Knotless suture anchors
Suture anchors with variable bone engagement features address the challenges of maintaining tension and anchor displacement by enhancing fixation and reducing suture slippage, particularly in minimally invasive surgeries.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- MEDOS INT SARL
- Filing Date
- 2022-04-26
- Publication Date
- 2026-05-15
AI Technical Summary
Existing suture anchors used for attaching soft tissue to bone face challenges such as difficulty in maintaining desired tension and complications during minimally invasive surgeries due to the complexity of knot-tying processes, and issues with anchor displacement and suture slippage.
The development of suture anchors with variable bone engagement features, including reverse-angled and variable-angle return portions, which enhance the anchor's ability to maintain tension and resist suture displacement by applying increased force to the surgical suture, facilitating easier insertion and secure fixation in bone.
The suture anchors effectively maintain tension and reduce suture displacement, ensuring secure attachment of soft tissue to bone, particularly in minimally invasive procedures like arthroscopy, by optimizing anchor design for improved engagement and resistance to suture movement.
Smart Images
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Abstract
Description
Technical Field
[0001] The present disclosure generally relates to methods and devices for fixing soft tissue to bone.
Background Art
[0002] Tearing of ligaments, tendons, and / or other soft tissues, or complete or partial detachment of ligaments, tendons, and / or other soft tissues from associated bones within the body is a common injury. Such an injury can result from excessive stress being applied to these tissues. As an example, tearing or detachment of tissue can result from an accident such as a fall, excessive exercise, during work-related tasks or during the course of a sports event. In the case of a tear or partial or complete detachment of soft tissue from bone, surgery is typically required to reattach the soft tissue (or graft tissue) to the bone.
[0003] One method of repairing such a rupture is to pass a length of suture through the tissue and close the rupture by tying the suture. The suture can also be used with one or more suture anchors to repair such tissue ruptures. The suture can be fastened to the suture anchor and the tissue using a "knotless" device and method in which one or more anchors and one or more sutures are connected and tensioned, either using knots tied by the surgeon during the repair procedure or without the need for the surgeon to tie knots during surgery. Knotless fixation is particularly useful for minimally invasive surgery, such as endoscopic or arthroscopic repair, where the surgeon must remotely manipulate the suture at the surgical site using instruments inserted through small percutaneous incisions, small-diameter cannulas, or endoscopic tubes, which can make the knot-tying process difficult and time-consuming.
[0004] During surgical procedures to reattach soft tissue, maintaining the desired tension in surgical sutures can be difficult. Furthermore, existing suture anchors used for inserting anchors into bone may have certain drawbacks that complicate their use and / or impose certain undesirable limitations. [Overview of the project] [Problems that the invention aims to solve]
[0005] Therefore, improved devices, systems, and methods are needed for attaching tissue to bone. [Means for solving the problem]
[0006] In one embodiment, several embodiments provide a suture anchor comprising an elongated body having a proximal end, a distal end, and an outer surface having a plurality of longitudinally spaced bone engagement features formed at least partially circumferentially on at least a portion of the length of the suture anchor. The proximal end has a lumen that at least partially extends into the elongated body, and the distal end may have suture engagement features adjacent thereto. A first series of bone engagement features has a dimension that increases from the distal end to the proximal end of each bone engagement feature of the first series of bone engagement features. A second series of bone engagement features has a dimension that decreases from the distal end to the proximal end of each bone engagement feature of the second series of bone engagement features.
[0007] The suture anchor can be modified in various ways. For example, the first and second sets of bone engagement features may be spaced apart along the length of the outer surface of the elongated body. In some embodiments, the first and second sets of bone engagement features may collectively surround about 360° around the elongated body. In at least some embodiments, the second set of bone engagement features may extend over less than half the circumference of the elongated body. In at least some embodiments, the second set of bone engagement features may extend from about 90° to about 120° around the elongated body.
[0008] The bone engagement features can have a variety of configurations. For example, each bone engagement feature may be a wedge-shaped return portion having a base extending radially from the outer surface of an elongated body and an inclined surface extending from the base to the outer surface of the elongated body. In some embodiments, a first series of bone engagement features may have a base positioned proximal to the inclined surface, and a second series of bone engagement features may have a base positioned distal to the inclined surface. In at least some embodiments, the inclined surface may be oriented at an angle of about 15° to about 30° with respect to the longitudinal axis of the elongated body. In at least some embodiments, the angle may be substantially the same for all bone engagement surface features. In at least some embodiments, the angle may be variable based on the longitudinal position of the bone engagement feature on the elongated body. In some embodiments, the angle may be greater in the proximal portion of the elongated body than in the distal portion of the elongated body.
[0009] The lumen can have various configurations. For example, the lumen can extend entirely through the elongated body from the proximal end to the distal end. In some embodiments, the lumen may be offset from the longitudinal axis of the elongated body.
[0010] The suture engagement feature can have various configurations. For example, the suture engagement feature may include an opening notch near the distal end. In some embodiments, the suture engagement feature may include a pair of longitudinally positioned arms that form a channel located proximal to the distal end.
