Soft locking suture anchor assembly and methods of use

[0001] This application claims benefit of U.S. Pat. App. No. 62/427,347 filed on Nov. 29, 2016; this application claims benefit of U.S. Pat. App. No. 62/471,260 filed on Mar. 14, 2017; and this application claims benefit of U.S. Pat. App. No. 62/482,663 filed on Apr. 6, 2017.

[0002] Not Applicable

[0003] Not Applicable

[0004] The present invention relates generally to systems and methods for securing sutures and other materials during surgical procedures. More particularly, embodiments of the present invention relate to systems and methods for suture fixation and systems and methods designed for the placement of surgical anchors for attaching tissues and sutures associated with orthopedic surgeries.

[0005] Open and arthroscopic meniscal repair has become a mainstay for the orthopedic surgeon. In the 1960s and 70s partial or total mastectomy was the norm. As arthroscopy and arthroscopic skills advanced arthroscopic combined with open or all arthroscopic meniscal repair became the standard of care. Multiple studies have demonstrated the ability of the meniscus to heal, particularly in the vascular zone which is in the first 3 mm of its capsular attachment. With advancement of arthroscopic meniscal repair tools more and varying types of meniscal tears have been successfully repaired.

[0006] The present weaknesses of meniscal repair systems are several. First the gold standard has been the “inside out” meniscal repair system. With this method, cannulae are passed through skin portals, and use long needles with sutures attached that are passed through the cannulae, through the knee joint, across the defect and out of the knee to be retrieved through an open incision and then tied against the deep capsular structures away from neurovascular structures. This technique allows for precise placement of sutures in the meniscus.

[0007] One of the problems associated with these types of procedures is the time and number of intubations needed to perform the various procedures endoscipically. In addition, this technique does not allow for precise placement of sutures thru the capsule, and therefore there is potential for neurovascular injury.

[0008] The outside-in techniques involve passing sutures through needles at the joint line across the tear, and then tying one end of the sutures together and tying the other ends of the sutures directly onto the capsule. Alternative techniques allow the sutures to be passed across the defect and tying the suture back on itself on the capsule. One advantage to this technique is that there is a low risk of neurovascular injury, since needles are passed thru precise thru the capsule. Potential disadvantages of the outside-in technique is that suture placement thru the meniscus may not be precise as well as difficulty in reducing the defect and opposing the edges while passing the sutures.

[0009] “All inside” devices have been developed for meniscal repair. These devices were developed in order to obviate the need for posterior corner incisions medial or lateral and to reduce the risk of neurovascular damage as a result of the surgery. These devices are deployed through the arthroscopic portals and either oppose the meniscal fragments and/or push a pre-tied knot onto the body of the meniscus. The present devices have created articular lesions due to protrusion as well as partially deployed devices that are proud.

[0010] Systems and methods such as that disclosed in U.S. Pat. Pub. No. 2006/0178680 Nelson et. al. illustrate some embodiments of an all-inside solution.

[0011] The “all inside” systems are limited by how accurate they are when repairing a meniscus and thus have never enjoyed as good a success rates as the inside out devices referenced above. Because the all inside devices are so large it is virtually impossible to accurately pass a suture and/or meniscal device into the under surface of the meniscus, thus the majority of the devices are passed on the top surface in an attempt to pinch the lower inferior portions together. This technique in actuality leaves the tear distracted on its inferior surface. Although many devices have been fabricated for all-inside meniscal repairs, which can be done endoscopically without the open-skin incision, the incidence of re-tear among patients who have undergone the procedure is higher over time compared with that for patients who were given inside-out permanent sutures

[0012] There is a benefit therefore from providing a suture anchor assembly and methods of use that allow accurate placement of the suture and suture anchor. There is also a benefit from providing assemblies and methods that minimize the number of incisions required for use.

Bone Anchor Systems:

[0013] There are numerous bone anchors with sutures attached that allow tissues to be approximated to specific bone attachment sites. Most systems deploy a three-step system wherein the hole is drilled, anchor placed and then the anchor holder removed and the anchor set by pulling on sutures. If the bone is of questionable quality, the anchor may only temporarily hold and loosen later through the rehabilitation phases. Also, if the first step of drilling a hole can be eliminated then it would be expected that the anchor would hold more securely, particularly in porous bone.

[0014] Systems such as those disclosed in U.S. Pat. Pub. No. 2007/0032821, Chao et. al. and U.S. Pat. Pub. No. 2006/0217762 Maahs et. al. show anchor systems that expand into an opening, however, they are not structured to open into and secure an element in bone.

[0015] Other systems rely on an anchor to flip, based on a second suture being placed at the end opposite the attached suture. There are also systems that anchor by means of screwing in or anchoring by means of flexible hooks.

[0016] There is a therefore a benefit from providing a suture anchor assembly and method of use that can be easily inserted and deployed through expansion.

[0017] The suture anchor assembly is an assembly that is capable of being inserted into a tissue or bone in a forward direction while also being able to create an expanded profile when subjected to a retrograde, or opposite direction, force. This expanded profile generally anchors and secures the assembly into the tissue or bone by a changing of position of elements of the assembly relative to other assembly elements. This changing of position creates an expanded profile of the assembly in the tissue which helps to frictionally engage the tissue and anchor the assembly. Embodiments of the assembly and methods of the present invention provide for the accurately positioning and of anchoring of elements to fix sutures in tissue or bone. In some embodiments, the suture anchor assembly has pliable elements and elements of the assembly are secured into the tissue by a deformation of assembly elements. In some embodiments, the assembly is capable of anchoring a suture in the tissue without the need to have to tie a knot in the suture.

[0018] In an example embodiment, a suture anchor assembly is provided comprising a button element having a body portion, an anchor suture engaged with the body portion, the body portion having a force connector and a delivery system configured to deliver the body portion into an anchor tissue. In some embodiments, the anchor tissue is a bone. In some embodiments, the anchor tissue is a bone and the retrograde force on the anchor suture causes the button element to deform and engage the bone and secure the button element in the bone. In some embodiments, the button element is a pliable button. In some embodiments, the suture anchor assembly is configured to anchor the button element and a tissue suture in the anchor tissue without having to put a knot in the tissue suture. In some embodiments, the anchor suture further comprises a locking mechanism.

[0019] In some embodiments, a suture anchor assembly is provided comprising a first body portion, a second body portion having a force connector and a means to connect the first body portion and the second body portion whereby a retrograde force on the force connector causes the first body portion to engage a tissue and secure the suture anchor assembly in the tissue.

[0020] In an example embodiment, the suture anchor assembly includes the first and second body portions being planar shaped and the suture anchor assembly further includes a cannula having a slot shaped hollow portion to receive the planar body portions whereby the position of the first and second body portions can be controlled by the position of the slot shaped hollow portion.

[0021] In an example embodiment, the suture anchor assembly further comprises a needle, a means of connecting the needle to the first body portion and a retrograde force element capable of connecting to the second body portion force connector.

[0022] In an example embodiment, the suture anchor assembly further includes the first body portion being elongated, the means to connect the first body portion and the second body portion comprises a connector connecting a first connection point on the first body portion and a second connection point on the second body portion and the location of the force connector relative to the first body portion and the first connection point causes the first body portion to pivot relative to the second body portion when a retrograde force is applied to the force connector.

[0023] In an example embodiment, the suture anchor assembly further includes the first body portion being capable of compressing to form a front end and a expansion end and the expansion end of the first body portion being biased to expand whereby a retrograde force on the force connector cause the expansion end to expand and engage the tissue and secure the suture anchor assembly in the tissue.

[0024] In an example embodiment, the suture anchor assembly includes the first body portion being capable of being compressed to form a front end and a expansion end, the means to connect the first body portion comprising a collar on the first body portion to receive the second body portion and the expansion end of the first body portion being biased to expand whereby a retrograde force on the force connector forces the second body portion to expand the first body portion whereby the expansion end engages the tissue and secures the suture anchor assembly in the tissue.

[0025] In an example embodiment, the suture anchor assembly comprises an impactor, an expandable first body portion having a distal collar and a proximal collar and a second body portion having a force connector whereby a retrograde force on the force connector forces the second body portion against the distal collar and a forward force on the impactor transfers the forward force to the proximal collar whereby the first body portion expands to secure the suture anchor assembly in the tissue.

[0026] In an example embodiment, the suture anchor assembly further includes a delivery rod and a means to connect the delivery rod to the force connector whereby a force applied to the delivery rod is transferred to the second body portion.

[0027] In an example embodiment, the suture anchor assembly further includes a means to retain the expansion of the first body portion to secure the suture anchor assembly in the tissue.

[0028] In an example embodiment, the suture anchor assembly comprises a pliable button with a first body portion and a second body portion whereby a retrograde force on a force connector causes the pliable button to deform and engage a tissue and secure the pliable button in the tissue.

[0029] In some embodiments, the button is resorbable or bioabsorbable and in some embodiments, the button is a woven fabric.

[0030] In some embodiments, the button is deformed by a forward force on the button which causes the button to deform and engage the tissue and secure the button in the tissue.

