

  In other embodiments, the implant I can be actuated with a balloon. FIG. 31 shows an implant I placed between adjacent spinous processes S. FIG. Balloon actuator 800 is inserted into implant I and expands as shown in FIG. 32 to move implant I to its expanded configuration. The balloon actuator 800 can be deflated and removed after expansion, leaving the implant I in an expanded configuration.

  In some embodiments, the balloon actuator 800 can have a plurality of round protrusions that expand on each side of the spinous process S. In other embodiments, multiple balloon actuators 800 can be used to expand the implant I.

  FIG. 33 is a cross-sectional view of an expandable implant 900 that can be expanded using the expansion device 950 shown in FIGS. The implant 900 has an elongated body portion 910 having a first end 901 and a second end 902. The first end 901 has an outer threaded portion 911 and the second end has an inner threaded portion 912. The implant 900 has an outer threaded portion 911 having a first outer diameter D1 and a second outer diameter D2 that is wider than the first outer diameter D1.

  The expansion device 950 includes a pull bar 960 and a compression bar 970. In some embodiments, the compression bar 970 defines a channel 975 having an inner thread 971 that mates with an outer threaded portion 911 of the implant 900 (see FIG. 34). The pull bar 960 has an outer thread 961 that mates with a threaded portion 912 inside the implant 900.

  In use, the compression bar 970 is coupled to the first end 901 of the implant 900 and abuts the implant 900 at a transition portion between the first outer diameter D1 and the second outer diameter D2, which transition portion Serves as a stop for the compression bar 970. In some embodiments, the outer diameter of the implant 900 is substantially constant and the inner diameter of the compression bar 970 is narrowed to serve as a stop for the compression bar 970. When the compression bar 970 is in place, the pull bar 960 is inserted through the channel 975 and through the second end 902 of the implant 900 via the threaded portion 912 inside the implant 900. (See FIG. 35). When the compression bar 970 and the pull bar 960 are coupled to the implant 900, the pull bar 960 can be pulled and opposing forces are applied to the compression bar 970 to expand the implant 900 (see FIG. 36). When the implant 900 is fully expanded, the compression bar 970 and pull bar 960 are removed and the implant remains posteriorly in the body.

  In the case of the expansion device described herein, the position of the protrusion can be selected in vivo rather than having a predetermined expansion position. Such a configuration reduces the need to prepare spacers of multiple sizes. Furthermore, the timing which a protrusion part expand | deploys can be changed.

  The various implants 100, 200, 300 described herein can be made from, for example, stainless steel, plastic, polyetheretherketone (PEEK), carbon fiber, ultra high molecular weight (UHMW) polyethylene, and the like. The material can have a tensile strength equal to or greater than that of bone.

  In another embodiment of the invention, the aperture comprises a first clamp having a first end and a second end. The second end of the first clamp is configured to engage the first spinous process. The second clamp has a first end and a second end. The second end of the second clamp is configured to engage a second spinous process spaced from the first spinous process. The connector is coupled to the first end of the first clamp and the first end of the second clamp.

  FIG. 38 is a schematic illustration of a medical device according to one embodiment of the present invention attached to two adjacent spinous processes. The device 1010 includes a first clamp 1012 configured to couple to the first spinous process S and a second clamp 1014 configured to couple to the second spinous process S. First clan 1012 and second clamp 1014 are configured to move away from each other in the direction indicated by arrow X. As the first clamp 1012 and the second clamp 1014 move away, the opening between adjacent spinous processes S expands. The insert 1050 can be inserted between the spinous processes S in the direction indicated by the arrow Y to maintain the opening between the spinous processes S. The clamps 1012, 1014 engage the spinous process S with sufficient force, and when the clamps 1012, 1014 are spread apart, the spinous process S is displaced laterally.

  FIG. 39 is a side view of a medical device according to one embodiment of the present invention coupled to a portion of the spinal cord. The tissue surrounding the spinal cord is not shown for clarity. The medical device 1000 includes a first clamp 1100 and a second clamp 1200. The first clamp 1100 has a proximal end 1120 and a distal end 1140. The distal end 1140 of the first clamp 1100 is configured to engage the first spinous process S. The second clamp 1200 has a first end 1220 and a second end 1240. The second end 1240 of the second clamp 1200 is configured to engage a second spinous process S that is spaced from the first spinous process S.

  The connector 1300 is coupled to the proximal end 1120 of the first clamp 1100 and the first end 1220 of the second clamp 1200. The position of the connector 1300 relative to the first clamp 1100 and the second clamp 1200 can be adjusted such that the distance between the first clamp 1100 and the second clamp 1200 can be adjusted. That is, the connector 1300 can be reconfigured between the first configuration and the second configuration. The first clamp 1100 is at a first distance from the second clamp 1200 when the connector 1300 is in the first configuration, and is at a second distance from the second clamp 1200 when the connector 1300 is in the second configuration.

  Referring to FIG. 40 in which the first clamp 1100 is shown, the first clamp 1100 includes a first meshing portion 1150 and a second meshing portion 1130 facing the first meshing portion 1150. First engagement portion 1150 and second engagement portion 1130 are configured to be movable between the first configuration and the second configuration. The first meshing portion 1150 and the second meshing portion 1130 are closer to each other in the second configuration than in the first configuration. In the second configuration, when the first engagement portion 1150 and the second engagement portion 1130 engage the spinous process S with sufficient force and the connector 1300 moves to the second configuration, thereby separating the spinous process S, The orientation of the first clamp 1100 and the second clamp 1200 with respect to the spinous process S can be substantially maintained. Second clamp 1200 has a similar configuration but is not shown for clarity. The material of the meshing portions 1150 and 1130 is a material that sufficiently engages the spinous process S as described above but does not damage the spinous process. Suitable materials include, for example, stainless steel, polyetheretherketone (PEEK), carbon fiber, ultra high molecular weight (UHMW) polyethylene, and the like. This material can have a tensile strength equal to or greater than that of bone. In some embodiments, the clamp 1200 can be made from stainless steel and a PEEK or carbon fiber coating and / or an outer coating or overcoat can be applied to the mating portions 1150, 1130.

  In some embodiments, the medical device 100 is used to separate adjacent spinous processes of a highly compressed vertebra. Further, the medical device 100 stabilizes the spinous process during the procedure without entering the vertebra.

  In some embodiments, the first clamp 1100 includes a first arm 1170, a second arm 1180, and a tensioning member 1160. Since the first arm 1170 and the second arm 1180 are elastically coupled, the first arm 1170 and the second arm 1180 move toward each other as the tensioning member 1160 advances toward the distal end 1140 of the clamp 1100. When the tensioning member 1160 moves away from the distal end 1140 of the clamp 1100, the first arm 1170 and the second arm 1180 return to their initial positions (ie, are separated).

  The tension member 1160 is such that when the first arm 1170 and the second arm 1180 move in the direction of each other, the first meshing portion 1150 and the second meshing portion 1130 move between the first configuration and the second configuration. Configured. When the tension member 1160 moves in the direction of the first engagement portion 1150 and the second engagement portion 1130, the first engagement portion 1150 and the second engagement portion 1130 engage with the spinous processes S. In some applications, the distal end 1140 of the clamp 1100 is positioned adjacent to a thin layer L of vertebrae to which the clamp 1100 is coupled. In some embodiments, clamp 1100 is attached proximate lamina L to minimize lever arms on the spinous processes. The distal end 1140 of the clamp 1100 does not penetrate the lamina L.

  In an alternative embodiment, the tension member comprises a thread that engages a thread on the first clamp. In such an embodiment, the tension member moves along the length of the first clamp by rotating the tension member. Returning to FIG. 40, the tensioning member 1160 optionally includes a tapered portion 1190 that fits into the tapered portion 1110 of the first clamp 1100. Such a configuration ensures that the force on the spinous process S is properly distributed. The second clamp 1200 is similarly configured and includes a tensioning member 126 and opposing mating portions.

  The swing arm 1700 is pivotally attached to the connector 1300 between the first clamp 1100 and the second clamp 1200. The swing arm 1700 has an arcuate portion 173 and moves along a range of motion. The arcuate portion 173 of the swing arm 1700 has a first end 1750 and a second end 1770.

  As best shown in FIGS. 41 and 42, the second end 1770 of the arcuate portion 173 of the swing arm 1700 is configured to receive a work tool 1840 such as, for example, a sharp trocar tip. The swing arm 1700 defines an opening 1740 in which at least one portion of the work tool 1840 is received. In some embodiments, the opening 1740 extends between the first end 1750 and the second end 1770 along the entire length of the arcuate portion 173. In some implementations, the optional handle 190 can be coupled to the first clamp 1100 and / or the second clamp 1200 to facilitate insertion of the clamps 1100, 1200 and increase the stability of the device 1000 in use. .

  Work tool 1840 is coupled to guidewire 1860. Guidewire 1860 has a first end 1810 and a second end 1830. Second end 1830 of guidewire 1860 is coupled to work tool 1840. A retainer 1820 (described in detail below) is coupled to the first end 1810 of the guidewire 1860 and is configured to maintain the position of the work tool 1840 relative to the swing arm 1700. The retainer 1820 is received in a recessed portion 1720 in the swing arm 1700 in a fitting manner. Guide wire 1860 is housed in an opening 1740 defined in swing arm 1700. The guide wire is received in the opening 1740 through a channel 1760 defined in the swing arm 1700 as best shown in FIG. In some alternative embodiments, the guidewire does not extend through the opening 1740 of the swing arm 1700. In yet another alternative embodiment, no guide wire is present.

  44 and 45 show a retainer 1820 having a first configuration and a second configuration, respectively. The retainer 1820 includes a housing 1880 that defines an opening 1870, and a guide wire 1860 is movably disposed through the opening 1870. Guide wire 1860 is coupled to holding member 1830. The holding member 1830 is biased by the spring 1850 toward the first end 1890 of the housing 1880. The spring 1850 is located between the second end 1810 of the housing 1880 and the holding member 1830.

  In use, the work tool is held in the swing arm 1700 when the retainer 1850 is in the first configuration (FIG. 44). When the retainer 1820 moves to the second configuration (FIG. 45), the work tool 1840 can be removed from the swing arm 1700. When the retainer 1820 is moved to the second configuration, it is displaced by a distance d, thereby increasing the effective length of the guide wire 1860 and the work tool 1840 is movable relative to the end of the swing arm 1700. In some embodiments, the distance d is approximately the same as the length of the portion of the work tool 1840 housed within the swing arm 1700.

  As shown in FIG. 46, the work tool 1840 'is inserted into an opening 1740' defined by the swing arm 1700 '. The swing arm 1700 'includes a protrusion 1920 in an opening 1740' that fits into a recess 1970 on the work tool 1840 '.

  39-42, in use, the first clamp 1100 is inserted through the body B and couples to the spinous process S. The tensioning member 1160 moves toward the distal end 1140 of the first clamp to engage the first engagement portion 1150 and the second engagement portion 1130 with the spinous process S. Next, the second clamp 1200 is inserted and similarly coupled to the adjacent spinous process S. When the connector 1300 is activated, the distance between the first clamp 1100 and the second clamp 1200 is increased, thereby separating adjacent spinous processes S. When the spinous process S is separated, the swing arm 1700 moves by the moving range M thereof.

  The swing arm 1700 moves by a moving range M from a position outside the main body B (see, for example, FIG. 41). The swing arm 1700 enters the main body B and moves by a moving range M until a target T (for example, see FIG. 39) between adjacent spinous processes S is reached.

  Movement of the swing arm 1700 into the body defines a passageway in tissue (not shown). The tissue is penetrated by a sharp protrusion (ie, work tool 1840). The passage M defined by the swing arm 1700 comprises a passage T between adjacent spinous processes S. After the passage is defined, the swing arm 1700 is removed and a spacer 500 (see FIG. 49), described in detail below, can be inserted between adjacent spinous processes S. In some embodiments of the present invention, the spacer 5000 can be removably attached to the swing arm 1700, inserted into the body, and then removed from the swing arm 1700.

  A medical device 2000 according to one embodiment of the present invention is shown in FIG. The medical device 2000 includes a handle 2900 coupled to the arm 2700. Arm 2700 has a first end 2750 and a second end 2770 and defines an opening 2740 along its length. The work tool 2840 can be received in the opening 2740 adjacent to the second end 2770. The arm 2700 also includes a recess 2720 that houses a retainer (not shown) similar to the retainer 1850 described above. Similar to the swing arm 1700 described above, the medical device 2000 is inserted between adjacent spinous processes. However, the depth and placement of the arm 2700 is determined by the user of the medical device 2000. Such medical devices can be used with or without the benefits of the clamps 1100, 1200 described above. That is, the medical device 2000 can be inserted between adjacent spinous processes S without first separating the spinous processes S.

  A medical device according to another embodiment of the present invention is shown in FIG. The medical device 2010 is a distraction tool having a handle 2011, a curved shaft 2020, and a distraction portion 2030. The distraction portion 2030 includes a sharp tip 2032 and an insertion position indicator 2034. The medical device 2010 is inserted into the patient's back and moved from the side of the spinous process between adjacent spinous processes (ie, posterior-side approach). The configuration of the curved shaft 2020 is useful for using side access to the spinous processes. The distraction portion 2030 defines a passage through the patient's tissue between adjacent spinous processes.

  The position indicator 2034 is a physical that can be confirmed by the physician by tactile sensation when the medical device 2010 is inserted an appropriate distance (eg, when the position indicator 2034 engages the spinous process). A ridge or detent can be used. The position indicator 2034 may alternatively be a radiopaque strip that can be imaged using a fluoroscope. According to yet another alternative, a fluoroscopic marking (not shown) can be placed on the shaft 2020 in the distraction portion 2030. This indicia can be imaged to determine the spacing between the spinous processes and / or the position of the distraction portion 2030 relative to the spinous processes. When the spinous process is properly distracted, the medical device 2010 is removed. After removal of the medical device 2010, an implant (not shown in FIG. 48) can be placed between the spinous processes using an insertion tool to limit the minimum distance between the spinous processes in the range of movement of the spinous processes.

  An alternative swing arm 1700 " used in the medical device 100 according to one embodiment of the present invention is shown in Figs. 49a-49c. As best shown in FIGS. 49a and 45c, the second end 1770 ″ of the swing arm 1700 ″ is configured to accommodate a work tool 1840 ″ such as a sharp trocar tip, for example. The The swing arm 1700 ″ defines an opening 1740 ″ in which at least a portion of the work tool 1840 ″ is received. In some embodiments, the opening 1740 ″ extends between the first end 1750 ″ and the second end 1770 ″ along the entire length of the swing arm 1700 ″ to define a passage or lumen. Define. The opening 1740 ″ is slightly larger than the diameter of the work tool 1840 ″ so that the work tool 1840 ″ is placed in the opening 1740 ″ in use.

  Work tool 1840 "is coupled to wire 1860". The wire 1860 "has a first end 1810" and a second end 1830 ". The second end 1830 ″ of the wire 1860 ″ is coupled to the work tool 1840 ″. A retainer 1820 '' (described in detail below) is coupled to the first end 1810 '' of the wire 1860 '' and is configured to hold the position of the work tool 1840 '' relative to the swing arm 1700 ''. Is done. In some embodiments, the wire 1860 ″ is substantially rigid so that when a force is applied to the work tool 1840 ″, the work tool 1840 ″ does not contract into the opening 1740 ″.

  The retainer 1820 "is housed in a recess 1720" in the swing arm 1700 ". The retainer 1820 "is held in the recess 1720" using a threaded fastener 173 ". In some alternative embodiments, the wire 1860 "does not extend through the opening 1740" of the swing arm 1700 ". In yet another alternative embodiment, there is no wire 1860 ''.

