Patent Description:
Surgical tools and techniques for introducing one or more suture anchors at a surgical site are described herein.

The described surgical tools include multiple prongs fixed relative to a shaft and may be utilized to introduce multiple suture anchors to a surgical site in a single step. The suture anchors may be interconnected with one or more sutures that may be utilized to apply compression to one or more of a graft, soft tissue, and bone.

A surgical tool assembly according to an exemplary aspect of the present disclosure includes a handle, a shaft extending from the handle, a first prong distal to and fixed relative to the shaft, and a second prong distal to and fixed relative to the shaft. A first anchor is disposed on the first prong, and a second anchor is disposed on the second prong. A first suture interconnects the first anchor and the second anchor.

A method according to an exemplary aspect of the present disclosure includes delivering a surgical tool assembly to a surgical site. The surgical tool assembly includes a pronged surgical tool, a first anchor, and a second anchor, which is interconnected to the first anchor. In the method, a first and second prong of the pronged surgical tool are inserted simultaneously through a soft tissue and a bone. The first and second prongs are removed, such that the first and second anchors remain at the surgical site.

A method according to an exemplary aspect of the present disclosure includes delivering a surgical tool assembly to a surgical site. The surgical tool assembly includes a pronged surgical tool, a first anchor, and a second anchor, which is interconnected to the first anchor by a first and second suture. In the method, a first and second prong of the pronged surgical tool are inserted simultaneously through a graft, a soft tissue, and into a bone. The first and second prongs are removed, such that the first and second anchors remain in the bone. The first and second suture are tensioned by sliding the first and second sutures within the first and second anchors.

These and other features and advantages of the invention will be more apparent from the following detailed description that is provided in connection with the accompanying drawings and illustrated exemplary embodiments of the invention.

This disclosure describes surgical tool assemblies and techniques for introducing one or more suture anchors at a surgical site. The surgical tools may be used to affix soft tissue to bone, to affix a graft to soft tissue, and/or to affix a graft to bone.

In some embodiments, the surgical site is one configured for a graft augmentation technique for repairing or reconstructing an unstable joint, such as in response to a massive irreparable rotator cuff tear or other injury. Although graft augmentation techniques associated with a shoulder joint are described throughout this disclosure as embodiments, this disclosure is not intended to be limited to shoulder surgeries. In other words, the various techniques described herein may be employed to reconstruct and/or improve the functionality of any joint of the human musculoskeletal system.

<FIG> illustrates a joint <NUM> of the human musculoskeletal system. The joint <NUM> may be any joint of the musculoskeletal system of the human body. In an embodiment, the joint <NUM> is the glenohumeral joint of a shoulder. The joint <NUM> includes multiple bones including a scapula <NUM> and a humerus <NUM>. Some of these bones articulate relative to one another. For example, the joint <NUM> includes a ball and socket joint formed between a head <NUM> of the humerus <NUM> and a glenoid <NUM>, which is a cup-like recession of the scapula <NUM> configured to receive the head <NUM>.

A capsule <NUM> generally covers the joint <NUM> and is surrounded and reinforced by various muscles, tendons and ligaments that are responsible for keeping the adjoining bones of the joint <NUM> together. The joint <NUM> may become unstable if there is significant disruption of the articulating bones (e.g., the humerus <NUM> and the glenoid <NUM>), the capsule <NUM>, or other surrounding muscles, tendons and/or ligaments. In an embodiment, the joint <NUM> could become unstable in response to a massive irreparable rotator cuff tear.

<FIG> illustrates an exemplary surgical tool <NUM> that may be used in a surgical procedure, such as a graft augmentation technique, for example. In other embodiments, the surgical tool <NUM> may be utilized in other surgical procedures, such as any procedure for securing tissue to bone, tissue to other tissue, graft to bone or tissue, etc. The surgical tool <NUM> may include a handle <NUM> and a shaft <NUM> extending from the handle <NUM>. The exemplary shaft <NUM> may be fixed relative to the handle <NUM>. Two prongs <NUM>, <NUM> may be distal from and are fixed relative to the shaft <NUM>. In some embodiments, as shown, a bridge <NUM> may be fixed transversely to the shaft <NUM> for integrally connecting the prongs <NUM>, <NUM> to the shaft <NUM>. The prongs <NUM>, <NUM> may extend distally away from the bridge <NUM>. In some embodiments, more than two prongs may be provided.

<FIG> illustrates the exemplary surgical tool <NUM> of <FIG> loaded with two anchors <NUM>, <NUM> to establish a surgical tool assembly <NUM>. The first anchor <NUM> may be provided on the first prong <NUM>, and the second anchor <NUM> may be provided on the second prong <NUM>. The exemplary first prong <NUM> may include pointed distal tips 34a, 34b, and the exemplary second prong <NUM> may include pointed distal tips 36a, 36b. The pointed distal tips 34a, 34b, 36a, 36b may be utilized to pierce one or more of graft, soft tissue, and bone during as surgical procedure, as detailed further below. More or fewer tips per prong may be provided in some embodiments.