[0031] In an example embodiment, a method of tissue repair comprises providing a suture anchor assembly having a retrograde or traction suture, inserting the suture anchor assembly into a tissue, applying a retrograde force on the retrograde force element to cause the suture anchor assembly to engage the tissue and secure the suture anchor assembly in the tissue and anchoring the retrograde force element to secure the suture anchor assembly.

[0032] In an example embodiment, the step of inserting a suture anchor assembly further includes inserting a needle connected to the suture anchor assembly and passing the needle and suture anchor assembly through the tissue.

[0033] In an example embodiment, the suture anchor assembly further includes a first body portion connected to a second body portion connected to the retrograde suture and the step of applying a retrograde force on the retrograde force element further includes causing the first body portion to engage the tissue.

[0034] In an example embodiment, the suture anchor assembly is planar and further comprises a cannula having a slot shaped hollow portion to receive the planar suture anchor assembly and the step of inserting the suture anchor assembly further includes positioning the insertion of the planar anchor assembly by the position of the slot shaped hollow portion.

[0035] In an example embodiment, the method of tissue repair further includes repeating the step of inserting the suture anchor assembly and applying the retrograde force with at least one second suture anchor assembly having a second retrograde or traction suture and the step of anchoring the retrograde force element further comprises anchoring the retrograde force element to the second retrograde force element to secure the suture anchor assemblies.

[0036] In an example embodiment, the step of inserting a needle includes inserting the needle through a cannula.

[0037] In an example embodiment, the first body portion is elongated and the step of applying a retrograde force to the retrograde force element causes the elongated first body portion to pivot relative to the second body portion and engage the tissue.

[0038] In an example embodiment, the first body portion is capable of being compressed to form a front end and an expansion end, the expansion end of the first body portion expands when not compressed and the step of applying a retrograde force on the retrograde force element includes causing the expansion end to expand and engage the tissue.

[0039] In an example embodiment, the first body portion is capable of being compressed to form a front end and a expansion end, the first body portion is connected to the second body portion by a collar on the to receive the second body portion, the expansion end of the first body portion expands when not compressed and the step of applying a retrograde force on the retrograde force element includes forcing the second body portion to expand the first body portion where the expansion end expands and engages the tissue.

[0040] In an example embodiment, a method of anchoring a suture into a tissue comprises providing a suture anchor assembly with an expandable first body portion, a second body portion and a force connector connected to the second body portion; inserting the expandable first body portion and second body portion of a suture anchor assembly into a tissue; expanding the first body portion of the suture anchor assembly by applying a retrograde force to the force connector to secure the suture anchor assembly in the tissue; and attaching a suture to the suture anchor assembly.

[0041] In an example embodiment, the step of inserting the second body portion further includes applying a first forward force on a sharpened distal end of the second body portion and the step of expanding the first body portion further includes applying the retrograde force to a distal end of the first body portion and applying a second forward force on a proximal end of the first body portion expanding the first body portion.

[0042] In an example embodiment the step of expanding the first body portion further includes applying the retrograde force by forcing a wedge shaped proximal end of the second body portion into a collar of the distal end of the first body portion and applying the second forward force with an impactor whereby the retrograde force and the second forward force expands the outer dimension of the first body portion.

[0080] A suture anchor assembly and methods of use will now be described in detail with reference to the accompanying drawings. Although embodiments are described for the anchoring of sutures and tissues in bone, it is understood that the methods and systems described can be used for the repair of other human or animal body defects. In particular it is contemplated that other embodiments of the invention can be used for repair and suture anchoring to other tissues such as cartilage or soft tissues. Notwithstanding the specific example embodiments set forth below, all such variations and modifications that would be envisioned by one of ordinary skill in the art are intended to fall within the scope of this disclosure.

[0081] Throughout this description, a retrograde force means a force applied generally opposite of the direction of insertion of the assembly. Additionally, the verbs anchor and secure as used throughout this description mean to hold fast or otherwise fix or fasten.

[0082] Similar embodiments of elements described herein include those elements disclosed in U.S. patent application Ser. No. 13/405,320 filed Feb. 26, 2012, now U.S. Pat. No. 9,445,804 issued Sep. 20, 2016; U.S. patent application Ser. No. 13/241,466 filed Sep. 23, 2011, now U.S. Pat. No. 8,512,377 issued Aug. 20, 2013; U.S. patent application Ser. No. 12/245,714 filed Oct. 4, 2008, now U.S. Pat. No. 8,052,719 issued Nov. 8, 2011; U.S. Patent Application 62/427,347 filed Nov. 29, 2016; and the entire contents of all referenced applications are incorporated herein by reference.

Suture Anchor Assembly:

[0083] One embodiment of the suture anchor assembly is shown in FIG. 1. The suture anchor assembly 100 shown and described is a device that provides elements to allow new combinations of some features of the “inside-out” and “all-inside” solutions. This solution takes advantage of the accuracy and reliability of inside-out and outside-in suture solutions but can result in a device with all-inside features once the system has been deployed. Thus, by using this assembly outside incisions can be minimized while the accuracy and effectiveness of the inside-out system can be duplicated.

[0084] The assembly disclosed provides a solution that can be accurately placed around the defect, can be placed with fewer incisions and can be positioned to reduce the incidence of protrusions that may irritate the tissue or bone around the defect.

[0085] As shown in FIG. 1, one embodiment of the suture anchor assembly 100 comprises at least one set of a retrograde force element 120, a button 110 and a delivery system.

[0086] The retrograde force element 120 is connected to the button 110 by a force connector 113. The retrograde force element 120 is used to deploy and anchor the button 110. As shown in FIG. 1, the retrograde force element 120 may comprise a retrograde suture that provides the retrograde force and also secures that suture and anchor pair to another suture/anchor pair so that the defect is repaired or reinforced. Any type of surgical suture is suitable for use as a retrograde suture with this assembly. It is also understood that other types of retrograde force elements can be used to deploy the anchor and secure assembly elements and tissue together. These other types of retrograde force elements may include, but not be limited to other securing elements such as rods, pins, staples and other materials that can transfer and maintain a tensile force.

[0087] As detailed in FIG. 1A, the button 110 is a rigid or semi-rigid element with a force connector 113. The button 110 is shaped to change or transform shape when a retrograde force is applied to the force connector 113. Although not required, this transformation can be done with some degree of control of the profile of the button. This change of shape allows the button 110 to anchor in the tissue and counter that same, or a different retrograde force. The button 110 can be made of biocompatible materials that include, but are not limited to metals, metal alloys or non-metallic materials such as nylon, polyethylene, polypropylene or any combination thereof. The force connector 113 provides the connection through which forces are transferred to the button 110. Although shown in this embodiment as a suture tie for the retrograde suture, the force connector 113 can comprise any element capable of connecting the retrograde force element to the button in a way that a tensile force can be applied and maintained on the force element. Suitable connection elements include, but are not limited to mating threads, clips, hooks, holes, permanent adhesive connections or any combination thereof.

[0088] In the embodiment shown in FIGS. 2A-2D, the button 210 comprises an expandable first body portion 212 and second retrograde force body portion 211 and a means to connect the two portions. In this embodiment, the expandable body portion 212 is a generally elongated and pointed section and the retrograde force body portion 211 is generally a broad section. The expandable and retrograde force portions each have a connection point and are connected to each connection point by a connector 214. The connection points comprise a means of receiving a connector such as a hole, slot or adhesive and the connector comprises a means of connecting the two body portions such as, but not limited to a pivot hinge or rivet. The retrograde force element in this embodiment comprises a retrograde suture 220. The retrograde suture 220 is connected to the retrograde force portion 211 of the button through the force connector comprising a suture tie 213. This suture tie 213 can be any method of securing a suture to the body portion. The suture tie as shown in FIGS. 2A 2D comprises an off-center hole in the retrograde force portion 211.

[0089] The means to connect the body portions of the button can include any connecting methods that allow the two portions to pivot and/or rotate about the connection points. For example, it is contemplated that the connector 214 may be comprised of a protrusion, hook or other connection element on one body portion that is capable of being connected to a complementary hole, slot or other connecting element on the other body portion.

[0090] The interoperation of the suture tie 213, the connection points and the two button body portions are such that a retrograde force on the suture tie urges the expandable body portion 212 to rotate or otherwise move in a direction at an angle different than the retrograde force. This rotation or movement causes an expanded profile of the button which frictionally increases the resistance that can be provided by the button and expansion suture. The elongated shape, where the length of the portion in an insertion position is greater than its width, of the expandable body portion causes this expanded profile when the expandable portion is moved about the connector. This interoperation to cause the expandable body portion to rotate can be provided by a location of the suture tie relative to the connection points. One example of this interoperation is shown in FIG. 2A where the location of suture tie 213 is off the center of the retrograde force body portion 211 while the connector 214 and connection point is located in the center of both button portions. As shown in FIG. 2B, a retrograde force on the suture tie 213 cause a force on the connector 214 that causes the expandable body portion 212 to pivot and/or rotate at an angle different than the direction of the retrograde force. Alternately, as shown in FIGS. 2C-2D, the location of the connection points on the expandable body portion to be off-center while the suture tie is on the center line of the body portion.

