JP2022524892A - Thrombectomy catheter and how to use - Google Patents

Abstract

A thrombosis catheter, a catheter or delivery sheath with a penetrating double lumen, the catheter having proximal and distal segments and a linear section coupled between them. , The distal segment is a catheter or delivery sheath configured as a loop and a port or opening formed within the double lumen of the catheter, wherein the port is in close proximity to the distal segment. A port or opening, a guide wire configured to longitudinally traverse one of the double cavities of the catheter, and a guide wire that is connected to one of the double cavities and for extracting biomaterial. A thrombectomy catheter with a catheter and a suction device configured to create a vacuum in the loop.

Description

Mutual Reference of Related Applications To the extent permitted by law, this US Continuing Partial Patent Application is a US provisional patent application filed on December 13, 2017, entitled "X-tractor Thrombectomy Camera and Methods of Use". Priority of US Patent Application No. 15 / 964,593, filed April 27, 2018, entitled "Thrombectomy Cather and Methods of Use," claiming priority in the specification 62 / 598,436. Priority and full benefit are claimed here, and these applications are incorporated herein by reference in their entirety.

The present disclosure relates generally to medical catheter devices, and more specifically to medical catheter devices with deployable instruments for removing thrombi (thrombus).

A catheter is a medical device or device made from a medical grade material that performs a wide range of functions, such as insertion into the body to treat a disease or perform a surgical procedure. In addition, catheters are often in elongated form with manipulator means at their distal ends and are utilized for the surgical manipulation of substances in limited or inaccessible spaces within the human or animal body. For example, catheters are utilized to perform amputations by sutures, knives or scissors, or by small arthroscopic, endoscopic incisions, percutaneous or through body openings and capture and recovery devices. May be good.

In addition, angioplasty, atherectomy, and stent and stent graft deployment, treatments for treating vascular disease often remove material or plaque from the vessel wall, resulting in the formation of clots or the release of embolisms. It can result in these being large enough to enter the bloodstream, block smaller downstream blood vessels, and potentially block the bloodstream to the tissue. As a result, if the obstruction occurs in important tissues such as the heart, lungs, or brain, it can pose a serious threat to the patient's health or life.

One conventional approach involves a catheter device with a cannula with an axial bore, where a remote actuator means at the proximal end activates a sliding elastically deformable loop to its distance. An elastically deformable loop and a barrier member attached to the loop, which extends beyond the boundary of the unfolded opening at the position end, is unfolded to achieve its unfolded configuration. One drawback of this approach is that elastically deformable loops can expand excessively or linearly, causing crevices in the tissue or blood vessels within the unfolded region. Another drawback of this technique is that the elastically deformable loop is expanded and / or stored in the unfolding opening and returned to the biopsy material. The agglomerates may be sliced or punctured, or pierced through the walls of blood vessels. Moreover, such elastically deformable loops generally cannot prevent the material from escaping from the filter (barrier member) during the folding and storage process.

Another conventional approach is a catheter with a self-expanding vascular device such as a support hoop that can be extended to the joint area to support a sack or mesh filter for filtering or removing substances from within the vasculature and capturing the embolus. Including devices. One drawback of this approach is that the mesh filter can reduce the flow through the blood vessel, resulting in damage to the downstream cells and tissues normally delivered by the occluded blood vessel. As a result, it can be difficult or impossible to use such a device within a small blood vessel.

Therefore, it unfolds without creating a crevice in the tissue or vessel, without slicing or puncturing the biopsy material, clot, or piercing the vessel wall, and scooping the material, clump, and embolus from the vessel wall. It is easy to see that there is a recognizable, yet unaddressed need for a thrombectomy catheter and its use that functions to collect and remove. Also, to prevent material from escaping from the filter (barrier member) during the folding and storage process, the flow through the blood vessel can result in damage to the downstream cells and tissues normally delivered by the occluded blood vessel. It is also to prevent degradation and to allow movement within small blood vessels.

Briefly, in an exemplary embodiment, the device is a catheter or delivery sheath with a double lumen (passageway) that extends through, the catheter being in the proximal and distal segments and between. The distal segment is a catheter or delivery sheath configured as a loop (pigtail) or rim and a port or opening formed within the double lumen of the catheter. The port is a guidewire configured to traverse longitudinally through one of the port and the double lumen of the catheter, located close to the distal segment, and is a mesh strainer (basket / net). ), The mesh strainer traverses through the other of the double lumen of the catheter, exits through the port, and follows the loop to form a retractable mesh strainer, thus tissue. Or deploy without causing tears in the vessel, without slicing or puncturing the biopsy material or clot, without piercing the vessel wall, scooping and collecting material, plaques, clumps, and embolisms from inside the vessel. Acting to remove, thereby preventing material from escaping from the filter (barrier member) during the folding and storage process, which can result in damage to downstream cells and tissues normally delivered by occluded blood vessels. Overcoming the shortcomings mentioned above by providing a guide wire and allowing movement within a small diameter vessel without causing diminished flow through the vessel, the thrombosis catheter and usage were recognized. Meet your needs.

Broadly speaking according to its main embodiment, the thrombosis catheter and the method of use is a catheter or delivery sheath with a penetrating double lumen, the catheter being a proximal segment and a distal segment and theirs. It has a linear section coupled between them, and the distal segment is a catheter or delivery sheath configured as a loop and a port or opening formed within said double lumen of the catheter, the port. Is a guide wire configured to traverse longitudinally through one of a port or opening and one of the catheter's double cavities, located in close proximity to the distal segment. It has a first end secured to the mesh strainer, which traverses longitudinally through the other of the double lumens of the catheter and exits through the port to provide a retractable mesh strainer. Includes a guide wire configured to follow the loop to form.

