Patent ID: 12256922

DETAILED DESCRIPTION

The following discussion is directed to various embodiments. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

The disclosure may generally include a method and system for transporting a flexible member such as a suture or tape from a first side of tissue to an opposite side of the tissue so as to be reliably discovered and manipulated thereafter. The method may include transporting the suture using a suture transporter assembly that may cooperate with a drill guide to reliably target the suture transport system through the tissue, maintain the flexible member within the tissue once transported and also allows for easy suture discovery at the opposing side. For example when used during ACL repair, the system may interact and be anchored with the ACL joint drill guide system.

Referring now toFIGS.1A and1B, an exemplary embodiment of a flexible member transporter assembly10is illustrated in a disassembled arrangement, including an outer tube20, an inner push tube30and flexible member40. Flexible member40may be operatively coupled to an expandable element45as defined herein. Expandable element45is operable to have a first configuration that is shaped or oriented to nest within a distal end of outer tube20and upon ejection from outer tube20(possibly using push tube30) may change orientation or change shape to have a larger cross section and thereby prevent retraction of element45and thereby flexible member40back into the tissue. One non-limiting example element may include a button style anchor that may be oriented in a first orientation while within the outer tube20and may rotate to a second orientation once out of outer tube30. Other non-limiting examples may include all-suture anchors, disclosed in more detail inFIGS.2A-2C and3A-3C. The expandable element45provides a temporary means of maintaining the flexible member40at the opposite end of the tissue and therefore does not need to provide long-term fixation. Flexible member40may be a single flexible member, or may be a bight, forming a flexible member distal end and expandable element45disposed at the flexible member distal end.

FIG.1Bshows the flexible member transporter assembly10with the outer tube20visible, the inner push tube30inserted therein. More detail of this assembly is shown inFIG.2A-2C. The flexible member40may extend along the inner tube30, with the expandable element45at a distal end of assembly, which as shown may be housed within outer tube20. Example assembly10is described in more detail in U.S. Pat. No. 9,962,149, and incorporated in its entirety by reference herein.FIGS.2A-2Cshow an example distal end of tube20, tube30and flexible member40. The embodiment of expandable element45shown inFIG.2Ais formed from a coarse braided material. More specifically, the structure utilized is a cylindrical, helically wound braid, such as the common biaxial braid. Pulling the entire braid along its length (i.e., putting the braid in tension) lengthens and narrows it. The length is gained by reducing the angle between the braided threads of the wound braid at the crossing points of the threads so that the braided threads align mostly parallel, which also reduces the radial distance between opposing sides and hence the overall circumference. When counter traction occurs, the opposite action occurs, and the braid contracts axially and expands radially, in this case by increasing the angle between the braided threads. This helically wound braid provides an advantage in that the structure can collapse and elongate naturally due to the alignment of the braids.

FIG.2Bshows the expandable element45in its elongated, compressed state and loaded into an inserter tube20in preparation for insertion through tissue and eventual deployment. The easily collapsible structure of the helically wound braid permits an installer to quickly and efficiently stretch the implant to the elongate position, and insert it into the inserter tube20. Upon insertion into and through tissue to an opposite side of the tissue, deployment of the soft anchoring expandable element45by tensioning the flexible member40, the fibers of the textile assume an orientation more orthogonally aligned with respect to the axis170.FIG.2Cshows this deployed state, wherein the expandable element45is generally shortened and larger in diameter or cross section than in the pre-deployed state (FIG.2A). In this example embodiment the outer tube may withdraw while the inner push tube30may remain stationary and tension on flexible member ends may deploy the expandable45.

A second non-limiting example assembly is shown inFIGS.3A-3C, similar to the assembly described in U.S. Pat. No. 8,795,334, incorporated in its entirety by reference herein. Expandable element45and a flexible member or flexible member40is interwoven through the expandable element45. The expandable element45may be formed of a malleable or flexible braided body, the body defining a plurality of openings formed crosswise through, or substantially along, the width W of the body. The flexible member40includes two terminal ends,40aand40b. One of the terminal ends40a,40bis passed through each of the openings in the body forming multiple curved portions35of the fixation member45to form substantially S-shaped curved portions35. The curved portions35may slide with respect to the flexible member40to form a cluster or bunch including a number of folds as shown inFIG.3Cand at least two S-shaped curved portions is preferred. The cluster in conjunction with the terminal ends40a,40b, may be used to secure flexible member40transported through to an opposing side of tissue as will be described in more detail heretoforth. Expandable element45may be a tape, mesh, tube, or other type of malleable or flexible structure, and the flexible member40may be made from a flexible member of different size depending upon the surgical procedure or application. In an alternative assembly, push tube may be a rod or sliding member operably coupled to expandable element45. The user may advance the rod30forward within the outer tube20to deploy the expandable element45from the outer tube20.

