Method and apparatus for treating intervertebral disks

• US 6,436,143 B1
• Filed: 05/12/2000
• Issued: 08/20/2002
• Est. Priority Date: 02/22/1999
• Status: Expired

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Anthony C. Ross, Peter A. Guagliano
• Inventors: Ross, Anthony C., Guagliano, Peter A.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/569,807
• Time in Patent Office: 830 Days
• Field of Search: 623/16.11, 623/17.16, 623/8, 623/66, 606/61, 606/86, 606/99, 606/92-94, 604/38, 604/95.03
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/465 using heating means
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins

Abstract

The method and apparatus as shown in FIGS. 8-10 in which a fluid expandable member (208) is positioned in concentric relation about a needle (202). The fluid expandable member (208) is expanded into the nucleus pulposus potential space bordered by the annulus fibrosus of an intervertebral disk. Then, thermoplastic material in a flowing state is injected by a needle (202) within the annulus fibrosus to collapse the fluid expandable member (208) and occupy the space formerly occupied by the fluid expandable member (208).

Claims

1. A method for treating an intervertebral disk of the spine, comprising:

selecting an intervertebral disk of the spine;

providing an injection device having an expandable member about an injection needle for a thermoplastic material;

injecting said expandable member and said needle into the annulus fibrosus of said selected disk;

expanding said expandable member into the annulus fibrosus of said selected disk; and

then injecting a thermoplastic material from said needle into said annulus fibrosus of said selected disk to occupy the space defined by said expandable member.

2. The method defined in claim 1, further comprising:

injecting said thermoplastic material from said needle under a pressure greater than the pressure for expanding said expandable member to effect collapsing of said expandable member with said thermoplastic material occupying the space formerly occupied by said expandable member.

3. The method defined in claim 1, further comprising:

removing nucleus pulposus from said annulus fibrosus prior to insertion of said expandable member and said needle into said annulus fibrosus.

4. An injection device fortreating an intervertebral disk of the spine of a patient, comprising:

a hollow needle for the injection of a thermoplastic material into the annulus fibrosus of a disk from the projecting end of the needle;

an expandable member about said hollow needle for expanding into the annulus fibrosus of the disk prior to injection of the thermoplastic material in the annulus fibrosus; and

a heater for heating said thermoplastic material to effect flowing thereof prior to injection into the annulus fibrosus.

5. An injection system for treating an intervertebral disk of a spines comprising:

an injection device including a hollow needle for injecting a thermoplastic material within the annulus fibrosus of a disk, and an expandable member about said hollow needle to form an annulus between said needle and said expandable member;

a fluid pressure device to provide pressurized fluid in said annulus for expanding said expandable member into said annulus fibrosus;

a heating device for heating the thermoplastic material; and

a force applying device for forcing said thermoplastic material from said needle in a flowing state.

6. The injection system as defined in claim 5, further comprising:

a concentric sleeve about said needle for forming said annulus between said sleeve and said needle, said expandable member mounted about said sleeve.

7. The injection system as defined in claim 6 wherein said sleeve has a plurality of openings therein for communicating fluid to said expandable member for expanding said expandable member within said annulus fibrosus.

8. The injection system as defined in claim 5 wherein said fluid pressure device includes a pressurized liquid, and a hydraulically actuated piston for pressurizing said liquid.

9. An injection gun for injecting a thermoplastic material between a joint of a patient, comprising:

a chamber for receiving said thermoplastic material in a non-flowing state;

a heater adjacent said chamber for heating said thermoplastic material to a flowing state;

a hollow injection needle operatively connected to said heater to receive the flowing thermoplastic material from said heater for injection between the joint of the patient; and

a hydraulic force applying assembly to apply hydraulic force against said thermoplastic material to force the thermoplastic material when heated to a flowing state from said needle.

10. The injection gun as defined in claim 9, further comprising:

a plug of said thermoplastic material within said chamber, said hydraulic force applying assembly including a hydraulically actuated piston adjacent said plug for forcing said thermoplastic material from said needle after said thermoplastic material is heated to a flowing state.

11. The injection gun as defined in claim 10, further comprising:

a fluid pressure source for said hydraulically actuated piston; and

a foot operated pedal associated with said fluid pressure source to provide a selected fluid pressure to said piston and heated thermoplastic material.

12. The injection gun as defined in claim 9, further comprising:

an expandable member about said hollow needle to form an annulus between said needle and said expandable member; and

a fluid pressure device to provide pressurized fluid in said annulus for expanding said expandable member.

13. The injection gun as defined in claim 9, further comprising:

a substantially rigid concentric sleeve about said hollow needle for forming an annulus between said sleeve and said needle;

an expandable member mounted about said sleeve; and

a fluid pressurization device to provide pressurization fluid in said annulus for expanding said expandable member, said expandable member being in fluid communication with said annulus.

14. The injection gun as defined in claim 9, wherein said thermoplastic material comprises gutta percha.

15. The injection gun as defined in claim 9, wherein said thermoplastic material comprises a gutta percha compound in which gutta percha is between 15% and 40% by weight of the compound.

16. The injection gun as defined in claim 9, wherein said heater heats said thermoplastic material compound for flowing at a temperature between about 150 C and 200 C.

17. The injection gun as defined in claim 9, further comprising:

a generally cylindrical housing forming the chamber to receive a plug of thermoplastic material and having opposed open ends, said cylindrical housing being removable from said injection needle; and

a threaded end plug for each of said open ends when said housing is removed from said injection needle for sealing of said thermoplastic material therein.

18. The injection device as defined in claim 17, wherein said heater is removably mounted adjacent one of said open ends upon removal of an associated end plug.