Unitary surgical device and method

• US 7,163,563 B2
• Filed: 07/15/2002
• Issued: 01/16/2007
• Est. Priority Date: 07/16/2001
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Plouhar, Pamela Lynn, Schwartz, Herbert E., Malaviya, Prasanna, Pelo, Mark Joseph, Singla, Amit K.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/195,344
• Publication Number:
  US 20030078617A1
• Time in Patent Office: 1,646 Days
• Field of Search: 606/215, 606/151, 623/14.12, 623/13.14, 623/23.72, 623/23.75, 623/23.76
• US Class Current: 623/23.76
• 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• 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 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/3094 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 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30281 : wedge-shaped
• CPC Class Codes: A61F 2002/30294 : Conical or frustoconical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30306 : harpoon-shaped
• CPC Class Codes: A61F 2002/30429 : made by inserting a hook into a cooperating slot
• CPC Class Codes: A61F 2002/30751 : for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30764 : Cartilage harvest sites
• CPC Class Codes: A61F 2002/30766 : Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0097 : Harpoon-shaped
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3654 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

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 fibrocartilage tissue in the patient, the unitary surgical device comprising:

a first length of suture;

a second length of suture; and

a tissue repair element connected to the first length of suture and the second length of suture prior to surgery, the tissue repair element including a bioresorbable base and a mass of tissue regeneration material on the base, the mass of tissue regeneration material including ECM foam, the base having a first hole receiving part of the first length of suture and a second hole receiving part of the second length of suture.

2. The unitary surgical device of claim 1 wherein the base comprises mammalian submucosa.

3. The unitary surgical device of claim 1 wherein the base comprises laminar ECM material.

4. The unitary surgical device of claim 3 wherein the ECM material is derived from mammalian submucosa.

5. The unitary surgical device of claim 1 further comprising a package holding the unitary surgical device.

6. A unitary surgical device for surgical implantation in a patient for regenerating tissue in the patient, the unitary surgical device comprising a tissue repair element and a first length of suture, the tissue repair element comprising a base and a mass of tissue regeneration material, wherein:

the base comprises an ECM laminate with a hole;

the mass of tissue regeneration material includes ECM foam on the base; and

the first length of suture extends through the hole in the base prior to surgery.

7. The unitary surgical device of claim 6 further comprising a package holding the unitary surgical device.

8. The unitary surgical device of claim 6 wherein the ECM laminate comprises naturally occurring small intestine submucosa and the ECM foam comprises naturally occurring small intestine submucosa.

9. The unitary surgical device of claim 6 further comprising a second length of suture secured to the base prior to surgery.

10. A unitary surgical device for surgical implantation in a patient for regenerating tissue in the patient, the unitary surgical device comprising:

a tissue repair element comprising a base made of ECM laminate and a mass of tissue regeneration material secured to the base, the tissue regeneration material including ECM foam;

a first length of suture secured to the base prior to surgery; and

a package holding the tissue repair element and first length of suture.

11. The unitary surgical device of claim 10 wherein the base has a hole and part of the first length of suture extends through the hole in the base.

12. The unitary surgical device of claim 10 wherein the ECM laminate comprises naturally occurring small intestine submucosa.

13. The unitary surgical device of claim 10 further comprising a second length of suture secured to the base prior to surgery.

14. A unitary surgical device for surgical implantation in a patient for regenerating tissue in the patient, the unitary surgical device comprising:

a tissue repair element comprising an ECM laminate base and a mass of tissue regeneration material, the base having two opposing edges and a plurality of holes along one of the edges of the base; and

the mass of tissue regeneration material comprising ECM foam positioned between the two opposing edges of the base.