  50-59 show various spacers 5000 that can be inserted between adjacent spinous processes S. FIG. When the spacer 5000 is inserted between the spinous processes S, depending on the type of the spacer 5000, the spacer 5000 can be deformed to be held in place. For example, in some embodiments, the balloon actuator 5500 can be inserted and expanded within the spacer, thereby expanding both ends of the spacer 5000 and holding the spacer 5000 between the spinous processes S (eg, FIG. 50, FIG. 52 and FIG. 56). When the spacer 5000 is expanded, the balloon actuator 5500 can be deflated and removed (see, eg, FIG. 57).

  In some embodiments of the present invention, the spacer 5000 includes an end portion 5750 that includes a recess 5970 configured to mate with a protrusion 1920 on the swing arm 1700 '(see FIG. 46).

  In another embodiment, the method includes transcutaneously inserting an expandable member having a first configuration, a second configuration, and a third configuration, respectively, into the body. The expandable member includes a support portion and a retention portion. The support portion has a longitudinal axis and is configured to be disposed between adjacent spinous processes. The retaining portion is configured to limit movement of the support portion along the longitudinal axis. The expandable member is disposed at a first position between adjacent spinous processes when in the first configuration. Next, the expandable member is expanded from the first configuration to the second configuration. The expandable member then contracts from the second configuration to the third configuration and is disposed at the second position, the second position being different from the first position.

  In some embodiments, the apparatus comprises an expandable member having a support portion, a holding portion, a first configuration, and a second configuration. The support portion has a longitudinal axis and is configured to be disposed between adjacent spinous processes. The retaining portion is disposed adjacent to the support portion and is configured to limit movement of the support portion along the longitudinal axis. When in the first configuration, the expandable member has a first volume. When in the second configuration, the expandable member has a second volume that is greater than the first volume. The expandable member is configured to move from the first configuration to the second configuration and from the second configuration to the first configuration.

  In some embodiments, the device comprises a sensor coupled to the expandable member. The sensor may be, for example, a strain gauge sensor or a piezoelectric sensor that measures the force applied to the expandable member and / or the pressure of the fluid within the expandable member.

  In some embodiments, the device comprises a substantially rigid support member, a first expandable member, and a second expandable member. The support member is configured to be disposed between adjacent spinous processes. The first expandable member is coupled to the proximal portion of the support member and has a first configuration having a first volume and a second configuration having a second volume greater than the first volume. Similarly, the second expandable member is coupled to the distal portion of the support member and has a first configuration having a first volume and a second configuration having a second volume greater than the first volume.

  60A-60D show a book placed adjacent to two adjacent spinous processes S in a first configuration (FIG. 60A), a second configuration (FIGS. 60B and 60D), and a third configuration (FIG. 60C). 1 is a schematic rear view of a medical device 4000 according to one embodiment of the invention. FIG. The medical device 4000 includes an expandable member 4002 having an inner region (not shown) and an outer surface 4010. The outer surface 4010 is configured to be disposed between the spinous processes S to prevent over-extension / compression of the spinous processes S. In some embodiments, the expandable member 4002 distracts adjacent spinous processes S. In other embodiments, the expandable member 4002 does not distract adjacent spinous processes S.

  The expandable member 4002 has a first configuration, a second configuration, and a third configuration, respectively. In each configuration, the expandable member 4002 has a corresponding volume. As shown in FIG. 60A, the first configuration represents a substantially contracted state where the expandable member 4002 has a minimum volume. When the expandable member 4002 is in the first configuration, the medical device 4000 is inserted between adjacent spinous processes S. As shown in FIGS. 60B and 60D, the second configuration represents an expanded state in which the expandable member 4002 has a large volume. When the expandable member 4002 is in the second configuration, the outer surface 4010 of the medical device 4000 contacts the adjacent spinous process S in at least a portion of the range of movement of the spinous process. As shown in FIG. 60C, the third configuration represents a partially expanded state where the expandable member 4002 has a volume between the volume corresponding to the first configuration and the volume corresponding to the second configuration. When the expandable member 4002 is in the third configuration, the medical device 4000 is repositioned between adjacent spinous processes, as indicated by the arrows in FIG. 60C. The medical device can then be expanded again to the second configuration, as shown in FIG. 60D.

  61A-61C are schematic rear views of a medical device 4000 disposed adjacent to two adjacent spinous processes S in a first configuration, a second configuration, and a third configuration, respectively. As described above, when the expandable member 4002 is in the first configuration, the medical device 4000 is inserted between adjacent spinous processes S. The expandable member 4002 then expands in a second configuration in which the outer surface 4010 of the medical device 4000 is disposed on the adjacent spinous process S. The expandable member 4002 then contracts to the third configuration, facilitating removal of the medical device 4000, as shown in FIG. 61C. Depending on the embodiment, the third configuration may be the same as the first configuration.

  In use, the adjacent spinous process S can be distracted prior to inserting the medical device 4000 into the body. Distraction of the spinous process is described herein. When the spinous process S is distracted, a trocar (not shown) can be used to define an access passage (not shown) for the medical device 4000. In some embodiments, a trocar can be used to define the passage and distract the spinous process S. After the access passage is defined, the medical device 4000 is inserted percutaneously and advanced between the spinous processes S and placed at a desired position between adjacent spinous processes S. When the medical device 4000 is in the desired position, the expandable member expands to the second state and the outer surface 4010 engages the spinous process S.

  In some embodiments, adjacent spinous processes can be distracted by a first expandable member (not shown) configured to distract the bone. After distraction, the first expandable member contracts and can be removed from the body. Next, the medical device 4000 is inserted percutaneously and advanced between the spinous processes S as described above to be placed and expanded at the desired location.

  In some embodiments, the medical device 4000 is inserted transcutaneously (ie, through an opening into the skin) in a minimally invasive manner. For example, as described herein, the overall size of the portion of the medical device 4000 may be such that the expandable member 4002 can be configured from the first configuration to the second configuration after the medical device 4000 is inserted between adjacent spinous processes S. It is increased by making a transition to. When expanded in the second configuration, the size of the portion of the medical device 4000 is larger than the size of the opening. For example, the size of the skin opening / incision may be 3 mm to 25 mm long across the opening. In some embodiments, the size of the medical device 4000 in the expanded second configuration is 3-25 mm across the opening.

  62A-62F are rear views of a spinal implant 4100 according to one embodiment of the present invention inserted between adjacent spinous processes S in a first lateral position (FIG. 62C) and a second lateral position (FIG. 62E). It is. The spinal implant 4100 includes an expandable member 4102, a sensor 4112, and a valve 4132. The expandable member 4102 has an inner region (not shown), an outer surface 4110, a support portion 4118, a proximal retention member 4114, and a distal retention portion 4116. The expandable member 4102 can be repeatedly repositioned in a first configuration (FIG. 62B), a second configuration (FIGS. 62C, 62E, and 62F), and a third configuration (FIG. 62D). In each configuration, the expandable member 4102 has a corresponding volume, as described below.

  In use, the spinal implant 4100 is placed in a substantially contracted first configuration upon insertion and / or removal (see FIG. 62B). As described above, the spinal implant 4100 is inserted between adjacent spinous processes S percutaneously. The distal retaining portion 4116 of the expandable member 4102 is first inserted and passes through the spinous process S, and the support portion 4118 is disposed between the spinous processes S. When in the first configuration, the support portion 4118 can be sized taking into account the ligaments and tissue surrounding the spinous processes S. For clarity, the ligaments and tissues so enclosed are not shown.

  As shown in FIG. 62C, the expandable member 4102, when placed in place, conveys fluid (not shown) from the area outside the expandable member 4102 to the area inside the expandable member 4102. Expand with the second configuration. This fluid is carried by an expansion tool 4130 such as a catheter that fits into valve 4132. Valve 4132 may be any valve suitable for sealingly connecting the inner region of expandable member 4102 to the outer region of expandable member 4102. For example, in some implementations, the valve 4132 can be, for example, a poppet valve, a pinch valve, or a two-way check valve. In other embodiments, the valve includes a coupling portion (not shown) configured to repeatedly couple the expansion tool 4130 to the valve 4132 and repeatedly remove it from the valve 4132. For example, in some implementations, the valve 4132 can include a threaded portion configured to fit the expansion tool 4130 and the valve 4132.

  This fluid is configured to remain in the inner region of the expandable member 4102 while maintaining fluid properties. In this manner, the spinal implant 4100 can repeatedly transition from the expanded second configuration to the first configuration and / or the third configuration by removing fluid from the inner region of the expandable member 4102. In some embodiments, the fluid may be a constant or nearly constant biocompatible liquid. An example of such a liquid is a physiological saline solution. In other embodiments, such fluid may be a biocompatible liquid configured to maintain sufficient fluid properties to allow removal of the fluid while having material properties that change over time. . For example, the viscosity of the fluid can be increased by adding a curing agent or the like. In this way, the fluid also maintains the ability to be removed from the inner region of the expandable member 4102 via the valve 4132 while providing essential structural support. In still other embodiments, the fluid may be a biocompatible gas.

  The outer surface 4110 of the support portion 4118 can distract adjacent spinous processes S when the expandable member 4102 expands in the second configuration, as indicated by the arrows in FIG. 62C. In some embodiments, support portion 4118 does not distract adjacent spinous processes S. For example, as described above, adjacent spinous processes S cannot be distracted by trocars and / or other devices suitable for distraction.

  In the second configuration, the outer surface 4110 of the support portion 4118 is configured to engage the spinous process S in at least a portion of the range of motion of the spinous process S and prevent over-extension / compression of the spinous process S. In some embodiments, the outer surface 4110 of the support portion 4118 does not engage the spinous process S continuously but engages after spinal extension.

  In the second configuration, the proximal retaining portion 4114 and the distal retaining portion 4116 each have a size S1 (shown in FIG. 63) that is greater than the vertical distance D1 (shown in FIG. 63) between the spinous processes. In this manner, the proximal retaining portion 4114 and the distal retaining portion 4116 are disposed adjacent to either side of the spinous process S (ie, in direct contact or contact through surrounding tissue), thereby causing the spine The implant 4100 is restricted from moving laterally along the longitudinal axis of the support portion 4118.

  The expandable member 4102 can be made from any number of biocompatible materials, such as, for example, PET, nylon, cross-linked polyethylene, polyurethane, and PVC. In some embodiments, the material selected may be substantially inelastic, resulting in the formation of a low compliant expandable member 4102. In other embodiments, the selected material may be relatively highly elastic, resulting in a highly compliant expandable member 4102. In still other embodiments, the expandable member 4102 is one portion of the expandable member 4102, eg, the support portion 4118, is low compliant and the other portion of the expandable member 4102, eg, the proximal retaining portion 4114 and The distal retaining portion 4116 can be manufactured from a combination of materials so that it is relatively highly compliant. In yet other embodiments, the expandable member 4102 can include a rigid, non-flexible material to provide structural rigidity. For example, the support portion 4118 can be composed of a composite material that includes a rigid inflexible material to facilitate distraction of adjacent spinous processes.

  In some embodiments, the expandable member 4102 includes a radiopaque material, such as bismuth, to facilitate tracking the position of the spinal implant 4100 during insertion and / or repositioning. In other embodiments, the fluid used to expand expandable member 4102 includes a radiopaque tracer to facilitate tracking the position of spinal implant 4100.

  In the illustrated embodiment, spinal implant 4100 includes a sensor 4112 coupled to expandable member 4102. In some embodiments, sensor 4112 is a strain gauge sensor that measures the force applied to support portion 4118 of expandable member 4102. The sensor 4112 can include multiple strain gauges to easily measure multiple amounts of force, such as compression force and / or tension. In other embodiments, sensor 4112 is a variable capacitance type pressure sensor configured to measure the force and / or pressure of fluid contained within the inner portion of expandable member 4102. In yet another embodiment, sensor 4112 is a piezoelectric sensor that measures the pressure of fluid contained within the inner portion of expandable member 4102. In still other embodiments, the spinal implant 4100 can include a plurality of sensors 4112 disposed at various locations to provide a spatial profile of force and / or pressure applied to the expandable member 4102. In this way, the practitioner can detect changes in the patient's condition that may cause loosening of the spinal implant 4100 and the like.

  In some embodiments, sensor 4112 can be remotely controlled by an external guidance device. For example, an external radio frequency (RF) transmitter (not shown) can be used to power and communicate with the sensor 4112. In other embodiments, an external acoustic signal transmitter (not shown) can be used to supply power to and communicate with the sensor 4112. In such a configuration, for example, the sensor can comprise a pressure sensor of the type described above for measuring pressure, an acoustic transducer, and an energy storage device. Acoustic transducers convert energy between electrical energy and acoustic energy. The energy storage device stores electrical energy converted by the acoustic transducer and provides electrical energy to assist the operation of the pressure sensor. In this way, acoustic energy from an external source can be received and converted into electrical energy that is used to power the pressure sensor. Similarly, the electrical signal output from the pressure sensor can be converted to acoustic energy and transmitted to an external source.

  At this point, the spinal implant 4100 needs to be repositioned. Such relocation may be necessary, for example, to optimize the lateral position of the support portion 4118 in the insertion process. In other cases, the spinal implant 4100 may need to be repositioned after the insertion process to accommodate changes in the patient's condition. In still other cases, spinal implant 4100 can be removed from the patient. In order to allow such repositioning and / or removal, the spinal implant can be repeatedly repositioned in the first configuration, the second configuration, and / or the third configuration. In FIG. 62D, for example, the expandable member 4102 is contracted to the third configuration by removing all or a portion of the fluid contained in the interior region, as described above. In this way, the spinal implant 4100 can be repositioned laterally as indicated by the arrows. When in the desired position, the expandable member is expanded to the second state as described above. Finally, as shown in FIG. 62F, the expansion tool 4130 is removed from the valve 4132.

  FIG. 63 is a side view of the spinal implant 4100 shown in FIGS. 62A-62F inserted between adjacent spinous processes S in the second configuration. 63 shows only the proximal retention portion 4114 of the expandable member 4102, the distal retention portion 4116 should be considered to have properties and functions similar to those described below with respect to the proximal retention portion 4114. It is. As shown, the proximal retaining portion 4114 has a size S1 that is greater than the vertical distance D1 between the spinous processes S. In this manner, the proximal retention portion 4114 and retention portion 4116 limit the lateral movement of the spinal implant 4100 when in the second configuration, as described above.

  FIG. 64 is a side view of a spinal implant 4200 inserted between adjacent spinous processes and according to one embodiment of the present invention in a second configuration. Similar to spinal implant 4100 described above, spinal implant 4200 includes an expandable member 4202 and a valve 4232. The expandable member 4202 has a support portion (not shown), a proximal retention portion 4214, and a distal retention portion (not shown). The expandable member 4202 can be repeatedly repositioned in the first configuration, the second configuration, and / or the third configuration. In each configuration, the expandable member 4202 has a corresponding volume as described above.

  In the illustrated embodiment, the proximal retaining portion 4214 of the expandable member 4202 includes a first radially extending portion 4236, a second radially extending portion 4238, and a third radially extending portion 4240. Have. As shown, the distance S1 between the ends of the radially extending portion is larger than the vertical distance D1 between the spinous processes S. In this way, the proximal retention portion 4214 and the distal retention portion limit lateral movement of the spinal implant 4200 when in the second configuration. In some embodiments, the proximal retaining portion and the distal retaining portion can take a variety of different shapes.

  65A and 65B are front views of a spinal implant 4300 according to one embodiment of the present invention in a first configuration and a second configuration, respectively. The spinal implant 4300 includes a proximal expandable member 4304, a distal expandable member 4306, a support member 4308, a sensor 4312, and a valve 4332. Support member 4308 has an inner region (not shown) and an outer surface 4310. The outer surface 4310 is configured to contact a spinous process (not shown). In some embodiments, the support member 4308 distracts adjacent spinous processes. In other embodiments, the support member 4308 does not distract adjacent spinous processes. In yet other embodiments, the support member 4308 does not engage the spinous process continuously, but engages after the spine is extended.

