WO2024158529A1 - Soulagement des douleurs dorsales et/ou reconstruction des disques intervertébraux - Google Patents
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools for implanting artificial joints
- A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8897—Guide wires or guide pins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
Definitions
- This invention relates to medical devices, medications and methods to relieve common back, leg, arm or neck pain and rebuild the disc matrix.
- Intervertebral discs are avascular. Oxygen, nutrients and pH buffer are diffused from capillaries in endplates of the vertebral bodies into the thick avascular discs. Disc degeneration and common back pain are mostly caused by diffusion hindrance into the mid-layer of the thick avascular intervertebral disc.
- An intervertebral conduit is implanted through a cannula by a solid advancer into the avascular disc to re-establish transport of oxygen, nutrients and pH buffer from the endplates into the mid-layer of the thick avascular disc.
- FIG. 1 shows capillaries 107 ending at the endplates 105 of the vertebral bodies 159 to supply oxygen, nutrients and pH buffer into the avascular intervertebral disc 100.
- FIG. 2 shows diffusion of nutrients/oxygen 131 and pH buffer 131 from capillaries 107 in endplates 105 to feed and maintain cells in the disc 100.
- FIG. 3 shows calcified layers 108 at the endplates 105, hindering diffusion of nutrient/oxygen and pH buffer 131 from capillaries 107. Lactic acid 162 is formed from anaerobic metabolism, leaking and burning nerves 118 to cause chronic discogenic pain.
- FIG. 4 shows a graph of oxygen pressure versus distance from endplate.
- FIG. 5 shows a photo of a hollow cavity 121 or fissure 121 caused by chronic starvation and hypoxia in the mid-layer of a cadaveric disc 100.
- FIG. 6 shows leakage of lactic acid' 162, burning or irritating the nerves 118 or nerve root 194 to cause chronic pain.
- FIG. 7 shows lactic acid 162 leaking through fissure 121 at the weakened 114 annulus 378 to cause the acid bum and pain.
- FIG. 8 shows a cavity 110 from disc degradation during starvation at the mid-layer, but nutrient/oxygen 131 and growth factor 160 are available near endplates 105.
- FIG. 9 shows an MRI image of a spine with no visible impingement from a degenerated disc 100D.
- the white dot is called the high intensity zone 135.
- FIG. 10 shows MRI scan to quantify lactic acid and proteoglycans in a degenerated disc 100D; high lactic acid and low proteoglycans correlate with discogenic pain.
- FIG. 11 shows a small spinal needle 460 for injecting X-ray contrast to expel the lactic acid 162 to diagnose discogenic pain, followed by a spinal needle 102.
- FIG. 12 shows a guide wire 103 replacing the small spinal needle 460.
- FIG. 13 shows a cone head 529 dilator 220 replacing the spinal needle 102.
- FIG. 14 shows a cannula 230 with a lumen 268 and snagging points 231.
- FIG. 15 shows the cannula 230 sliding over the cone head 529 dilator 220.
- FIG. 16 shows an intervertebral conduit 126 and a solid wire 101 as an advancer 101 containing a relatively flat side 278, base 616 and grippers 111.
- FIG. 17 shows a position of a handle 618 to identify or orient the flat side 278 of the advancer 101, and the grippers 111 extend from the base 616.
- FIG. 18 shows the rotational capability of the advancer 101 from the flat side 278.
- FIG. 19 shows 90° rotation of the handle 618 of the advancer 101 from FIG. 17 to show the lateral view of the flat side 278.
- FIG. 20 shows the oblique rotational position of the advancer 101 to expose the protrusion of the flat side 278.
- FIG. 21 shows a cross section of a disengaging position between the advancer 101 and conduit 126 in the lumen 268 of the cannula 230.
- FIG. 22 shows a cross section of an engaging position between the advancer 101 and conduit 126, where the flat side 278 and/or the gripper 111 engages the conduit 126.
- FIG. 23 shows a single gripper 111 protruded from the base 616.
- FIG. 24 shows another single gripper 111 protruded from the base 616.
- FIG. 25 shows the engaging position of the base 616 and gripper 111 of the advancer 101 to engage and push the conduit 126 out of the lumen 268 of the cannula 230.
- FIG. 26 indicates that the advancer 101 converts from the engaging position to disengaging position and partially withdraws into the cannula 230.
- FIG. 27 shows the advancer 101 re-engaging from the disengaging position to the engaging position to push or advance another section of the conduit 126 into the disc 100.
- FIG. 28 shows the conduit 126 winding on a transparent bobbin 152 inside a transparent cartridge 150 with a scale 145 for measuring the amount of conduit 126.
- FIG. 29 shows a cannula handle 132 containing a funnel 492 opening into the lumen 268 of the cannula 230, and a cartridge support 627 containing a male latch 626.
- FIG. 30 shows engagement of the male 626 and female 625 latches to position the cartridge support 627 with the cartridge 150, and the conduit 126 near the funnel 492.
- FIG. 31 shows repetitive advancement in FIG. 25 and partial withdraw in FIG. 26 of the advancer 101 to fill the hollow disc 100 with the conduit 126.
- FIG. 32 shows cutting of the conduit 126 proximal to the cannula handle 132, followed by repetitive advancement and withdraw of the advancer 101 to deposit the remaining conduit 126 in the cannula 230 into the disc 100.
- FIG. 33 shows an elastically curved advancer 101 depositing the conduit 126 toward the center of disc 100.
- FIG. 34 shows the conduit 126 delivery devices with markers to indicate equivalent depths between the device in patient and the subsequent delivery devices.
- FIG. 35 shows an ilium 140 blocking or shielding the L5-S1 disc 100A and L4-5 disc 100B.
- FIG. 36 shows a slanted entry of the spinal needle 102 sliding over the ilium 140 into the lower lumbar disc 100.
- FIG. 37 shows an off-central entry into the lower lumbar disc 100 due to blockade of the ilia 140 in FIGS. 35 and 36.
- FIG. 38 shows an elastically curved sleeve 165 containing a lumen 166, a handle 167 and a marker 174 showing the concave side of the curved sleeve 165.
- FIG. 39 shows a straight, rigid and cone-head 529 dilator 220 for straightening the elastically curved sleeve 165.
- FIG. 40 shows insertion of the resiliently straightened sleeve 165 into the disc 100.
- FIG. 41 shows withdraw of the rigid dilator 220 to resume the curvature of the sleeve 165.
- FIG. 42 shows inserting an elastic cannula 230 into the curved sleeve 165, followed by an elastic advancer 101 to implant the conduit 126 similar to FIG. 33.
- FIG. 43 shows implanting of the conduit 126 similar to FIGS. 25-27.
- FIG. 44 shows re-straightening of the curved sleeve 165 by re-inserting the rigid dilator 220 before withdrawing.
- FIG. 45 shows the repaired disc 100 after the withdraw of the sleeve 165 and dilator 220.
- FIG. 46 shows markers on the sequential delivery devices to align the distal ends to minimize X-ray exposure from the fluoroscope.
- FIG. 47 shows a conduit 126 through a window 601 and lumen 602 of a conduit holder 600.
- the holder 600 can be called a tube 600.
- FIG. 48 shows a handle 630 of the holder 600 and a transparent bobbin 152 anchored by a pin 146 or screw 146.
- FIG. 49 shows another wire 101 as the advancer 101 with a flat side 278, base 616, gripper 111 and a cylindrical side 279.
- a step 653 transitions to the flat side 278.
- FIG. 50 shows transition from the disengaging to engaging position of the advancer 101 with the conduit 126.
- Cross sections B and C are shown in FIG. 51 and FIG. 52.
- FIG. 51 shows the gripper 111 engaging the conduit 126 at the window 601.
- FIG. 52 shows the conduit 126 draping outside the holder 600.
- FIG. 53 shows the engaging position of the advancer 101 engaging and pushing the conduit 126 out of the holder 600.
- Cross section D is shown in FIG. 54.
- FIG. 54 shows that the flat side 278 of the advancer 101 and the conduit 126 are sized and configured to fit within the lumen 602 of the holder 600.
- FIG. 55 shows a step 653 transitioning from the stem 615 to the flat side 278 to stop the advancer 101 from excessively advancing the conduit 126.
- FIG. 56 shows partial withdraw and the disengaging position of the advancer 101; the spikes 604 or one-way valve 604 keep the conduit 126 outside the holder 600.
- FIG. 57 shows re-engagement from the disengaging to engaging position to readvance the advancer 101 to engage and deploy more conduit 126.
- FIG. 58 shows partial withdrawal of the advancer 101 below the window 601 to disengage the advancer 101 from the conduit 126.
- FIG. 59 shows repetitive engaging and disengaging positions by advancing and withdrawing the advancer 101 to fill the hollow disc 100.
- FIG. 60 shows an elastically curved advancer 101 with the flat 278 and cylindrical 279 sides, base 616, gripper 111, step 653, and marker 652 to show the flat 278 side.
- FIG. 61 shows a slanted window 601 indicated by a marker 646 on the holder 600 at angle 0 to facilitate advancement of the conduit 126 by the advancer 101.
- FIG. 62 shows the engaging position of the elastically curved advancer 101 with the gripper 111 to engage and advance the conduit 126 from the window 601.
- FIG. 63 shows a cross section of the advancer 101 showing the semi-cylindrical side 279, flat side 278, grippers 111 and the base 616 engaging the conduit 126.
- FIG. 64 shows partial withdraw of the advancer 101 into the holder 600 to reach the disengaging position beneath the window 601.
- FIG. 65 shows a narrow distal portion 655 of the advancer 101.
- FIG. 66 shows another narrow distal portion 655 of the advancer 101 extending from the lumen 602 of the holder 600.
- FIG. 67 shows a bend 654 at distal portion 655 bending from the flat 278 toward the semi-cylindrical 279 side of the curved advancer 101.
- FIG. 68 shows an indentation 614 at the distal portion 655 of the advancer 101.
- FIG. 69 shows the side view of the indentation 614 and the distal plane 113 distal to the bend 654 of the elastically curved advancer 101.
- FIG. 70 shows the distal portion 655 sliding in the lumen 602 of the holder 600 to transition from the disengaging to engaging position between the advancer 101 and the conduit 126.
