Patent ID: 12207814

DETAILED DESCRIPTION

The present invention includes multiple components, devices and methods to create and use an overall system for reattaching soft tissue to bone. It is particularly useful to create a robust repair of torn tendons, such as the supraspinatus tendon, in an arthroscopic rotator cuff repair. The implants and delivery devices make possible a faster, easier and lower failure rate anatomical repair. The tendon is securely attached and held with adequate force to its original footprint with very little creep during movement of the joint. This decreases a patient's time in a sling, increases the rate of healing reattachment of tendon to bone and allows early physical therapy to maintain range of motion and strength.

The implanted array of anchors with a continuous set of anchor-to-anchor single suture stitches creates a seam-like attachment akin to a sewing machine construct. Further, the small cross-sectional size of the anchors (less than 3 mm in diameter) allows the anchors to be placed in close proximity to one another (less than about 7 mm between adjacent anchors). This creates an anchor to anchor suture stitch. Combining this concept with the disclosed anchor design allows the suture stitch to be tightened and locked individually when the adjacent suture anchors are implanted. This can be repeated many times to implant a row of anchors with continuous independently tensioned and locked stitches between adjacent anchors. Also, because the anchors are in a high-density array, the tension force components on the tensioned suture are more vertically applied to the top surface of the tendon (or other connective tissue) to thereby hold the tendon against the footprint of the bone without creep or slippage during joint movement.

FIGS.1A-1Kare a series of illustrations of exemplary toggle bodies or toggle-type anchors that can be used in a procedure for attaching tendon to bone. The illustrations also show a single working suture slidably disposed in passages through the anchor and through a locking loop. The locking loop is configured to have an open position allowing movement of the single working suture, and a closed or locked position that prevents movement of the single working suture.

Referring toFIG.1A, a perspective view of a representative anchor in the form of a toggle body100is illustrated. The toggle body100can be an elongate body101having a length defined by a proximal end102and a distal end104. The elongate body101can be a generally cylindrical body but other shapes are possible. For example, as shown inFIG.1A, the toggle body100is generally cylindrical but the top surface105and bottom surface107have flat axially-extending surfaces that allow room for sutures when the toggle body100is in a round delivery tube. The length of the toggle body100is substantially longer than the diameter thereof, allowing the toggle body100to be inserted lengthwise or axially into a small bone hole. Once inserted, unlike most anchors used today, the entire body is pivoted or toggled so that it stays within the bone and has substantially its entire length compressed against material inside the bone. That is, the longitudinal axis of the toggle body100is rotated or pivoted from the direction used to insert through the bone hole, thereby preventing removal. This approach means that removal would require the anchor itself to fail, rather than simply being released from surrounding tissue, and provides high pullout strength (greater than 600 N before anchor failure when implanted in the array disclosed herein) from an anchor requiring a very small insertion hole (less than about 3 mm). As previously stated and described in detail below, small insertion holes allow much closer placement of anchors in a high-density array.

The toggle body100, can have a length of about 6 mm to about 10 mm in some embodiments. This length gives adequate strength while leaving enough room inside the bone for the high number of anchors implanted. The toggle bodies are preferably molded or machined from a polymeric material, preferably a high tensile strength material such a poly-ether-ether ketone (PEEK) which is highly biocompatible. In applications where MRI imaging would not be an issue, metal can be utilized in part or all of the toggle body.

Referring now also toFIG.1B(top view) and1C (bottom view), it can be seen that the toggle body100can include a number of holes or passages through the cross section of the toggle body100. As illustrated, the toggle body100has a proximal bore or passage110, a middle passage108and a distal passage106. The passages106,108,110extend from the top surface105to the bottom surface107such that the passages106,108,110extend through the cross section of the elongate body101. In other embodiments, the toggle body may have fewer or more bores or passages, such as having a single bore, two bores, or more than three bores. In the illustrated embodiment, the proximal passage110and distal passage106receive a portion of a common working suture slidable with respect to the toggle body100during use. The middle passage108receives a locking suture which is independent for each anchor used in an array of anchors.

The distal end104of the toggle body100has an angled surface. As shown, the angled surface creates a longer upper longitudinal surface105than lower longitudinal surface107. In other words, the upper surface projects a greater distance distally than the lower surface. This is useful during insertion of the toggle body100because the projecting distal surface plows into cancellous spongy bone when implanted to initiate at least partial rotation of the toggle body during insertion. Keeping in mind that the present toggle bodies100are preferably implanted through the tendon, it is important that the toggle body100toggle every time or it may pull out of the bone hole under tension yet not be visible as it will be under the tendon.

The proximal end102of the toggle body100can include one or more projecting fins112. The illustrated embodiment includes two fins112. Each fin112projects outward and proximally. Further, in some embodiments, as depicted, the fins112project downward as they extend proximally. The function of the fins112is best understood with reference toFIGS.1D and1Ewhich are distal and proximal end views of the toggle body100, respectively. A reference circle113is included which indicates the general maximum cross section or diameter of the elongate body101. The bone hole in which the implant will be placed is sized to closely match this dimension, as is the inner diameter of a delivery tube used to deliver the implant. In contrast, as shown, the fins112each project laterally beyond the outer cross section or diameter of the elongate body. During insertion the fins112flex inward under compressive force due to contact with the inner diameter of a delivery tube to fit in the bone hole.

Once delivered and released from compressive forces of the delivery tube, the fins112relax to a size greater than the bone hole. In some preferred embodiments, each fin tip extends about an additional 0.5 mm beyond the size of the bone hole where that feature is inserted. Such fin tips may also be described as extending about 0.5 mm beyond the maximum outer diameter of the rest of the anchor body, for example, in the range of 0.4 mm to 0.7 mm. This feature provides an added safeguard against the toggle body100backing out of the bone hole under tension if the toggle body100has not adequately toggled. Further, the fins112are positioned so that tension on the toggle body100causes the partially toggled anchor to grab cancellous bone and further rotate the anchor.

Alternative designs of the fins112are also depicted inFIGS.1F and1G. The fins112in these figures have alternative positions on the elongate body101and direction of proximal extension. The fins112ofFIG.1Fare widest at a centrally located position to keep the anchor centered in the delivery tube since the largest dimension is horizontal at the diameter of the tube during delivery. In some examples, the fins do not provide the pullout strength necessary for the implanted anchor to reattach the tendon. As previously stated, in preferred examples, each anchor toggles so that the full length of the anchor is pressed against interior bone structure to provide adequate pull out strength.