  Support member 4308 has a proximal portion 4324 to which proximal expandable member 4304 is coupled and a distal portion 4326 to which distal expandable member 4306 is coupled. Proximal expandable member 4304 and distal expandable member 4306 are each repeatedly repositionable in the first configuration (FIG. 65A) and the second configuration (FIG. 65B). As described above, the first configuration represents a substantially contracted state in which each of the proximal expandable member 4304 and the distal expandable member 4306 has a minimum volume. The spinal implant 4300 can be inserted, repositioned and / or removed when in the first configuration. In the illustrated embodiment, each of the proximal expandable member 4304 and the distal expandable member 4306 is housed within the inner region of the support member 4308 when the spinal implant 4300 is in the first configuration. In some embodiments, the proximal expandable member 4304 and the distal expandable member 4306 are not housed within the support member 4308.

  Conversely, the second configuration represents an expanded state in which the proximal expandable member 4304 and the distal expandable member 4306 each have a large volume. When spinal implant 4300 is in the second configuration, proximal expandable member 4304 and distal expandable member 4306 each have a size that is greater than the vertical distance between the spinous processes as described above. In this manner, the proximal expandable member 4304 and the distal expandable member 4306 engage the spinous process, thereby limiting the lateral movement of the spinal implant 4300.

  Proximal expandable member 4304 and distal expandable member 4306 provide fluid (not shown) from an area outside each expandable member 4304, 4306 to the inside defined by each expandable member 4304, 4306. Expand in the second configuration by transporting to the area. Fluid is conveyed through valve 4332 as described above. In the illustrated embodiment, the inner region of the proximal expandable member 4304, the inner region of the distal expandable member 4306, and the inner region of the support member 4308 are in fluid communication with each other to form a single inner region. To do. Thus, fluid can be conveyed by the single valve 4332 to both the inner region of the proximal expandable member 4304 and the inner region of the distal expandable member 4306. In some embodiments, the inner regions of the proximal expandable member 4304 and the distal expandable member 4306 are not in fluid communication. In such a configuration, each expandable member deforms separately between each configuration.

  The support member 4308 can be made from any number of biocompatible materials, such as stainless steel, plastic, polyetheretherketone (PEEK), carbon fiber, ultra high molecular weight (UHMW) polyethylene, and the like. The material of the support member 4308 can have a tensile strength equal to or greater than that of bone. In some embodiments, support member 4308 is substantially rigid. In other embodiments, the support member 4308 or a portion thereof can be elastically deformed so that it can conform to the shape of the spinous process. In still other embodiments, the support member 4308 includes a radiopaque material, such as bismuth, to facilitate tracking the position of the spinal implant 4300 during insertion and / or repositioning.

  Proximal expandable member 4304 and distal expandable member 4306 can be fabricated from any number of biocompatible materials, as described above. Proximal expandable member 4304 and distal expandable member 4306 can be coupled to the support member by any suitable means, such as a biocompatible adhesive.

  In the illustrated embodiment, spinal implant 4300 includes a sensor 4312 coupled to support member 4308. As described above, the sensor 4312 can be configured to measure multiple force amounts and / or pressures of fluid contained within the proximal expandable member 4304 and the distal expandable member 4306.

  In another embodiment, the device includes a support member, a proximal retention member, and a distal retention member. The support member is configured to be disposed between adjacent spinous processes. The proximal retention member includes a first configuration in which the proximal retention member is disposed substantially within the proximal portion of the support member and a first configuration in which a portion of the proximal retention member is disposed outside the support member. It has two configurations. The distal retaining member includes a first configuration in which the distal retaining member is disposed substantially within the distal portion of the support member, and a first configuration in which a portion of the distal retaining member is disposed outside the support member. It has two configurations.

  In some embodiments, each of the proximal retention member and the distal retention member comprises a first elongated member and a second elongated member. The second elongated member is configured to be slidably disposed within the first elongated member. The support member includes a sidewall defining a plurality of openings, each opening configured to receive a portion of at least one of the first elongate member or the second elongate member through the openings.

  In some embodiments, each of the proximal retaining member and the distal retaining member comprises an elongate member having a longitudinal axis and a rotating member having a longitudinal axis perpendicular to the longitudinal axis of the elongate member. . A portion of the elongated member is flexible in a direction perpendicular to the longitudinal axis. The rotating member is coupled to the elongated member and is configured to rotate about the longitudinal axis, thereby moving the elongated member along the longitudinal axis.

  In some embodiments, the method includes percutaneously inserting a support member configured to be positioned between adjacent spinous processes into the body. The support member defines an inner region and an opening substantially perpendicular to the longitudinal axis connecting the inner region and the outer region of the support member. The support member includes a first configuration in which the holding member is disposed substantially in the inner region, and a second configuration in which a portion of the holding member is disposed in the outer region of the support member through the opening. The support member is disposed at a position between adjacent spinous processes when the holding member is in the first configuration. The holding member moves from the first configuration to the second configuration.

  Certain parts of the device, such as one or more retaining members, are configured to move between the first configuration, the second configuration, and / or the third configuration for clarity, but the entire device is It may be referred to as a first configuration, a second configuration, and / or a third configuration. However, one of ordinary skill in the art having the benefit of this disclosure will appreciate that the device is configured to have more than three configurations. Further, in some implementations, the device can take many positions as it moves between the first configuration, the second configuration, and / or the third configuration. For the sake of clarity, the apparatus will be described as a first configuration, a second configuration, or a third configuration. Finally, in some embodiments, the apparatus comprises one or more holding members, but the drawings and accompanying description show and describe only a single holding member. In such cases, the description of a single holding member should be considered to apply to some or all other holding members included in the embodiments.

  66A and 66B are schematic rear views of a medical device 3000 according to one embodiment of the present invention disposed between two adjacent spinous processes S in a first configuration and a second configuration, respectively. The medical device 3000 includes a support member 3002, a proximal retention member 3010, and a distal retention member 3012. The support member 3002 has a proximal portion 3004 and a distal portion 3006 and is configured to be disposed between the spinous processes S to prevent over-extension / compression of the spinous processes S. In some embodiments, the support member 3002 distracts adjacent spinous processes S. In other embodiments, the support member 3002 does not distract adjacent spinous processes S.

  Proximal retention member 3010 has a first configuration disposed substantially within proximal portion 3004 of support member 3002, as shown in FIG. 66A. Similarly, the distal retention member 3012 has a first configuration that is disposed substantially within the distal portion 3006 of the support member 3002. The medical device 3000 can be positioned between adjacent spinous processes S when the proximal retaining member 3010 and the distal retaining member 3012 are each in their respective first configurations.

  Proximal retaining member 3010 can move from a first configuration to a second configuration that is disposed outside support member 3002 shown in FIG. 66B. Similarly, the distal retaining member 3012 is movable from the first configuration to the second configuration. Proximal retention member 3010 and distal retention member 3012, when in their respective second configuration, support spinous process S by contacting spinous process S (ie, directly or through surrounding tissue). The lateral movement of the member 3002 is limited. For the sake of clarity, the tissue surrounding the spinous processes S is not shown.

  In use, the adjacent spinous process S can be distracted prior to inserting the medical device 3000 into the patient's body. When the spinous process S is distracted, a trocar (not shown in FIG. 66A or 66B) can be used to define an access passage (not shown in FIG. 66A or 66B) of the medical device 3000. In some embodiments, the trocar can be used to define a passageway and distract the spinous process S.

  Once the access passage is defined, the medical device 3000 is advanced with the distal portion 3006 first percutaneously inserted between the spinous processes S. The medical device 3000 can be inserted from the side of the spinous process S (ie, posterior-side approach). By using a curved shaft, the use of lateral access to the spinous process S is facilitated. Once the medical device 3000 is placed in place between the spinous processes S, the proximal retaining member 3010 and the distal retaining member 3012 move sequentially or simultaneously to their respective second configurations. In this way, the lateral movement of the support member 3002 relative to the spinous process S is limited.

  If it is desirable to change the position of the medical device 3000, the proximal retaining member 3010 and the distal retaining member 3012 return to the first configuration, thereby allowing the support member 3002 to move laterally. . When the support member 3002 is repositioned, the medical device 3000 can return to the second configuration. Similarly, if it is desirable to remove the medical device 3000, the proximal retention member 3010 and the distal retention member 3012 can be moved from the first configuration to the second configuration, thereby allowing the support member 3002 to be removed. .

  In some embodiments, the medical device 3000 is inserted in a minimally invasive manner percutaneously (ie, through the skin opening). For example, as described in detail herein, the overall size of each portion of the medical device 3000 is determined by the proximal retention member 3010 and distal retention after the medical device 3000 is inserted between adjacent spinous processes S. The member 3012 can be increased by moving it to the respective second configuration. When expanded in the second configuration, the size of each portion of the medical device 3000 may be larger than the size of the opening. For example, the size of the skin opening / incision may be 3 to 25 mm long across the opening. In some embodiments, the size of the medical device 3000 in the expanded second configuration is 3 mm to 25 mm across the opening.

  67A, 67B, 68-71 illustrate a spinal implant 3100 according to one embodiment of the present invention. 67A and 67B are perspective views of spinal implant 3100 in a first configuration and a second configuration, respectively. The spinal implant 3100 includes a support member 3102, a proximal retention member 3110, and a distal retention member 3112. The support member 3102 is disposed between the adjacent spinous processes S as shown in FIGS. 67 and 67B, the proximal retaining member 3110 and the distal retaining member 3112 are each in a first configuration (FIG. 67A) substantially disposed within the support member 3102 and each retaining A part of the members 3110 and 3112 can be repeatedly arranged in the second configuration (FIG. 67B) arranged outside the support member 3102. When the spinal implant 3100 is in the first configuration, it can be inserted between adjacent spinous processes S, repositioned between adjacent spinous processes, and / or removed from the patient. The spinal implant 3100 is limited in lateral movement when in the second configuration, thereby maintaining the desired position of the support member 3102.

  In some embodiments, support member 3102 distracts adjacent spinous processes S. In other embodiments, support member 3102 does not distract adjacent spinous processes S. In yet another embodiment, the support member 3102 does not engage the spinous process S continuously but engages after spinal extension.

  The support member 3102 can be made of any biocompatible material, such as stainless steel, plastic, polyetheretherketone (PEEK), carbon fiber, ultra high molecular weight (UHMW) polyethylene, and the like. The material of the support member 3102 can have a tensile strength equal to or greater than that of bone. In some embodiments, the support member 3102 is substantially rigid. In other embodiments, the support member 3102 or a portion thereof can be elastically deformed, thereby adapting to the shape of the spinous process. In still other embodiments, the support member 3102 includes a radiopaque material, such as bismuth, to facilitate tracking the position of the spinal implant 3100 during insertion and / or repositioning.

  In the illustrated embodiment, spinal implant 3100 includes a sensor 3124 that is coupled to a support member 3102. In some embodiments, sensor 3124 is a strain gauge sensor that measures the force applied to support member 3102. In some implementations, the sensor 3124 can include multiple strain gauges to easily measure multiple amounts of force, such as compressive force and / or bending moment. In another embodiment, sensor 3124 is a variable capacitance type pressure sensor configured to measure force and / or pressure applied to support member 3102. In yet another embodiment, sensor 3124 is a piezoelectric sensor that measures the force and / or pressure applied to support member 3102. In still other embodiments, the spinal implant 3100 can include a plurality of sensors positioned at various locations to provide a spatial profile of force and / or pressure applied to the support member 3102. In this way, the practitioner can detect changes in the patient's condition that can result in loosening of the spinal implant and the like.

  In some embodiments, sensor 3124 can be remotely controlled by an external guidance device. For example, an external radio frequency (RF) transmitter (not shown) can be used to supply power to and communicate with the sensor 3124. In other embodiments, an external acoustic signal transmitter (not shown) can be used to supply power to and communicate with the sensor 3124. In such a configuration, for example, the sensor can comprise a pressure sensor of the type described above for measuring pressure, an acoustic transducer, and an energy storage device. Acoustic transducers convert energy between electrical energy and acoustic energy. The energy storage device stores electrical energy converted by the acoustic transducer and provides electrical energy to assist the operation of the pressure sensor. In this way, acoustic energy from an external source can be received and converted into electrical energy that is used to power the pressure sensor. Similarly, the electrical signal output from the pressure sensor can be converted to acoustic energy and transmitted to an external source.

  The support member 3102 includes an inner region 3120 and a sidewall 3108 that defines a plurality of openings 3114 that connect the inner region 3120 to an outer region of the support member 3102. When the spinal implant 3100 is in the first configuration, the proximal retention member 3110 and the distal retention member 3112 are disposed substantially within the inner region 3120 of the support member 3102 as shown in FIG. 67A. When the spinal implant 3100 is in the second configuration, a portion of each proximal retention member 3110 and distal retention member 3112 extends through the opening 3114 to a region outside the support member 3102. In the second configuration, the proximal retention member 3110 and the distal retention member 3112 engage adjacent spinous processes, thereby limiting lateral movement of the spinal implant 3100.

  Proximal retention member 3110 includes a first elongate member 3130 and a second elongate member 3132. Similarly, the distal retaining member 3112 includes a first elongated member 3131 and a second elongated member 3133. As shown in FIG. 71 showing a cross-sectional plan view of the proximal portion 3104 of the support member 3102, the first elongate member 3130 is slidably disposed within a pocket 3134 defined by the second elongate member 3132. . A biasing member 3136, such as a spring or elastic member, is disposed in the pocket 3134 and is coupled to the first elongate member 3130 and the second elongate member 3132. In this way, the holding member can be biased to the second configuration. In other embodiments, the biasing member 3136 can be configured to bias the retaining member to the first configuration. In still other embodiments, the retaining member does not include a biasing member and instead uses other mechanisms to maintain the desired configuration. Such mechanisms include, for example, mating tabs and slots configured to lockably engage when the retaining member is in a desired configuration.

  In use, the spinal implant 3100 is placed in a first configuration during insertion, removal or repositioning. As described above, the spinal implant 3100 is inserted between percutaneously adjacent spinous processes. The distal portion 3106 of the support member 3102 is initially inserted and passes through the spinous process, and the support member 3102 is disposed between the spinous processes. The support member 3102 can be sized in view of the ligaments and tissue surrounding the spinous processes S. In some embodiments, the support member 3102 contacts the spinous process and is disposed between the spinous processes in a portion of the range of movement of the spinous process S. In some embodiments, the support member 3102 of the spinal implant 3100 is a fixed size and is not compressible or expandable. In yet another embodiment, the support member 3102 can be compressed and conform to the shape of the spinous process S. Similarly, in some embodiments, the proximal retention member 3110 and the distal retention member 3112 are substantially rigid. In other embodiments, the retaining member or a portion thereof can be elastically deformed so that it can conform to the shape of the spinous process.

  In the illustrated embodiment, the spinal implant 3100 is held in a first configuration by an insertion tool (not shown) that overcomes the force exerted by the biasing member 3136, thereby allowing a portion of the first elongated member 3130 to be in the second length. It is placed in the pocket 3134 of the shape member 3132. In this way, the spinal implant 3100 can be repeatedly moved from the first configuration to the second configuration, thereby allowing for percutaneous repositioning and / or removal. As shown in FIG. 70, the first elongate member 3130 and the second elongate member 3132 each include a notch 3138 configured to receive a portion of the insertion tool. When the insertion tool is released, the biasing member 3136 extends freely, thereby displacing a portion of the first elongated member 3130 from the pocket 3134 of the second elongated member 3132. In this way, a portion of the first elongate member 3130 and the second elongate member 3132 extends through the adjacent opening 3114 to a region outside the support member 3102. In some embodiments, the proximal retention member 3110 and the distal retention member 3112 transition simultaneously between the first configuration and the second configuration, respectively. In other embodiments, the proximal retaining member 3110 and the distal retaining member 3112 transition continuously between the first configuration and the second configuration.

