Patent ID: 12185942

DETAILED DESCRIPTION

The following detailed description is presented to enable any person skilled in the art to make and use the invention. For purposes of explanation, specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not required to practice the invention. Descriptions of specific applications are provided only as representative examples. Various modifications to the preferred embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the scope of the invention. The present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.

Knotted button-suture assemblies lose tension after the knot is tied on the proximal side of the assembly during surgical procedures. Tying a knot in the sutures during surgery can be substantially difficult and, as previously described, may result in loss of tension after the knot is tied as it is released by the tying implements. This loss in tension allows the loop to relax or spring back at least one or more millimeters making the placement of the assembly during the surgical procedure less precise. The button-suture assembly100, described herein allows decreasing the length of suture loops124,125and126between the baseplate110and the button101and locking pin103sub-assembly (henceforth referred to as suspension device115) by means of pulling on loose suture ends121, which results in suture loops124and125moving relative to the baseplate110, but in the suture loops124,125and126preferably not moving relative to the locking pin103through transverse aperture109of which it passes.

At a state when the proximal surface of the baseplate110and the distal surface of the button101make contact with bone surfaces, applying tension (pulling force) in the proximal direction to the loose suture ends121, causes the locking pin103to translate proximally relative to the button101by a small amount that is preferably greater than zero but less than 1 mm and more preferably less than 0.50 mm and most preferably less than 0.25 mm. This proximal translation of the locking pin103is caused by the fact that the spacing between the loose suture ends121as they enter the button101(this spacing afforded them by openings104and105in the button103through which the loose suture ends121pass), is smaller than the spacing allowed by the proximal end of the locking pin103as the loose suture ends121exit the suspension device115(best seen in an embodiment inFIG.7A). Since the loose suture ends121are pulled in generally proximal direction during the tensioning step, this difference in spacing causes the suture ends to exert a proximally-directed force on the locking pin103.

When the tension applied to the suture ends is released, the tension stored in the suture loops124,125and126(which also results in compressive forces on the bony anatomy by the baseplate110and the button103) causes the locking pin103to translate distally thereby bottoming out on and applying pressure to the suture102around pinch points119shown for example inFIG.4and causing the assembly to lock and to resist further lengthening of the suture loops124,125and126(best seen in an embodiment inFIG.7B). It should be understood that the amount by which the locking pin103moves proximally during the tensioning step and the amount by which the locking pin103moves distally when the tension on the loose suture ends121is released is contemplated to be the amount by which the assembly will “spring back” or relax as discussed above. Therefore, the lower the proximal displacement of the locking pin103required to pull the suture102through the suspension device115—the lower the relaxation the full assembly will experience during the locking step.

Furthermore, it is contemplated that the size of elongate central opening105in the button101could prevent the suture loop124,125and126from passing through it resulting in a stable assembly where the locking pin103cannot be completely withdrawn from the button101after assembly and while the suture loop124,125and126passes through transverse opening109within it. Furthermore, due to each of the loose suture ends121passing through their own dedicated openings104and106in the button101, the assembly functions in a predictable manner where the suture ends and the locking pin103translate through the button101in preferably one dimension (generally in proximal and distal directions).

The button-suture assembly100is used for knotless stabilization of two or more tissue, bone or other body members. While the preferred embodiment is contemplated for the stabilization of two bone or tissue fragments, the button-suture assembly is versatile and can be used for a variety of different applications. In the procedure utilizing the preferred embodiment of the button-suture assembly100, a hole is drilled through bones, sutures are passed through the hole and fixated on the distal side of the hole. The bones are then pulled closer together and sutures tensioned via pulling on the loose suture ends121in the proximal direction allowing the individual performing the procedure to adjust the button-suture assembly100as necessary. Once the tensioning step is complete, the button-suture assembly100locks in place and holds the tension with preferably minimal relaxation or slip-back. The button-suture assembly100also allows for unlocking and loosening the assembly if re-tensioning or repositioning is desired by means of applying tension in the proximal direction to the locking pin103and causing it to translate proximally.

As will be appreciated byFIGS.1-4, the preferred embodiment of the button-suture assembly100consists of a suspension device115, a baseplate110, and suture102. The suspension device115is further comprised of a button101and a locking pin103, as shown inFIG.6. The button101is preferably round with three openings, the center opening105large enough to accept the distal member108of the locking pin103, the first opening104configured to mate with the suture102and second opening105configured to mate with the suture102located on either side of the center opening105The locking pin103mates with the center opening105of the button101and includes a retaining mechanism configured to allow the sutures102to pass through the indented portions116of the locking pin103positioned against the interior surface117of the circumference of the button101when and preferably, only when tension is applied to the loose suture ends121.

