Source: http://www.google.com/patents/US7326210?dq=oakley+5,387,949
Timestamp: 2017-04-25 06:17:44
Document Index: 726593817

Matched Legal Cases: ['art.\n8', 'art.\n11', 'art.\n15', 'art.\n18', '§ 119', 'art 289', 'art 290', 'art 289', 'art 289', 'art 290', 'art 289', 'art 289', 'art 290', 'art 289', 'art 289', 'art 289', 'art 290', 'art 289', 'art 289', 'art 289', 'art 289', 'art 290', 'art 289', 'art 290', 'art 289', 'art 289', 'art 290', 'art 290', 'art 289', 'art 289', 'art 289', 'art 290', 'art 298', 'art 290', 'art 298', 'art 289', 'art 289', 'art 298', 'art 298', 'art 290', 'art 290']

Patent US7326210 - Spinal stabilization device - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA flexible connection unit for use in a spinal fixation device, includes: a longitudinal member having first and second ends; at least one spacer located between the first and second ends, wherein the at least one spacer comprises a first portion made from a first material and a second portion made from...http://www.google.com/patents/US7326210?utm_source=gb-gplus-sharePatent US7326210 - Spinal stabilization deviceAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS7326210 B2Publication typeGrantApplication numberUS 11/072,886Publication dateFeb 5, 2008Filing dateMar 3, 2005Priority dateSep 24, 2003Fee statusPaidAlso published asCA2591277A1, CA2600672A1, CA2600672C, CA2675782A1, CN100586388C, CN101170952A, CN101636118A, CN101636118B, CN102283704A, EP1827265A2, EP1827265A4, EP1858424A1, EP1858424A4, EP1858424B1, EP2111171A1, US7988710, US20050203513, US20050203517, US20070225710, US20080234746, US20120209330, WO2006063107A2, WO2006063107A3, WO2006096414A1, WO2008100944A1Publication number072886, 11072886, US 7326210 B2, US 7326210B2, US-B2-7326210, US7326210 B2, US7326210B2InventorsTae-Ahn Jahng, Jason Yim, Brian BowmanOriginal AssigneeN Spine, IncExport CitationBiBTeX, EndNote, RefManPatent Citations (95), Non-Patent Citations (7), Referenced by (309), Classifications (51), Legal Events (13) External Links: USPTO, USPTO Assignment, EspacenetSpinal stabilization device
US 7326210 B2Abstract
A flexible connection unit for use in a spinal fixation device, includes: a longitudinal member having first and second ends; at least one spacer located between the first and second ends, wherein the at least one spacer comprises a first portion made from a first material and a second portion made from a second material; and at least one flexible member located in a longitudinal axial channel of the at least one spacer, wherein the first and second ends substantially limit motion of the at least one spacer in the longitudinal axial direction with respect to the at least one flexible member.
1. A flexible connection unit for use in a bony stabilization device, comprising:
a first bone coupling assembly;
a second bone coupling assembly;
a longitudinal member including:
a first rigid end including a surface received at least partially within and directly coupled to the first bone coupling assembly;
a second rigid end;
a flexible member located between the first and second rigid ends and coupled to the second rigid end; and
a spacer located between the first and second rigid ends, including:
a first part circumferentially disposed about the flexible member; and
a second part circumferentially disposed about the flexible member and received at least partially within and coupled to the second bone coupling assembly, wherein the first rigid end and the flexible member are a monolith, the first part extends at least partially between the first rigid end and the second part, and the first part limits the movement of the second part about the flexible member.
2. The flexible connection unit according to claim 1, wherein one of the first bone coupling assembly and the second bone coupling assembly is configured to be engagable by a pedicle of a first vertebra.
3. The flexible connection unit according to claim 2, wherein the other of the first bone coupling assembly and the second bone coupling assembly is configured to be engagable by a pedicle of a second vertebra.
4. The flexible connection unit according to claim 3, wherein the first vertebra is adjacent to the second vertebra.
5. The flexible connection unit according to claim 1, wherein one of the first bone coupling assembly and the second bone coupling assembly includes a shaft capable of fixably engaging bone.