[0091] It is also contemplated to have the shape of the body portions such that a retrograde force on the button causes the expandable body portion 212 to pivot and/or rotate. For example, the expandable body portion can have a barb or other protrusion on its expansion end that causes that portion to rotate when partially retracted by the application of a retrograde force.

[0092] In some embodiments, the shape of the button can be made such that it minimizes the possibility of undesired protrusions when the button is deployed. An undesired protrusion is a protrusion that can damage other tissues or bone. These undesired protrusions are different than the desired protrusions caused the normal expansion of the button. For example, as in FIGS. 2A-2D, the shape of the button can be made so that it is primarily a two-dimensional planar shape with a minimal profile in a third dimension. This allows the button to be inserted and to expand primarily in dimensions parallel to particular surfaces, such as the articular cartilage surfaces of the knee, while minimizing the potential for expanding perpendicular to those surfaces. This minimizes the possibility of having protrusions that may damages these surfaces or tissues. It is also contemplated that the shape of the cannula can be made to assist in the positioning of the button in deployment. This can be provided by, but not limited to an inner bore shape of the cannula that is primarily slot shaped to cooperate with a primarily two-dimensional shaped button. This would allow the profile of the button in the tissue to be controlled by the rotational position of the cannula. Other cooperating shapes of button and cannula bores are contemplated such as ovals, circles and rectangles.

[0093] Referring back to the embodiment shown in FIG. 1, the suture anchor assembly also comprises a delivery system for the button 110 and retrograde force element 120. As shown in the embodiment in FIG. 1, this delivery system comprises a needle 133, a traction suture 132 and a cannula 131.

[0094] The needle 133 is used to position and insert the button 110 and retrograde force element 120. The needle 133 comprises an elongated rod with a sharpened distal end 134 and a proximal end 135 that has an eye or other means to allow connection to the traction suture 132. As an example, and not for limitation, 12 inch long needles made of stainless steel or Nitinol are suitable for use with this assembly.

[0095] The traction suture 132 is connected to the needle's proximal end 135 and the button 110. Preferably, the traction suture is connected to a traction suture tie 115 on the sharpened end of button's expandable body portion 112. The traction suture 132 is used to connect the needle 133 and the button 110 allowing the button to be pulled through the tissue and the defect to be deployed on one side of the defect. Any type of surgical suture or similar connection means is suitable for use as a traction suture with this assembly.

[0096] The retrograde force element 120 is connected to the force connector 113 on a retrograde force body portion 111 of the button 110.

[0097] The cannula 131 is used to help position and deploy the needle 133. The cannula 131 is a hollow element with a longitudinal extending bore to receive the needle, the traction suture, the button and the expansion suture. As an example, and not for limitation, 6 inch hollow cannula of about ⅜ inch in diameter is suitable for use with this assembly. In one embodiment, the distal end of the cannula is bent at angles to help guide the needles into the proper direction and position.

[0098] And although the delivery system embodiment described includes a traction suture connected to a traction suture tie and the eye of a needle, other means to connect the needle and the button are contemplated that include flexible, semi-flexible or substantially rigid connecting elements. Examples of these connecting elements include but are not limited to a directly mating connection between the needle and the button such as a threaded connection, one element hooking into an eye of another or one element clipping into a recess of another. Other examples of connecting elements include, but are not limited to a connector connecting the needle and the button such as a flexible hook, chain, wire, rods or other means to removeably connect the two elements.

Alternative Button Embodiments:

[0099] Alternative embodiments of the button are shown in FIGS. 3A-5B.

[0100] FIGS. 3A and 3B illustrate one embodiment of the button 310. In the illustrated embodiment, the button 310 comprises an expandable first body portion 312 comprising expansion fingers 319, a collar 316 and a retrograde force body portion 311 that is shaped as a rod. The retrograde force body portion 311 is connected to both the traction suture 332 and the retrograde suture 320 (retrograde force element) and is received into a collar 316. As shown in FIG. 3A, this embodiment is able to be inserted into a patient's body starting with the traction suture end. In the insertion position of FIG. 3A, the fingers are compressed to minimize the profile of the assembly during insertion. When sufficient tension is placed on the retrograde force body portion 311 from the retrograde suture side, the retrograde force body portion 311 retracts towards the expandable body portion 312 and into the collar 316, deploying the expansion fingers 319. The expansion fingers 319 engage the retrograde force body portion 311 so that the fingers are urged to expand when the rod retracts. As shown in FIG. 3B, the fingers have an angled end 318A on the end that connects with a collar 316. When the retrograde force body portion 311 is retracted, this angled end 318A is rotated about a connection to the collar 316 forcing the expansion ends 318B of the fingers 319 to expand. Other methods of cooperation between the fingers and the retrograde force rod so that the fingers expand are contemplated to include any types of angles for the angled end 318A and any type of tethered connection to the collar that allows the fingers 319 to move and expand.

[0101] As shown in FIG. 3B, the deployment of the fingers 319 enables the button 310 to act as an obstruction and anchor for the retrograde suture 320 connected to the button.

[0102] FIGS. 4A and 4B illustrate another embodiment of a button 410. In the illustrated embodiment, the button comprises an expandable first body portion 412 comprising a flexible hoop that is biased to expand and a second retrograde force portion 411 shaped like a bar. The retrograde force body portion 411 is connected to the traction suture 432 and the retrograde suture 420. As shown in FIG. 4A, this embodiment is able to be inserted into a patient's body starting with the traction suture end and the flexible hoop is folded back, or otherwise compressed against its bias to expand and to minimize its profile during insertion. When compressed, the end of the flexible hoop nearest the traction suture is the front end and the opposite end of the hoop is the expansion end. When placed in position, the expandable body portion 412 is expanded about its front end by a trip or by the release of tension on the hoop. As shown in FIG. 4B, the expansion and deployment of the expansion end of the expandable body portion 412 enables the button 410 to engage the tissue and act as an obstruction and anchor for the retrograde suture connected to the button 410.

[0103] Embodiments of the buttons may include rigid buttons made of rigid bioabsorbable or resorbable materials such as but not limited to polyglycolic acid, polylactic acid enantiomers, poly-D-L-lactic acid copolymer polyglycolic acid, a combination of polylactic acid and hydroxyapatite or materials such as collagen.

[0104] Embodiments of buttons may also include pliable buttons made of soft or pliable material or a rigid material configured, such as a rigid material configured as a spring-like spiral or a woven mesh, to bend, fold, dilate, expand or otherwise deform upon application of a force on the button. Embodiments of pliable buttons may be made of bioabsorbable, resorbable or non-resorbable materials. For illustration only, and not for limitation, embodiments of a pliable button may be made of materials including braided sutures, sponges and sponge-like materials in solid form, perforated materials, woven/braided from biocompatible materials or fibers, such as, for example, polymer, polyester, polyethylene, cotton, silk, or other natural or synthetic materials, including sponges and sponge-like materials. The button may also be an elongated tubular or solid member or a two-dimensional member with or without internal bores. The button may have any properties that allow it to change shape. The button can be, for example, compliant, flexible, foldable, squashable, squeezable, deformable, limp, flaccid, elastic, low-modulus, soft, spongy, perforated or have any other flexible properties which allow it to change shape.

[0105] The pliability of the button allows the button to deform upon application of a force. The deformation may be any change in shape that helps the button become more secured in the tissue. For example, the deformation may be to extend, swell, enlarge, expand, widen, dilate, distend, inflate or become larger and taking up more space in a dimension that helps secure the button.

[0106] Two example embodiments of a generally tubular shaped pliable button are shown in FIGS. 10A and 10B. FIG. 10A illustrates a tubular sleeve shaped button 1010 having a first body portion 1012 and a second body portion 1011. In this embodiment, the force connector 1013 is on the first body portion 1012. The first body portion 1012 also has a means to connect the first body portion 1012 with the second body portion 1011 whereby a retrograde force on the force connector 1013 causes the button 1010 to deform and engage a tissue and secure the button 1010 in the tissue. In this embodiment, the means to connect the body portions is a middle body portion 1014 which is a continuation of the tubular sleeve between the two body portions and the force connector 1013 is a through hole extending through the wall of the button 1010. FIG. 10C illustrates one embodiment of a suture anchor assembly having a button 1010, a traction suture 1032, a needle 1033 and a suture 1020. The means to connect the needle to the first body portion by a suture tie which in this embodiment also functions as the force connector 1013. This illustration shows the assembly in a collapsed, insertion profile as it may look while being inserted and pulled through a tissue by the needle 1033 and traction suture 1032. FIG. 10D illustrates the embodiment of FIG. 10C with the traction suture and needle removed and a retrograde force F1 being applied to the suture 1020 and the force connector 1013. In this embodiment, the suture 1020 is the retrograde force element and it extends through a longitudinal inner bore of the button through a foot connector 1015. As shown, the button 1010 is deformed into a dilated anchor profile shape that helps anchor the button in the tissue. As can be seen, the foot connector 1015 is also shown which can retain the second body portion 1011 in relation to the first body portion 1012 so that the button 1010 resists eversion (e.g. inverting or “flipping inside out”) as the retrograde force is applied. In this embodiment, the foot connector 1015 is a through hole extending through the wall of the second body portion 1011 of the button 1010 and the foot connector 1015 is sized similar to the force connector 1013 so that it restricts the movement of the second body portion 1011 with respect to the first body portion 1012 to resist the button 1010 inverting or everting. As can also be seen, protrusions 1010P may also be formed in the deformation that helps the button 1010 engage the tissue.

