# Patent

## Title
Graft fixation

## Abstract

The present disclosure relates to an anchor for fixating a tissue graft to bone. The anchor includes a through hole extending an entire length of the anchor and a polymer composition having shape memory qualities. Other anchors and methods for fixating a tissue graft to bone are also disclosed.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a U.S. National Stage Application, submitted under 35 U.S.C. 371, claiming priority to PCT International Patent Application PCT/US2008/060401 filed on Apr. 16, 2008, which claims priority to U.S. Patent Application No. 60/912,828 filed on Apr. 19, 2007, the disclosures of which are incorporated herein by reference in their entirety.


BACKGROUND
1. Field of the Invention
The present disclosure relates generally to tissue graft fixation and, more particularly, to tissue graft fixation via the use of shape memory polymer material.
2. Related Art
A ligament, such as an anterior cruciate ligament (ACL), that has ruptured and is non-repairable, is generally replaced arthroscopically by a tissue graft. The tissue graft may be harvested from a portion of a patellar tendon having so called “bone blocks” at each end, and from the semitendonosis and gracilis. Alternatively, the tissue graft can be funned from synthetic materials or from a combination of synthetic and natural materials.
The replacement tissue graft is implanted by securing one end of the tissue graft in a socket formed in a passage within the femur, and passing the other end of the graft through a passage formed in the tibia. Generally, sutures arc used to affix each end of the tissue graft to a fastener (e.g., an interference screw or a post), which is then secured to the bone. The use of a fastener, such as an interference screw, may create complications for several reasons: the possibility of the screw threads damaging the grafts during screw installation if the screw is too big in relation to the graft and/or if the space between the passage and the grafts is too small, the graft rotating with the screw during screw installation so that the optimal position of the grafts is lost and/or the grafts are damaged, divergence of the grafts and/or screw occurring, the requirement of a range of fastener sizes for different patients, and, if the screw is non-metal, the possibility of the screw breaking during insertion.
SUMMARY
In one aspect, the present disclosure relates to an anchor for fixating a tissue graft to bone. The anchor includes a through hole extending an entire length of the anchor. The anchor includes a polymer composition including shape memory qualities. In an embodiment, the through hole is circular, star-shaped, or rectangular. In another embodiment, the anchor further includes a component disposed within the through hole of the anchor, wherein the component includes a polymer composition having shape memory qualities. In yet another embodiment, the through hole is divided into two sections. In a further embodiment, the through hole is divided into four sections.
In another aspect, the present disclosure relates to an anchor for fixating a tissue graft to bone. The anchor includes a first groove extending an entire length of the anchor and a second groove extending an. entire length of the anchor. The anchor includes a polymer composition. having shape memory qualities. In an embodiment, the first groove and the second groove both include barbs.
In yet another aspect, the present disclosure relates to an anchor for fixating a tissue graft to bone. The anchor includes a cross-section in a shape of a cross and a polymer composition including shape memory qualities.
In a further embodiment, the present disclosure relates to an anchor for fixating a tissue graft to bone. The anchor includes a body having a curved top portion, a curved bottom portion, and two sides located between the top portion and the bottom portion. In an embodiment, the sides are curved inward toward the body of the anchor.
In yet a further embodiment, the present disclosure relates to a method of fixating a tissue graft to bone. The method includes providing an anchor having a through hole extending an entire length of the anchor. The anchor includes a polymer composition having shape memory qualities; inserting an end of a tissue graft into the through hole; inserting the anchor into a bone tunnel; providing the anchor with energy to deform the anchor and fixate the graft within the bone tunnel.
In an embodiment, the method further includes a component disposed within the through hole, the component including a polymer composition having shape memory qualities. In another embodiment, the through hole is divided into two sections, wherein the method further includes inserting ends of a tissue graft into the sections. In yet another embodiment, the through hole is divided into the four sections, wherein the method further includes inserting ends of multiple tissue grafts into the sections.
In an embodiment, the present disclosure relates to a method of fixating tissue grafts to bone. The method includes providing at least two tissue grafts; coupling the at least two tissue grafts; inserting the at least two tissue grafts into a bone tunnel; inserting an anchor into the bone tunnel such that the anchor is located between the at least two tissue grafts; and providing energy to the anchor to deform the anchor and fixate the at least two tissue grafts within the bone tunnel.
Further features, aspects, and advantages of the present disclosure, as well as the structure and operation of various embodiments of the present disclosure, are described in detail below with reference to the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the description, serve to explain the principles of the disclosure. In the drawings:
FIGS. 1A and 1B show a cross-sectional view of an end of a tissue graft disposed within an anchor of a first embodiment of the present disclosure both before and after deformation of the anchor.
FIGS. 2A and 2B show cross-sectional views of an anchor of a second embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 2C and 2D show cross-sectional views of an anchor of a third embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 2E and 2F show cross-sectional views of an anchor of a fourth embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 3A and 3B show cross-sectional views of an end of a tissue graft disposed within an anchor of a fifth embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 4A and 4B show cross-sectional views of an anchor of a sixth embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 5A and 5B show cross-sectional views of an anchor of a seventh embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 6A and 6B show cross-sectional views of an anchor of an eighth embodiment of the present disclosure before and after deformation of the anchor.
FIGS. 7A and 7B show cross-sectional views of a bone tunnel having surface features on walls of the tunnel.
FIG. 8A shows a side view of an anchor of a ninth embodiment of the present disclosure
FIG. 8B shows a cross-sectional view of the anchor of FIG. 8A.
FIG. 8C shows a front view of the anchor of FIG. 8A.
FIG. 9 shows a cross-sectional view of the anchor of FIG. 8A in a bone tunnel and after deformation of the anchor.
FIG. 10 shows mechanical testing data for the anchor of the present disclosure.
FIGS. 11A and 11B show a method of fixating tissue grafts within a bone tunnel using an anchor of the present disclosure.