  As shown, the first elongate member 3130 and the second elongate member 3132 each include one or more tabs 3140 that engage the sidewall 3108 of the support member 3102 when in the second configuration. Together, thereby keeping the first and second elongated members coupled together, ensuring that portions of the first and second elongated members are properly positioned within the support member 3102. In other embodiments, the first elongate member 3130 and the second elongate member 3132 may include other mating tabs and slots configured to engage when the retention member reaches a predetermined expansion limit. Are coupled together by any suitable mechanism.

  72, 73A and 73B are cross-sectional views of a spinal implant 3200 according to one embodiment of the present invention. FIG. 72 shows a front cross-sectional view of the spinal implant 3200 in the second configuration, and FIGS. 73A and 73B show cross-sectional plan views of the spinal implant 3200 in the second configuration and the first configuration, respectively. The illustrated spinal implant 3200 includes a support member 3202, a retention member 3210, and a rotation member 3250. Although shown and described as having only a single retention member 3210, in some embodiments, it may include one or more additional retention members having similar characteristics and functions as with the retention member 3210. Can do.

  As shown in FIGS. 73A and 73B, the holding member 3210 has a first configuration that is substantially disposed within the support member 3202 and a second configuration in which a portion of the holding member 3210 is disposed outside the support member 3102. It can be arranged repeatedly. In the first configuration, spinal implant 3200 is inserted between adjacent spinous processes, repositioned between adjacent spinous processes, and / or removed from the patient. When the spinal implant 3200 is in the second configuration, lateral movement is limited, so that the desired position of the support member 3202 can be maintained.

  The support member 3202 includes an inner region 3220 and a sidewall 3208 that defines a plurality of openings 3214 that connect the inner region 3220 to an outer region of the support member 3202. When the spinal implant 3200 is in the first configuration, the retention member 3210 is disposed substantially within the inner region 3220 of the support member 3202 as shown in FIG. 73B. When the spinal implant 3200 is in the second configuration, a portion of the proximal retention member 3210 extends through the opening 3214 to a region outside the support member 3202. In the second configuration, the retention member 3210 is positioned adjacent to the spinous process, thereby restricting lateral movement of the spinal implant 3200.

  The retaining member 3210 includes an elongated member 3228 having two end portions 3244, a central portion 3242, and a longitudinal axis L1 (shown in FIG. 72). A portion of the elongated member 3228 is flexible and can be wrapped along the rotating member 3250 as described below. In some embodiments, it is flexible enough to wrap along the elongated member 3228, rotating member 3250, and is sufficient to limit the lateral movement of the support member 3202 when placed in the second configuration. Are integrally molded so as to be rigid. In other embodiments, the elongated member 3228 comprises separate components that are coupled together to form the elongated member 3228. For example, the central portion 3242 of the elongated member 3228 may be a separate component that is relatively flexible, while the end portion 3244 may be a separate component that is relatively rigid.

  In the illustrated embodiment, the elongated member 3228 engages the sidewall 3208 of the support member 3202 when in the second configuration, so that the elongated member 3228 does not extend freely outside the entire support member 3202. To. In other embodiments, a portion of the elongated member 3228 is retained within the support member 3202 by other suitable mechanisms. For example, the width of the central portion 3242 of the elongated member 3228 is greater than the width of the opening 3214 so that a portion of the elongated member 3228 remains within the support member 3202.

  Rotating member 3250 defines an outer surface 3252 and a slot 3254 through which elongated member 3228 is disposed. The rotating member 3250 has a longitudinal axis L2 (shown in FIG. 72) about which the rotating member 3250 rotates. As shown in FIG. 73B, when the rotating member 3250 rotates, the elongated member 3228 is wound along the outer surface 3252 of the rotating member 3250. As a result, the elongated member 3228 moves along the longitudinal axis L 1 and the end portion 3244 of the elongated member 3228 contracts inwardly through the opening 3214. In this way, the holding member 3210 can repeatedly transition between the first configuration and the second configuration.

  In some embodiments, the rotating member 3250 rotates using an insertion tool (not shown) that includes a ratchet mechanism. The insertion tool can rotate the rotating member 3250 in many different ways, such as manually, pneumatically or electronically.

  74 and 75A-75C are cross-sectional views of a spinal implant 3300 according to one embodiment of the present invention. FIG. 74 shows a front cross-sectional view of the spinal implant 3300 in the second configuration, and FIGS. 75A-75C show cross-sectional plan views of the spinal implant 3300 in the second configuration, the first configuration, and the third configuration, respectively. The illustrated spinal implant 3300 includes a support member 3302 and a retention member 3310. Although only one holding member 3310 is shown and described, in some embodiments, one or more additional holding members having similar characteristics and functions as in the case of the holding member 3310 may be provided.

  As shown in FIGS. 75A to 75C, the holding member 3310 can be repeatedly arranged in the first configuration, the second configuration, and the third configuration. A part of the holding member 3310 is arranged outside the support member 3302 when arranged in the second configuration. When the holding member 3310 is disposed in each of the first configuration and the third configuration, the holding member 3310 is substantially disposed in the support member 3202. As shown in FIGS. 75B and 75C, the orientation of the holding member 3310 is different between the first configuration and the third configuration. In this manner, the position of the spinal implant 3300 can be appropriately positioned depending on the direction in which the spinal implant 3300 moves. For example, the spinal implant 3300 can be arranged in a first configuration such that the support member 3302 can easily move laterally in a distal direction, such as during insertion. Conversely, spinal implant 3300 can be arranged in a third configuration to facilitate lateral movement of support member 3302 in a proximal direction, such as upon removal.

  The support member 3302 includes an inner region 3320 and a sidewall 3308 that defines a plurality of openings 3314 that connect the inner region 3320 to a region outside the support member 3302. When the spinal implant 3300 is in the second configuration, a portion of the proximal retention member 3300 extends through the opening 3314 to a region outside the support member 3302.

  The retaining member 3310 includes a first elongated member 3330, a second elongated member 3332, and a hinge 3360 having a longitudinal axis L2 (not shown). Each of first elongate member 3330 and elongate member 3332 is pivotally attached to hinge 3360 and distal end portion 3344 extending through opening 3314 when spinal implant 3300 is in the second configuration. A proximal end portion 3346. In use, hinge 3360 moves in a direction perpendicular to longitudinal axis L2, as indicated by the arrows in FIGS. 75B and 75C. The hinge movement is guided by a slot 3362 defined by the side wall 3308 of the support member 3302. The movement of the hinge 3360 causes each of the first elongate member 3330 and the second elongate member 3332 to rotate about the longitudinal axis L2 of the hinge 3360, thereby causing the distal end portion 3344 of each elongate member. Substantially within the inner region 3320 of the support member 3302.

  In some embodiments, slot 3362 includes a detent or any other suitable mechanism (not shown) suitable to hold hinge 3360 in the desired position. In other embodiments, the hinge 3360 includes a biasing member (not shown) configured to bias the hinge 3360 to either the first configuration, the second configuration, or the third configuration. In yet another embodiment, the elongate member comprises a mechanism suitable for holding the retaining member in a desired configuration. Such mechanisms include, for example, mating tabs and slots configured to lockably engage when the elongated member is in a desired configuration.

  In some embodiments, the first elongate member 3330 and the second elongate member 3332 are integrally formed from a substantially rigid material. In other embodiments, the first elongate member 3330 and the second elongate member 3332 comprise separate components having different material properties. For example, the distal end portion 3344 can be molded from a relatively flexible material and the proximal end portion 3346 can be molded from a substantially rigid material. In this manner, movement of the spinal implant 3300 is not limited when a portion of the distal end portion 3344 protrudes from the opening 3314 in the first or third configuration.

  76A and 76B are front cross-sectional views of a spinal implant 3400 according to one embodiment of the present invention. The illustrated spinal implant 3400 includes a support member 3402, a retaining member 3410, and a rotating member 3450. As shown in FIGS. 76A and 76B, the holding member 3410 has a first configuration that is substantially disposed within the support member 3402 and a second configuration in which a portion of the holding member 3410 is disposed outside the support member 3402. It can be arranged repeatedly. Although only one holding member 3410 is shown and described, some embodiments include one or more additional holding members that have similar characteristics and functions as the holding member 3410.

  Support member 3402 includes an inner region 3420 and a sidewall 3408 that defines a plurality of openings 3414 connecting the inner region 3420 to an outer region of support member 3402. When the spinal implant 3400 is in the second configuration, a portion of the proximal retention member 3410 extends through the opening 3414 to a region outside the support member 3402.

  The retention member 3410 includes a first elongate member 3430 and a second elongate member 3432, each of which has a distal end portion 3444 extending through the opening 3414 when the spinal implant 3400 is in the second configuration. And a proximal end portion 3446 and a longitudinal axis L1. As shown, the proximal end portion 3346 is joined by two elastic members 3468, such as springs or elastic bands. In some embodiments, the proximal end portion 3346 is joined by a single elastic member. In other embodiments, proximal end portion 3346 is indirectly coupled via rotating member 3450. In such a configuration, for example, the biasing member can be disposed between the sidewall of the support member and each elongated member, thereby biasing each elongated member against the rotating member.

  In the illustrated embodiment, each of the elongate members engages the side wall 3408 of the support member 3402 when in the second configuration, thereby allowing the elongate members 3430, 3432 to freely move completely outside the support member 3402. One or more tabs 3440 are provided to prevent extension. In other embodiments, the elongate member does not include a tab, but is held entirely within the support member 3402 by a resilient member 3468. In still other embodiments, the width of a portion of the elongated member can be greater than the width of the opening 3414, thereby retaining the elongated member within the support member 3402.

  Rotating member 3450 defines an outer surface 3452 having an eccentric shape and includes a longitudinal axis (not shown) about which rotating member 3450 rotates. As shown in FIGS. 76A and 76B, as the rotating member 3450 rotates about the longitudinal axis, a portion of the proximal end portion 3446 of the first elongate member 3430 and the second elongate member 3432 becomes Engage with outer surface 3452. As a result, the first elongate member 3430 and the second elongate member 3432 move along their respective longitudinal axes L1, and the end portions 3444 of each elongate member are indicated by arrows in FIG. 76A. , Extending outwardly through opening 3414. In this way, the holding member 3410 can repeatedly transition between the first configuration and the second configuration.

  In some embodiments, rotating member 3450 is rotated using an insertion tool (not shown) that includes a ratchet mechanism. The insertion tool can rotate the rotating member 3450 in many different ways, such as manually, pneumatically or electronically.

  77 and 78 illustrate a spinal implant 3500 according to one embodiment of the present invention. FIG. 77 is a front cross-sectional view of the spinal implant 3500 in the second configuration. FIG. 78 is a cross-sectional plan view of spinal implant 3500 taken along AA. The spinal implant 3500 includes a support member 3502 and a retention member 3510. Although only the second configuration, that is, the expanded configuration is shown, from the above description, the holding member 3510 is substantially the same as the first configuration in which the holding member 3510 is disposed within the support member 3502, and the holding member 3510 is partially outside the support member 3502. It should be considered that it can be repeatedly arranged with the second configuration arranged in the above.

  As illustrated, the holding member 3510 includes a first elongated member 3530 and a second elongated member 3532. The first elongate member 3530 is slidably disposed within the pocket 3534 defined by the second elongate member 3532. First elongated member 3530 and second elongated member 3532 each include one or more tabs 3540 that are coupled to sidewall 3508 of support member 3502 by one or more biasing members 3536. In this manner, the holding member 3510 is biased to the first configuration, that is, the contracted configuration. In other embodiments, the biasing member 3536 can be configured to bias the retaining member 3510 to the second configuration. In still other embodiments, the retaining member 3510 is not retained by the biasing member 3536, but other suitable mechanisms are used to maintain the desired configuration.

  In use, the retaining member 3510 is transitioned from the first configuration to the second configuration by supplying pressurized fluid (not shown) to the pocket 3534 via the valve 3570. The pressure exerted by the fluid on each of the first elongated member 3530 and the second elongated member 3532 overcomes the force exerted by the biasing member 3536 so that a portion of the first elongated member 3530 becomes a second elongated member. 3132 extends outwardly from the pocket 3534 so that a portion of each elongate member can extend through the adjacent opening 3514 to the outer region of the support member 3502. Similarly, the holding member 3510 transitions from the second configuration to the first configuration by opening the valve 3570 and relieving the pressure in the pocket 3534. In this way, the spinal implant 3500 can be repeatedly moved from the first configuration to the second configuration, thereby allowing percutaneous repositioning and / or removal.

  79A and 79B show respective views of a spinal implant 3600 according to one embodiment of the present invention. The spinal implant 3600 includes a support member 3602, a proximal retention member 3610, a distal retention member 3612, and an elastic member 3668. Support member 3602 defines a longitudinal axis L 1, has a side wall 3608 that defines an inner region 3620, and has an outer surface 3616. As shown in FIG. 79B, the outer surface 3616 defines a region A perpendicular to the longitudinal axis L1. As shown, the proximal retaining member 3610 and the distal retaining member 3612 are each in a first configuration (FIG. 79B) disposed substantially within region A, and a portion of each retaining member 3610, 3612 is a region. A second arrangement (FIG. 79A) arranged outside A can be repeatedly rearranged.

  As shown, the retention member 3610 and the distal retention member 3612 are joined by a resilient member 3668, a portion of which is disposed within the inner region 3620 of the support member 3602. In the illustrated embodiment, the elastic member 3668 has a side wall 3684 that defines a lumen 3676. In other embodiments, the elastic member may be, for example, a spring, an elastic band, or any other suitable device for elastically coupling the proximal holding member 3610 and the distal holding member 3612.

  Proximal retention member 3610 includes a first elongate member 3630 and a second elongate member 3632, each of which is pivotally attached to connecting member 3678 by a hinge 3660. Similarly, the distal retention member 3612 comprises a first elongate member 3631 and a second elongate member 3633, each of which is pivotally attached to the connection member 3678 by a hinge 3660.

  In FIG. 79A, when the spinal implant 3600 is in the second configuration, the resilient member 3668 applies a biasing force to each connecting member 3678 so that the connecting member 3678 remains adjacent to the support member 3602. In this configuration, the first elongate member 3630 and the second elongate member 3632 extend completely. The spinal implant 3600 is transitioned from the second configuration to the first configuration by extending a resilient member 3668 that allows the connecting member 3678 to be positioned away from the support member 3602, whereby the elongated member is Move into region A as shown in 79B. Support member 3602 includes a slot 3672 that allows the end portion of each elongate member to be positioned to maintain spinal implant 3600 in the first configuration.

  The elastic member 3668 can be configured to be stretched by an insertion tool (not shown), a portion of which is disposed within the lumen 3676 of the elastic member 3668. For example, the first portion of the insertion tool can engage the connection member 3678 of the proximal retention member 3610, while the second portion of the insertion tool engages the connection member 3678 of the distal retention member 3612. can do. Thus, the tool is configured to apply an external force to each of the connecting members 3678, thereby extending the elastic member 3668 and allowing the spinal implant to transition from the second configuration to the first configuration.

  While the spinal implant is shown and described above to have one or more retaining members that extend substantially symmetrically from the support member when in the second configuration, in some embodiments, the spinal implant Comprises a holding member extending asymmetrically from the support member in the second configuration. For example, FIGS. 80-82 illustrate a spinal implant 3700 according to one embodiment of the present invention comprising a proximal retention member 3710 and a distal retention member 3712 extending asymmetrically from a support member 3702. As shown in FIGS. 80 and 81, the proximal retention member 3710 and the distal retention member 3712 are each in a first configuration substantially disposed within the support member 3702, and a portion of each is a portion of the support member 3702. It is possible to repeatedly arrange the second configuration arranged outside.