In an exemplary embodiment of a remote operated surgical device, the remote operated surgical device is a flexible positioning instrument with an internal double luminal bore extending from the end of the first catheter to the end of the second catheter. An elongated catheter having a double lumen bore comprising an elongated catheter, both having a first lumen and a second lumen, and a pigtail attached to the end of the second catheter. One lumen extends through the elongated catheter and pigtail, the second lumen extends through the elongated catheter, and is extendable through the flexible positioning device and the first lumen and pigtail of the elongated catheter. A guide wire that is extendable from the pigtail and is configured to have a guidewire configured to tilt the pigtail, a proximal member, and a distal member coupled to the proximal member. A containment device, wherein the distal member has a deformable rim and a barrier membrane that is secured to a displaceable rim and is extendable through a second lumen of an elongated catheter. include.

In a further exemplary embodiment of the method for removing biomaterial from a patient's blood vessel, the method is a step of providing a remote controlled surgical device, wherein the remote controlled surgical device is a flexible positioning instrument. , An elongated catheter with an internal double luminal bore extending from the end of the first catheter to the end of the second catheter, both of which are the first cavities and the second tubing. It comprises an elongated catheter with a cavity and a pigtail attached to the end of a second catheter, the first lumen extending through the elongated catheter and the pigtail, and the second lumen passing through the elongated catheter. It has a flexible positioning device that extends through an elongated catheter and an extendable guide wire that extends through the first lumen of the pigtail, a proximal member, and a distal member coupled to the proximal member. A containment device configured as such, the distal member has a deformable rim and a barrier membrane that is secured to a displaceable rim and is extendable through a second lumen of an elongated catheter. Deformable from a second lumen, with a providing instrument, a step of manipulating the operating surgical device to pass through the patient's blood vessel, a step of placing the pigtail close to the biomaterial, and a second lumen. A step to deploy the rim and barrier membrane, a step to rotate the deformable rim and barrier membrane close to the biomaterial, a step to collect the biomaterial in the barrier membrane, and a deformable rim, barrier membrane, living body. Includes a step of storing the material through a second lumen.

Therefore, a feature of thrombectomy catheters and methods of use is that the pigtail or distal segment configured as a loop is rotated multiple times in close proximity to the undesired material to clots, plaques, embolisms, thrombi (thrombus), fat deposits. The ability to scoop objects, or other unwanted material or debris into a mesh blood strainer and extract them from human blood vessels.

Another feature of the thrombectomy catheter and usage is the ability to provide a mesh strainer or basket porous body, thereby clots, plaques, embolisms, thrombi (thrombus), fat deposits, or other. Blood cells are free to pass while unwanted material or debris is being captured.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide a double lumen catheter in which one lumen forms the passage of the guidewire and the other lumen forms the passage of the mesh strainer.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide remotely controllable surgical devices or guidewires.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide flexible double luminal catheters.

Yet another feature of the thrombectomy catheter and usage is that it has a flexible pigtail with a passage for the guide wire and a deployable or exit port formed in close proximity to or at the tip of the tip. The ability to provide a sex double luminal catheter.

Yet another feature of the thrombectomy catheter and usage is the ability to provide a retractable mesh strainer, which forms a basket or net across a distal segment configured as a loop. Scoop agglomerates, plaques, embolus, or other removal material into the mesh strainer.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide catheters with loops on the distal segment of the catheter, deployable mesh baskets that track around the pigtail, nets, and mesh strainers.

Yet another feature of thrombectomy catheters and methods of use is the ability to overcome the shortcomings of still known vascular filter nets and thrombectomy / embolectomy devices and to provide vascular devices with fewer components to use.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide vascular devices that can contract into small delivery profiles and thus allow the device to be used within small blood vessels.

Yet another feature of thrombectomy catheters and methods of use is the ability to provide vascular devices without the need for specialized delivery catheters.

Yet another feature of thrombectomy catheters and usage is that clots, plaques, embolisms, thrombi (thrombus), fat deposits, or other unwanted materials or debris escape from the device when it is stowed and removed. The ability to provide vascular devices to provide vascular devices that reduce risk.

Yet another feature of thrombectomy catheters and usage is clots, plaques, embolisms, thrombi (thrombus), fat deposits, or other undesired materials without surgery or feeding a clot buster. Alternatively, it is the ability to provide a vascular device for percutaneously removing debris from human blood vessels.

Yet another feature of thrombectomy catheters and methods of use is that a pigtail, loop, or distal segment configured as a loop can be simply spun multiple times in close proximity to an unwanted material to clot, plaque, embolus, thrombus ( The ability to provide a vascular device that captures blood clots), fat deposits, or other unwanted materials or debris from human blood vessels.

Yet another feature of the thrombectomy catheter and usage is the net, basket, deployment through a double luminal catheter without losing the position of the pigtail, loop, or distal segment configured as a loop adjacent to the work area. The ability to remove a possible mesh basket or mesh strainer multiple times.

Yet another feature of the thrombectomy catheter and method of use is by aspirating the undesired material into the distal end of the lumen in close proximity to the undesired material (suction thrombectomy) and pulling it out through the luminal channel. Provided is a vascular device having suction or inhalation through a suction device for collecting and removing clots, plaques, embolisms, thrombi (thrombus), fat deposits, or other unwanted materials or debris from human blood vessels. Ability.

These and other features of the thrombectomy catheter and method of use will become more apparent to those of skill in the art from the detailed description of the embodiments and claims below when read in the light of the accompanying drawings. ..