DETAILED DESCRIPTION OF THE EMBODIMENTS
FIGS. 1A and 1B show cross-sectional views of a cylindrical anchor 10 with a central through hole 11 into which an end 12a of a tissue graft 12 is placed. The anchor 10 is then loosely press fit into a pre-formed passage 13a in bone 13, such as a femoral passage in a femur, as described above. Upon providing the anchor 10 with energy, the anchor 10 expands radially and shrinks axially, as shown by arrows in FIG. 1B, thereby fixating the tissue graft 12 and anchor 10 to the bone 13.
Alternative embodiments of the anchor 10 include those shown in FIGS. 2A, 2C, and 2E, which are similar to the anchor described above except that the through holes 11 include those shaped as a star (FIG. 2A), a slot (FIG. 2C), and a toothed slot (FIG. 2E). FIGS. 2B, 2D, and 2F show the anchors 10 of FIGS. 2A, 2C, and 2E, respectively, after the anchors 10 arc provided with energy. Other shapes for the through holes 11 are also within the scope of this disclosure. It is believed that having a through hole with the shapes shown in FIGS. 2A, 2C, and 2E would increase the fixation of the graft to the anchor due to an increase in the amount of surface area and points of contact engaging the graft. The number of holes 11 in the anchor 10 may vary.
The anchor comprises polymeric shape memory material. Shape memory polymers, which can be resorbable or non-resorbable, are known in the art and any biocompatible polymeric shape memory material can be used in the context of the present disclosure. Specific polymers that may be used include polyetheretherketone (PEEK), polymethyl methacrylate (PMMA), polyethyl methacrylate (PTMA), polyacrylate, poly-alpha-hydroxy acids, polycaprolactones, polydioxanones, polyesters, polyglycolic acid, polyglycols, polylactides, polyorthoesters, polyphosphates, polyoxaesters, polyphosphoesters, polyphosphonates, polysaccharides, polytyrosine carbonates, polyurethanes, and copolymers or polymer blends thereof.
The anchor 10 may be formed by a process that would provide the anchor 10 with shape memory properties, such as, without limitation, zone drawing, hydrostatic extrusion, die drawing, compression flow molding, thermoforming, rolling, and roll drawing. The through hole 11 may be formed in the anchor 10 while it is being manufactured. Alternatively, the through hole 11 may be formed in the anchor 10 post processing by drilling or by any other method of forming the through hole 11.
Generally, polymers that display shape memory qualities show a large change in modulus of elasticity at the glass transition temperature (Tg). The shape-memory function can be achieved by taking advantage of this characteristic. Namely, a molded article (primary molded article) to which a definite shape (the original shape) has been imparted by a common method for molding plastics, is softened by providing the article with energy and heating to a temperature (Tf) higher than the Tg of the polymer, but lower than the melting temperature (Tm) thereof so as to deform it into a different shape. Next, the molded article is cooled to a temperature lower than the Tg, while maintaining the thus deformed shape (secondary molded article). When it is heated again to a temperature higher than the secondary molding temperature Tf, but lower than the Tm, the shape of the secondary molded article disappears and thus the article is recovered to the original shape of the primary molded article.
For the purposes of this disclosure, a molded article (i.e. the above-mentioned anchor), having a definite shape (original shape) is formed from polymer material and is provided with energy to heat the article to a temperature above the glass transition temperature of the polymer, but lower than the melting temperature (Tm thereof so as to deform it into a different shape and effectively wedge the article between the tissue graft and the bone. In this manner, the tissue graft becomes fixed to the bone. However, for the purposes of this disclosure, rather than cooling the anchor and heating it again until it recovers its original shape, the anchor is kept in this deformed shape so as to maintain fixation of the tissue graft to the bone. The glass transition temperature of the polymer material will vary based on a variety of factors, such as molecular weight, composition, structure of the polymer, and other factors known to one of ordinary skill in the art.
