Device from naturally occurring biologically derived materials

• US 8,337,537 B2
• Filed: 07/15/2002
• Issued: 12/25/2012
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Pelo, Mark Joseph, Plouhar, Pamela Lynn, Schwartz, Herbert Eugene, Malaviya, Prasanna, Whalen, Terrence David
• Primary Examiner(s): Stewart, Alvin
• Assistant Examiner(s): HOFFMAN, MARY C
• Application Number:
  US10/483,465
• Publication Number:
  US 20040220574A1
• Time in Patent Office: 3,816 Days
• Field of Search: 606 72- 73, 606 76- 77, 606/232, 623/23.61, 623/23.63, 623/23.75
• US Class Current: 606/329
• 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 or resorptive
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• 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 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/0864 : Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/087 : Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/0888 : Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• 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 2002/2839 : Bone plugs or bone graft dowels
• 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 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30199 : Three-dimensional shapes
• CPC Class Codes: A61F 2002/3021 : frustoconical
• CPC Class Codes: A61F 2002/30217 : hollow cones, e.g. tubular-like cones
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30233 : Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30281 : wedge-shaped
• CPC Class Codes: A61F 2002/30293 : Cylindrical body made by spirally rolling up a sheet or a strip around itself
• 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 2002/30429 : made by inserting a hook into a cooperating slot
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• 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 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30914 : Details of the mesh structure, e.g. disposition of the woven warp and weft wires
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/3096 : trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/30975 : made of two halves
• 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 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• 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 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2240/004 : Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• 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 27/3645 : Connective tissue
• 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: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Orthopaedic devices are disclosed. The devices include a part that is made of extracellular matrix material that has been hardened. One method of hardening the extracellular matrix is to comminute naturally occurring extracellular matrix and dry the comminuted material. The hardened extracellular matrix material can be machined to form a variety of orthopaedic devices.

Claims

1. An orthopaedic device comprising a tack for driving into a bone, the tack having a proximal head end portion, a distal pointed end portion, and an intermediate body portion, the tack being made of a hardened mass of comminuted naturally occurring extracellular matrix, wherein the naturally occurring extracellular matrix is selected from the group consisting of small intestinal submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane wherein the naturally occurring extracellular matrix has a hardness of at least 30 on the “

D”

scale.

2. The device of claim 1 in which the naturally occurring extracellular matrix is small intestinal submucosa.

3. The device of claim 2 in which the small intestinal submucosa has a hardness of at least 50 on the “

D”

scale.

4. The device of claim 2 in which the small intestinal submucosa has a hardness of at least 60 on the “

D”

scale.

5. The device of claim 2 in which the small intestinal submucosa has a hardness of at least 70 on the “

D”

scale.

6. An orthopedic device comprising comminuted naturally occurring extracellular matrix having a hardness greater than 30 HRD on the Rockwell D scale, wherein the naturally occurring extracellular matrix is selected from the group consisting of small intestinal submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.

7. The orthopedic device of claim 6 wherein the comminuted naturally occurring extracellular matrix has a hardness of at least 60 HRD on the Rockwell D scale.

8. The orthopedic device of claim 6 wherein the comminuted naturally occurring extracellular matrix has a hardness of at least 70 HRD on the Rockwell D scale.

9. The orthopedic device of claim 6 wherein the comminuted naturally occurring extracellular matrix has a density greater than 0.5 g/cc.

10. The orthopedic device of claim 6 wherein the comminuted naturally occurring extracellular matrix has a density greater than 0.7 g/cc.

11. The orthopedic device of claim 6 wherein the device comprises a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring bioremodelable collageneous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring bioremodelable collageneous tissue matrix having a density less than 0.7 g/cc;

a mat including a nonwoven naturally occurring bioremodelable collageneous tissue matrix;

braided naturally occurring bioremodelable collageneous tissue matrix;

a foam comprising bioremodelable collageneous tissue matrix;

a laminate comprising bioremodelable collageneous tissue matrix;

a woven material comprising bioremodelable collageneous tissue matrix;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven material; and

a mat including a nonwoven biologically absorbable polymer.

12. The orthopedic device of claim 6 wherein the device comprises a configuration selected from the group consisting of:

an orthopedic tack comprising a monolithic head portion and a body portion;

an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone;

an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs;

an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs;

an anchor for anchoring a bone plug in an opening formed in bone, the bioremodelable collageneous tissue matrix being configured to be wedged between the bone plug and the bone;

an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression;

a outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a hardness greater than 50 HRD on the Rockwell D Scale and the inner portion has a hardness less than 70 HRD on the Rockwell D Scale; and

a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally-occurring bioremodelable collageneous tissue matrix.

13. The orthopedic device of claim 12 wherein the device comprises a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring bioremodelable collageneous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring bioremodelable collageneous tissue matrix having a density less than 0.7 g/cc;

a mat of nonwoven naturally occurring bioremodelable collageneous tissue matrix;

a foam comprising bioremodelable collageneous tissue matrix;

a laminate comprising bioremodelable collageneous tissue matrix;

a woven material comprising bioremodelable collageneous tissue matrix;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven; and

a mat of nonwoven biologically absorbable polymer.

14. The orthopedic device of claim 13 wherein the comminuted naturally occurring extracellular matrix has a hardness of at least 50 HRD on the Rockwell D Scale.

15. The orthopedic device of claim 12 wherein the comminuted naturally occurring extracellular matrix has a hardness of at least 70 HRD on the Rockwell D scale.