The thrombectomy catheter and method of use of the present invention will be better understood by reading the detailed description of the embodiments with reference to the accompanying drawings. In drawings, similar reference numbers indicate similar structures and refer to similar elements throughout.

FIG. 3 is a top perspective view of an exemplary embodiment of a thrombectomy catheter. FIG. 1 is a perspective cross-sectional view of an exemplary embodiment of a double luminal elongated catheter for the thrombectomy catheter of FIG. 1A. FIG. 1 is a perspective sectional view of an exemplary embodiment of a single luminal pigtail of the thrombectomy catheter of FIG. 1A. FIG. 1A is a top perspective view of an exemplary embodiment of a thrombectomy catheter, showing a guide wire passing through a first lumen extending a pigtail. FIG. 3 is a top perspective view of an exemplary embodiment of a vascular medical device. FIG. 1 is a top perspective view of an exemplary embodiment of a thrombectomy catheter of FIG. 1, showing a guide wire traversing a first lumen and a retractable instrument traversing the second lumen. .. FIG. 1 is a perspective cross-sectional view of the elongated catheter of the thrombectomy catheter of FIG. 1, with guide wires and retractable instruments shown penetrating and traversing. FIG. 1 is a top perspective view of an exemplary thrombectomy catheter with retractable instruments deployed between pigtails. FIG. 5A is a front perspective view of a thrombectomy catheter of FIG. 5A equipped with a vascular medical device showing an undesired material or debris for recovery covered with a net. Top view of the thrombectomy catheter of FIG. 5A, which has passed through the heart and deployed into the blood vessels of the lung, and the retractable instrument is shown by netting unwanted material or debris for recovery. FIG. 6 is a flow chart of a method of deploying, using, and recovering a thrombectomy catheter of FIGS. 1-6 to remove unwanted material or debris from a blood vessel. FIG. 3 is a top perspective view of an exemplary embodiment of a thrombectomy catheter with a suction device. FIG. 8 is a top perspective view of an exemplary thrombectomy catheter of FIG. 8 in which an undesired material is drawn into the distal end of the lumen. FIG. 5 is a flow chart of a method of deploying, using, and recovering a thrombectomy catheter of FIGS. 1-6 and 8-9 to remove unwanted material or debris from a blood vessel by aspiration.

The drawings presented are for illustration purposes only and therefore limit this disclosure to any or all of the exact details of the structures shown, except where deemed essential to the claimed invention. Note that is neither desirable nor intentional.

In describing exemplary embodiments of the present disclosure, FIGS. 1A, 1B, 1C, 2, FIG. 3, FIG. 4A, FIG. 4B, FIG. 5A, FIG. 5B, FIG. 6, FIG. 7, FIG. As shown in FIGS. 9 and 10, certain terms are used for clarity. However, the present disclosure is not intended to be limited to the particular term so selected, and all techniques in which each particular element operates in a similar manner to achieve similar functionality. It should be understood that it includes a target equivalent. However, the embodiments of the claims may be embodied in many different embodiments and should not be construed as being limited to the embodiments described herein. The examples described herein are non-limiting examples and are merely examples among other possible examples.

Here, with reference to FIGS. 1A, 1B, and 1C, exemplary embodiments of the flexible surgical positioning instrument 10 are shown, but not by limitation, as an example. The surgical positioning instrument 10 can include a base section such as a handgrip 36, where the handgrip is a longitudinal linear member such as an elongated catheter 20 extending linearly from the handgrip 36, a cannula, a housing, a catheter, or a sheath. It has a first rotating flap 37 and a second rotating flap 38 coupled to. Preferably, the elongated catheter 20 is created with two or double axial bores penetrating it, or inside the elongated catheter 20, a space extending from the first catheter end 21 to the second catheter end 22. Can be included. Further, the penetrating two or double axial bores can include a first lumen 31 and a second lumen 32 separated by a partition 33.

Further, the second catheter end 22 of the surgical positioning instrument 10 is configured as a loop, open loop, or enclosure such as a pigtail 50 formed on it or attached to the second catheter end 22. Can be done. As used herein, the pigtail 50 may be formed in various sizes and configurations, including a first pigtail section 51 and a second pigtail section 52, the first pigtail section 51 being a second of the elongated catheter 20. Attached to the catheter end 22 of the, the second pigtail section 52 forms an enclosure that loops back to a position close to the second catheter end 22. As used herein, the elongated catheter 20 and pigtail 50 may preferably be constructed or constructed of plastic, and the polymeric materials include polytetrafluoroethylene, polyurethane, polyethylene, Teflon® and the like, such. The material is believed to provide a variety of forms, shapes, ease of manufacture, and flexibility, but has sufficient strength, flexibility, and / or durability to meet the purposes described herein. Other suitable materials may be used as long as they are materials. The material of the elongated catheter 20, the pigtail 50 of the second lumen 32, the second lumen or the medical device outlet opening 25 is, for example, the retractable instrument 60 constrained within the second lumen 32 and elongated. While being deformed by the catheter 20, it may be reinforced with fibers, rings, or longitudinal ribs to allow it to withstand the forces exerted by this device.

The first lumen 31 begins at the inlet hole, such as the first lumen or guide wire inlet opening 24, extends through the handgrip 36, elongated catheter 20, and pigtail 50, and extends through the first lumen or guide wire. It can exit the pigtail 50 in close proximity to the pigtail end 53 through an exit to the environment such as the outlet opening 26 or an opening of a development hole.

The second lumen 32 begins at the inlet hole such as the first instrument opening 23 and extends through the handgrip 36 and the elongated catheter 20 and is close to the second catheter end 22 such as the second instrument opening 25 and the like. Can exit from the elongated catheter 20 in close proximity to the second catheter end 22 through the exit or deployment hole of.