- FIG. 71 shows the engaged position between the advancer 101 and the conduit 126 with the indentation 614 cradling or holding the conduit 126 out of the holder 600.
- FIG. 72 shows the grippers 111 engaging the conduit 126, and the indentation 614 cradling the conduit 126.
- FIG. 73 shows that the flat portion 278 of the elastically curved advancer 101 and the conduit 126 are sized and configured to fit in the lumen 602 of the holder 600.
- FIG. 74 shows the one-way-valve 604 holding the conduit 126 from returning to the lumen 602 of the holder 600 during transition, from the engaging to disengaging position.
- FIG. 75 shows the gripper 111 on the convex side 279 or semi-cylindrical side 279 of the elastically curved advancer 101.
- FIG. 76 shows the gripper 111 and base 616 on convex side 279 or semi-cylindrical side 279, a flat 278 side and a bend 654 at the distal portion 655 of the advancer 101.
- FIG. 77 shows the base 616 and gripper 111 of the advancer 101 in the disengaging position sliding in the lumen 602 of the holder 600.
- FIG. 78 shows the engaged position between the advancer 101 and the conduit 126 at the window 601 of the holder 600.
- FIG. 79 shows another advancer 101 with a semi-cylindrical side 279 and a flat 278 side, longitudinal trough 619, base 616 and grippers 111 at the distal end.
- FIG. 80 shows that the trough 619 is sized and configured to fit the conduit 126 in the disengaging position between the advancer 101 and the conduit 126.
- FIG. 81 shows a slight rotation of the semi-cylindrical advancer 101.
- FIG. 82 shows the engaging position between the conduit 126 and the advancer 101 with the gripper 111 and base 616.
- FIG. 83 shows a lateral view of the semi-cylindrical advancer 101, flat side 278, semi-cylindrical 279 side, trough 619, gripper 111, and base 616.
- FIG. 84 shows the engaging position between the advancer 101 and the conduit 126 at the window 601 of the holder 600.
- Cross section E is shown in FIG. 85.
- FIG. 85 shows the engaging position to engage a gripper 111 with the conduit 126.
- FIG. 86 shows the engaging position of the advancer 101 to engage and advance the conduit 126 out of the holder 600.
- FIG. 87 shows converting from the engaging to disengaging position by partially withdrawing the advancer 101.
- Cross sections F, G, and H are shown in FIGS. 88-90.
- FIG. 88 shows the disengaging position between the trough 619 and the conduit 126.
- FIG. 89 shows that the trough 619 in disengaging position is sized and configured to, fit the conduit 126 extending from the window 601.
- FIG. 90 shows the draping conduit 126 outside the holder 600.
- FIG. 91 shows partial withdraw of the advancer 101 proximal to the window 601.
- FIG. 92 shows conversion from disengaging to engaging position by re-advancing the advancer 101 to deploy additional conduit 126.
- FIG. 93 depicts repetition of engaging and disengaging positions by slightly rotating and advancing, and by slightly counter rotating and withdrawing the advancer 101.
- FIG. 94 shows a cannula handle 132 containing a funnel 492 open into the lumen 268 of the cannula 230, and a cartridge support 627 containing a male latch 626.
- FIG. 95 shows the assembly of the holder 600, advancer 101, and conduit 126 extending from an opening 151 of the transparent cartridge 150 with a scale 145.
- FIG. 96 shows engagement of the male 626 and female 625 latches to position the cartridge 150 with the cannula handle 132, and the conduit 126 near the funnel 492.
- FIG. 97 shows a curved advancer 101 to direct and deliver the conduit 126.
- FIG. 98 shows a screw-like or spiral augur 111 as gripper 111 of the advancer 101 to advance the conduit 126 out of the holder 600 by rotating the advancer 101.
- FIG. 99 shows a cutter 605 with a razor 606 at the distal end and a lumen 611 sized and configured to fit over the holder 600 in Figure 101.
- FIG. 100 shows the cutter handle 607 with ridges 609 to facilitate rotation, distal protrusion 608 for advancing and proximal protrusion 610 for withdrawing.
- FIG. 101 shows the cutter 605 sliding over the holder 600 to cut the conduit 126 at the window 601 by rotating and advancing the cutter 605.
- FIG. 102 shows cutting of the conduit 126 by the cutter 605 in the cannula 230
- FIG. 103 shows the cutter 605 and holder 600 operating through the funnel 492 leading into the lumen 268 of the cannula 230.
- FIG. 104 shows filling the nucleus 128 of the disc 100 with the conduit 126 through the cannula 230, cutter 605, holder 600, and advancer 101.
- FIG. 105 shows injection of saline 131, pH buffer 131, antacid 131, nutrients 131, medicine 160, and/or cells 277 into the disc 100 through the conduit 126.
- FIG. 106 shows closure of the annulus 378 of the repaired disc 100.
- FIG. 107 shows a wire 600 as a holder 600 with a loop 601 as the window 600.
- FIG. 108 shows cutting the conduit 126 by applying tension on the wire loop 601, advancing and rotating of the cutter 605.
- FIG. 109 shows a cutter 605 with razor edges 606, sharp tip 656 and a lumen 611.
- FIG. 110 shows a lateral view of the cutter 605, a marker 657 aligned with the sharp tip 656.
- FIG. I l l shows the cutter 605 entering the proximal lumen 602 of the holder 600.
- the sharp tip 656 engages the conduit 126 extending from the window 601.
- FIG. 112 shows penetration of the sharp tip 656 of the cutter 605 into the conduit 126 to hold the conduit 126 stationary.
- FIG. 113 shows advancement of the cutter 605 to cut the conduit 126 with the razor edges 606.
- FIG. 114 shows sharp lateral opening 643 and proximal opening 641 of the window 601 of the holder 600.
- the advancer 101 holds the conduit 126 stationary.
- FIG. 115 shows holding the advancer 101 stationary, rotating and advancing the holder 600 to cut the conduit 126 by the sharp lateral 643 and proximal opening 641.
- FIG. 116 shows the conduit 126 absorbing the lactic acid 162 and bridging between the diffusion zones of nutrient, oxygen and pH buffer 131 from superior and inferior endplates 105.
- FIG. 117 shows transport of nutrients, oxygen, pH buffer 131 and growth factor 160 from the diffusion zones through the conduit 126 into the mid-disc layer 100.
- FIG. 118 shows increased disc height and low disc pressure during the relaxation cycle of the disc 100.
- FIG. 119 shows absorption of nutrients, oxygen and pH buffer bicarbonate 131 from endplates 105 circulation into the conduit 126 especially during low disc pressure.
- FIG. 120 shows decreased disc height and high disc pressure during the compression cycle of the disc 100.
- FIG. 121 shows discharge of nutrients, oxygen and pH buffer bicarbonate 131 from the conduit 126 during the compression cycle of the disc 100.
- FIG. 122 shows formation of proteoglycans 112 between strands of the braided nylon conduit 126 or suture 126 after 3 months in sheep disc in a histology slide.
- FIG. 123 shows formation of proteoglycans 112 between filaments in a strand of the. braided nylon conduit 126 or suture 126 at 12 months in sheep disc 100 in histology.
- FIG. 124 depicts hydration from the newly formed proteoglycans 112 to increase swelling pressure and elevate disc 100 height to lift the inferior articular process 143 to relieve the facet 129 loading and pain.
- FIG. 125 shows a healthy disc 100 supporting the facet joint 129, and a flattened disc 100D transferring load to erode the facet joint 129B.
- FIG. 126 depicts the conduit 126 serving as a nutrient and oxygen 131 spigot 126 and a scaffold 126 for cell 277 attachment to make proteoglycans 112, growth factor 160 and/or biologies 160.
- FIG. 127 shows the conduit 126 implanted between 0 mm and 10 mm from at least one of the superior and inferior endplates 105 to absorb nutrients, pH buffer and oxygen 131 to produce proteoglycans 112 and collagen 112.
- FIG. 128 shows a graph of relative concentration of lactic acid, bicarbonate, oxygen, and nutrients between the diffusion zones of a degenerated disc.
- FIG. 129 shows transport of lactic acid, bicarbonate, oxygen, and nutrients through the conduit 126 between the diffusion zones of a repaired disc.
- FIG. 130 shows braided strands 104 to form the conduit 126.
- FIG. 131 shows woven strands 104 to form the conduit 126.
- FIG. 132 shows knitted strands 104 to form the conduit 126.
- FIG. 133 depicts a slanted cut of the conduit 126 to show the slanted orientations of strands 104 relative to lengthwise of the conduit 126.
- FIG. 134 shows a cross-section of the conduit 126 made with parallel strands 104 wrapped, encircled, covered or enveloped by a sheath 127 or cover 127.
- FIG. 135 shows a cross-section of the conduit 126 made with parallel tubes 104 wrapped, encircled, covered or enveloped by a sheath 127 or cover 127.
- FIG. 136 shows a cross-section of the conduit 126 made with sponge 126 or foam 126 with pores 124.
- FIG. 137 shows a cross-section of a conduit 126 made with water-absorbing material 126.
- Intervertebral discs 100 are avascular.
- FIG. 1 shows capillaries 107 ending at the endplates 105 of the vertebral bodies 159 to supply oxygen, nutrients and pH buffer into the thick avascular intervertebral disc 100.
- FIG. 2 shows diffusion of nutrients/oxygen 131 and pH buffer 131 from capillaries 107 in the superior and inferior endplates 105 to feed and maintain cells in the disc 100. Thickness of human intervertebral disc varies; cervical disc is approximately 3-5 mm; thoracic disc is approximately 3-4 mm; and lumbar disc is approximately 7-12 mm.
- FIG. 3 shows calcified layers 108 at the endplates 105, blocking or hindering diffusion of nutrient/oxygen 131 and pH buffer 131 from capillaries 107 into the disc 100.
- Lactic acid 162 is formed from anaerobic metabolism, leaking and burning nerves 118 to cause chronic discogenic pain.
- FIG. 4 shows a graph of oxygen pressure versus distance from endplate, indicating oxygen content is low around the mid-disc layer.