In some embodiments, as shown, a portion of the first anchor <NUM> may be received between the distal tips 34a, 34b, and a portion of the second anchor <NUM> may be similarly configured with respect to the distal tips 36a, 36b. One or more of the distal tips 34a, 34b, 36a, 36b may include one or more sharp edges <NUM>. In some embodiments, the one or more sharp edges <NUM> allow the respective tip 34a, 34b, 36a, 36b to penetrate bone (not shown) through an applied force for seating the anchors <NUM>, <NUM> to a predetermined depth in the bone. The prongs <NUM>,<NUM> may be positioned at a predetermined distance d apart for implanting the anchors <NUM>, <NUM> at the predetermined distance d apart.

<FIG> illustrates the distal portion of the exemplary surgical tool <NUM> of <FIG> and <FIG> without the suture anchors <NUM>, <NUM> loaded thereon. A saddle <NUM> may be provided by the pointed distal tips 34a, 34b, and a saddle <NUM> may be provided by the pointed distal tips 36a, 36b. The saddle <NUM> may be contoured to receive the first anchor <NUM> (see <FIG>), and the saddle <NUM> may be contoured to receive the second anchor <NUM> (see <FIG>). Although the saddles <NUM> of the prongs <NUM>, <NUM> are shown at the distal ends therefore, other locations for receiving the anchors <NUM>, <NUM> are also contemplated within the scope of this disclosure. For example, the saddles could be located at an upper or lower outer surface of the prongs <NUM>, <NUM> at any location between the distal ends and the bridge <NUM>.

With reference to <FIG>, the saddles <NUM>, <NUM> are configured to engage external rounded surfaces of the respective anchors <NUM>, <NUM>. As shown in <FIG>, in some embodiments, the prongs <NUM>, <NUM> may further include notches <NUM> to accommodate suture, such as one or more suture strands that are arranged to interconnect the anchors <NUM>, <NUM> as discussed further below, while the prongs <NUM><NUM> are inserted into bone or tissue.

<FIG> further illustrates an exemplary suture anchor and suture configuration with the exemplary anchors <NUM>, <NUM> of <FIG>. Each anchor <NUM>, <NUM> may be made exclusively of suture-based materials. Therefore, the anchors <NUM>, <NUM> may be referred to as "soft" suture anchors. The suture-based materials confer the anchors <NUM>, <NUM> with the ability to be inserted into bone sockets/holes and bunch together, collapse, expand and/or change shape to fixate within the socket/hole. In some embodiments, soft suture-based materials may include yarns, fibers, filaments, strings, fibrils, strands, sutures, etc., or any combination of such materials. The soft suture-based materials may be synthetic or natural materials, or combinations of synthetic and natural materials, and may be bio-degradable or non-degradable within the scope of this disclosure.

The anchor <NUM> may include a first tubular sheath <NUM> and a first suture <NUM> passed through the tubular sheath <NUM>, and the anchor <NUM> may include a second tubular sheath <NUM> and a second suture <NUM> passed through the second tubular sheath <NUM>. The anchors <NUM>, <NUM> may be interconnected by one or both of the sutures <NUM>, <NUM>. For example, the first suture <NUM> may interconnect the tubular sheaths <NUM>, <NUM> of the anchors <NUM>, <NUM>. In some embodiments, as shown, the second suture <NUM> may interconnect the tubular sheaths <NUM>, <NUM> of the anchors <NUM>, <NUM>.

In some embodiments, the first suture <NUM> is spliced through the second suture <NUM> at a first splice section <NUM> (shown schematically). In some embodiments, splices lock the suture once it has been tightened between the two anchors and the tissue pulled down to bone. The first splice section <NUM> may be positioned within the second tubular sheath <NUM>. The second suture <NUM> may additionally or alternatively be spliced through the first suture <NUM> at a second splice section <NUM>. The second splice section <NUM> may be positioned within the first tubular sheath <NUM>. In some embodiments, the splices may be formed with a splicing device, such as an additional suture or wire, for example. The sutures <NUM>, <NUM> provide bridge portions <NUM> that are tensionable by pulling the free ends <NUM> of the sutures <NUM>, <NUM>. As explained further below, the bridge portions <NUM> may be utilized to apply compression to a graft or soft tissue located between the anchors <NUM>, <NUM>. In some embodiments greater or fewer than two sutures <NUM>, <NUM> may be utilized as part of the surgical tool assembly <NUM>.