The top and bottom views ofFIGS.1B and1Cshow details of the proximal110, middle108and distal106passages. In particular, the middle hole has a platform114formed within the elongate body101, part way through the cross section. That is, in this example, the middle passage108has a change in size or shape partway along its length, to define a platform114. From the bottom view, it can be seen that the middle passage108continues from the platform114with a slotted or oval shape or portion111, while having a circular profile from the top view. The function of these passages is detailed in the cross-section perspective views ofFIGS.1H and1Iwherein representative cords or sutures115,116have been pre-strung on the toggle body100.

First, there is a single suture, called herein the working suture115that extends into the proximal passage110from the top surface, and extends out at the bottom surface. The working suture115then extends up through the distal passage106from the bottom surface and out through the top surface. This leaves a section117of the working suture115extending past or adjacent the middle passage108along the bottom surface. The working suture115can be flossed or is slidable through the distal106and proximal passage110, meaning the toggle body100can slide on the working suture115when tension is applied. Second there is a locking loop118that encircles a portion of the section117of the working suture115extending adjacent the outer surface of the toggle body100between the proximal110and distal106passages. The locking loop118has a first open position as depicted inFIG.1Hwherein the working suture115is free to slide through the locking loop118and a second closed position depicted inFIG.1Iwherein the locking loop118engages the section117and prevents it from sliding within the locking loop118.

Several examples refer to a suture, cord, or thread, which can be used as the working suture115or in the locking loop118. These elements may be, for example, made of natural material such as silk and/or synthetic materials such as polyglycolic acid, polylactic acid, and polydioxanone, each of which are known for use as absorbable sutures, and/or nylon and polypropylene, which are typically non-absorbable. Various coatings, including antimicrobial, anti-wicking or lubricious coatings may be applied as well. More broadly, these elements115,118may include any item that can be used to couple together objects in a surgical environment, such as any sufficiently biocompatible metal, natural material, plastic or other artificial material adapted for use in a surgical procedure. Monofilaments or more complex structures including braids, weaves, windings, twisted threads, coated or multilayer member, etc. may be used.

In the embodiment depicted, the locking loop118extends from the bottom surface of the toggle body100through the middle passage108. The locking loop118includes a cord or suture having at least a slidable knot120tied therein to allow collapsing of the locking loop118when a free end or proximal end121of the suture lock116extending through the middle passage108is tensioned. As shown, the upper portion of the middle passage108is sized to receive at least a portion of the slidable knot120therein. The slidable knot120then contacts the surface of the platform114which does not allow the knot to pass through towards the bottom opening. The lower oval portion113of the middle passage108is a slot or oval which allows both legs of the locking loop118to pass therethrough, preferable side by side in the slot direction. The interaction of these components locks the working suture115with respect to the toggle body100.

As shown, especially seen inFIGS.1C and1I, the bottom of the toggle body100includes a channel125formed in the bottom surface107between the proximal110and distal106passage. When the working suture115is tensioned, it is pulled up into this channel125which is sized to make the suture less able to floss or move therethrough by increasing frictional resistance to such movement, but does not lock the suture. Further, the working suture then has two near 90-degree angle turns at the bottom openings of the distal106and proximal110passage which also make it more difficult to floss, but do not lock the working suture115. The locking loop118closing around the working suture115and pulling it toward and at least partially into the slot or oval portion113is the structure that locks the suture so that cumulative friction prevents slippage of the working suture115.

In the illustrative example shown inFIGS.1H to1K, the free end121of the suture lock116is configured to break away from the locking loop118proximal of the sliding knot120. A break knot is illustrated at122and is one example of a way of introducing weakness in the suture lock. The break knot122is located a distance above the sliding knot120, sufficient that when the suture lock116breaks away, the sliding knot120remains intact and secure; for example, 3 to 10 mm proximal of the sliding knot, or more or less. Rather than a break knot122, a nick or other point of weakness may be imparted at the desired or preferential point of failure in the suture lock116.

FIGS.1J and1Kdepict the way in which the locking loop118pulls the section117of the working suture115into the oval portion113in two different embodiments. The degree to which the section117of the working suture115enters the slot113will be dependent upon how tight the loop is closed, the size of the locking suture and the size of the slotted opening. In preferred embodiments, at least a portion of the cross section of the working suture115is pulled into the slot so that the edge surfaces of the slot walls provide significant friction and aid in locking. In another example, the preferential point of failure is designed to allow the locking loop118to be drawn into the slot before the failure occurs.

The locking loop118in combination with the design of the middle passage108is an assembly for locking a slidable working suture115when tensioned in a suture toggle body100during tissue fixation to bone. The locking loop118encircles a portion of the working suture115, wherein collapsing the locking loop118compresses the cross section of the working suture115to lock the working suture115when tensioned. The suture lock116is preferably formed of a suture having at least a slidable knot120tied therein to form the loop118to allow collapsing of the loop118when a tightening leg121through the second passage108is tensioned. The second passage108has an upper portion for receiving the slidable knot120at least partially therein that terminates in a platform114within the toggle body100that does not allow passage of the slidable knot. The second passage includes a lower portion having an oval shape for allowing both legs of the locking loop to pass therethrough side by side and out the passage. A particularly preferred knot is a 4-throw uni knot. However, other slidable knots120may be used, as desired. Further, the second passage oval portion is sized to allow movement of at least a portion of the working suture115to be pulled therein in response to tension on the locking cord. The working suture115is preferably a braided multistrand suture having a compressible cross-sectional area that reduces by at least about 25% when the locking loop is tightened during use. The working suture115can be a round and/or braided No. 2 suture in some embodiments. Other suture sizes and types may be used.

As also shown inFIGS.1I and1K, after the sliding knot120is tightened, and the working suture is drawn at least partly into the slot, the preferential point of failure in the locking loop116(such as the break knot or nick described above) breaks, leaving free tail at123on the locking loop, a distance above the sliding knot, while the rest of the proximal portion of the suture lock124can be discarded. In some examples, a more proximal portion of the suture lock is secured to a cartridge, so that a physician may cause the suture lock to break as shown by pulling on the cartridge itself, as further described below. In an example, the preferential point of failure is designed to allow tightening of the locking loop118onto the working suture115before the failure occurs. For example, the locking loop and the preferential point of failure may be configured for breaking under a pull strength in the range of 3-10 pounds of force, more preferably, 5-7 pounds of force, or more or less as desired. The pull strength needed to tighten the locking loop118onto the working suture may be less than the pull strength needed for breaking the preferential point of failure in some examples by, for example, an amount in the range of 0.5 to 3 pounds, or 0.75 to 2 pounds, or about 1 pound.

In some preferred embodiments, the above-described anchor does not function alone. Instead it is part of a pre-strung array of anchors having a common serially disposed working suture115therethrough.FIG.2Aillustrates a pre-strung array201. Each anchor200can be implanted sequentially within the array, then the working suture section extending from the just implanted anchor to the just previously implanted anchor can be tensioned, then locked at the just implanted anchor so that a suture stitch between the two anchors provides force against the tendon to hold it in place much like a single sewn stitch. With the array, multiple continuous stitches can be formed similar to a sewn seam.