- FIG. 5 shows a photo of a hollow cavity 121 or fissure 121 in the mid-layer of a cadaveric disc 100, probably caused by chronic starvation and hypoxia.
- FIG. 6 shows leakage of lactic acid 162, burning or irritating the nerves 118 or nerve root 194 to cause back, leg, arm and/or neck pain.
- FIG. 7 shows lactic acid 162 leaking through a fissure 121 at the weakened 114 annulus 378 to cause the acid burn and pain.
- FIG. 8 shows a cavity 110 at mid-layer from degradation of the nucleus 128 during starvation, while nutrient/oxygen 131 and growth factor 160 are available near the endplates 105.
- FIG. 9 shows an MRI image of a spine with no visible impingement from a degenerated disc 100D. The white dot is the high intensity zone 135, a possible location of lactic acid leakage or chronic inflammation sensitive to the acid bum.
- FIG. 10 shows an RI scan to quantify lactic acid and proteoglycans in a degenerated disc 100D; high lactic acid and low proteoglycans correlate with discogenic pain from lactic acid 162 bum.
- FIG. 11 shows a small spinal needle 460 for injecting X-ray contrast to expel the lactic acid 162 to diagnose discogenic pain, followed by sliding a spinal needle 102 into the painful disc 100.
- FIG. 12 shows a guide wire 103 replacing the small spinal needle 460.
- FIG. 13 shows a cone head 529 dilator 220 replacing the spinal needle 102 by sliding over the guide wire 103 in the lumen 116 of the dilator 220.
- FIG. 14 shows a cannula 230 with a lumen 268, snagging points 231 at the distal end.
- the cannula 230 can also be called a tube 230 or a sheath 230.
- FIG. 15 shows the cannula 230 sliding over the cone head 529 dilator 220.
- the lumen 268 of the cannula 230 is sized and configured to fit the dilator 220.
- FIG. 16 shows an intervertebral conduit 126 containing a first protrusion 463, a bendable portion 139, a second protrusion 462 and distal end 117.
- the length 122 between the first protrusion 463 and distal end 117 is 1 mm to 20 mm.
- a solid wire 101 is an advancer 101 containing stem 615, a relatively flat side 278, base 616 and grippers 111 for engaging the intervertebral conduit 126 in FIG. 16.
- FIG. 17 shows a position of a handle 618 to identify or orient the flat side 278 of the advancer 101.
- FIG. 18 shows the rotational capability of the advancer 101 from the flat side 278.
- FIG. 19 shows 90° rotation of the handle 618 of the advancer 101 from FIG.
- FIG. 20 shows the oblique rotational position of the advancer 101 to expose the protrusion of the flat side 278.
- FIG. 21 shows a cross section of a disengaging position between the advancer 101 and conduit 126 in the lumen 268 of the cannula 230. The disengaging position can also be called the position 1 between the flat side 278 of the advancer 101 and the conduit 126.
- the solid advancer 101 contains a relatively flat side 278, base 616, grippers 111 and a relatively semi-cylindrical side 279. In the disengaged position or position 1, the flat side 278 is not in substantial contact with the conduit 126.
- FIG. 22 shows a cross section of an engaged position or position 2 between the advancer 101 and conduit 126.
- the flat side 278, the gripper 111 and/or base 616 of the advancer 101 are in contact with the conduit 126 in the lumen 268 of the cannula 230.
- Changing from the disengaged position to the engaged position is by rotation of the advancer 101 to orient or position the flat side 278 containing the base 616 and/or gripper 111 to engage with the conduit 126.
- FIG. 23 shows a single gripper 111 protruded from the base 616.
- FIG. 24 shows another single gripper 111 protruded from the base 616.
- FIG. 25 shows the engaged position or position 1 of the advancer 101 to engage and push the conduit 126 into the nucleus 128 of the disc 100 with the base 616 and/or the gripper 111 of the advancer 101.
- FIG. 26 indicates that the advancer 101 retracts from the engaged position to disengaged position by partially withdrawing the advancer 101 into the cannula 230.
- FIG. 27 shows that the advancer 101 converts from the disengaging position to the engaging position to engage and advance another section of the conduit 126 into the disc 100.
- FIG. 28 shows the conduit 126 spooled on a transparent bobbin 152 mounted by a holding pin or screw 146 inside a transparent cartridge 150 with a scale 145 for measuring the amount of conduit 126 in the bobbin 152.
- the cartridge 150 contains an anterior panel 620, left lateral panel 621, right lateral panel 622, bottom panel 624, and a posterior panel 623 containing a female latch 625.
- the first 463 and second 462 protrusions of the conduit 126 extend from an opening 151 of the cartridge 150.
- FIG. 29 shows a cannula handle 132 containing a funnel 492 opening into the lumen 268 of the cannula 230, and a cartridge support 627 containing a male latch 626, left 628 and right 629 rails at the proximal end 499 of the cannula handle 132.
- FIG. 30 shows engagement of the male 626 and female 625 latches to position the cartridge 150 with the cartridge support 627 and the first 493 and second 492 protrusions of the conduit 126 to the funnel 492.
- FIG. 31 shows repetitive advancement in FIG. 25 and partial withdraw in FIG. 26 of the advancer 101 to fill the hollow disc 100 with the conduit 126.
- FIG. 32 shows cutting of the conduit 126 proximal to the cannula handle 132, followed by repetitive advancement and withdraw of the advancer 101 to deposit the remaining conduit 126 in the cannula 230 into the disc 100.
- FIG. 33 shows an elastically curved advancer 101 depositing the conduit 126 toward the center of disc 100.
- Markers on the conduit 126 delivery devices are used to indicate the similar depth or evenness of the distal ends of the devices to minimize the need for X-ray viewing and radiation exposure to the patient and physician.
- Annulus 378 contains mostly collagen with a net-like structural orientation.
- the spinal needle 102 with a single sharp point can penetrate through the net-like collagen in annulus 378.
- distal ends of subsequent devices have fork-like configurations with bases 616 between grippers 111 to be trapped or stopped by the net-like collagen.
- the folk-like distal ends are designed to operate within the relatively hollow nucleus 128 and cannot go through the collagen in the anterior annulus 378 to prevent puncturing the blood vessels anterior to the disc 100, including the abdominal aorta, left renal artery, inferior vena cava, or left renal vein.
- FIG. 34 shows the conduit 126 delivery devices with markers to indicate equivalent depths between current and subsequent delivery devices.
- the proximal end marker 157 on the guide wire 103 faces the physician.
- the spinal needle marker 155 on the guide wire 103 reaches the luer lock 531 of spinal needle 102, distal ends the spinal needle 102 and guide wire 103 are even or at a similar depth.
- the proximal end marker 506 on the dilator 220 faces the physician.
- proximal end marker 506 of the dilator 220 reaches the dilator marker 156 on the guide wire 103, distal ends of the guide wire 103 and dilator 220 are even.
- proximal handle 499 of the cannula 230 reaches the cannula marker 505 on the dilator 220, distal ends of the dilator 220 and cannula 230 are even.
- cannula marker 153 on the advancer 101 reaches the proximal handle 499 of the cannula 230, distal ends of the advancer 101 and cannula 230 are even.
- FIG. 35 shows an ilium 140 blocking or shielding the L5-S1 disc 100A and L4-5 disc 100B.
- FIG. 36 shows a slanted entry of the spinal needle 102 sliding over the ilium 140 into the lower lumbar disc 100, incapable of entering into the center of the lower lumbar disc 100 as shown in FIG. 37.
- the mid portions of the superior and inferior endplates 105 in FIG. 2 provide the highest permeation of nutrients/oxygen, pH buffer 131 from capillaries 107 into the thick avascular disc 100.
- FIG. 38 shows an elastically curved sleeve 165 containing a lumen 166, a handle 167 and a marker 174 showing the concave side of the curved sleeve 165.
- FIG. 39 shows a straight, rigid and cone-head 529 dilator 220 for straightening the elastically curved sleeve 165.
- FIG. 40 shows insertion of the resiliently straightened sleeve 165 into the disc 100.
- FIG. 41 shows withdraw of the rigid dilator 220 to resume the curvature of the sleeve 165.
- FIG. 42 shows inserting an elastic cannula 230 into the curved sleeve 165, followed by the advancer 101 to implant the conduit 126, similar as FIG. 25.
- FIG. 43 shows implanting of the conduit 126 by repeatedly advancing and withdrawing to engage and disengage between the advancer 101 and conduit 126 to fill the disc 100.
- FIG. 44 shows re-straightening of the curved sleeve 165 by re-inserting the rigid dilator 220 before withdrawing.
- FIG. 45 shows the repaired disc 100 after withdrawing of the sleeve 165 and dilator 220.
- FIG. 46 shows markers on the sequential delivery devices to align the distal ends to minimize the need of X-ray viewing and exposure from the fluoroscope.
- the proximal end marker 176 on the guide wire 103 faces the physician.
- the spinal needle marker 155 on the guide wire 103 reaches the luer lock 531 of spinal needle 102, distal ends the spinal needle 102 and guide wire 103 are even or at the similar depth.
- the proximal end marker 178 on the dilator 220 faces the physician.
- the proximal end marker 178 on the dilator 220 reaches the dilator marker 175 on the guide wire 103, distal ends of the guide wire 103 and dilator 220 are even.
- FIG. 47 shows a conduit 126 through a window 601 and lumen 602 of a conduit holder 600.
- the conduit holder 600 can also be called a tube 600 or sheath 600.
- the distal end of the holder 600 contains spikes 604 or one-way valve 604.
- a marker 649 shows the side of the window 601. Sizes of the first 463 and/or second 462 protrusions are larger than the lumen 602 of the holder 600.
- FIG. 48 shows a handle 630 of the holder 600 and a transparent bobbin 152 anchored by a pin 146 or screw 146.
- the conduit 126 from the bobbin 152 leads into the window 601 of the holder 600 as shown in FIG. 47.
- the bobbin 152 can also be housed in a transparent cartridge 150 with a scale 145, as shown in FIG. 28.
- FIG. 49 shows another wire 101 as the advancer 101 with a flat side 278, a base 616, a gripper 111, and a cylindrical side 279.
- a step 653 transitions between the flat side 278 and a stem 615 of the advancer 101.
