Apparatus and methods for treating bone

• US 20070055274A1
• Filed: 06/19/2006
• Published: 03/08/2007
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Appenzeller, Andreas, Dutoit, Christof, Stoll, Thierry, Benoit, Alfred, Mathys, Stefan, Rothlisberger, Erich
• Granted Patent: US 8,080,061 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/742 having one or more longitudinal elements oriented along or parallel to the axis of the neck
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/0256 for the spine

Abstract

Implants and methods for bone treatment, preferably minimally invasive treatment, including repositioning of vertebrae may comprise insertion of a bobbin having a wire, string, thread or band, coiled around the bobbin. During coiling, the diameter of the bobbing/band complex may increase. Such increase in diameter can push against the inner side of the endplates of the vertebral body, and augment the vertebral body to its original height. The implant may also take the form of a coiled sleeve which when inserted into the vertebral body is uncoiled. The force of the uncoiling sleeve pushes against the inner side o the endplates of the vertebral body, restoring the vertebral body to its original height. The implant may also take the form of fibrous masses comprised of a thread or other relatively thin structure, for example a fiber or strand, of any biocompatible material having desired characteristics, for example a shape memory alloy, titanium, stainless steel, another metal or metal alloy, a ceramic, a composite or any combination thereof. The, strand, thread or other fiber may be coiled, woven, matted, tangled or otherwise formed into a wool-like mass or body having a desired configuration. Expansion of the expandable member within the vertebral body or other bone may reposition the fractured bone to a desired height and augment the bone to maintain the desired height. A bone cement or other filler can be added to further treat and stabilize the vertebral body or other bone.

Claims

1. A bone treatment system comprising:

a bobbin having a diameter, and a first and second end, the bobbin configured for implantation within a bone; and

a band having a length substantially larger than its width or height, the band configured to contact and coil multiple times around the bobbin between the first and second end to increase the diameter of the bobbin when the bobbin is implanted within bone,

wherein coiling of the band about the bobbin can be performed manually or with the aid of a mechanized tool.

2. The system of claim 1 further comprising:

an elongated body having a proximal end and a distal end, the proximal end configured for manipulation by a user outside the patient to place the distal end in a desired position within the bone; and

a joint disposed between the second end of the bobbin and the distal end of the elongated body.

3. The system of claim 2, wherein the bobbin is cylindrical and comprises a hole through which a portion of said band passes.

4. The system of claim 2,

wherein the elongated body comprises at least a portion of a drive line assembly to rotate the bobbin when the bobbin is implanted within bone, the elongated body is configured to rotate, and the joint is configured to transfer rotation from the elongated body to rotate the bobbin, and

wherein the joint is releasable so that the elongated body can be detracted from the bobbin.

5. The system of claim 1, further comprising a guide mechanism configured to control the position of the band between the first and second end of the bobbin when the band is coiled around the bobbin.

6. The system of claim 1, further comprising a drive line assembly configured to releasably attach to and rotated the bobbin having a proximal end and a distal end, the proximal end configured in use to extend from the patient and be manipulated by a user to place the distal end in a desired position in the bone, the distal end releasably connected to the bobbin wherein the drive line assembly is rotatable to rotate the bobbin when the bobbin is located in the bone;

and

a guide mechanism comprising a guide moveable with respect to the bobbin to control the position of the band between the first and second ends when the band is coiled around the bobbin.

7. The system of claim 6, wherein the drive line assembly comprises a rotatable shaft and the guide mechanism comprises an elongated tube coaxial with the rotatable shaft, the elongated tube moveable in an axial direction relative to the bobbin and contacting the band to position the band between the first and second ends of the bobbin.

8. The system of claim 7, further comprising a knob connected to the elongated tube and containing a guide hole for the band.

9. The system of claim 7, wherein the bobbin has threads to assist in guiding the band.

10. The system of claim 6,

wherein the drive line assembly comprises a rotatable shaft having a proximal end and a distal end, the distal end of the shaft releasably and rotatably connectable to the first end of the bobbin, the shaft capable of transferring torque to the bobbin, and

wherein the guide mechanism comprises a guide tube having a proximal end and a distal end through which the band moves, the guide tube movable axially with respect to the shaft.

