Devices For Introduction Into A Body Via A Substantially Straight Conduit To Form A Predefined Curved Configuration, And Methods Employing Same

• US 20080208255A1
• Filed: 12/28/2005
• Published: 08/28/2008
• Est. Priority Date: 08/11/2004
• Status: Active Grant

• Current Assignee: SeaSpine, Inc. (Orthofix Medical Inc.)
• Original Assignee: Non-Invasive Technology Incorporated
• Inventors: Siegal, Tzony
• Granted Patent: US 7,918,874 B2
• Time in Patent Office: Days
• US Class Current: 606/246
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7094 Solid vertebral fillers; devices for inserting such fillers
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/4415 elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A device for introduction into a body in a straight configuration and assuming within the body a predefined curved configuration, includes an elongated element formed from a number of segments interconnected so as to form effective hinges therebetween. When the elongated element is confined to a straight state, the effective hinges transfer compressive forces from each segment to the next so that the elongated element can be pushed to advance it through a conduit. When the elongated element is not confined to a straight state, the effective hinges allow deflection of each segment relative to adjacent segments until abutment surfaces of the segments come into abutment, thereby defining a fully flexed state of the elongated element with a predefined curved configuration. The device can be produced with a wide range of two-dimensional and three-dimensional curved forms, and has both medical and non-medical applications.

Claims

1. A device for introduction into a body via a substantially straight conduit, the device assuming within the body a predefined curved configuration, the device comprising:

an elongated element formed primarily from a plurality of segments sequentially interconnected so as to form an effective hinge between adjacent of the segments, the segments and the effective hinges being configured such that;

(a) when the elongated element is confined to a substantially straight state, the effective hinges transfer compressive forces from each segment to the next so that the elongated element can be pushed so as to advance through the substantially straight conduit; and

(b) when the elongated element is not confined to a substantially straight state, the effective hinges allow deflection of each segment relative to adjacent segments until at least one abutment surface of each of the segments comes into abutment with at least one corresponding abutment surface of each adjacent segment, thereby defining a fully flexed state of the elongated element, the fully flexed state corresponding to a predefined curved configuration of the elongated element.

2. The device of claim 1, wherein the predefined curved configuration includes an arc turning through an angle of at least 180°

.

3. The device of claim 1, wherein the predefined curved configuration includes a first region having a first radius of curvature and a second region having a second radius of curvature greater than the first radius of curvature.

4. The device of claim 1, wherein the predefined curved configuration includes a conical spiral.

5. The device of claim 1, wherein the predefined curved configuration includes a helix.

6. The device of claim 5, wherein lateral surfaces of the segments are formed with complementary interlocking features so as to inhibit lateral displacement of successive coils of the helix.

7. The device of claim 1, wherein the predefined curved configuration includes:

(a) a first portion forming a planar spiral; and

(b) a second portion forming a helix.

8. The device of claim 1, wherein each of the effective hinges is formed by a flat connecting portion of flexible material interconnecting between adjacent of the segments.

9. The device of claim 8, wherein each of the flat connecting portions is integrally formed with adjacent of the segments.

10. The device of claim 8, wherein all of the segments and the flat connecting portions are integrally formed.

11. The device of claim 8, wherein each of the flat connecting portions is resiliently biased to deflect the segments so that the elongated element tends to assume the fully flexed state.

12. The device of claim 1, wherein each of the segments is formed as a non-hollow block of material.

13. The device of claim 1, wherein each of the segments is formed as a hollow block of material.

14. The device of claim 1, wherein the elongated element further includes a beveled distal tip angled so as to tend to deflect the elongated element into the fully flexed state as the elongated element advances through a medium.

15. The device of claim 1, wherein the abutment surface of each of the segments and the corresponding abutment surface of each adjacent one of the segments are configured with interlocking features such that, in the fully flexed state, the interlocking features help resist torsional deformation of the elongated element.

16. The device of claim 1, further comprising at least one fixation arrangement for fixing a part of the elongated element relative to the body such that the elongated element forms at least part of an implant.