[0107] FIG. 10B illustrates one embodiment of a button 1010 comprising a generally pliable weave or mesh tube. In some embodiments, the mesh button can be a self-expanding button designed similar to self-expanding stents described in U.S. Pat. No. 6,719,934 issued Apr. 13, 2004 to Jonathan S. Stinson which is herein incorporated by reference in its entirety. These weave or mesh embodiments may incorporate the other elements of buttons such as the force connector 1013, foot connector 1015 as well as the first body portion 1012, second body portion 1011 and the middle body portion 1014. Here the force connector 1013 and the foot connector 1015 can be portions of the mesh, or special loops in the mesh, that can be used to secure elements such as sutures.

[0108] FIG. 10E illustrates additional elements that may be used with the pliable button embodiments. As shown, this example suture anchor assembly has a second suture 1032-2 extending through the button 1010 and connected to the second body portion 1011, here at the foot connector 1015, and a second needle 1033-2. This second suture 1032-2, as a forward force element, is able to apply a forward force F2 on the second body portion through the foot connector 1015. This forward force F2, with or without an opposite retrograde force on the force connector, causes the button 1010 to deform into a dilated anchor profile shape that anchors the button 1010 into the tissue. In this embodiment, the deformation occurs closer to the position of the first body portion 1012 which may be helpful in positioning the button.

[0109] FIGS. 11A-11D illustrates another embodiment of a pliable suture anchor assembly. As shown in FIG. 11A, this embodiment has a button 1110 comprising a pliable generally planar sheet. This button 1110 has a first body portion 1112 and a second body portion 1111. The first body portion 1112 has a force connector 1113 and has a means to connect the first body portion 1112 with the second body portion 1111 whereby a retrograde force on the force connector 1113 causes the pliable button 1110 to deform and engage a tissue and secure the button in the tissue. In this embodiment, the means to connect the body portions is a middle body portion 1114 is a continuation of the sheet between the two body portions and the force connector 1113 is a through hole extending through the button. FIG. 11B illustrates one embodiment of the suture anchor assembly having a button, 1110, a traction suture 1132, a needle 1133 and a suture 1120 connected to the first body portion by a suture tie which in this embodiment is also the force connector 1113. The traction suture 1132 provides the means to connect the needle with the suture tie and the first body portion. This illustration shows the assembly in a collapsed, insertion profile as it may look being inserted and pulled through a tissue by the needle 1133 and traction suture 1132. FIG. 11C illustrates the embodiment of FIG. 11B with the traction suture and needle removed and a retrograde force F1 being applied to the suture 1120, as the retrograde force element, and the force connector 1113. As shown, the button 1110 is deformed into a dilated or folded anchor profile shape that helps anchor the button 1110 in the tissue. As can be seen, a foot connector 1115, here a through hole, is also shown which can retain the second body portion in relation to the first body portion so that the button resists eversion as the retrograde force is applied. In this embodiment, the foot connector 1115 is sized similar to the force connector 1113 so that it restricts the movement of the second body portion with respect to the first body portion and helps the button resist everting. In some embodiments, as shown, the retrograde force element is interwoven through multiple through holes, or foot connectors, along sections and alternating sides of the button which promotes dilated deformation and further preventing the button from everting.

[0110] FIG. 11D illustrates one embodiment where the anchor assembly further comprises a second suture 1132-2 extending through the button and connected to the second body portion 1111, here at the foot connector 1115, and a second needle 1133-2. This second suture 1132-2 as the forward force element is able to apply a forward force F2 on the second body portion 1111 through the foot connector 1115. This forward force F2, with or without an opposite retrograde force on the force connector 1113, causes the button 1110 to deform into a dilated shape that anchors the button 1110 into the tissue. In this embodiment, the deformation occurs closer to the position of the first body portion 1112 which may be helpful in positioning the button.

[0111] FIGS. 12A-12C illustrates another embodiment of a pliable suture anchor assembly. As shown in FIG. 12A, this embodiment has a button 1210 comprising a pliable, generally spiraled or coiled element. This button 1210 has a first body portion 1212 and a second body portion 1211. The first body portion 1212 has a force connector 1213 and has a means to connect the first body portion 1212 with the second body portion 1211 whereby a retrograde force on the force connector causes the button 1210 to deform and engage a tissue and secure the suture anchor assembly in the tissue. In this embodiment, the means to connect is a middle body portion 1214 which is a winding of the coiled element between the two body portions and the force connector 1213 is a closed loop in the first body portion 1212 of the button. FIG. 12B illustrates one embodiment of the suture anchor assembly having a button 1210, a traction suture 1232, a needle 1233 and a suture 1220 connected to the first body portion by a suture tie which in this embodiment also functions as the force connector 1213. The traction suture 1232 provides the means to connect the needle with the suture tie and the first body portion. This illustration shows the assembly in a collapsed insertion profile as it may look being inserted and pulled through a tissue by the needle 1233 and traction suture 1232. FIG. 12C illustrates the embodiment of FIG. 12B with the traction suture and needle removed and a retrograde force F1 being applied to the suture 1220 (retrograde force element) and the force connector 1213. As shown, the button 1210 is starting to deform into a dilated anchor profile shape that helps anchor the button in the tissue. As can be seen, a foot connector 1215 is also shown which can be shaped to help resist eversion of the button 1210 as the retrograde force F1 is applied. Similar to the above embodiments, this embodiment may have a second suture connected to the foot connector 1215 that can be used as a forward force element to deform the button 1210 with a forward force.

[0112] FIGS. 13A-13C illustrate example embodiments of button as they may look after being deformed to anchor the button in the tissue. FIG. 13A is a perspective view of the example embodiment of the button of FIG. 10A in a dilated anchor profile. FIG. 13B is a perspective view of the example embodiment of the button of FIG. 11A in a folded anchor profile. FIG. 13C is a side view of the example embodiment of the button of FIG. 12A in a dilated anchor profile

[0113] The embodiments of anchoring sutures described above are also suitable for anchoring sutures to other body parts such as bones. One embodiment particularly suitable as a bone suture anchoring system is shown in FIGS. 5A and 5B and described below.

Suture Anchor Assembly in Bone:

[0114] Referring to FIGS. 5A and 5B, another embodiment of the suture anchor assembly comprises an expandable first body portion 512 comprising one or more collars with expansion fingers 519, a second retrograde force portion 511 shaped as a trochar, a delivery rod 520 and an impactor 531. Although not limited to, this embodiment is particularly helpful for anchoring sutures to bone.

[0115] In this embodiment, the retrograde force body portion 511 is shaped as a wedge pin or trochar with sharpened distal end and a connectable proximal end including a force connector. In this embodiment, the force connector comprises a threaded portion to removably connect with the threaded end of the delivery rod 520. This retrograde force body portion 511 is preferably made from a rigid material such as a metal, plastic or a composite that allows a force to be applied to the threaded end while the sharpened end penetrates bone.

[0116] The delivery rod 520 is a rigid or semi-rigid element capable of receiving a force from one end of the rod and transferring that force to retrograde force body portion 511 of the button 510. The rod 520 is cable of receiving and transferring both a forward and retrograde force to the retrograde force body portion 511. The distal end of the rod is configured to mate with the force connector of the retrograde force portion of the button. In this embodiment, the delivery rod distal end is threaded to mate with the force connector. It is contemplated that either of these elements may have the male or female elements of a threaded connection.

[0117] Although this embodiment has a delivery rod 520 that connects with retrograde force portion 511 of the button 510 with the use of threaded connections, it is also understood that other means of connecting the delivery rod 520 and the button 510 are possible such as but not limited to mating clips, buttons, protrusions or other connection means.

[0118] In this embodiment shown in FIG. 5A, the expandable body portion 512 comprises a proximal collar 517, a distal collar 516 each attached to one or more expanding fingers 519. The collars and fingers are configured so that when forces are applied to urge both collars together, the fingers 519 are forced to flexibly expand outward from the center of the body portion. FIG. 5B illustrates this embodiment in an expanded configuration. This expansion creates the larger profile of the button 510. Although the fingers 519 are able to flexibly expand, they are rigid enough to provide a frictional connection when expanded against bone or other tissue. The expandable body portion 512 of this embodiment can be made of materials that include, but are not limited to metals, metal alloys or non-metallic materials such as nylon, polyethylene, polypropylene or any combination thereof.