[0011] In other embodiments, several models provide a suture anchor comprising an elongated body having a proximal end, a distal end, and an outer surface having a plurality of longitudinally spaced bone engagement features formed at least partially circumferentially on at least a portion of the length of the elongated body. The proximal end has a lumen that extends at least partially into the elongated body, and the distal end has suture engagement features adjacent thereto. Each bone engagement feature is a wedge-shaped barb having a base extending radially from the outer surface of the elongated body and an inclined surface extending from the base to the outer surface of the elongated body. The inclined surface is oriented at a variable angle based on the longitudinal position of the bone engagement feature on the elongated body.
[0012] The suture anchor can have various configurations. For example, the angle may be greater in the proximal portion of the elongated body than in the distal portion of the elongated body. In some embodiments, the angle may increase at fixed intervals from the most distally located bone engagement feature to the most proximal bone engagement feature. In at least some embodiments, the inclined surface may be directed at an angle with respect to the longitudinal axis of the elongated body, ranging from about 15° near the distal end of the elongated body to about 30° near the proximal end of the elongated body. In at least some embodiments, the angle may increase gradually along the length of the elongated body, or the angle may increase in steps based on regions spaced apart in the longitudinal direction of the elongated body. [Brief explanation of the drawing]
[0013] This disclosure will be better understood by reading the following detailed description in conjunction with the attached drawings. [Figure 1] This is a perspective view of one embodiment of a suture anchor. [Figure 2] Figure 1 is a side view of the suture anchor. [Figure 3] A perspective view of another embodiment of the suture anchor. [Figure 4] Figure 3 is a side view of the suture anchor. [Figure 5] This is a side view of another embodiment of the suture anchor. [Figure 6] This is a side view of another embodiment of the suture anchor. [Figure 7] This is a side view of another embodiment of the suture anchor. [Figure 8] This is a perspective view of one embodiment of an insertion device useful in surgical procedures for reattaching soft tissue using the type of suture anchor described herein. [Figure 9] A schematic diagram illustrates a surgical system, including the suture anchor shown in Figure 1, for reattaching soft tissue to bone. [Modes for carrying out the invention]
[0014] Herein, specific exemplary embodiments are described to provide an overall understanding of the structure, function, manufacturing and use principles of the apparatus and methods disclosed herein. One or more of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatus and methods described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined solely by the claims. Features illustrated or described in relation to one exemplary embodiment can be combined with features of other embodiments. Such modifications and variations are included within the scope of the invention.
[0015] Furthermore, in this disclosure, components with similar names in embodiments generally have similar characteristics, and therefore, in a particular embodiment, each characteristic of each component with a similar name is not necessarily described in full detail. In addition, 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 combination with such systems, devices, and methods. Those skilled in the art will recognize that dimensions equivalent to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of systems and devices, and their components, may depend at least on the anatomical structure of the object in which the systems and devices are used internally, the size and shape of the component in which the systems and devices are used, and the method and surgery in which the systems and devices are used. In addition, the terms “about” and “approximately” are defined as ranges based on manufacturing variability and variations across temperature and other parameters.
[0016] Normal soft tissue repair surgeries, such as rotator cuff repairs, require that suture anchors be firmly engaged within the bone to prevent displacement and / or removal, and that the surgical sutures be attached to the soft tissue and held in place against the bone by suture anchors that resist displacement under load. The most common mode of failure is due to suture displacement or slippage, which occurs when the load applied to the surgical suture exceeds the force applied by the suture anchor, compressing the surgical suture against the bone in which the suture anchor is embedded. Suture displacement occurs at loads lower than those that cause displacement or removal of the suture anchor. The suture anchors described herein provide an anchor design optimized to maintain sufficient force against the surgical suture to prevent suture displacement while maintaining a firm engagement of the anchor within the bone.
[0017] In at least some of the embodiments described herein, a suture anchor is provided that includes a variable bone engagement feature that allows the anchor to be retained in the bone with sufficient integrity while enabling it to resist suture movement to a greater extent by selectively providing increased force to the surgical suture. In the course of a surgical procedure utilizing the suture anchor described herein, which is typically performed arthroscopically, the suture anchor is detachably positioned on an elongated shaft of an insertion device to deliver the suture anchor to its implantation site.
[0018] In one embodiment described and illustrated herein, the variable bone engagement feature of the suture anchor may be a reverse-angled return portion positioned along the length of a portion of the suture anchor. In another embodiment, the variable-angle bone engagement feature of the suture anchor may be a return portion whose angle is variable based on the axial position of the return portion along the suture anchor. In embodiments including a reverse-angled return portion, the surgical suture used to fix soft tissue to bone interacts with the reverse-angled return portion on a portion of the anchor, such as the side of the anchor adjacent to the soft tissue to be reattached, to selectively increase the force applied to the surgical suture, thereby maintaining a desired level of tension with a reduced incidence of suture displacement. Thus, when the suture anchor is driven into the bone (e.g., by using an insertion instrument or other suitable instrument), the reverse-angled return portion holds the surgical suture under tension, while the combination of the reverse-angled return portion and the conventional angled return portion works together to firmly seat and maintain the suture anchor within the bone tunnel.
