Cartilage and bone harvest and delivery system and methods

A system for harvesting bone material from a bone may include a rotary cutter defining a rotary cutter longitudinal axis extending between a rotary cutter proximal end and a rotary cutter distal end. The rotary cutter may have a drive shaft configured to receive input torque, and an osteochondral cutter configured to cut the tissue and receive the tissue material in response to rotation of the osteochondral cutter under pressure against the tissue. The system may further include a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation sized to closely fit over the osteochondral cutter. At least one of the bone port proximal end and the bone port distal end may be securable to the tissue. A stratiform tissue graft may be delivered through the bone port.

TECHNICAL FIELD

The present disclosure relates to systems, methods and devices for bone and cartilage harvesting and delivery. The present disclosure further relates to systems, methods and devices for the repair of osteochondral defects and bone defects.

BACKGROUND

Most surgical repairs of osteochondral lesions (i.e., bone-cartilage lesions) are performed using an antegrade approach, meaning that the approach is from the cartilage side of the bone-cartilage defect. In many cases, because of the location of the lesion, these surgical repairs cannot be performed using an arthroscopic or minimally invasive technique; instead, these surgical repairs require an open procedure, increasing morbidity and the time required to recover from the surgery.

Another limitation of current surgical techniques for osteochondral lesion repair is the use of autograft or allograft osteochondral “plugs,” in which the plug is an intact specimen of cartilage with underlying bone taken from a single anatomic site. In the case of autograft osteochondral plugs, there are limitations to the size and number of plugs available in a patient. Furthermore, there is a notable risk of morbidity at the plug harvest site, such as post-operative pain and arthritic changes at the harvest site. In the case of allograft osteochondral plugs, there is a risk of an adverse immunological response as well as a risk of disease transmission.

Using a retrograde approach to surgically repair an osteochondral lesion, where the approach is from the bone side of the cartilage-bone defect, has several advantages over an antegrade approach. One major advantage is that the retrograde approach can be performed arthroscopically. Another advantage is the opportunity to use the bone and cartilage that is removed to obtain access to the lesion as autograft material for the repair. Existing retrograde approaches are technically demanding and rarely used in clinical practice.

There is a need for a simpler, more reproduceable, more reliable surgical technique for a retrograde approach for repairs of osteochondral lesions. Additionally, there is a need for alternative osteochondral graft materials that avoid the risks and complications associated with the use of autograft or allograft osteochondral plugs.

SUMMARY

The various bone and cartilage harvesting and delivery devices, systems, and methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available bone and cartilage harvesting and delivery devices, systems, and methods. In some embodiments, the bone and cartilage harvesting and delivery devices, systems, and methods of the present disclosure may provide improved bone and cartilage harvesting and delivery methods for treating bone, cartilage and osteochondral defects.

According to some embodiments, a system for harvesting tissue material, including bone and cartilage tissue, from a body, may include a rotary cutter defining a rotary cutter longitudinal axis extending between a rotary cutter proximal end and a rotary cutter distal end. The rotary cutter may have a drive shaft configured to receive input torque, and an osteochondral cutter configured to cut tissue and receive the tissue material in response to rotation of the osteochondral cutter under pressure against the tissue. The system may further have a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation sized to closely fit over the osteochondral cutter. At least one of the bone port proximal end and the bone port distal end may be securable to a bone.

The system may further include a plurality of additional rotary cutters, each of which comprises an osteochondral cutter having an outer diameter different from an outer diameter of the rotary cutter, and a plurality of additional bone ports, each of which comprises a bone port cannulation sized to closely fit over the osteochondral cutter of one of the plurality of additional rotary cutters.

The bone port distal end may be configured to be insertable into and retained in the bone.

The system may further include a bone pin comprising a distal end insertable into the bone. The bone port proximal end may have a pin aperture sized to receive the bone pin to secure the bone port proximal end to the bone.

The system may further include a delivery tube defining a delivery tube longitudinal axis extending between a delivery tube proximal end and a delivery tube distal end. The delivery tube distal end may be securable to the bone port proximal end such that the delivery tube longitudinal axis is coaxial with the bone port longitudinal axis.

The system may further include a funnel with a funnel proximal end having a flared shape, and a funnel distal end securable to the bone port and/or the delivery tube.

The system may further include a cap securable to the bone port proximal end. The cap may have a cap port configured to allow instruments to pass through the cap port while maintaining a leak resistant seal.

The system may further include a trial with a trial shaft with a trial shaft proximal end with a handle, and a trial shaft distal end insertable into the bone port cannulation, and a trial tip and configured to approximate a topography of a cartilage or bone surface. The bone port cannulation may be sized to closely fit over the trial tip.

The system may further have a plurality of additional rotary cutters, each of which has an osteochondral cutter having an outer diameter different from an outer diameter of the osteochondral cutter, a plurality of additional trial shafts, each of which has a trial shaft distal end, and a plurality of additional bone ports, each of which has a bone port cannulation sized to closely fit over the osteochondral cutter of one of the plurality of additional rotary cutters and to closely fit over the trial shaft distal end of one of the plurality of additional trial shafts. The system may further include a plurality of additional trial tips, each of which is attachable to the trial shaft distal end.

The plurality of additional trial tips may include at least a first trial tip with a first trial tip distal surface having a first shape, a second trial tip with a second trial tip distal surface having a second shape different from the first shape, and a third trial tip with a third trial tip distal surface having a third shape different from the first shape and the second shape.

The rotary cutter, the plurality of additional rotary cutters, the bone port, and the plurality of additional bone ports may all be configured to be reusable. The trial shaft, the plurality of additional trial shafts, the trial tip, and the plurality of additional trial tips may all be configured to be single-use.

The system may further have a trial with a trial shaft with a trial shaft proximal end having a handle, and a trial shaft distal end insertable into the bone port cannulation, and a trial tip attachable to the trial shaft distal end and configured to approximate a topography of a cartilage surface. The bone port may have orientation markings. At least one of the trial shaft and the trial tip may have a trial timing mark that can be aligned with the orientation markings to orient a tissue graft at a predetermined orientation relative to a graft site in which the tissue graft is to be placed.

According to some embodiments, a system for delivering a tissue graft to a graft site in a bone may have a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation. The system may further include a trial with a trial shaft having a trial shaft proximal end comprising a handle, and a trial shaft distal end insertable into the bone port cannulation, and a trial tip configured to approximate a topography of a cartilage surface. The bone port cannulation may be sized to closely fit over the trial shaft distal end and the trial tip. At least one of the bone port proximal end and the bone port distal end may be securable to the bone.

The bone port distal end may be configured to be insertable into and retained in the bone.

The system may further include a bone pin with a distal end insertable into the bone. The bone port proximal end may have a pin aperture sized to receive the bone pin to secure the bone port proximal end to the bone.

The system may further include a delivery tube defining a delivery tube longitudinal axis extending between a delivery tube proximal end and a delivery tube distal end. The delivery tube distal end may be securable to the bone port proximal end such that the delivery tube longitudinal axis is coaxial with the bone port longitudinal axis.

