Source: https://patents.google.com/patent/US20080319549A1/en
Timestamp: 2019-04-18 22:41:27+00:00

Document:
This application is a continuation of PCT International Application No. PCT/US2006/049607, filed Dec. 28, 2006 which claims the benefit of U.S. Provisional Application No. 60/754,4492, filed Dec. 28, 2005, which are incorporated herein by reference in their entireties.
Spinal stenosis is often caused by a shift in the vertebral bodies, which in turn change the static and dynamic nature of the spine. As the spine column shifts, load distributions change, tendons in the spine often shrink, and muscles reorganize and compensate. This can result in bone bumping into other bones. This can result in hypertrophy of the facet joints, or degenerative disc disease, which in turn can force the tissue surrounding the spinal cord and/or dorsal and ventral roots to compress and irritate the respective nerves. This irritation and compression can cause pain.
Over time this “downward spiral”, cascading process often gets worse. People with spinal stenosis may start to favor their spine, hunching over. This hunching can cause yet more load shifting, and more long term tissue damage and pain.
Existing mechanical treatment include a laminectomy, which removes the adjacent lamina and often a portion of the facet joints. Another procedure performed to treat spinal stenosis is a facetectomy, removing tissue from the facet joints, for example complete removal of the facet or partial removal using a rongeur. However, healthy tissue damage and destruction is required by either of these methods, whether used alone or in combination. Also, non-target tissue can be damaged, including spinal nerve tissue. Further this procedure is typically performed in an open surgery, requiring more damage and longer healing time.
Another treatment includes an attempt to mechanically restore adjacent vertebrae to an angle with respect to each other that will prevent the vertebrae from pinching the affected nerves. FIGS. 1 through 3 illustrate this concept. FIG. 1 illustrates that a first vertebra 102 can have a first vertebral plane 104. A second vertebra 106 can have a second vertebral plane 108. The first vertebra 102 can have a first vertebral goal plane 110. The first vertebral goal plane 110 is the plane at which the first vertebra 102 will not, or will minimally, press, pinch, or otherwise pathologically interfere with the surrounding nerves (e.g., spinal cord 112 or dorsal or ventral roots 114), such as shown at a compressed nerve area 116. The difference between the first vertebral plan 104 and the first vertebral goal plane 110 can be a vertebral angle 118. The first vertebral goal plane 110 and the second vertebral plane 108 can be substantially parallel.
The device 200 can be positioned near the treatment site, as shown in FIG. 1. The device may have a cam, or prop 202. The device can have straps or braces 204 to secure to the adjacent vertebra. FIG. 2 illustrates that the device 200 having a cam 202 can be inserted between the first and second vertebrae's' processes. FIG. 3 illustrates that the cam 204 can be turned to expand, as shown by arrows, pushing the dorsal ends of the vertebrae 102 and 106 apart. This rotates the first vertebra 102 so the first vertebral plane 102 becomes coplanar with the first vertebral goal plane 110. The affected nerve 116 will therefore be no longer compressed, or be less compressed.
One method of accomplishing this treatment includes the deployment of a static mechanical prop between vertebrae. The prop is used to wedge into place between adjacent vertebrae and push the adjacent vertebrae back to a naturally beneficial relative angle, often relieving the pressure on the affected nerve. The prop is commonly attached to the adjacent vertebrae using straps. However, the prop is not adjustable in height and the straps must be surgically attached around the adjacent vertebra.
FIGS. 9 and 10 a are perspective views of variations of the expandable support device.
FIG. 10 b is a side view of a variation of the expandable support device of FIG. 10 a.
FIGS. 11 a and 11 b illustrate a variation of a method for using a variation of the expandable support device.
FIGS. 12 a and 12 b illustrate a variation of a method for using a variation of the expandable support device.
FIGS. 13 a and 13 b illustrate a variation of a method for using a variation of the expandable support device.
FIG. 14 illustrates a variation of the expandable support device deployed in a spine.