[0119] In one embodiment, it is also contemplated that the shape of the retrograde force portion includes a hook, protrusion or other means to engage the proximal collar 517 so that the two collars can be retained together and the fingers 519 can be kept in their expanded position after deployment. For one embodiment shown in FIG. 5C, the engagement means comprises one or more protrusions 511A on the retrograde force body portion 511 that compress when forced through one direction of the bore of the proximal collar 517 and expand to prevent the collar from moving in the other direction to retain the collar in one position relative to the protrusions 511A. In this embodiment, the wedge shape of the distal end of the retrograde force body portion 511 creates a wedge edge 511B that transfers the retrograde force against the distal collar 516. The cooperation of the protrusions 511A engagement on the proximal collar 517 and the wedge edge 511B against the distal collar 516 retains the button 510 in a position where the fingers 519 are maintained in an expanded state after deployment. As shown in FIG. 5C, if there are multiple protrusions 511A, the retrograde force body portion 511 will urge the collars together until the fingers expand fully into the defect or bore and the protrusions will be retracted through the proximal collar to engage the proximal collar 517 in a tight position. As also shown in FIG. 5C, a threaded recess 511C provides one means to connect the delivery rod 520 with the retrograde force body portion 511. Also shown is FIG. 5C is an additional suture tie 511D to receive and secure a suture to the anchor assembly.

[0120] The impactor 531 is a rigid or semi-rigid element capable of receiving a force from one end of the impactor and transferring that force to the expandable body portion 512. In the embodiment shown, the impactor 531 is a rigid cannula with a longitudinal hollow bore to receive the delivery rod 520. In this embodiment, the bore is shaped to allow the delivery rod 520 to move within the bore while it is also shaped to provide a resisting force on the proximal collar 517 of the button 510. The impactor 531 is shaped to allow the required force to be applied. It is understood that this may require surfaces to either allow the force to be applied frictionally or for the surfaces to be shaped to allow a striking force to be applied. For example, and not for limitation, the impactor 531 may be shaped to have texture about its outer surface to allow the user to frictionally apply the forward force or it can include a flattened surface that would allow the impactor 531 to be struck by a device such as a hammer.

[0121] In this embodiment, the cooperation of the elements allows the anchor to be deployed without the need for a traction suture and needle.

[0122] It is understood and contemplated that the anchor elements, including the button elements, retrograde force elements and sutures, can be made with both resorbable and non-resorbable materials and each one has its individual characteristics which allow it to work best in tissue or in bone such as cortical and cancellous bone.

[0123] Embodiments of the buttons may include rigid buttons made of rigid bioabsorbable or resorbable materials. For illustration only, and not for limitation, the buttons may be made from polymers such as polyglycolic acid, polylactic acid enantiomers, poly-D-L-lactic acid copolymer polyglycolic acid, or a combination of polylactic acid and hydroxyapatite. In the later example embodiment, the polylactic acid dissolves in the body, and the hydroyxapatite may interact with the surrounding tissue to promote bone growth that can help fill in the holes made for or by the buttons.

[0124] Embodiments of the buttons may also include rigid buttons made of bioabsorbable or resorbable material such as collagen. In some embodiments, the button swells upon hydration and permits normal bone generation to assist in anchoring the button.

[0125] Embodiment of the buttons may also include rigid buttons have elements being made of a combination of bioabsorbable material and non-absorbable material. In some of these embodiments, some elements may have surfaces that are bioabsorbable, such as an exterior surface of the expansion fingers made of collagen, to help assist in anchoring the button into bone.

Alternative Embodiments of Suture Anchor Assembly for Anchoring Suture in Bone:

[0126] FIGS. 14A-16 illustrate embodiments of buttons that may function as suture anchors in bone. The embodiments utilize a retrograde force on the button to deform the button as help anchor it in tissues such as bone. Some embodiments may be resorbable and some may be made with a non-resorbable surgical material. Some embodiments made be used with other elements such as a bone screw or a wedge to provide a suture anchor that does not require the use of knots (see FIGS. 20A-20B). Embodiments may also be used with elements that can put a knot in a suture.

[0127] FIGS. 14A-14B illustrate an example embodiment of a suture anchor assembly with a pliable button to be used as a bone suture anchor. The suture anchor assembly functions similar to the anchor assemblies described above and have additional features. In this embodiment, the suture anchor assembly comprises the button with button elements 1410A and 1410B and the retrograde force element 1420. In this embodiment, the button is positioned by a delivery system comprising a hollow delivery rod 1472. Suture 1450 is a suture that comes from a tissue to be secured to the bone with the button. FIG. 14A shows the button in a delivery position and FIG. 14B shows the button in a deployed position. The button is changed from the delivery to the deployed position by applying a retrograde force on the suture 1420 which is attached to one of the button ends and threaded through the delivery rod 1472. The retrograde force pulls on the button end forcing the button end forward and further retrograde force causes the button to bunch up around the distal then of the delivery rod 1472. Suture 1450 is threaded through a loop in distal portions of suture 1420 and the suture 1450 is engaged when the retrograde force is applied to suture 1420. As shown in FIG. 14B, the suture 1450 is threaded between the delivery rod 1472 and the cannula 1474.

[0128] In this embodiment, the sizing of the button elements 1410A and 1410B are made to have a circumferential size small enough to allow the button elements to be received in a bone tunnel when the button is in the delivery position but they have a size large enough to serve as an anchor to wedge the button elements in the bone tunnel when the button elements 1410A and 1410B are in the deployed position. The sizing of the button elements 1410A and 1410B are also large enough that they are not pulled through the distal end opening of the delivery rod 1472. Although not shown, suture anchor assembly 1400 may also have a hook (similar to FIG. 16, hook 1662) positioned through the cannula 1474 and the sutures 1420 so that sutures 1450 may be threaded through the hook and pulled back through the cannula 1474.

[0129] The embodiments shown in FIGS. 15A-15F illustrate some example embodiments of buttons that may be used to anchor sutures in tissue such as bone. The embodiments function similar to the button and suture anchor assembly embodiments described above and has additional features. Referring to FIG. 15E, the retrograde body portion 1511 is coupled to retrograde force element, here suture 1520. When a retrograde force is applied to body portion 1511, the expandable body portion 1512 is urged to rotate, expanding an external profile of the button 1510. In these embodiments, when another suture is threaded through hole 1515, the expandable body portion 1512 is further urged to expand. When the tissue suture 1532 is from a tissue and the button 1510 is in a bone tunnel, the retrograde force on hole 1515 helps keep the profile of the button expanded and in the bone as well as allow the tissue suture 1532 to move through the hole and allow it to be tightened on the tissue.

[0130] FIG. 16 illustrates one example embodiment of a delivery system consistent with the button embodiments shown in FIGS. 15A-15F. Delivery rod 1672 helps position the button 1610 and the cannula 1674 helps contain the tissue sutures and helps insert the button 1610 through the body until the button 1610 is deployed. The hook 1662 is used to receive the tissue suture and when the hook 1662 is pulled distally, the tissue suture is pulled through a hole in the expandable body portion and through one of the delivery rod 1672 or the cannula 1674.

[0131] FIGS. 17A-17E illustrate example embodiments of a bone punch 1780. This is a bone punch that creates a bone tunnel with a profile that is larger under the surface of the bone than is the opening in the bone. For example, the shape is “bowl” shaped with a larger diameter bowl than the diameter of the opening into the bone (see FIGS. 19B and 20A-20B). FIG. 17A shows the cutting teeth 1782A and 1782B in a retaining sleeve 1786. The bone punch is configured to be pounded into the bone and when the retaining sleeve 1786 is retracted, as shown in FIG. 17B, the cutting teeth are exposed and are able to expand to a larger profile. The punch and/or cutting teeth are configured to be twisted to enlarge the bone tunnel with the cutting teeth 1782A and 1782B. A rod 1784 may be used to help urge the blades into their expanded profile. After creating the bowl shaped hole, the punch is configured to allow the retaining sleeve to be pushed back over the cutting teeth 1782A and 1782B, pulling the teeth back into the retaining sleeve and the punch can be withdrawn out of the hole. FIGS. 17C-17E show an alternative embodiment of bone punch 1780.

[0132] FIGS. 21A-21D illustrate example embodiments of a suture anchor assembly with a pliable button and a sliding lock. FIGS. 21A and 21B show the assembly with the delivery system 2172. FIG. 21A shows a side view illustrating an embodiment of the suture anchor assembly 2100 in a delivery position prior to being deployed. The suture anchor assembly 2100 comprises a button with button elements 2110A and 2110B and the retrograde force element, here multiple anchor sutures 2120A and 2120B. In this embodiment, the button elements 2110A and 2110B may comprise a woven fabric. The anchor sutures 2120A and 2120B are prepositioned in the button elements such that one portion is passed through one end of the body of the pliable button element and out the other end. The anchor suture may be passed through the longitudinal axis of the pliable button or it may be weaved through the button from one surface to the other. From the exiting end of the button element, the anchor suture is then passed over the button from one end to the other and then passed back into and through the delivery system. The ends of each anchor suture may be marked, colored, striped or otherwise coded to identify one portion of the anchor suture as the “traction” arm of the suture and one side as the “locking” arm of the anchor suture. The traction arm of the anchor suture, here 2120BT is the side that will be used pull on initially to start to deploy the button. The locking arm of the anchor suture, here 2120BL, is the side of the anchor suture that is configured to deploy the locking mechanism to lock the anchor suture and anchor in place.