InFIG.2Aa pre-strung array201of individual anchors200is depicted. The anchors200may be similar in form and function to the anchor100described herein. The shown array has four anchors200as a representative chain. It is believed chains of 4 to 12 anchors would be useful in tendon repair procedures such as rotator cuff repair. One particular embodiment includes 8 anchors in an array. As depicted inFIG.2A, the way in which the working suture115is pre-threaded through the series of anchors200is important to assure that they will toggle as desired and tension to form the stitch when the suture is tightened. The illustration shows the first anchor202to be implanted followed by the second anchor204, then the third anchor206and finally the fourth anchor208. With this order of implantation understood, the working suture115has been pre-threaded down through the top of the proximal hole210and back up through the distal hole211of the first anchor202. The working suture115then continues to the second anchor204where it is threaded down through the proximal hole212and back up through the distal hole213of the second anchor204. The working suture115then continues to the third anchor206where it enters the top of the proximal hole214and back up the distal hole215of the third anchor206. The working suture then continues to the fourth anchor208where it enters the top of the proximal hole216and passes up through the bottom of distal hole217of the fourth anchor208. If the array were more than four anchors, the pre-threading would continue as described for each subsequent anchor.

FIG.2Bis a cross sectional view of the array ofFIG.2Awhich more clearly shows the threading of the working suture115within the anchors200in the array201. The way in which the locking suture116is disposed in the middle passage is also shown for each anchor200as described above with each locking loop118independent for each anchor. The locking suture116can have a preferential point of failure so that it can be tightened then broken off above the slidable knot. This can be accomplished by tying a break knot, or making a nick in, in the free tail of the locking loop just above the slidable knot, as further illustrated inFIGS.1H to1K, above. In some preferred embodiments the slidable knot is a 4-throw uni knot and the break knot is in the free tail just above the uni knot. The suture lock may be designed to break at a desired tension with the slidable knot in place sufficient to lock the working suture.

To create an implanted serial array of tensioned and independently locked anchor to anchor suture stitches for attaching a tendon to bone, a surgeon would begin with the pre-strung array201described inFIGS.2A and2B. The first anchor202would be implanted through the tendon into a formed bone hole and the working suture locked. The second anchor204would then be implanted in close proximity to the first anchor202, preferably less than 7 mm away. The second anchor is toggled and the working suture tensioned at the same time by pulling on the working suture115that exits the distal hole213of the second anchor204. Tension at this location not only toggles the second anchor204but also tightens the working suture115going back to the first anchor202to form the tensioned stitch holding the tendon against the footprint. The second anchor204is then locked so that the stitch remains tensioned and is isolated or independent of other stitches. The process is repeated for the third anchor206and fourth anchor208or more. In one preferred array, eight anchors are implanted and 7 tensioned and locked stitches in a continuous row are formed. Further, in a rotator cuff repair, multiple arrays can be implanted such as one array extending across the tendon in the medial portion of the footprint and a second array more lateral to the medial position.

One preferred anchor delivery device300for transtendinous implantation of individual anchors in an array is depicted inFIG.3A. The delivery device300is particularly useful to implant anchors disclosed herein and detailed below with respect toFIGS.1A-1Kand the disclosed array inFIGS.2A-2B.

FIGS.3A-3Care perspective views of an example anchor delivery device in several configurations, andFIGS.3D-3Fare close up views of the distal end of the anchor delivery device corresponding toFIGS.3A-3C. Starting withFIG.3A, the delivery device300can be a gun-like component that has a proximal housing310that includes a pistol grip type handle311and trigger312that moves from a spring retained released position to an engaged position upon squeezing and holding the trigger (as further illustrated below). The trigger312is linked to moveable internal features within the proximal housing310to provide desired functions during implantation described below. The delivery device300includes an elongate tube306extending distally from the proximal housing310. As shown in the close-up view ofFIG.3D, the elongate tube306includes a longitudinal slot307over its length for receiving sutures therethrough as anchors are passed through the central lumen of the tube.

FIG.3Aalso shows that the proximal housing310is associated with a bone punch having a distal punch head322and a proximal punch head323. The proximal punch head323has a tapping surface324at its proximal side. Combined elements322and323form a punch head assembly. As illustrated inFIG.3D(which corresponds to the configuration ofFIG.3A), the bone punch also includes a punch pin320having a tapered point321adapted for probing through the tendon and/or grabbing the tendon to aid positioning. Positioning may include positioning the tendon in its original footprint, for tendons that are detached. In some examples, positioning as a separate step may be omitted or limited, such as when repairing a partial tear, such as a partial thickness articular side tear or combination of full thickness and articular partial thickness tears. A tendon can be considered positioned at a location for securing to bone either by virtue of having placed a fully torn or detached tendon at a location, such as its original footprint, where it can be re-attached, or, with a partial tear, when the tendon is located where a physician desired to have it when applying anchors to repair or otherwise address the partial tear.

The punch pin320and tip are configured for being pounded into bone to create a bone hole; the tapered point321is also used in some methods disclosed herein to engage and push against the proximal end of an anchor. The punch pin320extends through the proximal housing310and the elongate tube306. The punch pin320is affixed to the proximal punch head323and is slidable within the distal punch head322. The distal punch head322snap latches to the proximal housing310of the delivery device. The proximal punch head323and distal punch head322are connected by a spring-loaded mechanism that holds the punch pin320in a fully extended position when the proximal punch head323is pushed against the distal punch head322and latched. When the proximal punch head323is released from close connection with the distal punch head322, the spring loading causes the punch pin320to withdraw proximally to a partially retracted position with only a short distal portion of the punch pin320extending beyond the elongate tube306for use in probing a potential implant site. Such a configuration of the implant tool is shown inFIGS.3A and3D, where the punch pin320is the only piece extending from the distal tip of the elongate tube306, the distal punch head322is latched to the proximal housing310, and the proximal punch head323is not latched to the distal punch head322. Also included on the proximal housing310is a receiver398for receiving a magazine that carries cartridges which hold individual anchors of the array to be implanted, as is illustrated inFIG.4A, below.

FIG.3Band correspondingFIG.3Eshow another configuration of the delivery device300. Starting withFIG.3B, it can be seen that the trigger312remains in a relaxed position and is not depressed (similarly toFIG.3A). The proximal punch head323is now latched to the distal punch head322. Latching together of the punch head causes the distal end of the punch pin320to extend further from the distal end of the elongate tube306, as shown inFIG.3E. Now an additional element can be seen, in that the elongate tube306has an anchor delivery tube330disposed therein. The action of latching together the proximal punch head323with the distal punch head322advances the anchor delivery tube330distally, and forces a distal portion of the anchor delivery tube330past the distal end of the elongate tube306. The anchor delivery tube330also has a longitudinal slot331aligned with the longitudinal slot307of the elongate tube for passing a suture therethrough. With the anchor delivery device300configured as shown inFIGS.3B and3E, the device is ready for a surgeon to pound or tap the tapping surface324, such as with a surgical mallet, to force the punch pin320and its tip321into bone to create a bone hole.