Here, with reference to FIG. 2, as an example, but not limited to, an exemplary guide wire 40 for deployment and storage of the first lumen 31 of the elongated catheter 20 and the pigtail 50 within the pigtail lumen 31B. Embodiments are shown. The guide wire 40 can include a first guide wire end 41 and a second guide wire end 42. In use, the route or vascular guidance device, such as the guide wire 40, begins at the inlet hole, such as the first lumen inlet opening 24, and passes through the first lumen 31 of the elongated catheter 20 and the pigtail lumen 31B of the pigtail 50. Out of the pigtail 50 in close proximity to the pigtail end 53 through an exit to the environment or a deployment hole opening, such as a first lumen exit opening 26, beyond, or there. Extending from, reaching an extendable position, the second catheter end 22 and pigtail 50 can be assisted or guided through the vessel V for turning, bifurcation, or other vessel maneuvering. The first guide wire end 41 extends through a deployment opening such as the guide wire opening 26 and is remotely controlled from the second guide wire end 42. Further, when the guide wire 40 passes through the pig tail 50, the pig tail 50 may be tilted or straightened, depending on the flexibility or rigidity of the first guide wire end 41 passing through it. It may be at an angle such as well (as shown in FIG. 2) or a pigtail angle A (about 0 to 270 degrees perpendicular to the elongated catheter 20 and 9 to 12 o'clock counterclockwise). In addition, the first rotation R1 of the elongated catheter 20 causes or results in similar rotations such as rotation R2 of the pigtail 50. Both the pigtail angle A and the rotation R2 assist or guide the various positions of the first guide wire end 41 to pass through the guide wire 40, the pig tail 50, and the second catheter end 22 through the blood vessel V. Allows for placement, turning, branching, or other vascular maneuvers. Further, the movement or movement of the guide wire 40 such as the push / pull PI of the second guide wire end 42 causes the first guide wire end 41 to move inward and outward from the guide wire opening 26, and the guide wire 40, The pigtail 50 and the second catheter end 22 are assisted or guided or placed to pass through the blood vessel, turned, branched, or other vascular maneuvers.

Alternatively, the first lumen 31 and the pigtail lumen 31B may be for access to additional laparoscopic or endoscopic devices and / or for fluid access or withdrawal, or for medical instruments 40A such as lighting, video. It may be used as an access. Such endoscopes can also provide surgical instruments 40A such as lasers, scalpels, irrigation and suction means, visualization means and the like. The specific configuration and dimensions of the first lumen 31 and the pigtail lumen 31B will vary depending on the intended use of the surgical positioning instrument 10 and whether access is provided for the additional medical instrument 40A. .. Normally, the axial bore of the first lumen 31 can have an inner diameter of 6-12F (French = l / 3mm), but to accommodate the working channel of the endoscope, it is not described herein. The diameter of is considered.

Here, with reference to FIG. 3, an exemplary embodiment of a retractable instrument 60 for use with the surgical positioning instrument 10 is shown, but not by limitation, as an example. The retractable instrument 60 can include a proximal or elongated member or operating tool such as a proximal member 64 having a first member end 65 and a second member end 66. The first member end 65 may be configured to have a loop, enclosure, or basket, pigtail such as a deformable rim 67 configured on it and in close proximity to the second member end 66. good. As used herein, it is believed that the deformable rim 67 may preferably be configured in various sizes and shapes that match the size and shape of the pigtail 50.

Further, the deformable rim 67 may be composed of one or two components such as a first deformable section 61 and a second deformable section 62, or the first deformable. One or more pivot joints 68 may be included between the section 61 and the second deformable section 62. The deformable rim 67 is preferably made of a flexible, elastic, or shape memory material or alloy biocompatible material, which flexes into a configuration that allows access to and from the first instrument opening 23. , Bending or folding, traversing the axial bore of the second lumen 32, expanding into a net deployed after passing through the second instrument opening 26, and vascular or other vascular channels or It can be folded to allow biomaterial to be extracted from the conduit V and re-enter the second instrument opening 26.

As used herein, the deformable rim 67 is one such as a pivot point 68 placed around the deformable rim 67 or between a first deformable section 61 and a second deformable section 62. It can include one or more joints or hinges, whereby the deformable rim 67, the first deformable section 61, and the second deformable section 62 are linearly folded or tatami. Rarely, it is further conceivable that it may be possible to traverse through a first instrument opening 23, an axial bore of a second lumen 32, and a second instrument opening 25. It is further considered herein that the deformable rim 67 may form an opening such as a rim inlet 69.

When expanded, the deformable rim 67 can have a diameter of about 1 cm or less to about 3 cm, but other sizes are considered herein. In addition, a barrier membrane such as the mesh strainer 63 or other shifting or filtration membrane is preferably loosely extended, spread or secured to the deformable rim 67 to capture the rounded open end across the rim inlet 69. Form a net. The mesh strainer 63 may be utilized to filter or capture clots, plaques, embolisms, thrombi (thrombus), fat deposits, or other unwanted materials or debris from within human blood vessels y.

The specific configuration and dimensions of the axial bore of the second lumen 32 depend on the use of the surgical positioning instrument 10, the parameters of the retractable instrument 60 such as the insert / retract member 64, and the mesh strainer 63 being the first. A first deformable section 61 and a second deformable section in a constrained configuration, folded around a deformable section 61, a second deformable section 62, and an insertion / storage member 64. It is sized to accommodate the deformable rim 67 with 62. Typically, the axial bore of the second lumen 32 can have an axial bore or inner diameter of 6-12 F (French = l / 3 mm) to accommodate the retractable instrument 60 in a constrained configuration. However, other diameters are conceivable herein.

