# Patent

## Title
Fixation device for delivery of biological material between soft tissue and bone

## Abstract

A method for attaching soft tissue to bone. The method includes forming a bore in a bone, placing the soft tissue adjacent to the bone and above the bore, at least partially inserting a fixation device into the bore, and delivering biologic material through the soft tissue at an interface area between the soft tissue and the bone.

## Background
Various methods and devices for attaching soft tissue to a bone are known. Some methods use various suture anchors or expandable suture anchors, or rivets for knotless tying.
The present teachings provide fixation devices adapted for arthroscopic delivery of biologic material.
SUMMARY
The present teachings provide a fixation device deployable for attaching soft tissue to a bone. The fixation device includes a cannulated anchor and a cannulated insert engageable with the anchor. The anchor includes a soft-tissue engaging portion and a bone-anchoring portion. The bone-anchoring portion includes an expandable body having a proximal end and a distal end. The proximal end defines at least one radial delivery hole adjacent the soft-tissue engaging portion. The insert has a proximal end and a distal end and defines at least one radial delivery hole at the proximal end of the insert. The delivery holes of the anchor and insert are aligned and positioned such that biologic material can be delivered through the delivery holes and flow between the tissue and the bone when the fixation device is deployed.
The present teachings further provide a fixation device that includes an anchor and an insert engageable with the anchor and received in bone. The anchor and insert are movable between a non-deployed and a deployed position. The anchor has a first portion engaging soft tissue and an expandable second portion adjacent the first portion and received in bone below the soft tissue. The first portion has first and second ends, and the second portion has first and second ends. The second end of first portion is adjacent the first end of the second portion. The fixation device defines a plurality of radial delivery holes adjacent the first end of the second portion at an area between the soft tissue and the bone when the fixation device is in the deployed position, such that biologic material can be delivered through the delivery holes between the soft tissue and the bone.
The present teachings provide a fixation device deployable for attaching soft tissue to a bone and including a cannulated anchor and a cannulated insert. The anchor has a head engageable with the soft tissue and an expandable body receivable in the bone and defining at least one radial delivery hole at a proximal portion of the anchor under the head. The insert is movable relative to the anchor for expanding the expandable member. The insert defines at least one radial delivery hole. The delivery holes of the anchor and insert are aligned such that biologic material can be delivered through the delivery holes and flow between the tissue and the bone when the fixation device is deployed.
The present teachings provide an apparatus for attaching soft tissue to a bone and including a suture anchor having a first portion engageable with a suture and a second portion engageable with bone, and a cannulated shaft having a longitudinal bore, the shaft engageable with the first portion of the suture anchor. The shaft has at least one radial delivery aperture communicating with the longitudinal bore, the aperture located along the shaft at a position capable for delivering biologic material between the soft tissue and the bone when the shaft is engaged with the first portion of the anchor.
The present teachings provide a fixation device deployable for attaching soft tissue to a bone. The fixation device includes an anchor having a soft-tissue engaging portion and a bone-anchoring portion. The bone-anchoring portion includes a body having a proximal end and a distal end, the proximal end of the bone anchoring portion defining at least one radial delivery aperture defined adjacent the soft-tissue engaging portion and adapted for delivering biologic material through the anchor and between the soft tissue and the bone.
The present teachings also provide methods for attaching soft tissue to bone. In one aspect, the method includes forming a bore in a bone, placing the soft tissue adjacent to the bone and above the bore, at least partially inserting a fixation device into the bore, and delivering biologic material through the soft tissue at an interface area between the soft tissue and the bone.
In another aspect, the method includes forming a bore in a bone, placing a soft tissue adjacent to the bone and above the bore, holding the soft tissue against the bone with an enlarged head of a fixation device, inserting a bone-anchoring portion of the fixation device into the bore, and delivering biologic material through the soft tissue at an interface area between the soft tissue and the bone.
In another aspect, the method includes inserting a fixation device through the soft tissue into the bone, anchoring the soft tissue to the bone with the fixation device, and delivering biologic material at an interface area between the soft tissue and the bone.
Further areas of applicability of the present invention will become apparent from the description provided hereinafter. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the invention.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
FIG. 1 is a side view of a fixation device according to the present teachings, shown with a guide pin;
FIG. 2 is a perspective view of an expandable member of the fixation device of FIG. 1;
FIG. 2A is a side view of the fixation device of FIG. 2;
FIG. 3 is a perspective view of an insert of the fixation device of FIG. 1
FIG. 4 is a bottom perspective view of the fixation device of FIG. 1;
FIG. 5 is an environmental view of the fixation device of FIG. 1, shown with an insertion system;
FIG. 6 is an environmental view of the fixation device of FIG. 1, shown seated in bone;
FIG. 7 is an enlarged detail the fixation device of FIG. 1, shown after deployment in bone;
FIG. 8 is an environmental view of the fixation device of FIG. 1, shown after deployment in bone;
FIGS. 9 and 10 illustrate aspects of delivering biologic material through a fixation device according to the present teachings;
FIG. 11 is an environmental view of a fixation device according to the present teachings showing delivery of biologic material through the fixation device;
FIG. 11A is an environmental view of a fixation device according to the present teachings showing delivery of biologic material through the fixation device;
FIG. 12 is an environmental view of multiple fixation devices according to the present teachings showing delivery of biologic material through the fixation devices;
FIG. 13 is an environmental view of a fixation device according to the present teachings showing delivery of biologic material through the fixation device;
FIG. 13A is a detail of a delivery shaft that can be used with the fixation device of FIG. 13; and
FIG. 13B is a detail of a delivery shaft that can be used with the fixation device of FIG. 13.



