Patent Application
20240156586
The present disclosure relates to a graft tensioning system that includes at least one engagement element or foot that is configured to engage with tissue adjacent to an implant-receiving opening. The disclosed engagement element(s) support stable interaction between the graft tensioning system and the anatomical target region, while reducing the potential for tissue bruising/trauma/contusions. The disclosed engagement elements may be interchangeably mounted relative to the graft tensioning device, e.g., intraoperatively, to permit a surgeon to select an engagement element offering desired properties for the specific procedure and/or anatomical properties of the patient.
Graft tensioning devices are known in the art, and such devices find application in a range of surgical procedures, particularly in connection with joint-related procedures. For example, graft tensioning devices are routinely used in repairs of the anterior cruciate ligament (ACL) in which a soft tissue graft is attached at both ends through a hole drilled through the two bones that make up the knee joint: the femur and the tibia. Graft tension in ACL reconstruction is a factor in favorable clinical outcomes in ACL reconstruction procedures. See, e.g., Markolf et al., “Biomechanical Consequences of Replacement of the Anterior Cruciate Ligament With a Patellar Ligament Allograft. Part Two: Forces in the Graft Compared with Forces in the Intact Ligament,” J. Bone Joint Surg. Am., 78: 11, 1728-34 (November 1996); Tohyama et al., “Significance of Graft Tension in Anterior Cruciate Ligament Reconstruction. Basic background and clinical outcome,” Knee Surg. Sports Traumatol. Arthroscopy, 6 Suppl. 1, S30-7 (1998); Andersen et al., “Review on Tension in the Natural and Reconstructed Anterior Cruciate Ligament,” Knee Surg. Sports Traumatol. Arthroscopy, 2:4, 192-202 (1994); Yasuda et al., “Effects of Initial Graft Tension on Clinical Outcome After Anterior Cruciate Ligament Reconstruction. Autogenous Doubled Hamstring Tendons Connected in Series of Polyester Tapes,” Am. J. Sports Med., 25: 1, 99-106 (January 1997); Hamner et al., “Hamstring Tendon Grafts for Reconstruction of the Anterior Cruciate Ligament: Biomechanical Evaluation of the Use of Multiple Strands and Tensioning Techniques,” J. Bone Joint Surg. Am., 81:4, 549-57 (April 1999).
The patent literature also reflects work in developing beneficial tensioning devices/systems. See, e.g., U.S. Pat. Nos. 4,712,542; 5,037,426; U.S. Pat. No. Re 34,762; U.S. Pat. Nos. 5,713,897; 5,507,750; and 5,562,668.
Ligament and tendon repair procedures extend beyond knee-related procedures. For example, ligament and tendon repair procedures are routinely undertaken with respect to other anatomical regions, e.g., the foot and ankle, the shoulder and rotator cuff, the elbow, and the wrist and hand. In knee-related procedures, e.g., ACL repairs, it is frequently desirable to stabilize a graft tensioning device relative to the anatomical region of the patient. Such stabilization functionality is ideally accomplished with minimal bruising/trauma to the soft tissue surrounding the ligament/tendon introduction site, while permitting efficient access thereto for purposes of the repair procedure. Graft tensioning devices are generally not available and/or employed for use in anatomical regions other than the knee because tissue engagement requirements of other anatomical regions have not been effectively addressed.
Despite efforts to date, a need remains for devices and systems for use in ligament/tendon repair that provide effective stabilization while minimizing the potential for bruising/trauma to soft tissue surrounding the ligament/tendon introduction site. A need further remains for devices/systems that facilitate clinical flexibility in ligament/tendon procedures, whereby a surgeon/practitioner is able to easily/reliably select a desired stabilization element based on clinical variables and/or surgeon/practitioner preference. These and other needs are satisfied by the devices, systems and associated methods disclosed herein.
The present disclosure provides stabilization devices, systems and methods for use in connection with graft tensioning procedures, wherein the stabilization functionality is effectuated by at least one engagement element or foot that is configured to engage with either the bone or tissue adjacent or opposed to an implant-receiving opening depending on the procedure and/or surgeon's preferred technique. The disclosed engagement element(s) support stable interaction between the graft tensioning system and the anatomical target region, while reducing the potential for tissue bruising/trauma/contusions.
The disclosed engagement elements may be interchangeably mounted relative to the graft tensioning device, e.g., intraoperatively, to permit a surgeon/practitioner to select an engagement element offering desired properties for the specific procedure and anatomical properties of the patient. The disclosed engagement elements may include an attachment mechanism that facilitates ease of attachment/detachment from a graft tensioning device. The graft tensioning device may include one or more ancillary functionalities, e.g., a tensioning gauge and/or a guide channel for interaction with and tensioning of an implant.