FIG. 15 is a close-up view of a portion of a variation of the expandable support device deployed in a spine.
FIG. 16 a is a top view of a variation of the expandable support device during deployment in a spine.
FIG. 16 b is a front view of FIG. 16 a with different anatomical features shown.
FIG. 17 a is a top view of the expandable support device of FIG. 16 a further along during deployment in a spine.
FIG. 17 b is a front view of FIG. 17 a with different anatomical features shown.
FIG. 18 illustrates variations of methods for deploying the expandable support device.
The expandable support device 300 can have two, three, four or more struts The struts 302 can be rotationally connected to (i.e., attached to or intregrated with) some or all of the other struts 302. The expandable support device 300 can have a top plate 304 and/or a bottom plate 306. The plates 304 can be rotationally connected to one, some or all of the struts 302. The expandable support device 300 can have a first end plate 306 a and/or a second end plate 306 b. The struts 302 and/or plates 304 and/or 306 can rotationally connect to any or all of each other.
The struts 302 and/or plates 304 can have a first vertebral seat 308 a and/or a second vertebral seat 308 b. The first and second vertebral seats 308 a and 308 b can be configured to attach to the first and second vertebrae 102 and 106, respectively. The vertebral seats 308 can be configured to minimize or completely prevent lateral movement of the vertebrae 102 and 106. For example, the seats 308 can each have a seat first side 310 a and/or a seat second side 310 b. The seat first side 310 a can form a right or acute angle with the seat second side 310 b. The vertebral seats 308 can have a “V” configuration.
FIG. 9 illustrates that the expandable support device can have no vertebral seats 308. Adjacent struts 302 can join to form a vertebral anchor 330. Between the plates 306 a and 306 b, the expandable support device 330 can be entirely straight struts 302. The end plates 306 a can be individual and separated for each strut 302, and/or flexibly joined together.
FIG. 9 illustrates that the expandable support device can have a transverse axis 334. The transverse axis 334 can be perpendicular to the longitudinal axis 318 and/or expansion axis 320.
FIGS. 9 and 10 illustrate that the struts 302 (as shown), or plates 304 can have length adjusters 336. The length adjusters 336 can contract and expand, for example to fit the length of the expandable support device 300 to the length of the target site, also for example, to ease introduction of the expandable support device 300 through soft and hard tissue when being inserted to the target site. The length expanders 336 can be hinges, springs, or combinations thereof. The length expanders 336 can be configured to rotate, and/or expand, and/or contract. The length expanders 336 can be attached to, and/or integral with the adjacent struts 302 and/or plates 304.
FIG. 11 a illustrates that the expandable support device 300 can be inserted to the target site attached to a deployment tool 338. The deployment tool 338 can be part of a delivery system (not shown) that can include a catheter, trocar, drill, balloon, or a combination thereof. The deployment tool 338 can follow a guide wire into position between the tilted spinous process (e.g., of the stenotic vertebra 102 and 106) and deployed.
The expandable support device 300 can be inserted into the target site, for example along the longitudinal axis 318. The expandable support device 300 can be inserted into the target site in an orietantion perpendicular to the longitudinal axis 318, for example, the expandable support device 300 shown in FIGS. 4 a, 4 b and 5.
FIG. 11 b illustrates that when the expansion axis is aligned with the vertebrae 102 and 106, for example at the spinous processes, and/or when the vertebral seats 308 are aligned with the closest points of the vertebrae 102 and 106 (e.g., the closest points of the spinous processes), then the deployment tool 338 can compress, as shown by arrows 322, the expandable support device 300 along the compressive or longitudinal axis 318. The expandable support device 300 can then expand, as shown by arrows 324, in height along the expansion axis 332.
FIGS. 12 a and 12 b illustrate deployment and expansion of the expandable support device 300 similar to the expandable support device 300 shown in FIGS. 6 a, 6 b, 7 a and 7 b. The vertebral anchors 330 can attach to, and press in to the vertebrae 102 and 106 during expansion of the expandable support device 300.