The tubular sheaths <NUM>, <NUM> of the anchors <NUM>, <NUM> may provide internal passageways <NUM>, <NUM> for receiving the sutures <NUM>, <NUM>. The tubular sheaths <NUM>, <NUM> may be positioned over the splice sections <NUM>, <NUM> as shown.

<FIG> illustrates another exemplary suture anchor and suture configuration of suture anchors <NUM>, <NUM> having first and second splice sections <NUM>, <NUM> within tubular sheaths <NUM>, <NUM>. The first splice section <NUM> may be positioned within the second tubular sheath <NUM>. The second suture <NUM> may be spliced through the first suture <NUM> at a second splice section <NUM>. The second splice section <NUM> may be positioned within the first tubular sheath <NUM>.

As shown, the first suture <NUM> includes a first end <NUM> and passes into a first end <NUM> of the tubular sheath <NUM>, out of a second end <NUM> of the tubular sheath <NUM>, into a first end <NUM> of the second tubular sheath <NUM>, splicing through the second suture <NUM> at splice section <NUM>, and passes out of the second end <NUM> of the second tubular sheath <NUM> to second end <NUM>. The second suture <NUM> includes a first end <NUM> that passes through the first end <NUM>, the second end <NUM>, the first end <NUM>, splices through the first suture <NUM> at the splice section <NUM>, and passes out the second end <NUM> to a second end <NUM>. The sutures may be tensioned by a surgeon by pulling on the free ends <NUM>, <NUM>.

In some embodiments, as shown, the sutures <NUM> and <NUM> are spliced through the suture end <NUM>, and the sutures <NUM> and <NUM> are spliced through the suture end <NUM>. More specifically, as shown, at splice section <NUM>, the suture end <NUM> may splice through the suture end <NUM>, the suture <NUM> may splice through the end <NUM> as it passes from sheath end <NUM> to sheath end <NUM>. Alternatively or additionally, as shown, at splice section <NUM>, the suture end <NUM> may splice through the suture end <NUM>, and the suture <NUM> may splice through the suture end <NUM> as it passes from sheath end <NUM> to sheath end <NUM>. In some examples, in such a self-bunching design, when a surgeon pulls on a repair suture it constricts the suture loop that is created by piercing the suture through itself and deploys the bunching effect that sets the anchor <NUM>,<NUM>, such as under the cortical bone.

As shown in <FIG>, another exemplary suture anchor and suture configuration for the suture anchors <NUM>, <NUM> includes a single suture <NUM> utilized to interconnect tubular sheaths <NUM>, <NUM> in some embodiments.

<FIG> illustrates exemplary suture anchor and suture configuration for the suture anchors <NUM>, <NUM> utilizing a single suture <NUM> to interconnect the tubular sheaths <NUM>, <NUM>. The suture <NUM> includes an end <NUM> and passes through the first end <NUM> of the tubular sheath <NUM>, through the second end <NUM> of the tubular sheath <NUM>, through the end <NUM> of the tubular sheath <NUM>, out the end <NUM> of the tubular sheath <NUM>, back through the sheath end <NUM>, splices through itself at splice section <NUM>, passes out the sheath end <NUM> to provide free end <NUM>. The free end <NUM> may splice through the end <NUM> at splice section <NUM> as shown. The suture <NUM> may additionally or alternatively splice through end <NUM> as it passes from sheath end <NUM> to sheath end <NUM>.

As shown in <FIG>, in another exemplary suture anchor and suture configuration for the suture anchors <NUM>, <NUM>, there may only be a single splice of one suture through the other, such as the first suture <NUM> being spliced through the second suture <NUM> at a first splice section <NUM> or vice versa.

<FIG> shows another exemplary suture anchor and suture configuration for the suture anchors <NUM>, <NUM> in which there is a splice of one suture through the other within only one of the respective tubular sheaths. The configuration of <FIG> is substantially similar to that shown in <FIG>, except that the tubular sheath <NUM> includes splice section <NUM> in which suture <NUM> splices through suture <NUM>, and the tubular sheath <NUM> is free of a splice section.

In some embodiments, the splices described herein may be performed before the anchors <NUM>, <NUM> are inserted. In other embodiments, the splices described herein may be performed after the anchors <NUM>, <NUM> are inserted. The exemplary sutures disclosed may be slidable within the anchors <NUM>, <NUM>.

<FIG> schematically illustrates an exemplary use of the surgical tool assembly <NUM> for introducing the anchors <NUM>, <NUM> to a surgical site <NUM>. In some embodiments, the surgical site <NUM> is located at the joint <NUM> of <FIG>. However, other implementations are also contemplated within the scope of this disclosure.