It should be understood that the indented portions116are optional and generally serve the purpose of compensating for the thickness of the suture102and allowing the locking pin103to sit closer to the button101thereby reducing the prominence of the suspension device115above the bone (can be seen in an embodiment inFIG.7A). In an embodiment, the indented portions116may also serve the purpose constraining the side-to-side or rotational (excepting the twisting of the suture along its long axis) motion of the suture with the suspension device115.

The distal member108of the locking pin103contains a transverse opening109through which the suture can pass. The indentations116of the locking pin103are located on opposite sides of the proximal end107, which has a cross-sectional dimension greater than the opening of the button to prevent the locking pin from sliding out of the center button opening105. Each indentation116creates a passage118for the sutures102between the locking pin103and button101creating pinch points119. The indentations116have large surface area with rounded edges and flattened conical surfaces to preferably maximize the contact surface area between the suture102and the suspension device115.

The pinch points119create locking (pinching) force to the tension stored in the suture loop124,125and126of the assembly100as discussed above. Moreover, the indentations116of the locking pin103along with the individual openings104and105for each loose suture end121in this preferred embodiment help rotationally constrain the button-suture assembly100so that the sutures102do not twist (excepting the twisting of the suture along its long axis) while tensioning.

The baseplate110is preferably oblong in shape with at least two openings, but preferably four. In the preferred embodiment, the sutures loop three times through the two center openings111and112of the baseplate110forming the suture loops124and125, two times through the transverse opening109of the locking pin103forming the suture loop124,125and126and then through the two outer openings104and106of the button101and up through the pinch points119of the locking pin103as shown inFIG.1. The two outer openings of the baseplate113and114can be used for additional and optional operations such as housing the “passing sutures” used to pull the baseplate110through the hole drilled in bone. Unlike the prior art, the pinch points119along with the individual openings104and105for each loose suture end121also allow for rotational control to prevent twisting (excepting the twisting of the suture102along its long axis) of the suture102during use.

The button suture assembly100also contemplates the sutures102looping through the two center openings111and112of the baseplate110and transverse opening109of the locking pin103various numbers of time. For instance, as shown inFIG.3, the sutures102may loop through the two center openings111and112of the baseplate110twice and through the transverse opening109of the locking pin103once to form the suture loops124and125. Alternatively, the sutures may loop through the two center openings111and112of the baseplate110four times and through the transverse opening109of the locking pin103three times to form the suture loops124and125, as depicted inFIG.2. The increased number of suture loops (124and125) through the baseplate provides increased stability of the button suture assembly100and better procedure outcomes.

In an alternate embodiment, a baseplate is not used in the button-suture assembly100. Instead, the sutures loop through each other and through the transverse opening109of the locking pin103two times to form the suture loops132, as depicted inFIG.24, to secure a graft or other members during a procedure. It is also contemplated that the sutures may loop through each other and through transverse opening109of the locking pin103three times to form the suture loops132, as depicted inFIG.25.

In another alternate embodiment, the baseplate110comprises a sleeve member127to tension the construct around the suture with an interior and an exterior surface along a length defined between a first end130and a second end131, and at least two openings positioned along the length and extending from the interior and through the exterior surface, as shown inFIG.22. Similar to the baseplate110, the sleeve member127distributes the pressure evenly from the suture loops124,125and126and helps reduce stress or damage to any structure that the sutures are looped around, including bone, tendons, tendon graft, other sutures or surgical tape. The sleeve member127should be smooth to prevent friction and sliding of the sutures102and can be woven to the suture102after assembly on both sides, as shown inFIG.21. Also, as shown inFIG.23, the sleeve member127can be used on both sides of a graft during graft procedures to prevent sliding of and damage to the graft.

Suture102is contemplated as being manufactured out of a variety of fibers or filaments including but not limited to polymer filaments (e.g. HMWPE, UHMWPE, PET, PTFE, PEEK, PEKK, PLA, PLLA, etc.), metallic filaments (e.g. Nitinol, Titanium, Titanium alloys, Tantalum, Stainless Steel, etc.) or organic filaments (e.g. Collagen, Silk, etc.) or other filaments such as carbon fiber or carbon nanotubes, etc. Suture102is further contemplated to comprise, but not limited to, a coreless suture, a suture with a jacket and a central core, a tape or any other tension member available or contemplated. The length of the suture102is contemplated as being between 150 mm and 1000 mm in length and more preferably between 300 mm and 1000 mm in length and most preferably between 250 mm and 750 mm in length. To prevent glove tears, surgeons can use hemostat forceps to roll the suture102during a procedure utilizing the button suture assembly100.