FIGS. 13 a and 13 b illustrate deployment and expansion of the expandable support device 300 similar to the expandable support device 300 shown in FIG. 8. When deployed into an expanded configuration, the interdigitating struts 302 can rotate toward the same or opposite directions during deployment as the initial starting position of the strut 302 in the contracted configuration. For example, even though a first strut can be on a first side (e.g., top) and a second strut can be on a second side (e.g., bottom) in the contract configuration, the first strut can be on the second side (e.g., bottom) and the second strut can be on the first side (e.g., top) in the expanded configuration.
FIG. 14 illustrates that the first vertebra 102 can have a first spinous process 340 a and the second vertebra 106 can have a second spinous process 340 b. The expandable support device 300 can be deployed between spinous processes 340 on adjacent vertebra. The expandable support device 300 can be deployed between any equivalent peripheral anatomic feature of a vertebra on adjacent vertebrae. For example, the expandable support device can be deployed between adjacent vertebraes' facets, pedicles, laminae, inferior articular precesses, transverse processes, superior articular processes, accessory rocesses, or combinations thereof. More than one expandable support device can be deployed between a first vertebra 102 and a second vertebra 106, for example between different anatomical features on the vertebrae (e.g., between spinous processes and separately between transverse processes).
FIG. 15 illustrates in a partial view of a expandable support device 300 shown close-up deployed between a first spinous process 340 a and a second spinous process 340 b that the length adjusters 336 on various struts 302 can be expanded and contracted to different lengths, for example to accommodate the surrounding anatomy. For example, first length adjusters 336 a on the first strut 302 a can be more compressed than the length adjusters 336 b on the second strut 302 b. The length from the first spinous process 340 a to the second spinous process 340 b can physiologically be closer at the first strut 302 a than at the second strut 302 b.
FIGS. 16 a and 16 b illustrate that the expandable support device 300 can be deployed through a cut or inciscion 344 in soft tissue 342 between the first spinous process 340 a and the second spinous process 340 b. The cut or inciscion 344 can be performed before the expandable support device is inserted to the target site, and/or by the expandable support device 300, as the expandable support device 300 is inserted to the target site.
FIGS. 17 a and 17 b illustrate that when the expandable support device 300 is expanded, as shown by arrows 324 in FIG. 17 b, and longitudinally contracts, the tissue attachment devices 346 can attach to the soft tissue 342 adjacent to the expandable support device 300. As shown in FIG. 17 a, the expandable support device 300 can clamp, squeeze, or otherwise attach to the soft tissue 342. The tissue attachment elements 346 can attach to the soft tissue 342. Attachment of the expandable support device 300 to the soft tissue 342 (e.g., via compression of the soft tissue 342 and/or attachment by the tissue attachment elements 346) solely or additionally anchor and/or secure the expandable support device 300.
During expansion and deployment, the top plate 304 a can rotate relative to the bottom plate 304 b, for example as seen in FIG. 17 b. For example, the rotation can occur through flexing or bending in the expandable support device 300.
FIG. 18 illustrates paths of inserting the expandable support device 300 through the soft tissue of the back 348 and into the target site, for example adjacent to the first vertebra 102. The expandable support device 300 can be implanted from a posterior approach, as shown by arrow 350, lataral approach, as shown by arrow 352, or a hybrid approach (i.e., mix of posterior and lateral), as shown by arrow 354. The deployed expandable support device 300 can rotate the first vertebra 102 with respect to the second vertebra 106 the equivalent of about the negative vertebral angle 118.
The expandable support device 300 can be rigid or have controlled spring force. The device can have support arches. The expandable support device is stabilzed by the soft tissue and creates an interference fit.
The expandable support device 300 can be filled/covered with cement, bone, polymer, drug, collagen, or any other agent or material disclosed herein.