During implantation, the prongs <NUM> and <NUM> of the surgical tool <NUM> may pierce through a graft <NUM>, soft tissue <NUM>, and bone <NUM> to seat the anchors <NUM>, <NUM> into the bone <NUM>. The sutures, such as those in any of the exemplary configurations shown in <FIG>, may then be tensioned to compress the graft <NUM> against the tissue <NUM>, and both the graft <NUM> and the tissue <NUM> against bone <NUM>. The bridge portions <NUM> of the sutures may be opposite the graft <NUM> and the tissue <NUM> from the bone <NUM>, thereby allowing the sutures <NUM>, <NUM> to compress the graft <NUM> against the tissue <NUM> and the graft <NUM> and tissue <NUM> against the bone <NUM> in response to a tensioning force. Althought the bridge portions <NUM> are referenced in the figure, the bridges formed in any of the configurations shown in <FIG> may be utilized.

In some embodiments, as shown in <FIG>, a graft <NUM> may not be used, and the anchors <NUM>, <NUM> are inserted through soft tissue <NUM> and seated into bone <NUM> to compress the soft tissue against the bone <NUM>.

In some embodiments, the surgical tool <NUM> allows reproducible positioning of the anchors <NUM>, <NUM> relative to another in a single insertion step. The two anchors <NUM>, <NUM> may be introduced simultaneously at a predetermined distance apart. In some embodiments, more than two prongs <NUM>, <NUM> and/or anchors <NUM>, <NUM> may be utilized in a single surgical tool.

<FIG> illustrates another example surgical tool <NUM> that may be used in a surgical procedure, such as a graft augmentation technique, for example, and used as a surgical tool assembly with any of the exemplary suture anchor and suture configurations for the suture anchors <NUM>, <NUM> disclosed herein. The example tool includes a handle <NUM> and prongs <NUM> and <NUM> extending from the handle <NUM>. An outer sheath <NUM> may receive at least a portion of each of the prongs <NUM> and <NUM>. The prong <NUM> may be fixed, and a mechanism <NUM>(shown schematically) may be utilized to advance the prong <NUM> distally when desired.

Alternatively or additionally, as shown in <FIG>, the mechanism <NUM> may be utilized to retract prong <NUM> proximally when desired. In an embodiment, the prong <NUM> may be fixed.

<FIG> illustrates another example surgical tool <NUM> that may be used in a surgical procedure, such as a graft augmentation technique, for example, and used as a surgical tool assembly with any of the exemplary suture anchor and suture configurations for the suture anchors <NUM>, <NUM> disclosed herein. The example tool includes a handle <NUM> and fixed prongs <NUM> and <NUM> extending from the handle <NUM>.

The exemplary surgical tools <NUM>/<NUM>/<NUM> of this disclosure may be utilized in various graft augmentation techniques. These techniques may include superior capsular reconstruction, in some embodiments. In other embodiments, the exemplary surgical tools <NUM>/<NUM>/<NUM> may be utilized in any technique where a graft may be positioned against soft tissue and/or bone.

In some embodiments, only one of the anchors <NUM>, <NUM> may be seated into bone.

In some embodiments, the graft <NUM> may include either an allograft or an autograft. In some embodiments, the graft <NUM> is an acellular dermal extracellular matrix. ArthroFlex®, sold by Arthrex, Inc. , is one type of graft <NUM> suitable for use to perform an exemplary graft augmentation technique. In some embodiments, the graft <NUM> may be a suture patch or any other synthetic augmentation. The sutures <NUM>, <NUM> may include suture strands, suture tape, any other suture-like product, or any thread-like material.

A method according to this disclosure may include delivering a surgical tool, such as any of the surgical tools <NUM>/<NUM>/<NUM> described herein, to a surgical site. The method includes inserting, simultaneously, first and second prongs of the surgical tool through a soft tissue. The method includes removing the first and second prongs, such that the first and second anchors remain at the surgical site. In some embodiments, the anchors are implanted into bone and the anchors remain seated in the bone. In some embodiments, the method may include tensioning one or more sutures interconnecting the anchors for achieving graft and/or soft tissue compression.

In addition, the various figures accompanying this disclosure are not necessarily to scale, and some features may be exaggerated or minimized to show certain details of a particular component or arrangement.

Claim 1:
A surgical tool assembly, comprising:
a handle (<NUM>);
a shaft (<NUM>) extending from the handle (<NUM>);
a first prong (<NUM>) distal to and fixed relative to the shaft (<NUM>);
a second prong (<NUM>) distal to and fixed relative to the shaft (<NUM>);
a first anchor (<NUM>) disposed on the first prong (<NUM>);
a second anchor (<NUM>) disposed on the second prong (<NUM>); and
a first suture (<NUM>) interconnecting the first anchor (<NUM>) and the second anchor (<NUM>);
characterized in, that
the surgical tool assembly further comprises a second suture (<NUM>) interconnecting the first anchor (<NUM>) and the second anchor (<NUM>), and
wherein the first suture (<NUM>) is spliced through the second suture (<NUM>) at a first splice section (<NUM>).