The system may further include a plurality of additional trial tips including a first trial tip with a first trial tip distal surface oriented at a first angle, a second trial tip with a second trial tip distal surface oriented at a second angle different from the first angle, and a third trial tip with a third trial tip distal surface oriented at a third angle different from the first angle and the second angle.

The bone port may have orientation markings. At least one of the trial shaft and the trial tip may have a trial timing mark that can be aligned with the orientation markings to orient the tissue graft at a predetermined orientation relative to a graft site in which the tissue graft is to be placed.

According to some embodiments, a system for preparing a tissue graft for insertion in a bone may include a delivery tube defining a delivery tube proximal end and a delivery tube distal end, a tamp with a tamp distal end insertable into the delivery tube proximal end, a base securable to the delivery tube distal end, and a plurality of trial tips, each of which is attachable to at least one of the base and the delivery tube distal end. The delivery tube may be sized to fit closely over the tamp distal end and each trial tip of the plurality of trial tips. The plurality of trial tips may include at least a first trial tip with a first trial tip distal surface having a first shape, a second trial tip with a second trial tip distal surface having a second shape different from the first shape, and a third trial tip with a third trial tip distal surface having a third shape different from the first shape and the second shape.

Each of the plurality of trial tips may be attachable to the base, and the base may be attachable to the delivery tube distal end.

The system may further include a bone port defining a bone port longitudinal axis o extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation sized to closely fit around the tissue graft. At least one of the bone port proximal end and the bone port distal end may be securable to the bone. The delivery tube distal end may be securable to the bone port proximal end.

The bone port may have orientation markings. The delivery tube may have a trial timing mark that can be aligned with the orientation markings to orient the tissue graft at a predetermined orientation relative to a graft site in which the tissue graft is to be placed.

According to some embodiments, a system for harvesting tissue material from a body, preparing a tissue graft, and delivering the tissue graft to a graft site, may include a first rotary cutter defining a rotary cutter longitudinal axis extending between a rotary cutter proximal end and a rotary cutter distal end. The first rotary cutter may have a drive shaft configured to receive input torque, and an osteochondral cutter configured to cut tissue and receive the tissue material in response to rotation of the osteochondral cutter under pressure against the tissue. The system may further include a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end, the bone port comprising a bone port cannulation, a delivery tube defining a delivery tube proximal end and a delivery tube distal end, a base securable to the delivery tube distal end, and a trial. The trial may include a trial shaft with a trial shaft proximal end with a handle, and a trial shaft distal end. The trial may further include a trial tip attachable to the trial shaft distal end, and a plurality of additional trial tips, each of which is attachable to the base and to the trial shaft distal end. At least one of the bone port proximal end and the bone port distal end may be securable to a bone. The bone port cannulation may be sized to closely fit over the trial tip and the osteochondral cutter. The delivery tube may be sized to fit closely over the trial shaft distal end and each trial tip of the plurality of additional trial tips. The plurality of additional trial tips may include at least a first trial tip with a first trial tip distal surface having a first shape, a second trial tip with a second trial tip distal surface having a second shape different from the first shape, and a third trial tip with a third trial tip distal surface having a third shape different from the first shape and the second shape.

According to some embodiments, a method of treating an osteochondral defect may include determining a local cartilage topography or a local subchondral bone topography surrounding a perimeter of an osteochondral defect, wherein the perimeter is circumscribed by a tunnel with a retrograde approach through a bone and through the osteochondral defect, and delivering a stratiform osteochondral graft, including a bone graft material and a tissue graft material, to the perimeter through the tunnel using the retrograde approach such that a surface of the tissue graft material closely matches the local cartilage topography or the local subchondral bone topography.

The bone graft material may be selected from the group consisting of autograft bone, allograft bone, xenograft bone, demineralized bone matrix, bone graft substitutes, extracellular matrix, bone cells, growth factors, blood derivatives, bone marrow aspirate, synthetic bone, and combinations thereof.

The tissue graft material may be selected from the group consisting of autograft cartilage, allograft cartilage, xenograft cartilage, extracellular matrix, tissue scaffolds, cartilage cells, cell sheets, biological glues, growth factors, blood derivatives, bone marrow aspirate, synthetic cartilage, and combinations thereof.

The method may further include, prior to delivering the stratiform osteochondral graft to the perimeter, fabricating the stratiform osteochondral graft by shaping the stratiform osteochondral graft such that, with the stratiform osteochondral graft in the tunnel, the surface is positionable to match the local cartilage topography or the local subchondral bone topography.

Fabricating the stratiform osteochondral graft may further include shaping the bone graft material such that a surface of the bone graft material closely matches the local cartilage topography or the local subchondral bone topography.

Determining the local cartilage topography or the local subchondral bone topography may include inserting a trial into the tunnel, the trial having a distal surface, advancing the trial through the tunnel until the distal surface aligns with the local cartilage topography or the local subchondral bone topography, and confirming that the distal surface is shaped to match the local cartilage topography or the local subchondral bone topography.

Determining the local subchondral bone topography may include inserting a trial into the tunnel, the trial having a distal edge around the distal surface, advancing the trial through the tunnel until the distal edge of the distal surface aligns with the circumferential edge of the subchondral bone, which is in intimate contact with the circumferential edge of the cartilage, and confirming that the distal edge is shaped to match the local subchondral bone topography.

The trial may have a trial shaft and a trial tip with the distal surface. The method may further include, prior to inserting the trial into the tunnel, selecting the trial tip from a plurality of trial tips that are matable with the trial shaft. The plurality of trial tips may include a plurality of distal surfaces of different shapes and/or orientations. The method may further include mating the trial tip to the trial shaft.

Fabricating the stratiform osteochondral graft may include shaping the tissue graft material to match the distal surface of the trial.

Fabricating the stratiform osteochondral graft may include compressing the bone graft material and/or the tissue graft material in a delivery tube. Delivering the stratiform osteochondral graft to the perimeter may include connecting the delivery tube, containing the stratiform osteochondral graft, to the tunnel, and moving the stratiform osteochondral graft out of the delivery tube and into the tunnel.

The method may further include attaching a bone port proximal end and/or a bone port distal end of a bone port to the bone. Delivering the stratiform osteochondral graft to the perimeter may include inserting the stratiform osteochondral graft through the bone port.

According to some embodiments, a method of fabricating a stratiform osteochondral graft to treat an osteochondral defect may include determining a local cartilage topography or a local subchondral bone topography surrounding a perimeter of the osteochondral defect, shaping a bone graft material, positioning a tissue graft material adjacent to the bone graft material, and causing a surface of the tissue graft material to match the local cartilage topography or the local subchondral bone topography.

The bone graft material may be selected from a group consisting of autograft bone, allograft bone, xenograft bone, demineralized bone matrix, bone graft substitutes, extracellular matrix, bone cells, growth factors, blood derivatives, bone marrow aspirate, synthetic bone, and combinations thereof.

The tissue graft material may be selected from a group consisting of autograft cartilage, allograft cartilage, xenograft cartilage, extracellular matrix, tissue scaffolds, cartilage cells, cell sheets, biological glues, growth factors, blood derivatives, bone marrow aspirate, synthetic cartilage, or combinations thereof.