DESCRIPTION OF VARIOUS ASPECTS
The following description is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. For example, although the present teachings are illustrated in connection particular fixation devices used in arthroscopic surgery, the present teachings can be applied to other fixation devices. The present teachings can be applied, for example, to expandable fixation devices, such as the fixation device illustrated in FIG. 1, or the fixation devices disclosed in co-pending patent application Ser. No. 11/006,418, filed Dec. 7, 2004, (“Ref. A”), now U.S. Pat. No. 7,572,283, Ser. No. 11/006,398 filed Dec. 7 , 2004 (“Ref. B”), and Ser. No. 11/451,250 filed Jun. 12, 2006 (“Ref. C”). now published as US 2006-0235413. The disclosures of these applications are incorporated herein by reference. Further, the present teachings can be applied to non-expandable fixation devices, such as, for example, suture anchors, as illustrated in FIG. 13, or other fixation devices.
Generally, the fixation devices can include any type of soft tissue fixation device, including for example, tacks, or suture anchors or expandable or deployable devices, cannulated rivets, screws or other anchors. The fixation device 100 can be used with an inserter or other cannulated or tubular shaft to deliver biologic material 90 at the interface between the soft tissue 82 and the bone 80 for various soft tissue repair procedures, as described below. The biologic material 90 can flow at the interface of the soft tissue 82 and bone 80 through cannulation and/or other apertures of the fixation device 100, as described below in connection with FIGS. 1-12, and/or through apertures of an inserter shaft that can be used to insert the fixation device and/or deliver the biologic material, as described in connection with FIGS. 13-13B.
It will be appreciated that depending on the particular fixation and delivery/inserter devices, the biologic material can be delivered after the fixation device is fully deployed or fully seated, or while the fixation device is partially seated or partially deployed. In other applications, deploying or seating the fixation device can cause delivery of the biologic material, or conversely, delivering the biologic material can cause seating or deployment of the fixation device.
Referring to FIGS. 1-12, the present teachings provide an expandable fixation device 100, shown in FIG. 1 that can be arthroscopically implanted through soft tissue into bone. The fixation device 100 can be made of a resorbable material, such a resorbable copolymer, Lactosorb© or other biocompatible material. The fixation device 100 can be implanted into a prepared hole in the bone, for example, and used to reattach damaged soft tissue. The fixation device 100 can be used in various arthroscopic procedures, including, but not limited to, various shoulder repair procedures, such as, bankart procedures, SLAP lesion repairs, acromioclavicular separation repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs, rotator cuff repairs, and others. The fixation device 100 can provide strong tissue fixation while eliminating knot tying and suture management problems.
The fixation device 100 can include various structural features that allow the delivery of biologic materials at the fixation site, as described below. The biologic materials can be selected, for example, for promoting the healing of soft tissue and/or bone during arthroscopic surgery, for improving and/or increasing the rate of fixation, or for other purposes. The biologic materials can include, for example, platelet-rich plasma, growth factors, bone/soft tissue glue, stem cells, pharmaceuticals, nutrients, or other biologic materials.
Referring to FIGS. 1-4, an exemplary fixation device 100 according to the present teachings can include a cannulated anchor 102 having a longitudinal bore 118a, and a cannulated insert 120 having a longitudinal bore 118b. The bores 118a, 118b of the anchor 102 and the insert 120 are coaxial and define a longitudinal bore 118 of the fixation device 100. The anchor 102 includes an expandable body 104. The expandable body 104 can include expanding members 106 defined by longitudinal slots 116. The expanding members 106 can include ridges, barbs, or other bone-anchoring formations 108 that can engage bone when the expandable body 104 is in an expanded configuration, as discussed below. The anchor 102 can also include a washer-like head 110 with a distal portion 11 3 defining teeth, spikes, barbs, serrations or other anchoring protrusions 112. A guide pin 200 can pass through the longitudinal bore 118 of the fixation device 100 for guiding the insertion of the fixation device 100 and facilitating deployment of the expandable members 106, as discussed below and in more detail in Ref. A.
The insert 120 can be bullet-shaped portion and have distal portion 122 that tapers distally, an intermediate portion 124 that tapers proximally, and a proximal portion 128. The insert 120 can include a pair of opposing and distally tapering flanges 130 that can engage an insertion instrument, as described in Ref. A. The proximal portion 128 can include a grip portion 132 with circumferential protrusions or other grip elements for firmly engaging the insert 120 into the bore 128a of the anchor 102 in the deployed configuration. These and other features of the anchor 102 and insert 120 as well as alternative features can be found in Refs. A-C.
Referring to FIGS. 5 and 6, an exemplary method of using the fixation device 100 to attach soft tissue 82 to a bone 80 is illustrated. A deployment instrument 250 can be used to insert the fixation device 100 to a bone bore 84 drilled in the bone 80. The deployment instrument 250 can be in the form of a gun that includes a handle 250, a tubular shaft 230 having a longitudinal bore 236 and a trigger 252 that can be used for actuating movement of the guide pin 200. The tubular shaft 230 can pass over the guide pin 200 and engage the head 110 of the anchor 102. The anchor 102 can be pushed down the bone bore 84 to a desired depth. While applying downward pressure on the head 110 of the anchor 102 with the tubular shaft 230 toward the bone 80, the trigger 252 can be pulled upward away from the bone 80 pulling the guide pin 200. The guide pin 200 can exert a proximal force on the insert 120 to pull the intermediate portion 124 of the insert 120 into the body 102, urging the expanding members 106 outward and deploying the fixation device 100 in engagement with bone 80, as shown in FIGS. 8 and 9. Various other actuating arrangements for deploying the fixation device 100 can be used as described in the pending patent applications referenced above and incorporated herein by reference.