  Support member 3702 includes an inner region 3720 and sidewalls 3708 that define two openings 3714 that connect the inner region 3720 to an outer region of the support member. When the spinal implant 3700 is in the second configuration, a portion of the proximal retaining member 3710 and a portion of the distal retaining member 3712 extend through the opening 3714 to a region outside the support member 3702.

  In the illustrated embodiment, the proximal retaining member 3710 and the distal retaining member 3712 each comprise a first end portion 3746 and a second end portion 3744. Proximal retention member 3710 and first end portion 3746 of distal retention member 3712 are joined by a connecting member 3782 having a longitudinal axis L1 (shown in FIG. 77). In some embodiments, connecting member 3782, proximal retaining member 3710, and distal retaining member 3712 are separate components that are coupled together to form the illustrated structure. In other embodiments, the connecting member 3782, the proximal retaining member 3710, and the distal retaining member 3712 are integrally formed.

  The connecting member 3782 defines a longitudinal axis L1 about which the connecting member 3882 rotates. As shown, when the connecting member 3782 rotates, the proximal retaining member 3710 and the distal retaining member 3712 also rotate so that the proximal retaining member 3710 and the end portion 3744 of the distal retaining member 3712 open. Extends outward through portion 3714. In this way, the holding member 3210 can repeatedly transition between the first configuration and the second configuration.

  In some embodiments, the connecting member 3782 is rotated using an insertion tool (not shown) that includes a ratchet mechanism. The insertion tool can rotate the connecting member 3782 in many different ways, for example manually, pneumatically or electronically.

  In one embodiment, the apparatus comprises a first body coupled to the second body. The first body and the second body are collectively configured to be releasably coupled to an implant device configured to be disposed between adjacent spinous processes. The first engagement portion is coupled to the first body and the second engagement portion is coupled to the second body. The first engagement portion and / or the first engagement portion is configured to be received within a first opening defined by the implant device. The first body is configured to move relative to the second body so that the distance between the first engagement portion and the second engagement portion moves between the first distance and the second distance. At the same time, the length of the implant device moves between a first length and a second length.

  In another embodiment, the kit comprises an implant that is reconfigurable between an expanded configuration and a collapsed configuration when placed between adjacent spinous processes. The implant has a longitudinal axis and defines an opening. The deployment tool is configured to be releasably coupled to the implant. The deployment tool includes an engagement portion that is removably received within the opening of the implant and is configured to extend transversely to the longitudinal axis when the deployment tool is coupled to the implant. The deployment tool is configured to move the implant between a collapsed configuration and an expanded configuration when the implant is positioned between adjacent spinous processes.

  83 and 84 are schematic views of a medical device according to one embodiment of the present invention located between two adjacent spinous processes. FIG. 83 shows a medical device having a first configuration, and FIG. 84 shows a medical device having a second configuration. The medical device 6000 includes an implant 6010 and a deployment tool 6020. Implant 6010 includes a distal portion 6012, a proximal portion 6014, and a central portion 6016. The implant 6010 is configured to be inserted between adjacent spinous processes S. The central portion 6016 contacts the spinous processes S when adjacent spinous processes S move in the direction of each other in their range of movement, providing a minimum spacing between the spinous processes S, and overstretching / compressing the spinous processes S. Configured to prevent. In some embodiments, the central portion 6016 does not distract the substantially adjacent spinous process S. In other embodiments, the central portion 6016 does not distract adjacent spinous processes S. Implant 6010 and deployment tool 6020 are each inserted into the patient's back and moved from the side of the spinous process between adjacent spinous processes (ie, posterior-side approach). The use of a curvilinear insertion shaft helps with the use of side access to the spinous process.

  The implant 6010 has a collapsed configuration in which the proximal portion 6014, the distal portion 6012, and the central portion 6016 share a common longitudinal axis. In some embodiments, proximal portion 6014, distal portion 6012, and central portion 6016 define a tube having a constant inner diameter. In other embodiments, the proximal portion 6014, the distal portion 6012, and the central portion 6016 define a tube having a constant outer diameter and / or inner diameter. In still other embodiments, the proximal portion 6014, the distal portion 6012, and / or the central portion 6016 have different inner and / or outer diameters.

  The implant 6010 is movable from a collapsed configuration to an expanded configuration, as shown in FIG. In the expanded configuration, the proximal portion 6014 and the distal portion 6012 each have a larger outer perimeter (eg, outer diameter) than in the collapsed configuration, and the proximal portion 6014 and the distal portion 6012 each have a central portion. Has an outer perimeter (eg, outer diameter) greater than 6016. In the expanded configuration, the proximal portion 6014 and the distal portion 6012 are arranged to limit the lateral movement of the implant 6010 relative to the spinous process S. Proximal portion 6014 and distal portion 6012 are configured to engage the spinous process (ie, directly or through surrounding tissue and depending on the relative position of adjacent spinous processes S) in the expanded configuration. . For the sake of clarity, the tissue around the spinous process S is not shown.

  In some embodiments, the proximal portion 6014, the distal portion 6012, and the central portion 6016 are integrally formed. In other embodiments, one or more of the proximal portion 6014, the distal portion 6012, and / or the central portion 6016 are separate components that are coupled together to form the implant 6010. For example, the proximal portion 6014 and the distal portion 6012 can be integrally formed and the central portion 6016 can be a separate component coupled thereto. These various parts are joined together by, for example, friction fitting, welding, adhesives and the like.

  Implant 6010 is configured to be coupled to deployment tool 6020. The deployment tool 6020 includes an elongated member 6022 and two or more engagement portions 6024. For the embodiment shown in FIGS. 83 and 84, two engagement portions 6024-1 and 6024-2 are shown, but it should be considered that more than two engagement portions 6024 can be provided. is there. The elongated member 6022 can include a first body portion 6026 that is coupled to a second body portion 6028. In some embodiments, the first body portion 6026 is threadedly coupled to the second body portion 6028. First body portion 6026 and second body portion 6028 are configured to move relative to each other. For example, a screw connection between the first body portion 6026 and the second body portion 6028 can be used to increase or decrease the distance between the first body portion 6026 and the second body portion 6028. The first body portion 6026 and the second body portion 6028 may have a variety of different sizes and shapes, the same shape and / or size, or different shapes and / or sizes. For example, in some embodiments, the first body portion comprises a straight distal end and a straight proximal end, and the second body portion comprises a straight proximal end and a curved or circular distal end. The curved distal end serves to insert the deployment tool into the lumen of the implant and also serves to insert the medical device into a portion of the patient's body.

  The first engagement portion 6024-1 can be coupled to the first body portion 6026 and the second engagement portion 6024-2 can be coupled to the second body portion 6028. Engagement portion 6024 can be, for example, substantially rectangular, square, circular, elliptical, semicircular, or semilunar. The engagement portion 6024 may be a spring loaded device that is coupled to the elongated member 6022 of the deployment tool 6020 so that the engagement portion 6024 is in a position transverse to the longitudinal axis A defined by the elongated member 6022. Energized and extends from the outer surface of the elongated member 6022. When a force is applied on the engagement portion 6024, the engagement portion 6024 can be moved or crushed to a position substantially below the outer surface of the elongated member 6022. The engagement portion 6024 may alternatively move the engagement portion 6024 from a position transverse to the longitudinal axis A and extending from the outer surface of the elongated member 6022 to a position substantially below the outer surface of the elongated member 6022. It can couple | bond with the actuator (not shown) comprised.

  94-96 illustrate the movement of the engagement portion 6024 as it passes through the spinous process S when the implant and deployment tool (also collectively referred to as a medical device) are coupled together and inserted between adjacent spinous processes. In some cases, when the medical device is inserted, an engagement portion 6024 extending from the proximal portion of the implant contacts the spinous process (or other tissue). To allow the engagement portion 6024 to pass through the spinous process, the engagement portion 6024 can pass through the spinous process when moved downward (as described above). FIG. 94 shows an engagement portion 6024 having a spring biased structure. The engagement portion 6024 comprises a curved portion 6048 that first contacts the spinous process S when the medical device is inserted adjacent to the spinous process S. When the curved portion 6048 contacts the spinous process S, the engagement portion 6024 moves downward and enters at least partially within the implant 6010 as shown in FIG. The engagement portion 6024 moves back to the extended position (eg, the surface of the implant 6010) after the engagement portion has passed the spinous process S by the bias of a spring (not shown), as shown in FIG. Extending in the transverse direction).

  Deployment tool 6020 can be used to move implant 6010 from a collapsed configuration to an expanded configuration, or vice versa, as described in detail below. First body portion 6026 and second body portion 6028 are collectively configured to at least partially insert into the lumen of implant 6010 (not shown in FIGS. 83 and 84), so that at least one of The engagement portion 6024 extends through an opening defined by the implant 6010 (not shown in FIGS. 83 and 84). The implant 6010 is configured with one or more such openings, each opening configured to receive an engagement portion 6024 disposed on the elongated member 6022 (eg, a first body). Portion 6026 or second body portion 6028). The opening defined by the implant 6010 can be, for example, circular, elliptical, square, rectangular, or the like. FIG. 85 is one example of an implant 6110 that defines a curved rectangular opening 6136, and FIG. 98 illustrates an implant 6310 that defines a curved circular opening 6336.

  The opening is at least partially defined on the implant 6010 by an edge (not shown in FIGS. 83 and 84). The engagement portion 6024 on the deployment tool 6020 includes a surface configured to engage or contact the edge of the opening of the implant 6010 when the elongated member 6022 is inserted into the lumen of the implant 6010 ( (Not shown in FIGS. 83 and 84).

  In use, the spinous process S can be distracted prior to insertion into the implant 6010. As the spinous process is distracted, a trocar can be used to define an access passage for the implant 6010. In some embodiments, the trocar can be used to define a passageway and distract the spinous process S. Once the access passage is defined, the distal end 6012 of the implant 6010 can first be inserted percutaneously and advanced between the spinous processes, with the central portion 6016 positioned between the spinous processes S. In some embodiments, the implant 6010 can be coupled to the deployment tool 6020 before being inserted between adjacent spinous processes. In other embodiments, the implant 6010 can be inserted between adjacent spinous processes without being coupled to the deployment tool 6020. In the latter configuration, the deployment tool 6020 can be inserted into the lumen defined by the implant 6010 after the implant 6010 is positioned between adjacent spinous processes.

  Once the implant 6010 is placed in place between the spinous processes and the deployment tool 6020 is placed in place within the lumen of the implant 6010, the implant 6010 is moved to the second configuration (by actuating the deployment tool 6020). That is, it can be moved to an expanded configuration. For example, when the deployment tool 6020 is inserted into the lumen of the implant 6010, the first body portion 6026 is positioned at a first distance from the second body portion 6028 and the first engagement portion 6024-1 is shown in FIG. As shown at 83, the first engagement portion 6024-2 is disposed at a first distance. Thus, the deployment tool 6020 can be actuated at the proximal end portion (eg, by rotating the handle) (not shown in FIGS. 83 and 84), so that the first body portion 6026 and the second Due to the screw connection with the body portion 6028, the first body portion 6026 and the second body portion 6028 move in the direction of each other, and the first body portion 6026 is moved from the second body portion 6028 as shown in FIG. It becomes the second distance (closes). This movement similarly moves the first engagement portion 6024-1 and the second engagement portion 6024-2 closer to each other. For example, in FIG. 83, the first engagement portion 6024-1 is changed from the second engagement portion 6024-2 to the first engagement portion 6024-1 and the second engagement portion 6024-2 shown in FIG. 84. It is arranged at a position larger than the distance between.

  As the first engagement portion 6024-1 and the second engagement portion 6024-2 move relative to each other, the surface on the engagement portion 6024 (described in detail below) is an opening defined by the implant. A force is applied to the edge of the part (as described above in detail below) to move the implant from the collapsed configuration to the expanded configuration.

  Deployment tool 6020 is configured such that deployment tool 6020 can be removed from implant 6010 after the implant has been moved to the expanded configuration. The implant can remain unrestricted between the spinous processes or can be removed as needed. For example, the deployment tool 6020 can be reinserted into the lumen of the implant 6010 and actuated in the opposite direction to move the implant 6010 back from the expanded configuration to the collapsed configuration. In the collapsed configuration, the implant can be removed from the patient's body or repositioned to a new location between the spinous processes.

  In some embodiments, the implant 6010 is inserted percutaneously (ie, through the skin opening) and in a minimally invasive manner. For example, as described below, the size of the portion of the implant is expanded after inserting the implant between the spinous processes. After expansion, the size of the expanded portion of the implant is larger than the size of the opening. For example, the size of the skin opening / incision is 3-25 mm in length across the opening. In some embodiments, the size of the implant in the expanded configuration is 3 mm to 25 mm across the opening.

  85-87 show an implant according to one embodiment of the present invention. Implant 6110 includes a proximal portion 6114, a distal portion 6112, and a central portion 6116. The implant 6110 also defines a plurality of openings 6132 on the outer surface of the implant 6110. Opening 6132 is in fluid communication with lumen 6158 (shown in FIG. 92) defined by implant 6110. Opening 6132 is partially defined by first edge 6136 and second edge 6138. Implant 6110 includes an expandable portion disposed on distal portion 6112 and proximal portion 6114. The expandable portion 6140 can be coupled to the implant 6110 or can be integrally formed with the implant 6110 as shown in FIG. As shown in FIG. 97, the elongated slot 6134 can be defined on the outer surface of the implant 6110. The elongated slot 6134 forms a fragile region on the implant 6110 and forms an extended portion 6142 as shown in FIG. 86 so that the expandable portion 6140 can be crushed when an axial force is applied. To do.

  The implant 6110 is inserted between adjacent spinous processes (not shown) in a collapsed configuration as shown in FIG. 85 and then moved to the expanded configuration as shown in FIG. The implant 6110 can then return to the collapsed configuration as shown in FIG. 87, which shows the expandable portion 6140 in a partially collapsed configuration. Although FIG. 87 shows a partially collapsed configuration, in some embodiments, the implant can return to the collapsed configuration as shown in FIG.

  To move the implant 6110 from the collapsed configuration to the expanded configuration or vice versa, a deployment tool may be used, as described above, as shown in FIGS. Deployment tool 6120 includes an elongated member 6122 coupled to a handle 6144. The elongate member 6122 includes a first body portion 6126 that is coupled to a second body portion 6128 through a screw coupling 6150. A pair of engaging portions 61124-1 is disposed on the first body portion 6126, and a pair of engaging portions 612-2 is disposed on the second body portion 6128. Engaging portions 614-1 and 614-2 (collectively referred to as engaging portions 6124) include a surface 6146 and a circular portion 6148. The screw coupling portion 6150 between the first body portion 6126 and the second body portion 6128 moves the first body portion 6126 and the second body portion 6128, so that the first body portion 6126 and the second body portion 6128 are connected. Used to change the distance between. For example, FIG. 89 shows a first distance d−1 between the first body portion 6126 and the second body portion 6128, and FIG. 90 shows the first distance between the first body portion 6126 and the second body portion 6128. Two distances d-2 are shown. As shown in FIGS. 89 and 90, when the distance between the first body portion 6126 and the second body portion 6128 changes, the distance between the engaging portions 614-2 and 614-2 also changes.

