Patent Application
20220338857
The present disclosure relates generally to methods and devices for securing soft tissue to bone.
Tearing of, or complete or partial detachment of ligaments, tendons and/or other soft tissues from their associated bones within the body are commonplace injuries. Such injuries can result from excessive stresses being placed on these tissues. By way of example, tissue tearing or detachment may occur as the result of an accident such as a fall, over-exertion during a work-related activity, or during the course of an athletic event. In the case of tearing or a partial or complete detachment of soft tissue from a bone, surgery is typically required to reattach the soft tissue (or a graft tissue) to the bone.
One method of repairing such a tear is to stitch it closed by passing a length of suture through the tissue and tying the suture. Suture can also be used in conjunction with one or more suture anchors to repair such tissue tears. Sutures can be fastened to suture anchors and to tissue using knots tied by the surgeon during a repair procedure, or using “knotless” devices and methods, where one or more anchors and one or more sutures can be connected and tensioned without the surgeon needing to tie knots during the surgery. Knotless anchoring is of particular utility for minimally invasive surgeries, such as endoscopic or arthroscopic repairs, where the surgeon remotely manipulates the suture at the surgical site using tools inserted through a small percutaneous incision, small diameter cannula, or an endoscopic tube, which can make the knot-tying process difficult and tedious.
It can be challenging to maintain the desired alignment and tension on the operative suture in the course of a surgical procedure to reattach soft tissue. Further, existing suture anchors used to insert the anchors into bone may have certain disadvantages that complicate their use and/or impose certain undesirable limits.
Accordingly, there is a need for improved devices, systems, and methods for attaching tissue to bone.
In one aspect, suture anchor system includes a cannulated inserter tool having a lumen extending therethrough and an elongate inserter shaft with an anchor receiving portion that is proximal to a distal extension. The anchor receiving portion has at least one drive feature formed thereon and the distal extension has a diameter that is less than a diameter of the anchor receiving portion. A cannulated suture anchor is removably disposed on the anchor receiving portion of the inserter tool. The suture anchor has at least one bone-engaging feature disposed on an external surface thereof. A cannulated suture seating member is removably disposed on the distal extension in a clearance fit. The suture seating member being rotationally independent of the suture anchor and having a lumen extending therethrough with an opening on a distal portion thereof, where the distal end of the suture seating member has a suture seating surface.
The suture anchor system can have various configurations. For example, at least one stay suture loop can extend through the lumen and the opening of the suture seating member.
The suture seating member can have various configurations. For example, the suture seating surface can be at least one of a flat surface and a contoured surface. In some embodiments, the contoured surface can be a generally concave surface. In at least some embodiments, the suture seating member can further include a collapsible section, and the suture seating surface can be arranged on the distal end of the collapsible section. In at least some embodiments, the suture seating member can include a pair of opposed suture seating features arranged on opposed side surfaces of the suture seating member, the suture seating features being configured to maintain a desired orientation of one or more operative suture strands. In at least some embodiments, the suture seating member can be spaced a distance from the suture anchor along the inserter shaft. In at least some embodiments, the suture seating surface can be configured to maintain one or more operative sutures in a predetermined orientation.
The cannulated inserter tool can have various configurations. For example, a length of the anchor receiving portion can be greater than or equal to a length of the suture anchor. In some embodiments, the anchor receiving portion can have a non-cylindrical cross-sectional shape. In at least some embodiments, the anchor receiving portion can have a hexagonal cross-sectional shape. In at least some embodiments, a distal end of the anchor receiving portion can include a shoulder that is adjacent to a proximal end of the suture seating member.
The suture anchor can have various configurations. For example, the suture anchor can include at least one driven feature disposed in a lumen thereof that is configured to engage the drive member of the anchor receiving portion. In at least some embodiment, the lumen of the suture anchor can have a cross-sectional shape that is complementary to a cross-sectional shape of the anchor receiving portion.
In another aspect, a method for attaching soft tissue to bone can include securing one or more operative sutures to a soft tissue to be reattached to bone. Free suture limbs of one or more operative sutures are passed through at least one stay suture loop formed from at least one stay suture, with the at least one stay suture loop extending from an opening on a distal end of a cannulated suture seating member, and the suture seating member being positioned distally to a suture anchor removably mounted on a cannulated inserter. The at least one stay suture is tensioned to close the at least one stay suture loop such that the one or more operative sutures are trapped between a suture seating surface arranged on the suture seating member and the at least one stay suture loop. The one or more operative sutures are placed within a bone hole adjacent the soft tissue to be reattached to bone by inserting into the hole the inserter having the anchor and suture seating member mounted thereon. A desired amount of tension is applied to the free suture limbs while the one or more operative sutures are positioned within the hole. The suture anchor is implanted into the bone hole to engage bone while maintaining the desired tension on the one or more operative sutures to bring the soft tissue into a desired engagement with bone while maintaining a rotational position of the suture seating member and substantially maintaining a position of the free suture limbs of the one or more operative sutures relative to the suture seating member. The at least one stay suture and inserter are then removed.