Referring to FIGS. 1, 3, 7, and 8, the fixation device 100 can include radial openings for delivering biologic material at the interface between the soft tissue 82 and the bone 80. In particular, radial delivery holes or other radial delivery apertures 114 can be formed around the circumference and through the body 104 of the anchor 102 at a distance “D” from the proximal surface of the head 110. The distance D is determined such that the delivery holes 114 are substantially at the level of the interface between the soft tissue 82 and the bone 80 when the fixation device is employed, as shown in FIG.8. The delivery holes 114 can be aligned with and located proximally relative to the slots 116 of the expandable body 102. The insert 120 can also include openings 126, which can be aligned with the delivery holes 114 when the fixation device 100 is fully seated and deployed in engagement with the walls of the bone bore 84.
Referring to FIGS. 9-12, after the fixation device 100 is fully seated and deployed in engagement with the bone 80, the deployment instrument 250 together with the guide pin 200 can be decoupled from the tubular shaft 230 and removed leaving the tubular shaft 230 in engagement with the fixation device 100. Alternatively, the tubular shaft 230 can also be removed and replaced with a cannula that is positioned in communication with the longitudinal bore 118 along axis A of the fixation device 100. A syringe or other biologic delivery device 260 can be connected with the shaft 230 and used for delivering biologic material 90 through the longitudinal bore 236 of the tubular shaft 230 and the longitudinal bore 118 of the fixation device 100, as shown in FIG. 11. The biologic material can exit the aligned radial delivery holes 114, 126 of the anchor 102 and insert 120 and flow at the interface of the soft tissue 82 and bone 80. Optionally, biologic material 90 can also flow through the longitudinal bore 118 of fixation device 100 and fill the bone void at the bottom of the bone bore 84 in the bone 80, as also illustrated in FIG. 11, or not, as illustrated in FIG. 11A. It will appreciated than more than one fixation devices 100 can be used for securing the soft tissue 82 to the bone 80, as illustrated in FIG. 12, in which two fixation devices are shown.
It will be appreciated that the relative location of the delivery holes 114 of the body 104 and/or the delivery holes 126 of the insert 120 can be adjusted such that biologic material 90 can be delivered while the fixation device 100 is partially seated or partially deployed. In other aspects, seating or deploying the fixation device 100 can cause the delivery of biologic material 90, or delivering biologic material 90 can cause the fixation device 100 to be seated or deployed.
As discussed above, the present teachings are not limited to expandable fixation devices. Referring to FIGS. 13-13B, the present teachings are illustrated in connection with a fixation device 100 in the form of a threaded suture anchor that includes an eyelet 126 through which suturing or other flexible strands 218 can pass. The strands 218 can be attached to the soft tissue 82, thereby coupling the fixation device 100 to the soft tissue 82. A tubular shaft 230 can be used for inserting the fixation device 100 and for delivering the biologic material 90. The tubular shaft 230 can include one or more radial apertures 214 located along the shaft 230 and communicating with the longitudinal bore 236 of the tubular shaft 230 such that biologic material 90 can be delivered to the interface between the soft tissue 82 and the bone 80, while the fixation device 100 is partially or fully seated.
Referring to FIGS. 13A and 13B, the tubular shaft 230 can include an engagement surface 232, such as a hex surface, for engaging the proximal end of the fixation device 100 with an inserter or driver or other tubular delivery shaft 230. The radially located apertures 214 can be radial holes located off the distal end 234 of the tubular shaft 230, as shown in FIG. 13A, or slots located at the distal end 234 of the tubular shaft 230. The configuration of FIG. 13A can allow the delivery of biologic material 90 at the interface between the soft tissue 82 and the bone 80 before or after the fixation device 100 is fully seated, depending on the location of the radial apertures 214. The configuration of FIG. 13B can allow the delivery of biologic material 90 at the interface between the soft tissue 82 and the bone 80 before the fixation device 100 is fully seated.
As described above, the present teachings provide fixation devices 100 that can be used for delivering biologic material 90 at the interface of soft tissue 82 and bone 80. The fixation devices 100 can be, for example, rivets, expandable anchors, suture anchors, screws, or other devices that can be axially inserted in a pre-drilled bore in the bone 80 or threadably inserted directly into the bone 80. Biologic material 90 can be delivered at the interface of the soft tissue 80 and the bone 80 while the fixation device 100 is deployed, or when it is fully deployed or fully seated, or when it is partially deployed or partially seated. The biologic material 90 can be delivered through radial delivery apertures 114 of the fixation device 100 and/or through radial delivery apertures 214 of a cannulated insert 120 or an inserter or other tubular delivery shaft 230 that can be used for deploying, inserting or engaging the fixation device 100.
The foregoing discussion discloses and describes merely exemplary arrangements of the present invention. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the invention as defined in the following claims.

