Claims
- 1. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space; and one or more fluid control devices adapted to control the flow of biomaterial from the biomaterial delivery apparatus to the balloon, the fluid control device comprising an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery.
- 2. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor delivery pressure of the biomaterial.
- 3. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor volume of biomaterial delivered.
- 4. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor distraction of the intervertebral disc.
- 5. The apparatus of claim 1 wherein the at least one catheter comprises a first adapted to deliver biomaterial and a second lumen adapted to evacuate fluid from the balloon during delivery of the biomaterial.
- 6. The apparatus of claim 1 wherein the fluid control device comprises a fluid control valve.
- 7. The apparatus according to claim 1 wherein the balloon is fabricated from a substantially non-compliant material.
- 8. The apparatus according to claim 1 wherein the balloon is fabricated from a substantially compliant material.
- 9. The apparatus according to claim 8 wherein the material comprises a block copolymer selected from the group consisting of castable thermoplastic polyurethanes.
- 10. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to adjust the flow rate of the biomaterial.
- 11. The apparatus of claim 1 wherein the biomaterial delivery apparatus delivers the biomaterial at an initial delivery pressure greater than a subsequent delivery pressure.
- 12. The apparatus according to claim 1 comprising an adaptor for use in shunting biomaterial between the biomaterial delivery device and the balloon.
- 13. The apparatus according to claim 1 wherein the balloon is provided in a collapsed form within a delivery cannula.
- 14. The apparatus according to claim 13 wherein cannula is provided with a fluted portion adapted to permit the cannula to be secured to tissue within the disc space.
- 15. The apparatus according to claim 1 wherein delivery of biomaterial provides a delivery pressure within a range of from about 0.2 mPA to about 1.5 mPA.
- 16. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 60 seconds.
- 17. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 30 seconds.
- 18. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 15 seconds.
- 19. The apparatus according to claim 1 wherein the biomaterial when cured exhibits a compression modulus of between about 0.1 MPa and about 50 Mpa when measured using ASTM method D575A at a physiological strain range between 3-20%.
- 20. The apparatus according to claim 1 wherein the biomaterial when cured comprises a compression modulus of between about 1 MPa and about 25 Mpa.
- 21. The apparatus according to claim 1 wherein the balloon comprises different regions, having compliant and non-compliant properties, respectively.
- 22. The apparatus according to claim 1 wherein the balloon comprises a lateral wall that is sufficiently non-compliant, and superior and inferior walls that are sufficiently compliant, so as to permit a distraction force generated upon biomaterial delivery to be in a generally vertical direction.
- 23. The apparatus according to claim 1 wherein the balloon comprises two or more layers of materials having the same or different levels of expandability.
- 24. The apparatus according to claim 1 wherein the filled balloon provides a semi-flattened ovoid configuration.
- 25. The apparatus according to claim 1 wherein the balloon is prepared from polymeric materials selected from the group consisting of polyether-based polyurethanes and polycarbonate-based polyurethanes.
- 26. The apparatus according to claim 1 wherein the expandable balloon includes two or more layers formed, respectively, from different polymeric materials having different physical and functional properties.
- 27. The apparatus according to claim 1 wherein the balloon comprises:
at least one inner layer formed of a polymeric material that provides exotherm-resistant properties; and at least one outer layer formed of a polymeric material that provides resistance to physical damage greater than the inner layer.
- 28. The apparatus according to claim 1 wherein the balloon and biomaterial are adapted to permit the formation of covalent bonds between the curing polymer and balloon.
- 29. The apparatus according to claim 1 wherein the balloon provides an exterior surface adapted to facilitate tissue in-growth.
- 30. The apparatus of claim 1 wherein the at least one biomaterial delivery apparatus comprises a plurality of biomaterial delivery apparatuses.
- 31. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to mix a plurality of biomaterial parts and deliver the flowable biomaterial to the balloon.