- a marker 652 on a stem 615 shows the flat side 278 of the advancer 101.
- FIG. 50 shows the transition from the disengaging position to engaging position between the gripper 111 of the advancer 101 and the conduit 126 at the window 601 of the conduit holder 600.
- Cross sections B and C are shown in FIGS. 51-52.
- FIG. 51 shows the gripper 111 engaging the conduit 126 at the window 601 of the holder 600.
- the cylindrical side 279 of the advancer 101 slides along and supported by the inner wall 617 of the holder 600.
- FIG. 52 shows the semi- cylindrical side 279 is supported by the inner wall 617 of the holder 600 during advancement of the advancer 101 to pull the conduit 126 from outside through the window 601 of the holder 600.
- FIG. 53 shows the engaging position of the advancer 101 engaging the conduit 126 with the base 616 and/or gripper 111.
- Cross section D is shown in FIG. 54.
- FIG. 54 shows that the flat side 278 of the advancer 101 and the conduit 126 are sized and configured to fit in the lumen 602 of the holder 600.
- FIG. 55 shows the step 653 between the flat side 278 and the stem 615 to stop the advancer 101 from excessively advancing the conduit 126.
- the combined diameters of the stem 615 and the conduit 126 are too large to pass through the lumen 602.
- FIG. 56 shows the disengaging position by partially withdrawing the advancer 101; the spikes 604 or one-way valve 604 keep the conduit 126 from returning into the lumen 602 of the holder 600.
- FIG. 57 shows repetitive advancing and withdrawing of the advancer 101 from the engaging to disengaging positions between the advancer 101 and conduit 126 to deploy more conduit 126 into the disc.
- FIG. 58 shows the disengaged position by partially withdrawing the advancer 101 below the window 601 of the holder 600.
- FIG. 59 shows repetitive engaging and disengaging positions by advancing and withdrawing the advancer 101 to fill the hollow disc 100 or tissue.
- the marker 649 on the holder 600 indicates the location of the window 601. When the disc 100 is nearly full, resistance can be felt during re-advancement of the advancer 101.
- the conduit 126 can be cut at the proximal end the holder 600, similar to the procedure in FIG. 32. Re-advancing and rewithdrawing of the advancer 101 are repeated to implant the remaining conduit 126 in the holder 600 into the degenerated disc 100.
- FIG. 60 shows an elastically curved advancer 101 with the relatively flat 278 side and semi-cylindrical 279 side, base 616, gripper 111, step 653, and marker 652 to show the flat 278 or concave side.
- FIG. 61 shows a slanted window 601 at angle 0 of the holder 600 to facilitate advancement of the conduit 126 by the advancer 101.
- the angle 9 opening of the window 601 is preferred to be less than 90° slanting or sloping from outer wall toward the one-way-valve 604 of the holder 600.
- the preferred angle 0 opening is between 5° and 70°.
- the conduit 126 enters through the window 601 and lumen 602 of the holder 600.
- the marker 649 on the holder 600 indicates the side or location of the window 601.
- the distal end of the conduit 126 contains a first protrusion 463 and a distal end 117.
- the outer diameter of the first protrusion 463 is larger than the inside diameter of the lumen 602 of the holder 600.
- FIG. 62 shows the engaged position of the elastically curved advancer 101 using the gripper 111 and base 616 in FIG. 60 to engage and advance the conduit 126 from the window 601 of the holder 600.
- FIG. 63 shows a cross section of the advancer 101 with the semi-cylindrical side 279, flat side 278, grippers 111 and the base 616 to engage the conduit 126.
- the flat side 278 and the gripper 111 hold and escort the conduit 126 out of the holder 600.
- Distance between the grippers 111 is preferred to be less than the outer diameter of the conduit 126.
- the flat side 278 or the base 616 can be wider than the outer diameter of the conduit 126.
- FIG. 64 shows partial withdraw of the elastically curved advancer 101 pressing the conduit 126 on the one-way-valve 604 or pointed protrusion 604 to retain the conduit 126 outside the holder 600.
- the advancer 101 will be in the disengaged position with the conduit 126.
- Advancement and partial withdrawal of the advancer 101 are repeated to deploy multiple sections of conduit 126 to pack the hollow disc 100 by repeating the engaging and disengaging positions between the advancer 101 and conduit 126.
- FIG. 65 shows a narrow distal portion 655 of the advancer 101.
- FIG. 66 shows another narrow distal portion 655 of the advancer 101 extending from the lumen 602 of the holder 600.
- FIG. 67 shows a bend 654 at distal portion 655 bending from the flat 278 toward the semi-cylindrical 279 side of the curved advancer 101.
- FIG. 67 shows a bend 654 at distal portion 655 bending from the flat 278 toward the semi-cylindrical 279 side of the curved advancer 101.
- FIG. 67 also shows the flat side 278, semi-cylindrical side 279, bend 654, base 616, and a distal plane 113 formed by angle a between the flat 278 and semi-cylindrical 279 sides of the curved advancer 101.
- the base 616 can be the distal edge 616 of the advancer 101.
- the bend 654 facilitates sliding of the distal portion 655 of the advancer 101 in the lumen 602 of advancer 101, as shown in FIG. 70.
- the concave side 279 or the semi-cylindrical side 279 conforms and slides on the inner wall 617 of the holder 600.
- the base 616 alone in the engaged position can engage and advance the conduit 126 from the holder 600 as indicated in FIG. 62 without the gripper 111.
- FIG. 68 shows an indentation 614 at the distal portion 655 of the advancer 101.
- FIG. 69 shows a side view of the indentation 614 and the distal plane 113 distal to the bend 654 of the elastically curved advancer 101.
- FIG. 70 shows the distal portion 655 distal to the bend 654 sliding on the lumen wall 617 of the holder 600 to transition from the disengaged to engaging position between the advancer 101 and the conduit 126 at the window 601.
- the flat side 278 oriented or positioned by the bend 654 also minimizes sinkage into the window 601 of the holder 600.
- FIG. 71 shows the engaged position between the advancer 101 and the conduit 126 with the indentation 614 cradling or holding the conduit 126 to exit from the holder 600.
- FIG. 72 shows the grippers 111 engaging the conduit 126 and the indentation 614 cradling and holding the conduit 126 to facilitate deployment.
- FIG. 73 shows that the flat portion 278 of the elastically curved advancer 101 and the conduit 126 are sized and configured to fit in the lumen 602 of the holder 600 to advance the conduit 126.
- FIG. 75 shows the gripper 111 on the convex side 279 of the elastically curved advancer 101.
- the convex side 279 is also the semi-cylindrical 279 side
- the flat 278 is also the concave 278 side of the curved advancer 101.
- the distal plane 113 is formed by an angle a between the flat 278 and semi-cylindrical 279 side.
- the angle CC is smaller than 90 degree and preferred between 15 and 85 degree.
- FIG. 75 also shows the step 653 transitioning between the flat side 278 and the stem 615 of the advancer 101 for stopping excessive advancement of the conduit 126.
- FIG. 75 also shows the marker 652 on the stem 615 to indicate the concave 278 side of the advancer 101.
- FIG. 76 shows the gripper 111 and base 616 on convex side 279 or semi-cylindrical side 279.
- FIG. 76 shows the flat 278 side and bend 654 at the distal portion 655 of the elastically curve advancer 101. The bend 654 is also bending from the flat 278 to the semi-cylindrical 279 side of the advancer 101.
- FIG.76 also shows the gripper 111 protruded from the base 616; the distal plane is formed by an angle a between the flat 278 and semi -cylindrical 279 sides.
- FIG. 77 shows the disengaged position of the base 616 and gripper 111 at the semi-cylindrical 279 or convex 279 side of the elastically curved advancer 101.
- the flat The flat
- FIG. 78 shows the engaging position between the conduit 126 and the advancer 101 by the base 616 and gripper 111 at the convex 279 or semi-cylindrical
- the advancer 101 goes from the disengaging to engaging position by longitudinal movement on the inner wall 617 of the holder 600.
- FIG. 79 shows another advancer 101 with a semi-cylindrical 279 side and a flat 278 side, longitudinal trough 619 and grippers 111 at the distal end.
- the base 616 and grippers 111 are formed by the angle a between the flat 278 and semi-cylindrical 279 sides of the advancer 101.
- the angle a is between 15-80 degrees.
- the functional structure is the distal semi-cylindrical portion; the proximal portion can be a thin cylindrical stem 615 or other shape.
- FIG. 80 shows the trough 619 sized and configured to fit the conduit 126 in the disengaged position.
- FIG. 81 shows a slight rotation of the semi-cylindrical advancer 101.
- FIG. 82 shows the engaged position between the conduit 126 and the advancer 101 with the gripper 111 by the slight rotation of the semi- cylindrical advancer 101.
- FIG. 83 shows a lateral view of the semi-cylindrical advancer 101, angle a between the flat side 278 and semi-cylindrical 279 side, trough 619, gripper 111, distal plane 113 and base 616.
- FIG. 84 shows the engaging position between the advancer 101 and the conduit 126 at the window 601 of the holder 600 by the slight rotation and advancement of the advancer 101
- Cross section E is shown in FIG. 85.
- FIG. 85 shows one of the grippers 111 and the base 616 engaging the conduit 126.
- FIG. 86 shows the engaging position of the advancer 101 to engage and advance the conduit 126 out of the holder 600.
- FIG. 87 shows reversal from the engaged to disengaging position by slight counter rotating and partially withdrawing the semi-cylindrical advancer 101.
- Cross sections F, G, and H are shown in FIGS. 88-90.
- FIG. 88 shows the disengaged position between the gripper 111 of the advancer 101 and the conduit 126. In the disengaged position, FIG. 89 shows that the trough 619 is sized and configured to fit the conduit 126 extending from the window 601.
- FIG. 90 shows the draping conduit 126 outside the holder 600.
- FIG. 91 shows partial withdrawal of the semi-cylindrical advancer 101 to disengaged position proximal to the window 601.
- FIG. 92 shows conversion from disengaging to engaging position by re-advancing the advancer 101 to deploy additional conduit 126.