Shaping the bone graft material may include causing a surface of the bone graft material to match the local cartilage topography or the local subchondral bone topography.

Shaping the bone graft material may include compressing the bone graft material with a first compression force. Causing the surface of the tissue graft material to match the local cartilage topography or the local subchondral bone topography may include compressing the tissue graft material with second compression force. The first compression force may be higher than the second compression force.

Causing the surface of the tissue graft material to match the local cartilage topography or the local subchondral bone topography may include causing a bone graft material surface of the bone graft material to match the local subchondral bone topography, and causing a tissue graft material surface of the tissue graft material to match the local cartilage topography.

According to some embodiments, a method of delivering a stratiform osteochondral graft to a bone tunnel in a bone may include attaching a bone port proximal end and/or a bone port distal end of a bone port to the bone, attaching a delivery tube distal end of a delivery tube to the bone port proximal end, the delivery tube containing a stratiform osteochondral graft, and delivering the stratiform osteochondral graft to the bone tunnel from the delivery tube through the bone port.

The method may further include, after delivering the stratiform osteochondral graft to the bone tunnel, moving the stratiform osteochondral graft through the bone tunnel such that a surface of the stratiform osteochondral graft matches a local cartilage topography or a local subchondral bone topography surrounding an internal opening of the bone tunnel.

The method may further include, prior to delivering the stratiform osteochondral graft to the bone tunnel, fabricating the stratiform osteochondral graft by shaping the stratiform osteochondral graft such that, with the stratiform osteochondral graft in the bone tunnel, the surface is positionable to match the local cartilage topography or the local subchondral bone topography.

The stratiform osteochondral graft may further include of a bone graft material and a tissue graft material.

The bone graft material may be selected from a group consisting of autograft bone, allograft bone, xenograft bone, demineralized bone matrix, bone graft substitutes, extracellular matrix, bone cells, growth factors, blood derivatives, bone marrow aspirate, synthetic bone, and combinations thereof.

The tissue graft material may be selected from a group consisting of autograft cartilage, allograft cartilage, xenograft cartilage, extracellular matrix, tissue scaffolds, cartilage cells, cell sheets, biological glues, growth factors, blood derivatives, bone marrow aspirate, synthetic cartilage, or combinations thereof.

These and other features and advantages of the present disclosure will become more fully apparent from the following description and appended claims or may be learned by the practice of the devices, systems, and methods set forth hereinafter.

It is to be understood that the drawings are for purposes of illustrating the concepts of the present disclosure and may not be drawn to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure.

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings, could be arranged, and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the implants, systems, and methods, as represented in the drawings, is not intended to limit the scope of the present disclosure, but is merely representative of exemplary embodiments of the present disclosure.

The following examples have been included to provide guidance to one of ordinary skill in the art for practicing representative embodiments of the presently disclosed subject matter. In light of the present disclosure and the general level of skill in the art, those of skill in the art can appreciate that the following examples are intended to be exemplary only and that numerous changes, modifications, and alterations can be employed without departing from the scope of the presently disclosed subject matter.

For purposes of interpreting this specification, the following definitions will apply. If any definition set forth below conflicts with any document incorporated herein by reference, the definition set forth below shall control.

Bone and cartilage, collectively, are referred to as tissue herein. Bone-cartilage defect, osteochondral defect and osteochondral lesion are synonymous, and generally referred to herein as a lesion. Bone marrow edema, focal osteolysis and a bone cyst are generally referred to herein as a bone defect. Proximal means closer to a user, distal means farther away from a user. For example, the handle of a screwdriver is on a proximal end, and the drive tip of a screwdriver is on a distal end.

FIG.1is a perspective view of a reusable kit of instruments, or system100, for tissue harvesting and delivery. The system100may include a guidewire110, a plurality of trephines120, a plurality of bone ports130, a plurality of tamps140, and a plurality of obturators150. The trephines120, bone ports130, tamps140, and obturators150are each shown in 5 sizes, ranging from 6 mm to 14 mm in 2 mm increments, where the size is the size of the tissue tunnel to be formed by the selected subset of the system100. Other sizes and other increments are possible, for example, ranging from 4 mm to 20 mm in 1 mm increments.

FIG.2is an exploded view of a subset200of the instruments of the system100ofFIG.1for a select tissue tunnel size that have shared interconnection features. The subset200includes the guidewire110, a trephine220, a bone port230, a tamp240, and an obturator250. The select tunnel size in this case is 10 mm, or the middle size in the range of sizes in the system100ofFIG.1.

The guidewire110may be a surgical guide wire of any known type, such as a K-wire or Steinmann Pin. The guidewire110may have a guidewire outer diameter112.

The trephine220may have a trephine proximal end222, a trephine distal end224, a trephine longitudinal axis225extending between the trephine proximal end222and the trephine distal end224, a drive shaft226located near the trephine proximal end222, and a drive shaft cannulation227extending along the trephine longitudinal axis225. The guidewire outer diameter112may be sized to closely fit inside the drive shaft cannulation227, optionally with some clearance so that the trephine220can slide along the guidewire110. Approaching the trephine distal end224, the trephine220may have an osteochondral cutter228terminating in a set of teeth229configured to cut tissue as the trephine220is rotated and pressed against tissue, forming a tunnel. The osteochondral cutter228may have a trephine outer diameter223.

The trephine220is just one of many different types of rotary cutters that may be used to cut tissue according to the present disclosure. In alternative embodiments, different rotary cutters, such as drills, reamers, and/or augers, may be used in addition to or in place of the trephine220. The term “rotary cutter” encompasses all of these alternatives in addition to a trephine.

The bone port230may have a bone port proximal end232, a bone port distal end234, a bone port longitudinal axis235extending between the bone port proximal end232and bone port distal end234, and a bone port cannulation237. The bone port cannulation237may have a bone port inner diameter233sized to closely fit over the outer diameter of the osteochondral cutter228so that the bone port longitudinal axis235and the trephine longitudinal axis225are coaxial when the bone port230and the trephine220are engaged. Further, the bone port230may have a pin aperture238and a series of orientation markings239proximate the bone port proximal end232. Teeth231on the bone port distal end234may help anchor the bone port230to bone when tapped or drilled into place.

The tamp240may have a tamp proximal end242, tamp distal end244, and a tamp outer diameter246. The tamp proximal end242may have a handle247that is designed to be pressed by hand and/or impacted with a mallet or other instrument to compress graft material at the tamp distal end244. A series of depth markings, such as circumferential grooves249, may be arranged along the length of the proximal portion of the tamp240, and may help the user gauge the motion travelled by the tamp240in the course of compacting tissue material, and thence, the degree of compaction applied by the tamp240to the tissue material. Additionally, the tamp distal end244may be used to move graft material from one position to another.

The obturator250may have an obturator proximal end252, an obturator distal end254, and an obturator outer diameter256, which may be substantially equal to the trephine outer diameter223, the bone port inner diameter233, and the tamp outer diameter246. The obturator distal end254may be tapered to facilitate insertion of the obturator250into an opening tissue, such as a pre-existing bone tunnel, in order to widen and/or prepare the opening for further steps.