6. The flexible connection unit according to claim 1, wherein one of the first bone coupling assembly and the second bone coupling assembly includes a shaft capable of fixably engaging a pedicle of a vertebra.
7. The flexible connection unit of claim 1, further comprising a cladding surrounding a portion of the first part between the first rigid end and the second part.
8. The flexible connection unit of claim 7, wherein the first part includes an elastomer.
9. A rod for use in a bony stabilization device, comprising:
a first rigid end including a surface received at least partially within and directly coupled to a first bone coupling assembly; and
a flexible member located between the first and second rigid ends and coupled to the second rigid end;
a first spacer part circumferentially disposed about the flexible member and located between the first and second rigid ends;
a second spacer part circumferentially disposed about the flexible member and the first spacer part and located between the first and second rigid ends and intended to be received at least partially within and coupled to a second bone coupling assembly,
wherein the first rigid end and the flexible member are a monolith, the first spacer part extends at least partially between the first rigid end and the second spacer part and the first spacer part limits movement of the second spacer part about the flexible member.
10. The flexible connection unit for use in a bony stabilization device according to claim 1, wherein the second part is circumferentially disposed about the flexible member and the first part.
11. The flexible connection unit for use in a bony stabilization device according to claim 1, wherein the first part substantially limits movement of the second part about the flexible member.
12. The rod for use in a bony stabilization device according to claim 9, wherein the first spacer part substantially limits movement of the second spacer part about the flexible member.
13. A flexible connection unit for use in a bony stabilization device, comprising:
a first rigid end including a surface received at least partially within and coupled to the first bone coupling assembly;
a flexible member consisting of one of a wire, a plurality of wires, and a braided cable, the flexible member located between the first and second rigid ends and coupled to the first rigid end and the second rigid end; and
a spacer located entirely between the first and second rigid ends, including:
a second part circumferentially disposed about the flexible member and received at least partially within and coupled to the second bone coupling assembly,
wherein the first part extends at least partially between the first rigid end and the second part and the first part limits the movement of the second part about the flexible member.
14. The flexible connection unit for use in a bony stabilization device according to claim 13, wherein the second part is circumferentially disposed about the flexible member and the first part.
15. The flexible connection unit for use in a bony stabilization device according to claim 13, wherein the first part substantially limits movement of the second part about the flexible member.
16. A flexible connection unit for use in a bony stabilization device, comprising:
a flexible member located between the first and second rigid ends and coupled to the first rigid end and the second rigid end; and
wherein the first part extends at least partially between the first rigid end and the second part and the first part holds the second part in a substantially fixed position about the flexible member.
17. The flexible connection unit for use in a bony stabilization device according to claim 16, wherein the second part is circumferentially disposed about the flexible member and the first part.
18. The flexible connection unit for use in a bony stabilization device according to claim 16, wherein the flexible member consists of one of a wire, a plurality of wires, and a braided cable.
19. A rod for use in a bony stabilization device, comprising:
a first rigid end including a surface intended to be received at least partially within and coupled to a first bone coupling assembly; and
a second spacer part circumferentially disposed about the flexible member and the first spacer part and located entirely between the first and second rigid ends and intended to be received at least partially within and coupled to a second bone coupling assembly,
wherein the first spacer part extends at least partially between the first rigid end and the second spacer part and the first spacer part holds the second spacer part in a substantially fixed position about the flexible member.
20. The rod for use in a bony stabilization device according to claim 19, wherein the flexible member consists of one of a wire, a plurality of wires, and a braided cable.
21. A flexible connection unit for use in a bony stabilization device, comprising:
a second part circumferentially disposed about the flexible member and the first part and received at least partially within and coupled to the second bone coupling assembly,
wherein the first rigid end and the flexible member are a monolith, the first part extends at least partially between the first rigid end and the second part, and the first part limits the movement of the second part about the flexible member.
22. The flexible connection unit of claim 16 wherein a flexible cladding encapsulates the first part of the spacer and the flexible member between the first and second rigid ends.