Additional embodiments of the expandable support device 300 and methods for use of the expandable support device 300, as well as devices for deploying the expandable support device 300 can include those disclosed for the expandable support device in the following applications which are all incorporated herein in their entireties: PCT Application No. PCT/US2005/034115, filed 21 Sep. 2005; U.S. Provisional Patent Application No. 60/675,543, filed 27 Apr. 2005; PCT Application No. PCT/US2005/034742, filed 26 Sep. 2005; PCT Application No. PCT/US2005/034728, filed 26 Sep. 2005; PCT Application No. PCT/US2005/037126, filed 12 Oct. 2005; U.S. Provisional Patent Application No. 60/723,309, filed 4 Oct. 2005; U.S. Provisional Patent Application No. 60/675,512, filed 27 Apr. 2005; U.S. Provisional Patent Application No. 60/699,577, filed 14 Jul. 2005; and U.S. Provisional Patent Application No. 60/699,576, filed 14 Jul. 2005. The aforementioned spinal lift device can be deployed into the target site, for example, after the tissue in the target site has been removed and/or the target site surfaces have been prepared by the expandable support device 300.
Any or all elements of the expandable support device 300 and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET), polyester (e.g., DACRON® from E.I. Du Pont de Nemours and Company, Wilmington, Del.), poly ester amide (PEA), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold.
Any or all elements of the expandable support device 300 and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E.I. Du Pont de Nemours and Company, Wilmington, Del.), poly ester amide (PEA), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone, any other material disclosed herein, or combinations thereof.
The agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE® from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E2 Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J Surgery 86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties.
compressing the expandable support device.
2. The method of claim 1, wherein compressing comprises applying a compressive force in a first direction, and wherein compressing further comprises expanding the expandable support device in a second direction.
3. The method of claim 2, wherein the second direction is substantially perpendicular to the first direction.
4. The method of claim 1, wherein compressing comprises applying a compressive force along an axis that is substantially perpendicular to a line from an anatomical landmark on the first vertebra to the anatomical landmark on the second vertebra.
5. The method of claim 1, wherein compressing comprises expanding the height of the expandable support device.
6. The method of claim 1, wherein the height is measured along an axis that is substantially parallel with a line from an anatomical landmark on the first vertebra to the anatomical landmark on the second vertebra.
7. The method of claim 1, wherein compressing comprises applying a compressive force along an axis that is substantially perpendicular to a line from an anatomical landmark on the first vertebra to the anatomical landmark on the second vertebra.
8. The method of claim 1, further comprising sensing the compressed expandable support device, then further compressing the compressed expandable support device.
9. The method of claim 8, wherein sensing comprises visualizing.
10. The method of claim 1, further comprising sensing the compressed expandable support device, then further expanding the expandable support device.
11. The method of claim 10, wherein sensing comprises visualizing.
wherein the first elongated element has a first elongated element first end and a first elongated element second end, and wherein the second elongated element has a second elongated element first end and a second elongated element second end, and wherein the first connector connects the first elongated element to the second elongated element, and wherein the expandable frame is configured to expand in a first direction when the expandable frame is compressed in a second direction.
13. The device of claim 12, wherein the first elongated element and the second elongated element interdigitate.
14. The device of claim 12, further comprising a second connector connecting the first elongated element to the second elongated element.
15. The device of claim 12, wherein the first connector is connected to the first elongated element at the first elongated element first end.
16. The device of claim 15, wherein the second connector is connected to the first elongated element at the first elongated element second end.
17. The device of claim 12, wherein the connection between the first elongated element and the first connector comprises the first connector being integral with the first elongated element.
18. The device of claim 12, wherein the first connector is configured to attach to a compression tool.
19. The device of claim 18, wherein the second connector is configured to attach to the compression tool.
20. The device of claim 12, wherein the expandable frame is configured to bend about an axis substantially parallel with the first direction.
21. The device of claim 12, wherein the expandable frame is configured to bend about an axis substantially perpendicular to the first direction and the second direction.
22. The device of claim 12, wherein the first elongated element comprises a seat configured to attach to the first bone, and wherein the seat is configured in a different shape than the adjacent portion of the first elongated element.

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