# US 8,771,363 B2 · Resilient knee implant and methods

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- Number: US 8,771,363 B2
- Document ID: US8771363B2
- Status: Granted
- Kind: B2
- Application number: 13/574,499
- Filed: 2011-01-19
- Published: 2013-01-31
- Granted: 2014-07-08
- Earliest claimed: 2010-01-22
- Applicants: R. Thomas Grotz
- Inventors: R. Thomas Grotz
- Web page: https://patentgrep.com/patent/US8771363B2

## 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)}
- 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 2002/30583: {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 2002/3863: {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
- 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)

## Abstract

This disclosure is directed to a resilient interpositional arthroplasty implant for application into a knee joint to pad cartilage defects, cushion a joint, 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. Rather than using periosteal harvesting for cell containment in joint resurfacing, 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 to avoid extrusion or dislocation. Appendages of the implant may repair or reconstruct tendons or ligaments, and an interior of the implant that is inflatable may accommodate motions which mimic or approximate normal joint motion.

## Claims

### Claim 1

An implant configured for deployment between a femur and a tibia of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage a medial condyle and a lateral condyle of the femur of the knee joint,
a second portion that is configured to engage the tibia of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of inflatable non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to the femur of the knee joint.

### Claim 2 (depends on 1)

The implant of claim 1, comprising at least one attachment element in configured to couple with the intercondylar notch.

### Claim 3 (depends on 1)

The implant of claim 1, comprising at least one attachment element superiorly configured to couple with the distal end of the femur anteriorly.

### Claim 4 (depends on 1)

The implant of claim 1, comprising at least one posterior reign configured to cinch up the implant from inside a posterior intercondylar notch toward a connection site around the femur.

### Claim 5 (depends on 1)

The implant of claim 1, comprising at least one suture-like lanyard configured to cinch up the implant from inside a posterior intercondylar notch toward a connection site around the femur.

### Claim 6 (depends on 1)

The implant of claim 1, in which the first portion comprises a first wall, the second portion comprises a second wall, and the side portion comprises a side wall.

### Claim 7 (depends on 1)

The implant of claim 1 further comprising an inflation port in communication with the interior of the balloon for inflation of the interior of the balloon with the first inflation medium.

### Claim 8 (depends on 1)

The implant of claim 1, in which a first chamber of the plurality of individually inflatable chambers is adapted to be inflated with the first inflation medium, and a second chamber of the plurality of individually inflatable chambers is adapted to be inflated with a second inflation medium.

### Claim 9 (depends on 8)

The implant of claim 8, in which the first inflation medium imparts at least one of rigidity in the implant and cushion in the implant.

### Claim 10 (depends on 1)

The implant of claim 1, comprising a second appendage coupling the balloon to at least one of: the femur of the joint and the tibia of the joint.

### Claim 11

An implant configured for deployment between a femur and a tibia of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage at least one condyle of the femur of the knee joint,
a second portion that is configured to engage the tibia of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to the femur of the knee joint.

### Claim 12 (depends on 11)

The implant of claim 11, in which the at least one condyle is the medial condyle.

### Claim 13 (depends on 11)

The implant of claim 11, in which the at least one condyle is the lateral condyle.

### Claim 14 (depends on 11)

The implant of claim 11, wherein the balloon is at least one of: at most about 1.5 cm in diameter, at most about 1.75 cm in diameter, at most about 2 cm in diameter, at most about 2.25 cm in diameter, at most about 2.5 cm in diameter, at most about 2.75 cm in diameter, at most about 3 cm in diameter, at most about 3.25 cm in diameter, at most about 3.5 cm in diameter, at most about 3.75 cm in diameter, at most about 4 cm in diameter, at most about 4.25 cm in diameter, at most about 4.5 cm in diameter, at most about 4.75 cm in diameter, at most about 5 cm in diameter, at most about 5.25 cm in diameter, at most about 5.5 cm in diameter, at most about 5.75 cm in diameter, at most about 6 cm in diameter, at most about 6.25 cm in diameter, at most about 6.5 cm in diameter, at most about 6.75 cm in diameter, at most about 7 cm in diameter, at most about 7.25 cm in diameter, at most about 7.5 cm in diameter, at most about 7.75 cm in diameter, at most about 8 cm in diameter, at most about 3 cm in length along the longest length of the balloon, at most about 3.25 cm in length along the longest length of the balloon, at most about 3.5 cm in length along the longest length of the balloon, at most about 3.75 cm in length along the longest length of the balloon, at most about 4 cm in length along the longest length of the balloon, at most about 4.25 cm in length along the longest length of the balloon, at most about 4.5 cm in length along the longest length of the balloon, at most about 4.75 cm in length along the longest length of the balloon, at most about 5 cm in length along the longest length of the balloon, at most about 5.25 cm in length along the longest length of the balloon, at most about 5.5 cm in length along the longest length of the balloon, at most about 5.75 cm in length along the longest length of the balloon, at most about 6 cm in length along the longest length of the balloon, 6.25 cm in length along the longest length of the balloon, at most about 6.5 cm in length along the longest length of the balloon, at most about 6.75 cm in length along the longest length of the balloon, at most about 7 cm in length along the longest length of the balloon, at most about 7.25 cm in length along the longest length of the balloon, at most about 7.5 cm in length along the longest length of the balloon, at most about 7.75 cm in length along the longest length of the balloon, and at most about 8 cm in length along the longest length of the balloon.