Examples of adding energy to the polymer material include electrical and thermal energy sources, the use of force, or mechanical energy, and/or a solvent. Examples of thermal energy sources include a heated liquid, such as water or saline. It is also within the scope of this disclosure that once the anchor 10 is placed in the bone, body heat would be transferred from blood and tissue, via thermal conduction, to provide the energy necessary to deform the shape memory polymer material. In this instance, body temperature would be used as the thermal energy source. Examples of electrical energy sources include heat generating devices such as a cauterizing device or insulated conductor, as more fully described in PCT Application No. PCT/US2008/056828, the disclosure of which is incorporated herein by reference in its entirety, or a heating probe, as more fully described in PCT Application No. PCT/US2008/056836, the disclosure of which is incorporated herein by reference in its entirety. For instance, the anchor 10 may include a hole in the body of the anchor 10 that a heating device, such as the heating probe described above, may be inserted into.
Any suitable force that can be applied either preoperatively or intra-operatively can be used as a form of energy. One example includes the use of ultra sonic devices, which can relax the polymer material with minimal heat generation. Solvents that could be used as the form of energy include organic-based solvents and aqueous-based solvents, including body fluids. Care should he taken that the selected solvent is not contra indicated for the patient, particularly when the solvent is used intra-operatively. The choice of solvents will also be selected based upon the material to be relaxed. Examples of solvents that can be used to relax the polymer material include alcohols, glycols, glycol ethers, oils, fatty acids, acetates, acetylenes, ketones, aromatic hydrocarbon solvents, and chlorinated solvents.
A further embodiment of the anchor is shown in FIGS. 3A and 3B. The anchor 20 includes a through hole 21 and a component 22 disposed within the through hole 21. Multiple grafts 23 can be placed into the through hole 21 along with the component 22, which, as shown in FIG. 3B, decreases in length and increases in diameter, similar to anchor 20, thereby providing further fixation of the grafts 23 to anchor 20 and therefore the bone 24. The anchor 20 and component 22 may be formed by a process that would provide the anchor 20 and component 22 with shape memory properties, such as, without limitation, zone drawing, hydrostatic extrusion, die drawing, compression flow molding, thermoforming, rolling, and roll drawing. The through hole 21 may be formed in the anchor 20 while it is being manufactured. Alternatively, the through hole 21 may be formed in the anchor 20 post processing by drilling or by any other method of forming the through hole 21.
Another embodiment is shown in FIGS. 4A-4B, 5A-5B, and 6A-6B. The anchor 30 of FIG. 4A includes a through hole 31 that is divided into four separate openings 31a-31d allowing the possibility of up to four tissue graft ends being fixated to the anchor 30 when the anchor 30 is provided with energy, as shown in FIG. 4B. FIGS. 5A-5B show an. anchor 40 having two grooves 41, both of which may extend the entire length of the anchor 40 or a partial length. Surfaces 41a of the grooves 41 include features, such as barbs 41a′, which may allow further fixation of the anchor 40 to the graft upon providing the anchor 40 with energy, as shown in FIG. 5B. FIGS. 6A-6B show an anchor 50 in the shape of a cross. Similar to the anchor 30 of FIGS. 4A-4B, anchor 50 allows for the possibility of four tissue graft ends being fixated to the anchor 50 when the anchor 50 is provided with energy, as shown in FIG. 6B.
The anchors 40,50 of FIGS. 5A and 6A expand to cause an interference fit against walls 42a,52a of the bone tunnels 42,52, thereby not only fixating the anchors 40,50 to the walls 42a,52a, but also fixating tissue graft ends to the bone 43,53, which allow direct osseointegration of the graft to the walls 42a,52a. The anchors 30, 40, 50 may be formed by a process that would provide the anchors 30, 40, 50 with shape memory properties, such as, without limitation, zone drawing, hydrostatic extrusion, die drawing, compression flow molding, thermoforming, rolling, and roll drawing. The through hole 31, openings 31a-31d, grooves 41, and barbs 41a′ may be formed in the anchors 30, 40 while it is being manufactured. Alternatively, these features may be formed in the anchors 30,40 post processing by drilling or by any other method.
As shown in FIGS. 7A and 7B, the walls 61a may include surface features 62, such as barbs and/or spikes, which would allow more integration of the anchor 60 into the bone 63 upon providing the anchor 60 with energy, thereby increasing fixation of the anchor 60, and therefore a graft, to the bone 63. The surface features 62 may be made via the use of a mechanical tool or other devices known to one of skill in the art for making the features 62.