FIGS.3C and3Fshow a next configuration of the delivery device. Here, the distal punch head322is no longer engaged with the proximal housing310, and the proximal and distal punch heads323,322, are not latched together. The disengagement of the distal punch head322and housing310, and disengagement of the proximal and distal punch heads323,322, is caused by actuation of the trigger311, as further discussed below. As described in the method illustration ofFIGS.6A-6G, below, this configuration would arise after a bone hole is created, and is used to introduce an anchor/suture into the anchor delivery tube for implant. To facilitate such a step in the procedure, a portion of the anchor delivery tube330referred to as the nub332remains extended from the distal end of the elongate tube306, as shown byFIG.3F. With the bone punch retracted or removed, the anchor delivery tube330now defines an open lumen333to allow an anchor to be introduced and passed therethrough with the aid of the re-inserted bone punch, as detailed below. As also highlighted inFIG.3F, optionally, the distal end of the elongate tube306may be tapered as shown at308. The taper308, in some examples, provides the elongate tube306with a blunt distal tip that can be used to maintain force against the outside of a tendon during manipulation of an anchor and/or tensioning of a stitch between two anchors.

At a high level, the procedure may be understood as follows. With the anchor delivery device300in the configuration shown inFIGS.3A/3D, the physician may probe the surgical site to identify a location where an anchor is to be implanted. Once the desired location is identified, the physician applies force to the tapping surface324of the bone punch to force the bone punch through the tendon and to create a bone hole using the distal tip321of the punch pin320. As the physician advances the bone punch in this manner, the proximal and distal punch heads323,322will become latched together to form the configuration as shown inFIGS.3B/3E. The same action of advancing the bone punch relative to the elongate tube also advances the anchor delivery tube330and nub332beyond the distal end of the elongate tube306. Next, the trigger311is actuated to release the bone punch, pushing the bone punch in a proximal direction to create the configuration as shown inFIGS.3C/3F. The implant tool300is held in position, using the nub332to maintain registration with the formed bone hole. In some examples, a portion of the nub will be inserted into the bone hole. An anchor is then introduced into the anchor delivery tube330and passed down the lumen333thereof to the distal end, with force applied to advance the anchor using the bone punch assembly. Complete insertion of the anchor can be confirmed by maintaining pressure against the tendon to hold the nub332in the desired registration relative to the bone hole, and pushing the proximal punch head323in the distal direction until the distal punch head322latches with the proximal housing310and the proximal punch head323latches with the distal punch head322. Now the trigger311will again be actuated, however, due to mechanisms that will be explained below, this second actuation of the trigger after insertion of the anchor will apply positive retraction force, along with spring force, to retract the anchor delivery tube330and nub332into the distal end of the elongate tube306, as well as retracting the bone punch. With the nub retracted, the physician can manipulate toggling of the anchor using the working suture without the nub332possibly damaging the working suture, while force can be maintained against the tendon and bone by pressing the distal tip of the elongated tube306against the tendon. After toggling the anchor, the delivery tool300is pulled back from the implant position and the suture lock is secured by pulling on the suture lock cord. If the anchor is the second or a subsequent anchor in a series, the physician may tighten the working suture to form a stitch while keeping pressure against the tendon with the elongated tube306prior to moving the delivery device to a next position. The delivery device is then reset and the configuration ofFIG.3A/3D is again assumed.

Turning now to the detailed mechanics of an illustrative example shown in the drawings,FIGS.3G-3Iare partial cut-away views of the anchor delivery device in several configurations.FIG.3Ggenerally corresponds to the configuration ofFIGS.3A/3D, in which the distal punch head322is latched to the proximal housing310, and the proximal punch head323is not latched against the distal punch head, as can be confirmed in the drawing by noting that punch head spring325is in an extended position. A nub coupler bar355is illustrated, and is pushed forward by the proximal punch head via proximal punch head pin356, having a ridge thereon to interact with the nub coupler bar355. The device contains a slide stop350and an ejector352. The ejector352is in turn secured to a trigger coupler313that is pivotably attached at one end to the trigger312and at its other end to the ejector352. The ejector352, at its own proximal end in the configuration shown, rests against the distal punch head322. The anchor delivery tube is connected at its proximal end to a nub sub coupler340which is itself spring loaded by nub spring343relative to the proximal housing310. As noted with respect toFIG.3D, in this configuration the anchor delivery tube nub is retracted into the elongate tube, meaning that the nub spring343is in a relaxed state, as shown.

FIG.3Hcorresponds to the configuration ofFIGS.3B/3E, in which the distal punch head322is latched to the proximal housing310, and the proximal punch head323is now latched to the distal punch head322, as can be confirmed in the drawing by noting that punch head spring325is now compressed. The same action of pushing the proximal punch head323to latch with the distal punch head322also pushes the nub coupler bar355distally, in turn pushing the nub sub coupler340and anchor delivery tube in a distal direction, compressing the nub spring343and advancing the anchor delivery tube so that the nub extends from the distal end of the elongate shaft, as shown byFIG.3E. This movement also changes the juxtaposition of the slide stop350and the nub sub coupler340, which, as can be seen, are now positioned so that the proximal edge of the nub sub coupler340is distal of an upper portion of the slide stop350.

FIG.3Ishows the use of the trigger312to force a change of configuration from that ofFIGS.3B/3E to that ofFIGS.3C/3F. Here, the trigger312is squeezed against the grip311. The trigger coupler313forces the ejector352to move proximally, overcoming the latch force of the proximal and distal punch heads323,322relative to the housing310and disengaging a latch coupling the proximal and distal punch heads323,322to each other (seeFIG.3R, below), forcing retraction of the bone punch. However, the nub332is not retracted into the elongate tube306because the slide stop350engages with the nub sub coupler340, blocking it from moving in the proximal direction. The nub spring343stays compressed.

FIG.3Jshows in a closer view, taken from a rear angle as a partial cut-away view of the proximal housing. Here it can be seen that the nub sub coupler340abuts against the slide stop350at location345. The slide stop350is carried on a pin357, to allow lateral movement as will be further noted below. The pin357carries a slide stop spring359that pushes the slide stop350laterally toward the position shown inFIG.3J. An additional function of the slide stop350is illustrated inFIG.3K, which provides another angle to view the partial cut-away (with the slide stop spring359omitted). Here, the slide stop350includes an extension at351which is the part that will abut against the nub sub coupler340in the step shown inFIG.3I/3J. Also visible is a ramp353on the ejector352which will push against the extension351to prevent an ejector hook354from engaging with a corresponding nub sub coupler hook346by pressing the ejector352down. As can be seen, the slide stop350in this configuration prevents retraction of the nub by limiting the movement of the nub sub coupler340in the proximal direction and also preventing engagement of the ejector hook354with the nub sub coupler hook346.