Alternatively, the second lumen 32 may be used for access to additional laparoscopic or endoscopic devices and / or for fluids or for medical devices 40A such as lighting, video. .. Such endoscopes can also provide surgical instruments 40A such as lasers, scalpels, irrigation and suction means, visualization means and the like.

Referring again to FIG. 1A, the outer diameter of the catheter 20 is the application, the size of the first lumen 31 and the second lumen 32, the first deformable section 61 and the second deformable section 62. Is there access for the size of the deformable rim 67 of the retractable device 60 with, access to additional laparoscopic or endoscopic devices, and / or fluid access or withdrawal, lighting, video, etc. 40A? It may vary depending on whether and whether additional lumens are contained within the surgical positioning instrument 10.

Here, with reference to FIGS. 4A and 4B, an exemplary, but not limited to, retractable instrument 60 for use in deploying and retracting a surgical positioning instrument 10 within a second lumen 32. Embodiments are shown. Further, the second guidewire end 42 can be pulled and the guidewire 40 can be retracted through the pigtail 50 so that the pigtail 50 can return to the pigtail or loop configuration as shown in FIGS. 1 and 4A. ..

In use, the deformable rim 67 of the first member end 65 may preferably be folded, and the mesh strainer 63 may include the deformable rim 67 and / or the first member end of the retractable instrument 60. It may be folded or wrapped around the portion 65. The folded deformable rim 67 and the folded mesh strainer 63 can be inserted into the first instrument opening 23 of the second lumen 32. The folded deformable rim 67 and the folded mesh strainer 63 are placed in the second lumen 32 of the elongated catheter 20, extended through it, traversed, and through the second lumen. Can exit or deploy and be extendable from there. When the deformable rim 67 and the folded mesh strainer 63 exit the second lumen 32, the deformable rim 67 expands into the unfolded deformable rim 67, where the mesh strainer 63 is a pigtail. It is spread out into an extended collection state that is placed close to 50. The unfolded first deformable section 61 and the second deformable section 62 of the deformable rim 67 extend back to the uncompressed position as shown in FIG. 5, thereby the rim inlet 69 and the mesh. An extended deformable rim 67 with a strainer 63 is created, in which case the extended deformable rim 67 preferably mates with or is in close proximity to the pigtail 50, as shown in FIG. Or can be placed inside the pigtail.

Here, with reference to FIGS. 5A and 5B, an exemplary embodiment of the retractable instrument 60 unfolded and shown from the second lumen 32 of the surgical positioning instrument 103 is, by way of example, not limited. ,It is shown. In use, the push / pull PI of the second member end 66 is deformable within the pigtail 50 or beyond the range of the second instrument opening 25 on the distal end of the second catheter end 22. The rim 67 can be unfolded or extended to unfold the deformable rim 67 and the mesh strainer 63 attached to it to achieve its unfolded configuration. The rotation R3 of the second member end 66 causes or results in similar rotations such as the rotation R4 of the deformable rim 67 having the rim inlet 69 and the mesh strainer 63. The rotating R4 also has a deformable rim 67 with a retractable instrument 60 rim inlet 69 and a mesh strainer 63 clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other undesirable. The material or debris M is to be scooped, collected, or captured from vessel V. Further, the rotation R1 of the elongated catheter 20 results in the rotation R2 of the pigtail 50. Further deformable with a rim inlet 69 and a mesh strainer 63 by abutment or contact between the pigtail 50 and the deformable rim 67 as a result of rotation R2 (the deformable rim 67 abuts on the pigtail 50). Brings rotation R4 of the rim 67. The rotating R4 also has a retractable instrument 60 rim inlet 69 and a deformable rim 67 with a mesh strainer 63 such as clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other. Scoop, collect, or capture unwanted material or debris M from vessel V. The undesired material or debris M extracts a deformable rim 67 having a retractable instrument 60 containing the undesired material or debris M and a rim inlet 69 and a mesh strainer 63 and folds the deformable rim 67 into a second. Blood vessels by returning into the instrument opening 25 and pulling the retractable instrument 60 out through the second lumen 32 of the surgical positioning instrument 10 and out of the first instrument opening 23 as shown in FIGS. 4A and 4B. Can be removed from V. The push / pull PI of the second member end 66 can recover the deformable rim 67 by folding the deformable rim 67, and the mesh strainer 63 is the deformable rim 67 and / or the first. The retractable instrument 60, which may be folded or wrapped around the member end 65 of the member and has an undesired material or debris M, is pulled through a second instrument opening 25 and a first. Can be exited from the instrument opening 23 of.

As used herein, the deformable rim 67 and the pigtail 50 allow contact or contact between the pigtail 50 and the deformable rim 67 (the deformable rim 67 abuts on the pigtail 50). , Circumference and / or diameter, etc. may be similar or may be similar in size and shape.

Here, with reference to FIG. 6, an exemplary embodiment of a surgical device, i.e., a combination of a retractable instrument 60 and a surgical positioning instrument 10, is shown, but not by limitation. In use, the surgical positioning instrument 10 is shown with the pigtail 50 inserted into the patient and meandering and deployed into the pulmonary vessel V through the vessel V, heart H, lung L. As used herein, it is believed that the surgical positioning instrument 10 may be deployed in any fluid carrying vessel that needs to be debris removed.