[0019] Similarly, in embodiments including a variable angle return portion, the surgical suture used to fix soft tissue to bone interacts with the variable return portion to selectively increase the force applied to the surgical suture at different positions on the anchor (e.g., different axial and / or radial positions) to maintain a desired level of tension with a reduced incidence of suture movement. The variable angle return portion can be designed such that, in at least a portion of the anchor, the proximal return portion can have a larger angle than the return portion with a more distal placement. As described below, the return angle may vary such that the angle of the return portion gradually increases from distal to proximal. Alternatively, the return portions may have the same angle in a particular region along the axial length of the anchor, and the return angle of each region increases from distal to proximal along the length of the anchor. In this way, the distal return portion enables easier insertion of the anchor into the bone hole, while the proximally placed return portion applies a greater suture holding force to the surgical suture and enables the surgical suture to resist movement.
[0020] FIGS. 1-2 show an embodiment of a suture anchor 100 including an elongated body 102 having a proximal end 102p, a distal end 102d, and an outer surface 104 having a first series of bone engagement features 106 and a second series of bone engagement features 108. In this embodiment, each of the plurality of longitudinally spaced bone engagement features 106, 108 can be formed at least partially circumferentially on the outer surface 104 over at least a portion of the length of the suture anchor 100. The proximal end 102p can have a lumen 110 that extends at least partially into the elongated body 102, and the lumen 110 is configured to removably secure the anchor 100 to an insertion shaft, as will be described in detail below. The lumen shown in FIGS. 1-2 terminates within the anchor body 102, but those skilled in the art will understand that the lumen 110 can extend completely through the anchor body 102 from the proximal end 102b to the distal end. The illustrated lumen 110 is shown aligned with the longitudinal axis LA of the elongated body 102, but the lumen 110 may alternatively be offset from the longitudinal axis LA.
[0021] The distal end 102d of the anchor 100 can have a suture engagement feature 112 that enables the surgical suture to be engaged by the anchor 100 when the anchor 100 is implanted into bone during a surgical procedure to reattach soft tissue to bone. The suture engagement feature 112 can take various forms as understood by those skilled in the art. In the embodiments shown in FIGS. 1-2, the suture engagement feature 112 is a notch disposed proximate to the distal end 102d. Alternative designs for the suture engagement feature 112 can include, but are not limited to, an opening, a groove, etc.
[0022] The first and second series of bone engagement features 106, 108 can be disposed over at least a portion, and generally over a majority, of the length of the outer surface 104 of the elongated body 102. Additionally, the first and second series of bone engagement features 106, 108 can collectively surround approximately 360° around the elongated body 102. In one embodiment, the second series of bone engagement features 108 can extend over less than half of the circumference of the elongated body 102, such as within a range of approximately 90° to approximately 120° around the elongated body 102.
[0023] The first and second series of bone engagement features 106, 108 can have various configurations. For example, the first and second series of bone engagement features 106, 108 are formed from individual bone engagement features 107, 109. In this embodiment, each of the bone engagement features 107, 109 is a wedge-shaped return portion including bases 107a, 109a extending radially from the outer surface 104 of the elongated body 102, and inclined surfaces 107b, 109b extending away from the bases 107a, 109a and back to the outer surface 104 of the elongated body 102. Each of the first series of bone engagement features 107 may have a base 107a located proximal to the inclined surface 107b, and each of the second series of bone engagement features 109 may have a base 109a located distal to the inclined surface 109b. In other words, the return portion 107 of the first series of bone engagement features 106 has a return width that increases distally to proximal (i.e., in the direction of anchor insertion), allowing for generally easier insertion of the anchor into a bone hole sized for interference fit with the anchor. Conversely, the return portion 109 of the second series of bone engagement features 108 has a return width that decreases distally to proximal. Thus, the return portion 109 may be referred to herein as a “reverse angle” return portion, or as having a “reverse angle.” If the bone engagement feature is a wedge-shaped return portion, it is understood that the interface between the base portion 107a and the inclined surface 107b may be a sharp corner, but does not necessarily have to be. Rather, this interface may be somewhat rounded, or substantially parallel to the longitudinal axis LA.
[0024] The presence of the reverse-angled portion 109 may cause additional resistance to the insertion of the anchor 100 into the bone tunnel, but the reverse-angled portion 109 tends to apply greater force to the surgical suture, thus reducing the possibility of suture displacement.
[0025] Each bone engagement feature 107 of the first series of bone engagement features 106 may have dimensions such as an inclination angle θ1 of the inclined surface 107b, which increases from the distal end to the proximal end of each bone engagement feature 107 of the first series of bone engagement features 106. Similarly, each bone engagement feature 109 of the second series of bone engagement features 108 may have dimensions such as an inclination angle θ2 of the inclined surface 109b, which decreases from the distal end to the proximal end of each bone engagement feature 109 of the second series of bone engagement features 108. In this embodiment, the inclined surfaces 107b and 109b may be oriented such that the inclination angles θ1 and θ2 are in the range of about 15° to about 30° with respect to the longitudinal axis LA of the elongated body 102. The inclination angle θ1 of all bone engagement features 107 of the first series of bone engagement features 106 may be substantially the same as the inclination angle θ2 of all bone engagement features 109 of the second series of bone engagement features 108, or the inclination angles θ1 and θ2 may vary within each of the first and second series of bone engagement features 106 and 108.
[0026] As described above, suture anchors can include various types of bone engagement features. As a non-limiting example, Figures 3-4 show another embodiment of suture anchor 200 including a series of bone engagement features 206 having variable angled return sections. Figure 5 shows a further embodiment of suture anchor 300 including a series of variable threaded bone engagement features 306. Figure 6 shows yet another embodiment of suture anchor 400 including a series of variable threaded bone engagement features 406.