23. The flexible connection unit of claim 16 wherein a flexible cladding fills one or more spaces between the first part of the spacer and the flexible member and the first and second rigid ends so as to limit motion of the spacer relative to the flexible member and the first and second rigid ends.
24. The flexible connection unit of claim 16 wherein the location of the spacer substantially corresponds to a location of a joint between adjacent superior and inferior vertebrae of the patient's spine when the first bone coupling assembly is fixed to the inferior vertebra and the second bone coupling assembly is fixed to the superior vertebra.
25. The flexible connection unit of claim 16 wherein the flexible member comprises a single shaft.
26. The flexible connection unit of claim 16 wherein the flexible member is located eccentric from the longitudinal axis so as to provide a first level of stiffness when the connection unit is bent in a first direction and a second level of stiffness, different from the first level of stiffness, when the connection unit is bent in a second direction.
27. The flexible connection unit of claim 16 wherein the spacer is capable of movement in six degrees of freedom while experiencing resistance to such movement in each of the six degrees of freedom.
The present application is a continuation-in-part of U.S. patent application Ser. No. 11/009,097, filed Dec. 10, 2004, which is continuation-in-part of U.S. patent application Ser. No. 10/798,014, filed Mar. 10, 2004, which is a continuation-in-part of U.S. patent application Ser. No. 10/728,566, filed on Dec. 5, 2003, which claims the benefit of priority under 35 U.S.C. § 119(a) to Korean Application Serial No. 2003-0066108, filed on Sep. 24, 2003, the entirety of which is incorporated by reference herein.
Additionally, in a conventional surgical method for fixing the spinal fixation device to the spinal column, a doctor incises the midline of the back to about 10-15 centimeters, and then, dissects and retracts it to both sides. In this way, the doctor performs muscular dissection to expose the outer part of the facet joint. Next, after the dissection, the doctor finds an entrance point to the spinal pedicle using radiographic devices (e.g., C-arm flouroscopy), and inserts securing members of the spinal fixation device (referred to as “spinal pedicle screws”) into the spinal pedicle. Thereafter, the connection units (e.g., rods or plates) are attached to the upper portions of the pedicle screws in order to provide support and stability to the injured portion of the spinal column. Thus, in conventional spinal fixation procedures, the patient's back is incised about 10˜15 cm, and as a result, the back muscle, which is important for maintaining the spinal column, is incised or injured; resulting in significant post-operative pain to the patient and a slow recovery period.
FIG. 52A illustrates a cross sectional diagram of a metal-hybrid spacer as shown in FIG. 52, in accordance with one embodiment of the present invention.
FIG. 12A illustrates a further embodiment of a flexible connection unit 36 having two rigid end portions 9′ and an exemplary number of spacers 37 interposed between the end portions. In one embodiment, the rigid end portions 9′ and spacers can be made of bio-compatible metal, metal-hybrid, and/or synthetic materials as discussed above. The connection unit 36 further includes a flexible member or wire 32, as discussed above with respect to FIG. 9, which traverses an axial cavity or hole (not shown) in each of the rigid end portions 9′ and spacers 37. FIG. 12B illustrates an exploded view of the connection unit 36 that further shows how the wire 32 is inserted through longitudinal axis holes of the rigid end portions 9′ and spacers 37. As further shown in FIG. 12B, each of the end portions 9′ and spacers 37 include a male interlocking member 38 which is configured to mate with a female interlocking cavity (not shown) in the immediately adjacent end portion 9′ or spacer 37. FIG. 12C illustrates an exploded side view and indicates with dashed lines the location and configuration of the female interlocking cavity 39 for receiving corresponding male interlocking members 38.
The wire 32 shown in FIG. 48 is physically separated at both ends from the end portions 9′. This may be accomplished by cladding the wire 32 individually to create a metal-hybrid wire and assembling it with the end portions 9′ prior to cladding the spacer 37. Alternatively the metal-hybrid wire 32, may be clad by extruding elastomer around the wire 32 or sliding it into a pre-formed extruded elastomer prior to assembly. The latter method of manufacturing has the advantage of allowing the wire 32 to slide along its axis within the elastomer cladding 278, thereby decreasing axial stiffness of the connection unit 36 relative to its flexural and shear stiffness. Those skilled in the art will recognize that if the flexible wire 32 is free to slide as described herein, then the flexural and shear stiffness of the connection unit 36 may be altered by varying the diameter of the wire 32, with minimal change in the axial stiffness of the connection unit 36. As known in the art, “flexural stiffness” relates to an amount that an object may bend and “shear stiffness” relates to an amount that an object can withstand lateral shear forces. “Axial stiffness” relates to an amount that an object can be stretched or compressed.
