# US 10,307,258 B2 · Resilient interpositional arthroplasty device

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- Number: US 10,307,258 B2
- Document ID: US10307258B2
- Status: Granted
- Kind: B2
- Application number: 16/033,050
- Filed: 2018-07-11
- Published: 2019-02-07
- Granted: 2019-06-04
- Earliest claimed: 2011-09-01
- Assignees: Iorthopedics, Inc.
- Applicants: iOrthopedics, Inc.
- Inventors: Robert Thomas Grotz
- Web page: https://patentgrep.com/patent/US10307258B2

## CPC

- A61F 2/3859: {Femoral components}
- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- A61B 17/562: {Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain}
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/3817: {Cartilage-forming cells, e.g. pre-chondrocytes}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- C08L 75/04: Polyurethanes
- A61B 2017/561: {Implants with special means for releasing a drug}
- A61F 2/38: for elbows or knees
- A61F 2/3872: {Meniscus for implantation between the natural bone surfaces}
- A61F 2002/30563: {having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers}
- A61F 2002/30578: {having apertures, e.g. for receiving fixation screws}
- A61F 2002/30583: {filled with hardenable fluid, e.g. curable in-situ}
- A61F 2002/30586: {having two or more inflatable pockets or chambers}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30754: {Implants for interposition between two natural articular surfaces}
- A61F 2002/30772: {Apertures or holes, e.g. of circular cross section}
- A61F 2002/3863: {Condyles fitted on an anchored base}
- A61L 2300/402: Anaestetics, analgesics, e.g. lidocaine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- A61L 2300/414: Growth factors
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/452: Lubricants
- A61L 2300/64: Animal cells
- A61L 2430/24: for joint reconstruction
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

This disclosure is directed to a resilient interpositional arthroplasty implant. Such implants function to pad cartilage defects, cushion, and replace or restore the articular surface, which may preserve joint integrity, reduce pain and improve function. The implant may endure variable joint compressive and shear forces and cyclic loads. The implant may repair, reconstruct, and regenerate joint anatomy, and thereby improve upon joint replacement alternatives. The walls of this invention may capture, distribute and hold living cells until aggregation and hyaline cartilage regrowth occurs. The implant may be deployed into debrided joint spaces, molding and conforming to surrounding structures with sufficient stability so as to enable immediate limb use after outpatient surgery. Appendages of the implant may repair or reconstruct tendons or ligaments, and menisci by interpositional inflatable or compliant polymer arthroplasties that promote anatomic joint motion.

## Claims

### Claim 1

An implant system comprising:
(a) an implant configured for deployment between a femur and a tibia of a knee joint, the implant comprising
a first portion that is configured to directly engage a medial condyle and a lateral condyle of the femur of the knee joint,
a second portion that is configured to directly engage the tibia of the knee joint,
a first appendage configured to couple the first portion to a first condyle of the femur of the knee joint, the first appendage having a pre-set curvature configured to simulate curvature of the first condyle and at least one pre-formed hole for securing the first appendage to the first condyle,
a second appendage configured to couple the first portion to a second condyle of the femur of the knee joint, the second appendage having a pre-set curvature configured to simulate curvature of the second condyle and at least one pre-formed hole for securing the second appendage to the second condyle,
a slot between the first appendage and the second appendage,
wherein the first portion, the second portion, the first appendage, and the second appendage together comprise a single contiguous polymeric sheet,
and
(b) at least one coupler wherein the at least one coupler is accommodated by at least one pre-formed hole.

### Claim 2 (depends on 1)

The implant system of claim 1, wherein the polymeric sheet comprises a thermoplastic polyurethane polycarbonate.

### Claim 3 (depends on 1)

The implant system of claim 1, further comprising a pharmacologic agent.

### Claim 4 (depends on 3)

The implant system of claim 3, wherein the pharmacologic agent comprises growth factors, antibodies, biomolecules, biologics, chemical compounds, tissue regeneration agents, orthobiologics, analgesics, antibiotics, anticancer agents, viscolubricants or combinations thereof.

### Claim 5 (depends on 4)

The implant system of claim 4, wherein the tissue regeneration agents comprise stem cells, living chondrocytes, genes or combinations thereof.

### Claim 6

An implant system comprising:
(a) an implant configured for deployment between a femur and a patella of a knee joint, the implant comprising
a first portion that is configured to directly engage a medial condyle and a lateral condyle of the femur of the knee joint,
a second portion that is configured to directly engage the patella of the knee joint,
a first appendage configured to couple the first portion to a first condyle of the femur of the knee joint, the first appendage having a pre-set curvature configured to simulate curvature of the first condyle and at least one pre-formed hole for securing the first appendage to the first condyle,
a second appendage configured to couple the first portion to a second condyle of the femur of the knee joint, the second appendage having a pre-set curvature configured to simulate curvature of the second condyle and at least one pre-formed hole for securing the second appendage to the second condyle,
a slot between the first appendage and the second appendage,
wherein the first portion, the second portion, the first appendage, and the second appendage together comprise a single contiguous polymeric sheet,
and
(b) at least one coupler wherein the at least one coupler is accommodated by at least one pre-formed hole.

### Claim 7 (depends on 6)

The implant system of claim 6, wherein the polymeric sheet comprises thermoplastic polyurethane polycarbonate.

### Claim 8 (depends on 6)

The implant system of claim 6, further comprising a pharmacologic agent.

### Claim 9 (depends on 8)

The implant system of claim 8, wherein the pharmacologic agent comprises growth factors, antibodies, biomolecules, biologics, chemical compounds, tissue regeneration agents, orthobiologics, analgesics, antibiotics, anticancer agents, viscolubricants or combinations thereof.

### Claim 10 (depends on 9)

The implant system of claim 9, wherein the tissue regeneration agents comprise stem cells, living chondrocytes, genes or combinations thereof.

### Claim 11

An implant system comprising:
(a) an implant configured for deployment between a tibia and a patella of a knee joint, the implant comprising
a first portion that is configured to directly engage a medial condyle and a lateral condyle of the tibia of the knee joint,
a second portion that is configured to directly engage the patella of the knee joint,
a first appendage configured to couple the first portion to a first condyle of the tibia of the knee joint, the first appendage having a pre-set curvature configured to simulate curvature of the first condyle and at least one pre-formed hole for securing the first appendage to the first condyle,
a second appendage configured to couple the first portion to a second condyle of the tibia of the knee joint, the second appendage having a pre-set curvature configured to simulate curvature of the second condyle and at least one pre-formed hole for securing the second appendage to the second condyle,
a slot between the first appendage and the second appendage,
wherein the first portion, the second portion, the first appendage, and the second appendage together comprise a single contiguous polymeric sheet,
and
(b) at least one coupler wherein the at least one coupler is accommodated by at least one pre-formed hole.

### Claim 12 (depends on 11)

The implant system of claim 11, wherein the polymeric sheet comprises a thermoplastic polyurethane polycarbonate.

### Claim 13 (depends on 11)

The implant system of claim 11, further comprising a pharmacologic agent.

### Claim 14 (depends on 13)

The implant system of claim 13, wherein the pharmacologic agent comprises growth factors, antibodies, biomolecules, biologics, chemical compounds, tissue regeneration agents, orthobiologics, analgesics, antibiotics, anticancer agents, viscolubricants or combinations thereof.

### Claim 15 (depends on 14)

The implant system of claim 14, wherein the tissue regeneration agents comprise stem cells, living chondrocytes, genes or combinations thereof.