- FIG. 93 depicts the repetition of engaging and disengaging positions by slightly rotating and advancing, and by slightly counter rotating and withdrawing the advancer 101 to pack the conduit 126 into the disc 100 or tissue.
- FIG. 94 shows a cannula handle 132 containing a funnel 492 open into the lumen 268 of the cannula 230, and a cartridge support 627 containing a male latch 626, similar to FIG. 29.
- FIG. 95 shows the conduit 126 spooled on a transparent bobbin 152 anchored by a pin 146 or screw 146 in a transparent cartridge 150 with a scale 145; the scale is used to estimate the amount of conduit 126.
- FIG. 95 also shows the assembly of the holder 600, advancer 101, and a conduit 126 extending from the opening 151 of the transparent cartridge into the window 601 and lumen 602 of the holder 600.
- FIG. 96 shows that the cartridge 150 is supported by the bottom cartridge support 627, left rail 628 and right rail 629 of the cannula handle 132, similar to FIGS. 28-30.
- the first 463 and the second protrusion 462 of the conduit 126 are formed outside the lumen 602 of the holder 600.
- FIG. 96 also shows the conduit 126 and holder 600 are positioned to insert into the funnel 492 of the cannula 230 into the degenerated disc 100.
- the engaging and disengaging positions of the advancer 100 are used to implant the conduit 126 to repair the degenerated disc 100.
- FIG. 97 shows the engaging position between the conduit 126 and the elastically curved advancer 101 capable of reaching the central L5-S1 and L4-5 discs.
- the elastically curved advancer 101 can be withdrawn and resiliently straightened in the rigid conduit holder 600 to resume the disengaged position.
- FIG. 98 shows a screw-like or spiral augur 111 as gripper 111 of the advancer 101 to advance the conduit 126 out of the holder 600 by rotating the advancer 101.
- FIG. 99 shows a cutter 605 with a razor edge 606 at the distal end, and a lumen 611 sized and configured to fit over the holder 600.
- FIG. 100 shows the cutter handle 607 with ridges 609 to facilitate rotation, a distal protrusion 608 to facilitate advancing and a proximal protrusion 610 to facilitate withdrawing the cutter 605.
- FIG. 101 shows the cutter 605 sliding over the holder 600 to cut the conduit 126 extending from the window 601 by rotating and advancing the cutter 605.
- FIG. 102 shows cutting of the conduit 126 in the cannula 230 by rotation and advancement of the cutter 605 in the cannula 230.
- FIG. 103 shows the cutter 605 over the holder 600 in the funnel 492 leading into the lumen 268 of the cannula 230.
- the marker 613 on the holder 600 reaches the proximal protrusion 610 of the cutter handle 607, the one-way -valve 604 or pointed protrusion 604 of the holder 600 is at the similar depth as the razor edge 606 of the cutter 605.
- FIGS. 101-103 show the conduit 126 draping outside the cutter 605 and holder 600.
- FIG. 104 shows filling the nucleus 128 of the disc 100 with the conduit 126 through the cannula 230, cutter 605, holder 600, and advancer 101. When the nucleus 128 is relatively full of the conduit 126, physician or operator can feel resistance during advancement of the advancer 101.
- the cutter 605 is advanced to cut the conduit 126 at the window 601 of the holder 600 as shown in FIG. 101.
- FIG. 104 also shows the conduit 126 extending outside the body of the patient for retrieval by the physician or operator.
- an injection needle 460 with a syringe 276 can be inserted into the cannula 230 as shown in FIG. 105.
- the syringe 276 is filled with saline 131, pH buffer 131, antacid 131, nutrients 131, medicine 160, antibiotic 160, anti-inflammatory 160, proteolytic enzymes 160, collagenase 160, matrix metalloproteinase 160, aggrecanases 160, cathepsins 160, aminopeptidases 160, neutral proteinases 160, growth factor 160, chelating agents 160, cells 277 and/or other therapeutic agents into the disc 100 implanted with the conduit 126.
- the injection of therapeutic agent 131, 160 and/or 277 can also be injected days, months or years after the implantation of the conduit 126 by fluoroscopic guidance of the injection needle 460.
- FIG. 106 shows closure of the annulus 378 of the repair disc 100.
- the pain-relieving agent 131, 160 and/or disc-rebuilding agent 131, 160, 277 can be injected or coated on the conduit 126 into the disc 100.
- Autograft disc cells 277 from a healthy disc 100 of the patient can be injected or coated on the conduit 126 to promote disc regeneration by continual supply of nutrients and oxygen 131 from capillaries 107 in endplates 105 through the conduit 126. Since the disc 100 is avascular and possibly immuno isolated, allograft from another disc of the patient can be used for disc regeneration.
- Donor cells can increase the capacity for producing chondroitin sulfate, keratan sulfate and collagen.
- Donor cells 277 can be notochordal, mesenchymal stem cells, chondrocytes, fibroblasts, autograft disc cells 277, or other donor cells 277.
- Permeation of the therapeutic agents 131, 160 from the endplates 105 through the body circulation into the avascular disc 100 is minimal and slow. Injection or coating of the therapeutic agents 131, 160 on the conduit 126 into the avascular disc 100 is direct with appropriate therapeutic concentration.
- Discitis is a painful infection or inflammatory lesion in the intervertebral disc 100 of adults and children.
- Staphylococcus aureus is the most common bacteria found in discitis.
- Antibiotic 160 such as nafcillin, cefazolin, dicloxacilin, clindamycin, bactrim, penicillin, mupirocin (bactroban), vancomycin, linezolid, rifampin, sulfamethoxazoletrimethoprim or others can be injected or coated on the conduit 126 to treat staphylococcus aureus infection as shown in FIG. 105.
- Corynebacterium is also found in discitis.
- Antibiotic 160 such as erythromycin, vancomycin, eifampin, penicillin or tetracycline can be injected, coated or embedded into the conduit 126 to treat corynebacterium infection.
- Other antibiotics 160 such as cefdinir, metronidazole, tinidazole, cephamandole, latamoxef, cefoperazone, cefmenoxime, furazolidone or others 160, can also be injected or coated on the conduit 126.
- Antibiotic disrupts bacteria cell wall, protein production, or DNA replication.
- Nonsteroidal anti-inflammatory drugs (NSAID) 160 such as aspirin, diflunisal, salsalate, ibuprofen, naproxen, fenoprofen, ketoprofen, flurbiprofen, oxaprozin, indomethacin, sulindac, etodolac, ketorolac, diclofenac, nabumetone, piroxicam, meloxicam, tenoxicam, droxicam, lornoxicam, isoxicam, mefenamic acid, meclofenamic acid, flufenamic acid, tolfenamic acid, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib, firocoxib, nimesulide, licofelone or other NSAID 160
- NSAID 160 such as aspirin, diflunisal, salsalate, ibuprofen, naprox
- Steroidal anti-inflammatory drugs/analgesics 160 such as betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone or other steroid 160 can be injected or coated on the conduit 126 to treat inflammation in or around the disc 100 for pain relief.
- Steroidal antiinflammatory decreases the production and activity of inflammatory immune cells, such as T cells and B cells.
- Anesthetics 160 such as procaine, amethocaine, cocaine, lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine, methohexital, thiopental, diazepam, lorazepam, midazolam, etomidate, ketamine, propofol, alfentanil, fentanyl, remifentanil, sufentanil, buprenorphine, butorphanol, diamorphine, hydromorphone, levophanol, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine or other anesthetic 160 can be injected or coated on the conduit 126 to interfere with the pain signal, especially the ion channel for instant pain relief.
- Muscle relaxant 160 such as succinylcholine, decamethonium, mivacurium, rapacuronium, atracurium, cisatracurium, rocuronium, vecuronium, alcuronium, doxacurium, gallamine, metocurine, pancuronium, pipecuronium, tubocurarine or other relaxant 160 can be injected or coated on the conduit 126 to relieve muscle tension and ache as shown in FIG. 105.
- Muscle relaxant 160 such as succinylcholine, decamethonium, mivacurium, rapacuronium, atracurium, cisatracurium, rocuronium, vecuronium, alcuronium, doxacurium, gallamine, metocurine, pancuronium, pipecuronium, tubocurarine or other relaxant 160 can be injected or coated on the conduit 126 to relieve muscle tension and ache as shown in FIG. 105.
- Buffering agents 160 such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, calcium carbonate, barium carbonate, potassium phosphate, sodium phosphate or other buffering agent 160 can be injected or coated on the conduit 126 to neutralize the lactic acid 162 and spontaneously alleviate pain caused by acid irritation or bum.
- Alkaline agents 160 such as magnesium oxide, magnesium hydroxide, sodium hydroxide, potassium hydroxide, barium hydroxide, cesium hydroxide, strontium hydroxide, calcium hydroxide, lithium hydroxide, rubidium hydroxide, neutral amines or other alkaline agent can be injected or coated on the conduit 126 to neutralize lactic acid 162 and spontaneously alleviate pain caused by acid irritation.
- Nutrients 131 such as sulfate, galactosamine, glucuronate, galactose, D-glucosamine, magnesium hydroxide, glycine, proline, hydroxyproline, alanine, arginine, leucine, lysine, glutamate, glutamine, mannose, glucose, N-acetylneuraminate, chondroitin sulfate, keratan sulfate, hyaluronate or others are precursors or ingredients for biosynthesis chondroitin sulfate, keratan sulfate, hyaluronate, or collagen. These nutrients 131 can be injected or coated on the conduit 126 to repair the degenerated disc 100, as depicted in FIG. 105.
- High concentration of nutrients 131 can be injected into the disc 100 after implanting the conduit 126 to create high osmolarity, as shown in FIG. 105. High osmolarity promotes fluid inflow into the disc 100.
- the high concentration of nutrients 131 can also be coated on the conduit 126.
- High concentration of sulfate 131 and amino acids 131 can be injected and/or coated on conduit 126 to boost osmolarity.
- Magnesium sulfate 131, potassium sulfate 131 or sodium sulfate 131 have high water solubilities for disc 100 injection and/or conduit 126 coating to biosynthesize glycosaminoglycans in the nucleus pulposus 128.
- Proline 131 and glycine 131 have high water solubilities for disc 100 injection and/or conduit 126 coating to biosynthesize collagen in the annulus 378.
