IP Library Granted Patent US 9,642,712
Granted Patent B2
US 9,642,712 · App. 14/613,551 · Granted May 9, 2017

Methods for treating the spine

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Quick Facts
Patent No.
US 9,642,712
App. No.
14/613,551
Granted
May 9, 2017
Kind
B2
Abstract

Method and apparatus are disclosed for distracting tissue and particularly spinal tissue. The device and method may include insertion of at least one elongated member and an augmenting member to form a structure between the tissues to be distraction, such that a dimensional aspect of the structure is augmented upon movement of the augmenting structure.

Claims (109)

1. A method of distracting adjacent tissue layers of a spine, comprising:

inserting a first elongated member in a generally linear, planar configuration between adjacent tissue layers of a spine;

inserting a second elongated member in a generally linear, planar configuration between the adjacent tissue layers to cooperate with the first elongated member to define a structure in situ having a dimensional aspect in a direction extending between the tissue layers;

moving the first and second elongated members from the generally linear, planar configuration to a generally less linear configuration;

inserting a flexible augmenting elongated member in a generally linear, planar configuration at least partially between and in contact with said first and second elongated members to cause separation of the first and second elongated members to increase the dimensional aspect of at least a portion of the structure in situ; and

moving the augmenting elongated member from the generally linear, planar configuration to a generally less linear configuration, wherein the structure in situ is substantially rigid in a direction extending between the tissue layers and flexible in a different direction.

2. The method of claim 1 in which the first elongated member and the second elongated member are simultaneously inserted between the adjacent tissue layers.

3. The method of claim 1 in which said moving the first and second elongated members from the generally linear, planar configuration to a generally less linear configuration includes moving the first and second elongated members to a generally curved configuration in situ with spaced apart proximal and distal ends.

4. The method of claim 1 in which said first and second elongated members have at least one stress relief configuration that reduces bending stress in the generally less linear configuration.

5. The method of claim 1 in which each of at least two of said elongated members contains a radiopaque marker, with the radiopaque markers located to indicate alignment of said at least two of said elongated members between the adjacent tissue layers.

6. The method of claim 1 in which

the first elongated member has an inferior surface adjacent to a first surface of the augmenting elongated member,

the second elongated member has a superior surface adjacent to a second surface of the augmenting elongated member, and

said inserting a flexible augmenting elongated member includes causing at least one of the first surface of the augmenting elongated member and the second surface of the augmenting elongated member to interact with at least one of the inferior surface of the first elongated member and the superior surface of the second elongated member to resist relative movement therebetween.

7. The method of claim 1 , further comprising a pull wire connected to at least one of said first and second elongated members, wherein said moving the first and second elongated members from the generally linear, planar configuration to a generally less linear configuration includes using the pull wire to exert a force on said at least one of said first and second elongated members to change said at least one of said first and second elongated members between the generally linear, planar configuration and the generally less linear configuration.

8. The method of claim 1 in which said moving the first and second elongated members from the generally linear, planar configuration to a generally less linear configuration includes moving the first and second elongated members to a substantially annular configuration in situ.

9. The method of claim 1 , further comprising introducing a filler material between the adjacent tissue layers of the spine.

10. The method of claim 9 in which

said moving the first and second elongated members from the generally linear, planar configuration to a generally less linear configuration includes moving the first and second elongated members to a substantially annular configuration in situ in which the structure in situ defines a resident volume, and

said introducing a filler material between the adjacent tissue layers of the spine includes introducing the filler material into the resident volume.

11. The method of claim 1 , wherein at least one of the first, second, and augmenting elongated members has a non-uniform thickness along its length, such that the structure in situ has a non-uniform thickness.

12. The method of claim 11 , wherein the structure in situ has a non-uniform thickness configured to adjust the lordotic angle of the spine.

13. The method of claim 1 , wherein each elongated member is generally rectangular in cross-sectional shape and defined by elongated upper and lower surfaces, proximal and distal ends, and elongated lateral side surfaces.

14. The method of claim 13 , wherein each of the elongated members includes

a longitudinally extending wall,

a plurality of similarly shaped first teeth extending laterally from the wall in one direction, and

a plurality of similarly shaped second teeth extending laterally from the wall in an opposite direction and differently configured from said first teeth.

15. The method of claim 13 , wherein

the proximal end of each of the first and second elongated members is ramped,

the distal end of the augmenting elongated member is tapered, and

said inserting the flexible augmenting elongated member includes causing the tapered distal end of the augmenting elongated member to engage and separate the first and second elongated members when inserted therebetween.

16. A method of distracting adjacent tissue layers of a spine comprising:

inserting a flexible first elongated member between adjacent tissue layers of a spine;

inserting a flexible second elongated member between the adjacent tissue layers to cooperate with the first elongated member to define a structure in situ having a dimensional aspect in a direction extending between the tissue layers;

inserting an augmenting elongated member in a generally linear, planar configuration from a position that is not between said first and second elongated members to a position at least partially between and in contact with said first and second elongated members to cause separation of the first and second elongated members to increase the dimensional aspect of at least a portion of the structure in situ; and

moving the augmenting elongated member in one direction from the generally linear, planar configuration to a generally less linear configuration, wherein the augmenting elongated member is substantially rigid in a different direction.

