ANCHORING SYSTEMS AND INTERFACES FOR FLEXIBLE SURGICAL IMPLANTS FOR REPLACING CARTILAGE

• US 20090132047A1
• Filed: 11/30/2005
• Published: 05/21/2009
• Est. Priority Date: 11/30/2004
• Status: Abandoned Application

• Current Assignee: Formae, Inc.
• Original Assignee: Formae, Inc.
• Inventors: Potter, Alvin A., Mansmann, Kevin A.
• Application Number:
  US12/067,654
• Publication Number:
  US 20090132047A1
• Time in Patent Office: Days
• US Class Current: 623/14.120
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• 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 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/3877 Patellae or trochleae
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4637 for connecting or disconnecting two parts of a prosthesis
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30115 circular-O-shaped
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30181 : Y-shaped
• CPC Class Codes: A61F 2002/302 : toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30299 : umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30354 : Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30459 : stapled
• CPC Class Codes: A61F 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30495 : using a locking ring
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30738 : Sleeves
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/30822 : Circumferential grooves
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/006 : Y-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/0023 : differing in porosity

Abstract

Surgical implants for replacing cartilage are provided with hydrogel polymers affixed to anchors made of “shape-memory” materials, such as nitinol alloys. These implants can be flexed, allowing them to be inserted into joints arthroscopically. After insertion, an implant will return to its manufactured size and shape, and can be anchored to bone or other tissue. The anchoring components can grip and hold hydrogels or other soft polymers by means of an interface of porous fabric. The fabric can support a reinforcing mesh embedded within the soft polymer, and its bottom surface can promote tissue ingrowth, leading to stronger anchoring. Two or more porous layers can enclose a soft polymer, for purposes such as sustained drug release or holding transplanted cells.

Claims

1. A surgically implantable device, comprising:

a. at least one first part made from a shape-memory material; and

,

b. at least one second part made from a polymer material,

wherein said device is designed for surgical replacement of cartilage in a mammalian joint.

2. The implantable device of claim 1 wherein said first part is formed as a rim that has been secured to at least one peripheral edge of said second part and that is provided with means for anchoring said rim to a bone.

3. The implantable device of claim 2 wherein said means for anchoring said rim to a bone are selected from the group consisting of:

(i) a plurality of pegs, affixed to said rim and designed for insertion into accommodating anchoring devices that can be emplaced in a bone surface prior to arthroscopic insertion of the implantable device; and

, (ii) means for affixing to said rim a plurality of pegs designed for insertion into accommodating anchoring devices that can be emplaced in a bone surface.

4. The implantable device of claim 1 wherein said first part is formed as a polymer-supporting component affixed to a single peg that is designed for insertion into an accommodating anchoring device that can be emplaced in a bone surface prior to arthroscopic insertion of the surgically implantable device.

5. The implantable device of claim 1 wherein said first part made from a shape-memory material has dimensions that are designed to provide:

a. a first nondeformed shape and size that were established by a manufacturing process;

b. a second narrowed shape and size having dimensions that will enable insertion of the implantable device, via a minimally-invasive incision, into a joint that is being repaired; and

,

c. a third shape and size that emulates the first nondeformed shape and size.

6. The implantable device of claim 1 wherein said polymer material is a flexible polymeric component affixed to said first part.

7. The implantable device of claim 1 wherein said flexible polymeric component is a synthetic hydrophilic polymer that becomes a flexible hydrogel when hydrated with saline solution.

8. The implantable device of claim 1 wherein a layer of porous material that promotes tissue ingrowth is affixed to said first part.

9. The implantable device of claim 2 wherein a layer of porous material that promotes tissue ingrowth is affixed to said rim and is completely surrounded by said rim.

10. The implantable device of claim 8 wherein said second part made from a polymer material is affixed to said layer of porous material that promotes tissue ingrowth.

11. The implantable device of claim 8 wherein said second part made from a polymer material is affixed to said layer of porous material by means of a fibrous mesh that is embedded within said second part and that is also affixed to said layer of porous material.