[0027] Similar to the suture anchor 100, Figures 3 and 4 show an embodiment of a suture anchor 200 comprising an elongated body 202 having a proximal end 202p, a distal end 202d, and an outer surface 204 having various groups of bone engagement features, each group of which is oriented at different angles. As an example, Figures 3 and 4 show an embodiment having a first series of bone engagement features 206, a second series of bone engagement features 208, and a third series of bone engagement features 212. In this embodiment, each of the multiple longitudinally spaced bone engagement features 206, 208, and 212 can be formed at least partially circumferentially on the outer surface 204 over at least a portion of the length of the suture anchor 200. The proximal end 202p may have a lumen 210 that extends at least partially into the elongated body 202, as will be described in detail below, and the lumen 210 is configured to removably secure the anchor 200 to the insertion shaft. The lumen shown in Figures 3 and 4 terminates within the anchor body 202, but those skilled in the art will understand that the lumen 210 can extend entirely through the anchor body 202 from the proximal end 202b to the distal end. The illustrated lumen 210 is shown aligned with the longitudinal axis LA of the elongated body 202, but the lumen 210 may alternatively be offset from the longitudinal axis LA.
[0028] Similar to anchor 100, the distal end 202d of anchor 200 may have a suture engagement feature 212 located on the distal end 202d, which allows the anchor 200 to engage with surgical sutures when it is embedded in the bone during a surgical procedure to reattach soft tissue to the bone. The suture engagement feature 212 can take various forms as understood by those skilled in the art, but in the embodiments shown in Figures 3-4, the suture engagement feature 212 is a notch located close to the distal end 202d. Alternative designs for the suture engagement feature 212 include, but are not limited to, openings, grooves, etc.
[0029] The first, second, and third series of bone engagement features 206, 208, and 212 can be positioned over at least a portion, and generally over most, of the length of the outer surface 204 of the elongated body 202. In one embodiment, each of the first, second, and third series of bone engagement features 206, 208, and 212 can extend over about one-third of the total length of the elongated body 202. Those skilled in the art will understand that each series of bone engagement features, which may be more than three or fewer in number, can extend over different or variable amounts of the total length of the elongated body 202. In addition, each of the first, second, and third series of bone engagement features 206, 208, and 212 can surround about 360° around the elongated body 202.
[0030] The first, second, and third series of bone engagement features 206, 208, and 212 can have various configurations. For example, the first, second, and third series of bone engagement features 206, 208, and 212 are formed from individual bone engagement features 207, 209, and 213. In this embodiment, each of the individual bone engagement features 207, 209, and 213 is a wedge-shaped return portion including bases 207a, 209a, and 213a extending radially from the outer surface 204 of the elongated body 202, and inclined surfaces 207b, 209b, and 213b extending away from the bases 207a, 209a, and 213a and returning to the outer surface 204 of the elongated body 202. Each of the first series of bone engagement features 207 may have a base 207a located proximal to the inclined surface 207b, each of the second series of bone engagement features 209 may have a base 209a located proximal to the inclined surface 209b, and each of the third series of bone engagement features 213 may have a base 213a located proximal to the inclined surface 213b.
[0031] Each bone engagement feature 207 of the first series of bone engagement feature 206 may have dimensions such as an inclination angle θ3 of the inclined surface 207b, which may be the same for each bone engagement feature 207 within the first series of bone engagement feature 206, or may increase from the distal end to the proximal end of the first series of bone engagement feature 206 together with each consecutive bone engagement feature 207 within the first series of bone engagement feature 206. In addition, each bone engagement feature 209 of the second series of bone engagement feature 208 may have dimensions such as an inclination angle θ4 of the inclined surface 209b, which may be the same for each bone engagement feature 209 within the second series of bone engagement feature 208, or may increase from the distal end to the proximal end of the second series of bone engagement feature 208 together with each consecutive bone engagement feature 209 within the second series of bone engagement feature 208. Furthermore, each bone engagement feature 213 of the third series of bone engagement feature 212 may have dimensions such as the inclination angle θ5 of the inclined surface 213b, which may be the same for each bone engagement feature 213 within the third series of bone engagement feature 212, or may increase from the distal end to the proximal end of the third series of bone engagement feature 212 together with each consecutive bone engagement feature 213 within the third series of bone engagement feature 212.
[0032] In this embodiment, the inclined surfaces 207b, 209b, and 213b may be oriented such that their inclination angles θ3, θ4, and θ5 are within a range of approximately 15° to approximately 30° with respect to the longitudinal axis LA of the elongated body 202. In addition, in this embodiment, each inclination angle of each bone engagement feature may be variable based on the longitudinal position of the bone engagement feature on the elongated body 202. The inclination angle of the bone engagement feature is greater at the proximal portion 202p of the elongated body 202 than at the distal portion 202d of the elongated body 202. For example, inclination angle θ3 is smaller than inclination angle θ4, and inclination angle θ4 is smaller than inclination angle θ5. The variation in inclination angle can have various configurations as it moves from the distal end 202d to the proximal end 202p. For example, the inclination angle of each successive bone engagement feature can increase at fixed intervals from the most distal bone engagement feature 207 to the most proximal bone engagement feature 209. In addition, another configuration may include an inclination angle of each consecutive bone engagement feature that gradually increases along the length of the elongated body 202, or the inclination angle increases in steps based on regions spaced apart in the longitudinal direction of the elongated body 202. In this embodiment, a larger inclination angle results in greater force being applied to the surgical suture, thus minimizing the risk of suture migration after implantation of the suture anchor 200.