[0133] In this embodiment, the force connector coupling the anchor suture and the button element comprising the weaving of the anchor suture through the button element. It is understood that other force connectors may be suitable to couple the anchor suture with the button element so that the button element will move to a deployed configuration when a retrograde force is put on the traction suture. For example, and not for limitation, the force element may include eyelets, rivets, loops or another other method of coupling the anchor suture to the button element.

[0134] In this embodiment, the button elements are positioned by a delivery system comprising a hollow delivery rod 2172. Both ends of the anchor sutures are passed through the delivery system so that a retrograde force may be placed on them by pulling through the delivery system.

[0135] Although not shown, it is understood that the suture anchor assembly may further comprise a handle and other elements to help position assembly elements. The other elements may also have cleats and other features to temporarily hold elements such as anchor sutures before they need to be manipulated.

[0136] As shown, tissue suture arms 2150A and 2150B are two arms from one or more sutures coming from a tissue, such as a mattress suture to be secured to the bone as an anchor tissue with the button. Tissue suture arms 2150A and 2150B are passed through open loops formed by the configuration of anchor sutures 2120A and 2120B so that they may be frictionally engaged by anchor sutures 2120A and 2120B. The ends of each tissue suture arms 2150A and 2150B may also be marked, colored, striped or otherwise coded to identify them as being different than the arms of the anchor sutures 2120A and 2120B.

[0137] FIG. 21B shows the button in a deployed position. The button is changed from the delivery to the deployed position by applying a retrograde force on the anchor suture 2120AT or 2120BT which is coupled to or exiting from one of the ends of the button elements and threaded through the delivery rod 2172. The retrograde force on the traction arm 2210BT pulls on the end of the button element forcing the end of the button element forward and a further retrograde force causes the button element to bunch up around the distal then of the delivery rod 2172. The locking arm 2120BL can then be pulled to cause the locking mechanism to engage the traction arm 2120BT of the anchor suture 2120B such that it locks the anchor suture 2120B and the button element 2110B in the deployed position. As shown, tissue suture arms 2150A and 2150B are threaded through loops formed by the distal portions of anchor sutures 2120A and 2120B and the tissue suture arms 2150A and 2150B are engaged when the retrograde force is applied to anchor suture 2120. As shown in FIG. 21B, the tissue suture arms 2150A and 2150B may be threaded between the delivery rod 2172 and the cannula 2174.

[0138] FIGS. 21C and 21D generally show the embodiment of FIGS. 21A and 21B without the delivery system to expose an embodiment of the locking mechanism. The locking mechanism may be any type of mechanism that allows one arm of an anchor suture, the traction arm, to slide through as a retrograde force is placed on that arm and the locking mechanism will engage, or lock on that traction arm when a retrograde force is put on the locking arm 2120BT that includes the locking mechanism. The locking mechanism may be any type of mechanism that provides the necessary function. In some embodiments, the locking mechanism is a sliding knot such as a slip knot, a double overhand sliding knot, a tautline hitch, a Paulos-Klekas knot, a Duncan knot, a Giant knot, an SMC know or other types of arthroscopic sliding knots. In FIG. 21A, the embodiment of the locking mechanism is a pre-tied knot 2121B positioned around the traction arm 2120BT of anchor suture 2120B. The pre-tied knot 2121B locks onto the traction arm 2120BT when a retrograde force is put on the locking arm 2120BL. A similar configuration of knots and suture arms is shown for anchor suture 2120A.

[0139] As shown in FIG. 21D, as a retrograde force is put on traction arm 2120BT, the button 2110B bunches up and the pre-tied knot 2121B slides along the traction arm 2120BT and up towards the button element 2110B. When the traction arm 2120BT has been pulled sufficiently, the sliding knot 2121B is in position and a retrograde force can then be put on the locking arm 2120BL of the anchor suture 2120B to lock the sliding knot 2121B onto the traction arm 2120BT securing the position of the anchor suture 2120B around the button element 2110B. A similar configuration of knots and anchor suture arms is shown and used for suture 2120A.

[0140] FIGS. 22A-22C show an example embodiment of a sliding knot 2221, here a Paulos-Klekas knot. This knot configuration would be used for the one or more anchor sutures securing the soft button. Here, anchor suture 2220 has a traction arm 2220T and a locking arm 2220L. The locking arm 2220L is used to create two securing loops 2221A and 2221C and also to create bunching loops 2221B. Although the example embodiment shows specific numbers of bunching loops and securing loops, any number loops, to include zero are sufficient as long as the knot functions to lock the anchor suture 2220 in a proper configuration with the button elements. FIG. 22B shows the knot as some retrograde force is applied and the knot 2221 tightens and FIG. 22C shows the sliding knot 2221 tightening further after the application of more retrograde force.

[0141] FIG. 23A shows an alternative embodiment with a single anchor suture 2320 securing one or more button elements, here single button element 2310 with a single pre-tied knot 2321 (the delivery system is not shown). This embodiment functions similar to the embodiments described above with the traction arm 2320T and the locking arm 2320L. As illustrated here, embodiments of the suture anchor assembly having an anchor suture 2320 configured to bunch a button element 2310 when a retrograde force is placed on the traction arm 2320T of the anchor suture 2320, the anchor suture 2320 may be weaved through the button element 2310 to enhance its bias to bunch and fold on itself. And although some illustrated embodiments may show the traction arms of the anchor suture looping over the surface of the button element, the traction arm of the anchor suture may also be weaved through the button element to enhance the functioning of the assembly.

[0142] FIG. 23B illustrates an example embodiment of the suture anchor assembly wherein the delivery system 2372 has suture guides 2372G on its distal end. As shown, these suture guides or portions of the outer wall of the delivery system generally define one or two pairs of opposing slots extending from the distal end of the delivery system. The opposing slots define channels extending generally perpendicular to the longitudinal axis of the delivery system. One of the channels generally retains the button element 2110. The suture guides 2372G may be used to temporally hold and position the anchor suture 2120 so that the distal loops in the anchor suture 2120 may be maintained so that other sutures, such as tissue suture arms from a tissue, may be more easily passed through another channel in the delivery system and through the distal loops of the anchor suture 2120. Once positioned, the delivery system 2372 may be pulled retrograde or removed. Similarly, separate suture guides 2372G may be used with the delivery system 2372 so that they may provide the same function and may be removed without having to remove the delivery system 2372.

[0143] It is understood that the pliable button elements 2110A and 2110B may enhanced or otherwise coupled with other elements to enhance their effect as an anchor. For example, semi-rigid or flexible elements may be used with the pliable button element 2110A and 2110B to provide more friction against the surface of the walls to anchor the button elements.

[0144] In the above embodiments with button elements, referring to FIGS. 21A and 21B for illustration purposes only, the sizing of the button elements 2110A and 2110B are made to have a size small enough to allow the button elements 2110A and 2110B to be received in a bone tunnel when the button element are in the delivery position but they have a size large enough to serve as an anchor to wedge the button elements in the bone tunnel when the button elements 2110A and 2110B are in the deployed position. In some embodiments, the sizing of the button elements 2110A and 2110B are also large enough that they are not pulled through the distal end opening of the delivery rod 2172 when a retrograde force is put on the anchor suture 2120A and 2120B arms. The shaping of the button elements 2110A and 2110B may be of any shape including the shapes of the pliable buttons disclosed herein. Although not shown, the suture anchor assembly 2100 may also have a hook (similar to FIG. 16, hook 1662) or grasper positioned through the cannula 2174 so that the tissue suture arms 2150A and 2150B may be threaded through the hook and pulled back through the cannula 2174. The cannula 2174 may also be slotted to allow the tissue suture arms 2150A and 2150B to be position inside the cannula 2174. The cannula 2174 may also be clear to help the user visually see and position the tissue suture arms 2150A and 2150B.

[0145] The embodiment of FIGS. 24A-24D illustrate embodiments of a suture anchor assembly with different views showing their use with tissue anchors. In the front view of FIG. 24A and side view of FIG. 24B, the tissue sutures 2450A and 2450B are threaded through an open area “A” at the distal end of the delivery system 2472 (here a cannulated rod). The open area “A” is defined by the distal loops of anchor suture 2420. The distal loops overlap so that they allows a single pass of an arm of the tissue suture 2450A or 2450B to pass through both loops. And as can be seen in FIG. 24B, the tissue suture arms 2450A and 2450B are passed in opposite directions and then run up alongside the delivery system 2472. A cannula (not shown) with a longitudinal slot may be used to allow the tissue suture arms to be slid inside the outer cannula when the cannula is positioned around the delivery system 2472 and the tissue suture arms 2450A and 2450B.