In exemplary clinical implementations of the disclosed graft tensioning device, the device may be positioned by the surgeon on the side that is opposite the side on which the implant is inserted or alternatively may be placed on the same side on which the implant is inserted. Thus, in such clinical implementations, the disclosed graft tensioning device is effective to interact with an implant, e.g., a graft, that has been inserted to an anatomical channel on an opposite side of the patient and pull/draw the implant/graft (and/or a suture associated with the implant/graft) into the device, applying a desired level of tension to the implant/graft before fixation in the implant site.
In further embodiments of the present disclosure, the disclosed graft tensioning device may be secured relative to an engagement assembly that is particularly suited to other types of clinical procedures, e.g., ACL replacement procedures. The engagement assembly may define spaced guide arms that facilitate controlled routing of sutures from the implant region to a suture retention structure associated with the graft tensioning device. The suture retention structure may be rotatably mounted relative to the graft tensioning device, thereby permitting the suture retention structure to rotate/swivel in response to the forces exerted by/to the sutures on either side of the central axis of the graft tensioning device. In this way, the forces applied to/experienced by the sutures may be advantageously balanced.
Additional features and functions associated with the disclosed engagement element(s) and graft tensioning system that may be used in conjunction with the disclosed engagement element(s) will be apparent from the description which follows, particularly when read in conjunction with the appended figures.
To assist those of skill in the art in making and using the disclosed engagement elements and associated graft tensioning systems, reference is made to the accompanying figures, wherein:
The present disclosure provides stabilization devices, systems and methods for use in connection with graft tensioning procedures. The disclosed stabilization devices, systems and methods generally include at least one engagement element or foot that is configured to mount relative to a graft tensioning device. In exemplary embodiments of the present disclosure, the engagement element is associated with an engagement assembly that detachably mounts relative to a graft tensioning device. However, the present disclosure is not limited by or to implementations wherein interaction between the engagement element/engagement assembly and the graft tensioning device is detachable. Rather, the present disclosure expressly encompasses implementations where the engagement element/engagement assembly is integrally formed with the graft tensioning device, i.e., as a unitary assembly.
The disclosed engagement element(s) support stable interaction between the graft tensioning system and the anatomical target region, while reducing the potential for tissue bruising/trauma/contusions. The graft tensioning device may include one or more ancillary functionalities, e.g., a tensioning gauge, guide channel(s) for passage of instrument(s)/implant(s), and the like.
With initial reference to
With further reference to
The contour region 14 angles relative to the mounting region 12 of engagement assembly 10. In the exemplary embodiment of
As shown in
A slidable tensioning assembly 58 is mounted with respect to elongated shaft 52. Gripping extensions 62 are formed at (or adjacent) a proximal end of tensioning assembly 58 to permit a surgeon/practitioner to slide/translate the tensioning assembly 58 proximally relative to proximal handle 56. A locking mechanism is generally operative relative to tensioning assembly 58 and may be used to releasably secure the tensioning assembly 58 at a desired position relative to shaft 52. In the exemplary embodiment of
In the exemplary embodiment of
A tensioning gauge 67 is associated with tensioning assembly 58. Tensioning gauge 67 includes an internal spring (not pictured) that is biased against proximal motion of tensioning assembly 58 relative to shaft 52. As a surgeon/practitioner draws the tensioning assembly 58 proximally (through interaction with gripping extensions 62), the internal spring is loaded. The degree to which the spring is loaded is correlated with the indicia on the face of tensioning assembly 58 (e.g., 0, 20N, 40N, 60N). An indicator 71 is visible through side slot 72 which allows the surgeon/practitioner to gauge the degree to which a ligament/tendon/graft is being tensioned by the disclosed assembly. A complementary indicator/side slot combination is generally provided on the opposite side of tensioning assembly (not visible in
With reference to
With reference to
As is most apparent in
The flexibility of the engagement element 16 in absorbing forces, as described above, minimizes the potential for bruising/trauma/contusions to tissues surrounding an anatomical target region. In achieving the desired flexibility and resilience, the engagement element 16 is generally fabricated from a material selected from various polymers or metals with an appropriate modulus of elasticity, e.g., polymers such as acetal (polyoxymethylene), nylon, polypropylene and high molecular weight polyethylene (HMWPE), and metals such as titanium and Nitinol (nickel/titanium alloy). In exemplary implementations, e.g., where a metal is employed, an over-mold of silicon or other material having softer/less rigid properties may be undertaken to minimize traumatic effects associated with tissue engagement. The cross-section of arms 80a, 80b, 80c is generally in the range of 1/32 to ¼ inches. The cross-section of the arms themselves may take various forms, e.g., circular, oval, elliptical, rectangular, etc. As is apparent from
In use, the disclosed engagement assembly 16 is detachably secured relative to tensioning device 50 by introducing keyed extension 60 into keyed opening 18 and bringing latching hook 22 into engagement with latching shelf 76 in stop 54. The engagement element 16 is placed against a tissue/anatomical surface “S” adjacent a desired surgical site, as shown in
The surgeon/practitioner tensions the ligament/tendon/graft by sliding the tensioning assembly 58 proximally relative to shaft 52 (through interaction with gripping extensions 62). Once the desired tension is achieved (as measured by the tensioning gauge 66), the tensioning assembly 58 may be locked relative to the shaft 52, thereby maintaining the desired tension on the ligament/tendon/graft. Of note, application of the tensioning force necessarily imparts a force on the tissue adjacent the target site as the engagement element 16 is pressed thereagainst. The advantageous design/geometry of the disclosed engagement element 16 spreads such force out across the surface of arms 80a, 80b, 80c and absorbs a portion of the force through flattening of the dome-shaped geometry. In this way, potential bruising/trauma/contusion of such tissue is advantageously reduced.