More specifically, after a hole is drilled through the surface of a bone or other member, the doubled-up suture120is passed through the indentions116of the suspension device115and tensioned by pulling on the ends121of the double suture120in the proximal direction, and locking the button-suture assembly100in place once the tensioning force is released as discussed above. As shown inFIG.7B, when no pull is applied to the suture ends121, the tension in the double loop120(or the suture loop124,125,126) section prevents the loop from lengthening via sutures102being locked in the pinch points119. Alternatively, pulling on the locking pin103unlocks the suspension device115. In this state, the double suture loop120can be lengthened by pulling on the button101, as shown inFIGS.8A-8B.

The suspension device115can be unlocked in any way that separates the locking pin103from the button101. These mechanisms include, but are not limited to, prying the locking pin103with a pick-like instrument, or the locking pin may103have specialized features for pulling it up with either general or specialized surgical instruments. In the preferred embodiment, the locking pin103is long enough that it can be pushed back through the suspension device from the distal side. The button-suture assembly100also contemplates various additional features to aid in the unlocking of the suspension device115, such as a threaded locking pin122and tool access cuts123in the exterior of the button101as shown inFIGS.14and16.

While the suspension device115described above is the preferred embodiment of the button-suture assembly100, the tension can be maintained with the self-locking mechanism of the embodiment shown inFIG.9. In this embodiment, the button201contains four openings in the interior surface which the flat locking pin203with two center holes205and206sits on top of, and the same baseplate207is used from the preferred embodiment. The sutures202pass through two of the button holes205and206in the same way they pass through the transverse opening109of the locking pin103forming the suture loop204equivalent in function to the suture loop124,125and126of the embodiment ofFIG.1for example, and up through indentations208on the sides of the modified locking pin203. In this embodiment the locking mechanism does not control the rotation of the sutures while tensioning, primarily because the locking pin203is not translationally captured within the button201(i.e. can move indefinitely in the proximal dimension up to and including the point of disengaging from the suture202).

While the preferred embodiment of the invention contemplates tapered indentations116for the sutures to pass through with increased surface area, a generally rectilinear but rounded cross-section300of the proximal end of the locking pin103can also be used to form the pinch points119, as shown inFIG.13A-13B.

The button-suture assembly100can also utilize pull rings301for procedures such as tendon grafts. Pulling on suture-ends121to tension the button-suture assembly100could be uncomfortable to a user, so the pull-rings301are contemplated to improve the ergonomics of this step. In this embodiment, the pull rings301are located at the suture ends302to reduce loop length. The pull rings301can be made out of woven, braided or embroidered fiber or comprise solid metal or polymer components. Also, a thicker continuous loop303is utilized rather than the doubled suture suspension loop120of the preferred embodiment. The increased surface area of the continuous loop303is intended to prevent the “sawing” effect on the tendon graft by better distributing the stresses.

The button-suture assembly100is generally compatible with drilled bone holes of generally smaller diameter than largest dimension of the button101. However, a footprint extender400can be added to the suspension device115in any embodiment to accommodate bone or other holes of diameters larger than the largest dimension of the button101. In the preferred embodiment, the footprint extender400contains an opening401on one side allowing the footprint extender400to slide around and envelop the suspension device115, as can be appreciated inFIG.11A. As shown inFIG.11B, the interior of the footprint extender402is hollow allowing the sutures from the suspension device115to pass to and from the baseplate110without obstruction.

In the second embodiment, the footprint extender500mirrors the exterior shape of the suspension device in a larger scale and envelops the suspension device allowing the sutures202to again pass through without obstruction, as shown inFIG.12B. As shown inFIGS.12C and12D, the suspension device217can be pulled through and snapped into the footprint extender500.

Surgical procedures which would use the button-suture assembly100may benefit from the aid of an expandable sounder instrument600as shown inFIG.18A. The expandable sounder instrument600is comprised of a tip601, inner shaft606, compression spring603, sounder body604, spring plunger607, and push button605, and is used to assess whether a drilled hole breaks through the distal cortex of bone. If the sounder tip601is located past the distal cortex, then pressing the push button605and expanding the tip601will result in the user not being able to pull the sounder instrument601out of the hole because the tip601is larger than the hole diameter when expanded. Specifically, when the push button605of the sounder instrument600is pressed engaging the compressing spring603, the diameter of the tip601of the instrument is expanded and unable to exit the hole in the bone, as shown inFIG.18C.

