SPINAL TISSUE DISTRACTION DEVICES

• US 20130190880A1
• Filed: 03/12/2013
• Published: 07/25/2013
• Est. Priority Date: 08/16/2005
• Status: Active Grant

• Current Assignee: IZI Medical Products LLC (Halma PLC)
• Original Assignee: Benvenue Medical, Inc. (Halma PLC)
• Inventors: Schaller, Laurent
• Granted Patent: US 9,044,338 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

Spinal tissue distraction devices that include a member which has a pre-deployed configuration for insertion between tissue layers and a deployed configuration in which the member, by change of configuration, forms a support structure for separating and supporting layers of spinal tissue

Claims

1. An intravertebral implant for insertion into a vertebral body, comprising:

a generally elongated implant having a proximal end portion and a distal end portion;

the generally elongated implant having a substantially linear insertion configuration for insertion into the vertebral body and a generally helical implanted configuration defining a vertically extending generally helical support structure that includes a plurality of vertically adjacent windings, wherein the vertically extending generally helical support structure separates and/or supports tissue of the vertebral body;

the elongated implant including a longitudinal internal passageway extending between the proximal and distal end portions for directing the flow of bone filler material therethrough, and

a plurality of apertures located along an inside wall of the implant, the apertures communicating with the passageway and being open in the implanted configuration to direct the flow of bone filler into an interior of the helical support structure within the vertebral body.

2. The intravertebral implant of claim 1 in which the apertures are spaced apart uniformly along the implant.

3. The intravertebral implant of claim 1 in which the apertures comprise a plurality of slots spaced apart along the implant so as to define alternating slots and intermediate members located along the implant, the intermediate members being free of contact with adjacent intermediate members when the implant is in the implanted configuration so that the slot therebetween remains open into the interior of the helical support structure.

4. The intravertebral implant of claim 3 in which the slots are uniformly spaced apart along the implant.

5. The intravertebral implant of claim 1 including a guide wire removably received within the passageway for guiding the implant into the implanted configuration within a vertebral body.

6. The intravertebral implant of claim 5 including an ultrasonic power source operatively coupled to the guidewire.

7. The intravertebral implant of claim 1 at least two adjacent windings include contacting surfaces that are configured to resist lateral shifting between the windings.

8. The intravertebral implant of claim 1 including a delivery cannula having a lumen through which the implant can be inserted into a vertebral, the implant having a non-circular cross-sectional shape and the lumen having a complementary cross-sectional shape.

9. The intravertebral implant of claim 1 including a delivery cannula having a proximal end, a distal end and a lumen extending at least partially therethrough, the cannula having a closed distal tip and a side exit port communicating with the lumen, the lumen being configured to allow passage of the implant through the lumen and the exit port and into a vertebral body.

10. An intravertebral implant for insertion into a vertebral body, comprising:

a generally elongated implant having a proximal end portion and a distal end portion;

the generally elongated implant having a substantially linear insertion configuration for insertion into the vertebral body and a generally helical implanted configuration defining a vertically extending generally helical support structure that includes a plurality of vertically adjacent windings, wherein the vertically extending generally helical support structure separates and/or supports tissue of the vertebral body; and

the generally helical support structure includes a plurality of vertically adjacent windings with at least one of the windings contacting an immediately adjacent winding, the at least one and immediately adjacent windings including contacting surfaces that are configured to resist lateral shifting between the windings, and

a plurality of slots spaced apart along the implant so as to define alternating slots and intermediate members located along the implant, the slots extending through upper, lower and inside surfaces of the implant, and intermediate members being free of contact with adjacent intermediate members when the implant is in the implanted configuration.

11. The intravertebral implant of claim 10 in which the slots are uniformly spaced apart along the implant.

12. The intravertebral implant of claim 10 including a guide wire removably received within the passageway for guiding the implant into the implanted configuration within a vertebral body.

13. The intravertebral implant of claim 12 including an ultrasonic power source operatively coupled to the guidewire.

14. The intravertebral implant of claim 10 including a delivery cannula having a lumen through which the implant can be inserted into a vertebral, the implant having a non-circular cross-sectional shape and the lumen having a complementary cross-sectional shape.

15. The intravertebral implant of claim 10 including a delivery cannula having a proximal end, a distal end and a lumen extending at least partially therethrough, the cannula having a closed distal tip and a side exit port communicating with the lumen, the lumen being configured to allow passage of the implant through the lumen and the exit port and into a vertebral body.

16. A method of treating a vertebral body having a cortical rim and superior and inferior endplates defining an internal region therewithin, the method comprising:

inserting a generally elongated intravertebral implant in a substantially linear configuration into the internal region of the vertebral body, the general elongated intravertebral implant including a plurality of open slots spaced apart along the implant, the slots extending through upper, lower and inside surfaces of the implant;

forming the generally elongated intravertebral implant into a generally helical implanted configuration within the interior region of the vertebral body defining support structure that includes a plurality of vertically adjacent windings and wherein the slots of the generally elongated intravertebral implant remain open through the inside surface in the implanted configuration.

17. The method of claim 16 including injecting bone filler material through the implant and through the slots into the vertebral body.

18. The method of claim 16 including advancing the intravertebral implant along a guidewire into the implanted configuration in the vertebral body.

19. The method of claim 16 further comprising:

providing access into the internal region of the vertebral body through an elongated cannula;

advancing a guide wire through the cannula and into the internal region of the vertebral body, a distal end portion of the guidewire forming a vertical helical configuration in the internal region;

advancing the implant along and constrained by the guidewire to form the implant into a helical configuration within the internal region;

withdrawing the guidewire from the internal region and injecting bone filler material through the implant and through the slots into the vertebral body.

20-65. -65. (canceled)