FIGS.3L-3Nare partial cut-away views further illustrating the interaction of internal components of the anchor delivery device.FIG.3Lillustrates decoupling of the slide stop350from the nub sub coupler340and the ejector352. A plunger control arm385, which is inserted as shown below inFIGS.4A-4D, pushes the slide stop laterally so that the nub sub coupler340cannot engage with the extension351, and also moves the slide stop along the pin357so that the ejector352no longer presses against the extension351when moved in a proximal direction. The slide stop spring359is thus compressed, and remains so until the nub sub coupler340is again advanced when pounded to create the next bone hole. In an alternative arrangement, decoupling of the slide stop350from the nub sub coupler340may be achieved by having item385coupled to a switch or lever on the housing, rather than using the plunger action, if desired. The position of the slide stop spring359is illustrative; other configurations and positions may be used.

The movement of the slide stop350allows a different interaction to occur when the trigger is subsequently pulled, as highlighted inFIG.3M. Now, when the trigger is squeezed, the slide stop is no longer blocking movement of other parts, and so the slide stop is omitted from the view ofFIG.3M. The assembly remains extended until trigger actuation even with the slide stop moved laterally due to the latching of the proximal and distal punch heads to one another and latching of the distal punch head to the proximal housing. Here, it can be seen that the proximal end of the nub sub coupler340is free to move proximally. Moreover, positive retraction force can be applied by the ejector352when it is forced in the proximal direction by the trigger, because the ejector hook354can now engage with the corresponding nub sub coupler hook346. To ensure the hooks346and354interact, a ramp358on the underside of the ejector352presses against the plunger control arm385. The resulting action is shown by the view inFIG.3N, which shows how the nub sub coupler340moves past the slide stop350, allowing retraction of the nub when desired, using force applied via the trigger actuation as well as force applied by the nub spring343.

FIG.3Ois a partial cut-away view of the anchor delivery device during a second actuation of the trigger. Here, the trigger312is squeezed against the grip311, and the trigger bar313forces the ejector352in a proximal direction, unlatching the distal punch head322from the proximal housing310. With the slide stop moved laterally out of the way, the nub sub coupler340is forced in a proximal direction as well, under the positive force applied by the trigger311via trigger bar313, ejector352, and hooks354,346(FIG.3M). By positive force, what is meant is that more than the spring force is being applied, such as by the mechanical linkage of the trigger311, trigger bar313, ejector352and hooks354,346. In addition, the nub spring343also provides force to move the nub proximally and will hold the nub in the retracted position inside the elongate tube306until the nub is used again for placement of another anchor.

FIGS.3P and3Qdepict features of an illustrative anchor delivery tube. The anchor delivery tube330, in this example, has a slot at331through which sutures as well as the suture lock cord can pass during use. An inner lumen is defined as shown at333, through which anchors can pass, as well as the bone punch. If desired, the lower surface of the anchor delivery tube330may be stamped or otherwise formed with an indentation or internal trough or channel, as shown at335, to accommodate a suture336passing on the lower side of the anchor delivery tube330. Such stamping may not be necessary in some examples, depending on the size of sutures used and how closely the features of the anchor and the anchor delivery tube lumen333line up. The proximal end of the anchor delivery tube may be formed with, or may have added thereto, additional material shown at337for securing within the proximal housing310.

In an alternative configuration, the anchor delivery tube may be replaced by a push wire coupled to a relatively short nub portion having a slotted cylindrical shape. The nub portion may have a length of 3-5 centimeters, for example, such that a portion thereof can extend from within the lumen of the elongate tube306without entirely exiting the elongate tube. The push wire can then extend up the elongate tube to the proximal housing, where it would then be physically coupled to the nub sub coupler340. Thus a full-length anchor delivery tube may be replaced with a shorter nub portion, if desired. The push wire (as well as the anchor delivery tube) may be pushed in the distal direction when the bone punch is advanced at the proximal end thereof (by including a pusher or linkage attached to the push wire or the nub sub coupler for example) if desired, or at the distal end thereof (by providing a shoulder for example toward the distal end of the bone punch to interact with the nub and/or a short anchor delivery tube).

FIG.3Rillustrates coupling of the bone punch assembly. InFIG.3R, the ejector352is shown, including its proximal end having an angled surface at347. The angled surface at347is aligned with latch arm348, which is itself part of the proximal punch head. The latch arm348is shown engaged with spring base349, which is part of the distal punch head, and carries the punch head spring325. As can then be understood, as the trigger is depressed, the ejector352will move in a proximal direction, engaging latch arm348and pushing the latch arm348outward, disengaging the latch arm348from the spring base349, releasing the proximal punch head from the distal punch head. In some examples, the physician may use this maneuver without causing the distal punch head to disengage from the housing, such as by lightly pulling the trigger, causing the proximal punch head to release from the distal punch head and thereby retracting the punch pin and pointed distal tip. As a result, this feature allows the physician to readily control how far the distal tip of the punch pin extends beyond the nub and/or the distal end of the outer tube of the anchor delivery device.

FIGS.4A-4Dillustrate features of a plunger for delivering anchors from individual cartridges to the delivery device and a magazine for holding cartridges on the anchor delivery device. Starting withFIG.4A, the delivery device is generally shown at300with the proximal housing at310. On one side of the proximal housing is a receiver370into which a plunger380can be slidably placed and retained. The top of the receiver includes a slot372for receiving a cartridge392that carries an anchor to be implanted. The cartridge392can be seen to have at least first and second ends of a working suture393extending therefrom.

The delivery device is shown relative to a patient400having a patient portal402, which may be for example a shoulder portal that is formed for performing arthroscopic surgery. In the example shown, the removed cartridge392is shown with the working suture393extending on either side thereof. The physician may pull the cartridge away from the magazine and the delivery device, as well as the portal402, in order to floss the working suture393so that an amount of slack is available on either side of the anchor contained in the cartridge392. The purpose of this maneuver is to ensure that as the anchor is advanced through the delivery device and into the patient, there will be enough slack to make this passage easy. That is, while it is possible to floss the suture through the anchor during delivery and implantation, it may be preferable to generate slack before the implantation to make advancement of the anchor into position relatively easier. Once the anchor is positioned, the extra slack can be taken out as the physician tensions the working suture to create a stitch between the anchor being toggled and a previously placed anchor.