In an embodiment shown in FIGS. 8A-8C, an anchor 70 has been shaped to aid insertion into a bone tunnel containing ligaments or bone block, as will be further described below. The anchor 70 includes substantially rounded top and bottom portions 71,72 and two sides 73,74, located between the top and bottom portions 71,72, both of which are configured to house graft ends when the plug is disposed within a hone tunnel, as will be further described below. The anchor 70 also includes a tapered front portion 75, an angled back portion 76, and an opening 77 that partially extends a length of the anchor 70. The opening 77 is configured for engagement with a delivery device for delivery of the anchor 70 into a bone tunnel, as will be further described below.
In use, as shown in FIG. 9, the anchor 70 is inserted into a bone tunnel 78, via the use of a delivery device, as mentioned above, such that the graft ends 79 extend along the sides 73,74 of the anchor 70. The anchor 70 is then provided with energy, via the use of one of the heating devices described above, by inserting the heating device into the opening 77 and activating it, thereby resulting in the anchor 70 expanding to compress the graft ends 79 against the bone tunnel wall 78a and fixate the plug 70 and the graft ends 79 within the bone tunnel 78. Other energy sources may also be used. The anchor 70 may be of various sizes to accommodate the size of the bone tunnel 78 and substantially increase the possibility of engagement of the anchor 70 and the graft ends 79 with the wall 78a upon deformation of the anchor 70.
The anchor 70 may be formed by a process that would provide the anchor 70 with shape memory properties, such as, without limitation, zone drawing, hydrostatic extrusion, die drawing, compression flow molding, thermoforming, rolling, and roll drawing. Alternatively, the anchor 70 is processed via one of the methods described above and subsequently machined to include the shape of the sides 73,74 and the top and bottom portions 71,72. The opening 77 may be formed in the anchor 70 while it is being manufactured. Alternatively, the opening 71 may be formed in the anchor 70 post processing by drilling or by any other method of forming the opening 71.
EXAMPLE
An 8.5 mm hole was drilled through the centre of a block of 20 pcf sawbone having the following dimensions: 42 mm long, 31 mm wide, and 31 mm thick.
Two pieces of 7 inch long 125 lb braided nylon rope were doubled over and inserted into the hole so that the four ends of rope passed all the way through the hole in the sawbone. An anchor including Poly (D,L lactide-co-glycolide) and calcium carbonate was inserted into the hole ensuring that the strands of nylon rope passing through the hole did not cross over one another and each of the four ends of nylon had its own quadrant of the hole. The anchor was processed via a die drawing process to include shape memory qualities. The ratio of lactide:glyeolidc was 85:15 and the calcium carbonate was present at between about 35.5% by weight of the polymer composition. Once in place, the plug was relaxed by immersion of the block, plug, and rope into hot water (approximately 80° C. for 5 min). When the block containing the plug and rope had cooled to room temperature, it was inserted into an aluminum sleeve having similar dimensions to the sawbone block.
Mechanical testing was carried out using an Instron 5566 with a 10 kN load cell. The aluminum sleeve housing the sawbone block was clamped in a first grip of the Instron and the nylon loops were clamped in a second grip, specifically, the loops were clamped to the crosshead of the Instron. The crosshead was extended until the loops were taut, which, as shown in FIG. 10, occurred when the crosshead was extended 21 mm, and then testing began. Testing was carried out with a crosshead speed of 25 mm/min and a pre-load of 22.3N. As shown in FIG. 10, the plug was found to have a maximum fixation strength of 532 N.
A further embodiment is shown in FIGS. 11A and 11B. In order to substantially reduce the graft ends 80a from slipping between an anchor 90 and the bone tunnel wall 100a, the ends 80a may be coupled at one point via a biocompatible connector 200 including, without limitation, a suture, a clip, or staple. The grails 80 arc placed into a previously drilled hone tunnel 100 and an anchor 90 is then inserted between the grafts 80 and deformed by providing the anchor 90 with energy, as shown in FIG. 11B, to fixate the grafts 80 within the tunnel 100.