- glucose or sugars injection can produce additional lactic acid 162 through anaerobic metabolism to cause severe acid bum and discogenic pain.
- Growth factor 160 expedites rebuilding of the disc matrix.
- the growth factor 160 such as bone morphogenetic protein (BMP -2, BMP -4 and BMP-7) or other BMP bind to specific receptors on chondrocytes to activate biosynthesis of chondroitin sulfate.
- growth factors 160 include platelet-rich plasma, platelet-derived growth factor (PDGF)- AB, PDGF-BB, FGF (aFGF, FGF-1), basic FGF (bFGF, FGF-2), int-2 (FGF-3), hst/KS3 (FGF-4), FGF-5, FGF-6, keratinocyte growth factor (FGF-7), androgen-induced growth factor (AIGF or FGF-8), glia activating factor (GAF or FGF-9), PDGF, or other growth factors can be injected or coated on the conduit 126 to promote growth of the disc matrix.
- Calcium channel blocker 160 inhibits activation of neuro-receptor by blocking the neural calcium influx channel to alleviate pain.
- the calcium channel blocker 160 such as dihydropyridines, phenylalkylamines, benzothiazepines, magnesium ion, Amlodipine, Felodipine, Isradipine, Lacidipine, Lercanidipine, Nicardipine, Nifedipine, Nimodipine, Nisoldipine, Verapamil, Diltiazem or other calcium channel blocker 160 can be injected or coated on the conduit 126.
- Proteolytic enzymes 160 can be used as endplate-opening agents by digesting the proteoglycans, aggrecan and/or collagen blocking permeation at the endplates 105.
- Proteolytic enzymes 160 such as collagenase 160, matrix metalloproteinase 160, aggrecanases 160, cathepsins 160, aminopeptidases 160, neutral proteinases 160 or other enzymes 160 can be injected or coated on the conduit 126 as shown in FIG, 105 to increase endplate 105 permeation into the avascular disc 100.
- Chelating agents 160 can also be used as endplate-opening agents by extracting or removing the calcium or other minerals from the calcified layer, which blocks or hinders the endplate 105 permeation to increase permeation of nutrients/oxygen and pH buffer 131 into the degenerated disc 100.
- the chelating agent 160 such as ethylenediaminetetraacetic acid, citrate, deferoxamine, penicillamine, succimer, dimercaptosuccinic acid, dimercaprol, deferiprone, pentetic acid, sodium edetate, nitrilotriacetic acid, trientine, deferasirox, calcium edetate, edetate disodium ⁇ dimercapto succinic acid, egtazic acid, oxalic acid, ethylenediamine, hydroxyethylethylenediaminetriacetic acid, diethylenetriamine, sodium diethyldithiocarbamate, 2,2 ’-bipyridine, enterobactin, 2,3 -dimercapto- 1 -propanesulfonic acid, or other chelator 160 can be injected or coated on the conduit 126 to increase endplate 105 permeation
- Anti-depressants 160 such as tricyclic antidepressant, serotonin-norepinephrine reuptake inhibitors, serotonin-reuptake inhibitor, norepinephrine reuptake inhibitor, serotonin-norepinephrine reuptake inhibitor, or other anti-depressants can be injected into the painful disc 100 as shown in FIG. 105, or can be coated on the conduit 126 to reduce back pain.
- the visibility of the conduit 126 in the disc 100 or tissue can be helpful.
- the conduit 126 can be coated with an X-ray contrast for visibility within the tissue or disc 100.
- the contrast can be barium sulfate, diatrizoic acid, metrizoic acid, iodamide, iotalamic acid, ioxitalamic acid, ioglicic acid, acetrizoic acid, iocarmic acid, methiodal, diodone, metrizamide, iohexol, ioxaglic acid, iopamidol, iopromide, iotrolan, ioversol, iopentol, iodixanol, iomeprol, iobitridol, ioxilan and/or other X-ray contrast.
- the conduit 226 can also be coated with a MRI contrast for visibility of the conduit 126 within the disc 100 or tissue.
- the MRI contrast can be ionic gadolinium, nonionic gadolinium, linear gadolinium, cycle gadolinium, macrocylic gadolinium, or other MRI contrast.
- the conduit 226 can also be coated with an ultrasound contrast for visibility of the conduit 126 within the disc 100 or tissue.
- the ultrasound contrast can be perflutren lipid microspheres, perflutren protein microsphere, perfluorobutane phospholipid microsphere, sulfur hexafluoride phospholipid microsphere, or other ultrasound contrast.
- the conduit 126 can also be coated with hydrophilic or swelling agents, such as polyethylene glycol, collagen, hyaluronic acid, alginate, agarose, poly(N- isopropylacrylamide, sodium polyacrylate, cellulose nanofibrils, Carbopol, chitosan, poly-vinyl alcohol, polyacrylamide, dextran, cyclodextrins, or other swelling agents to improve water absorption and/or biocompatibility.
- hydrophilic or swelling agents such as polyethylene glycol, collagen, hyaluronic acid, alginate, agarose, poly(N- isopropylacrylamide, sodium polyacrylate, cellulose nanofibrils, Carbopol, chitosan, poly-vinyl alcohol, polyacrylamide, dextran, cyclodextrins, or other swelling agents to improve water absorption and/or biocompatibility.
- Lactic acid inhibitor 160 or lactate dehydrogenase inhibitor 160 can minimize lactic acid production.
- the lactic acid inhibitor 160 or lactate dehydrogenase inhibitor 160 such as fluoropyruvic acid, fluoropyruvate, levulinic acid, levulinate, oxamic acid, N- substituted oxamic acids, oxamate, oxalic acid, oxalate, beta-bromopropionate, betachloropropionate, malonate, sodium formaldehyde bisufite, chloroacetic acid, alphachloropropionate, alpha-bromopropionate, beta-iodopropionate, acrylate, acetoin, malic acid, glycolate, diglycolate, acetamide, acetaldehyde, acetylmercaptoacetic acid, alpha ketobutyrate, thioglycolic acid, nicotinic acid, alpha-ketoglutarate, but
- Immune inhibitors 160 can be injected or coated on the conduit 126 to prevent fibrotic encapsulation over the conduit 126 to maximize fluid transport between the avascular disc 100 and endplate circulation.
- the cytokine inhibitor includes TNF-alpha inhibitors (adalimumab, etanercept), IL-6 inhibitors (tocilizumab), IL-12/IL-23 inhibitors (ustekinumab).
- the B-cell inhibitor includes Rituximab, belimumab, ofatumumab.
- the spleen tyrosine kinase inhibitor includes Tacrolimus and cyclosporine, Fostamatinib, and peridarthinib.
- the T cell activation inhibitor includes calcineurin, Tacrolimus, cyclosporine.
- immune inhibitor includes sphingosine 1 -phosphate receptor modulators (fingolimod), eculizumab, actinomycin-D, aminopterin, azathioprine, chlorambucil, corticosteroids, crosslinked polyethylene glycol, cyclophosphamide, cyclosporin A, 6-mercaptopurine, methylprednisolone, methotrexate, niridazole, oxisuran, paclitaxel, polyethylene glycol, prednisolone, prednisone, procarbazine, prostaglandin, prostaglandin Ei, sirolimus, steroids or other immune suppressant drugs 160.
- sphingosine 1 -phosphate receptor modulators fingolimod
- eculizumab actinomycin-D
- aminopterin azathioprine
- chlorambucil corticosteroids
- crosslinked polyethylene glycol cyclophosphamide
- the anti-angiogenic compound 160 can be injected or coated on the conduit 126.
- the anti-angiogenic compounds 160 include, but are not limited to, Marimastat from British Biotech [a synthetic inhibitor of matrix metalloproteinases (MMPs)], Bay 12-9566 from Bayer (a synthetic inhibitor of tumor growth), AG3340 from Agouron (a synthetic MMP inhibitor), CGS 27023 A from Novartis (a synthetic MMP inhibitor), COL-3 from Collagenex (a synthetic MMP inhibitor, Tetracycline® derivative), Neovastat from Aetema, Sainte-Foy (a naturally occurring MMP inhibitor), BMS-275291 from Bristol- Myers Squib (a synthetic MMP inhibitor), TNP-470 from TAP Pharmaceuticals, (a synthetic analogue of fumagillin; inhibits endothelial cell growth), Thalidomide from Celgene (targets VEGF, bFGF), Squalamine from Magainin Pharmaceutical
- MMPs matrix metalloproteinases
- FIG. 107 shows a wire 600 as a holder 600 with a loop 601 as the window 600.
- the diameter of the wire loop 601 is larger than the diameter of the conduit 126, but smaller than the outer diameter of the cutter 605.
- FIG. 108 shows applied tension on the wire holder 600 from outside the cannula 230 to position the conduit 126 on the razor edge 606. The conduit 126 is cut by the tension on the wire holder 600, rotation and advancement of the cutter 605.
- FIG. 109 shows a cuter 605 with razor edges 606, a cuter lumen 611 and a sharp tip 656.
- FIG. 110 shows a lateral view showing a marker 657 aligned with the sharp tip 656.
- the marker 657 can also be on the handle of the cuter 605 to orient the sharp tip 656 and the razor edges 606 toward the window 601 of the holder 600.
- FIG. I l l shows the cuter 605 entering from the proximal lumen 602 of the holder 600.
- the sharp tip 656 engages the conduit 126 extending from the window 601.
- FIG. 112 shows penetration of the sharp tip 656 of the cuter 605 into the conduit 126 to hold the conduit 126 stationary.
- FIG. 113 shows advancement of the cutter 605 to cut the conduit 126 with the razor edges 606.
- the proximal portion of the conduit 126 is retrieved from the lumen 268 of the cannula 230.
- FIG. 114 shows a sharp lateral edge 643 and a sharp proximal edge 641 at the window 601 of the holder 600.
- the advancer 101 holds the conduit 126 stationary.
- FIG. 115 shows rotation and advancement of the holder 600 to cut the conduit 126 by the sharp lateral opening 643 and the sharp proximal opening 641.
- FIG. 116 shows the conduit 126 absorbing the lactic acid 162 and bridging between the diffusion zones of nutrient, oxygen and pH buffer 131 from capillaries 107 in superior and inferior endplates 105.