  In use, the first body portion 6126 and the second body portion 6128 are collectively disposed within the lumen 6158 of the implant 6110, and the engagement portion 6124 has an opening 6132 as shown in FIGS. Through the axis B defined by the implant 6110. In this position, the surface 6146 of the engagement portion 6124 is configured to contact the edge 6136 of the opening 6132. 91 and 92 show a first body portion 6126 and a second body portion 6128 disposed within the lumen of the implant 6110 when the implant is in a collapsed configuration. In this position, the first body portion 6126 is at a first distance from the second body portion 6128, the engagement portion 6124-1 is at a first distance from the engagement portion 6124-2, and the implant is first It has a length L1.

  Once the implant is placed between the spinous processes S, the deployment tool 6120 can be actuated to move the implant 6110 to the expanded configuration, as shown in FIG. When the deployment tool 6120 is actuated, the first body portion 6126 moves toward the second body portion 6128 and the engagement portion 6124-1 moves toward the engagement portion 6124-2. When this condition occurs, the surface 6146 on the engaging portion 6124 exerts a force on the edge 6136 of the opening 6132 to compress the implant 6110 axially, and the implant 6110 has a second length as shown in FIG. L-2.

  To move the implant 6110 back to the collapsed configuration, the deployment tool 6120 is positioned with the surface 6146 of the engagement portion 6124 facing the opposite direction and contacts the edge 6138 of the implant 6110 as shown in FIG. It can be reconfigured so that it can be configured. In some embodiments, the engagement portion 6124 can be removed, for example, and recombined with the elongated member 6122 (eg, the first body portion 6126 and the second body portion 6128) and simply recombined with the same engagement portion 6124. Can do. In other embodiments, a second deployment tool can be used in which the engagement portions are arranged in opposite directions. In either case, the deployment tool is inserted into the lumen 6158 of the implant 6110 as described above, the engaging portion 6124 extends through the opening 6132 of the implant 6110, and the surface 6146 is the edge of the implant 6110. 6136 is contacted. Thus, the deployment tool 6120 operates in the opposite direction (eg, rotates in the opposite direction), and the first body portion 6126 and the second body portion 6128 move threadably away from each other. In doing so, the engagement portion 6124-1 moves further away from the engagement portion 6124-2, the surface 6146 of the engagement portion 6124 applies a force to the edge 6138 of the opening 6132 (not the edge 6136), As a result, the implant 6110 is moved back to the collapsed or straight configuration. Thus, the implants described in all embodiments of the present invention can be repeatedly moved between the collapsed configuration and the expanded configuration as needed to place or remove the implant as desired. .

  FIG. 99 illustrates a deployment tool according to another embodiment of the present invention. The deployment tool 6220 includes an elongated member 6222 having a first body portion 6226 that is coupled to the second body portion 6228 through a screw coupling 6250. In this embodiment, the deployment tool 6220 comprises two sets of four engagement portions 6224 (eight in total) (only six engagement portions are shown in FIG. 99). The first set of engagement portions 6224-1 is coupled to the first body portion 6226, and the second set of engagement portions 6224-2 is coupled to the second body portion 6228. The engagement portion 6224 includes a first surface 6246 and a second surface 6252. When the deployment tool 6220 is coupled to the implant, the first surface 6246 is configured to contact the edge of the opening defined on the implant (such as the edge 6136 of the implant 6110) and the second surface 6252 is Configured to contact the opposing edge on the opening defined by (such as edge 6138 on implant 6110).

  Thus, in this embodiment, the deployment tool 6220 can be used to insert into the implant and move the implant between the collapsed configuration and the expanded configuration to reposition the engagement portion 6224. Or the use of a second deployment tool. To move the implant from the collapsed configuration to the expanded configuration, the deployment tool 6220 is actuated in the first direction. To move the implant back to the collapsed configuration, the deployment tool 6220 is actuated in the opposite direction (eg, rotated in the opposite direction). When the deployment tool 6220 is activated and the implant moves from the collapsed configuration to the expanded configuration, the surface 6246 of the engagement portion 6224 applies a force to the edge of the opening (eg, the edge 6136 of the implant 6110), resulting in the implant. Is compressed in the axial direction as described above. When the deployment tool 6220 is activated and the implant moves from the expanded configuration to the collapsed configuration, the surface 6252 of the engagement portion 6224 applies a force to the opposing edge of the opening (eg, the edge 6138 on the implant 6110), resulting in a result. The implant is substantially straight as described above.

  FIG. 100 illustrates a deployment tool according to another embodiment of the present invention. The deployment tool 6420 is similar to the deployment tool 6220 described above, except that in this embodiment there are only two sets of two engagement portions 6424 (four total). Engagement portion 6424 is similar to engagement portion 6224 except that engagement portion 6424 is substantially rectangular. The engagement portion 6424 comprises a surface 6446 configured to contact the edge of the opening defined by the implant and a surface 6452 configured to contact the opposing edge of the opening defined by the implant. .

  FIG. 101 illustrates a deployment tool according to yet another embodiment of the present invention. The deployment tool 6520 is configured and functions in the same manner as in the above embodiment. Deployment tool 6520 includes an elongated member 6522 having a first body portion 6526 and a second body portion 6528. In this embodiment, the first body portion 6526 and the second body portion 6528 are smaller than those shown in the above embodiment, and the engagement portion 6524 is elongate in the first and second body portions 6526 and 6528 than described above. Combined with

  A kit according to one embodiment of the invention may comprise at least one implant and at least one deployment tool as described above. For example, the kit can comprise one implant and two deployment tools, one deployment tool configured to move the implant from the collapsed configuration to the expanded configuration, and the other deployment tool expanded the implant. Configured for use to move from a configuration to a collapsed configuration. Alternatively, the kit can comprise a single deployment tool having a plurality of engagement portions that can be releasably coupled to the elongate member of the deployment tool as described herein. For example, one type or style of engagement portion is used to move the implant from the collapsed configuration to the expanded configuration, and another type or style of engagement portion moves the implant from the expanded configuration to the collapsed configuration. Can be used for. The kit can include an engagement portion having any of a variety of shapes and sizes, and a user can select a particular one or more engagement portions depending on the particular application.

  118-120 illustrate an implant according to another embodiment of the present invention. Implant 6610 includes an outer shell 6670 having a distal portion 6612, a proximal portion 6614, and a central portion 6616. The implant 6610 is movable between the collapsed configuration shown in FIGS. 118 and 119 and the expanded configuration shown in FIG. Proximal portion 6614 and distal portion 6612 include an expandable portion that forms an extended portion 6642 that extends radially from outer shell 6670 when implant 6610 is in an expanded configuration.

  The implant 6610 also includes an inner core 6672 disposed within a lumen 6658 defined by the outer shell 6670. Inner core 6672 can be configured to provide increased compressive strength relative to central portion 6616 of outer shell 6670. In some embodiments, the inner core 6672 defines a lumen, and in other embodiments, the inner core 6672 can have a substantially solid configuration. The inner core 6672 can be coupled to the central portion 6616 of the outer shell 6670 by, for example, a friction fit. Inner core 6672 is disposed within lumen 6658 substantially along the entire length of outer shell 6670 or along only a portion of the length of outer shell 6670. Inner core 6672 is further coupled to distal portion 6612 of outer shell 6670 by engagement portion 6664.

  Engagement portion 6684 can be, for example, a screw joint that can be used to move implant 6610 between a collapsed configuration and an expanded configuration. For example, if the implant 6610 is positioned between adjacent spinous processes, the device may be used to rotate the engagement portion 6674 in the first direction to pivot proximally of the distal portion 6612 of the outer shell 6610. A directional force is applied and the distal portion 6612 is pulled toward the proximal portion 6614. In so doing, the outer shell 6670 is crushed or bent as in the above embodiment, and the implant 6610 moves to the expanded configuration. To move the implant 6610 from the expanded configuration to the collapsed configuration, the engagement portion 6664 is rotated in the opposite direction to apply an axial force in the distal direction of the distal portion 6612 of the outer shell 6610, and the distal portion 6612. Is moved distally to move the implant 6610 to the collapsed configuration.

  FIG. 103 is a flowchart illustrating a method according to an embodiment of the present invention. The method at 6060 places the expandable member percutaneously in an initial position between adjacent spinous processes in the patient's body when the expandable member is in a collapsed configuration. The expandable member is coupled to a deployment tool that includes an engagement portion configured to be received through an opening defined by the expandable member. In other embodiments, the deployment tool can be coupled to the implant after the implant is positioned between the spinous processes. After the implant is positioned between adjacent spinous processes, at 6062, the expandable member can be moved from the collapsed configuration to the expanded configuration. The deployment tool can then be actuated when the expandable member is positioned between adjacent spinous processes so that the engagement portion of the deployment tool applies a force to the first position of the expandable member. The expandable member moves from the collapsed configuration to the expanded configuration. After the deployment tool is activated and the expandable member is moved from the collapsed configuration to the expanded configuration, the deployment tool can optionally be removed from the expandable member at 6064. In embodiments where the deployment tool has been removed, the deployment tool can then be reinserted into the expandable member.

  At 6066, after the deployment tool is activated to move the implant from the collapsed configuration to the expanded configuration, the deployment tool is activated again and the engaging portion is different from the first position on the expandable member. A force is applied to the upper second position and the implant moves from the expanded configuration to the collapsed configuration.

  After the deployment tool is activated and the expandable member is moved from the expanded configuration to the collapsed configuration, the expandable member is optionally placed at a second position between adjacent spinous processes at 6068 that is different from the first position. can do. In some embodiments, after the deployment tool is actuated to move the expandable member from the expanded configuration to the collapsed configuration, the expandable member may optionally be placed in a second position outside the patient's body at 6070. it can.

  The various implants and deployment tools described herein include various biocompatible materials such as titanium, titanium alloys, surgical steel, biocompatible alloys, stainless steel, plastics, polyetheretherketone (PEEK), carbon. It can be composed of fiber, ultra high molecular weight (UHMW) polyethylene, biocompatible polymer material, and the like. The material of the central portion of the implant can have a compressive strength, for example, similar to or greater than that of bone. In one embodiment, the central portion of the implant disposed between two adjacent spinous processes is constructed using a material having a modulus of elasticity greater than that of the bone forming the spinous processes. In another embodiment, the central portion of the implant is constructed using a material having a higher modulus of elasticity than the material used to construct the distal and proximal portions of the implant. For example, the central portion of the implant has a higher modulus of elasticity than bone and the proximal and distal portions have a lower modulus of elasticity than bone. In yet another embodiment, the implant is constructed using an outer shell and an inner core. The outer shell can be constructed using a material having a higher modulus of elasticity than the inner core (eg, the outer shell is made of a titanium alloy and the inner core is made of a polymer material). Alternatively, the outer shell can be constructed using a material that has a lower modulus of elasticity than the inner core (eg, the outer shell is made of a polymer material and the inner core is made of a titanium alloy material).

  The apparatus comprises an elongate member having a proximal portion configured to repeatedly move between a first configuration and a second configuration, for example upon application of an axial load or a radial load. The elongate member has a distal portion configured to move from the first configuration to the second configuration, for example upon application of an axial load or a radial load. The non-expanding central portion is disposed between the proximal portion and the distal portion. This non-expanding central portion is configured to engage adjacent spinous processes after spinal extension.

  In some embodiments, the elongate member can have multiple portions that each move simultaneously or sequentially from the first configuration to the second configuration. Furthermore, the device or a part thereof can be configured in a number of intermediate positions when moving between the first configuration and the second configuration. For clarity, the entire device is described as a first configuration or a second configuration, but the device and / or portions thereof are considered to have a range of movement that includes many configurations including the first configuration and the second configuration. Should.

  FIG. 104 is a schematic illustration of a medical device according to one embodiment of the present invention adjacent to two adjacent spinous processes. The medical device 7010 includes a proximal portion 7012, a distal portion 7014, and a central portion 7016. The medical device 7010 has a first configuration that can be inserted between or removed from adjacent spinous processes S. Central portion 7016 is configured to contact spinous process S to prevent overstretching / compression of spinous process S. In some embodiments, the central portion 7016 does not distract the substantially adjacent spinous process S. In other embodiments, the central portion 7016 does not distract adjacent spinous processes S. The medical device 7010 is inserted into the patient's back and moved from the side of the spinous process to the adjacent spinous process (ie, posterior-side approach). The use of a curved insertion shaft is useful for the use of side access to the spinous process S.

  In the first configuration, the proximal portion 7012, the distal portion 7014, and the central portion 7016 share a common longitudinal axis. In other embodiments, these portions do not share a common longitudinal axis. In some embodiments, the proximal portion 7012, the distal portion 7014, and the central portion 7016 define a tube having a constant inner diameter. In other embodiments, the proximal portion 7012, the distal portion 7014, and the central portion 7016 define a tube having a constant outer diameter and / or inner diameter. In still other embodiments, the proximal portion 7012, the distal portion 7014, and / or the central portion 7016 have different inner and / or outer diameters.

  The medical device 7010 can be moved from the first configuration to the second configuration as shown in FIG. In the second configuration, the proximal portion 7012 and the distal portion 7014 are arranged to limit the lateral movement of the device 7010 relative to the spinous process S. Proximal portion 7012 and distal portion 7014 are configured to engage the spinous process in a second configuration (ie, directly or through surrounding tissue). For the sake of clarity, the tissue around the spinous process S is not shown. Note that the medical device and / or portion thereof can engage the spinous process S in all or part of the range of movement of the spinous process S corresponding to patient movement.

  In some embodiments, the proximal portion 7012, the distal portion 7014, and the central portion 7016 are integrally molded. In other embodiments, one or more of the proximal portion 7012, the distal portion 7014, and the central portion 7016 are separate components that are capable of forming a medical device 7010 coupled to one another. For example, the proximal portion 7012 and the distal portion 7014 can be integrally formed and the central portion 7016 can be a separate component coupled thereto. Proximal portion 7012, distal portion 7014, and central portion 7016 can be the same material or different materials. These various parts can be joined by, for example, friction fitting, welding, adhesives, and the like.

  In use, the spinous process S can be distracted prior to insertion into the medical device 7010. Distraction of the spinous process is described herein. As the spinous process is distracted, a trocar can be used to define an access path for the medical device 7010. In some embodiments, the trocar can be used to define a passageway and distract the spinous process S. After the access passage is defined, the medical device 7010 is advanced by first percutaneously inserting the distal end 7014 between the spinous processes and the central portion 7016 is positioned between the spinous processes S. After the medical device 7010 is in place between the spinous processes, the proximal portion 7012 and the distal portion 7014 move sequentially or simultaneously to the second configuration.

  In some embodiments, the medical device 7010 is inserted percutaneously (ie, through the skin opening) and in a minimally invasive manner. For example, as described in detail herein, the size of the portion of the implant is smaller than the size of the opening when inserted. The size of the portion of the implant is expanded after the implant is inserted between the spinous processes. Once expanded, the size of the expanded portion of the implant is greater than the size of the opening. When crushed, the size of each part of the spinal implant again becomes smaller than the size of the opening. For example, the size of the skin opening / incision is 3 mm to 25 mm in length across the opening. In some embodiments, the size of the implant in the expanded configuration is 3 mm to 25 mm across the opening.

  In some embodiments, the proximal portion 7012 and the distal portion 7014 can return to their original or substantially original configuration and have been repositioned or inserted between adjacent spinous processes Removed from the body.

  FIG. 106 is a schematic illustration of a deformable element 7018 that represents the characteristics of the distal portion 7014 of the medical device 7010 in a first configuration, for example. The deformable member 7018 includes notches A, B, C along its length to define a fragile position that allows the deformable member 7018 to deform in a predetermined manner. Depending on the depth d of the notches A, B, and C and the width w of the throats T1, T2, and T3, the method by which the deformable member 7018 deforms under load can be controlled and changed. Furthermore, the method by which the deformable member 7018 is deformed can be controlled and changed according to the length L between the notches A, B, and C (that is, the length of the material between the notches).