### Claim 15 (depends on 11)

The implant of claim 11, in which the first portion comprises a first wall, the second portion comprises a second wall, and the side portion comprises a side wall.

### Claim 16 (depends on 11)

The implant of claim 11 further comprising an inflation port in communication with the interior of the balloon for inflation of the interior of the balloon with the first inflation medium.

### Claim 17 (depends on 11)

The implant of claim 11, in which a first chamber of the plurality of individually inflatable chambers is adapted to be inflated with the first inflation medium, and a second chamber of the plurality of individually inflatable chambers is adapted to be inflated with a second inflation medium.

### Claim 18 (depends on 17)

The implant of claim 17, in which the first inflation medium imparts at least one of rigidity in the implant and cushion in the implant.

### Claim 19 (depends on 11)

The implant of claim 11, comprising a second appendage coupling the balloon to at least one of: the femur of the joint and the tibia of the joint.

### Claim 20 (depends on 11)

The implant of claim 11, comprising at least one attachment element in configured to couple with the intercondylar notch.

### Claim 21 (depends on 11)

The implant of claim 11, comprising at least one attachment element superiorly at the distal end of the femur anteriorly.

### Claim 22 (depends on 11)

The implant of claim 11, comprising at least one posterior reign configured to cinch up the implant from inside a posterior intercondylar notch toward a connection site around the femur.

### Claim 23 (depends on 11)

The implant of claim 11, comprising at least one suture-like lanyard configured to cinch up the implant from inside a posterior intercondylar notch toward a connection site around the femur.

### Claim 24

An implant configured for deployment between a femur and a patella of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage at a trochlear groove of the femur of the knee joint,
a second portion that is configured to engage the patella of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to the femur of the knee joint.

### Claim 25 (depends on 1, 11)

The implant of any of claims 1, 11, and 24 comprising couplers that couple the appendage to the femur.

### Claim 26 (depends on 25)

The implant claim 25, wherein the coupler is bioabsorbable.

### Claim 27 (depends on 25)

The implant claim 25, wherein the coupler is at least one of: a screw, a washer, a suture, a suture anchor, a rivot, a staple, a staple having teeth, a stabilizer, a glue, a hook, a wire, a string, a lasso, a lanyard, a spike, and combinations thereof.

### Claim 28

An implant configured for deployment between a tibia and a patella of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage at a tibia of the knee joint,
a second portion that is configured to engage the patella of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to a femur of the knee joint.

### Claim 29 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, comprising an ingrowth matrix on at least a portion of the implant adjacent the femur.

### Claim 30 (depends on 29)

The implant of claim 29, wherein the ingrowth matrix comprises at least one of: autologous cells, allograph cells, and xenograph cells to restore an articular surface of the femur.

### Claim 31 (depends on 29)

The implant of claim 29, wherein the ingrowth matrix comprises at least one of: autologous cells, allograph cells, and xenograph cells to repair an articular surface of the femur.

### Claim 32 (depends on 29)

The implant of claim 29, wherein the ingrowth matrix comprises living chondrocytes.

### Claim 33 (depends on 32)

The implant of claim 32, wherein the implant is configured to release the chondrocytes over time.

### Claim 34 (depends on 32)

The implant of claim 32, wherein the implant comprises a bioabsorbable polymer configured to release the chondrocytes over time.

### Claim 35 (depends on 32)

The implant of claim 32, wherein the implant comprises a polymer configured to release the chondrocytes over time, wherein the polymer is not bioabsorbable.

### Claim 36 (depends on 28)

The implant of claim 28, comprising couplers that couple the appendage to the tibia.

### Claim 37 (depends on 36)

The implant claim 36, wherein the coupler is bioabsorbable.