17. The method of claim 16 in which the augmenting elongated member is substantially rigid in said direction extending between the tissue layers.

18. The method of claim 16 in which the augmenting elongated member is substantially rigid in a direction generally perpendicular to the direction in which the augmenting elongated member is moved to change the augmenting elongated member from the generally linear, planar configuration to the generally less linear configuration.

19. The method of claim 18 further comprising moving the first and second elongated members in one direction from the generally linear, planar configuration to a generally less linear configuration after inserting the first and second elongated members between the tissue layers, wherein the first and second elongated members are substantially rigid in a direction generally perpendicular to the direction in which the first and second elongated members are moved to change the first and second elongated members from the generally linear, planar configuration to the generally less linear configuration.

20. The method of claim 16 , further comprising moving the first and second elongated members in one direction from the generally linear, planar configuration to a generally less linear configuration after inserting the first and second elongated members between the tissue layers, wherein the first and second elongated members are substantially rigid in a different direction.

21. The method of claim 20 in which the first and second elongated members are substantially rigid in said direction extending between the tissue layers.

22. The method of claim 16 in which said moving the augmenting elongated member in one direction from the generally linear, planar configuration to a generally less linear configuration includes moving the augmenting elongated member to a substantially annular configuration in situ.

23. The method of claim 16 , further comprising introducing a filler material between the adjacent tissue layers of the spine.

24. The method of claim 23 in which

said moving the augmenting elongated member in one direction from the generally linear, planar configuration to a generally less linear configuration includes moving the augmenting elongated member to a substantially annular configuration in situ in which the structure in situ defines a resident volume, and

said introducing a filler material between the adjacent tissue layers of the spine includes introducing the filler material into the resident volume.

25. The method of claim 16 , wherein at least one of the first, second, and augmenting elongated members has a non-uniform thickness along its length, such that the structure in situ has a non-uniform thickness.

26. The method of claim 25 , wherein the structure in situ has a non-uniform thickness configured to adjust the lordotic angle of the spine.

27. The method of claim 16 , wherein each elongated member is generally rectangular in cross-sectional shape and defined by elongated upper and lower surfaces, proximal and distal ends, and elongated lateral side surfaces.

28. The method of claim 27 , wherein each of the elongated members includes

a longitudinally extending wall,

a plurality of similarly shaped first teeth extending laterally from the wall in one direction, and

a plurality of similarly shaped second teeth extending laterally from the wall in an opposite direction and differently configured from said first teeth.

29. The method of claim 27 , wherein

the proximal end of each of the first and second elongated members is ramped,

the distal end of the augmenting elongated member is tapered, and

said inserting the augmenting elongated member includes causing the tapered distal end of the augmenting elongated member to engage and separate the first and second elongated members when inserted therebetween.

30. The method of claim 16 , wherein

the first and second elongated members are inserted between the adjacent tissue layers in a generally linear, planar configuration and moved from the generally linear, planar configuration to a generally less linear configuration prior to inserting the augmenting elongated member at least partially between and in contact with the first and second elongated members,

the first and second elongated members are retained in said generally less linear configuration while the augmenting elongated member is inserted at least partially between and in contact with the first and second elongated members, and

said moving the augmenting elongated member in one direction from the generally linear, planar configuration to the generally less linear configuration includes moving the augmenting elongated member along a path defined by the first and second elongated members retained in said generally less linear configuration.

31. A method of distracting adjacent tissue layers of a spine comprising:

inserting a flexible first elongated member between adjacent tissue layers of a spine;

inserting a flexible second elongated member between the adjacent tissue layers to cooperate with the first elongated member to define a structure in situ having a dimensional aspect in a direction extending between the tissue layers;

inserting an augmenting elongated member in a generally linear, planar configuration at least partially between and in contact with said first and second elongated members to cause separation of the first and second elongated members to increase the dimensional aspect of at least a portion of the structure in situ; and

moving the elongated members from the generally linear, planar configuration to a substantially annular configuration.

32. The method of claim 31 in which the first elongated member and the second elongated member are simultaneously inserted between the adjacent tissue layers.

33. The method of claim 31 , further comprising a pull wire connected to at least one of said first and second elongated members, wherein said moving the elongated members from the generally linear, planar configuration to a substantially annular configuration includes using the pull wire to exert a force on said at least one of said first and second elongated members to change said at least one of said first and second elongated members between the generally linear, planar configuration and the substantially annular configuration.

34. The method of claim 31 in which the augmenting elongated member is substantially rigid in said direction extending between the tissue layers.

35. The method of claim 31 in which the first and second elongated members are substantially rigid in said direction extending between the tissue layers.

36. The method of claim 31 , further comprising introducing a filler material between the adjacent tissue layers of the spine.

37. The method of claim 36 in which the structure in situ defines a resident volume when the elongated members are in the substantially annular configuration, and said introducing a filler material between the adjacent tissue layers of the spine includes introducing the filler material into the resident volume.