Assembly10may cooperate with a drill guide50, illustrated inFIGS.4A-4C. Drill guide50may be similar to known ACL drill guides and may include an aperture60sized for receiving a drill tip80therethrough. Drill tip80may slide within a drill guide cannula85, and cannula85may define an OD that inhibits the cannula from extending through aperture60, and therefore abuts a first side60A of aperture60. Once drill tip80is removed from cannula85, assembly10may then be inserted along cannula85and through aperture60. Assembly outer tube20is therefore sized to extend through drill cannula85and aperture60. Expandable element45may then be deployed so as have a second larger cross sectional shape or orientation, preventing expandable element45and thereby flexible member40from extending back through aperture60, as shown inFIG.4C.FIG.4Cshows the expandable element embodiment disclosed inFIG.3A-3C. Expandable element45is disposed on the far side60B of aperture60. Drill guide55may then be removed, drawing the flexible member40and expandable element45with it. The flexible member40is sufficiently long or coupled to a further surgical device such that it remains disposed along the tunnel and out of both openings of the tunnel for later shuttling. The captured portion of the flexible member may then be disengaged from the drill guide and a secondary element such as tissue or surgical device may be selectively coupled to flexible member40. Pulling the opposite end of flexible member40may then draw or shuttle the secondary element into the tissue tunnel.

An example method of transporting and capturing a flexible member40that may be used to shuttle a secondary device during a surgery of the knee200is shown inFIGS.5A-5D.FIG.5Ashows a femur220, tibia230and a portion of the patient skin210. Drill guide55is shown extending through a skin incision211. In this procedure a second skin incision212is not needed. The method may include using the drill guide55to form a tunnel95through the bone. The tunnel95may have been prepared using a drill80that extends through a cannula85, and the flexible member transporter assembly10may slide along the cannula85once the drill80has been removed. The method may include sliding a flexible member transporter assembly10through and along a prepared tunnel95and adjacent an aperture60of a drill guide. In some embodiments, an expandable element45is operatively coupled to the flexible member40and a distal portion of assembly10may be inserted through the aperture60. The expandable element45may then be deployed to an expanded or deployed configuration that cooperates with the aperture60to prevent the expandable element45and flexible member40from being drawn back through the aperture60as shown inFIG.5C. Drill guide and captured portion of flexible member40may then be removed from tunnel opening in the direction indicated by arrow A and through an existing skin incision formed to insert the drill guide55. A second incision for example area around 212 is therefore avoided. The captured portion may be disengaged from the gill guide and coupled to a secondary element42. Expandable element45may be removed to couple the secondary element42. Secondary element42may be drawn into the tunnel, indicated by arrow B and shown inFIG.5D.

A further example method of transporting and capturing a flexible member40that may be used to draw a secondary element towards a tissue surface during surgery on the shoulder700is shown inFIGS.7A-7C. Details of an example shoulder procedure that this method and system may be useful for, are disclosed in more detail in at least U.S. Pat. No. 9,402,650, commonly owned and herein incorporated in its entirety by reference.FIG.7Ashows a glenoid drill guide716inserted through a portal715in the patient's skin725adjacent the glenoid712. An engagement member714on the distal end of the glenoid drill guide716(e.g., a hook) is placed at a selected position on the glenoid710and the drill guide716is aligned. Engagement member714may include a means to engage a suture transport system such as an aperture760as disclosed herein. A tunnel721is shown drilled from a first glenoid surface722to a second surface723and the second surface may be configured to receive a graft thereon. A drill bullet (not shown) may form a tunnel. The method may include using the drill guide716to form a tunnel721through the bone. Illustrated inFIG.7Bthe flexible member transporter assembly10may then be inserted through tunnel721, and may be inserted along a cannulation of the drill guide716. In some embodiments, an expandable element45is operatively coupled to the flexible member40and a distal portion of assembly10may be inserted through the aperture760. The expandable element45may then be deployed to an expanded or deployed configuration that cooperates with the aperture760to prevent the expandable element45and flexible member40from being drawn back through the aperture760as shown inFIG.7B. Engagement member714and captured portion of flexible member40may then be removed through portal715, illustrated inFIG.7C. The captured portion may be disengaged from the engagement member714(and drill guide) and coupled to a secondary element (not shown). Expandable element45may be removed to couple the secondary element. Secondary element may be drawn through portal715, around the glenoid and may be drawn towards the second surface723. Secondary element may be drawn into the tunnel721. A second incision for example area around area730is therefore avoided to place a secondary element adjacent second surface723. Secondary element may be a coracoid graft that may be attached to the second surface723of the glenoid712. The method may therefore include coupling a coracoid graft (not shown) to the flexible member40and drawing the coracoid graft onto the surface723.