The method can have various configurations. For example, implanting the suture anchor can comprise rotating the suture anchor. In some embodiments, following removal of the inserter and the at least one stay suture, the one or more operative sutures can be knotlessly secured between the suture anchor and the bone hole. In at least some embodiments, following removal of the inserter and the at least one stay suture, the suture anchor can compress the suture seating member against a bottom of the bone hole and the suture seating member can compress against the bottom of the bone hole a portion of the one or more operative sutures distal to the suture seating member.
The cannulated suture anchor can have various configurations. For example, cannulated suture anchor can include at least one bone-engaging feature disposed on an external surface thereof. In some embodiments, the at least one bone-engaging feature can be one of a thread and bone engaging barbs.
The cannulated suture seating member can have various configurations. For example, the suture seating member can be not rotated when the suture anchor is rotated.
The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used. In addition, the terms “about” and “substantially” are defined as ranges based on manufacturing variations and variations over temperature and other parameters.
Successful soft tissue repair surgery, such as rotator cuff repair, requires that the suture anchor be securely engaged within bone to avoid migration and/or dislodgement, and that the operative suture attached to the soft tissue and maintained against the bone by the suture anchor resist migration when subjected to loads. The most common mode of failure is due to suture migration or slippage, which occurs when the load applied to the operative suture exceeds the force resisting such slippage or migration. This resisting force results from the suture anchor compressing the operative suture against the bone in which the suture anchor is implanted. Suture migration occurs at lower loads when the sutures themselves are misaligned and overlap within the bone hole. This can be particularly disadvantageous when an area of the bone adjacent to one of more strands of suture is softer and/or less healthy. The suture anchor systems described herein provide anchor implantation system designs optimized to maintain alignment of the operative suture (e.g., by maintaining the suture in a desired positon or with desired spacing between operative suture strands) during and following insertion of the suture anchor to avoid suture migration and overlap, while maintaining secure engagement of the anchor within bone.
In at least some of the described embodiments, a suture anchor system is provided that includes a suture seating member that enables the strands of the operative suture to be separated and maintained in a desired position around the anchor with sufficient spacing to prevent an undue degree of suture overlap while enabling the anchor to be inserted into the bone to secure soft tissue to the bone using the operative suture. During the course of a surgical procedure utilizing the suture anchor systems described herein, which is typically conducted arthroscopically, a suture anchor is removably disposed on an elongate inserter shaft of an inserter tool for delivery to its implantation site where it will engage operative sutures to maintain the operative suture in tension and thus reattach soft tissue to bone. The suture anchor system also includes a suture seating member removably mounted on the inserter device distal to the suture anchor. The suture seating member is mounted in such a way that it is rotationally independent of the suture anchor and the inserter tool. As explained in more detail below, the suture seating member includes at its distal end a suture seating surface that assists in maintaining the suture strands in a desired position and/or with a suitable degree of separation.
The suture seating surface of the suture seating member can be any sort of distally oriented surface that can assist in maintaining separation, spacing, or position of the operative suture strands. In one embodiment described and illustrated herein, the suture seating surface of the suture seating member can be a flat surface, a contoured surface, and/or other surface shape arranged at the distal-facing surface of the suture seating member. In this way, the operative suture can be captured by the suture seating surface while the suture anchor is being inserted to maintain the operative suture in proper alignment and/or with sufficient spacing between strands to prevent any undesired repositioning or overlap of the suture strands as the anchor is rotated into or otherwise implanted into bone.
The suture seating member can be attached to the inserter tool and/or the suture anchor in such a way that the suture seating member is independently rotatable relative to the suture anchor, forming an implantable suture anchor construct. That is, rotation of the suture anchor will not result in rotation of the suture seating member. Independent rotation of the suture seating member can be achieved in a variety of ways. For example, the suture seating member need not be attached to the suture anchor. In this way, any rotation of the suture anchor will not result in rotation of the suture seating member, thus maintaining the desired position of the suture strands as established by the suture seating surface.