In use, the push / pull PI of the guidewire 40 may be extended through the pigtail 50 so that the pigtail 50 depends on the flexibility or rigidity of the first guidewire end 41 passing through. It can be straight or elongated within the vessel V (as shown in FIG. 2), or it can be at an angle such as the pigtail angle A. Further, the first rotation R1 of the elongated catheter 20 similarly rotates the pigtail 50 in the blood vessel V with the rotation R2. For both the pigtail angle A and the rotation R2, various positions of the first guide wire end 41 pass through the guide wire 40, the pig tail 50, and the second catheter end 22 through the blood vessel V, the heart H, and the lung L. Accurately maneuver and place the pigtail 50 within the vessel V, allowing it to meander, turn, steer a branch, or perform other vascular maneuvers so as to or within it. .. The purpose of the surgical positioning instrument 10 is preferably to place the pigtail 50 at a specific location within the patient's blood vessels.

As a result of the push / pull PI of the second member end 66, the deformable rim 67 with the rim inlet 69 and the mesh strainer 63 is in close proximity to the junction between the second catheter end 22 and the second. Exit or deploy through the instrument opening 25, pass through the second instrument opening 25 to a position close to the pigtail 50 in the vessel V, and then extend to the deformable rim 67 deployed with the mesh strainer 63. do.

Further, as a result of the rotation R3 of the second member end 66, a rotation R4 of the deformable rim 67 in the blood vessel V having the rim inlet 69 and the mesh strainer 63 is obtained, which further results in the retractable instrument 60 of the retractable instrument 60. Does the deformable rim 67 with the rim inlet 69 and mesh strainer 63 scoop up clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other unwanted materials or debris M from vessel V? , Or collect or capture.

Further, the rotation R1 of the elongated catheter 20 results in a rotation R2 of the pigtail 50 within the blood vessel V, which rotation R2 is further provided by contact or contact between the pigtail 50 and the deformable rim 67 to enter the rim. It results in a rotation R4 of a deformable rim 67 with 69 and a mesh strainer 63, which rotation R4 further provides a rim inlet 69 of the retractable instrument 60 and a deformable rim 67 with a mesh strainer 63. A plaque, embolus, thrombus (thrombus), fat deposit, biomaterial, or other unwanted material or debris M is to be scooped up, collected, or captured from vessel V.

As a result of the push / pull PI of the second member end 66, the folded deformable rim 67 with the rim inlet 69 and the mesh strainer 63 is stowed or entered in the second instrument opening 25. It reaches the first instrument opening 23 through the second lumen 32 and removes unwanted material or debris M trapped in the mesh strainer 63 from the blood vessel V. As used herein, such capture and recovery of undesired material or debris M is multiple passage, deployment, storage, and multiple passage, deployment, storage, and storage of the retractable instrument 60 through the second lumen 32 of the surgical positioning instrument 10. It may be achieved multiple times by recovery.

As used herein, angioplasty of the second lumen 32, atherectomy, and deployment of stents and stent grafts, procedures for treating vascular disease may be deployed through the second lumen 32. Conceivable. Such instruments often remove material or plaque from the vessel wall of vessel V, which can result in the formation of clumps or the release of biomaterials such as embolisms, unwanted materials or debris M. Can be large enough to enter the bloodstream, block smaller downstream blood vessels, and potentially block blood flow to the tissue. As a result, if the obstruction occurs in important tissues such as the heart, lungs, or brain, it can pose a serious threat to the patient's health or life. As used herein, a retractable instrument 60 can be utilized to traverse a second lumen 32 to capture and remove unwanted material or debris M from blood vessel V.

As used herein, a pigtail 50 surrounding the deformable rim 67 protects the blood vessel V as the deformable rim 67 expands, preventing contact with the blood vessel V and allowing the tissue or blood vessel in the unfolding area to come into contact with the blood vessel V. It is further believed that rifts can be prevented.

As used herein, the pigtail 50 surrounding the deformable rim 67 protects blood vessel V when the deformable rim 67 expands or contracts, preventing contact with blood vessel V, biopsy material, agglomerates. It is further believed that it can be prevented from slicing or puncturing the vessel or piercing the vessel wall of the vessel V.

As used herein, the second lumen 32 is another medical device, such as a suture for performing a biopsy, or other medical device to meet the needs of medical applications performed using the surgical positioning device 10. It is further believed that it can be used for delivery of instruments.

As used herein, it is believed that the second lumen 32 may be sized or configured to be adjustable to accommodate medical devices 60 of different diameters or sizes.

Referring here to FIG. 7, a flow chart utilizing a surgical positioning instrument 10 and a retractable instrument 60 to remove the release of agglomerates or embolisms, unwanted materials or biomaterials such as debris M from vessel V. 700 is shown. In the block or step 710, a surgical positioning instrument 10 is provided, which is an elongated member through which two or double axial bores such as the first lumen 31 and the second lumen 32 penetrate. 20 and the pigtail 50 at one end (folding the deformable rim 67, wrapping the mesh strainer 63 around the first member end 65, and opening the first instrument in the second lumen 32). (Insert into 23) and (by push / pull of PI at the end 66 of the second member) across the first instrument opening 23 and the second instrument opening 25 of the second lumen 32. It has an integrated retractable instrument 60 with a deformable rim 67 and a mesh strainer 63 as described above in FIGS. 1-6, including.

In the block or step 715, the guide wire 40 is operated or moved (by push / PI of the guide wire 40 or by rotating the elongated member 20 with R1) of the pigtail 50 for a route or vascular guidance device. The surgical positioning instrument 10 is repositioned to steer or advance, turn, branch, or perform other vascular maneuvers, and the pigtail 50 is made of material or debris M. Position in close proximity to.