11. The system of claim 10,

wherein the rotatable shaft and guide tube are located in a needle, the rotatable shaft is axially fixed with respect to the needle and the guide tube moves axially with respect to the needle,

wherein a portion of the needle is positioned along side and adjacent the bobbin.

12. The system of claim 10, further comprising a drive train to convert the rotary motion of the drive line assembly to an axial motion, the drive train connectable to the drive line assembly and the guide tube to move the guide tube axially.

13. The system of claim 12, wherein the drive train comprises a gear connectable with the rotatable drive train, a rotatable cam disk and an axially moveable but non-rotatable follower, the cam disk having a groove along its outer surface and the follower including a projection, the projection extending into the groove.

15. The system of claim 1, wherein the band is coated with or form part of a matrix with other materials to include osteo-inductive materials, osteo-conductive materials, antibiotics, tricalcium phosphate, bone morphogenetic proteins.

16. The system of claim 1,

wherein the band, having radio opaque properties, is resistant to tension of at least 100 N, and

wherein the band slides along the tissue of the bone but not along the outer diameter of the bobbin.

17. The system of claim 1, wherein the band may be composed of suture material, metal, metal coated with bone material, metal with a polymer surface allowing for welding the bobbin and surrounding tissue together.

14. The system of claim 14, wherein the follower is a spool holder and the projection is a dowel pin insertable through a hole in the spool holder.

18. A system for minimally invasive bone treatment, comprising:

an elongated body having a first end and a second end, the body having a length along its longitudinal axis, configured for implantation within a bone;

an insertion device for inserting the elongated body within a bone, the insertion device comprising a band and configured to cause the band to coil multiple times around the elongated body between the first and second end to increase the diameter of the body and band assembly, the insertion device releasably connectable to the body,

wherein the insertion device comprises a drive line assembly to apply a rotational force to the elongated body to cause the elongated body to rotate about its longitudinal axis to coil the band around the elongated body, to increase the diameter of the elongated body and band assembly implanted within the region of bone.

19. A system according to claim 18, further comprising an axial guide mechanism movable axially with respect to the elongated body, the axial guide mechanism in connection with and controlling the position of the band along the length of the elongated body as it rotates.

20. A system according to claim 19, wherein:

the drive line assembly comprises a rod connected to the elongated body, the rod being rotatable which in turn rotates the elongated body,

wherein the guide mechanism comprises an outer cannula, causing the band to reposition along the length of the elongated body; and

wherein continued rotation of the elongated body causes the diameter of the elongated body and band assembly to increase due to the coiling of the band around the elongated body.

21. A system according to claim 19, wherein:

the drive line assembly comprises a drive mechanism, a drive shaft, and a flexible shaft connected serially to the elongated body;

the guide mechanism comprising a band guide conduit, a spool holder, and a rotatable cam disk;

wherein the cam disk and spool holder converts the rotational force of the cam disk to an oscillating force applied to the band guide conduit causing the band guide conduit to move forward and backward relative to the elongated body; and

wherein the band guide conduit comprises an interior passage way having a proximal and distal opening and wherein the band is positioned in and moves through the interior passage way of the band guide conduit out the distal opening where it coils around the body.

22. A system according to claim 21, wherein the insertion device further comprises a drive train to couple the drive shaft of the drive line assembly to the cam disk of the guide mechanism so as to have the cam disk rotate at a different velocity than the drive shaft,

wherein the drive train comprises a drive gear, a sprocket, and another gear.

23. A system for minimally invasive bone treatment, comprising:

an elongated body having a first end and a second end, the body having a length along its longitudinal axis, configured for implantation within a bone;

an insertion device for inserting the elongated body within a bone, the insertion device comprising a band and configured to cause the band to coil multiple times around the elongated body between the first and second end to increase the diameter of the body and band assembly, the insertion device releasably connectable to the body,

wherein the insertion device comprises;

a drive line assembly to apply a rotational force to the elongated body to cause the elongated body to rotate about its longitudinal axis to coil the band around the elongated body, to increase the diameter of the elongated body and band assembly implanted within the region of bone, the drive line assembly comprises a drive mechanism, a drive shaft and a flexible shaft connected serially to the first end of the elongated body;

an axial guide mechanism movable axially with respect to the elongated body, the axial guide mechanism in connection with and controlling the position of the band along the length of the elongated body as it rotates, the guide mechanism comprising a band guide conduit, a spool holder, and a rotatable cam disk, wherein the cam disk having a groove along its outer surface and the spool holder including a projection, the projection extending into the groove of the cam disk; and