[0033] In other words, the barb 207 of the first series of bone engagement features 206 has an inclination angle θ3, allowing for generally easier insertion of the anchor into a bone hole sized for interlocking with the anchor. Conversely, the barb 213 of the third series of bone engagement features 212 has an inclination angle θ5, allowing for generally greater force to be applied to the surgical suture, and thus reducing the possibility of suture movement.
[0034] As described above, Figure 5 shows one embodiment of a suture anchor 300, comprising an elongated body 302 having a proximal end 302p, a distal end 302d, and an outer surface 304 having a series of bone engagement features 306. In this embodiment, the series of multiple longitudinally spaced bone engagement features 306 can be formed at least partially circumferentially on the outer surface 304 over at least a portion of the length of the suture anchor 300. The proximal end 302p may have a lumen (not shown) that extends at least partially within the elongated body 302, as will be described in detail below, and the lumen is configured to removably secure the anchor 300 to an insertion shaft. The lumen terminates within the anchor body 302, but those skilled in the art will understand that the lumen can extend entirely through the anchor body 302 from the proximal end 302b to the distal end 302d.
[0035] Similar to the suture anchor 100, the distal end 302d of the anchor 300 may have a suture engagement feature 312 located on the distal end 302d, which allows the anchor 300 to engage with a surgical suture when the anchor 300 is embedded in the bone during a surgical procedure to reattach soft tissue to the bone. The suture engagement feature 312 can take various forms as understood by those skilled in the art, but in the embodiment shown in Figure 5, the suture engagement feature 312 is a notch located close to the distal end 302d. Alternative designs for the suture engagement feature 312 include, but are not limited to, openings, grooves, etc.
[0036] The series of bone engagement features 306 can be arranged over at least a portion, and generally over most, of the length of the outer surface 304 of the elongated body 302. In one embodiment, the series of bone engagement features 306 can surround approximately 360° around the elongated body 302. The series of bone engagement features 306 can have various configurations. For example, the series of bone engagement features 306 is formed from individual bone engagement features 307, 309. In this embodiment, each of the individual bone engagement features 307, 309 is a thread having a changing thread shape that extends radially from the outer surface 304 of the elongated body 302.
[0037] In this embodiment, the length x1, height h1, and inclination angle θ6 of the bone engagement feature 307 may be smaller than the length x2, height h2, and inclination angle θ7 of the bone engagement feature 309. Variations in length, height, and inclination angle can have various configurations as it moves from the distal end 302d to the proximal end 302p. For example, the length, height, and inclination angle of each successive bone engagement feature can increase at fixed intervals from the distally located bone engagement feature 309 to the proximal bone engagement feature 307. The length, height, and inclination angle of each successive bone engagement feature can increase at fixed intervals from the most distally located bone engagement feature to the most proximal bone engagement feature. In this embodiment, larger lengths, heights, and inclination angles generally allow for greater force to be applied to the surgical suture, thus reducing the possibility of suture movement. In addition, smaller lengths, heights, and inclination angles generally allow for easier insertion of the anchor into the bone hole sized for interlocking with the anchor.
[0038] In addition, Figure 6 shows one embodiment of a suture anchor 400, comprising an elongated body 402 having a proximal end 402p, a distal end 402d, and an outer surface 404 having a series of bone engagement features 406. In this embodiment, the series of multiple longitudinally spaced bone engagement features 406 can be formed at least partially circumferentially on the outer surface 404 over at least a portion of the length of the suture anchor 400. The proximal end 402p may have a lumen 410 that extends at least partially within the elongated body 402, as will be described in detail below, and the lumen 410 is configured to removably secure the anchor 400 to the insertion shaft. The lumen 410 terminates within the anchor body 402, but those skilled in the art will understand that the lumen can extend entirely through the anchor body 402 from the proximal end 402b to the distal end 402d.
[0039] Similar to the suture anchor 300, the distal end 402d of the anchor 400 may have a suture engagement feature 412 located on the distal end 402d, which allows the anchor 400 to engage with a surgical suture when the anchor 400 is embedded in the bone during a surgical procedure to reattach soft tissue to the bone. The suture engagement feature 412 can take various forms as understood by those skilled in the art, but in the embodiment shown in Figure 6, the suture engagement feature 412 is a notch located close to the distal end 402d. Alternative designs for the suture engagement feature 412 include, but are not limited to, openings, grooves, etc.
[0040] The series of bone engagement features 406 can be arranged over at least a portion, and generally over most, of the length of the outer surface 404 of the elongated body 402. In one embodiment, the series of bone engagement features 406 can surround about 360° around the elongated body 402. The series of bone engagement features 406 can have various configurations. For example, the series of bone engagement features 406 is formed from individual bone engagement features 407, 409. In this embodiment, as in the previous embodiment of the suture anchor, each of the individual bone engagement features 407, 409 is a thread having an alternative, changing thread configuration that extends radially from the outer surface 404 of the elongated body 402.