[0146] FIGS. 24C-24D illustrate different views of embodiments similar to those of FIGS. 24A and 24B with the addition of a longer pair of slots in delivery system 2472. This longer pair of slots in the distal end of the delivery system 2472 allows for an additional open area “B” to extend through the delivery system 2472 at a position proximal to the button element. As shown, the anchor suture 2420 is threaded through the delivery system 2472 with a traction suture arm 2420T and a locking suture arm 2420L extending through to the proximal end of the system. The open area “B” provides another area where the arms of the tissue suture 2450A and 2450B to be passed around the button element 2410. As shown in FIG. 24D, the arms of the tissue suture 2450A and 2450B may be passed through the open area “A” in one direction and pass through the open area “B” in another essentially wrapping the tissue suture arms 2450A and 2450B around the button 2410. In some embodiments, as shown in FIG. 24A, a sliding knot (only partially shown as 2421) is positioned within the delivery system and one of the loops of the knot, here a securing loop 2421A, so that when the sliding knot 2421 is used to secure the button 2410 and the anchor suture 2420, the sliding knot 2421 also helps secure the anchor suture 2450 to the button 2410 and the tissue such as bone. A slotted cannula and/or a clear cannula may also be used with this embodiment.

[0147] Although suture guides 2472G in FIGS. 24A-24D are shown as multiple prongs, any configuration of a suture guide that allows the proper positioning of the distal loop or loops and allows for the anchor to remain in the tissue when the delivery system is removed is sufficient. For example a single suture guide for one or more distal loops may be sufficient.

[0148] Some embodiments of the suture anchor assemblies may be sized to work with arthroscopic surgical instruments and procedures and some may be sized to work with other surgical instruments and procedures.

Meniscal Repair Method with Meniscal Suture Anchor Assembly:

[0149] One method of operating one embodiment of the suture anchor assembly shown in FIG. 1 is shown as process steps in FIG. 6. Although particular embodiments of the suture anchor assembly are described, and particular uses of the methods are described, these uses and embodiments are used for illustration purposes and not for limitation. This method 600 comprises the steps of:

[0150] Following the starting step 610, a suture anchor assembly is provided as step 620. In one embodiment, the suture anchor assembly comprises a needle, a traction suture, a button, a retrograde force connector and a cannula. The needle is connected to the button with the traction suture and the retrograde force connector is also connected to the button.

[0151] Step 630 includes making a small incision to provide access to the tissue to be repaired. For meniscal repair embodiments, this includes making a small incisions on either the medial or lateral joint line down to the outer lining of the joint capsule.

[0152] Step 640 includes inserting the needle and traction suture of the suture anchor assembly through the cannula and joint lining and through the defect in the meniscus. The needle is passed from the inside of the joint to the outside while carefully protecting the neurovascular structures.

[0153] FIG. 7A illustrates the use of one suture anchor assembly in step 640 where the needle 733 is passed through a tissue 740, such as a meniscus, through the defect 741 and outside of the joint lining surface 742. FIG. 7A shows the other elements of the suture anchor assembly prior to pulling the button 710 and retrograde suture 720 (retrograde force element) into the meniscus 740 with the traction suture 732.

[0154] Step 650 includes pulling the button through the tissue with the needle and the traction suture. The button need not be pulled entirely through the tissue but may be pulled across the defect and into a position such that the button will anchor into the tissue on the opposing side of the defect. The buttons are preferably not placed near significant neuro-vascular structures. The buttons are also placed to make sure it is buried in the tissue so that no sharp edges are exposed to other tissues or bone.

[0155] In one embodiment for meniscal repair, it is beneficial, but not necessary, in this method to have the button shaped generally flat or planar so that its profile once inserted can be generally parallel to the surfaces of the knee joints to minimize the possibility of protrusions that would irritate the tissues of the joint. For control purposes, the hollow of the cannula can be shaped to receive the button and control its profile during insertion. For example, the button can be planar shaped and the hollow of the cannula can be slot shaped allowing a rotation of the cannula to rotation the planar position of the button.

[0156] In one embodiment, of meniscal repair, the final position of the buttons may also be pulled totally through the meniscus to include but not limited to, positions that rest on the outer surface of the meniscus or positions outside of the joint capsule.

[0157] Step 660 includes applying a retrograde force on the retrograde force element to deploy the button and urge the tissue defect into the desired position. Typically, but not necessarily, this desired position is to urge opposing edges of a defect together. The retrograde force on the retrograde suture is transferred to a retrograde force to the button which forces the button to deploy and anchor the expansion suture.

[0158] It is not necessary to perform step 660 prior to adding a second button and retrograde force element.

[0159] Although not required, step 670 includes repeating the above steps (610-660) for at least a second time. For embodiments where the retrograde force element is a retrograde suture, the placement of the needle and the retrograde suture into the tissue is such that it can form sutures such as, but not limited to vertical or horizontal mattress sutures to repair the meniscal defect.

[0160] Step 680 includes anchoring the retrograde force element to maintain the tissue defect in the desired position. For embodiments where the retrograde force element is a retrograde suture, the fixation arms of the sutures can be anchored by tying knots in or otherwise knotting the sutures separately or knotting the expansion sutures together to repair the defect.

[0161] Step 690 includes removing the traction suture. The traction suture and needle may be removed from the button at any time after the button is positioned properly. One method of removal is to have the traction suture configured as a loop through both the button and the needle whereby cutting one segment of the loop allows the entire suture to be pulled out of the button.

[0162] The method is finished with step 695.

[0163] In suture anchor assembly embodiments, such as those illustrated in FIGS. 10E and 11D that utilize a forward force to help anchor the button, the second suture is configured and inserted through the tissue similar to the traction suture. After the second suture is used to provide the forward force and the anchor is properly positioned, the suture is removed by cutting a section of the suture loop and pulling the suture through the foot connector and out of the tissue.

[0164] The result of this embodiment for a miniscal repair, as illustrated in 7B, are retrograde sutures 720 that are anchored on either side of a miniscal defect 741 to maintain the tissue 740 in a position to repair or promote healing of the defect. FIG. 7B shows two sutures 720A and 720B anchored by two buttons 710A and 710B across the tissue defect 741.

[0165] With this embodiment of the method, incisions that are normally needed in the inside-out procedures to secure the fixation arms of the sutures are not needed. Additionally, the ability to use needles to position the buttons and sutures allows more accurate position of the devices within the tissue and around neuro-vascular structures.

[0166] Other methods of use are contemplated as would be envisioned by those skilled in the art. For example, it is contemplated to have pre-tied knots in the sutures to either create a knot in a single suture or to tie two or more sutures together.

[0167] It is also contemplated that the method of using needles and traction sutures to position the anchor can be used with other suture anchor systems. Needles and elements to provide the function of the traction suture can be used with existing suture anchor systems.

[0168] It is also contemplated that the above method may be performed without the need to use a needle and traction suture to position the button. For these embodiments, it is envisioned that the button may be manufactured to include a distal end that can insert itself and the retrograde suture sufficiently or it can be designed to receive an element such as a guide pin that can be removed once the button is positioned properly. In these embodiments, it is also envisioned that the cannula or other guide means can be designed to provide the force to position the button for meniscal repair.

[0169] Although the above description is illustrative of the methods for use with meniscal repair, it is also contemplated that the methods can be applied to the repair of other tissues such as but not limited to stomachs and cartilage associated with joints such as a hip, elbow or shoulder.

Bone Anchoring Method with Bone Suture Anchor Assembly:

[0170] One method 800 of using one embodiment of the bone suture anchor assembly shown in FIG. 5 is outlined in FIG. 8 and described below.

[0171] Following step 810, a bone suture anchor assembly is provided in step 820. In one embodiment, the assembly includes an expandable first body portion comprising one or more collars with expanding fingers, a second retrograde force portion shaped as a trochar, a delivery rod and an impactor. As shown in FIG. 9A, the delivery rod 920 is connected to the proximal end of the retrograde force portion 9110. The delivery rod 920 is received through the proximal collar 917 and distal collar 916 of the expandable first body portion 912 and the impactor 931 is placed around the delivery rod 920 forcing the expandable body portion 912 to be positioned between trochar 9110 and the impactor 931.

[0172] Step 830 includes making an incision to provide access to the bone.

[0173] Step 840 includes positioning the sharpened end of the trochar against the bone and impacting the anchor assembly into the bone. This step typically includes striking the delivery rod with a weighted object such as a hammer. This forward force is transferred through the delivery rod to the sharp end of the trochar causing the trochar to penetrate the bone. In this step, the sharp trochar is inserted into the bone followed by the insertion of the expandable body portion. The size and shape of the trocar is such that its penetration of the bone forms a cavity of a size to allow the first body portion to also penetrate the bone. Embodiments of this assembly can be inserted into the bone with or without pre-drilling.

[0174] Once the trochar and expandable first body portion have penetrated the bone, step 850 includes applying a retrograde force the retrograde force element. In one embodiment, this retrograde force is applied by the delivery rod that is connected to the trochar by the cooperation of the threaded end of the delivery rod and the threaded end of the trochar. The application of this retrograde force subjects the trochar and the distal end of the expandable body portion to that retrograde force while the proximal end of the expandable body portion is subjected to an opposite, forward force from the impactor. These opposing forces force the trochar to pass through the middle of the anchoring device until the outer dimension of the trochar can no longer fit the interior dimension of the distal collar of the first body portion. When the trochar can no longer pass, the retrograde force is transferred to the distal collar forcing the collar to move toward the proximal collar and expand the first body portion until the body portion can no longer expand. This anchor will expand until its profile generally fills the bore created by the trochar. At that point the expanding trochar will stop its retrograde progression. In this position, the anchor is frictionally engaged and held in the bone bore.