12. The implantable device of claim 8 wherein said layer of porous material that promotes tissue ingrowth is affixed to said first part by means comprising mechanical gripping of an elastomeric material that surrounds a portion of said porous material, by said first part.

13. The implantable device of claim 1 wherein said polymer material has been given a negative surface charge and is suited for replacing hyaline cartilage in at least one type of mammalian joint.

14. A surgically implantable device, comprising:

a. at least one first part made from an elastic material that is designed to allow insertion of the implantable device into a mammalian joint in a deformed shape via a minimally-invasive incision, and to then return to a nondeformed shape within the joint; and

,

b. at least one second part made from a synthetic polymer,

wherein said device is designed for surgical replacement of cartilage in a mammalian joint.

15. The implantable device of claim 14 wherein said first part is formed as a rim that has been secured to at least one peripheral edge of said second part and that is provided with means for anchoring said rim to a bone.

16. The implantable device of claim 14 wherein said first part is formed as a polymer-supporting component affixed to a single peg that is designed for insertion into an accommodating anchoring device that can be emplaced in a bone surface prior to insertion of the surgically implantable device.

17. The implantable device of claim 14 wherein said first part made from an elastic material has dimensions that are designed to provide:

a. a first nonstressed shape and size that were established by a manufacturing process;

b. a second narrowed shape and size having dimensions that will enable insertion of the implantable device, via a minimally invasive incision, into a joint that is being repaired; and

,

c. a third shape and size that emulates the first nonstressed shape and size.

18. The implantable device of claim 14 wherein said polymer material is a flexible polymeric component affixed to said first part.

19. The implantable device of claim 14 wherein said flexible polymeric component is a synthetic hydrophilic polymer that becomes a flexible hydrogel when hydrated with saline solution.

20. The implantable device of claim 14 wherein a layer of porous material that promotes tissue ingrowth is affixed to said first part.

21. The implantable device of claim 14 wherein said second part made from a polymer material is affixed to said layer of porous material that promotes tissue ingrowth.

22. The implantable device of claim 14 wherein said second part made from a polymer material is affixed to said layer of porous material by means of a fibrous mesh that is embedded within said second part and that is also affixed to said layer of porous material.

23. The implantable device of claim 14 wherein said synthetic polymer has been given a negative surface charge and is suited for replacing hyaline cartilage in at least one type of mammalian joint.

24. A surgically implantable device, comprising:

a. at least one first part made from an elastic material that is designed to allow insertion of the implantable device into a mammalian recipient in a deformed shape, via an arthroscopic insertion tube, and to then return to a nonstressed shape within the joint, in a manner that will enable permanent anchoring of the implantable device to bone or tissue in the mammalian joint;

b. at least one second part made from a flexible polymer;

c. at least one tissue anchoring layer comprising a porous layer of material that promotes tissue ingrowth into said layer of material, after surgical implantation;

d. means for securing said tissue anchoring layer to said first part; and

,

e. means for securing said tissue anchoring layer to said second part.

25. The implantable device of claim 24 wherein a fibrous reinforcing mesh is embedded within at least a portion of the flexible polymer of said second part, and wherein said fibrous reinforcing mesh is secured to said tissue anchoring layer.

26. The implantable device of claim 24 wherein said flexible polymer comprises a synthetic hydrogel polymer.

27. The implantable device of claim 24 wherein said flexible polymer has been given a negative surface charge and is suited for replacing hyaline cartilage in at least one type of mammalian joint.

28. A surgically implantable device, comprising:

a. at least one first part made from a shape-memory material; and

,

b. at least one second part made from a soft polymer that is suited for protecting and nurturing transplanted cells.

29. The surgically implantable device of claim 28, wherein the soft polymer is made from a synthetic hydrophilic polymer that becomes a flexible hydrogel when hydrated with saline solution.

30. The surgically implantable device of claim 28, wherein the second part made from a soft polymer is enclosed within two or more porous layers affixed to a shape-memory anchoring device.