[0041] In this embodiment, the threads 407 may be identical, have a length Y1, and be positioned along the length of the elongated body 402. The threads 409 may have a longer length Y2 than the threads 407 and be positioned between the two threads 407. In this embodiment, a longer thread length generally allows for greater force to be applied to the surgical suture, thus reducing the possibility of suture movement and providing generally stronger fixation in the bone. In addition, a shorter thread length generally allows for easier insertion of the anchor into a bone hole sized for interlocking with the anchor.
[0042] As described above, suture anchors can include various types of bone engagement features. As a non-limiting example, Figure 7 shows another embodiment of a suture anchor 650 that includes a series of bone engagement features 506, 508, and 512 in the form of variable diameter return sections.
[0043] Similar to the suture anchor 100, Figure 7 shows an embodiment of a suture anchor 500 comprising an elongated body 502 having a proximal end 502p, a distal end 502d, and an outer surface 604 having various groups of bone engagement features, each group having a different diameter. As an example, Figure 7 shows an embodiment having a first series of bone engagement features 506, a second series of bone engagement features 508, and a third series of bone engagement features 512. In this embodiment, each of the multiple longitudinally spaced bone engagement features 506, 508, and 512 can be formed at least partially circumferentially on the outer surface 504 over at least a portion of the length of the suture anchor 500. The proximal end 502p may have a lumen that extends at least partially into the elongated body 602, as described below, and the lumen is configured to removably secure the anchor 500 to the insertion shaft.
[0044] Similar to anchor 100, the distal end 502d of anchor 500 may have a suture engagement feature 515 located on the distal end 502d, which allows the anchor 500 to engage with surgical sutures when it is embedded in the bone during a surgical procedure to reattach soft tissue to the bone. The first, second, and third series of bone engagement features 506, 508, 512 may be arranged over at least a portion, and generally over most, of the length of the outer surface 504 of the elongated body 502. In one embodiment, the first, second, and third series of bone engagement features 506, 508, 512 may each extend over about one-third of the total length of the elongated body 502. Those skilled in the art will understand that each series of bone engagement features, which may be more than three or fewer in number, may extend over different or variable amounts of the total length of the elongated body 502. In addition, the first, second, and third series of bone engagement features 506, 508, and 512 can each surround approximately 360° around the elongated body 502.
[0045] The first, second, and third series of bone engagement features 506, 508, and 512 can have various configurations. For example, the first, second, and third series of bone engagement features 506, 508, and 512 are formed from individual bone engagement features 507, 509, and 513. In this embodiment, each of the individual bone engagement features 507, 509, and 513 is a wedge-shaped return portion including a base portion 507a, 509a, and 513a extending radially from the outer surface 604 of the elongated body 602, and an inclined surface 507b, 509b, and 513b extending away from the base portion 507a, 509a, and 513a and returning to the outer surface 604 of the elongated body 502.
[0046] Each bone engagement feature 507 of the first series of bone engagement features 506 may have dimensions such as the diameter of the base 507a, which may be the same for each bone engagement feature 507 within the first series of bone engagement features 506, or may increase from the distal end to the proximal end of the first series of bone engagement features 506 together with each consecutive bone engagement feature 507 within the first series of bone engagement features 506. In addition, each bone engagement feature 509 of the second series of bone engagement features 508 may have dimensions such as the diameter of the base 509a, which may be the same for each bone engagement feature 509 within the second series of bone engagement features 508, or may increase from the distal end to the proximal end of the second series of bone engagement features 508 together with each consecutive bone engagement feature 509 within the second series of bone engagement features 508. Furthermore, each bone engagement feature 513 of the third series of bone engagement features 512 may have dimensions such as the diameter of the base 513a, which may be the same for each bone engagement feature 513 within the third series of bone engagement features 512, or may increase from the distal end to the proximal end of the third series of bone engagement features 512 together with each consecutive bone engagement feature 513 within the third series of bone engagement features 512.
[0047] In this embodiment, the diameter of each bone engagement feature may be variable based on the longitudinal position of the bone engagement feature on the elongated body 502. The diameter of the bone engagement feature is greater at the proximal portion 502p of the elongated body 602 than at the distal portion 502d of the elongated body 502. The variation in diameter can have various configurations as it moves from the distal end 502d to the proximal end 502p. For example, the diameter of each consecutive bone engagement feature can increase at fixed intervals from the most distal bone engagement feature 507 to the most proximal bone engagement feature 509. In addition, another configuration may include a gradually increasing diameter of each consecutive bone engagement feature along the length of the elongated body 502, or the diameter can increase in steps based on regions spaced apart in the longitudinal direction of the elongated body 502. In this embodiment, a larger diameter means greater force is applied to the surgical suture, thus minimizing the risk of suture migration after implantation of the suture anchor 500.
[0048] To insert the suture anchor 100 into the bone, an insertion instrument can be used to help align and push the suture anchor into the bone. As shown in Figure 8, the insertion instrument 600 may be of a type known to those skilled in the art and includes an elongated body 602, one or more engaging features 604 located at the distal end 502d of the elongated body 602, and a handle 606 located at the proximal end 602p of the elongated body 602. The engaging features 604 can be configured to engage with the suture anchor 100. It should be understood that the engaging features 604 can have a variety of configurations. For example, in the illustrated embodiment, the engaging feature 604 is a fork with a notch for engaging with a complementary feature in the lumen 110 of the anchor 100.