- FIG. 117 shows transport of nutrients, oxygen and pH buffer 131 and growth factor 160 from the diffusion zones through the conduit 126 into the middisc layer 100.
- the pH buffer 131 from the diffusion zones of the endplates neutralizes the lactic acid 162 to relieve acid bum and discogenic pain.
- Oxygen 131 inhibits the formation of the lactic acid 162.
- Nutrients 131 and growth factor 160 feed disc cells to produce a new disc matrix.
- the conduit 126 is a transporter 126 of nutrients 131, and a scaffold 126 for cellular and new disc matrix atachment.
- FIG. 118 shows the relaxation cycle of the disc 100.
- Disc pressure is low, and disc height increases.
- FIG. 119 shows absorption of nutrients, oxygen, pH buffer bicarbonate 131 and growth factor 160 from endplates 105 circulation into the conduit 126, especially during low disc pressure.
- FIG. 120 shows the compression cycle of the disc 100.
- Disc pressure is high, and disc height decreases.
- FIG. 121 shows discharge of nutrients, oxygen and pH buffer bicarbonate 131 from the conduit 126 during the compression cycle of the disc 100.
- the pH buffer 131 neutralizes the lactic acid 162 to extinguish the acid bum and relieve the discogenic pain.
- Nutrients 131 and growth factor 160 feed the disc cells to rebuild disc matrix.
- Relaxation and compression cycles of the disc 100 expedite re-establishment of fluid exchange between mid-disc layer 100 and body circulation through the conduit 126.
- Initial conduit 126 is a braided nylon suture 126 made with many nylon filaments in each strand.
- FIG. 122 shows Safranin-0 histology staining of proteoglycans 112 between strands of the braided nylon conduit 126 at 3 months in sheep disc 100.
- FIG. 123 shows Safranin-0 histology staining of proteoglycans 112 between the nylon filaments within a strand of the braided nylon conduit 126 at 12 months in sheep disc 100.
- hematoxylin and eosin histology staining showed no immune response to or fibrotic encapsulation over the braided nylon conduit 126 in sheep discs after 1-, 3-, 6-, 12- and 30-months. Histology report concluded that the braided nylon conduit 126 is inert in the sheep discs.
- the conduit 126 is a fluid transporter 126, wick 126 and a scaffold 126 for attachment of cells 277 and disc matrix.
- FIG. 124 depicts re-hydration from the newly formed proteoglycans 112 to increase swelling pressure and elevate disc 100 height to lift the inferior articular process 143 to relieve the facet 129 loading and pain.
- FIG. 125 shows a superior articular process line 142AL extending from a healthy facet joint 129 toward a healthy disc 100; and a superior articular process line 142BL extending from an eroded or painful facet joint 129B toward a degenerated or flattened disc 100D. As the disc 100 is flattening from degeneration, additional load is transferred to erode the facet joint 129 causing pain.
- FIG. 124 depicts re-hydration from the newly formed proteoglycans 112 to increase swelling pressure and elevate disc 100 height to lift the inferior articular process 143 to relieve the facet 129 loading and pain.
- FIG. 125
- FIG. 127 shows the conduit 126 implanted between 0 mm and 10 mm from at least one of the superior and inferior endplates 105 to absorb nutrients, pH buffer and oxygen 131 to produce proteoglycans 112 and collagen 112.
- the preferred implant distance of the conduit 126 is between 0 mm and 5 mm from at least one of the superior and inferior endplates 105.
- Intervertebral discs 100 are immuno-isolated, probably due to the avascular and aneural (no neural tissue) construction. Hematoxylin and eosin histology stain showed no immune and no inflammatory response to the braided nylon conduit 126 at 1, 3, 6, 12 and 30 months in sheep discs 100. Similarly, there was no noticeable inflammatory reaction to the conduit 126 in a human pilot clinical study in 1 week, 3, 6, 12 and 24 months. Internal transport of nutrients/oxygen/pH buffer 131 from superior and/or inferior diffusion zones infiltrates into the intervertebral disc 100 through the conduit 126.
- the avascular disc 100 is well sealed and immuno-isolated. Even small molecules, such as sulfate or proline, are greatly limited from diffusing into the nucleus pulposus 128.
- the well-sealed disc 100 may be able to encapsulate donor cells 277 from a disc 100 of another person, cadaver or even animal without triggering an immune response, and probably not needing anti-rejection drug.
- the donor cells 277 can also be stem cells 277, notochord 277 or chondrocytes 277. These donor cells 277 can also be injected into a disc 100 implanted with the conduit 126, or the donor cells 277 can be coated or embedded into the conduit 126 before implanted into the disc 100, as shown in FIG.
- the conduit 126 draws nutrients/oxygen/pH buffering solute 131 to feed the donor cells 277.
- the disc 100 containing the conduit 126 seems to be free from infiltration of giant cells, macrophages, mononuclear phagocyts, T-cells, B-cells, lymphocytes, Null cells, K cells, NK cells, mask cells, immunoglobulins, IgM, IgD, IgG, IgE, other antibodies, interleukins, lymphokines, monokines or interferons.
- cell transplants from cadavers or live donors have been successful in providing therapeutic benefits.
- islet cells from a donor pancreas are injected into a type I diabetic patient’s portal vein, leading into the liver.
- the islets begin to function as they normally do in the pancreas by producing insulin to regulate blood sugar.
- the diabetic patient requires a lifetime supply of anti-rejection medication.
- the side effects of these immuno-suppressive drugs may include cancer. The benefit of cell transplant may not outweigh the potential side effects.
- the intervertebral disc 100 with a conduit 126 can be used as a semi-permeable capsule to house the injected therapeutic donor cells 277, as shown in FIG. 105, to evade the immune response; hence no life-long immuno-suppressive drug would be required. These donor cells can also be coated or loaded on the conduit 126.
- a variety of donor cells 277 or agent can be harvested and/or cultured from the pituitary gland (anterior, intermediate lobe or posterior), hypothalamus, adrenal gland, adrenal medulla, fat cells, thyroid, parathyroid, pancreas, testes, ovary, pineal gland, adrenal cortex, liver, renal cortex, kidney, thalamus, parathyroid gland, ovary, corpus luteum, placenta, small intestine, skin cells, stem cells, gene therapy, tissue engineering, cell culture, other gland or tissue.
- the donor cells 277 are immuno-isolated within the discs 100, nutrients/oxygen/pH buffer 131 are supplied through the conduit 126.
- the donor cells 277 can be from human, animal or cell culture.
- the biosynthesized product 160 or molecules 160 made by the donor cells 277 can be adrenaline, adrenocorticotropic hormone, aldosterone, androgens, angiotensinogen (angiotensin I and II), antidiuretic hormone, atrial-natriuretic peptide, calcitonin, calciferol, cholecalciferol, calcitriol, cholecystokinin, corticotropin-releasing hormone, cortisol, dehydroepiandrosterone, dopamine, endorphin, enkephalin, ergocalciferol, erythropoietin, follicle stimulating hormone, y-aminobutyrate, gastrin, ghrelin, glucagon, glucocorticoids, gonadotropin-releasing hormone, growth hormone-releasing hormone, human chorionic gonadotrophin, human growth hormone, insulin, insulin-like growth factor, leptin, lipotropin
- the biosynthesized therapeutic products 160 (hormones, peptides, neurotransmitter, enzymes, catalysis or substrates) generated within the disc 100 with the conduit 126 may be able to regulate bodily functions including blood pressure, energy, neuro-activity, metabolism, and activation and suppression of gland activities. Some hormones and enzymes govern, influence or control eating habits and utilization of fat or carbohydrates. These hormones or enzymes may provide weight loss or gain benefits.
- Producing neurotransmitters, such as dopamine, adrenaline, noradrenaline, serotonin or y- aminobutyrate, from the donor cells 277 within the disc 100 with the conduit 126 can treat depression, Parkinson’s disease, learning disability, memory loss, attention deficit, behavioral problems, mental or neuro-related diseases.
- Release of the biosynthesized therapeutic products 160 by the donor cells 277 in the disc 100 with the conduit 126 can be synchronized with body activity.
- the pressure within the disc 100 is usually high to expel the biosynthesized therapeutic products 160 by the donor cells 277 into circulation to meet the demands of the body.
- pressure within the disc 100 is low; fluid inflow 161 into the conduit 126 is favorable, bringing nutrients/oxygen/pH buffer 131 into the disc 100 to nourish the cells 277.
- islets of Langerhans from a donor’s pancreas can be implanted or injected into the conduit 126.
- the insulin released from the disc 100 with the conduit 126 is minimal to prevent hypoglycemia.
- biosynthesized products 160 by the donor cells 277 are released concurrent with physical activity to meet the demands of the body.
- Donor cells 277 can also be seeded on the conduit 126 or injected days, weeks, months or even years after implantation of the conduits 126, to ensure favorable biological conditions, including pH, electrolytic balance and nutrients and oxygen 131, for cell 277 survival and proliferation in the disc 100.
- FIG. 128 shows a graph of relative concentration of lactic acid, bicarbonate, oxygen, and nutrients between the diffusion zones and endplates of a degenerated disc.
- Concentration of lactic acid is high in the mid-layer and low at the diffusion zones.
- concentration of bicarbonate, oxygen and nutrients are high at the diffusion zones and low at the mid-layer.
- FIG. 129 depicts absorbing or transporting lactic acid, bicarbonate, oxygen and nutrients through the conduit 126 by bridging between the superior and inferior diffusion zones.
- FIG. 130 shows braided strands 104 to form the conduit 126.
- the braided structure provides a thin conduit 126 with tensile strength.
- FIG. 131 shows woven strands 104 to form the conduit 126.
- Woven conduit 126 provides durability.
- FIG. 132 shows knitted strands 104 to form the conduit 126.
- Knitted conduit 126 provides stretching capability and high-water absorbency.
- FIG. 133 depicts a slanted cut of the conduit 126 to show the slanted orientations of strands 104 relative to lengthwise of the conduit 126.
- FIG. 134 shows a cross-section of the conduit 126 made with parallel strands 104 wrapped, encircled, covered or enveloped by a sheath 127 or cover 127.