In the block or step 720, the retractable instrument 60 by expanding the deployed deformable rim 67 with the mesh strainer 63 after passing through the second instrument opening 25 to a position close to the pigtail 50. (Deformable rim 67 and mesh strainer 63 are unfolded from the second lumen 32). When unfolded, the first deformable section 61 and the second deformable section 62 of the deformable rim 67 expand back to the uncompressed position.

In block or step 730, the deformable rim 67 and mesh strainer 63 are rotated by rotation R3 in close proximity to the material or debris M by rotating the second member end 66 of the retractable instrument 60. The result is a rotary R4 of the deformable rim 67 with a rim inlet 69 and a mesh strainer 63, which is further expanded and deformable with a retractable instrument 60 rim inlet 69 and a mesh strainer 63. The rim 67 scoops, collects, or captures clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other unwanted materials or debris M from vessel V. ..

In block or step 730, by rotating the elongated catheter 20, the deformable rim 67 and mesh strainer 63 are rotated with a rotation RI in close proximity to the material or debris M, resulting in rotation R2 of the pigtail 50. As a result of rotation R2, further contact or contact between the pigtail 50 and the deformable rim 67 results in rotation R4 of the deformable rim 67 having a rim inlet 69 and a mesh strainer 63, which further rotates R4. A deformable rim 67 with a retractable instrument 60 rim inlet 69 and a mesh strainer 63 can be a clot, plaque, embolus, thrombus (thrombus), fat deposit, biomaterial, or other unwanted material or debris. Make M scoop, collect, or capture from vessel V.

In block or step 735, clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other unwanted materials or debris M from vessel V are scooped up or collected in the mesh strainer 63. The material or debris M is collected in the mesh strainer 63 by either or by capturing.

In block or step 740, the rim 67, mesh strainer, which is deformable through the second instrument opening 25 of the second lumen 32 by folding the rim 67 deformable by the push / pull PI of the second member end 66. The 63 and the material or debris M are stored to retrieve the folded deformable rim 67 and the mesh strainer 63 is folded into the deformable rim 67 and / or the first member end 65. Alternatively, the retractable device 60, which may be wrapped and has an undesired material or debris M, can be pulled through or into the second device opening 25 and exit from the first device opening 23. ..

In the block or step 745, steps 715 to 740 are repeated.

Here, with reference to FIG. 8, exemplary embodiments of the flexible surgical positioning instrument 10 are shown, but not by limitation, as an example. The surgical positioning instrument 10 can include an access hub or port such as a suction port 90 located in close proximity to the handgrip 36 or the first catheter end 21. The suction port 90 may provide access to a first lumen 31 through the length of the elongated catheter 20, a pigtail lumen 31B of the pigtail 50, and a pigtail end 53, which are communicated with each other. May be good. Further, the surgical positioning instrument 10 can include a distal end such as a first tube end 81 and a proximal end or a side arm such as a suction tube 80 that can include a second tube end 82. Alternatively, it can include a conduit. The second tube end 82 may be fixed to the suction port 90 or detachably fixed. The suction tube 80 can include a three-way stop cock valve 84 with a cock bar 85. The cockbar 85 is between an open position for passage and suction, a detour position for diversion of the debris M to the threaded port and cap 83, and a closed position for sealing the second tube end 82. It may be rotated by (it may be a rotary type). Further, the surgical positioning instrument 10 can include a suction, vacuum or negative pressure device such as a suction device 70. The suction device 70 is delivered to a syringe having a housing or body such as a syringe barrel 72, a plunger 71 disposed therein and retracted or moved like a move M within the syringe barrel 72, and a syringe barrel 72. Can include an adapter port 73 and an adapter port 73 that provides an exit or inlet for the. The suction device 70 or, more specifically, the adapter port 73 is interconnected or detachably connected to a first tube end 81, preferably a suction tube 80, a suction port 90, an elongated catheter. Suction, vacuum, or suction S can be performed through the lumen 31 of 20 and the pigtail cavity 31B of the pigtail 50, and the pigtail end 53.

Here, with reference to FIG. 9, in the vicinity of, but not limited to, clots, plaques, embolisms, thrombi (thrombus), fat deposits, biomaterials, or other unwanted materials or debris M within blood vessel V. An exemplary embodiment of the pigtail 50 shown below is shown. Further, by suction or suction, the suction device 70 is preferably sucked, pulled, pulled (pulled / sucked), collected, or captured by the debris M into the pigtail end 53. As a result. Further, by continuous suction or suction by the suction device 70 (suction thrombectomy), the debris M is either pulled or the pigtail cavity 31B of the pigtail 50, the cavity 31 of the elongated catheter 20, the suction port 90, and The debris M is removed from the blood vessel y by traversing the suction tube 80 to the suction device 70.

In the present specification, it is considered that the pigtail 50 may have an extended configuration as shown in FIG. 2 instead of the curled configuration as shown in FIG. 5 during suction or suction (suction thrombus removal) of the debris M. Be done.

Now with reference to FIG. 10, the surgical positioning instrument 10 and the retractable instrument 60 are utilized to release a clot or embolus, an unwanted material or a biomaterial such as debris M from the blood vessel V by suction or suction. The flow chart 1000 to be removed is shown. In block or step 1010, a surgical positioning instrument 10 is provided, the surgical positioning instrument comprising two or double axial bores that penetrate such as the first lumen 31 and the second lumen 32. It comprises an elongated member 20, a pigtail 50 at one end, and a suction port 90, a suction tube 80, and a suction device 70 as described above in FIGS. 8-9.

In block or step 1015, the first catheter end 21 is manipulated or moved to reposition the pigtail 50 for a pathway or vascular guidance device to allow the surgical positioning instrument 10 to pass through vessel V. To steer or advance, turn, branch, or perform other vascular maneuvers, and place the pigtail 50 in close proximity to the material or debris M at block or step 1020.