Also, a button inserter/flipper700can be used in surgical procedures in which the button-suture assembly100is employed. The button inserter/flipper700depicted inFIGS.19A-19Bis comprised of a main body701, compression spring702, tip703push button707, spring plunger704, and inner shaft/flipper705. The button/inserter flipper700inserts the button-suture assembly100through a bone bore and flips it behind the distal cortex in a forward motion. The button suture assembly100is loaded into the tip703of the instrument and existing sutures102are passed along the lengthwise groove and lightly tensioned to facilitate passing through the hole708. The button inserter/flipper700is then inserted into the drilled hole708. When the button101is past the distal cortex, it is flipped by simultaneously applying tension on the sutures102and pushing the proximal push button707fully as shown inFIG.19E. The button101may provide tactile feedback when fully pressed by means of spring plunger704. While button/inserter flippers700known in the art flip the button in a retrograde motion, the tension is actually maintained in the button-suture assembly100and allows for forward actuation of the button101. The button inserter/flipper700is then withdrawn from the hole708, leaving a flipped button101on the distal bone surface.

Finally, a measurement plate800as shown inFIG.20is an auxiliary tool for implantation of the button-suture assembly100. The measurement plate800comprising a measurement base801, a primary reference member802, a secondary reference member803, an engagement feature804, a tertiary reference member805, and a terminal reference member806.

The measurement base801provides a means to measure the length of a surgical corridor and distances in-between; for example, the canal for anterior cruciate ligament (ACL) repair. Length measurements are marked about the measurement plate's800primary axis. The primary reference member802can be positioned to indicate a primary frame of reference. In this example, it would indicate a starting measurement point at the distal femoral cortex in an ACL repair.

The secondary reference member803is adjustable in position about the axis of the primary reference member802. The adjustable position of the secondary reference member803could indicate a second measurement; in this example, it would indicate the length of a loop attached to a button as used in ACL repair. The secondary reference member803can have an engagement feature804which could serve the purpose of attaching an item to aid in or simulate the procedure. In this case, it could be used to hold one end of a surgical graft used in ACL repair. Holding the graft would allow for a simulated view of how the graft is positioned and/or measured relative to the femur and tibia. The T, adjustable in position about the primary axis of the measurement base801, can be positioned to indicate a secondary measurement or location. In this example, the tertiary reference member805can be positioned to indicate the proximal femoral cortex in ACL repair. The distance between the primary reference member802and the tertiary reference member805would equal the total length of the femoral bone tunnel.

The terminal reference member806, adjustable in position about the primary axis of the measurement base801, can be positioned to indicate a third measurement or location. In this example, the terminal reference member806can be positioned to indicate the proximal tibial cortex in ACL repair. The distance between the primary reference member802and the terminal reference member806would be the overall length as measured from the distal cortex of the femur to the proximal cortex of the tibia.

The terms “comprising,” “including,” and “having,” as used in the claims and specification herein, shall be considered as indicating an open group that may include other elements not specified. The terms “a,” “an,” and the singular forms of words shall be taken to include the plural form of the same words, such that the terms mean that one or more of something is provided. The term “one” or “single” may be used to indicate that one and only one of something is intended. Similarly, other specific integer values, such as “two,” may be used when a specific number of things is intended. The terms “preferably,” “preferred,” “prefer,” “optionally,” “may,” and similar terms are used to indicate that an item, condition or step being referred to is an optional (not required) feature of the invention.

The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention. It will be apparent to one of ordinary skill in the art that methods, devices, device elements, materials, procedures and techniques other than those specifically described herein can be applied to the practice of the invention as broadly disclosed herein without resort to undue experimentation. All art-known functional equivalents of methods, devices, device elements, materials, procedures and techniques described herein are intended to be encompassed by this invention. Whenever a range is disclosed, all subranges and individual values are intended to be encompassed. This invention is not to be limited by the embodiments disclosed, including any shown in the drawings or exemplified in the specification, which are given by way of example and not of limitation. Additionally, it should be understood that the various embodiments of the suspension device described herein contain optional features that can be individually or together applied to any other embodiment shown or contemplated here to be mixed and matched with the features of that device.

While the invention has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed herein. Accordingly, the scope of the invention should be limited only by the attached claims.

All references throughout this application, for example patent documents including issued or granted patents or equivalents, patent application publications, and non-patent literature documents or other source material, are hereby incorporated by reference herein in their entireties, as though individually incorporated by reference, to the extent each reference is at least partially not inconsistent with the disclosure in the present application (for example, a reference that is partially inconsistent is incorporated by reference except for the partially inconsistent portion of the reference).