Turning to
In contrast to the three S-shaped arms associated with engagement element 16, the engagement assembly 116 includes three legs 180a, 180b, 180c that together define a tripod structure. The three legs 180a, 180b, 180c extend downward and outward from a central hub region 182 that is joined relative to the contour region 114. Each of the legs defines a curved geometry such that an abutment surface 196a, 196b, 196c is formed by each leg at a distance removed from the hub region 182. The legs 180a, 180b, 180c are sufficiently flexible/resilient that, as downward force is applied from the tensioning device (i.e., as the ligament/tendon/graft is tensioned), the legs flatten, thereby absorbing and spreading such force over the underlying tissue. In this way, engagement element reduces the potential for bruising/trauma/contusion to the tissue. Once the force is removed, the legs 180a, 180b, 180c advantageously return to (or nearly to) their initial tripod orientation. The engagement element 116 is generally fabricated from a material selected from various polymers or metals with an appropriate modulus of elasticity, e.g., polymers such as acetal (polyoxymethylene), nylon, polypropylene and high molecular weight polyethylene (HMWPE), and metals such as titanium and Nitinol (nickel/titanium alloy). In exemplary implementations, e.g., where a metal is employed, an over-mold of silicon or other material having softer/less rigid properties may be undertaken to minimize traumatic effects associated with tissue engagement. The cross-section of arms 180a, 180b, 180c is generally in the range of 1/32 to ¼ inches. The cross-section of the arms themselves may take various forms, e.g., circular, oval, elliptical, rectangular, etc.
Turning to
With reference to
Turning to
Graft tensioning device 400 includes an upstanding suture retention structure 470 that is mounted relative to the slidable tensioning assembly 458. Suture retention structure 470 includes a pair of spaced suture channels 472, 474 on opposite sides of a central support 476. Suture channels 472, 474 define central regions 472a, 474a that are bounded by inner side walls and outer side walls. Central regions 472a, 474a generally define a circular suture engagement surface that facilitates wrapping of a suture therearound. Suture channels 472, 474 may be angularly oriented relative to central support 476, such that an upper region of suture channels 472, 474 is further removed from central support 476 as compared to a lower region of suture channels 472, 474. The angular orientation may be on the order of 5° to 10° relative to a non-angular orientation.
Suture retention structure 470 is generally rotatable relative to the axis of central support 476. In this way, suture channel 472 and suture channel 474 may assume a position relative to a patient that balances the forces exerted by suture wrapped around suture channels 472, 474, respectively. Rotatable or swivel motion of retention structure 470 is generally permitted by providing a rotatable mounting mechanism (not pictured) between the retention structure 470 and the tensioning assembly 458, e.g., a ball bearing mechanism, a rotatable coupling mechanism, and the like. The rotatable mounting mechanism may include one or more stops that limit rotation of retention structure within a desired angular range, e.g., less than 30° relative to an axis that is perpendicular to shaft 452, less than 15° relative to the noted perpendicular axis, etc.
As noted above, engagement assembly 410 is detachably mounted relative to graft tensioning device 400. Engagement assembly 410 includes first and second tissue engagement surfaces 412, 414 on opposite sides of central channel region 415. Of note, central channel region 415 defines an open space between tissue engagement surfaces 412, 414 within which an implant region may be positioned in clinical use. Each of the tissue engagement surfaces 412, 414 include a plurality of spaced apertures for receipt of securing elements 416a, 416b, 418a, 418b, e.g., screws, for detachably securing the engagement assembly 410 relative to a desired anatomical location. Opposed guide arms 422, 424 are defined by engagement assembly 410 and may be used for routing sutures in a spaced/controlled manner from the implant region to the suture retention structure 470.