[0049] Those skilled in the art will understand that the suture anchors described herein can be used in a variety of surgical procedures to fix and / or reattach soft tissue to bone. The surgical procedure can be performed as an open surgical procedure or as a minimally invasive surgical procedure such as arthroscopic procedure. Following patient preparation, an appropriate incision is made to access the surgical site. One or more holes are formed in the bone adjacent to the tissue repair site to receive one or more anchors to be used to fix the soft tissue. One or more strands of surgical suture are then passed through the isolated tissue and then bonded to or positioned adjacent to one or more suture anchors to be used in the procedure. One or more suture anchors are then embedded in the corresponding bone holes(s) using an appropriate insertion instrument, and the surgical sutures are appropriately tensioned before or after insertion of the anchors to bring the isolated tissue closer to the bone. In this process, the surgical sutures(s) are compressed within the bone hole between the anchor and the wall defining the bone hole. Once the anchor is properly seated and the tissue is properly positioned adjacent to the bone, the sutures are ligated (either by tightening or tying the knots), any excess sutures are removed, and the incision is closed.
[0050] Figure 9 shows the final stage of such a procedure in which a suture anchor 100 fixes soft tissue 10 to bone 12. The suture anchor 100 is attached to the distal end 602d of an insertion device 600 (which needs to be further removed), with the distal end 502d of the suture anchor 100 being removably fixed within the lumen 110 of the suture anchor 100. As shown, a surgical suture 20 with a free end 30 is fixed to the soft tissue 10 and then supplied through the suture engagement feature 112 of the suture anchor 100. With the surgical suture 20 connected to the anchor 100, the suture anchor 100 is placed in a previously drilled bone hole 14. Once the suture anchor 100 is properly seated, the insertion device 600 is removed and the suture anchor 100 remains in the bone hole 14. Those skilled in the art will understand that the placement of the surgical suture 20 between the bone tunnel wall and the suture anchor 100 maintains sufficient tension on the surgical suture, and that the suture anchor bone engagement feature described herein reduces the possibility of suture displacement. Figure 9 further shows that the reversed angle
[0051] The methods and systems described herein may have different variations. For example, in each embodiment, multiple sutures can be used to connect tissue to bone. Also, one or more surgical sutures can be loaded into the anchor before or during a surgical procedure. For example, in some embodiments, the suture anchor may have at least one surgical suture pre-loaded so that the suture anchor contains the suture. Furthermore, in some embodiments, the anchor may be pre-loaded on the insertion shaft. In some cases, a tray or other container may contain multiple suture anchors, and a single insertion instrument can be used to attach to one suture anchor, embed it, connect to another suture anchor, embed it, and so on.
[0052] The devices disclosed herein may be designed to be discarded after a single use or to be designed for multiple uses. However, in either case, the devices may be readjusted for reuse after at least one use. Readjustment may include any combination of disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device may be disassembled, and any number of specific parts or components of the device, such as shafts, may be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device may be reassembled for subsequent use either in a readjustment facility or by a surgical team immediately before surgical intervention. Those skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly are available for readjusting the device. The use of such techniques and the resulting readjusted devices are all within the scope of this application.
[0053] Preferably, the components of the system described herein are processed before surgery. First, new or used instruments are obtained and cleaned if necessary. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and instruments are then placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation kills bacteria on the instruments or inside the container. After this, the sterilized instruments can be stored in a sterile container. The sealed container keeps the instruments sterile until opened in the medical facility.
[0054] It is preferable that these components be sterilized. This can be done by various methods known to those skilled in the art, such as beta-ray or gamma-ray emission, ethylene oxide, steam, and liquid baths (e.g., cold immersion).
[0055] Those skilled in the art will recognize further features and advantages of the subject matter described based on the embodiments described above. Therefore, this disclosure is not limited to what is specifically 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.
[0056] [Implementation Method] (1) A suture anchor, An elongated body having a proximal end, a distal end, and an outer surface having a plurality of longitudinally spaced bone engagement features formed at least partially circumferentially on at least a portion of the length of the suture anchor, wherein the proximal end has a lumen that extends at least partially into the elongated body, and the distal end has a suture engagement feature adjacent to the distal end, The first series of bone engagement features has a dimension that increases from the distal end to the proximal end of each bone engagement feature of the first series of bone engagement features. The second series of bone engagement features has dimensions that decrease from the distal end to the proximal end of each bone engagement feature of the second series of bone engagement features. Suture anchor. (2) The suture anchor according to Embodiment 1, wherein the first series of bone engagement features and the second series of bone engagement features are spaced apart along the length of the outer surface of the elongated body. (3) The suture anchor according to Embodiment 1, wherein the first series of bone engagement features and the second series of bone engagement features collectively surround the elongated body in a range of approximately 360°. (4) The suture anchor according to Embodiment 1, wherein the second series of bone engagement features extends over less than half the circumference of the elongated body. (5) The suture anchor according to Embodiment 4, wherein the second series of bone engagement features extends over approximately 90° to approximately 120° around the elongated body.