FIGS. 50A-D illustrate a variety of features for improved fixation of the elastomer cladding 278 to the surface of any rigid element 281. FIG. 50A illustrates an undercut cavity in the rigid element 281 wherein the body of the cavity 282 is larger than the neck 283, thereby capturing the elastomer cladding 278 within the cavity 282. The cavity further includes smaller undercut grooves 283 in the wall of the cavity for interdigitation of the elastomer cladding 278. The undercut grooves 283 and undercut cavity 282 may be utilized independently as well. FIG. 50B illustrates an external barb 284 on the rigid element 281 around which the elastomer cladding 278 is molded. FIG. 50C illustrates holes 285 through the wall of the rigid element 281 through which the elastomer cladding 278 is molded. In one embodiment, the elastomer cladding 278 covers both the interior and exterior surfaces of the wall around the hole 285. FIG. 50D illustrates a roughened surface 281 of the rigid element 281 at the interface with the elastomer cladding 278. The roughened surface may be formed by a variety of methods, including for example, grit blasting, bead blasting, plasma spraying, chemical etching and a variety of machining techniques. Any of the features illustrated in FIG. 50A-D may be used in combination with each other or in combination with surface treatments such as cleaning, passivation or chemical priming of the surface of the rigid element 281.
FIG. 52 illustrates another embodiment of a connection unit 284 having two rigid end portions 285 and 286, and a middle portion in which a flexible member 287 connects end portions 285 and 286 and traverses an axial hole in a metal-hybrid spacer 288. In one embodiment, metal-hybrid spacer 288 is formed from at least one metal, second part and one elastomer material, first part, such that the metal, second part 289 of the spacer 288 is configured to be accepted and retained by a securing member such as a pedicle screw or laminar hook, and the elastomer, first part 290 of the spacer 288 is located on opposite sides of the metal, second part 289 and adjacent to respective end portions 285 and 286.
Referring to FIG. 52, when end portion 285 and second metal spacer part 289 are retained by respective securing members 2 (FIG. 2), for example, and affixed to adjacent vertebrae, the connection unit 284 provides stability while simultaneously permitting motion to the vertebrae in six degrees of freedom (i.e., x-axis, y-axis, z-axis, pitch, roll and yaw). Although the end portions 285 and 286 substantially limit the motion of the metal-hybrid spacer 288 in the longitudinal axial direction, the compressibility and elasticity of the elastomer, first spacer part 290 on both sides of the metal, second spacer part 289 allows for stabilized motion of the metal, second spacer part 289 relative to the end portions 285 and 286 and/or flexible connecting member 287 in each of the six degrees of freedom while also providing a resistance and stability of motion in each of the six degrees of freedom. Thus, in one embodiment, the connection unit 284 provides a greater range of dynamically stabilized motion. Additionally, in one embodiment, the elastomer first part 290 comprises a high-friction material that resists sliding of the metal-hybrid second spacer part 289 on flexible middle portion 287, thereby providing further resistance to movement of the metal second spacer part 289 in the longitudinal axial direction. End portions 285 and 286 are connected to respective ends of metal-hybrid spacer 288 using any of the techniques discussed above or other known methods. End portion 285 is configured to have sufficient length to be accepted and retained by a pedicle screw or other type of securing member. When the metal second part 289 of the hybrid spacer 288 is coupled to and secured to a securing member 2 (FIG. 3), for example, end portion 286 extends beyond the securing member 2 (on the side opposite the space between the two securing members 2). Thus, end portion 286 is configured to be short along the axis of the connection unit 284, in order to minimize the length of the connection unit 284 that extends beyond the securing member 2.