- 32. The apparatus of claim 1 wherein the biomaterial comprises a two-part system and the biomaterial delivery apparatus is adapted to deliver the two parts of the biomaterial at a substantially constant flow rate.
- 33. The apparatus of claim 1 wherein the biomaterial comprises a two-part system and the biomaterial delivery apparatus is adapted to deliver the two parts of the biomaterial at a substantially continuous flow rate.
- 34. The apparatus of claim 1 wherein the fluid control device permits the balloon to be inflated less than the entire volume of the intervertebral disc space.
- 35. The apparatus of claim 1 comprising a lumen adapted to deliver biomaterial in the intervertebral disc space outside of the balloon.
- 36. The apparatus of claim 35 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.
- 37. The apparatus of claim 35 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.
- 38. The apparatus of claim 1 comprising one or more endplates and fixation components adapted to be located in the intervertebral disc space.
- 39. The apparatus of claim 1 wherein the biomaterial comprises a curable polyurethane composition comprising a plurality of parts capable of being aseptically processed or sterilized, stably stored, and mixed at the time of use in order to provide a flowable composition and initiate cure, the parts including: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols, and one or more diisocyanates, and optionally, hydrophobic additives, and (2) a curative component comprising one or more polyols, one or more chain extenders, one or more catalysts, and optionally, other ingredients such as antioxidants, and dyes.
- 40. The apparatus of claim 1 wherein the biomaterial comprises an aromatic diisocyanate.
- 41. The apparatus of claim 1 wherein the biomaterial comprises diphenylmethane diisocyanates.
- 42. The apparatus of claim 1 wherein the biomaterial comprises toluene di-isocyanate.
- 43. The apparatus of claim 1 wherein the biomaterial comprises paraphenylenediisocyanate.
- 44. The apparatus of claim 1 wherein the biomaterial comprises aliphatic diisocyanates.
- 45. The apparatus of claim 1 wherein the biomaterial comprises hard segments of about 20% -70% by weight.
- 46. The apparatus of claim 1 wherein the biomaterial comprises a chain extender selected from the group consisting of short chain diols, short chain triols, short diamines, or combinations thereof.
- 47. The apparatus of claim 1 wherein the biomaterial comprises soft segments of polytetramethylene oxide, polyhexamethylene oxide.
- 48. The apparatus of claim 1 wherein the biomaterial comprises a mixture of MWs and polytetramethylene oxide.
- 49. The apparatus of claim 1 wherein the biomaterial comprises a cross-linking agent of trimethylol propane.
- 50. The apparatus of claim 1 wherein the biomaterial comprises a silicone modified polyurethane.
- 51. The apparatus of claim 1 wherein the biomaterial comprises a catalyst of 1-1% by weight of the total composition.
- 52. The apparatus of claim 1 wherein the biomaterial comprises a catalyst of 0.01-.1% by weight of the total composition.
- 53. The apparatus of claim 1 wherein the biomaterial comprises a molar ratio of NCO:OH of about 0.8:1 to about 1.2:1.
- 54. The apparatus of claim 1 wherein the biomaterial comprises a molar ratio of NCO:OH ratio of about 0.9:1 to about 1.1:1.
- 55. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to deliver the biomaterial at a substantially constant flow rate.
- 56. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to deliver the biomaterial at a substantially continuous flow rate.
- 57. The apparatus of claim 1 wherein the biomaterial delivery apparatus comprises a mixer with about 45 to about 65 mixing elements.
- 58. The apparatus of claim 1 wherein the biomaterial delivery apparatus comprises a mixer with about 50 to about 60 mixing elements.
- 59. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to purge a volume of biomaterial prior to delivery to the balloon.
- 60. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to purge a volume of biomaterial equal to about 1 to about 4 times a volume of a mixer prior to delivery of the biomaterial to the balloon.
- 61. The apparatus of claim 1 wherein the balloon is constructed from a porous material.
- 62. The apparatus of claim 1 wherein the balloon is constructed from a porous material with pore sizes of about 50 micrometers to about 1000 micrometers.