  FIG. 107 is a schematic diagram of the expansion characteristics of the deformable member 7018 shown in FIG. For example, when a load is applied in the direction indicated by the arrow X, the deformable member 7018 is deformed by a predetermined method based on the characteristics of the deformable member 7018 as described above. As shown in FIG. 107, the deformable member 7018 deforms most at the notches B and C due to the configuration of the notch C and the short distance between the notches B and C. In some embodiments, the length of deformable member 7018 between notches B and C is sized to fit one side of the adjacent spinous process.

  The deformable member 7018 is relatively stiff at the notch A because the depth of the notch A is shallow. As indicated in FIG. 107, a smooth transition is defined by the deformable member 7018 between the notches A and B. In the case of such a smooth transition, less stress is applied to the tissue surrounding the side of the adjacent spinous process than a relatively large transition between the notches B and C (that is, a relatively steep wall). . The dimensions and configuration of the deformable member 7018 can also determine the timing of deformation at various notches. A relatively fragile (ie, relatively deep and wide) notch deforms ahead of a relatively strong (ie, relatively shallow and narrow) notch.

  108 and 109 show spinal implant 7100 in a first configuration and a second configuration, respectively. As shown in FIG. 108, the spinal implant 7100 is collapsed in a first configuration and can be inserted between adjacent spinous processes. The spinal implant 7100 has a first deformable portion 7110, a second deformable portion 7120, and a central non-deformable portion 7150. The first deformable portion 7110 has a first end 7112 and a second end 7114. Second deformable portion 7120 has a first end 7122 and a second end 7124. Central portion 7150 is coupled between second end 7114 and first end 7122. In some embodiments, spinal implant 7100 is integrally molded.

  First deformable portion 7110, second deformable portion 7120, and central portion 7150 have a common longitudinal axis A along the length of spinal implant 7100. The central portion 7150 can have the same inner diameter as the first deformable portion 7110 and the second deformable portion 7120. In some embodiments, the outer diameter of the central portion 7150 is smaller than the outer diameter of the first deformable portion 7110 and the second deformable portion 7120.

  In use, the spinal implant 7100 is inserted percutaneously between adjacent spinous processes. The first deformable portion 7110 is first inserted and passes through the spinous process, and the central portion 7150 is disposed between the spinous processes. The outer diameter of the central portion 7150 may be slightly smaller than the space between the spinous processes, taking into account the surrounding ligaments and tissue. In some embodiments, the central portion 7150 directly contacts the spinous process and is disposed between the spinous processes. In some embodiments, the central portion of spinal implant 7100 is a fixed size and is not compressible or expandable. The spinal implant 7100 and / or the first deformable portion 7110, the second deformable portion 7120, and the central portion 7150 engage the spinous process in all or part of the range of movement of the spinous process corresponding to patient movement. Note that it is possible.

  The first deformable portion 7110 includes, for example, expansion members 7115 and 7117. An opening (not shown) is defined between the expansion members 7115 and 7117. As above, the size and shape of the opening affects the way in which the expansion members 7115, 7117 are deformed when an axial load is applied. Second deformable portion 7120 includes expansion members 7125 and 7127. An opening (not shown) is defined between the expansion members 7125 and 7127. As described above, the size and shape of the opening affects how the expansion members 7125, 7127 deform when an axial load is applied.

  When an axial load is applied to the spinal implant 7100, the spinal implant 7100 expands in the second configuration, as shown in FIG. In the second configuration, the first end 7112 and the second end 7114 of the first deformable portion 7110 move in the direction of each other, and the expansion members 7115, 7117 are substantially laterally away from the longitudinal axis A. Protrusively. Similarly, the first end 7122 and the second end 7124 of the second deformable portion 7120 move in the direction of each other, and the expansion members 7125, 7127 protrude laterally away from the longitudinal axis A. The second configuration expansion members 7115, 7117, 7125, 7127 form protrusions that extend to positions adjacent to the spinous processes between which the spinal implant 7100 is inserted. In the second configuration, the expansion members 7115, 7117, 7125, 7127 prevent lateral movement of the spinal implant 7100, and the central portion 7150 moves adjacent spinous processes relative to each other when the spine is extended, and the diameter of the central portion 7150 To prevent access closer than the distance defined by.

  The first end 7112 of the first deformable portion 7110 defines a threaded opening 7113. Central portion 7150 defines a second threaded opening 7155. The second end 7124 of the second deformable portion 7120 defines a third threaded opening 7123. The threaded openings 7113, 7155, 7123 house portions of the actuator 7200 (see FIG. 110) and, as will be described in detail herein, the first deformable portion 7100 and the second deformable portion 7120. Move between each of the first and second configurations. In some embodiments, the first threaded opening 7113 has a larger diameter than the second threaded opening 7155 and the third threaded opening 7123 (see FIGS. 108-111). In some embodiments, the second threaded opening 7155 and the third threaded opening 7123 have the same diameter (see FIGS. 108-111). In other embodiments, the first threaded opening 7113 ′ and the second threaded opening 7155 ′ have the same diameter (see FIGS. 112-115), and the third threaded opening 7123 ′ is the first threaded opening 7123 ′. It has a smaller diameter than the threaded opening and the second threaded opening. The threaded openings 7113, 7155, 7123, 7113 ', 7155', 7123 'are arranged coaxially. In other embodiments, the threaded openings may be any combination of different or the same size.

  The spinal implant 7100 is deformed by a compressive force applied substantially along the longitudinal axis A of the spinal implant 7100. As shown in FIG. 110, this compressive force is applied to the first deformable portion 7110 by the actuator 7200. The actuator includes a first portion 7210 and a second portion 7220 that are movably housed within the first portion 7210. In some embodiments, the second portion 7220 is slidably received within the first portion 7210. In other embodiments, the first portion 7210 and the second portion 7220 are screwed together. Each first portion 7210 and second portion 7220 are provided with outer threads 7212 and 7222, respectively, which engage threaded openings 7113, 7155, 7123, 7113 ', 7155', 7123 '.

  110, a compressive force is applied to the first deformable portion 7110, for example, attaching the threaded portion 7212 to the first threaded opening 7113 and attaching the threaded portion 7222 to the second thread of the central portion 7150. Attach to the spigot opening 7155 and apply the second portion 7220 by pulling along the longitudinal axis A while applying an opposing force against the first end 7112 of the first deformable portion 7110. The opposing force creates a compressive force that expands the spinal implant 7100 as described above.

  As the first deformable portion 7110 moves to the second configuration, the threaded portion 7222 is threaded through the second threaded opening 7155 and threadedly coupled to the third threaded opening 7123. The compressive force is applied to the second deformable portion 7120 of the spinal implant 7100, so that the second portion 7220 of the actuator is pulled in the direction indicated by the arrow F, using the first portion 7210 of the actuator. Apply opposing forces to the spinal implant 7100. The opposing force creates a compressive force that causes the spinal implant to expand, as shown in FIG.

  In some embodiments, the first deformable portion 7110 and the second deformable portion 7120 include the actuator second portion 7220 coupled to the third threaded opening 7123 and the first portion 7210 coupled to the first threaded opening 7113. When the compression force is applied, it expands at the same time.

  In embodiments where the first threaded opening 7113 ′ has the same diameter as the second threaded opening 7155 ′ (eg, best shown in FIGS. 112 and 113), the first threaded portion 7212 is The second threaded opening 7155 ′ can be threadedly coupled, and the second threaded portion 7222 can be threadedly coupled to the third threaded opening 7123 ′. Thus, compressive force is applied between the central portion 7150 and the second end 7124 of the second deformable portion 7120. After the second deformable portion 7120 is in the second configuration, the first threaded portion 7212 can be threadably coupled to the first threaded opening 7113 ′, and the first deformable portion 7110 can be the second thereof. It can be transformed into a configuration.

  Each of the first deformable portion 7110 and the second deformable portion 7120, after moving to the second expanded configuration, is then subjected to force in an opposing direction along the longitudinal axis A, for example as shown in FIGS. To return to the first collapsed configuration. In this example, as described above, the spinal implant 7100 shown in FIGS. 112-115 has a first threaded opening 7113 'having the same diameter as the second threaded opening 7155'.

  When the first threaded portion 7212 is coupled to the second threaded opening 7155 ′ and the second threaded opening 7222 is coupled to the third threaded opening 7123 ′, the second portion 7220 of the actuator 7200 is moved to the arrow F To move the second deformable portion 7120 to the first collapsed configuration.

  As a result, the first threaded portion 7212 is coupled to the first threaded opening 7113 ′, the second portion 7220 of the actuator 7200 moves again in the direction of arrow F, and the first deformable portion 7110 is Move to 1 crushing configuration. When the entire spinal implant 7100 is fully crushed, the spinal implant 7100 can be repositioned between the spinous processes or removed from the position between the spinous processes and removed from the previously inserted body. In some embodiments, the first deformable portion 7110 and the second deformable portion 7120 are not fully crushed but move to a configuration between a fully expanded configuration and a fully crushed configuration. In this manner, spinal implant 7100 can be repositioned or removed without being completely crushed.

  In some embodiments, the first deformable portion 7110 and the second deformable portion 7120 can be moved between the first configuration and the second configuration using a balloon as an actuator. As a result, as shown in FIG. 116, the second deformable portion 7120 is moved from the second configuration to the first configuration by applying a longitudinal force resulting from the inflation of the balloon 7300 with liquid and / or gas. . When balloon 7300 is inflated, it is squeezed against center portion 7150 and second end 7124 of second deformable portion 7120. The force applied by balloon 7300 is generally in the direction indicated by arrow F. In some embodiments, the balloon 7300 is a low compliant balloon configured to expand to a pre-defined shape, so that the force is applied primarily in the longitudinal direction substantially as indicated by arrow F. .

  The second deformable portion 7120 moves substantially to its collapsed configuration, and the balloon 7300 contracts and moves to the first deformable portion 7110. Balloon 7300 is then inflated as shown in FIG. 117 and exerts a force in the direction indicated by arrow F. In some embodiments, the same balloon 7300 is used to collapse both the first deformable portion 7110 and the second deformable portion 7120. In other embodiments, different balloons are used for each portion 7110, 7120. As the entire implant 7100 moves to the first configuration, the balloon is deflated and removed. In some embodiments, balloon 7300 remains in spinal implant 7100, and spinal implant 7100 and balloon 7300 are removed simultaneously.

  In some embodiments, the shaft to which the balloon is coupled has an outer thread (not shown) that fits into the first threaded openings 7113, 7113 ′ and / or the second threaded openings 7155, 7155 ′. . In other embodiments, neither the opening nor the shaft to which the balloon is coupled is threaded. In yet another embodiment, balloon 7300 is inserted through first portion 7210 of actuator 7200. On the other hand, the actuator 7200 and balloon 7300 can be used in conjunction with a spinal implant to expand and / or contract the first deformable portion 7110 and the second deformable portion 7120.

  In other embodiments, there are no threaded openings defined in the spinal implant 7100. For example, a spinal implant can have multiple actuator engaging portions that are not threaded but instead are contact or support surfaces for various types of actuators. For example, an actuator (not shown) can be configured to grip the outer surface of the spinal implant and simultaneously apply a force against the distal portion of the spinal implant to move the implant to a collapsed configuration.

  The spinal implant 7100 can be made from, for example, stainless steel, plastic, polyetheretherketone (PEEK), carbon fiber, ultra high molecular weight (UHMW) polyethylene, or some combination thereof. For example, the first deformable portion and the second deformable portion can be made from one material and the non-expandable central portion can be made from a different material. Such non-expanding central portion material can have a tensile strength equal to or greater than that of bone.

  While various embodiments of the present invention have been described above, it should be considered that these embodiments are presented by way of example and not limitation. Although the methods and steps described above illustrate certain events that occur in a certain order, those skilled in the art having the benefit of this disclosure can alter the order of certain steps, and such modifications are not It will be appreciated that this is a variation of the invention. Furthermore, certain steps can be performed simultaneously in parallel processes, if possible, or continuously as described above. Accordingly, the breadth and scope of the present invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the appended claims and their equivalents. Although the invention has been particularly illustrated and described with respect to specific embodiments thereof, it will be appreciated that various changes in shape and detail are possible.

  For example, while the above embodiment has been described primarily as a spinal implant configured to be placed between adjacent spinous processes, in an alternative embodiment, the implant can be a bone, tissue or other Although configured to be positioned adjacent to the body structure, it is desirable to maintain the spacing while preventing axial or longitudinal movement of the implant.

  Although the implants described herein are primarily described as not distracting adjacent spinous processes, in alternative embodiments, the implant is configured to expand to distract adjacent spinous processes. It is possible.

  Although the implant has been described as inserting directly between adjacent spinous processes, in an alternative embodiment, the implant can be delivered through a cannula.

  For example, although the swing arm 1700 has been described as having an arcuate portion, in alternative embodiments of the invention, the entire swing arm 1700 may have an arcuate configuration. Further, the opening defined in the swing arm 1700 may extend the entire length of the swing arm 1700.

  Although the swing arm 1700 is described and illustrated as having a circular opening at the end thereof, in alternative embodiments, the opening may be any shape, including a working tool and The shape of the spacer portion can be a shape that fits into the opening of the swing arm.

  The connection between the oscillating arm and the work tool is shown such that the oscillating arm is a female component and the work tool is a male component; The direction of the relationship may be reversed.

  Although the first arm 1170 and the second arm 1180 of the first clamp 1100 are described as being elastically coupled, in an alternative embodiment of the invention, the first arm 1170 and the second arm 1180 are pivotally attached or Butterfly.

  Although the first clamp and the second clamp are disclosed as having a mating portion that engages opposite sides of the spinous process, in an alternative embodiment, the first clamp and the second clamp engage the spinous process. Other configurations may be provided, such as suction, adhesive, pins / protrusions, and the like.

  Although the first clamp and the second clamp are disclosed as being movable relative to each other, in an alternative embodiment, the first clamp or the second clamp is fixed in place and the other clamps are fixed. May move relative to the clamp.

  Although the first arm and the second arm of the clamp are shown to be elastically biased away from each other, in an alternative embodiment, the first arm and the second arm have different configurations ( For example, a scissor arrangement can be used to manually move in the direction of each other and away from each other.

  Although an embodiment is disclosed that shows a wire coupled to a swing arm using a retainer, in an alternative embodiment, it is not necessary to use a retainer. The wire can be coupled to the swing arm using other holding methods, such as a slit in which the wire is clamped.

  Furthermore, although the work tool 1840 is disclosed as a trocar tip, the work tool may be any work tool such as a spacer, balloon actuator, bone tamp, etc.

  While the above embodiments are primarily described as spinal implants configured to be placed between adjacent spinous processes, in alternative embodiments, the implants are adjacent to bone, tissue or other body structure. In this case, it is desirable to maintain the spacing while preventing axial or longitudinal movement of the implant.

  Although the implants described herein are primarily described as not distracting adjacent spinous processes, in alternative embodiments, the implant is configured to expand to distract adjacent spinous processes. be able to.

  Although the implant is described as being inserted directly between adjacent spinous processes, in an alternative embodiment, the implant can be delivered through a cannula.

  Although the actuator used to move the spinal implant from the expanded configuration to the collapsed configuration has been described as a rod assembly or balloon, in an alternative embodiment, the actuator moves the implant to its collapsed configuration. Can be any device configured to provide sufficient longitudinal force. For example, the actuator may be a piston / cylinder assembly, a ratchet assembly, or the like.

