Prosthetic implant

• US 5,496,371 A
• Filed: 06/01/1993
• Issued: 03/05/1996
• Est. Priority Date: 06/10/1991
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Sander, Thomas, Torgerson, Robert D., Eppley, Barry
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/069,452
• Time in Patent Office: 1,008 Days
• Field of Search: 623/11, 623/16, 623/18, 623/66, 433/171, 433/172, 433/173, 433/174
• US Class Current: 623/17.18
• CPC Class Codes: A61F 2/18 Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/186 Nose parts
• 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 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30721 Accessories
• CPC Class Codes: A61F 2002/2807 Chin implants
• CPC Class Codes: A61F 2002/2882 Malar or zygomatic implants
• CPC Class Codes: A61F 2002/2885 Paranasal implants
• CPC Class Codes: A61F 2002/2889 Maxillary, premaxillary or molar implants
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30708 Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30962 using stereolithography
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0028 Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2250/0084 : Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
• 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: A61L 2/28 : Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 27/26 : Mixtures of macromolecular compounds
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: C08L 33/12 : Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C08L 33/14 : of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen

Abstract

Flexible prosthetic implants for repairing, replacing or augmenting hard tissue or bone. The flexible implant comprises a plurality of segments that are connected by flexible retainers which enable the segments to be re-oriented in relation to one another to accommodate the contour, size and shape of the body part being treated. A method for making such flexible prosthetic implants is also disclosed.

Claims

1. A subcutaneous prosthetic maxillofacial implant for tissue or bone comprising at least two segments, at least one of said segments being connected to another segment by a flexible connecting member, said segments having inner and outer surfaces, said outer surfaces configured and dimensioned to alter the appearance of tissue underlying said segments, said inner surfaces adapted to abut surface of underlying bone, whereby said segments and said flexible connecting member cooperate to conform said implant to the contour of at least a portion of underlying bone, wherein said inner surfaces of said segments are configured to conform to at least a portion of maxillofacial bone.

2. A prosthetic implant according to claim 1, wherein said flexible connecting member further comprises means for anchoring said flexible member to at least one of said segments.

3. A prosthetic implant according to claim 2 wherein said flexible connecting member comprises an I-shaped retainer and said anchoring means comprises flanges on opposing ends of said retainer, each flange being disposed in one of said segment members.

4. A prosthetic implant according to claim 3 wherein said I-shaped retainer has distally disposed apertures.

5. A prosthetic implant according to claim 1 wherein said flexible connecting member comprises a bar shaped retainer.

6. A prosthetic implant according to claim 1 wherein said flexible connecting member is comprised of a material selected from the group consisting of stainless steel, titanium, silicon rubber, polyurethane, nylon, polyethylene, polyesters, collagen fiber, aluminum oxide, carbon fiber, carbon composites, titanium alloy, Co-Cr alloy, and Co-Cr-Mo alloy.

7. A prosthetic implant according to claim 6 wherein said material is woven into a mesh.

8. A prosthetic implant according to claim 6 wherein said material is woven into a braid.

11. A prosthetic implant according to claim 1 wherein said implant is a malar implant comprising upper and lower segments.

12. A prosthetic implant according to claim 11 wherein said upper segment of said malar implant is larger than said lower segment of said malar implant.

13. A prosthetic implant according to claim 1 wherein said implant is a paranasal implant comprising upper and lower segments.

14. A prosthetic implant according to claim 13 wherein said upper segment of said paranasal implant is larger than said lower segment of said paranasal implant.

15. An implant as recited in claim 1, wherein at least one of said segments being connected to another segment is joined by a plurality of flexible connecting members.

16. An implant according to claim 1, wherein said segments are composed of a material selected from the group consisting of polymers, polymer/ceramic composites, ceramics and metals.

17. An implant according to claim 1, wherein at least one of said segments is comprised of a resorbable material selected from the group consisting of copolymers of glycolide, lactide and polydioxanone.

9. A subcutaneous prosthetic chin implant for tissue or bone comprising at least two segments, at least one of said segments being connected to another segment by a flexible connecting member, said segments having inner and outer surfaces, said outer surfaces adapted to alter the appearance of tissue overlying said segments, said inner surfaces adapted to abut surface of underlying bone, whereby said segments and said flexible connecting member cooperate to conform said implant to the contour of at least a portion of underlying bone, wherein said inner surfaces of said segments are configured to conform to at least a portion of a mandible.

10. A prosthetic implant according to claim 9 wherein said chin implant is comprised of three adjacent segment members.

18. A subcutaneous maxillofacial implant for replacing or augmenting hard tissue or bone comprising at least first and second segments composed of polymethylmethacrylate polyhydroxyethylmethacrylate composite, said segments having inner and outer surfaces, said outer surfaces adapted to alter the appearance of tissue overlying said segments, said inner surfaces adapted to abut surface of underlying bone, said segments linked by a separate flexible member having a first end connected to said first segment and a second end connected to said second segment.

19. An implant according to claim 18, wherein said flexible member is embedded in said segments during the process of molding said segments.

20. An implant according to claim 18, wherein said flexible member is composed of a resilient material.

21. An implant according to claim 18, wherein said flexible member is composed of stainless steel.

22. An implant according to claim 18, wherein said flexible member is composed of titanium.

23. An implant according to claim 18, wherein said flexible member is composed of a woven material.

24. An implant according to claim 18, further comprising a third segment wherein said third segment is joined to said second segment by a second flexible connecting member.

25. An implant according to claim 18, further comprising a third segment interposed between said first and second segment, said flexible member being of sufficient length to extend from said first segment to said second segment.

26. A subcutaneous maxillofacial implant for body tissue or bone comprising

at least a first rigid segment;

at least a second rigid segment adjacent said first segment; and

means for joining said first and second segments to allow re-orientation of said second segment in relation to said first segment whereby said first and second segments are positionable to conform to the contour of at least a portion of said body tissue or bone, wherein at least a portion of said segments are configured to conform to at least a portion of maxillofacial bone and each of said first and second segments having outer surfaces, said outer surfaces being shaped and configured to alter the appearance of tissue overlying said segments.

27. An implant according to claim 26, wherein said first and second segments are spaced apart from one another.

28. An implant as recited in claim 26, wherein said joining means comprising a retaining element composed of a flexible material, said retaining element having a first end connected to said first segment and a second end connected to said second segment.

29. An implant according to claim 28, wherein each end of said retaining element is embedded in said respective segment.

30. An implant according to claim 28, comprising a third rigid segment, said third segment disposed adjacent and spaced apart from said second segment.