In the block or step 1030, the suction device 70 is operated (sucked or sucked) to collect and capture the debris M in the pigtail end 53. Further, by continuous suction or suction (suction thrombectomy) step 1040 by the suction device 70, the debris M is pulled or the pigtail lumen 31B of the pigtail 50, the lumen 31 of the elongated catheter 20, the suction port 90. , And across the suction tube 80 to reach the suction device 70 (step 1050), whereby the debris M is removed from the blood vessel V.

The above description and drawings include exemplary embodiments of the present disclosure. Although exemplary embodiments have been described as described above, those skilled in the art are merely exemplary within the disclosure, and various other alternatives, conforming forms, and modifications within the scope of the present disclosure. Please note that you can do. Simply enumerating or numbering the steps of a method in a particular order does not constitute any restrictions on the order of the steps of the method. Many modifications and other embodiments of the present disclosure will come to mind to those skilled in the art relating to the present disclosure, who benefit from the above description and the teachings presented in the relevant drawings. Although specific terms may be used herein, they are used only in a general and descriptive sense and are not used for limited purposes. Further, although this disclosure has been described in detail, it is understood that various changes, substitutions, and modifications may be made without departing from the spirit and scope of the disclosure as defined by the appended claims. sea bream. Accordingly, the present disclosure is not limited to the particular embodiments shown herein, but only to the extent of the appended claims.

Claims (21)

A remote-controlled surgical device, wherein the surgical device is
A flexible positioning device, an elongated catheter having an internal double luminal bore extending from the end of the first catheter to the end of the second catheter, wherein the double luminal bores are all first. It has an elongated catheter with one lumen and a second lumen, and a pigtail attached to the end of the second catheter, the first lumen passing through the elongated catheter and the pigtail. And the second lumen extends through the elongated catheter, with a flexible positioning device.
A guide wire that is extendable through the first lumen of the elongated catheter and extendable from the pigtail and is configured to tilt the pigtail.
A remote-controlled surgical device comprising a suction device coupled to the first lumen and configured to create a vacuum in the first lumen of the elongated catheter and in the pigtail. The remote control according to claim 1, further comprising a guide wire inlet opening located close to the first catheter end and a guide wire outlet opening located close to the pigtail end of the pigtail. Surgical device. The remote-controlled surgical device of claim 1, wherein the rotation of the elongated catheter results in the rotation of the pigtail. The remote-controlled surgical device of claim 1, further comprising a handgrip secured to the end of the first catheter. The remote-controlled surgical device of claim 3, wherein the pigtail is disposed at a location within a patient's blood vessel. The first aspect of claim 1, further comprising a first instrument opening located close to the first catheter end and a second instrument opening located close to the second catheter end. Remote control surgical device. The remote-controlled surgical device of claim 1, wherein the pigtail further comprises a pigtail lumen communicating with the first lumen. The remote-controlled surgical device of claim 7, further comprising a suction port located close to the end of the first catheter, wherein the suction port communicates with the first lumen. The remote-controlled surgical device of claim 8, further comprising a suction tube having a first tube end and a second tube end, wherein the second tube end communicates with the suction port. The remote-controlled surgical device according to claim 9, further comprising a suction device that communicates with the first tube end. 10. The remote-controlled surgical device of claim 10, wherein the suction device further comprises a syringe having a syringe barrel, a plunger disposed within the syringe barrel, and an adapter port exiting the syringe barrel. The remote-controlled surgical device of claim 9, wherein the suction tube comprises a stop cock valve having a cock bar that rotates between an open position, a detour position, and a closed position. 10. The remote-controlled surgical device of claim 10, wherein the rotation of the first catheter end results in the rotation of the pigtail end adjacent to the internal biomaterial. 13. The suction in the suction device creates a suction force in the suction tube, the suction port, the first cavity, and the pigtail tube, and collects the biomaterial inside the suction tube. The remote controlled surgical device described. 14. The remote-controlled surgery of claim 14, wherein further suction within the suction device sucks the biomaterial into the suction device through the pigtail cavity, the first cavity, the suction port, and the suction tube. device. A method for removing biomaterials from a patient's blood vessels.
A step in providing a remote-operated surgical device, said remote-operated surgical device, is a flexible positioning instrument with an internal double luminal bore extending from the end of the first catheter to the end of the second catheter. The double lumen bore is an elongated catheter having a first lumen and a second lumen, and a pigtail attached to the end of the second catheter. The flexible positioning device and the elongated catheter, wherein the first lumen extends through the elongated catheter and the pigtail, and the second lumen extends through the elongated catheter. A guide wire that is extendable through the first lumen and the pigtail and is coupled to the first lumen and configured to create a vacuum in the first lumen and the pigtail of the elongated catheter. With a suction device, the steps to provide,
The step of maneuvering the operational surgical device through the patient's blood vessels,
The step of placing the pigtail in close proximity to the biomaterial,
The step of sucking the suction device and
A method comprising collecting the biomaterial into the first lumen. 16. The method of claim 16, further comprising moving the guide wire within the first lumen to straighten the pigtail at an angle. 16. The method of claim 16, further comprising a step of rotating the first catheter end, thereby rotating the pigtail in close proximity to the biomaterial. 16. The method of claim 16, further comprising moving the guide wire within the first lumen to bringing the pigtail into close contact with the biomaterial. 18. The method of claim 18, further comprising rotating the first catheter end to rotate the pigtail in close proximity to the biomaterial. 20. The method of claim 20, further comprising sucking the biomaterial through the first lumen and collecting the biomaterial into the suction device.

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