[0175] Although step 850 includes pulling the trochar retrograde into the expandable body portion, it is also contemplated that the anchor assembly can engage the tissue by maintaining the position of the trochar and forcing the expandable body portion onto the shape of the trochar. This forcing can be applied by the impactor and can also cause the expandable body portion to expand into the bore.

[0176] FIG. 9B illustrates this embodiment of the bone suture anchor assembly having been impacted into the bone.

[0177] Step 860 includes removing the delivery rod from the trochar.

[0178] Step 870 includes attaching a suture or other surgical device to the anchor assembly's first or second body portion. The suture is attached to the anchor assembly under tension which keeps the expandable body portion in an expanded position.

[0179] The method is finished with step 880.

[0180] The result of this embodiment is shown in FIG. 9B. The trochar 911 (retrograde body portion) is retracted against the distal collar 916. The proximal collar 917 has been retained to urge the fingers 919 to expand. Once expanded, the fingers 919 are frictionally engaged within an opening 941 in the bone originally caused by the trochar 911 being impacted into the bone.

Alternative Methods of Using Suture Anchor Assembly in Bone:

[0181] FIGS. 18A-20B shows methods of using the buttons as part of a suture anchor assembly in bone. Although the example of use for repairing tissue in the shoulder, it is understood the methods may be used with other tissues and bones.

[0182] In FIG. 18A, the suture 1832 is attached or otherwise coupled to the tissue to be anchored. Access to the surgical site may be provided by a cannula 1876 and the sutures 1832 are pulled through the tissue and the cannula 1876.

[0183] FIG. 18B shows inserting the bone punch 1880 into the cannula 1876 to create the bone tunnel in the bone 1840. The punch is pounded into the bone and when the retaining sleeve is retracted, the cutting teeth expand and are exposed (see FIGS. 17A-17E). The punch is twisted to enlarge the bone tunnel with the cutting teeth. The rod may be used to help urge the blades into their expanded profile. When the bowl shaped hole is created, the retaining sleeve is then pushed back over the cutting teeth and the punch is withdrawn out of the hole.

[0184] FIG. 19A shows the bone tunnel 1941 in the bone 1940.

[0185] FIG. 19B shows the sutures 1932 having been pulled through the button and out through the delivery system. The sutures 1932 may be pulled through the delivery system 1970 using an embodiment of a suture anchor having a hook (similar to hook 1662 in FIG. 16 where the suture 1932 is threaded through the distal end opening of the hook and a retrograde force on the hook pulls suture 1932 though the delivery system 1970). In this configuration, tension is applied to sutures 1920 and 1932 to help deploy the expandable body portion of the button so that is it held in the bone tunnel 1941.

[0186] FIG. 20A shows a button in the bone tunnel after withdrawal of the delivery system. While tension is still applied to sutures 2032 and 2020, wedge 2092 and wedge delivery rod 2094 are inserted through the cannula.

[0187] FIG. 20B shows the positioning of the wedge 2092 in the bone tunnel frictionally engaging the sutures 2032 and 2020 and securing them to the bone without having to put a knot in the sutures 2032 and 2020. In some embodiments, a knot may be used on either side of the wedge to further secure the sutures.

[0188] The embodiment of suture anchors illustrated in FIGS. 14A and 14B may be similarly anchored in a bone tunnel. The suture 1450 may be positioned between the distal loop of suture 1420 and the button elements (1410A and 1410B) and pulled through the cannula 1474 with a hook or suture grasper (not shown) or manually either while button elements are inside or outside of the body. The delivery system 1472 and cannula 1474 can then be used to position the button elements 1410A and 1410B into the bone tunnel while they are in the delivery position. Once positioned in the bone tunnel, the suture 1420 may be pulled with a retrograde force to position the button elements 1410A and 1410B in the deployed position and anchor the button in the tunnel. Suture 1450 may also be pulled with a retrograde force to increase the tension on suture 1450 to secure the suture 1450 and the tissue it is attached to. In some embodiments, the suture 1450 is secured without having to tie a knot in the suture 1450 due to the suture 1450 being frictionally engaged and secured between the outer surface of the button elements and the inner wall of the bone tunnel. In some knotless embodiments, the suture 1450 is frictionally held in place with additional elements such as a wedge (e.g., see wedge 2092 of FIGS. 20A-20B). In some embodiments, a knot may be used to further secure the sutures.

[0189] The embodiments of the suture anchor assemblies illustrated in FIGS. 21A-21D may be similarly anchored in a bone tunnel. The arms of the tissue suture 2150A and 2150B may be positioned between the distal loop of anchor sutures 2120A and 2210B and the outer surface of button elements (2110A and 2110B) and pulled through the cannula 2174 with a hook (not shown), a suture grasper (not shown) or manually either while the button elements are inside or outside of the body. In some embodiments, the tissue suture arms 2150A and 2150B are passed through the distal loops of the anchor sutures 2120A and 2120B in opposite directions. With the tissue suture arms 2150A and 2150B threaded through the distal loops of the anchor sutures 2120A and 2120B, the anchor sutures and the tissue sutures are tensioned parallel to the delivery system 2172 (e.g., inserter shaft) and cleated or otherwise secured to the delivery system 2172 or another assembly element. A bone tunnel can then be punched or drilled into the bone using the cannula 2174 as a guide that has been positioned on the bone where the tissue suture arms 2150A and 2150B will be anchored. The anchor sutures 2120A and 2120B, button elements 2110A and 2110B and tissue suture arms 2150A and 2150B, positioned at the distal end of the delivery system 2172 can then be placed through the shaft of the cannula 2174 and into the bone tunnel while they are in the delivery position. Typically, the distal end of the anchor assembly 2100 is positioned in the bone tunnel by tapping the proximal end of the delivery system 2172 so that the anchor sutures 2120A and 2120B, button elements 2110A and 2110B and tissue suture arms 2150A and 2150B are urged into the predrilled bone tunnel. The depth of the insertion of these elements into the bone may be determined by a predefined marking on the outside surface of the delivery system indicating the distance between the marking and the end of the button elements. Once positioned in the bone tunnel, the anchor sutures 2120A and 2120B, in particular the traction arms 2120AT and 2120BT are pulled with a retrograde force to position the button elements 2110A and 2110B in the deployed position and anchor them against the sidewalls of the bone tunnel. During the tensioning of the traction arms 2120AT and 2120BT, the tissue suture arms 2150A and 2150B may also be tensioned to ensure proper positioning with the button elements 2110A and 2110B. Once at or near the deployed position, the locking arms 2120AL and 2120BL are pulled to lock the locking mechanism onto the traction arm of the anchor sutures 2120A and 2120B. The locking mechanism locks the anchor sutures 2120A and 2120B in a position such that they keep the button elements 2110A and 2110B in the deployed position. Before or while the locking mechanism is being locked, the tissue suture arms 2150A and 2150B may also be pulled with a retrograde force to increase the tension on tissue suture arms 2150A and 2150B to secure these tissue suture arms and the tissue it is attached to into the bone tunnel. During tensioning of the tissue suture arms 2150A and 2150B and/or the anchor suture 2120A and 2120B arms, the delivery system 2172 may be used to provide a forward force on the button elements or other assembly elements to help keep the button elements and sutures in the bone tunnel. Once the tissue suture arms 2150A and 2150B and the anchor assembly elements are properly anchored, the loose ends of the anchor sutures and the tissue suture arms are cut flush to the anchor tissue.

[0190] In some embodiments, the tissue suture arms 2150A and 2150B are secured without having to tie a knot in them due to the tissue suture arms 2150A and 2150B being frictionally engaged and secured between the outer surface of the button elements 2110A and 2110B, the anchor sutures 2120A and 2120B and the inner wall of the bone tunnel. In some embodiments, the tissue sutures 2150A and 2150B are frictionally held in place with additional elements such as a wedge (e.g., see wedge 2092 of FIGS. 20A-20B). In some embodiments, a knot (e.g., a half hitch or similar sliding knot) may be used to further secure the anchor and/or the tissue suture arms.

[0191] The embodiment of FIGS. 23A and 23B may be similarly anchored in a bone tunnel using methods similar to those of the embodiment shown in FIGS. 21A-21D.

[0192] The embodiment of FIGS. 24A-24D illustrate embodiments of a suture anchor assembly with a single button element that may be similarly anchored in a bone tunnel using methods similar to those of the embodiment shown in FIGS. 21A-21D and 23A-23B.

[0193] It is understood that other elements such as bone screws may be used to secure the sutures to the bone in the bone tunnel.

[0194] It is also understood that the button and button elements may also be used with a knot pusher and pushing a suture knot to the button.

[0195] With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.

[0196] Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.