38. The method of claim 31 , wherein at least one of the first, second, and augmenting elongated members has a non-uniform thickness along its length, such that the structure in situ has a non-uniform thickness to match the lordotic angle of the spine.

39. The method of claim 38 , wherein the structure in situ has a non-uniform thickness configured to adjust the lordotic angle of the spine.

40. The method of claim 31 , wherein each elongated member is generally rectangular in cross-sectional shape and defined by elongated upper and lower surfaces, proximal and distal ends, and elongated lateral side surfaces.

41. The method of claim 40 , wherein each of the elongated members includes

a longitudinally extending wall,

a plurality of similarly shaped first teeth extending laterally from the wall in one direction, and

a plurality of similarly shaped second teeth extending laterally from the wall in an opposite direction and differently configured from said first teeth.

42. The method of claim 40 , wherein

an elongated T-shaped slot is defined in the lower surface of one of the first and second elongated members,

an elongated T-shaped slot is defined in the upper surface of the other one of the first and second elongated members,

the upper and lower surfaces of the augmenting elongated member each includes an elongated T-shaped rail, and

said inserting the augmenting elongated member includes advancing each of the T-shaped rails of the augmenting elongated member into a different one of the T-shaped slots of the first and second elongated members.

43. The method of claim 31 , wherein

the first and second elongated members are inserted between the adjacent tissue layers in a generally linear, planar configuration, and

said moving the elongated members from the generally linear, planar configuration to the substantially annular configuration includes

moving the first and second elongated members to the substantially annular configuration prior to inserting the augmenting elongated member at least partially between and in contact with the first and second elongated members,

retaining the first and second elongated members in the substantially annular configuration while the augmenting elongated member is inserted at least partially between and in contact with the first and second elongated members, and

moving the augmenting elongated member along a path defined by the first and second elongated members retained in the substantially annular configuration.

44. A method of distracting adjacent tissue layers of a spine, comprising:

providing a first elongated member, a second elongated member, and an augmenting elongated member each being generally rectangular in cross-sectional shape and defined by elongated upper and lower surfaces, proximal and distal ends, and elongated lateral side surfaces;

inserting the first and second elongated members in a generally linear first configuration between adjacent tissue layers of a spine to define a structure in situ having a dimensional aspect in a direction extending between the tissue layers;

moving the first and second elongated members from the first configuration to a second configuration that is less linear than the first configuration; and

inserting the augmenting elongated member between and in contact with said first and second elongated members while said first and second elongated members are positioned between the adjacent tissue layers to cause separation of the first and second elongated members to increase the dimensional aspect of at least a portion of the structure in situ.

45. The method of claim 44 , wherein each of the elongated members includes

a longitudinally extending wall,

a plurality of similarly shaped first teeth extending laterally from the wall in one direction, and

a plurality of similarly shaped second teeth extending laterally from the wall in an opposite direction and differently configured from said first teeth.

46. The method of claim 44 , wherein

an elongated T-shaped slot is defined in the lower surface of one of the first and second elongated members,

an elongated T-shaped slot is defined in the upper surface of the other one of the first and second elongated members,

the upper and lower surfaces of the augmenting elongated member each includes an elongated T-shaped rail, and

said inserting the augmenting elongated member includes advancing each of the T-shaped rails of the augmenting elongated member into a different one of the T-shaped slots of the first and second elongated members.

47. A method of distracting adjacent tissue layers of a spine, comprising:

providing a first elongated member, a second elongated member, and an augmenting elongated member each being generally rectangular in cross-sectional shape and defined by elongated upper and lower surfaces, proximal and distal ends, and elongated lateral side surfaces;

inserting the first and second elongated members in a generally linear first configuration between adjacent tissue layers of a spine to define a structure in situ having a dimensional aspect in a direction extending between the tissue layers;

moving the first and second elongated members from the first configuration to a second configuration that is less linear than the first configuration; and

after moving the first and second elongated members to the second configuration, inserting the augmenting elongated member between and in contact with said first and second elongated members to cause separation of the first and second elongated members to increase the dimensional aspect of at least a portion of the structure in situ.

Assignments (5)
SECURITY INTEREST Recorded May 31, 2024
From: SPINAL ELEMENTS, INC.; CUSTOM SPINE ACQUISITION, INC.; OMNI ACQUISITION INC.
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 067596/0295 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 3, 2021
From: BENVENUE (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
To: SPINAL ELEMENTS, INC.
Reel/Frame 055480/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 3, 2021
From: BENVENUE MEDICAL, INC.
To: BENVENUE (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 055480/0516 →
SECURITY INTEREST Recorded Dec 18, 2015
From: BENVENUE MEDICAL, INC.
To: CRG SERVICING LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 037334/0292 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 4, 2015
From: SCHALLER, LAURENT; MCGRATH, TIMOTHY; CONNOLLY, RYAN; NEEDLEMAN, DAVID; GOLDEN, STEVEN; ASHLEY, JOHN; LEE, JAMES; EMERY, JEFFREY; BURLEY, J. BROOK
To: BENVENUE MEDICAL, INC.
Reel/Frame 034884/0506 →