A person skilled in the art will appreciate that the suture anchor systems described herein can be used in a variety of surgical techniques to secure and/or reattach soft tissue to bone. The surgical procedure can be conducted as an open surgical procedure or as a minimally invasive surgical procedure, such as an arthroscopic procedure. Following preparation of the patient, an appropriate incision is made to access the surgical site. One or more holes are formed in bone as required by the particular surgical procedure, in proximity to the tissue repair site, to receive the one or more anchors to be used to anchor the soft tissue. One or more strands of operative suture are then passed through the detached tissue and then passed through a stay suture or positioned adjacent to the one or more suture anchors to be used in the procedure. The one or more suture anchors are then implanted into the corresponding bone hole(s) using an appropriate inserter tool as the operative sutures are appropriately tensioned to bring the detached tissue in proximity to bone. In so doing, the operative suture(s) are compressed within the bone hole between the anchor and the wall that defines the bone hole. Excess suture is then removed, and the incision is closed.
The cannulated suture anchor 102 is configured to secure operative suture strands within a bone hole between the external surface of the anchor and the bone itself to reattach soft tissue to bone. The suture anchor 102 generally includes a proximal end 102p, a distal end 102d, and an external surface 104 with a series of bone-engaging features 106. In this embodiment, each of the plurality of longitudinally spaced bone-engaging features 106 can be formed at least partially circumferentially on the external surface 104 over at least a portion of a length of the suture anchor 102. Additionally, the suture anchor 102 can include a lumen 108 extending through the suture anchor 102 from the proximal end 102p to the distal end 102d, with the lumen 108 being configured to removably secure the anchor 102 to an inserter device, as described in detail below.
In embodiments where the suture anchor 102 includes threaded bone-engaging features 106, the internal surface of the lumen 108 includes a driven feature 110 formed into the lumen. While the driven feature 110 can take a variety of forms that will be understood by a person skilled in the art, in the embodiment illustrated in
In order to ensure a suitable retention force of the anchor 102, the series of bone-engaging features 106 can be disposed over at least a portion of, and generally a majority of, a length of the external surface 104 of the anchor 102. Additionally, the series of bone-engaging features 106 can collectively encompass about 360° of a circumference of the anchor 102. While the bone-engaging features 106 can take a variety of forms that will be understood by a person skilled in the art, in the embodiment illustrated in
The inserter device is used to apply a force (e.g., a rotational force) to the suture anchor to drive the anchor 102 into bone. In this embodiment, the inserter tool 121 can be configured to rotate the suture anchor 102 into a bone hole. The inserter tool 121 generally includes an elongate inserter shaft 122 having a distal end 122d and a proximal end 122p with a lumen 128 extending therebetween. In some embodiments, the lumen 128 has a smooth inner surface to help prevent rotational motion from being transferred to a suture seating member during rotation of the inserter tool 121.
The inserter shaft 122 includes an anchor receiving portion 125 arranged somewhat proximal to the distal end 122d. The anchor 102 can be configured to be removably arranged on the inserter shaft 122 at the anchor receiving portion 125, with the inserter shaft 122 disposed within the lumen 108 of the anchor 102. The inserter shaft 122 can have a drive feature 126 arranged on an external surface 124 at the anchor receiving portion 125 of the inserter shaft 122. The drive feature 126 has a shape that is complimentary to that of the driven feature 110 of the suture anchor 102 in order to transfer rotation motion from the inserter shaft 122 to the suture anchor 102. While the drive feature 126 can take a variety of forms that will be understood by a person skilled in the art, in the embodiment illustrated in
In addition to the anchor receiving portion 125, the inserter shaft 122 can include a distal extension 123 at the distal end 122d that extends distally beyond the suture anchor 102. The distal extension 123 is configured to removably seat the suture seating member 112 distal to the suture anchor 102. In one example, and as illustrated in
The inserter shaft can have various configurations. For example, the inserter shaft 122 can have a length that makes it suitable for arthroscopic procedures. That is, the length of inserter shaft 122 is sufficient to have a distal end that seats the suture anchor 102 and the suture seating member 112 that form the anchor construct such that the anchor construct can access a hole drilled in bone while the proximal end 122p of the inserter shaft extends out of the body and can be manipulated by a surgeon. The distal end 122d of the inserter shaft 122 should be sufficient to seat the suture seating member 112 at a distal most end thereof and to seat the suture anchor 102 proximal to the suture seating member 112. Although the suture seating member 112 is shown to be spaced apart from the suture anchor 102 in
The cannulated suture seating member 112 is a cannulated member that helps maintain the position and alignment of operative sutures, as well as a suitable amount of tension on the operative sutures, during implantation, such as by rotational insertion, of the suture anchor 102 into a bone hole.
