Meniscus-type implant with hydrogel surface reinforced by three-dimensional mesh

• US 6,629,997 B2
• Filed: 03/27/2001
• Issued: 10/07/2003
• Est. Priority Date: 03/27/2000
• Status: Active Grant

• Current Assignee: Kevin A. Mansmann
• Original Assignee: Kevin A. Mansmann
• Inventors: Mansmann, Kevin A.
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US09/818,811
• Publication Number:
  US 20020022884A1
• Time in Patent Office: 924 Days
• Field of Search: 623/11.11, 623/14.12, 623/16.11, 623/17.12, 623/17.16, 623/18.11, 623/23.54
• US Class Current: 623/14.12
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4225 for feet, e.g. toes
• CPC Class Codes: A61F 2/4241 for hands, e.g. fingers
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0028 : differing in fibre orientations
• CPC Class Codes: A61F 2250/0031 : made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

A device for surgical implantation to replace damaged tissue in a joint (such as a meniscus in a knee) is created from a hydrogel that is reinforced by a three-dimensional flexible fibrous mesh. In a meniscal implant, the mesh is exposed at one or more locations around the periphery, to provide anchoring attachments that can be sutured, pinned, or otherwise securely affixed to tissue that surrounds the implant. The fibrous mesh should extend throughout most of the thickness of the hydrogel, to create an “interpenetrating network” (IPN) of fibers modelled after certain types of natural body tissues. Articulating surfaces which will rub and slide against cartilage should be coated with a hydrogel layer that is completely smooth and nonabrasive, and made of a material that remains constantly wet. This composite structure provides a meniscal implant with improved strength, performance, and wettability compared to implants of the prior art. This type of implant may also be useful in repairing other joints, such as shoulders, wrists, ankles, or elbows, and in repairing injured or diseased hands, fingers, feet, or toes.

Claims

1. A non-resorbable Meniscal device designed for surgical emplacement in a mammalian joint, comprising a synthetic non-resorbable hydrogel component and a flexible fibrous mesh component, wherein:

a. the synthetic non-resorbable hydrogel component provides a smooth and lubricious surface, on at least one surface area which will contact and rub against a natural cartilage surface in the joint;

b. the flexible fibrous mesh component reinforces the smooth and lubricious surface, and provides reinforced means for anchoring the device to tissue which surrounds the joint, and extends throughout essentially all of the hydrogel component other than one or more smooth surfaces,

and wherein the device is non-resorbable, and is designed for surgical implantation without cells embedded within the hydrogel component.

2. The non-resorbable device of claim 1, having a size and shape which render the device suitable for implantation in a human knee joint to replace a damaged meniscus, wherein the device:

a. has a first smooth and lubricious surface designed to articulate against femoral cartilage,

b. has a second smooth and lubricious surface designed to articulate against tibial cartilage, and,

c. has a peripheral surface designed to enable secure anchoring of the device to tissue surrounding a knee joint.

3. The device of claim 1, having a size and shape which render the device suitable for implantation in a joint selected from the group consisting of shoulders, wrists, ankles, and elbows.

4. The device of claim 1, having a size and shape which render the device suitable for implantation in an appendage selected from the group consisting of feet and hands.

5. The device of claim 1, having a first relatively soft hydrogel portion which provides a lubricious surface on at least one surface area of the device, and having a second hydrogel portion which has greater hardness and stiffness in at least one portion of the device.

6. The device of claim 1, having a hydrogel portion which provides a lubricious surface on at least one surface area of the device, and having at least one interior portion comprising an elastomeric material which is not a hydrogel.

7. A non-resorbable meniscal device for surgical implantation, comprising:

a. a body made of elastomeric material, and a flexible fibrous mesh component embedded within the body of the device, wherein at least a portion of said elastomeric material comprises a hydrogel material which retains water molecules that are able to permeate into and out of the hydrogel material;

b. at least one articulating surface made of a smooth and lubricious synthetic non-resorbable hydrogel material, wherein the articulating surface is designed to press against at least one bone or cartilage surface following implantation of the device, and,

c. at least one anchoring surface having an exposed porous surface, made of fibrous mesh material that will promote tissue ingrowth into the porous surface following implantation of the device;

and wherein the flexible fibrous mesh component embedded within the body of said device is sized and positioned in a manner which;

(i) provides a flexible supporting structure beneath at least one articulating surface, which reinforces and strengthens said articulating surface, and (ii) provides an anchoring accommodation which will reinforce anchoring of the device to surrounding tissue after surgical implantation of the device,

and wherein the non-resorbable device is designed for surgical implantation without embedded cells.