The anchor 90 may be formed by a process that would provide the anchor 90 with shape memory properties, such as, without limitation, zone drawing, hydrostatic extrusion, die drawing, compression flow molding, thermoforming, rolling, and roll drawing.
The anchors described above may include a reinforced polymeric material. Preferably, the reinforced polymeric material comprises a composite or matrix including reinforcing material or phases such as fibers, rods, platelets, and fillers. More preferably, the polymeric material can include glass fibers, carbon fibers, polymeric fibers, ceramic fibers, or ceramic particulates. Other reinforcing material or phases known to one of ordinary skill in the art could also be used. One or more material from which the anchor is formed may be porous. Porosity can allow infiltration by cells from surrounding tissues, enhancing integration of the device by processes such as osseointegration.
In addition, one or more actives/agents may be incorporated into the material of the anchor. Suitable actives/agents include bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma/solution, platelet poor plasma/solution, bone marrow aspirate, and any cells sourced from flora or fauna, such as living cells, preserved cells, dormant cells, and dead cells. It will be appreciated that other bioactive agents known to one of ordinary skill in the art may also be used. Preferably, the active agent is incorporated into the polymeric shape memory material, to be released during the relaxation or degradation of the polymer material. Advantageously, the incorporation of an active agent can act to combat infection at the site of implantation and/or to promote new tissue growth.
The anchor described above may also include at least one feature, such as protrusions, that arc coupled to a surface of the anchor via a variety of methods, such as an interference fit between the polymer and the protrusions, adhesion of the protrusion to the polymer, or any other method known to one of ordinary skill in the art. In addition, the number of protrusions present on the surface of the anchor may vary. The protrusions may provide multiple contact points to increase the friction between the anchor and the bone, thereby providing increased fixation between the tissue graft and the bone. The protrusions may be selected from a group that includes a metal material, a non-metal material, a polymer material, and combinations thereof and may be of any shape or size. If a polymer material is used for the protrusions, the polymer material may include a resorbable or non-resorbable polymer material.
Use of the protrusions may he eliminated by including a particulate material within or on an outer surface of the anchor. The particulate material may include a ceramic material, a crystalline polymer, or any other type of material that would provide the polymer material with multiple contact points to increase the friction between the polymer material and the bone.
The anchors described above, and especially anchors 10,20, may he biaxially oriented to have an internal diameter that decreases and an external diameter that increases when the anchor is provided with energy. This allows for the internal diameter to further grip the anchor to the tissue graft(s) and the outer diameter to engage the surrounding bone, thereby locking the tissue graft(s) in place. In order to make an anchor of biaxially oriented shape memory polymer material, a rod of shape memory polymer material may be die drawn over a mandrel. Further discussion of this process can he found in U.S. Patent Application Ser. No. 60/912,740, the disclosure of which is incorporated herein by reference in its entirety.
The shape memory anchors of the present disclosure may substantially reduce the need to thrcad/pre-tap the bone tunnel before insertion of the anchor into the bone tunnel, especially when a patellar tendon is used as the tissue graft. In addition, it is believed that the anchor would offer improved fixation over existing systems. Furthermore, the anchors may substantially reduce the possibility of making a range of fasteners to fit the patient, thereby possibly offering a ‘one size fits all’ approach.
In view of the foregoing, it will be seen that the several advantages of the invention are achieved and attained.
The embodiments were chosen and described in order to best explain the principles of the disclosure and its practical application to thereby enable others skilled in the art to best utilize the disclosure in various embodiments and with various modifications as are suited to the particular use contemplated.
As various modifications could be made in the constructions and methods herein described and illustrated without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.