In another embodiment (not shown), the flexible member 287 may be located eccentric from the central longitudinal axis of the connection unit 284. This eccentric configuration provides different levels of stiffness, depending on the direction the connection unit 284 is bent. This may be advantageous if it is desired to provide a greater level of stiffness when the connection unit 284 is flexed during spinal extension (e.g., when a patient bends backward) and a lesser level of stiffness when the connection unit 284 is flexed during spinal flexion (e.g. when a patient bends forward). Additionally, or alternatively, different levels of stiffness v. direction of bending profiles may be achieved by applying different amounts or thicknesses of the first elastomer part 290 on one side of the connection unit 284 than on other sides of the connection unit 284. Additionally, different amounts and/or types of cladding or elastomer materials 290 may be applied on either side of the second spacer part 289. Thus, the connection unit 284 can provide different levels of stiffness in different directions of movement of the spacer 288 and, hence, varying levels of stability can be provided to different directions of movement of a vertebra secured to the second spacer part 289 via a securing member 2. In these embodiments wherein the level of stiffness of the connection unit 284 depends on the direction of bending, appropriate markings (e.g., laser etchings, physical features, etc.) may be placed on the connection unit 284 to indicate the proper orientation of the connection unit 284 prior to securing the connection unit 284 to a patient's spine.
In various embodiments, the flexible member 287 as shown in FIGS. 52, 54 and 55 may be a solid member of rigid material, such as a biocompatible metal, preferably the same material as end portions 285 and 286 integrally formed with end portion 285 and permanently fixed to end portion 286. Alternatively, connecting member 287 may be a wire, plurality of wires, braided cable or other structure for connecting end portions 285 and 286. It will be clear to one skilled in the art that the structure, length and diameter of the connecting member will affect the flexibility of the connection unit 284. Similarly, the metal second spacer part 289 may be made of a biocompatible metal, preferably the same material as end portions 285 and 286, and the first elastomer part may be made of a biocompatible elastomer, for example, silicone or polyurethane and preferably polycarbonate urethane. The metal second spacer part 289 is shown to be of substantially the same outside diameter as the rigid end portions 285 and 286. Alternatively, the elastomer first part 290 of the spacer 288 may be smaller or larger in diameter, or may be variable in diameter. It will be clear to one skilled in the art that the flexibility of the connection unit 284 may be changed by the selection of the cladding or elastomer material and varying its dimensions.
The non-metal or elastomer first portions 290 of the metal-hybrid spacer 288 may be attached to the surfaces of the respective end portions 285 and 286, the metal second spacer part 289 and/or the flexible member 287 by a variety of methods including those shown in FIGS. 50A-50D. As shown in FIGS. 52-55, the elastomer or cladding first part 290 maintains the metal second spacer part 289 in a substantially fixed position with respect to the end portions 285 and 286, while allowing some relative movement of the second spacer part 289 when external forces cause the elastomer or cladding first part 290 to bend or compress in any direction. Thus, in one embodiment, the flexibility of the connection unit 284 is substantially limited by the compressibility of the elastomer first part 290 of the hybrid spacer 288, which may be compressed in various directions by the motion of the metal second part 289 of the spacer 288, when the metal second part 289 is fixed to the vertebral bone by a securing member 2.
FIG. 55 illustrates an embodiment of a connection unit 296 with a metal-hybrid spacer 297 comprised of more than two different materials. The spacer 297 has a metal second part 289 and an elastomer first part 290 as described in FIG. 52 and an additional bio-absorbable part 298, shown external to the elastomer first part 290. The bio-absorbable part 298 of the metal-hybrid spacer 297 is configured to substantially extend from each end of the metal second part 289 of the spacer 297 to the nearest end of respective rigid end portions 285 and 286 and to restrict motion of the metal second part 289, until bio-absorbable part 298 is softened or degraded in the body. The bio-absorbable part 298 of the spacer 297 may be comprised of at least one material selected from a group of known bio-absorbable materials consisting of: polylactic acid, polyglycolic acid, polyglactic acid, polydioxanone, polyglyconate, calcium sulfate, calcium phosphate and combinations thereof. Other known bio-absorbable materials, and even those that will be discovered in the future, may be utilized in accordance with the present invention.