The guidewire110, the trephine220, the bone port230, the tamp240, and/or the obturator250may be designed for reuse. Thus, these components may be formed of durable and readily sterilizable, and re-sterilizable, materials, such as stainless steel, or any other material known for use in the manufacture of surgical instruments. In alternative embodiments, one or more of these components may be designed for single use, and may thus be formed of less durable materials, such as plastics, if desired. In the present embodiment, the components of the system100may be designed for use with a system300of single use components. The system100and the system300may combine to define a system with reusable components (from the system100) and disposable components (from the system300). In some embodiments, the components of the system100may be sterilized and provided in a reusable assembly such as a re-sterilizable instrument tray. The components of the system300may also be sterilized, but may be provided in disposable, single-use packaging, such as one or more sealed plastic packages. The components of the system300may be formed of less expensive less durable materials, such as plastic materials, if desired. Alternatively, some or all of the components of the system300may be formed of durable re-sterilizable materials and added to the reusable instrument tray and/or provided separately.

FIG.3is a perspective view of the system300, which may be a single use kit of instruments that complements the system100shown inFIG.1to facilitate a surgical procedure for the select tissue tunnel size of 10 mm. Separate systems may be provided for each size tissue tunnel that is desired for treatment. For example, in addition to the system300, additional systems (not shown) may be provided along with the system100to facilitate treatment using 6 mm, 8 mm, 12 mm, and 14 mm tissue tunnels. The system300may include a fixation pin310, a plurality of trial tips320, a base330, a cap340, a delivery tube350, a funnel360, and a trial shaft370.

Like the guidewire110, the fixation pin310may be any type of bone pin known in the art. For example, the fixation pin310may be a k-wire or the like. The fixation pin310may be sized to slide into the pin aperture238of the bone port230, and may fit sufficiently tightly within the pin aperture238such that the bone port230is maintained at a constant relative orientation by engagement of the pin aperture238with the guidewire310.

Each of the trial tips320may have a trial tip proximal end322, a trial tip distal end324, and a trial tip outer diameter326. Each of the trial tips320may further have an attachment feature, such as a slot327, that facilitates attachment to the base330and/or the trial shaft370. Thus, each of the trial tips320may be interchangeably attachable to the same male attachment feature.

Each trial tip distal end324may be planar, but the orientation of the trial tip distal end324may vary among the trial tips320. The orientation of the trial tip distal end324may range, among the trial tips,320, from 0° to 50°, measured as the offset from a plane perpendicular to the axis extending from the trial tip proximal end322to the trial tip distal end324. Each of the trial tips320may have an angle indicator329that indicates the orientation of the trial tip distal end324.

In alternative embodiments, different increments may be used; such increments may be greater than or smaller than 5° (for example, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 12.5°, 15°, 20°, 22.5°, or)25°. Further, the orientation of the trial tip distal end324need not have a maximum of 50°; a smaller or greater maximum orientation may be used (for example, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, or)80°. In some embodiments, where it is desired to approach an osteochondral defect from an orientation nearly parallel to the cartilage surface, the maximum orientation may approach 90°.

In alternative embodiments, the trial tip distal end324of the trial tips320may have any range of unique shapes, including concave, convex, or even more complex shapes. Additionally or alternatively, the trial tip distal end324of each of the trial tips320may be shaped to match a specific cartilage topography for a specific osteochondral defect for a specific patient. For trial tip distal ends that are not planar, two trial tips with complementary shapes (not shown) may be used for a specific osteochondral defect. The first trial tip may directly correspond to a cartilage surface when it is used as a trial as shown inFIG.8AandFIG.8B, and the second trial tip may correspond to the negative (i.e., a Boolean subtraction) of the cartilage surface when it is used to compact bone graft material and cartilage graft material as shown inFIG.10BandFIG.11.

The base330may have a body332, a plateau334, and an attachment feature configured to mate with the slot327of the trial tips320, such as a slider337. The body332may have an enlarged shape that can be readily grasped by a user and/or placed on a flat surface during use. The plateau334may have a width similar in size to that of the delivery tube350. The plateau334and/or the slider337may optionally be incorporated into an insert, separate from the body332, that can be assembled with the body332(for example, via insertion of the insert into a hole in the body332) to provide the assembled configuration shown inFIG.3.

The cap340may be sized to fit over the bone port proximal end232and/or the delivery tube proximal end352. Thus, the cap340may have a bore344with an interior diameter (not shown) that is close to the outer diameter of the bone port proximal end232and the delivery tube proximal end352. The cap340may further have a cap port346that provides a leak resistant seal. The cap port346may be flexible and self-closing, so that instruments can be passed through the cap port346and still maintain a leak resistant seal. The cap340may be formed of a resilient, flexible material, such as rubber, to help provide a seal between the cap340and the bone port proximal end232and/or the delivery tube proximal end352, and the seal provided by the cap port346.

The delivery tube350may have a delivery tube proximal end352, a delivery tube distal end354, and a delivery tube longitudinal axis355extending between the delivery tube proximal end352and delivery tube distal end354. The delivery tube distal end354may be sized to closely fit into the bone port proximal end232so that the delivery tube longitudinal axis355and the bone port longitudinal axis235are coaxial when the delivery tube350and the bone port230are coupled together.

The funnel360may have a funnel proximal end362, a funnel distal end364, a funnel longitudinal axis365extending between the funnel proximal end362and funnel distal end364. The funnel distal end364may be sized to closely fit into the bone port proximal end232and/or the delivery tube proximal end352and/or delivery tube distal end354, so that the funnel longitudinal axis365is coaxial with the bone port longitudinal axis235or the delivery tube longitudinal axis355, respectively. The funnel proximal end362may have a flared shape configured to facilitate insertion of graft material and instruments into the funnel360, and thence into the bone port230and/or delivery tube350.

The trial shaft370may have a trial shaft proximal end372, a trial shaft distal end374, and a trial shaft outer diameter376, which may be substantially equal to the trephine outer diameter223, the bone port inner diameter233, and the tamp outer diameter246. The trial shaft distal end374may have an attachment feature, such as a slider377, that is designed to mate with the slot327of each of the trial tips320. The slider377may have an enlarged tip and the slot327may have a complementary shape so that, when coupled to each other, each of the trial tips320cannot be pulled distally away from the trial shaft370. The trial shaft370may further have a handle378at the trial shaft proximal end372, and a series of depth markings379between the trial shaft proximal end372and the trial shaft distal end374.

The assembled trial shaft370and one of the trial tips320are referred to as a trial, which may have an outer diameter substantially equal to the tamp outer diameter246. To accommodate the select tunnel size of 10 mm, the trephine outer diameter223of the osteochondral cutter228, the inner diameter of the bone port cannulation237, the tamp outer diameter246, and the trephine outer diameter223may all be nominally 10 mm in size. Those of skill in the art will recognize that some variation from the nominal size may be desirable; for example, the inner diameter of the bone port cannulation237may be slightly larger than the trephine outer diameter223, the trial tip outer diameter326, and the trial shaft outer diameter376so that the trephine220, each of the trial tips320, and/or the trial shaft370may be inserted and relatively freely slide into the bone port cannulation237of the bone port230.