## Claims

1. An anchor for fixating a tissue graft to bone, the anchor comprising:
an elongated body disposable into a bone tunnel in a bone and made from a shape-memory material, the elongated body comprising:
a non-tapered proximal portion, comprising:
a first concave outer surface extending longitudinally along the entire non-tapered proximal portion to define a first longitudinal channel along a first side of the elongated body wherein the first concave outer surface has a shape memory configured to compress a first tissue graft end portion against the bone tunnel wall in response to receiving a shape memory activation energy;
a first convex outer surface extending longitudinally along an entire second side of the non-tapered portion and configured to engage a bone tunnel wall of the bone when the elongated body is inserted into the bone tunnel; and

a tapered distal portion extending longitudinally from the non-tapered proximal portion wherein the-first concave outer surface extends longitudinally along the entire tapered distal portion.

2. The anchor of 1, further comprising a cavity extending longitudinally into the elongated body from a proximal end of the elongated body, the cavity shaped to receive a delivery device and/or a heating device.

3. The anchor of claim 2, wherein the non-tapered proximal portion further comprises:
a second concave outer surface extending longitudinally along the entire non-tapered proximal portion to define a second longitudinal channel along a third side of the elongated body opposite the first side of the elongated body wherein the second concave outer surface has a shape memory configured to compress a second tissue graft end portion against the bone tunnel wall in response to receiving the shape memory activation energy; and
a second convex outer surface extending longitudinally along an entire fourth side of the non-tapered portion opposite the second side of the non-tapered portion and configured to engage the bone tunnel wall of the bone when the elongated body is inserted into the bone tunnel.

4. The anchor of claim 3, wherein the second concave outer surface extends longitudinally along the entire tapered distal portion.