## Claims

1. A method for attaching soft tissue to bone comprising:
forming a bone bore through an outer surface of a bone and into the bone;
placing the soft tissue on the outer surface of the bone and above the bone bore;
inserting a bone-anchoring member of an expandable fixation device into the bone bore, the bone-anchoring member having a body, a head, a first longitudinal bore through the body and the head, and a first radial aperture communicating with the first longitudinal bore;
engaging the head to the soft tissue;
inserting an expansion insert of the fixation device into the first longitudinal bore of the bone-anchoring member, the expansion insert defining a second longitudinal bore and a second radial aperture communicating with the second longitudinal bore;
aligning the first radial aperture with the second radial aperture; and
delivering a separate biologic material through the first and second radial apertures of the fixation device between the soft tissue and the outer surface of the bone after placing the soft tissue on the outer surface of the bone and above the bone bore.

2. The method of claim 1, further comprising attaching the fixation device to soft tissue with a flexible strand.

3. The method of claim 1, wherein the biologic material selectively comprises platelet-rich plasma, growth factors, stem cells, pharmaceuticals, nutrients, or combinations thereof.

4. The method of claim 1, wherein the soft tissue and the bone are associated with a shoulder repair procedure, including Bankart repair, or SLAP lesion repair, or acromioclavicular separation repair, or capsular shift reconstruction, or capsulolabral reconstruction, or biceps tenodesis, or deltoid repairs, or rotator cuff repair.

5. A method for attaching soft tissue to bone comprising:
forming a bone bore in a bone;
placing a soft tissue on an outer surface of the bone and above the bone bore;
holding the soft tissue against the bone with an enlarged head of a fixation device;
inserting a bone-anchoring portion of the fixation device into the bone bore;
inserting an expansion insert into the bone fixation device;
expanding an expandable body of the fixation device;
aligning a radial aperture of the expandable body of the fixation device with a radial aperture of the expansion insert, the radial apertures configured to be substantially between the soft tissue and the outer surface of the bone when the fixation device is fully deployed; and
delivering biologic material between the soft tissue and the outer surface of the bone through the aligned radial apertures after placing the soft tissue on the outer surface of the bone and above the bone bore.

6. The method of claim 5, further comprising delivering biologic material through aligned longitudinal bores of the head and the expandable body of the fixation device.