The flexible connection unit 296 can be advantageously utilized in any situation where it is desirable to provide varying levels of stability. Additionally, the relative amount and type of bio-absorbable material incorporated into the connection unit 296 can be varied to alter the initial stiffness of the connection unit 296 and the time required to fully absorb all of the bio-absorbable portion(s) 298. In one embodiment, two or more different types of bio-absorbable materials having different stiffness characteristics and/or absorption times can be utilized to provide transitions from multiple levels of stiffness. In a further embodiment, a connection unit configured to stabilize multiple spine segments can incorporate bio-absorbable materials in one or more flexible portions of the connection unit to provide varying states of flexibility by various flexible portions of the multi-spine segment connection unit. Additionally, the bio-absorbable material 298 may be applied to completely encapsulate a flexible portion (e.g., the metal-hybrid spacer 288) of a connection unit, or simply cover select portions of the connection unit, or fill gaps, spaces and/or channels of the connection unit. In other words, the application of one or more bio-absorbable materials 298 can be implemented in various ways to achieve desired initial and final stiffness characteristics for one or more flexible portions of a connection unit. Additionally, it is not necessary to combine bio-absorbable claddings 298 with non-bio-absorbable elastomers or claddings first spacer part 290. Thus, in one embodiment, the elastomer or cladding first spacer part 290 of the connection unit 296 illustrated in FIG. 55 may be omitted altogether or replaced by the bio-absorbable cladding 298, or another bio-absorbable cladding (not shown) having different stiffness and/or degradation/absorption characteristics.
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spine* Cited by examinerClassifications U.S. Classification606/86.00AInternational ClassificationA61B17/34, A61F2/36, A61F11/00, A61F2/00, A61B17/60, A61B, A61F2/32, A61F5/00, A61F2/38, A61B19/00, A61F2/34, A61F2/30, A61B17/00, A61B17/56, A61B17/58, A61B17/70, A61B17/17Cooperative ClassificationA61B17/3468, A61B17/3472, A61B17/8897, A61B17/3439, A61B2017/00004, A61B17/7026, A61B17/7007, A61B17/3423, A61B17/7029, A61B17/3421, A61B2017/00862, A61B17/7032, A61B17/1757, A61B17/7031, A61B17/702, A61B17/705, A61B17/7028, A61B90/39, A61B2090/3916, A61B2090/363, A61B2090/3987European ClassificationA61B17/34G4, A61B17/34J, A61B17/70B2, A61B17/70D2, A61B19/54, A61B17/70B1R2, A61B17/70B1R12, A61B17/70B1R10, A61B17/70B1R10B, A61B17/70B1R10D, A61B17/70B1C4, A61B17/17S4Legal EventsDateCodeEventDescriptionJun 23, 2005ASAssignmentOwner name: N SPINE, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:JAHNG, TAE-AHN;YIM, JASON;BOWMAN, BRIAN;REEL/FRAME:016399/0494Effective 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ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:DEPUY SPINE, LLC;REEL/FRAME:032319/0190Effective date: 20121230Nov 11, 2014RRRequest for reexamination filedEffective date: 20140903Feb 17, 2015ASAssignmentOwner name: DEPUY SYNTHES PRODUCTS, INC., MASSACHUSETTSFree format text: CHANGE OF NAME;ASSIGNOR:DEPUY SYNTHES PRODUCTS, LLC;REEL/FRAME:035001/0970Effective date: 20141219Jul 22, 2015FPAYFee paymentYear of fee payment: 8Jul 26, 2016LIMRReexamination decision: claims changed and/or cancelledKind code of ref document: C1Free format text: REEXAMINATION CERTIFICATE; THE PATENTABILITY OF CLAIMS 14, 17, 19 AND 20 IS CONFIRMED. CLAIMS 13, 15, 16, 18 AND 22-27 ARE CANCELLED. CLAIMS 1-12 AND 21 WERE NOT REEXAMINED.Filing date: 20101216Effective date: 20160718RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services