While the mating connections between bone port230, delivery tube350, funnel360, and cap340are shown with specific male and female arrangements, in alternative embodiments (not shown), the connections can be easily reversed and still preserve the coaxial relationship between respective longitudinal axes required to ensure proper function. Further, many different mating and non-mating connections may be used, including but not limited to clips, claps, mechanical fasteners, bayonet fittings, and/or the like.

The system100and/or the system300may be used to help repair osteochondral defects in bone. In some embodiments, this may be accomplished by (1) harvesting tissue, (2) preparing the harvested tissue, and (3) placing the prepared tissue at the defect site. Notably, this approach assumes that the tissue is natural (i.e., autograft, allograft, or even xenograft). However, the system100and/or the system300may also be used with synthetic graft or bone graft substitutes; in such cases, (1) and/or (2) above may not be needed.

In some embodiments, the process of harvesting the tissue may be formed as part of the process of removing the osteochondral defect and/or preparing the defect site for repair. Healthy tissue at or around the repair site may be removed, prepared, and inserted back into the repair site, optionally with additional natural or synthetic tissue.FIGS.4through8illustrate the process of harvesting tissue and preparing a defect site for repair (i.e., step (1) in the preceding paragraph) according to one embodiment.

FIG.4is a perspective view from a lateral viewpoint of a proximal tibia400with the guidewire110placed into the proximal tibia400and into the central aspect of an osteochondral lesion410from a retrograde approach (i.e., through the tissue beneath the osteochondral lesion410). The placement of the guidewire110into the bone and cartilage can be accomplished using a powered pin driver (not shown), and the guidewire110can be placed manually or using a targeting drill guide (not shown) known in the art. Fluoroscopy and/or other medical imaging may be used to guide placement of the guidewire110. In some embodiments, direction visualization (for example, via arthroscopic cameras inserted into the knee joint) may be used to guide and/or confirm placement of the guidewire110.

The proximal tibia400is used in the figures is for illustrative purposes. The systems and methods of the present disclosure may be used to treat any bone and/or cartilage location in the body. Cartilage is found in all the articular joints of the body. In the example ofFIG.4, the osteochondral lesion410is located in the knee joint. Other articular joints in the body that may be treated with the systems and methods presented herein include, but are not limited to: a metatarsal-phalangeal joint, a metatarsal-tarsal joint, a tarsal-tarsal joint, a subtalar joint, a calcaneal-tarsal joint, an ankle joint, a hip joint, a metacarpal-phalangeal joint, a metacarpal-carpal joint, a carpal-carpal joint, a wrist joint, an elbow joint, a shoulder joint, and spine facet joint.

FIG.5Ais a perspective view from a lateral viewpoint of the proximal tibia400shown in partial cross section and the trephine220placed and slid over the guidewire110and into the proximal tibia400and through the osteochondral lesion410from a retrograde approach, forming a tissue tunnel500underneath the repair site. The drive shaft cannulation227may fit closely over the guidewire110such that the trephine220tracks precisely to the osteochondral lesion410. In an alternative embodiment, a cannulated drill or other cannulated cutter known in the art (not shown) may be used in place of or in addition to the trephine220to form the tissue tunnel500. The tissue tunnel500may extend sufficiently far to include the osteochondral lesion410. In this application, the term “tissue tunnel” is intended to cover tunnels through various types of tissue, including but not limited to tunnels through bone, cartilage, and combinations of bone and cartilage.

In this example, the tissue tunnel500may be approximately 10 mm in size because the trephine outer diameter223of the osteochondral cutter228may be about 10 mm. Any of the trephines120ofFIG.1may be used to provide a tissue tunnel of the appropriate size for a particular joint and/or a particular osteochondral defect.

FIG.5Bis a perspective view from a lateral viewpoint of the proximal tibia400shown in partial cross section and an obturator250placed over the guidewire110and a bone port230placed over the obturator250and into the proximal tibia400. The obturator250may be used to facilitate placement of the bone port230such that the bone port cannulation237is coaxial with the tissue tunnel500(not shown).

FIG.6is the view ofFIG.5Awith the bone port230placed and slid over the trephine220and secured to the proximal tibia400.FIG.6is also the view ofFIG.5Bwith bone port230used to guide the trephine220into the formation of tissue tunnel500. The bone port inner diameter233may closely fit over the trephine outer diameter223to ensure that the bone port longitudinal axis235and the trephine longitudinal axis225are coaxial, irrespective of which is placed first. The teeth231on the bone port distal end234may be serrated and may allow the bone port distal end234to be inserted along the bone port longitudinal axis235into the bone, thereby securing the bone port230to the bone. Alternatively, or in combination with securing of the bone port distal end234to the bone, the bone port230can be secured to bone adjacent to the bone port proximal end232. For example, the pin aperture238may receive the fixation pin310to secure the bone port230to the bone.

Notably, the bone port230need not necessarily be used to dilate or retract tissue; rather, these steps may be performed with other instruments, such as the obturator250, prior to application of the trephine220. The trephine220may guide placement of the bone port230as the bone port230may be slid into position over the trephine220, or the bone port230may guide placement of the trephine220. Formation of the tissue tunnel500with the trephine220prior to attachment of the bone port230may facilitate and/or enable the bone port230to be used for other functions besides guiding the trephine220. For example, the bone port230may maintain retraction of the surrounding soft tissue such as muscle, fat and skin (not shown). This may be advantageous for subsequent operative steps, such as visualizing the interior of the tissue tunnel500with an endoscope (not shown), removing additional tissue from the interior of the tissue tunnel500, accessing an intra-articular space, and/or delivering bone graft materials and/or cartilage graft materials to the repair site through the tissue tunnel500.

FIG.7is the view ofFIG.6with the trephine220removed. With the trephine220removed, a user may attach the cap340to the bone port proximal end232to form a leak resistant seal to facilitate the performance of an arthroscopic procedure in the knee joint space. The cap port346may provide another leak resistant seal when instruments are passed through the cap port346. For example, the user can insert an endoscope (not shown) through the cap port346and into the tissue tunnel500to allow for direct visualization of the cartilage layer and underlying bone to ensure that all the damaged/diseased cartilage and/or bone associated with the osteochondral lesion410have been removed. If damaged/diseased cartilage and/or bone remain, then the user can pass a curette or other cutting instrument (not shown) to excavate the remaining damaged/diseased tissue.

Loose tissue may be removed from the tissue tunnel500. Much of the loose tissue may come out of the tissue tunnel500with the removal of trephine220. Additional instruments, suction, and/or the like may be used to remove any remaining pieces of bone or cartilage from the tissue tunnel500.

FIG.8Ais a perspective view from a lateral viewpoint of the proximal tibia400shown in partial cross section, with the trial shaft370and a trial tip800, attached to the trial shaft370, placed through the bone port230. The trial tip800may be one of the trial tips320, angled at 45° . As shown, the trial tip800may be positioned and oriented such that the trial tip distal end324is positioned to match the surface topography of the surrounding cartilage and/or bone around the repair site. The trial shaft outer diameter376may be approximately 10 mm to provide for a close sliding fit inside the bone port inner diameter233. The trial shaft370with an attached trial tip such as the trial tip800is also referred to herein as a “trial.”

