Unitary surgical device and method

• US 7,871,440 B2
• Filed: 12/11/2006
• Issued: 01/18/2011
• Est. Priority Date: 12/11/2006
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Plouhar, Pamela Lynn, Schwartz, Herbert E., Pelo, Mark Joseph, Singla, Amit K., Malaviya, Prasanna
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US11/609,114
• Publication Number:
  US 20080140094A1
• Time in Patent Office: 1,499 Days
• Field of Search: 623/23.76, 623/14.12, 623/23.75, 606/151, 606/215
• US Class Current: 623/14.12
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/30751 for attaching cartilage scaffolds to underlying bone

Abstract

Unitary surgical devices (10) are disclosed. One group of the illustrated devices has a pair of biocompatible, bioresorbable anchors (16,18) connected to fixed lengths suture. The anchors (16,18) and fixed length of suture are connected to each other prior to surgery. Another group of unitary surgical devices has a pair of fixating mechanisms (15,17) connected to a base (21) prior to surgery. The second group of illustrated devices generally includes extracellular matrix material either as part of the base (21) or supported on the base (21). The extracellular matrix material serves as tissue regenerating material. In the second group of unitary surgical devices, the fixating mechanisms illustrated generally comprise suture, anchors or pre-formed holes in the base. All of the illustrated unitary surgical devices are useful in repairing a damaged meniscus. The first group of unitary surgical devices can be used to approximate inner surfaces of a tear in the meniscus. The second group of devices can be used either as an insert to be placed between and approximated to the inner surfaces of the tear or as an insert to replace a void in the meniscus left after a meniscectomy.

Claims

1. A unitary surgical device for surgical implantation in a patient for regenerating meniscal tissue in the patient, the unitary surgical device comprising a tissue repair element and a fixating member:

the tissue repair element comprising a base and a mass of tissue regeneration material, the base comprising a panel with upper and lower surfaces; and

the tissue regeneration material being generally wedge-shaped and fixed to at least one of the surfaces of the base;

wherein the base comprises ECM laminate and the tissue regeneration material comprises non-laminar ECM;

wherein the fixating member is associated with at least one of the base and the tissue regeneration material; and

wherein the ECM of at least one of the base and the tissue regeneration material includes a material selected from the group consisting of;

small intestine submucosa,

stomach submucosa,

bladder submucosa,

alimentary submucosa,

respiratory submucosa,

genital submucosa, and

liver basement membrane.

2. The unitary surgical device of claim 1 wherein the fixating member includes at least one of the following:

a length of suture fixed to the base;

at least one hole in the base;

a biocompatible anchor fixed to the base;

a biocompatible anchor fixed to the tissue regeneration material; and

a length of suture fixed to the tissue regeneration material.

3. The unitary surgical device of claim 1 wherein the non-laminar ECM comprises an ECM foam.

8. The unitary surgical device of claim 1 wherein the ECM laminate comprises a plurality of ECM sheets.

4. A unitary surgical device for surgical implantation in a patient for regenerating meniscal tissue in the patient, the unitary surgical device comprising a tissue repair element and a fixating mechanism, the tissue repair element including a base and tissue regeneration material, wherein the base includes ECM laminate defining two panels having a V-shaped configuration in cross-section, the two panels meeting along an apex portion and having end portions spaced distally from the apex portion, the end portions being spaced from each other to provide a gap, wherein the tissue regeneration material comprises non-laminar ECM, wherein the tissue regeneration material is positioned between the two panels of the base and wherein the ECM of at least one of the base and the tissue regeneration material includes a material selected from the group consisting of:

small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.

5. The unitary surgical device of claim 4 wherein the fixating mechanism includes at least one of the following:

a length of suture fixed to the base;

at least one hole in the base;

a biocompatible anchor fixed to the base;

a biocompatible anchor fixed to the tissue regeneration material; and

a length of suture fixed to the tissue regeneration material.

6. The unitary surgical device of claim 4 wherein the unitary surgical device includes a plurality of fixating mechanisms comprising opposing anchors on the end portions of the base panels, the opposing anchors being suitable for fixation to the native meniscus.

7. The unitary surgical device of claim 4 wherein the tissue regeneration material comprises a wedge of ECM foam.

9. The unitary surgical device of claim 4 wherein the ECM laminate comprises a plurality of ECM sheets.