[0057] (6) The suture anchor according to Embodiment 1, wherein each bone engagement feature is a wedge-shaped return portion having a base portion extending radially from the outer surface of the elongated body and an inclined surface extending from the base portion to the outer surface of the elongated body. (7) The suture anchor according to Embodiment 6, wherein the first series of bone engagement features has a base located proximal to the inclined surface, and the second series of bone engagement features has a base located distal to the inclined surface. (8) The suture anchor according to Embodiment 7, wherein the inclined surface is oriented at an angle of approximately 15° to approximately 30° with respect to the longitudinal axis of the elongated body. (9) The suture anchor according to Embodiment 8, wherein the angle is substantially the same for all bone engagement surface features. (10) The suture anchor according to Embodiment 8, wherein the angle is variable based on the longitudinal position of the bone engagement feature on the elongated body.
[0058] (11) The suture anchor according to Embodiment 10, wherein the angle is greater in the proximal portion of the elongated body than in the distal portion of the elongated body. (12) The suture anchor according to Embodiment 1, wherein the lumen extends completely through the elongated body from the proximal end to the distal end. (13) The suture anchor according to Embodiment 1, wherein the lumen is offset from the longitudinal axis of the elongated body. (14) The suture anchor according to Embodiment 1, wherein the suture engagement feature includes an opening notch adjacent to the distal end. (15) The suture anchor according to Embodiment 1, wherein the suture engagement feature includes a pair of longitudinally positioned arms that form a channel located proximal to the distal end.
[0059] (16) A suture anchor, An elongated body comprising a proximal end, a distal end, and an outer surface having a plurality of longitudinally spaced bone engagement features formed at least partially circumferentially on at least a portion of the length of the elongated body, wherein the proximal end has a lumen that extends at least partially into the elongated body, and the distal end has a suture engagement feature adjacent to the distal end, Each bone engagement feature is a wedge-shaped return portion having a base portion extending radially from the outer surface of the elongated body and an inclined surface extending from the base portion to the outer surface of the elongated body, wherein the inclined surface is oriented at a variable angle based on the longitudinal position of the bone engagement feature on the elongated body. Suture anchor. (17) The suture anchor according to embodiment 16, wherein the angle is greater in the proximal portion of the elongated body than in the distal portion of the elongated body. (18) The suture anchor according to Embodiment 17, wherein the angle increases at fixed intervals from the most distal bone engagement feature to the most proximal bone engagement feature. (19) The suture anchor according to Embodiment 18, wherein the inclined surface is directed at an angle with respect to the longitudinal axis of the elongated body, ranging from approximately 15° near the distal end of the elongated body to approximately 30° near the proximal end of the elongated body. (20) The suture anchor according to Embodiment 19, wherein the angle gradually increases along the length of the elongated body, or the angle increases in steps based on regions spaced apart in the longitudinal direction of the elongated body.
Claims
1. It is a suture anchor, An elongated body having a proximal end, a distal end, and an outer surface, wherein the proximal outer surface has a plurality of longitudinally spaced bone engagement features formed at least partially circumferentially on it over at least a portion of the length of the suture anchor, the proximal end has a lumen that extends at least partially into the elongated body, and the distal end has a suture engagement feature adjacent to the distal end, the elongated body comprising: Each bone-engaging feature is a wedge-shaped return portion having a base portion extending radially from the outer surface of the elongated body perpendicular to the longitudinal axis of the elongated body, and an inclined surface extending from the base portion to the outer surface of the elongated body. Each bone engagement feature of the first series of bone engagement features has a base located proximal to the inclined surface, and each bone engagement feature of the second series of bone engagement features has a base located distal to the inclined surface. The proximal end of each bone engagement feature of the first series of bone engagement features is located at the same longitudinal position as the proximal end of the corresponding bone engagement feature of the second series of bone engagement features. The distal end of each bone engagement feature of the first series of bone engagement features is located at the same longitudinal position as the distal end of the corresponding bone engagement feature of the second series of bone engagement features. Suture anchor.
2. The suture anchor according to claim 1, wherein the first series of bone engagement features are spaced apart from the second series of bone engagement features along the longitudinal length of the outer surface of the elongated body.
3. The suture anchor according to claim 1, wherein the combination of the first series of bone engagement features and the second series of bone engagement features surrounds approximately 360° around the elongated body.
4. The suture anchor according to claim 1, wherein the second series of bone engagement features extends over less than half the circumference of the elongated body.
5. The suture anchor according to claim 4, wherein the second series of bone engagement features extends over approximately 90° to approximately 120° around the elongated body.
6. The suture anchor according to claim 1, wherein the inclined surface is directed at an angle of approximately 15° to approximately 30° with respect to the longitudinal axis of the elongated body.
7. The suture anchor according to claim 6, wherein the angle is substantially the same for all bone engagement features.
8. The suture anchor according to claim 6, wherein the angle differs based on the longitudinal position of the bone engagement feature on the elongated body.
9. The suture anchor according to claim 8, wherein the angle is greater in the proximal portion of the elongated body than in the distal portion of the elongated body.
10. The suture anchor according to claim 1, wherein the lumen extends completely through the elongated body from the proximal end to the distal end.
11. The suture anchor according to claim 1, wherein the lumen is offset from the longitudinal axis of the elongated body.
12. The suture anchor according to claim 1, wherein the suture engagement feature includes an opening notch adjacent to the distal end.
13. The suture anchor according to claim 1, wherein the suture engagement feature includes a pair of longitudinally positioned arms that form a channel located proximal to the distal end.