The trial tip800shown inFIG.8has a surface810on the trial tip distal end324that is a plane at a 45-degree angle to the bone port longitudinal axis235. Users can select from a plurality of trial tips (for example, from the trial tips320ofFIG.3) to find the trial tip with a trial tip distal end that is most conformal to the topography of the surrounding cartilage and/or bone. Some trial and error may be needed. In addition to the depth markings379, the trial shaft370and/or the trial tip800have one or more trial timing marks820that are used to indicate the circumferential orientation of the trial relative to the bone port230as measured against the one or more circumferential timing marks, such as the orientation markings239of the bone port230. As shown inFIG.8, the circumferential orientation is approximately55degrees.

The depth markings379of the trial shaft370may be measured against the bone port o proximal end232to indicate the depth that the trial tip800extends beyond the entry hole into the tissue tunnel500, thus allowing measurement of the length of the tissue tunnel500when the trial tip distal end324is flush with the surrounding cartilage surface. As shown inFIG.8A, the length of the tissue tunnel500is approximately 35 mm. The circumferential orientation and the length may be noted by the user in preparation for future steps.

FIG.8Bis a perspective view from a lateral viewpoint of the proximal tibia400shown in partial cross section and a trial shaft370with an attached angled trial tip800placed through a bone port230and with the trial tip distal end324positioned to match the surface topography of the surrounding cartilage and/or bone. An optional orientation storage feature may be coupled to the bone port proximal end232and used to record the orientation of the trial tip800when aligned with the surrounding cartilage.

More precisely, the orientation storage feature may include a dial850with a generally annular shape that can be rotatably coupled to the bone port proximal end232. The dial850may have a pointer852that can be aligned, via rotation of the dial850on the bone port230, with the trial timing mark820of the trial shaft370. When the trial shaft370and the trial tip800are removed from the bone port230, the dial850may remain in place to facilitate alignment of the bone graft with the surrounding cartilage, in a manner that matches the alignment of the trial tip800with the surrounding cartilage.

The dial850is an optional feature. It may be used in place of, or in addition to, the orientation markings239of the bone port230. In some embodiments, the dial850may be aligned with the trial timing mark820as described above, and then partially removed so that the user can see which of the orientation markings239is aligned with the pointer852. This orientation may then be recorded for future use without requiring further use of the dial850.

After performance of the steps illustrated inFIG.8Aand/orFIG.8B, removal of the damaged and/or diseased tissue from the proximal tibia400may be complete. All information needed to prepare the replacement tissue may have been obtained. Thus, the user may proceed to prepare the replacement tissue, as will be shown and described in connection withFIGS.9A through11. Advantageously, the bone port230may remain attached to the tissue tunnel500during preparation of the replacement tissue to facilitate the subsequent insertion of the replacement tissue into the graft site.

FIG.9Ais a perspective view showing the base330(with assembled insert, if applicable) next to the trial tip800connected to the trial shaft370. The base330may releasably attach to the trial tip proximal end322such that the trial tip distal end324faces away from the base330. The base330may also releasably attach to the delivery tube distal end354, for example, at or around the plateau334. The base330may have a base timing mark900that aligns with the trial timing mark820on the trial tip800when the trial tip800is assembled to the base330.

FIG.9Bis the view ofFIG.9Ashowing the transfer of the trial tip800from the trial shaft370to the base330. The trial tip800may releasably connect to each of the trial shaft370and the base330by sliding the trial tip800in from the side of the trial shaft370and base330, respectively, such that the slot327receives the slider377of the trial shaft370or the slider337of the base330. However, any other releasable connection feature that resists dislodgement during use may be substituted for the slot327, the slider377, and the slider337.

FIG.10Ais a perspective view showing the delivery tube350attached to the base330with the tamp240positioned in the delivery tube350. The delivery tube350has a delivery tube timing mark1000and a delivery tube depth scale1010. The delivery tube depth scale1010and/or the circumferential grooves249can be referenced to create a graft having the same length as the previously measured length of the tissue tunnel500. When assembled to the base330, the delivery tube timing mark1000and the trial timing mark820may be aligned with the base timing mark900. If desired, one of the circumferential grooves249may be replaced with a reference line1030to show a preferred depth of insertion of the tamp240.

FIG.10Bis a close-up view ofFIG.10Awith the delivery tube350cut away to show bone graft material compacted proximally by a tamp240and distally by the trial tip800used to simulate repair of the osteochondral lesion410inFIG.8to form a formed end on the compacted bone graft1020corresponding to the trial tip distal end324of the trial tip800. High forces, typically generated by strikes from a surgical mallet, may be applied (for example, to the handle247of the tamp240) to fully compact the bone graft material to form the compacted bone graft1020.

FIG.11is a perspective view in partial cross-section of the trial shaft370and the delivery tube350, showing cartilage graft material1100compacted into the delivery tube distal end354distally by the trial tip800with trial shaft370attached, thereby fabricating a stratiform osteochondral graft1110with a formed end1120, having the cartilage graft material1100, that corresponds to the shape of the trial tip distal end324of the trial tip800. Alternatively, trial tip800could be attached to base330(ofFIGS.9A through10B) to shape cartilage graft material1100. The trial timing mark820and the delivery tube timing mark1000may be maintained in alignment during the compaction process. The delivery tube timing mark1000and/or the depth markings379of the trial shaft370may again be used to ensure that the stratiform osteochondral graft1110has the appropriate length to match the length of the tissue tunnel500.

Compaction may be performed under light force, typically generated by hand pressure, to avoid compromising the biological viability of the cartilage graft material1100. The method of compacting the bone graft material under high force (described above in connection withFIGS.10A and10B) as a distinct and separate step from compacting the cartilage graft material under low force is advantageous for fabricating the stratiform osteochondral graft1110that has sound structural properties and cohesiveness while preserving the biological viability of the more delicate biological components of the cartilage graft material1100.

It is advantageous to fabricate a stratiform osteochondral graft1110from constituent graft materials for several reason. First, the use autograft or allograft osteochondral plugs can be avoided when desired. The former has risk of harvest site morbidity, and the latter has risk of availability, immunological reactions, and disease transmission. Furthermore, the stratiform osteochondral graft1110can be created layer by layer, allowing the selection of the graft material that has the highest potential to remodel and heal into the same tissue constituency and structure as normal osteochondral tissue. For example, normal osteochondral tissue presents with the following distinct biological zones: 1) a cartilage surface layer, where elongate cartilage cells are arranged with their long axes parallel to the surface, 2) a cartilage transition layer, 3) a cartilage deep layer, where elongate cartilage cells are arranged with their long axes perpendicular to the surface, 4) a demarcation layer called the tidemark, 5) a calcified cartilage layer, and 6) a subchondral bone layer. Optimal graft materials can be selected to optimally reproduce the biological constituency and structure of each of these biological layers. A list of graft materials for cartilage and bone is provided below.