1 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration adjacent to two adjacent spinous processes. FIG. FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a second configuration adjacent to two adjacent spinous processes. 1 is a schematic illustration of a deforming element according to an embodiment of the invention in a first configuration. FIG. 4 is a schematic side view of the expansion element shown in FIG. 3. 1 is a side view of a medical device according to an embodiment of the present invention in a first configuration. FIG. FIG. 6 is a side view of the medical device shown in FIG. 5 in a second configuration. 1 is a perspective view of a medical device according to an embodiment of the present invention in a first configuration. FIG. FIG. 6 is a rear view of a medical device according to an embodiment of the present invention, a portion of which is in a second configuration. FIG. 8 is a rear view of the medical device shown in FIG. 7 fully deployed in a second configuration. FIG. 8 is a front view of the medical device shown in FIG. 7 in a second configuration. 2 is a side cross-sectional view of a medical device according to another embodiment of the present invention in a first configuration. FIG. FIG. 12 is a side cross-sectional view of the medical device shown in FIG. 11 in a partially expanded configuration. FIG. 12 is a rear view of the medical device of FIG. 11 inserted between adjacent spinous processes in a second configuration. FIG. 12 is a side view of the medical device of FIG. 11 inserted between adjacent spinous processes in a second configuration. 1 is a perspective view of an implant expansion device according to one embodiment of the present invention. FIG. FIG. 16 is a cross-sectional view of a portion of the device shown in FIG. 15 taken along line AA in FIG. FIG. 16 is a cross-sectional view of a portion of the device shown in FIG. 15 taken along line BB in FIG. FIG. 16 is an alternative perspective view of the implant expansion device shown in FIG. 15. FIG. 16 is a perspective view of a portion of the implant expansion device shown in FIG. 15. 1 is a perspective view of an implant expansion device according to an embodiment of the present invention in a first position. FIG. FIG. 19 is a perspective view of the implant expansion device shown in FIG. 18 in a second position. FIG. 19 is a partial cross-sectional view of the implant expansion device shown in FIG. 18 inserted into a spinal implant. FIG. 20 is a partial cross-sectional view of the implant expansion device shown in FIG. 19 inserted into a spinal implant. FIG. 3 is a side view of a partially expanded spinal implant. FIG. 3 is a side view of an expanded spinal implant. FIG. 7 is a side cross-sectional view of an implant expansion device according to an alternative embodiment of the present invention in a first configuration. FIG. 25 is a side cross-sectional view of the implant expansion device shown in FIG. 24 in a second configuration. FIG. 6 is a cross-sectional plan view of an implant expansion device according to yet another embodiment of the present invention in a first configuration. FIG. 27 is a partial side view of an implant used in the implant expansion device shown in FIG. 26. FIG. 27 is a cross-sectional plan view of the implant expansion device shown in FIG. 26 in a second configuration. FIG. 6 is a cross-sectional plan view of an implant expansion device according to another embodiment of the present invention in a first configuration. FIG. 30 is a side cross-sectional view of the implant expansion device shown in FIG. 29. FIG. 7 shows a rear view of a spinal implant that can be expanded by an implant expander of an expansion device according to another embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 7 shows a rear view of a spinal implant that can be expanded by an implant expander of an expansion device according to another embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 3 shows a side cross-sectional view of a spinal implant according to one embodiment of the present invention. FIG. 34 is a side view of an implant expansion device used in the spinal implant shown in FIG. 33 according to one embodiment of the present invention. FIG. 34 is a side view of an implant expansion device used in the spinal implant shown in FIG. 33 according to one embodiment of the present invention. FIG. 36 shows the use of the implant expansion device shown in FIGS. 34 and 35 with the spinal implant shown in FIG. FIG. 36 shows the use of the implant expansion device shown in FIGS. 34 and 35 with the spinal implant shown in FIG. 1 is a schematic diagram of an apparatus according to an embodiment of the present invention. 1 is a front view of a device according to one embodiment of the present invention and a portion of a spine. FIG. 40 is a cross-sectional view of the components of the device shown in FIG. 39 taken along line 40-40 of FIG. 39 and a portion of the spine. FIG. 40 is a side plan view of the apparatus shown in FIG. 39. FIG. 40 is a side plan view of the components of the apparatus shown in FIG. 39. 43 is a front view of the components of the apparatus shown in FIG. 42. FIG. FIG. 3 is a partial cross-sectional view of a removable trocar tip used in a device according to an embodiment of the present invention in a first configuration. FIG. 6 is a cutaway view of a removable trocar tip used in a device according to an embodiment of the invention in a second configuration. FIG. 3 is a partially exploded view of a removable trocar tip used in a device according to one embodiment of the present invention. FIG. 6 is a side plan view of a medical device according to another embodiment of the present invention. FIG. 6 is a perspective view of a medical device according to another embodiment of the present invention. 1 is a perspective view of an apparatus according to one embodiment of the present invention. FIG. 49B is an exploded view of a portion of the apparatus shown in FIG. 49A. FIG. 49B is an exploded view of a portion of the apparatus shown in FIG. 49A. FIG. 6 is a perspective view of a spacer configured to be inserted between adjacent spinous processes according to one embodiment of the present invention. FIG. 6 is a side view of a spacer according to an embodiment of the present invention in a first configuration, inserted between adjacent spinous processes. FIG. 50 is a side view of the spacer of FIG. 49 in a second configuration, inserted between adjacent spinous processes. FIG. 6 is a diagram of a spacer according to an alternative embodiment of the present invention. FIG. 6 is a diagram of a spacer according to an alternative embodiment of the invention. FIG. 6 is a diagram of a spacer according to an alternative embodiment of the present invention. FIG. 6 is a side view of a spacer according to an alternative embodiment of the present invention in a first configuration. FIG. 57 is a side view of the spacer shown in FIG. 56 in a second configuration, inserted between adjacent spinous processes. FIG. 9 is a side view of a spacer according to yet another embodiment of the present invention inserted between adjacent spinous processes. FIG. 6 is a side view of a spacer according to yet another alternative embodiment of the present invention inserted between adjacent spinous processes. FIG. 61 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration (FIG. 60A), a second configuration (FIGS. 60B and 60D) and a third configuration (FIG. 60C). FIG. 61 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration (FIG. 60A), a second configuration (FIGS. 60B and 60D) and a third configuration (FIG. 60C). FIG. 61 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration (FIG. 60A), a second configuration (FIGS. 60B and 60D) and a third configuration (FIG. 60C). FIG. 61 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration (FIG. 60A), a second configuration (FIGS. 60B and 60D) and a third configuration (FIG. 60D). FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration, a second configuration, and a third configuration, respectively. FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration, a second configuration, and a third configuration, respectively. FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration, a second configuration, and a third configuration, respectively. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. 1 is a rear view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a first lateral position and a second lateral position. FIG. FIG. 63 is a side view of the medical device shown in FIGS. 62A-62F inserted between adjacent spinous processes in a second configuration. FIG. 6 is a side view of a medical device according to one embodiment of the present invention inserted between adjacent spinous processes in a second configuration. 2 is a front view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 2 is a front view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 2 is a front view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 1 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration, disposed between two adjacent spinous processes. FIG. FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a second configuration, disposed between two adjacent spinous processes. 2 is a perspective view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 2 is a perspective view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. FIG. 67 is a rear view of the medical device shown in FIGS. 67A and 67B disposed between adjacent spinous processes in a second configuration. FIG. 69 is a side view from the proximal view AA of the medical device shown in FIG. 68 positioned between adjacent spinous processes in a second configuration. FIG. 67 is a front cross-sectional view of the medical device shown in FIGS. 67A and 67B in a second configuration. FIG. 68 is a cross-sectional plan view taken along section AA of the medical device shown in FIGS. 67A and 67B in a second configuration. FIG. 6 is a front cross-sectional view of a medical device according to an embodiment of the present invention in a second configuration. FIG. 73 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 72 in the second configuration and the first configuration, respectively. FIG. 73 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 72 in the second configuration and the first configuration, respectively. FIG. 6 is a front cross-sectional view of a medical device according to an embodiment of the present invention in a second configuration. FIG. 75 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 74 in the second configuration, the first configuration, and the third configuration, respectively. FIG. 75 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 74 in the second configuration, the first configuration, and the third configuration, respectively. FIG. 75 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 74 in the second configuration, the first configuration, and the third configuration, respectively. 2 is a front cross-sectional view of a medical device according to an embodiment of the present invention in a second configuration and a first configuration, respectively. FIG. 2 is a front cross-sectional view of a medical device according to an embodiment of the present invention in a second configuration and a first configuration, respectively. FIG. FIG. 6 is a front cross-sectional view of a medical device according to an embodiment of the present invention in a second configuration. FIG. 78 is a cross-sectional plan view taken along section AA of the medical device shown in FIG. 77 in the second configuration. 2 is a perspective view of a medical device according to an embodiment of the present invention in a second configuration and a first configuration, respectively. FIG. 2 is a perspective view of a medical device according to an embodiment of the present invention in a second configuration and a first configuration, respectively. FIG. 2 is a side view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. 2 is a side view of a medical device according to an embodiment of the present invention in a first configuration and a second configuration, respectively. FIG. FIG. 80B is a perspective view of the medical device shown in FIGS. 80A and 80B in a first configuration and a second configuration, respectively. FIG. 80B is a perspective view of the medical device shown in FIGS. 80A and 80B in a first configuration and a second configuration, respectively. FIG. 83 is a cross-sectional plan view of the medical device shown in FIGS. 80A and 80B in a second configuration. 1 is a schematic illustration of a medical device according to one embodiment of the present invention in a collapsed configuration adjacent to two spinous processes. FIG. 84 is a schematic illustration of the medical device of FIG. 83 in an expanded configuration adjacent to two spinous processes. 1 is a side perspective view of an implant according to one embodiment of the present invention in an expanded configuration. FIG. FIG. 88 is a side perspective view of the implant of FIG. 85 shown in a collapsed configuration. FIG. 89 is a side perspective view of the medical device of FIG. 85 shown in a collapsed configuration. 1 is a side view of a deployment tool according to one embodiment of the present invention. FIG. FIG. 89 is a side view of a portion of the deployment tool of FIG. 88 shown in a first configuration. FIG. 90 is a side view of a portion of the deployment tool of FIG. 89 shown in a second configuration. FIG. 89 is a side view of a portion of the deployment tool of FIG. 89 and the implant of FIG. 85, the implant being shown in an expanded configuration. FIG. 92 is a cross-sectional view of the deployment tool and implant portion shown in FIG. 91. FIG. 92 is a cross-sectional view of the deployment tool and implant of FIG. 91, wherein the implant is shown in a collapsed configuration disposed between adjacent spinous processes. FIG. 4 is a side view of a portion of a medical device according to one embodiment of the present invention, showing an engagement portion in an extended configuration and disposed adjacent to a spinous process. FIG. 95 is a side view of the portion of the medical device of FIG. 94, showing the engagement portion in a partially collapsed configuration. FIG. 95 is a side view of the portion of the medical device of FIG. 94, showing the engagement portion in an extended configuration after being inserted beyond the spinous process. FIG. 86 is a side perspective view of the implant of FIG. 85 shown rotated around the longitudinal axis of the implant. FIG. 6 is a side perspective view of an implant according to another embodiment of the present invention. FIG. 6 is a side view of a deployment tool according to another embodiment of the present invention. FIG. 6 is a side view of a deployment tool according to another embodiment of the present invention. FIG. 6 is a side view of a deployment tool according to another embodiment of the present invention. FIG. 6 is a side view of a deployment tool according to another embodiment of the present invention. 3 is a flowchart of a method according to an embodiment of the present invention. 1 is a schematic rear view of a medical device according to an embodiment of the present invention in a first configuration adjacent to two adjacent spinous processes. FIG. FIG. 6 is a schematic rear view of a medical device according to an embodiment of the present invention in a second configuration adjacent to two adjacent spinous processes. 1 is a schematic illustration of a deforming element according to an embodiment of the invention in a first configuration. FIG. 107 is a schematic side view of the expansion element shown in FIG. 106. 1 is a side sectional view of a medical device according to an embodiment of the present invention in a first configuration. FIG. FIG. 109 is a side cross-sectional view of the medical device shown in FIG. 108 in a second configuration. FIG. 3 is a side cross-sectional view of a medical device and actuator according to one embodiment of the present invention, with a portion of the medical device deployed in a second configuration. FIG. 3 is a side cross-sectional view of a medical device and actuator according to an embodiment of the present invention, wherein the medical device is fully deployed in the second configuration. 2 is a side cross-sectional view of a medical device according to another embodiment of the present invention in a first configuration. FIG. FIG. 113 is a side cross-sectional view of the medical device of FIG. 112 in a second configuration. 1 is a side cross-sectional view of a medical device and actuator according to an embodiment of the present invention, with a portion of the medical device returning to its first configuration. FIG. 1 is a cross-sectional side view of a medical device and actuator according to one embodiment of the present invention, the medical device returning to its first configuration. FIG. 1 is a cross-sectional side view of a medical device and actuator according to one embodiment of the present invention, the medical device returning to its first configuration. FIG. 1 is a cross-sectional side view of a medical device and actuator according to one embodiment of the present invention, the medical device returning to its first configuration. FIG. 1 is a side perspective view of an implant according to one embodiment of the present invention shown in a collapsed configuration. FIG. FIG. 24 is a cross-sectional view of the implant of FIG. 118 taken along line 23-23. FIG. 119 is a cross-sectional view of the implant of FIG. 118 shown in an expanded configuration.

Claims (10)

An apparatus comprising the expandable elongated member configured to deform from a first configuration to a second configuration to expand at least a portion of the expandable elongated member, the expandable elongated member comprising:
The proximal portion having a first end configured to deform from the first configuration to the second configuration to expand at least a portion of the proximal portion;
The distal portion having a second end configured to deform from the first configuration to the second configuration to expand at least a portion of the distal portion;
A non-expandable central portion extending along a longitudinal axis between the proximal portion and the distal portion, the non-expandable central portion configured to engage an adjacent spinous process. And
Wherein the proximal portion content, between said central portion and said first end portion includes a plurality of first extension member extending parallel to the longitudinal axis when in the first configuration, the plurality An opening is defined between the first expansion members ;
The distal portion includes a plurality of second expansion members between the second end and the central portion that extend parallel to the longitudinal axis when in the first configuration, An opening is defined between the two expansion members;
In the second configuration, at least a part of the first expansion member protrudes laterally away from the longitudinal axis between the first end portion and the central portion, and the second end portion And at least a portion of the second expansion member projects laterally away from the longitudinal axis between the central portion and the central portion . The apparatus of claim 1, wherein the non-expanding central portion is configured to engage the adjacent spinous process after expansion of the spine. The proximal portion comprises a tab and a slot, the tab and the slot being spaced apart in the first configuration and mating in the second configuration, the tab and the slot being mated after the proximal The apparatus according to claim 1 or 2, wherein the apparatus is configured to limit further deformation of the portion. 4. The device according to any one of claims 1 to 3, wherein the proximal portion, the distal portion, and the central portion together form a tube having a substantially constant inner diameter. The deformable proximal portion and the deformable distal portion are movable from the first configuration to the second configuration with an axial load applied to compress the device. The apparatus according to any one of claims 4 to 4 . The proximal portion of the second configuration comprises at least two protrusions disposed adjacent to the sides of the adjacent spinous processes, the distal end of the first protrusion of the at least two protrusions When the distance defined between the distal end of the second protrusion of the at least two protrusions, space larger than any one of claims 1 to 5 between the adjacent spinous processes The device described in 1. The apparatus according to any one of claims 1 to 6 , wherein the proximal portion, the distal portion, and the central portion are integrally molded. The proximal portion, the distal portion, and the central portion are physically separate components;
Apparatus according to any one of claims 1 to 6. The expandable elongated member is configured to be inserted between percutaneously adjacent spinous processes;
Apparatus according to any one of claims 1 to 8 . Said proximal portion and said distal portion, wherein in a state where adjacent spinous processes does not substantially extend, deforms the second configuration from the first configuration, according to any one of claims 1 9 Equipment.

Images