8. The non-resorbable device of claim 7, having a size and shape which render the device suitable for implantation in a human knee joint to replace a damaged meniscus, wherein the device:

a. has a first smooth and lubricious surface designed to articulate against femoral cartilage,

b. has a second smooth and lubricious surface designed to articulate against tibial cartilage, and,

c. has a peripheral surface designed to enable secure anchoring of the device to tissue surrounding a knee joint.

9. The device of claim 7, having a size and shape which render the device suitable for implantation in a joint selected from the group consisting of shoulders, wrists, ankles, and elbows.

10. The device of claim 7, having a size and shape which render the device suitable for implantation in an appendage selected from the group consisting of feet and hands.

11. The device of claim 7, having a first relatively soft hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and having a second hydrogel portion which has greater hardness and stiffness in an interior portion of the device.

12. The device of claim 7, having a hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and having at least one interior portion comprising an elastomeric material which is not a hydrogel.

13. A non-resorbable device for surgical implantation to replace meniscal tissue in a joint, comprising a body made of elastomeric material with a reinforcing flexible fibrous mesh, and having:

a. a first smooth and lubricious hydrogel articulating surface designed to articulate against femoral cartilage;

b. a second smooth and lubricious surface designed to articulate against tibial cartilage, and,

c. at least one anchoring surface having exposed pores that will promote tissue ingrowth into the exposed pores following implantation of the device,

wherein the reinforcing flexible fibrous mesh extends throughout essentially all of the elastomeric material except for a first coating layer which provides the first smooth and lubricious articulating surface, and a second coating layer which provides the second smooth and lubricious articulating surface,

and wherein the non-resorbable device is designed for surgical implantation without cells embedded within the device.

14. A method of surgically replacing damaged meniscal tissue in a mammalian joint, comprising the step of surgically implanting, into the joint, a non-resorbable device comprising a synthetic non-resorbable hydrogel component and a flexible fibrous mesh component, wherein:

a. the mesh component extends throughout essentially all of the hydrogel component other than one or more smooth surfaces, and provides the non-resorbable device with means for securely anchoring the device to tissue which surrounds the joint; and

,

b. the hydrogel component provides a smooth and lubricious surface, in a first surface area which will contact and rub against a femoral cartilage surface in the joint, and in a second surface area which will contact and rub against a tibial cartilage surface in the joint and wherein the non-resorbable device is designed for surgical implantation without cells embedded therein.

15. The method of claim 14, wherein the device has a first relatively soft hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and a second hydrogel portion which has greater hardness and stiffness in an interior portion of the device.

16. The method of claim 14, wherein the non-resorbable device has a first hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and at least one interior portion comprising an elastomeric material which is not a hydrogel.

17. A method of surgically replacing damaged meniscal tissue in a mammalian joint, comprising the step of surgically implanting, into the joint, a non-resorbable device comprising an elastomeric body component and a flexible fibrous mesh component embedded within the elastomeric body component, wherein the elastomeric body component is provided with:

a. a first smooth and lubricious hydrogel articulating surface designed to articulate against femoral cartilage; and

,

b. a second smooth and lubricious surface designed to articulate against tibial cartilage, and,

c. at least one anchoring surface made of a porous material that will promote tissue ingrowth into the porous material following implantation of the device;

and wherein the mesh component embedded within the elastomeric body component is sized and positioned in a manner which;

(i) provides a flexible supporting structure beneath at least one articulating surface, which reinforces and strengthens said articulating surface, (ii) provides a plurality of fibrous anchoring accommodations, which will reinforce anchoring of the device to surrounding tissue after surgical implantation of the device, and (iii) extends throughout essentially all of the elastomeric body component other than the first and second smooth and lubricious surfaces,

and wherein the non-resorbable device is designed for surgical implantation without cells embedded therein.

18. The method of claim 17, wherein the device has a first relatively soft hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and a second hydrogel portion which has greater hardness and stiffness in an interior portion of the device.

19. The method of claim 17, wherein the device has a first hydrogel portion which provides a lubricious surface on at least one articulating surface of the device, and at least one interior portion comprising an elastomeric material which is not a hydrogel.