An alternative embodiment of a suture transporter system may include a flexible suture member capture member(s)120associated with the drill guide155, schematically shown inFIGS.6A-6C. This may eliminate the need for an expandable element as described in previous embodiments. Flexible member40may therefore be pushed through cannula185by a forked rod for example, which pushes the flexible member40through an aperture160of the drill guide and then through an aperture of the flexible capture member120. Suture capture member120may, in some embodiments comprise a suture capture cartridge selectively disposed over aperture160, aperture160being configured to receive a drill tip80as disclosed in previous embodiments. Suture capture cartridge may selectively couple and uncouple from drill guide155. Alternatively, suture capture member120may be a separate instrument having a handle that may place suture capture member120adjacent drill guide aperture160. Referring now toFIGS.6A,6B and6C, suture capture member120comprises an elongate aperture130formed by edges204,206on each opposed side. Edges204,206may further comprise suture capture surfaces208in certain embodiments. Suture capture member may operate in a similar manner to the suture cartridge disclosed in more detail in U.S. Pat. No. 9,211,118, commonly owned and herein incorporated in its entirety by reference. Suture capture surface208may be configured as opposed serrated edges, a plurality of interdigitating teeth, a plurality of opposed notches, or other similar opposed edge features. Suture capture cartridge125further comprises deflecting portions210,212(i.e., arms210,212) which extend from edges204,206respectively, and may be formed in a curved or arcuate shape. In certain embodiments, cartridge125and/or the components of suture capture member120are preferably comprised of high temper spring steel material.

The flexible member40may therefore by pushed through cannula185, with a forked push rod230, the forked portion configured to hold a flexible member40. Forked push rod230is advanced through aperture130and thereby between deflecting portions210,212. As forked rod and flexible member40pass through aperture130, forked rod230contacts edges204,206such that each of arms210,212are deflected away from rod230. The deflection of arms210,212is designed to be elastic such that arms210,212respectively return to or spring back into a pre-deflected or lesser-deflected position upon the subsequent withdrawal of rod130through aperture130. With the flexible member bight portion40′ protruding through suture capture member120, rod230may be withdrawn through aperture130and returned to a retracted position. As rod230is withdrawn through suture capture member120, arms210,212spring back to a non-deflected position such that aperture130and suture capture surface208are allowed to close around flexible member bight portion40′. Aperture130is large enough and the spring deflection of arms210,212is great enough that these characteristics of suture capture member120do not restrict the movement of rod230during displacement to the extended position. In addition, aperture130is sufficiently small when arms210,212are in the non-deflected configuration so that flexible member portion40′ is not allowed to pass back through suture capture member120. A loop or bight of flexible member40′ then remains between edges of suture capture member125. Drill guide155or just the removable cartridge125may then be removed from tunnel end, drawing the bight portion40′ with it. While drawing the bight portion40′ away from the tunnel end, the flexible member40may be sufficiently long to extend from both end of the tunnel. Flexible member bight portion40′ may then be disengaged from cartridge125. A secondary element such as tis5555sue or surgical device may be selectively coupled to bight portion40′ as described previously. Flexible member40may therefore act as a shuttling member.

The method of transporting and capturing the flexible member40may therefore include preparing a tunnel through tissue, which may include using a drill guide having a distal opening for guiding the second or distal end of the tunnel location. A suture capture member may then be placed near the second end of the tunnel and may be operatively coupled to the drill guide and over the distal opening of the drill guide. A suture transporter push rod230selectively coupled to a flexible member40may then be inserted from a tunnel first or proximal end through the prepared tunnel95and through an aperture160of a drill guide. Drill guide may include a cannula185and the tunnel95may have been prepared using a drill80that extends through cannula185; the push rod230may also slide along the cannula85once the drill80has been removed. Suture capture member120may include at least one flexible arm member defining a portion of a suture capture slot or aperture130. Push rod230may be operable to elastically deflect flexible arm member to place a bight portion40′ of flexible member40through aperture130and upon withdrawal of push rod230from within the aperture, the flexible member40may be released from push rod230and captured by the aperture130as the flexible arm springs back. Suture capture member120may then be removed, with a portion40′ of the flexible member40captured therein, the flexible member40still extending from the first or proximal opening of tissue tunnel. The captured portion of the flexible member40′ may then be disengaged from the suture capture member120and may be coupled to a second element such as but not limited to a second suture, flexible member, medical device or tissue such as a graft. Tension on the flexible member extending from the proximal tunnel opening may draw the second element towards the tunnel. Tension may further draw the second element into the tunnel second end.

Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.