Opposite the plunger380is a magazine390that can be releasably secured to the proximal housing310and carries a plurality of cartridges391. A cartridge ejector is shown at394for ejecting cartridges391/392one at a time. The magazine is shown with 7 cartridges391therein, the 8thcartridge392having already been ejected. In the example shown, at least one additional cartridge has already been ejected and used, since the working suture393can be seen to extend into the elongate tube306and into the patient portal402. It will be understood as well that the magazine is carried on receiver398(FIG.3A). Greater detail regarding the magazine and its use can be found in U.S. patent application Ser. No. 17/551,811, filed Dec. 15, 2021, DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, the disclosure of which is incorporated herein by reference.

More details of the plunger and receiver are shown inFIGS.4B and4C. Starting withFIG.4B, the plunger itself is shown at380, in an extended position relative to a receiver370. The slot372can be observed in this top view of the proximal housing310. When a cartridge (not shown) is placed in the slot372, the plunger can be depressed as shown inFIG.4C. Doing so laterally transfers the anchor from the cartridge into the bore through the length of the delivery device. The anchor is then ready to be inserted by advancing the bone punch through the proximal housing and down the anchor delivery lumen. Referring back toFIG.4B, the anchor is carried in a cartridge392such that when the cartridge392is inserted into slot372, the anchor generally lies along line374, while the midline of the anchor delivery tube is shown generally at376. The plunger prepares the anchor for delivery by pushing the anchor laterally to the midline of the anchor delivery tube at376, and holds the anchor in position until the bone punch is advanced to push the anchor down the anchor delivery tube.

In addition, the plunger being depressed causes the changes in configuration previously described within the proximal housing. In particular, in the illustrative example that is shown herein, depressing the plunger moves the slide stop350discussed above laterally out of the way of the nub sub coupler340and out of the way of the ejector352, allowing the retraction of the nub after the anchor has been inserted. In some examples, the anchor delivery device will not allow the plunger to be actuated from its extended position to its depressed position while the bone punch is extended down the lumen of the anchor delivery tube. That is, until the bone punch has been retracted after a physician has first actuated the trigger, the plunger cannot be depressed fully in some examples.

FIG.4Dshows the plunger in isolation. Here, the plunger380can be seen to include an anchor pusher384including an anchor platform383that sits under the anchor, and matching bars382that extend into matching slots of the cartridge. The plunger control arm385is also shown. The control arm385is the element discussed previously that moves the slide stop350laterally to allow retraction of the anchor delivery tube and nub after the anchor is fully implanted. The control arm385also serves to push the ejector352upwards when in position to ensure coupling of the ejector (and hence the trigger) to the nub sub coupler that in turn attaches to the anchor delivery tube and nub. Guide arms381are used to guide the plunger380as it slides in and out of the receiver370.

Referring back toFIG.3M, the plunger latch386(not visible inFIG.4D) is carried on the control arm385. The plunger latch386, when the plunger is fully inserted, rests against plunger catch387to prevent removal of the plunger380. When the ejector352is used to pull back the nub sub coupler340, the bottom of the ejector352pushes the control arm385in a proximal direction and, as shown inFIG.3M, allows the plunger latch386to be released once the nub and bone punch have been at least initially retracted. The body of the plunger380may connect to the anchor pusher384, in some examples, with a wave spring (not shown, but residing inside the body of the plunger380) that allows overtravel to ensure latching of the control arm385and plunger latch386. When the plunger latch386is released, the wave spring (or another spring, if provided) pushes the plunger back to its extended position. The slide stop may also move back to its original position under spring pressure.

In an alternative configuration, the control arm385may not be part of the plunger, and may instead be coupled to a switch or lever on the proximal housing, allowing the physician to determine the mode of trigger operation without using a plunger. To this end, item399inFIG.4Amay be used as a switch or button to control position of the slide stop, for example.

In another alternative, the slot372may be placed directly in line with the central axis376(FIG.4B) of the anchor delivery tube, and rather than lateral movement out of the cartridge, an anchor may be placed in position for advancement down the anchor delivery tube directly. As an example, the slot372may instead be positioned at location372A inFIG.4B, and the plunger380and receiver370could then be omitted. For example, a physician may remove a pre-strung anchor from sterile packaging and directly place the anchor into a centrally positioned slot. Alternatively, a physician could place the anchor in a central slot such as that at372A by insertion of the cartridge. While some examples herein show a cartridge configured for lateral removal of an anchor, in an alternative in which the cartridge is inserted in a centrally located slot (372A), a cartridge as shown inFIG.5A/5B may instead have an opening as shown at527that allows removal of the anchor in an axial direction (such an arrangement may omit the boss512and/or has the working suture positioned on top of the boss512to allow axial movement). Other alternatives can be used as well.

To recap regarding the implantation procedure, the physician uses the configuration ofFIG.3Ato probe the surgical site and identifies a location at which an anchor is to be placed. The physician then taps or pounds on the proximal punch head which causes the bone punch to advance. As the bone punch is advanced, the proximal punch head latches with the distal punch head, assuming the configuration ofFIG.3B, also forcing the nub distal of the distal end of the outer elongate tube. As the tapping force is applied, each of the bone punch pin and tip extend through the tendon and into bone, and the nub is pushed into registration with the bone hole, at least partly engaging the nub with the bone hole. While this order of operations is useful in one example, the steps may be reordered as desired, such as by latching the punch head together prior to probing, if desired.

The physician then pulls the trigger a first time. Because the plunger is not engaged/depressed at this time, the trigger actuation results in retraction of the bone punch, but not the nub at the end of the anchor delivery tube. A cartridge is taken from the magazine, extended out from the magazine to create slack on either side of the cartridge in the working suture, and inserted into the slot for receiving cartridges on the delivery device housing. Before or after cartridge placement, the bone punch is retracted to a position that places the distal tip of the bone punch proximal of the location of the plunger, allowing the plunger to now be depressed. With the cartridge in place and bone punch retracted, the plunger is used to push the anchor into alignment with the anchor delivery tube. The bone punch is then advanced to push the anchor to and out of the distal tip of the anchor delivery tube. Full extension of the bone punch is demonstrated by latching the proximal punch head to the distal punch head, which is latched to the proximal housing of the delivery tool.

The physician will again squeeze the trigger. This second actuation of the trigger occurs with the plunger fully inserted, meaning that actuation of the trigger retracts the bone punch as well as the anchor delivery tube, as the plunger insertion will have moved the slide stop out of the path of the nub sub coupler and forces engagement of the ejector thereto, actively pulling the nub as well as the bone punch out of the bone hole. The same trigger action also releases the plunger as the ejector pushes the control bar to release the plunger under spring action. What remains, as discussed inFIGS.6A-6I, are the steps of completing the toggling of the anchor and tensioning the working suture, followed by securing the suture lock, before moving on to the next anchor. Though not shown, the anchor delivery tool may optionally include a punch stop to prevent the bone punch from being removed entirely from the device.