- FIG. 135 shows a crosssection of the conduit 126 made with parallel tubes 104 wrapped, encircled, covered or enveloped by a sheath 127 or cover 127.
- FIG. 136 shows a cross-section of the conduit 126 made with sponge or foam with pores 124.
- FIG. 137 shows a cross-section of a conduit 126 made with water-absorbing material.
- the conduit 126 for disc 100 repair is hydrophilic with measurable characteristics under ambient temperature and pressure for transporting and retaining fluid to relieve pain and/or rebuild the disc 100.
- Water absorbency or weight gain of the conduit 126 is between 10% and 500% by absorbing water within the matrix of the conduit 126.
- a healthy human disc 100 contains 80% water.
- the preferred water absorbency after water saturation is between 25% and 150%.
- the conduit 126 can have pore 124 sizes between 10 and 500 micrometers, serving as water retaining pockets or water transporting channels. Pores 124 in the conduit 126 also function as scaffolding or housing for cell 277 attachment and cellular proliferation, as shown in FIGS. 126-127. Water contact angle on the conduit 126 is between 0 and 60 degrees.
- the preferred water contact angle of the conduit 126 is between 0 and 30 degrees. Height of capillary action for drawing or transporting saline with a visible blue dye up the conduit 126 is between 0.5 and 300 cm. Height of capillary action for drawing or transporting pork blood up the conduit 126 is between 0.5 and 50 cm. The preferred height of capillary action for drawing pork blood up the conduit 126 is between 1 cm and 25 cm. Saline siphoning transport rate through the conduit 126 is between 0.1 and 10 cc per 8 hours in a humidity chamber. Human lumbar disc 100 loses between about 0.5 and 1.5 cc fluid per day due to compression. The saline siphoning transport rate through the conduit 126 is preferred between 0.5 and 5 cc per 8 hours in a humidity chamber. Pork blood siphoning transport rate through the conduit 126 is between 0.1 and 10 cc per 8 hours in a humidity chamber. The pork blood siphoning transport rate through the conduit 126 is preferred between 0.5 and 3 cc per 8 hours in a humidity chamber.
- the conduit 126 is preferred to be made with biocompatible and hydrophilic material, absorbing, retaining or drawing fluid with nutrients/oxygen/pH buffer solutes 131 from the diffusion zone of endplates 105.
- the filament 126 can be a suture 126, approved for human implant. Instead of fastening tissue, the suture 126 is used as the conduit 126 to transport fluid from the diffusion zones to alleviate back pain.
- the conduit 126 can be made with a hydrophilic sponge or foam with pores 124 to transport and retain fluid in the disc 100.
- the pores 124 can be open, connecting to other pores 124.
- the pores can also be closed, not connecting to other pores 124 to retain fluid and cells 277.
- the conduit 126 used in the sheep and human clinical studies have the following physical properties under ambient temperature and pressure: (1) weight gain 100% after water saturation, (2) water contact angle zero degree, (3) height of capillary action 11 cm with pork blood, 40 cm with saline with blue dye, and (4) rate of siphoning pork blood 1.656 +/- 0.013 cc per 8 hours in a humidity chamber.
- the disc conduit 126 is preferred to be made with permanent material to provide long-lasting pain relief.
- a wide range of non-degradable materials can be used to fabricate the conduit 126.
- the conduit 126 can be made with synthetic or biomaterial material. Synthetic materials include polymers, such as nylon, polytetrafluoroethylene, polypropylene, polyethylene, polyamide, polyester, polyurethane, silicon, poly-ether- ether-ketone, acetal resin, polysulfone, polycarbonate and acrylic are possible candidates.
- Fiberglass can also be a part of the conduit 126 to provide capillarity for transporting nutrients 131 and waste 162 or lactic acid 162.
- Biomaterials include collagen, hyaluronate, elastin, proteoglycans, chitin, chitosan, silk, cotton, linen, cellulose, alginate, fibrin, protein or carbon-based material are possible candidates to form the conduit 126.
- biodegradable conduits 126 may provide evidence within weeks or months. Since the disc conduit 126 degrades within months, any unforeseen adverse outcome would be dissipated. If the investigative-degradable conduit 126 shows promise, permanent conduit 126 can then be implanted to provide continuous benefits.
- the biodegradable conduit 126 can be made with poly(a-hydroxy esters) including poly(lactic acid) (PLA), poly(glycolic acid) (PGA) and their copolymers (PLGA), polylactate, polyglycolic, poly-lactide-co-glycolide, polycaprolactone, trimethylene carbonate, silk, catgut, collagen, poly-p-dioxanone or combinations of these materials.
- poly(a-hydroxy esters) including poly(lactic acid) (PLA), poly(glycolic acid) (PGA) and their copolymers (PLGA), polylactate, polyglycolic, poly-lactide-co-glycolide, polycaprolactone, trimethylene carbonate, silk, catgut, collagen, poly-p-dioxanone or combinations of these materials.
- degradable polymers such as polydioxanone, poly anhydride, trimethylene carbonate, poly-beta-hydroxybutyrate, polyhydroxyvalerate, poly-gama- ethyl-glutamate, poly-DTH-iminocarbonate, poly-bisphenol-A-iminocarbonate, poly- ortho-ester, polycyanoacrylate or polyphosphazene can also be used.
- the advancer 101 and the curved sleeve 165 can be made with nickel-titanium, 17- 7PH Condition C stainless steel, other alloy or with polymers, e.g. polypropylene, polyethylene, polycarbonate, polyether ether ketone, or other polymers.
- the guide wire 103, dilator 220, holder 600, cannula 230 or cutter 605 can be made with stainless steel, nickel-titanium, other alloy or polymers, e.g. polyether ether ketone or other polymers.
- the advancer 101, sleeve 165, guide wire 103, dilator 220, holder 600, cannula 230 or cutter 605 can be coated with lubricant, analgesic, antibiotic, radiopaque, magnetic and/or echogenic agents.
- the disc conduit 126 or filament 126 alleviates back pain by (1) drawing nutrients/oxygen/pH buffer 131 into the disc 100, (2) neutralizing lactic acid 162 to alleviate acid burn, (3) converting anaerobic to aerobic conditions to reduce lactic acid 162 production, (4) increasing sulfate incorporation in neutral pH for biosynthesis of proteoglycan 112, (5) increasing ATP production from aerobic metabolism of sugars to drive biosynthetic reactions in disc 100, (6) increasing disc 100 height to take load off the painful facet joints 129, (7) fortifying the disc 100 to reduce spinal instability and muscle tension, (8) rebuilding disc matrix to increase osmolarity and fluid intake and absorption, (9) re-establishing the swelling pressure to sustain disc 100 compression, (10) rectifying the biochemistry in the disc 100 for long term pain relief, (11) delivering drugs into the disc 100, and/or (12) delivering therapeutic donor cells 277 for rebuilding the disc 100 or biosynthesizing therapeutic molecules 160.
- benefits of the disc conduit 126 include (1) spinal motion preservation, (2) no tissue removal, (3) reversible by extraction, (4) micro-invasive, (5) out-patient procedure, (6) regulatory approved implant material, (7) 15-40 minutes per disc, (8) long-lasting and no-harm-done, (9) no incision, (10) compatible with drugs, conservative treatment or surgical intervention, if needed, (11) drug coated conduit if needed to expedite pain relief and/or regrowth of disc matrix, (12) near instant recovery, and/or (13) low cost intervention.
- a pH electrode may be exposed near the tip of the needle 102 to detect the acidity within the disc 100.
- An endoscope may be used in the cannula.
- the conduit 126 can be called a filament, strand, thread, line, wick, sponge, scaffold, spigot or absorbent.
Landscapes
- Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
L'invention concerne un conduit de transport de fluide dans une canule qui est introduit dans un disque détérioré à l'aide d'un fil avec un côté plat afin d'aspirer l'oxygène, les nutriments et la solution tampon pour pH près du plateau vertébral jusqu'à la couche intermédiaire ou vide du disque détérioré. Le conduit de transport de fluide est acheminé par une position de mise en prise et une position de désolidarisation entre le fil et le conduit. En position de mise en prise, le côté plat du fil se raccorde au conduit et le fait avancer depuis une bobine jusqu'au disque. En position de désolidarisation, le côté plat du fil se détache et se retire du conduit. Les positions de mise en prise et de désolidarisation entre le fil et le conduit sont répétées pour remplir le disque creux ou détérioré avec le conduit de transport de fluide. Lorsque le disque est rempli, un dispositif de coupe sectionne le conduit à l'intérieur du disque réparé.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202363576215P | 2023-01-23 | 2023-01-23 | |
US63/576,215 | 2023-01-23 | ||
US202363628269P | 2023-07-05 | 2023-07-05 | |
US63/628,269 | 2023-07-05 |
Publications (1)
Publication Number | Publication Date |
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WO2024158529A1 true WO2024158529A1 (fr) | 2024-08-02 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2024/000003 WO2024158529A1 (fr) | 2023-01-23 | 2024-01-22 | Soulagement des douleurs dorsales et/ou reconstruction des disques intervertébraux |
Country Status (1)
Country | Link |
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WO (1) | WO2024158529A1 (fr) |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100030241A1 (en) * | 2006-07-25 | 2010-02-04 | Yeung Jeffrey E | Spooled filament to repair tissue |
US20110077655A1 (en) * | 2009-09-25 | 2011-03-31 | Fisher Michael A | Vertebral Body Spool Device |
US20160058566A1 (en) * | 2011-03-23 | 2016-03-03 | Jeffrey E. Yeung | Method for tissue repair with spirals of filament |
-
2024
- 2024-01-22 WO PCT/US2024/000003 patent/WO2024158529A1/fr unknown
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100030241A1 (en) * | 2006-07-25 | 2010-02-04 | Yeung Jeffrey E | Spooled filament to repair tissue |
US20110077655A1 (en) * | 2009-09-25 | 2011-03-31 | Fisher Michael A | Vertebral Body Spool Device |
US20160058566A1 (en) * | 2011-03-23 | 2016-03-03 | Jeffrey E. Yeung | Method for tissue repair with spirals of filament |
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