- 63. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space; and a mechanical distraction mechanism adapted to distract the disc space during delivery and curing of the biomaterial.
- 64. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a first lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the balloon through the first lumen while the balloon is located in the intervertebral disc space; and a second lumen adapted to deflate the balloon as the biomaterial is delivered.
- 65. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space; and one or more fluid control devices adapted to control the flow of biomaterial from the biomaterial delivery apparatus to the balloon, wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions with a more rigid outer region and a more flexible inner region.
- 66. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; and at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial at a substantially constant flow rate to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space.
- 67. An apparatus for forming an-intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; and at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial at a substantially continuous flow rate to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space.
- 68. An apparatus for forming an intervertebral disc prosthesis in situ, the device comprising:
a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial; a catheter with at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon; a purge mechanism adapted to purge a volume of biomaterial prior to delivery to the balloon; and at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the balloon through the at least one lumen while the balloon is located in the intervertebral disc space.
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of Ser. No. 09/649,491, filed Aug. 28, 2000 for INTERVERTEBRAL DISC PROSTHESIS, which is a continuation-in-part of U.S. Pat. No. 6,306,177, filed Dec. 18, 1997 for BIOMATERIAL SYSTEM FOR IN SITU TISSUE REPAIR, which is a continuation application of International patent application Ser. No. PCT/US97/20874, filed Nov. 14, 1997 for BIOMATERIAL SYSTEM FOR IN SITU TISSUE REPAIR; and as a continuation-in-part of U.S. patent application Ser. No. 60/056,624, filed Aug. 20, 1997 for JOINT RESURFACING SYSTEM; and as a continuation-in-part of U.S. patent application Ser. No. 08/749,429, filed Nov. 15, 1996, now abandoned, for MINIMALLY INVASIVE RESURFACING SYSTEM, which is a continuation-in-part of application Ser. No. 08/742,444, filed on Nov. 2, 1996, issued Aug. 18, 1998 as U.S. Pat. No. 5,795,353, for JOINT RESURFACING SYSTEM, which is a continuation of application Ser. No. 08/474,113 filed on Jun. 7, 1995, now abandoned, which is a divisional of prior application Ser. No. 08/239,248, filed on May 6, 1994, now U.S. Pat. No. 5,556,429, issued Sep. 17,1996, for JOINT RESURFACING SYSTEM; and as a continuation-in-part of U.S. patent application Ser. No. 08/903,455, filed Jul. 30, 1997, now abandoned, which is a continuation-in-part of application Ser. No. 08/590,293, filed Jan. 23, 1996, issued Mar.30, 1999 as U.S. Pat. No. 5,888,220 for ARTICULATING JOINT REPAIR.
Provisional Applications (1)
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Number |
Date |
Country |
|
60056624 |
Aug 1997 |
US |
Divisions (1)
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Number |
Date |
Country |
Parent |
08239248 |
May 1994 |
US |
Child |
08474113 |
Jun 1995 |
US |
Continuations (3)
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Number |
Date |
Country |
Parent |
PCT/US97/20874 |
Nov 1997 |
US |
Child |
08993468 |
Dec 1997 |
US |
Parent |
08749429 |
Nov 1996 |
US |
Child |
08993468 |
Dec 1997 |
US |
Parent |
08474113 |
Jun 1995 |
US |
Child |
08742444 |
Nov 1996 |
US |
Continuation in Parts (4)
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Number |
Date |
Country |
Parent |
09649491 |
Aug 2000 |
US |
Child |
10365868 |
Feb 2003 |
US |
Parent |
08993468 |
Dec 1997 |
US |
Child |
09649491 |
Aug 2000 |
US |
Parent |
08742444 |
Nov 1996 |
US |
Child |
08749429 |
Nov 1996 |
US |
Parent |
08590293 |
Jan 1996 |
US |
Child |
08903455 |
Jul 1997 |
US |