FIGS.5A-5Dillustrate a cartridge for holding a toggle anchor. Starting withFIG.5A, a cartridge500is illustrated with a handle502adapted for grasping by the user/physician. An inner holder is shown at510, and is surrounded by a cover520. The inner holder510secures an anchor100between an upper anchor support511and a boss512. In the configuration shown inFIG.5A, the cartridge is “closed” in that the anchor100cannot be removed.

FIG.5Bshows the cover520raised to an “open” position in which the anchor100is no longer secured by the cover520. The cover defines two channels at522,524. First channel522provides a path for the working suture out of the cartridge500, and second channel524provides a path for the suture lock, as will be further detailed below. The cover may be spring biased to the closed position, if desired, to prevent inadvertent removal of the anchor100during handling. Alternatively, the cover can include detents to hold the cover in a closed position until pressure is applied during insertion. In addition, the upper anchor support511and boss512are spaced so that the anchor100is held in position against falling out.

As noted previously, an alternative design may have the inner holder510open in alignment with slot527to allow anchor removal in an axial, rather than lateral direction. For such an alternative, in an example, the upper anchor support511and boss512would be positioned higher up on the inner holder, such that the anchor100would be held at position516as shown inFIG.5B.

FIG.5Cshows the cartridge500in the closed position again with the cover down. The working suture530is now shown passing through first channel522. The suture lock is shown as well, with the free end540of the suture lock passing through second channel524and the locking loop shown at542. As can be seen, the boss512holds the working suture530away from the underside of the anchor510, making flossing of the working suture easier prior to release of the anchor510from the cartridge. That is, because the bottom side of the anchor510may include a channel that makes flossing of the working suture therethrough more difficult, keeping the working suture530away from the bottom side of the anchor100may make flossing easier. Also, when the working suture530is pulled close to the bottom side of the anchor100, the path that must be navigated when flossing includes first and second near ninety degree turns, increasing friction as the working suture530is flossed. Therefore, the boss512can be seen to make flossing easier in some examples. In other examples, the boss512may be designed so that the working suture does not wrap around it, and instead a simple support on the bottom side of the anchor100may be provided, with the working suture then resting between the support and the bottom side of the anchor. It may also be noted that having the working suture placed as shown may aid in retaining the anchor in place until it is ejected by the insertion of the plunger in the examples shown above.

FIG.5Dshows the back side of the cartridge500. Of note here, the free end540of the locking loop542passes into a channel and then to a spool514. In an example, the free end540is attached to the spool514, such as by a knot, so that the free end can be pulled a select distance (10 to 20 cm, for example) before reaching a point where it can no longer unspool. When the physician seeks to use the locking loop, the cartridge500can be grasped and pulled until the spool runs out. The physician can then pull on the cartridge and therefore on the free end of the locking loop until the locking loop breaks at the break knot (or other preferential point of failure), as described below and above. The result is that the physician can manually grasp the cartridge to easily lock the locking loop and break the free end of the locking loop without needing a special tool and/or without needing to attempt to grasp the thin cord of the free end of the locking loop. It can be observed that the spool514includes inner features515allowing a tool to be inserted and twisted to spool the free end540of the locking loop onto the spool514. As with steps of toggling and/or tensioning a stitch, the distal end of the anchor delivery tool may be used to apply exterior pressure on the tendon as the locking loop is tightened and the free end is broken off.

FIG.5Eillustrates interaction of a cartridge ofFIGS.5A-5Dwith a plunger as inFIGS.4A-4D. The rest of the proximal housing of the anchor delivery tool is omitted, but it may be understood that insertion of the cartridge500into the slot for receiving the cartridge has now raised the cover520to an open position. The plunger is then slid into the position shown. With the plunger depressed, the anchor pusher structure584passes through the cartridge, with the anchor support383and matching rails382passing through the cartridge. The rails382pass on either side of the upper anchor supports511, and ensure that the working suture is released from the cartridge when the plunger is depressed. As can also be seen, the control bar385is now inserted and performs the functions of moving the slide stop discussed above.

Additional details regarding an illustrative magazine and its use may be found in U.S. patent application Ser. No. 17/551,811, filed Dec. 15, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, the disclosure of which is incorporated herein by reference.

It should be noted that the illustrative anchor implantation system shown is but one example of how the presently disclosed anchor system may be implanted. For example, a system that fully withdraws the distal end of the bone punch back to the proximal housing as shown may not be necessary. Separate cartridges for each bone anchor are illustrated in the implantation system; in other examples, several anchors may be disposed together in one cartridge in a longitudinal fashion, for example, for sequential loading. Another anchor delivery tool is disclosed, for example, in U.S. Provisional Patent Application Ser. No. 63/172,629, filed Apr. 8, 2021 and titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, the disclosure of which is incorporated herein by reference. Rather than lateral release of an anchor from a cartridge, an axial release may be used. In some examples, a cartridge can be omitted entirely. Any suitable implantation system may be used, as desired.

InFIGS.6A through6G, an exemplary method for implanting individual and an array of anchors is depicted. Further,FIGS.6H and6Iillustrate example suture stitch arrays as implanted on the surface of a rotator cuff tendon having anchor to anchor continuous stitches that are independently tensioned and locked that can result from using this method.

Referring first toFIG.6A, a schematic of select parts of the shoulder rotator cuff600is depicted in order to explain the methods of implantation. The illustration includes a portion of the humeral head602shown including an outer cortical shell layer604and an inner cancellous bone material606. A tendon, in this case the supraspinatus tendon608is shown overlaying a portion of the humeral head where is attached to the footprint. The method is a transtendinous or through the tendon repair. The tendon608is first positioned in a desired location for reattachment to bone in the footprint of original attachment. The delivery device ofFIGS.3A-3R, or similar is then utilized to implant the toggle type suture anchor through the tendon608. To begin the delivery device is set as inFIG.3Cwith the distal nub332extending from the distal end of the implant delivery tube330and elongate tube306. The bone punch320is fully inserted distally so that it extends beyond the distal end of the nub332and is locked in place, as is the nub locked in place. The device as configured is positioned on the tendon at the desired anchor placement and pounded in until the distal end of the outer tubular member is in contact with the tendon as shown inFIG.6A. At this point the nub332extends through at least a portion of the cortical shell604(in thinner bone the nub332can extend into the cancellous bone606) and the distal end of the bone punch320extends deeper into the cancellous bone606. To achieve the desired depth of implantation to assure toggling, the bone punch extends beyond the elongate tube306distal end a distance of greater than or equal to about 20 mm. Further, to assure nub registration with the bone hole, the nub portion332extends beyond the elongate tube306distal end a distance of about 6 to about 10 mm.

