Engineered sterile cartilage allograft implant plug with sterile, specific instrument kit(s)

Patent metadata

Field	Value
Publication number	US-2016250042-A1
Application number	US-201615048518-A
Country	US
Kind code	A1
Filing date	Feb 19, 2016
Priority date	Feb 27, 2015
Publication date	Sep 1, 2016
Grant date	—

Abstract

An apparatus and a method are provided for performing cartilage allograft implant surgeries. The apparatus comprises an allograft plug kit comprising one or more grafts configured to treat osteochondral defects in various bone joint locations in a patient's body. Each of the grafts comprises a cartilage layer coupled with a bone portion. The cartilage layer comprises a thickness selected to closely match the thickness of existing cartilage at an implant location. The bone portion comprises surface features configured to encourage the patient's bone tissue to grow into the bone portion, thereby accelerating incorporation of the graft into the patient's bone. An instrument kit comprises a multiplicity of instruments configured for implantation of the grafts into the patient's body, including at least a graft inserter, a guidewire, a reamer, and a size gauge.

First claim

What is claimed is:

1 . An apparatus for performing cartilage allograft implant surgeries, comprising:
a sterile allograft plug kit comprising one or more grafts configured to treat osteochondral defects in various bone joint locations in a patient's body, the one or more grafts each comprising a cartilage layer coupled with a bone portion; and at least one sterile instrument kit comprising a multiplicity of instruments including at least a graft inserter, a guidewire, a reamer, and a size gauge, the multiplicity of instruments being configured for implanting the one or more grafts into the patient's body.

2 . The apparatus of claim 1 , wherein the graft inserter comprises an elongate member having a distal graft retainer and a proximal applicator, the distal graft retainer comprising an opening configured to receive and hold the graft, the proximal applicator being in mechanical communication with the distal graft retainer by way of an interior channel of the elongate member whereby the proximal applicator may be used to push the graft out of the distal graft retainer and into an osteochondral bore in the patient's body.

3 . The apparatus of claim 2 , wherein the graft inserter comprises a viewport and a graft length indicator, the viewport facilitating direct observation of the graft within the distal graft retainer, the graft length indicator comprising a series of ring lines positioned adjacent to the viewport with a sequentially increasing distance from the distal graft retainer.

4 . The apparatus of claim 3 , wherein when the graft is fully received into the distal graft retainer, the position of the top of the cartilage layer relative to the graft length indicator provides a visual indication of a total length of the graft.

5 . The apparatus of claim 1 , wherein the guidewire comprises an elongate shaft having a distal pointed tip and a proximal blunt end, wherein the distal pointed tip is configured to advance through obstructive tissues and structures within bone joints, and wherein the proximal blunt end facilitates manipulation of the guidewire by hand.

6 . The apparatus of claim 5 , wherein the guidewire is comprised of a surgical stainless steel.

7 . The apparatus of claim 1 , wherein the reamer comprises a rigid elongate shaft having a distal cutting end and a proximal shank, the distal cutting end comprising a cutting edge suitable for rotatably clearing an osteochondral bore, and the proximal shank being configured to be grasped by a chuck of a surgical drill, or other equivalent rotary tool.

8 . The apparatus of claim 7 , wherein the distal cutting edge comprises a spiral cutting edge.

9 . The apparatus of claim 7 , wherein the reamer comprises a central, lengthwise hole whereby the reamer is mountable onto the guidewire so as to direct the distal cutting end to an implant location within the bone joint.

10 . The apparatus of claim 1 , wherein the size gauge comprises an elongate member having a depth indicator and a proximal handle portion, the depth indicator comprising a series of ring lines positioned on the elongate member with a sequentially increasing distance from a distal end of the size gauge, the ring lines being configured to indicate the depth of an osteochondral bore into which the distal end is inserted.

11 . The apparatus of claim 10 , wherein the depth indicator correlates with a graft length indicator of the graft inserter so as to enable a surgeon to ensure that the osteochondral bore is drilled to a depth suitable to receive the graft.

12 . The apparatus of claim 10 , wherein the elongate member comprises a central, lengthwise hole having a diameter suitable to receive the guidewire so as to direct the depth indicator to the osteochondral bore.

13 . The apparatus of claim 1 , wherein the one or more grafts comprise diameters ranging from substantially 5 millimeters (mm) to substantially 15 mm, and each of the one or more grafts comprises a length of substantially 12 mm.

14 . The apparatus of claim 1 , wherein the one or more grafts are each harvested as a one-piece component from a bone joint location in a cadaver.

15 . The apparatus of claim 14 , wherein the cartilage layer comprises a thickness which closely matches a thickness of existing cartilage at an implant location.

16 . The apparatus of claim 1 , wherein the bone portion comprises a multiplicity of surface features configured to encourage the patient's bone tissue to grow into the bone portion, thereby accelerating incorporation of the graft into the patient's bone.

17 . The apparatus of claim 16 , wherein the surface features comprise holes, dimples, or circumferentially distributed longitudinal grooves.

18 . The apparatus of claim 17 , wherein the holes comprise diameters depending upon the size of the grafts and the locations within the patient's body where the grafts are intended to be implanted.

19 . The apparatus of claim 17 , wherein the longitudinal grooves may be implemented with a variety of widths, lengths, depths and cross-sectional shapes within the bone portion.

20 . A method for an instrument kit for implanting grafts into bone joints of a patient, comprising:
configuring one or more grafts to treat osteochondral defects in various bone joint locations in the patient's body, the one or more grafts each comprising a cartilage layer coupled with a bone portion; assembling the one or more grafts into a sterile allograft plug kit, the one or more grafts having different diameters that are suitable for the various bone joint locations in the patient's body; and combining the sterile allograft plug kit with a multiplicity of instruments configured for implantation of the one or more grafts into the patient's body, the multiplicity of instruments including at least a graft inserter, a guidewire, a reamer, and a size gauge.

21 . The method of claim 20 , wherein configuring comprises forming the one or more grafts such that the diameters of the one or more grafts range from substantially 5 mm to substantially 15 mm.

Assignees

• In2Bones Usa Llc

Inventors

• Wahl Rebecca Hawkins

Classifications

• A61F2/30756

  Cartilage endoprostheses (A61F2/3603 takes precedence) · CPC title

• A61F2002/30759

  Mosaicplasty, i.e. using a plurality of individual cartilage plugs for filling a substantial cartilage defect · CPC title

• A61B17/17

  Guides {or aligning means} for drills {, mills, pins or wires} · CPC title

• A61F2002/3093

  for promoting ingrowth of bone tissue · CPC title

• A61F2/4618 Primary

  of cartilage · CPC title