While the suture seating member 112 can take a variety of forms, in the embodiment illustrated in
With the extensions 112a, 112b extending radially outward, a distal-facing suture seating surface 116 is formed by the extensions 112a, 112b. In this embodiment, since the extensions 112a, 112b are perpendicular to the central stem of the suture seating member 112, the suture seating surface is a substantially flat surface. Due to the arrangement of the suture seating surface 116, operative sutures can extend distally towards the distal end 112d along a front side of the suture seating member 112, pass along and contact the suture seating surface 116, and then extend proximally back towards the suture anchor 102 along the back side of the suture seating member 112. In this way, operative sutures can be tensioned during insertion of the suture anchor 102, while the suture seating surface 116 maintains the operative sutures in a desired position on the suture seating member 112.
As mentioned above, the suture seating member 112 can be arranged relative to the suture anchor 102 in such a way that the suture seating member 112 is independently rotatable relative to the suture anchor 102. Independent rotation of the suture seating member 112 can be achieved in a variety of ways. In the illustrated embodiment of
In addition to the suture seating surface of the suture seating member 112, the suture anchor system 100 can further include a stay suture to aid in capturing and then aligning the operative sutures during insertion of the anchor construct. The stay suture 140 includes a loop 142 and free suture limbs 144. In some embodiments, the stay suture 140 is removably disposed in the lumen 128 of the inserter shaft 122 such that a loop 142 of suture extends from the distal end 122d of the inserter shaft 122 and the two free suture limbs 144 extend from a proximal end 122p of the inserter shaft 122. The loop 142 is configured to be selectively tightened around operative sutures passing through the loop by tensioning one or both of the free suture limbs 144.
Similar to the suture seating member 112, in the embodiment illustrated in
As stated above, the collapsible extension section 217 is configured to be oriented in both uncompressed and compressed conditions. The suture seating member 212 is substantially in the shape of diamond when in the uncompressed condition, as shown in
With the extensions 218b, 220b extending radially inward, a distal-facing suture seating surface 216 is formed by the extensions 218b, 220b. In this embodiment, since the collapsible section 217 is in an uncompressed condition, the suture seating surface 216 is a substantially slanted surface.
When a compressive force is applied to the collapsible section 217, the extensions 218a, 220a pivot towards extensions 218b, 220b, thus reducing the gap 227, as illustrated in
Similar to the suture seating member 112, in the embodiment illustrated in
With the curved extensions 312a, 312b extending radially outward, a concave distal-facing suture seating surface 316 is formed by the extensions 312a, 312b. In this embodiment, the suture seating surface 316 is a substantially curved surface, which helps prevent the operative sutures from disengaging with the suture seating surface 316 once tensioned.
Similar to the suture seating member 112, in the embodiment illustrated in
With the sidewalls 412a, 412b and side suture seating surfaces 417 extending radially outward, a distal-facing suture seating surface 416 is formed by the body 411. In this embodiment, the suture seating surface 416 is a flat surface, however one skilled in the art will appreciate that it can have other shapes, including concave. As shown in
Similar to the suture seating member 412, in the embodiment illustrated in
With the sidewalls 512a, 512b and side suture seating surfaces 517 extending radially outward, a distal-facing suture seating surface 516 is formed by the body 511. In this embodiment, the suture seating surface 516 is a flat surface, however one skilled in the art will appreciate that it can have other shapes, including concave. As shown in
A curved distal-facing suture seating surface 616 is formed in a gap between the extensions 612a, 612b, and in the illustrated embodiment the suture seating surface 616 is a curved surface. Additionally, a pair of opposed concave side suture seating surfaces 617 are arranged on the side of the body 611 adjacent to extensions 612a, 612b. Thus, opposed surfaces 617 and suture seating surface 616 cooperate to form the surfaces that seat the operative suture, acting to maintain the position of the operative sutures and to prevent them from disengaging with the suture seating member 612.
In some embodiments of a suture seating member, such as illustrated in
As illustrated in
The entire assembly shown in
The inserter shaft 222 is then disposed in the previously drilled bone hole 14 and the operative suture 150 is tensioned to the desired degree by pulling on the free ends 154, as illustrated in
Once the anchor construct 230 is properly seated, the stay suture 140 is removed and pulled out of the lumen 228, as illustrated in
The methods and systems described herein can have different variations. For example, in each of the embodiments, multiple sutures can be used to couple tissue to bone. Also, one or more operative sutures can be loaded within the anchor before or during a surgical procedure. For example, in some embodiments, a suture anchor can have at least one operative suture pre-loaded thereto such that the suture anchor includes the suture. Furthermore, in some embodiments, the anchor may be pre-loaded on the inserter shaft.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device, e.g., the shafts, can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the components of the system described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
It is preferred the components are sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).
One skilled in the art will appreciate further features and advantages of the described subject matter based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