The bone graft material may be selected from a group consisting of autograft bone, allograft bone, xenograft bone, demineralized bone matrix, bone graft substitutes, extracellular matrix, bone cells, growth factors, blood derivatives, bone marrow aspirate, synthetic bone, and combinations thereof. Bone graft substitutes may be selected from a group consisting of: tricalcium phosphates, hydroxyapatites, calcium phosphates, calcium sulfates, bioglasses, collagen, and combinations thereof. Extra cellular matrix may be selected from a group consisting of proteoglycans (including heparan sulfate, chondroitin sulfate and keratan sulfate), hyaluronic acid, collagen, elastin, fibronectin, laminin. Bone cells may be selected from the group consisting of osteocytes, osteoblasts, mesenchymal stem cells, embryonic stem cells, and combinations thereof. Growth factors may be selected from a group consisting of transforming growth factor (TGF), bone morphogenic protein (BMP), insulin-like growth factor (IGF), vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), hepatocyte growth factor (HGF), and combinations thereof. Blood derivatives may be selected from a group consisting of whole blood, platelet rich plasma, and combinations thereof.

Cartilage graft material may be selected from a group consisting of autograft cartilage, allograft cartilage, xenograft cartilage, extracellular matrix, tissue scaffolds, cartilage cells, cell sheets, biological glues, growth factors, blood derivatives, bone marrow aspirate, synthetic cartilage, or combinations thereof. Cartilage cells are selected from a group consisting of chondrocytes, chondroblasts, mesenchymal stem cells, embryonic stem cells, and combinations thereof. Biological glues are selected from a group consisting of fibrin glue, mussel glue, vitronectin, chondronectin, osteonectin, fibronectin, laminins, arginine-glycine-aspartic acid peptide, and combinations thereof.

Notably, autograft materials may be harvested from other locations in the body, besides the vicinity of the osteochondral lesion410. For example, in some embodiments, a second tissue tunnel (not shown) may be formed through the proximal tibia400to obtain bone and/or cartilage from a different portion of the proximal tibia400. Additionally or alternatively, tissue may be obtained from a different bone and/or joint through the use of the systems and methods set forth above.

Once the compaction process ofFIG.11has been carried out, the stratiform osteochondral graft1110may be ready for placement in the graft site. One manner in which this may be accomplished will be shown and described in connection withFIGS.12and13.

FIG.12is a perspective view from a lateral viewpoint shown in partial cross section of the proximal tibia400, showing the delivery tube350engaged with the bone port230. The stratiform osteochondral graft1110may have a graft proximal end1200and a graft distal end1210. The compacted stratiform osteochondral graft1110may be positioned in the delivery tube350such that the graft distal end1210, with the cartilage graft material1100, is oriented toward the graft site.

FIG.13is a perspective view from a lateral viewpoint shown in partial cross section of the proximal tibia400, shown with tamp240pushing the graft proximal end1200so that the graft distal end1210is aligned with the cartilage surface1300at the graft site. The stratiform osteochondral graft1110may be moved toward the cartilage surface1300until the cartilage graft material1100is flush with the cartilage surface1300. The bone graft1020may then occupy the tissue tunnel500, proximal to the cartilage surface1300, as shown.

Once the stratiform osteochondral graft1110has been positioned as shown inFIG.13, the tamp240, the delivery tube350, and the bone port230may be removed from the proximal tibia400. The wound site may be closed and allowed to heal. The stratiform osteochondral graft1110may then integrate with the surrounding tissue. For example, the cartilage graft material1100may integrate with the cartilage surface1300, and the bone graft1020may integrate with the bone surrounding the tissue tunnel500. The instruments of the system300used in the procedure may be disposed of. The instruments of the system100used in the procedure may be re-sterilized and prepared for use in another procedure.

In some procedures, defective tissue may be found outside the periphery of the tissue tunnel500. In some cases, the ideal retrograde approach may not pass through all of the diseased or damaged tissue that needs to be removed. In other cases, diseased or damaged tissue outside the tissue tunnel500may be located (for example, endoscopically) after the tissue tunnel500has been formed. Curettes and/or other instruments known in the art may be inserted into the tissue tunnel500, through the bone port230or directly without the bone port230, and used to remove damaged tissue from the walls of the tissue tunnel500. Further, in other embodiments, the systems and methods disclosed herein may be used to repair bone defects below an articular surface. In any of the above cases, the damaged tissue may be replaced with any of the materials listed previously. One method for doing this will be shown and described in connection withFIGS.14through17.

FIG.14is a perspective view from a lateral viewpoint shown in partial cross section of the proximal tibia400with the bone port230secured to the proximal tibia400to facilitate access to a tissue tunnel1400. An enlarged bone defect site1410may be located adjacent to the tissue tunnel1400. InFIG.14, the enlarged bone defect site1410may be below the articular surface of the proximal tibia400; thus, the tissue tunnel1400may be a blind hole through the bone of the proximal tibia400, that stops short of the articular cartilage. The tissue tunnel1400may be formed, the bone port230may be attached, and visualization of the tissue tunnel1400may be obtained substantially as set forth previously in the descriptions ofFIGS.4-7.

The funnel360may be attached to the bone port230to facilitate insertion of a tissue replacement material, such as bone graft material, into the enlarged bone defect site1410. In particular, the funnel distal end364may be secured to the bone port proximal end232such that the funnel longitudinal axis365is coaxial with the bone port longitudinal axis235. The funnel proximal end362may be flared to facilitate insertion of material into the funnel proximal end362, and thence into the tissue tunnel1400through the funnel360and the bone port230.

Alternatively, a delivery tube350(as shown inFIG.3) may be used between the funnel360and the bone port230.

FIG.15is the view ofFIG.14showing rotation and pushing of a trial to displace bone graft material1500into the enlarged bone defect site1410. In this embodiment, the bone graft material1500may be a loose and/or uncompacted material. The trial may include the trial shaft370and the trial tip800with a trial tip distal end324that is angled at 45° .

The angulation of the trial tip distal end324may help the trial tip800displace the bone graft material1500transverse to the axis of the tissue tunnel1400, into the enlarged bone defect site1410. Prior to placement of the bone graft material1500, the position of the enlarged bone defect site1410relative to the tissue tunnel1400may be assessed, for example, with medical imaging. The position may be recorded and the trial may be rotated to align the trial tip distal end324with the enlarged bone defect site1410, for example, by aligning the trial timing marks820with the orientation markings239of the bone port230. The funnel360is illustrated inFIG.15but is optional; if desired, the funnel360may be omitted to facilitate alignment of the trial timing marks820with the orientation markings239.

After the bone graft material1500has been inserted into the enlarged bone defect site1410, the bone graft material1500may optionally be further pressed into the enlarged bone defect site1410. For example, a different selection from the trial tips320may be attached to the trial shaft370and advanced through the bone port230to further press the bone graft material1500into the enlarged bone defect site1410. Alternatively a tamp240(as shown inFIG.2) can be used.

FIG.16is the view ofFIG.15showing a delivery tube350loaded with compacted bone graft material1600. The delivery tube350may be attached to the bone port230as inFIG.12. The compacted bone graft material1600may optionally include only bone, rather than being a stratiform graft, as only bone is to be replaced. The compacted bone graft material1600may be formed as shown and described in connection withFIGS.9A and9B, but may be made with a cylindrical shape rather than having an angled distal surface. Thus, one of the trial tips320with a trial tip distal end324having a perpendicular orientation and a circular shape may be attached to the base330in place of the trial tip800, and used in the compaction of the bone graft1020to form the compacted bone graft material1600with the generally cylindrical shape.