Engagement assembly 410 includes a contour region 426 that defines an arcuate transition for the central channel region 415. As with the previously described contour regions, contour region 426 generally defines an overall angular orientation between the axis of the graft tensioning device 400 and the plane defined by the implant region of about 15° and 35°, although alternative angular orientations that fall outside the noted range may be implemented without departing from the spirit or scope of the present disclosure.
Turning to
Graft tensioning device 500 includes upstanding suture retention structure 570 (that corresponds to suture retentions structure 470 described above) that is mounted relative to the slidable tensioning assembly 558. Suture retention structure 570 includes a pair of spaced suture channels 572, 574 on opposite sides of a central support 576. Suture channels 572, 574 define central regions 572a, 574a that are bounded by inner side walls 572b, 574b and outer side walls 572c, 574c. Central regions 572a, 574a generally define a circular suture engagement surface that facilitates wrapping of a suture therearound. Suture channels 572, 574 may be angularly oriented relative to central support 576, such that an upper region of suture channels 572, 574 is further removed from central support 576 as compared to a lower region of suture channels 572, 574. The angular orientation may be on the order of 5° to 10° relative to a non-angular orientation.
Suture retention structure 570 is generally rotatable relative to the axis of central support 576. In this way, suture channel 572 and suture channel 574 may assume a position relative to a patient that balances the forces exerted by suture wrapped around suture channels 572, 574, respectively. Rotatable or swivel motion of retention structure 570 is generally permitted by providing a rotatable mounting mechanism (not pictured) between the retention structure 570 and the tensioning assembly 558, e.g., a ball bearing mechanism, a rotatable coupling mechanism, and the like. The rotatable mounting mechanism may include one or more stops that limit rotation of retention structure within a desired angular range, e.g., less than 30° relative to an axis that is perpendicular to shaft 552, less than 15° relative to the noted perpendicular axis, etc.
As noted above, engagement assembly 510 is detachably mounted relative to graft tensioning device 500. Engagement assembly 510 includes first and second tissue engagement surfaces 512, 514 on opposite sides of central channel region 515. Central channel region 515 defines an open space between tissue engagement surfaces 512, 514 within which an implant region may be positioned in clinical use. Each of the tissue engagement surfaces 512, 514 include a plurality of spaced apertures for receipt of securing elements 516a, 516b, 518a, 518b, e.g., screws, for detachably securing the engagement assembly 510 relative to a desired anatomical location. Engagement assembly 510 includes a first guide arm 522 on a first side of central channel region 515 and a second guide arm 524 on an opposite side of central channel region 515. The second guide arm 524 defines a hook region 525 for controlled engagement of suture that passes therethrough. Thus, first and second guide arms 522, 524 may be used for routing sutures in a spaced/controlled manner from the implant region to the suture retention structure 470.
As shown in
Engagement assembly 510 includes a contour region 526 that defines an arcuate transition for the central channel region 515. As with the previously described contour regions, contour region 526 generally defines an overall angular orientation between the axis of the graft tensioning device 500 and the plane defined by the implant region of about 15° and 35°, although alternative angular orientations that fall outside the noted range may be implemented without departing from the spirit or scope of the present disclosure.
Of note, the various engagement assemblies disclosed herein may be used interchangeably. Indeed, a surgeon/practitioner may substitute one of the disclosed engagement assemblies for another of the disclosed engagement assemblies at any time, e.g., during a surgical procedure, if desired. Thus, if the anatomical properties of a particular procedure are better suited to the design/geometry of engagement assembly 10, the surgeon/practitioner can easily detach/remove a previously selected engagement assembly, e.g., engagement assembly 110 or engagement assembly 210 or engagement assembly 310, and substitute engagement assembly 10 therefore. In addition, an engagement assembly that is particularly suited for an implant in the foot may be replaced by an engagement assembly that is particularly suited for an implant in the knee, thereby further enhancing the flexibility and modularity of the disclosed devices and systems. The disclosed modular substitutability of engagement assemblies thus greatly enhances the efficacy of the disclosed devices, systems and methods.
Although the present disclosure has been described with reference to exemplary embodiments, the present disclosure is not limited by or to such exemplary embodiments. Rather, the devices, systems and methods of the present disclosure are susceptible to various refinements, modifications and enhancements without departing from the spirit or scope of the present invention.
The present application claims priority benefit to a U.S. provisional application entitled “Graft Tensioning System with Modular Engagement Element,” which was filed on Mar. 5, 2021, and assigned Ser. No. 63/157,407. The entire content of the foregoing provisional application is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/017724 | 2/24/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63157407 | Mar 2021 | US |
