# US 11,298,235 B2 · Ameliorating joint conditions including injuries and diseases

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- Number: US 11,298,235 B2
- Document ID: US11298235B2
- Status: Granted
- Kind: B2
- Application number: 16/840,132
- Filed: 2020-04-03
- Published: 2020-10-22
- Granted: 2022-04-12
- Earliest claimed: 2008-12-04
- Assignees: Subchondral Solutions, Inc.
- Applicants: Subchondral Solutions, Inc.
- Inventors: Derek Dee
- Web page: https://patentgrep.com/patent/US11298235B2

## CPC

- A61F 2/30756: {Cartilage endoprostheses (A61F2/3603 takes precedence)}
- A61B 17/562: {Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain}
- A61F 2/2846: {Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006)}
- A61F 2/30: Joints
- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- A61F 2/38: for elbows or knees
- A61F 2/3859: {Femoral components}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2/40: for shoulders
- 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]}
- A61F 2002/2825: {Femur}
- A61F 2002/2892: {Tibia}
- A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped}
- A61F 2002/30171: {rosette- or star-shaped}
- A61F 2002/30563: {having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers}
- A61F 2002/30759: {Mosaicplasty, i.e. using a plurality of individual cartilage plugs for filling a substantial cartilage defect}
- A61F 2002/30766: {Scaffolds for cartilage ingrowth and regeneration}
- A61F 2002/30784: {Plurality of holes}
- A61F 2002/30841: {Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes}
- A61F 2002/30845: {with cutting edges}
- A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2002/30932: {for retarding or preventing ingrowth of bone tissue}
- A61F 2002/3895: {unicompartimental}
- 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)

## Abstract

A method for ameliorating joint conditions and diseases and preventing bone hypertrophy can include facilitating cartilage regrowth and preventing bone overgrowth to a damaged bone at a treatment site within a body joint to promote healing. The method can include providing a device having a first section comprising a joint-ward end having an inner surface and an outer surface and fenestrations between the inner and outer surfaces. A second section can include an opposing leading end and a lateral wall extending between the joint-ward end and the leading end. The leading end can be penetrated into the bone to a depth to substantially position: 1) the joint-ward end in a cartilage zone or at a boundary/transition area; and 2) the second section in the bone. Bone overgrowth into the cartilage zone may be prevented within the body joint when the device is positioned at the treatment site.

## Claims

### Claim 1

A method of promoting healing in or adjacent to a portion of a bone layer at a treatment site within a body joint, the method comprising:
providing an implantable device having a body formed of non-resorbable material, the implantable device comprising:
an axis defining an axial direction of the device;
a first section comprising:
a joint-ward end having an inner surface and an outer surface spaced apart from one another along the axial direction of the device, the outer surface defining a convex or a concave profile, the joint-ward end further having first fenestrations extending fully through the joint-ward end in a manner that includes extending between and through the inner surface of the joint-ward end and the convex or concave profile of the outer surface of the joint-ward end; and
a second section arranged along the axial direction from the first section and comprising:
an opposing leading end; and
a lateral wall extending between the joint-ward end and the leading end, wherein the lateral wall comprises threads configured to engage the bone layer at the treatment site;
penetrating the leading end into the bone layer to a depth;
positioning the second section in the bone layer; and
positioning the joint-ward end in a position to facilitate transmission through the first fenestrations into a cartilage zone by positioning the joint-ward end at a transition area substantially between a cartilage layer in the cartilage zone and the bone layer at the treatment site such that the joint-ward end is beneath the cartilage zone or otherwise not extending entirely through the cartilage zone.

### Claim 2 (depends on 1)

The method of claim 1, wherein the device is positioned and configured to provide active or passive dampening support to the bone at the treatment site so as to dissipate and dampen shock within the bone to promote healing.

### Claim 3 (depends on 1)

The method of claim 1, wherein the lateral wall further comprises second fenestrations configured to promote osseointegration of the second section at the treatment site.

### Claim 4 (depends on 1)

The method of claim 1, wherein the joint-ward end is substantially positioned such that cartilage can grow through, around, and over the first fenestrations in the joint-ward end.

### Claim 5 (depends on 1)

The method of claim 1, wherein the cartilage is articular cartilage.

### Claim 6 (depends on 1)

The method of claim 1, wherein healing includes mitigating bone hypertrophy when the joint-ward end is positioned at the transition area so as to protect against forces applied to the body joint.

### Claim 7 (depends on 6)

The method of claim 6, wherein mitigating bone hypertrophy includes preventing trabecular thickening of cancellous bone.

### Claim 8 (depends on 1)

The method of claim 1, wherein the transition area is located substantially in a cortical bone base plate.

### Claim 9 (depends on 1)

The method of claim 1, wherein the transition area is located substantially between cancellous bone and the cartilage zone.

### Claim 10 (depends on 1)

The method of claim 1, wherein the device inhibits bone growth into the cartilage zone when the joint-ward end is positioned at the transition area.

### Claim 11 (depends on 1)

The method of claim 1, wherein the device prevents bone fracture when the joint-ward end is positioned at the transition area thus protecting against forces applied to the body joint.

### Claim 12 (depends on 1)

The method of claim 1, wherein at least one of:
the body joint is a knee; or
the treatment site includes a subchondral lesion.

### Claim 13 (depends on 1)

The method of claim 1, wherein the first fenestrations promote intracellular nutrient transmission.

### Claim 14 (depends on 1)

The method of claim 1, wherein a thickness of cartilage regrowth at the treatment site is substantially uniform after healing.

### Claim 15 (depends on 1)

The method of claim 1, wherein a thickness of cartilage regrowth at the treatment site is substantially the same as a thickness of healthy native cartilage adjacent the treatment site after healing.

### Claim 16 (depends on 1)

The method of claim 1, wherein the device is made of titanium or alloys thereof.

### Claim 17 (depends on 1)

The method of claim 1, wherein at least the outer surface of the joint-ward end is coated with hydroxyapatite.

### Claim 18 (depends on 1)

The method of claim 1, wherein the first section and the second section are reversibly attached.

### Claim 19 (depends on 1)

The method of claim 1, wherein the first section and the second section are fused together.

### Claim 20 (depends on 1)

The method of claim 1, wherein the lateral wall further comprises second fenestrations on the second section, wherein the second fenestrations are between 300 microns and 1200 microns in size.

### Claim 21 (depends on 1)

The method of claim 1, wherein the first fenestrations on the joint-ward end of the first section are between 100 microns to 800 microns in size to promote cartilage regrowth.

### Claim 22 (depends on 21)

The method of claim 21, wherein the first fenestrations on the joint-ward end of the first section are between 400 microns to 600 microns in size to promote cartilage regrowth.

### Claim 23 (depends on 1)

The method of claim 1, wherein the bone layer is a cortical bone base plate.

### Claim 24 (depends on 1)

The method of claim 1, wherein the joint-ward end is positioned at a boundary of the transition area, said boundary being located substantially between a cancellous bone and the cartilage zone.

### Claim 25 (depends on 1)

The method of claim 1, wherein the joint-ward end forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation when the joint-ward end is positioned at the treatment site.