FIG.17is the view ofFIG.16showing tamp240pushing the compacted bone graft material1600into final position adjacent to the enlarged bone defect site1410. The user may rely on the “feel” (i.e., resistance to distal motion) to know when to stop pushing on the handle247of the tamp240. Additionally or alternatively, medical imaging may be used to assess the location of the enlarged bone defect site1410relative to the tissue tunnel1400, and the depth markings (i.e., circumferential grooves249) of the tamp240may be used to push the bone graft material1500to the appropriate depth. Once in place, the compacted bone graft material1600may help retain the bone graft material1500in place in the enlarged bone defect site1410, and may also fill and facilitate healing of the tissue tunnel1400.

In addition to use of the systems and methods of the present disclosure to address tissue defects, these systems and methods may also be used to fill tissue voids resulting from bone atrophy, other surgical procedures, or prior surgical procedures that did not address the tissue void. One example of this will be presented in connection withFIGS.18-20.

FIG.18is a perspective view from a lateral viewpoint shown in partial cross section of the proximal tibia400with obturator250inserted through the bone port230. The existing tissue tunnel1800may be created by the user to facilitate an arthrodesis by placing compacted bone graft material across a joint, or it may be the result of a failed prior surgery, such as a tissue tunnel in a failed anterior cruciate ligament reconstruction surgery. The existing tunnel1800may be in the bone only, or may go all the way through the cartilage, like tunnel500inFIG.7. The existing tissue tunnel1800may be accessed, for example, with the aid of the obturator250, the bone port230may be attached, and visualization of the existing tissue tunnel1800may be obtained substantially as set forth previously in the descriptions ofFIGS.4-7. The obturator distal end254may be bullet shaped to facilitate entry into the existing tissue tunnel1800.

FIG.19is a perspective view from a lateral viewpoint shown in partial cross section of the proximal tibia400with the bone port230secured to the proximal tibia400, the delivery tube350attached to the bone port230, and the delivery tube loaded with compacted bone graft material1900. As inFIGS.16and17, the compacted bone graft material1900may be formed, for example, as set forth in connection withFIGS.9A and9B, and may have a generally cylindrical shape. In alternative embodiments, the compacted bone graft material1900may be shaped differently to suit the shape of the portion of the existing tissue tunnel1800in which it is to reside.

FIG.20is the view ofFIG.19showing tamp240pushing the compacted bone graft material1900into final position within the existing tissue tunnel1800. The tamp240may be used to push the compacted bone graft material1900distally until the compacted bone graft1900has reached the desired location within the existing tissue tunnel1800, which may be a blind end of the existing tissue tunnel1800as shown inFIG.19.

FIG.21is a flow chart showing a method2100of treating an osteochondral defect, according to one embodiment. The method2100may summarize steps that are shown and described in greater detail inFIGS.4through13, and in the accompanying descriptions above.

In a step2110, a tissue tunnel may be created to circumscribe the osteochondral defect from a retrograde approach. The step2110may include the procedures shown inFIGS.4through7.

In a step2120, trialing may be performed to determine the local cartilage and/or bone topography. The step2120may include the procedures shown inFIGS.8A and8B.

In a step2130, a stratiform osteochondral graft may be fabricated. The step2130may include the procedures shown inFIGS.9A through11.

In a step2140, the stratiform osteochondral graft may be delivered into the tissue tunnel. The step2140may include the procedures shown inFIGS.12and13.

FIG.22is a flow chart showing a method2200of fabricating a stratiform osteochondral graft, according to one embodiment. The method2200may be a more detailed version of the step2130of the method2100, and may summarize steps that are shown and described in greater detail inFIGS.9A through11, and in the accompanying descriptions above.

In a step2210, bone graft material may be compacted so that the distal end of the bone graft material closely matches the local cartilage and/or bone topography. The step2210may include the procedures shown inFIGS.9A through10B.

In a step2220, cartilage graft material may be compacted so that the distal end of the cartilage graft material closely matches the local cartilage and/or bone topography. The step2220may include the procedures shown inFIG.11.

FIG.23is a flow chart showing a method2300of treating a bone defect, according to one embodiment. The method2300may summarize steps that are shown and described in greater detail inFIGS.14through17, and in the accompanying descriptions above. Steps fromFIGS.9A through10Bmay also be included.

In a step2310, a bone tunnel may be created to access a bone defect. The step2310may include the procedures shown inFIG.14.

In a step2320, a bone defect Space adjacent to the bone tunnel may be filled with bone graft material. The step2320may include the procedures shown inFIGS.15and16.

In a step2330, bone graft material may be compacted, or a bone graft plug may be otherwise obtained. The step2330may include the procedures shown inFIGS.9A through10B.

In a step2340, the compacted bone graft material or the bone graft plug may be delivered to the bone tunnel. The step2340may include the procedures shown inFIG.17.

FIG.24is a flow chart showing a method2400of treating an existing bone tunnel, according to one embodiment. The method2400may summarize steps that are shown and described in greater detail inFIGS.18through20, and in the accompanying descriptions above. Steps fromFIGS.9A through10Bmay also be included.

In a step2410, an existing bone tunnel may be located with an obturator and a bone port. The step2410may include the procedures shown inFIG.18.

In a step2420, bone graft material may be compacted, or a bone graft plug may be otherwise obtained. The step2420may include the procedures shown inFIGS.9A through10B.

In a step2430, the compacted bone graft material or the bone graft plug may be delivered to the bone tunnel. The step2430may include the procedures shown inFIGS.19and20.

The method2100, the method2200, the method2300, and the method2400may utilize the system100, the subset200, and/or the system300. In the alternative, the method2100, the method2200, the method2300, and the method2400may employ differently configured instruments. Likewise, the system100, the subset200, and/or the system300may be utilized in methods different from the method2100, the method2200, the method2300, and the method2400. Further, steps may be added to, omitted from, and/or replaced with alternatives in any of the method2100, the method2200, the method2300, and the method2400, as would be envisioned by a person skilled in the art.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the present disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any embodiment requires more features than those expressly recited in that embodiment. Rather, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

As used herein, the term “proximal” means a location relatively closer to a user (i.e., a surgeon) when the user is installing the implant. The term “distal” means a location relatively further from the user. For example, when a user installs a bone screw into a material with a driver, the end of the bone screw engaged with the driver is the proximal end, and the tip of the bone screw that first engages the material is the distal end. The term “cannulated” means having a central bore extending along a longitudinal axis of a part between a proximal end and a distal end of the part.

The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “coupled” can include components that are coupled to each other via integral formation, as well as components that are removably and/or non-removably coupled with each other. The term “abutting” refers to items that may be in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two or more features that are connected such that a fluid within one feature is able to pass into another feature. As defined herein the term “substantially” means within +/−20% of a target value, measurement, or desired characteristic.

While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of this disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the devices, systems, and methods disclosed herein.