As depicted inFIG.6B, the bone punch320is then retracted while maintaining the elongate tube306and nub portion332in place, with the nub portion332providing registration with the formed hole in the bone. Absent such registration with the bone hole by the nub portion332, the location under the tendon would be lost and it would be very difficult to feed an anchor through the tendon which would tend to fill the hole through which the bone punch traveled. In some examples, as described above, this step of the method may be performed by depressing a trigger on an implant tool where the implant tool is configured to maintain the nub portion332extended under certain circumstances (for example, with the slide stop in place) while applying a positive retraction force to the bone punch320.

The first toggle type anchor is transferred or inserted into the proximal portion of the anchor delivery tube inside the elongate tube306. As shown inFIG.6C, the bone punch320is then reinserted into the lumen of the anchor delivery tube and advanced distally. As shown inFIG.6C, the toggle body100of the anchor is pushed out the distal end by the bone punch320. The bone punch320continues to be advanced in the distal direction to its original depth to push the toggle body100into the bone. It has been found that pushing the proximal end of the anchor deep into the bone with the toggle body100having an angled distal end causes or at least initiates rotation of the toggle body100. This initial rotation assures continued rotation upon pulling tension on the working suture115outside the body.

As shown inFIG.6E, the bone punch320and nub332are then retracted by the application of positive force by the trigger (as shown in examples above), as well as with spring action. This assures the nub332does not cut or fray the working suture. The bone hole remains shown in the drawings. The distal portion of the working suture extending from the distal passage is then pulled to complete the toggling of the anchor as aided by the proximal fins on the toggle body. This is shown inFIG.6E. With continued tension on the working suture, the toggle body100is pulled toward the inside surface of the cortical shell of the bone as shown inFIG.6F. To aid this step, the anchor delivery tool distal end may be pressed against the tendon to provide a counterforce against pullout during toggling and/or suture tensioning; that is, as the anchor is toggled and the suture is tensioned, the toggle body100may reach and press against the cortical shell. Additional counterforce can be applied in particular in regions of thinner cortical shell, such at the edges or outside of a tear footprint, and/or between the greater and lesser tubricals of the humerus. As depicted inFIG.6G, once the working suture115is tensioned, the locking suture is tensioned to close the locking loop118around the working suture115and fix the working suture relative to the toggle body100. In some examples, the locking suture is broken during this step at the knot which is at or inside the central bore of the anchor100, thus,FIG.6Gshows only the working suture extending back into the elongate tube306.

With implantation of the first anchor, the working suture115is simply locked as it cannot be tensioned to form a stitch until the second anchor is implant. In some examples, the first anchor in a chain of anchors can be pre-locked for this purpose; in other examples the surgeon will lock the first anchor suture lock at the time of implant. Therefore, in preferred methods, the second anchor is implanted repeating the above steps, except to the extent that the suture lock is differently engaged. As the working suture is pulled to toggle the anchor, any loose working suture between the first and second anchors is pulled through to form the tensioned stitch. During suture tensioning the distal end of the elongate tube306can be maintained against the outer surface of the tendon to prevent pullout or even possible bone fracture at the cortical shell. Once properly tensioned, the second anchor is locked. These steps are repeated for the rest of the anchors in an array.

As shown inFIGS.6H and6I, using the above method and device can create a row of continuous stitches that closely spaced, individually tensioned and tightened. A preferred pattern includes a row of stitches generally perpendicular to the direction of the tendon as shown inFIG.6H. In a rotator cuff repair these would all be placed in a medial portion of the original tendon footprint. In some preferred embodiments a second row of anchors is also implanted, especially in a rotator cuff repair. The second row is implanted laterally of the first row and can include a zig zag pattern to put some anchors in the lateral portion of the original footprint and other anchors lateral of the footprint to hold down edges of the torn tendon. Other configurations are also possible depending on the size and shape of the tear. For example, on a small tear a single zig zag row of stitches could be used as shown inFIG.6I. Anchors may also be placed to create stitches over attached portions of the tendon to reinforce the margins/edges of fully or partially torn tendons.

The preceding provides a relatively complete description of the anchor itself, pre-strung anchor arrays, suture lock, cartridge, magazine, and anchor delivery tool. A range of inventions are thus disclosed, and not all components or parts needs to be used together. For example, the delivery tool may be configured to for use with other anchors, cartridges, magazines, etc. Likewise, the anchors may be used in different configurations with other working suture and suture lock arrangements, other cartridges, magazines and delivery tools. Thus the overall combination shown can be modified in a variety of ways.

Additional features and alternative designs for various components, subassemblies and assemblies may be found in the following patent applications, each of which is incorporated herein by reference:

U.S. Prov. Pat. App. No. 63/172,564, filed Apr. 8, 2021, titled KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patent application Ser. No. 17/551,588, filed Dec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,565, filed Apr. 8, 2021, titled TENSIONABLE AND LOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patent application Ser. No. 17/551,709, filed Dec. 15, 2021, titled TENSIONABLE AND LOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,613, filed Apr. 8, 2021, titled KNOTLESS MICRO SUTURE ANCHOR ARRAY FOR HIGH DENSITY ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patent application Ser. No. 17/551,728, filed Dec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHOR ARRAY FOR HIGH DENSITY ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,614, filed Apr. 8, 2021, titled METHOD FOR CREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patent application Ser. No. 17/551,779, filed Dec. 15, 2021, titled METHOD FOR CREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,629, filed Apr. 8, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. Prov. Pat. App. No. 63/281,411, filed Nov. 19, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patent application Ser. No. 17/551,811, filed Dec. 15, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,624, filed Apr. 8, 2021, titled CARTRIDGE DEVICE FOR SUTURE ANCHOR AND SUTURE MANAGEMENT DURING IMPLANTATION OF A MICRO SUTURE ANCHOR ARRAY, and U.S. patent application Ser. No. 17/551,838, Filed Dec. 15, 2021, titled CARTRIDGE DEVICE FOR SUTURE ANCHOR AND SUTURE MANAGEMENT DURING IMPLANTATION OF A MICRO SUTURE ANCHOR ARRAY.

U.S. Prov. Pat. App. No. 63/172,630, filed Apr. 8, 2021, titled METHODS FOR TRANSTENDINOUS IMPLANTATION OF KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYS, and U.S. patent application Ser. No. 17/551,885, filed Dec. 15, 2021, titled METHODS FOR TRANSTENDINOUS IMPLANTATION OF KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYS.

Each of these non-limiting examples can stand on its own or can be combined in various permutations or combinations with one or more of the other examples.

The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” Moreover, in the claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, innovative subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the protection should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.