17. The device of claim 1, further comprising a drilling element associated with a distal end of the elongated element.

18. The device of claim 1, wherein a length of the elongated element is at least ten times greater than each transverse dimension of the elongated element.

19. A method for deploying a predefined curved configuration of a device within a body comprising the steps of:

(a) providing an elongated element formed primarily from a plurality of segments sequentially interconnected so as to form an effective hinge between adjacent of the segments, the segments and the effective hinges being configured such that;

(i) when the elongated element is confined to a substantially straight state, the effective hinges transfer compressive forces from each segment to the next so that the elongated element can be pushed so as to advance through the substantially straight conduit; and

(ii) when the elongated element is not confined to a substantially straight state, the effective hinges allow deflection of each segment relative to adjacent segments until at least one abutment surface of each of the segments comes into abutment with at least one corresponding abutment surface of each adjacent segment, thereby defining a fully flexed state of the elongated element, the fully flexed state corresponding to a predefined curved configuration of the elongated element

(b) introducing the elongated element into the body along a substantially straight conduit so as to confine the elongated element to the substantially straight state; and

(c) causing the elongated element to assume the predefined curved configuration within the body.

20. The method of claim 19, wherein the predefined curved configuration is such that the elongated element follows an arcuate path so that a distal end of the elongated element re-exits the body.

21. The method of claim 19, wherein the elongated element is formed with a solid distal tip configured to displace and compress material of the body as it advances through the body.

22. The method of claim 19, wherein the elongated element is formed with a hollow distal tip configured to cut a sample of material from the body.

23. The method of claim 19, further comprising anchoring the elongated element to a part of the body in at least one region.

24. The method of claim 19, wherein the predefined curved configuration includes a substantially helical portion.

25. The method of claim 19, wherein the body is a human body, and wherein the elongated element is introduced into the spinal column of the human body.

26. The method of claim 25, wherein the elongated element is introduced so as to pass through at least two vertebrae of the human body.

27. The method of claim 26, wherein the elongated element is introduced through a first vertebra and a distal end of the elongated element exits via a second vertebra.

28. The method of claim 27, wherein the elongated element engages four cortical regions of bone.

29. The method of claim 26, wherein the elongated element is introduced through a pedicle of a first vertebra and assumes a substantially helical reinforcing structure passing through a plurality of adjacent vertebrae.

30. The method of claim 25, wherein the elongated element is introduced so as to increase a spacing between at least part of two adjacent vertebrae.

31. The method of claim 30, wherein the predefined curved form includes a plurality of coils each having a central axis aligned substantially perpendicular to an extensional direction of the spinal column.

32. The method of claim 30, wherein the predefined curved form includes a plurality of coils of sequentially increasing diameter such that a spacing between the at least part of the two adjacent vertebrae is varied incrementally during introduction of the elongated element.

33. The method of claim 30, wherein the predefined curved form includes a plurality of stacked coils each lying substantially in an axial plane such that a spacing between the at least part of the two adjacent vertebrae is varied incrementally during introduction of the elongated element.

34. The method of claim 33, wherein the elongated element is formed with lateral interlocking features configured such that successive coils of the plurality of stacked coils are interengaged to maintain a substantially cylindrical stack.

35. The method of claim 33, wherein the elongated element has a distal portion configured to form a substantially planar spiral configuration.

36. The method of claim 30, wherein the elongated element is introduced ipsilaterally between the adjacent vertebrae so as to at least partially correct scoliosis misalignment between the adjacent vertebrae.

37. The method of claim 25, wherein the elongated element is introduced within a single vertebra, and wherein the predefined curved configuration is configured to increase an effective height of the vertebra.

38. The method of claim 25, wherein the predefined curved configuration includes a plurality of coils together forming at least a partial enclosure, the method further comprising the step of introducing a quantity of biocompatible structural filler material into the at least partial enclosure.

39. The method of claim 25, wherein the predefined curved configuration includes a plurality of coils together forming at least a partial enclosure, the method further comprising the step of introducing a quantity of a therapeutic agent into the at least partial enclosure.

40. The method of claim 25, further comprising, after the step of introducing the elongated element, fixing the elongated element by anchoring directly or indirectly to a pedicle of one of the vertebrae.