Soft tissue spacer

• US 7,887,587 B2
• Filed: 06/04/2004
• Issued: 02/15/2011
• Est. Priority Date: 06/04/2004
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Hamel, Ross J., Griffiths, Bryan
• Primary Examiner(s): RAMANA, ANURADHA
• Application Number:
  US10/860,885
• Publication Number:
  US 20050273165A1
• Time in Patent Office: 2,447 Days
• Field of Search: 623/11.11, 623/16.11, 623/23.5, 623/23.51, 623/23.53, 623/23.55, 623/23.57, 623/23.58, 623/23.6
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/8071 for the jaw
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61F 2002/2807 Chin implants
• 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 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30672 temporary
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2300/00 : Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 27/16 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/048 : obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 23/06 : Polyethene

Abstract

An orthopedic tissue spacer comprising a body portion having first and second ends, an outer surface and a longitudinal axis, at least one of the ends configured to engage a first bone segment, wherein at least a portion of the body portion is flexible and the outer surface is configured to resist tissue adhesion thereto.

Claims

1. An orthopedic tissue spacer comprising:

a body portion comprising;

a front surface, a back surface, and top and bottom surfaces extending between the front and back surfaces, the body portion further defining a first end and a second end;

a central longitudinal axis extending from the first end to the second end along a mid-line between the front surface and the back surface;

a first portion defined by and between the front surface and the central longitudinal axis and a second portion defined by and between the back surface and the central longitudinal axis;

a first series of recesses extending into the body portion from the front surface and terminating in the second portion of the body portion; and

a second series of recesses extending into the body portion from the back surface and terminating in the first portion of the body portion;

wherein each of the recesses in the first series are alternatingly arranged with each of the recesses in the second series along the central longitudinal axis from the first end to the second end of the body portion.

2. The spacer of claim 1, wherein the spacer comprises a height defined by the distance between the top surface and the bottom surface measured perpendicular to the central longitudinal axis, and a portion of each of the recesses in the first and second series has a depth greater than one-half the height of the spacer.

3. The spacer of claim 1, wherein each of the recesses in the first and second series defines a length extending along a direction between the front surface and the back surface, and a depth extending along a direction between the top surface and the bottom surface, the depth of the recess being variable along the length.

4. The spacer of claim 1, wherein at least two recesses have different dimensions.

5. The spacer of claim 1, wherein the recesses in the first and second series are substantially parallel.

6. The spacer of claim 1, wherein the recesses in the first and second series are approximately equally spaced along the longitudinal axis.

7. The spacer of claim 1 being made of a biocompatible material that is also a bioinert material.

8. The spacer of claim 7, wherein the biocompatible material is Ultra High Molecular Weight Polyethylene.

9. The spacer of claim 7, wherein the biocompatible material is capable of resisting tissue ingrowth and/or adhesion.

10. The spacer of claim 1, wherein the body portion is generally elliptical in cross-section transverse to the longitudinal axis.

11. The spacer of claim 1, wherein the first end and second end have different shapes from each other.

12. The spacer of claim 1, wherein the first end and second end each have a shape that substantially conforms to a contacted bone segment.

13. The spacer of claim 1, wherein at least a portion of the spacer is coated with at least one therapeutic agent.

14. The spacer of claim 13, wherein the therapeutic agent is an antibiotic.

15. The spacer of claim 13, wherein the therapeutic agent is an antiseptic.

16. The spacer of claim 13, wherein the at least one therapeutic agent is applied by spraying, dipping, soaking, impregnating, or chemical vapor deposition, or a combination thereof.

17. The spacer of claim 13, wherein the at least one therapeutic agent is selected at least in part from the group of IGF (insulin-like growth factors), TGF (transforming growth factors), FGB (fibroblast growth factors), EGF (epidermal growth factors), BMP (bone morphogenic proteins) and PDGF (platelet-derived growth factors).

18. The spacer of claim 1, wherein the body further comprises a bore defining a longitudinal axis, the bore being disposed in the body such that the longitudinal axis of the bore is coextensive with the longitudinal axis of the body.

19. The spacer of claim 18, wherein the spacer further comprises an outer surface, the bore having an inner surface that substantially conforms to the shape of the outer surface.

20. The spacer of claim 19, wherein the bore comprises about 90% of a cross sectional area of the body of the spacer.

21. The spacer of claim 18, wherein each end of the spacer has a cross-sectional dimension, wherein the bore has a diameter that is substantially smaller than the cross-sectional dimension of each end.