a drive train coupling the drive shaft of the drive line assembly to the cam disk of the guide mechanism so as to have the cam disk rotate at a different velocity than the drive shaft, the drive train comprises a drive gear, a sprocket, and another gear,

wherein the cam disk and spool holder converts the rotational force of the cam disk to an oscillating force applied to the band guide conduit causing the band guide conduit to move forward and backward relative to the elongated body, and

wherein the band guide conduit comprises an interior passage way having a proximal and distal opening and wherein the band is positioned in and moves through the interior passage way of the band guide conduit out the distal opening where it coils around the body,

wherein the flexible shaft and band guide conduit are located in a needle, the flexible shaft is axially fixed with respect to the needle and the band guide conduit moves axially with respect to the needle,

wherein a portion of the needle is positioned along side and adjacent the bobbin, and

wherein continued rotation of the elongated body causes the diameter of the elongated body and band assembly to increase due to the coiling of the band around the elongated body.

24. An apparatus for minimally invasive osteopathic treatment, comprising a fibrous mass configured and dimensioned for insertion into a region of bone through a cannula,

wherein the fibrous masses having a first dimension for insertion through the cannula and a second dimension after insertion into bone.

25. The apparatus of claim 24, wherein the fibrous mass comprises a shape memory alloy, titanium, a stainless steel, a metal alloy, a resorbable polymer, a non-resorbable polymer, a ceramic or a combination thereof.

26. The apparatus of claim 25, wherein the shape memory alloy comprises nitinol.

27. The apparatus of claim 24, comprising a plurality of said fibrous masses linked together, said plurality of masses configured for implantation into a bone.

28. The apparatus of claim 24,

wherein the fibrous masses comprise a continuous or segment thread, wire, strand, fiber that is intertwined, meshed together, and

wherein the fibrous masses may be composed-of any biocompatible material.

29. An system for bone treatment, comprising:

a body comprising a sheet coiled multiple times, the body having a first diameter configured for implantation within a bone,

wherein said body is configured to expand to a second diameter by uncoiling the sheet when said body is implanted in the bone,

wherein insertion of the body into bone can be accomplished using a sheath or cannula.

30. The apparatus of claim 29, wherein said sheet comprises any of stainless steel, a nickel titanium alloy, a cobalt alloy, another metal alloy, a polymer, or a combination thereof.

31. The apparatus according to claim 29, further comprising an axial member having a first end and second end that is substantially cylindrical,

wherein the body may be coiled around the axial member,

wherein the axial member comprises a lumen through which a filler material can be injected into the bone.

32. The apparatus according to claim 29, wherein said sheet comprises a plurality of holes, said holes dimensioned to allow the filler material to penetrate said body.

33. The apparatus according to claim 29, wherein the axial member is rotated in a direction opposite of the coiling of the body to expand the body by partially uncoiling the coiled sheet.

34. A method of treating bone comprising:

inserting a body into bone, the body adapted to receive a band configured to coil multiple times around said body to increase a diameter of the body;

causing the band to coil around the body to increase the diameter of the device, and;

leaving the body implanted within the bone.

35. The method of claim 34, wherein causing the band to coil comprises rotating said body about a longitudinal axis and positioning the band over the length of the body using a guide axially movable with respect to the body.

36. A method of distracting bone comprising:

disposing between at least two bone segments a device comprising an elongated body adapted to receive a band configured to coil multiple times around the elongated body and increase a diameter of the device;

coiling the band around the elongated body to increase the diameter of the device and apply a force to the at least two bone segments;

applying the force to move one bone segment with respect to the other bone segment.

37. The method of claim 36, wherein the at least two bone segments comprise spinous processes of adjacent vertebrae.

38. The method of claim 36, wherein the at least two bone segments comprise an upper and a lower endplate of a vertebral body, and said disposing comprises inserting the elongated body into the vertebral body between the endplates.

39. The method of claim 38, further comprising leaving a portion of the device including the coiled band within the vertebral body.

40. A method of treating bone comprising:

inserting inside a bone a mass of fibers adapted to be inserted into bone having a first dimension/size;

causing the mass to expand the bone; and

leaving the device implanted within the bone to maintain the desired position of the bone.