### Claim 38 (depends on 36)

The implant claim 36, wherein the coupler is at least one of: a screw, a washer, a suture, a suture anchor, a rivot, a staple, a staple having teeth, a stabilizer, a glue, a hook, a wire, a string, a lasso, a lanyard, a spike, and combinations thereof.

### Claim 39 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, comprising a phamacologic agent.

### Claim 40 (depends on 39)

The implant of claim 39, wherein the pharmacologic agent is on a surface of the implant adjacent the femur.

### Claim 41 (depends on 39)

The implant of claim 39, wherein the pharmacologic agent is released from the implant over time.

### Claim 42 (depends on 39)

The implant of claim 39, wherein the pharmacologic agent is released from within the implant over time.

### Claim 43 (depends on 39)

The implant of claim 39, wherein the pharmacologic agent is released from within the balloon over time.

### Claim 44 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the inflation medium is compressible.

### Claim 45 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the inflation medium comprises a viscolubricant.

### Claim 46 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the inflation medium comprises an NSAID.

### Claim 47 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the inflation medium comprises chondrocytes.

### Claim 48 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein at least a portion of the implant is configured to anneal to a periphery of a cartilage defect.

### Claim 49 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein at least one of the first portion, the second portion, and the side portion of the implant comprises of vacuoles that contain at least one of a pharmacologic substance and an active agent.

### Claim 50 (depends on 49)

The implant of claim 49, wherein the vacuoles may be on a bone-engaging portion of the implant.

### Claim 51 (depends on 49)

The implant of claim 49, wherein the active agent comprises at least one of: stem cells, growth factors, antibiotics, and viscolubricants.

### Claim 52 (depends on 49)

The implant of claim 49, wherein the active agent comprises iatrigenically gene mutated cells.

### Claim 53 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant comprises bubbles comprising an active substance such as a pharmacologic substance or other active agent.

### Claim 54 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant comprises enzyme absorptive sponges that could be sucked out or evacuated at or around the time of implant delivery to the joint.

### Claim 55 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant comprises spaces filled with an active substance such as a pharmacologic substance or other active substance.

### Claim 56 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver by dissolution of the implant material.

### Claim 57 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver by release through pores of the implant.

### Claim 58 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver by fracture of a vacuole by a catalyst such as ultrasound or pressure or other fracturing catalyst.

### Claim 59 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to at least one of: pad cartilage, cushion the joint, deliver a pharmacologic substance, remove noxious enzymes, debride upon implantation, debride the joint following implantation, deliver a therapeutic substance, deliver a biologic substance, and deliver living stem cells.

### Claim 60 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver a chemotherapeutic agent to a bone or other surrounding tissues.

### Claim 61 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver an anti-infectious medication to a bone or other surrounding tissues.

### Claim 62 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to deliver at least one of an antibiotic, antifungals, and analgesics agent.

### Claim 63 (depends on 1, 11, 24)

The implant of any of claims 1, 11, 24, and 28, wherein the implant is configured to be selectively inflated to realign limbs.

### Claim 64

An implant configured for deployment between a femur and a tibia of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage at least one condyle of the femur of the knee joint,
a second portion that is configured to engage the tibia of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to the femur of the knee joint;
wherein the first portion, the second portion, and the side portion each have an interior surface, and wherein at least one interior surface comprises of a honeycomb structure.

### Claim 65 (depends on 64)

The implant of claim 64, wherein at least one of the first portion, the second portion, and the side portion of the implant comprises of vacuoles that contain at least one of a pharmacologic substance and an active agent.

### Claim 66 (depends on 65)

The implant of claim 65, wherein the vacuoles may be on a bone-engaging portion of the implant.

### Claim 67 (depends on 65)

The implant of claim 65, wherein the active agent comprises at least one of: stem cells, growth factors, antibiotics, and viscolubricants.

### Claim 68

An implant configured for deployment between a femur and a tibia of a knee joint, the implant comprising:
a balloon comprising:
a first portion that is configured to engage at least one condyle of the femur of the knee joint,
a second portion that is configured to engage the tibia of the knee joint,
a side portion connecting the first portion and the second portion, in which the side portion facilitates relative motion between the first portion and the second portion, and
an interior comprising of a plurality of non-communicating chambers configured to be selectively inflated and selectively deflated; and
a first appendage configured to couple the balloon to the femur of the knee joint;
wherein the balloon comprises of a polymer.

### Claim 69 (depends on 68)

The implant of claim 68, wherein the polymer is polycarbonate urethane.
