Devices and methods for the restoration of a spinal disc

• US 20050182418A1
• Filed: 04/06/2005
• Published: 08/18/2005
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Boyd, Lawrence M., Upton, Maureen L.
• Granted Patent: US 7,601,157 B2
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• 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 2/4675 for cleaning or coating bones, e.g. bone cavities, prior to endoprosthesis implantation or bone cement introduction for cleaning teeth cavities A61C17/00; irrigators A61M3/02
• 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 2002/4677 using a guide wire
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

A system and method is provided for maintaining a proper intervertebral disc height during the replacement or augmentation of the spinal disc. In one embodiment, a cannulated distractor is used to distract the adjacent vertebrae and maintain a proper disc space height . The cannulated distractor is fluidly connected to a source of fluent material for injection into the disc space. The distraction includes a distraction tip resident within the disc space that includes a central lumen and a number of openings communicating with the lumen to dispense the fluent material within the disc space.

Claims

1-32. -32. (canceled)

33. A device for distracting two adjacent vertebral bodies defining a disc space therebetween and for delivering a flowable material into the disc space, comprising a body including a proximal portion, an opposite distal portion defining a shape adapted to distract the disc space, and a first longitudinal passageway extending through the body and defining a first opening in the distal portion opening into the disc space.

34. The device of claim 33 wherein:

the passageway further defines an injection port in the proximal portion of the body; and

the device further comprises an injection device having a port attached to the injection port.

35. The device of claim 34 wherein the injection device is a syringe.

36. The device of claim 33 wherein the shape adapted to distract is adapted to distract upon insertion into the disc space.

37. The device of claim 36 wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height

38. The device of claim 36 wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space.

39. The device of claim 33 wherein the shape adapted to distract is removable.

40. The device of claim 33 further comprising a stop means extending radially from a longitudinal axis of the proximal portion of the body.

41. The device of claim 33 wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle.

42. The device of claim 33 further comprising a tube having an open distal end adapted for insertion in the injection port.

43. The device of claim 33 wherein the body further includes a second longitudinal passageway extending through the body and defining a second opening in the distal portion opening into the disc space.

44. The device of claim 33 wherein the first opening into the disc space is located within a distal half of the shape adapted to distract.

45. The device of claim 33 wherein the first opening into the disc space is located within a distal quarter of the shape adapted to distract.

46. The device of claim 33 wherein the first opening into the disc space is located at the distal end of the shape adapted to distractor.

47. A method for distracting two vertebral bodies and delivering a flowable material into an intervertebral disc space having an outer annulus, comprising the steps of:

a) providing a device for distracting and delivering a flowable material comprising, a body having a proximal portion and a distal portion, the distal portion defining a shape adapted to distract, the body also having a longitudinal passageway defining a first opening in the distal portion, and a first injection port in the proximal portion;

b) inserting the distal portion of the device through the outer annulus;

c) distracting the vertebral bodies with the shape; and

d) introducing the flowable material into the disc space through the injection port.

48. The method of claim 47 further comprising the step of:

e) removing the device after step d).

49. The method of claim 47 wherein the shape is adapted to distract upon insertion and the distraction step is accomplished by advancing the device into the disc space.

50. The method of claim 47 wherein the shape is a spreader and the distraction step is accomplished by rotating the device.

51. The method of claim 47 wherein the step of inserting is accomplished through a single incision in the outer annulus.

52. A kit for providing a nucleus pulposus replacement material, comprising:

a) device for distracting two adjacent vertebral bodies defining a disc space therebetween and delivering a flowable material into the disc space including a body having;

i) a proximal portion;

ii) a distal portion comprising a shape adapted to distract the disc space; and

iii) a longitudinal passageway extending through the body and defining a first opening in the distal portion opening into the disc space; and

b) a flowable material suitable for use as a nucleus pulposus replacement material.

53. A device for distracting two adjacent vertebral bodies defining a disc space therebetween and delivering a flowable material into the disc space, comprising:

means for distracting the disc space, and

means for delivering a flowable material into the disc space.