22. The spacer of claim 21, wherein there are a plurality of bores suitable for accepting at least one suture.

23. The spacer of claim 1, wherein the spacer has at least one bore, the bore having a longitudinal axis substantially non-parallel to that of the body portion, wherein there are a plurality of bores suitable for accepting at least one suture.

24. The spacer of claim 1, wherein the spacer is preformed in a preselected shape.

25. The spacer of claim 24, wherein the preselected shape is configured to substantially mimic at least a portion of removed bone.

26. The spacer of claim 25, wherein the removed bone is a portion of a human mandible.

27. The spacer of claim 26, wherein the removed bone is a portion of a human chin.

28. The spacer of claim 1, wherein at least a portion of the body portion has a dull finish to reduce glare in the surgical work site.

29. The spacer of claim 1, wherein at least a portion of the body portion has a roughened finish to reduce glare in the surgical work site.

30. The spacer of claim 1, wherein at least one of the ends has a roughened finish to enhance engagement of the end with the associated bone segment.

31. An orthopedic tissue spacer, comprising:

a body portion comprising;

a front side having a front surface, a back side having a back surface, a top having a top surface, a bottom having a bottom surface, the top and bottom surfaces extending between the front and back surfaces, the body portion further defining a first end and a second end opposite the first end, wherein the top surface and the bottom surface are separated by a distance therebetween which defines a height, the height being measured perpendicular to the central longitudinal axis;

a first series of recesses defined by the body portion and extending from the top surface in a direction toward the bottom surface, a plurality of the recesses in the first series terminating in the body portion at a location such that the plurality of the recesses in the first series extends through more than half the height of the body portion between the top surface and the bottom surface; and

a second series of recesses defined by the body portion and extending from the bottom surface in a direction toward the top surface, a plurality of the recesses in the second series terminating in the body portion at a location such that the plurality of the recesses in the second series extends through more than half the height of the body portion between the top surface and the bottom surface.

32. The tissue spacer of claim 31 wherein at least one of the first series of recesses and at least one of the second series of recesses alternate in position from the first end to the second end of the body portion.

33. The tissue spacer of claim 32, wherein the front surface and the back surface are separated by a distance therebetween, and at least one of the first series of recesses extends from the front surface toward the back surface a distance of at least one-half the distance between the front surface and the back surface.

34. The tissue space of claim 33 wherein at least one of the second series of recesses extends from the back surface toward the front surface a distance of at least one-half the distance between the front surface and the back surface.

35. The tissue spacer of claim 34 wherein the body portion is made of a biocompatible material that is also a bioinert material.

36. The tissue spacer of claim 34 wherein the body portion is made of ultra high molecular weight polyethylene.

37. The tissue spacer of claim 34 wherein the body portion further comprises a central, internal bore.

38. An orthopedic tissue spacer, comprising:

a body portion comprising;

a curved front side having a front surface, a curved back side having a back surface, a top having a top surface, a bottom having a bottom surface, the top and bottom surfaces extending between the front and back sides, the body portion further defining a first end and a second end opposite the first end, wherein the top surface and the bottom surface are separated by a distance therebetween which defines a height, the height being measured perpendicular to the central longitudinal axis;

a first series of recesses defined by the body portion and extending from the top surface in a direction toward the bottom surface, a plurality of the recesses in the first series extending through more than half the height of the body portion between the top surface and the bottom surface and terminating within the body portion; and

a second series of recesses defined by the body portion and extending from the bottom surface in a direction toward the top surface, a plurality of the recesses in the second series extending through more than half the height of the body portion between the top surface and the bottom surface and terminating within the body portion.

39. The tissue spacer of claim 38 wherein at least one of the first series of recesses and at least one of the second series of recesses alternate in position from the first end to the second end of the body portion.

40. The tissue spacer of claim 39, wherein the front surface and the back surface are separated by a distance therebetween, and at least one of the first series of recesses extends from the front surface toward the back surface a distance of at least one-half the distance between the front surface to the back surface.

41. The tissue space of claim 40 wherein at least one of the second series of recesses extends from the back surface toward the front surface a distance of at least one-half the distance between the front surface and the back surface.

42. The tissue spacer of claim 41 wherein the body portion is made of a biocompatible material that is also a bioinert material.

43. The tissue spacer of claim 41 wherein the body portion is made of ultra high molecular weight polyethylene.

44. The tissue spacer of claim 41 wherein the body portion further comprises a central, internal bore.