Suture tensioning and fixation devices, systems, and methods

Abstract

The system and method for collecting, tensioning, and clamping multiple suture leads can be used for any of a range of possible surgical applications. The system includes a suture clamp assembly including a receptacle and a plug component, where a suture lead passed through the receptacle is secured when the plug is inserted into the receptacle to lock the suture lead in place, a collecting suture including a collecting loop, an instrument for securing the multiple suture leads, and optionally an anchor secured to the collecting suture. The system can be used to address applications in rotator cuff repair, labral repair, biceps tenodesis, acromioclavicular joint stabilization, and other joints and bones within the body.

Description

[Technical field]

[0001] Related Applications and Priorities This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 814,700, filed March 6, 2019, No. 62 / 816,633, filed March 11, 2019, and No. 62 / 863,383, filed June 19, 2019, each of which is entitled "SUTURE LOCK AND TENSION INSTRUMENT," and each of which is incorporated herein by reference in its entirety.

[0002] Provided herein are suture tensioning and fixation devices, systems, and methods for fixating two or more suture leads. Benefits realized include the ability to fix multiple suture leads to a single fixation point while simultaneously minimizing or eliminating reliance on knots on any one or more suture leads. [Background technology]

[0003] In the field of rotator cuff repair, transosseous fixation is considered the gold standard because it has been shown to provide good and excellent long-term outcomes for patients and has been demonstrated to provide favorable performance based on biomechanical studies. When performed by an experienced arthroscopic surgeon using modern arthroscopic techniques, it allows for good fixation strength and excellent outcomes. Arthroscopic rotator cuff repair also offers advantages over open repair, including visual access to the glenohumeral joint to evaluate pathology and characterize tear patterns, preservation of the deltoid origin, and a reduced incidence of reported postoperative pain and stiffness.

[0004] Various fixation techniques and configurations are used in arthroscopic rotator cuff repair utilizing multiple sutures, each of which passes through the tissue to be repaired, typically including two loose ends or "leads," or in some instances, one lead and one fixed end secured to an anchor secured to the bone. Fixation of these suture loose ends or leads is necessary to maintain tension on each suture to secure and repair the tissue, and therefore the leads must be secured by means that can include knots, and suture anchors. For most surgeons, suture anchors are the primary means for securing suture leads. Suture anchors are typically metal, plastic, or woven devices that are driven and / or actuated to secure by toggles, knots, or frictional fixation within the bone, with toggle and knot fixation typically involving fixation against the inner surface of the cortical bone adjacent to the cancellous bone. Currently, suture leads are attached to bone anchors or tied with knots to adjacent suture leads.

[0005] Depending on the configuration of suture placement, the surgeon may have multiple suture leads to secure after the tissue is sutured. For example, one known surgical technique involves double row transosseous fixation, which has been shown to be a superior method of rotator cuff repair fixation with improved biomechanical properties (i.e., strength, stiffness, load to failure, and gap), increased compression across the rotator cuff footprint for maximal healing, and high radiographic cure rates. Despite these benefits, there are inefficiencies in the operating room in terms of substantially increased operative time and implantation costs due to the use of twice the number of suture anchors. Furthermore, when multiple anchors are fixed within the bone, there may be unacceptable compromises to the bone, for example, in the rough bone footprint and / or when there is less bone volume to support the anchor fixation.

[0006] Additionally, when suture lead knots are utilized to achieve fixation, inefficiencies exist in the operating room in terms of substantially increased surgical time due to the challenges of tying knots on many leads and associated challenges including lead breakage and cuts to the surgeon's gloves and / or fingers. Extensive training is required for surgeons to learn how to tie suture leads. Tying multiple suture leads in the operating room can take a significant amount of time and lead to unsecured suture leads. There are several examples in the field of clips and specialized types of suture materials that help address some of the challenges associated with the use of anchors and knots on suture leads. However, such devices used in the art are generally focused on soft tissue and low force suture applications. In the case of rotator cuff surgery, the secured sutures are typically exposed to large forces equivalent to those applied to the suture knots. Also, many clip designs in the art apply sharp point loads to the suture material, creating potential failure points for the suture lead.

[0007] For example, in the context of rotator cuff repair, surgical procedures involving fixation of soft tissue to bone present many challenges, and improved devices, systems, and methods are needed to ensure positive outcomes and minimize challenges and risks. Summary of the Invention

[0008] The present invention provides an alternative embodiment of a suture clamp assembly including a receptacle and plug component, the receptacle component incorporating rounded lead-in and lead-out features that contact the suture lead passed through the receptacle and serve to minimize deformation of the suture lead when the plug is inserted into the receptacle to lock the suture lead in place. The present invention further provides an apparatus for securing multiple suture leads by utilizing a suture clamp assembly, a collecting suture including a collecting loop, and optionally an anchor secured to the collecting suture. Typically, the suture leads are tied individually. The present invention allows for collection, pre-tensioning, final tensioning, and clamping of one or more suture leads. In some embodiments, at least one to twenty or more suture leads may be utilized. The suture collecting loop of the collecting suture, the suture clamp assembly, and the fixation apparatus may be used in any of a range of possible surgical applications, including, but not limited to, surgery addressing rotator cuff repair, as exemplified herein. Other examples include labrum repair, biceps tenodesis, acromioclavicular joint stabilization, and applications to other joints within the body. [Brief description of the drawings]

[0009] Features and advantages of the general inventive concept will become apparent from the following description taken with reference to the accompanying drawings, including the drawings represented herein in the accompanying drawing set of the Brief Description below.

[0010] [Figure 1] 1 illustrates a base receptacle of a clamping assembly according to the present disclosure, the base receptacle having a tapered ribbed inner surface. [Diagram 2] 1 shows a plug having tapered ribbed inner surfaces. [Diagram 3] 1 shows a base receptacle and plug assembly. [Figure 4] 1 shows the tensioning device from an oblique bottom view. [Diagram 5] 1 shows the tensioning device from a side longitudinal section view. [Figure 6] 1 shows the tensioning device from an oblique bottom view (opposite side). [Figure 7] FIG. 13 shows the tensioning device from a side longitudinal view with the suture lead attached to the carriage. [Figure 8] 1 shows the assembly of a tapered rib spiral plug and a receptacle having a tapered spiral surface. [Figure 9] 1 shows a base receptacle having a tapered spiral inner surface. [Figure 10] 1 shows a plug having a tapered helical inner surface. [Figure 11] 1 shows a flow chart of an embodiment of a surgical procedure according to the present disclosure. [Figure 12] It depicts a one-way mechanism that allows the suture to be pulled through in one direction and resist the force of being pulled back in the other direction. [Figure 13] 1 shows a collecting suture constructed with a free end passing through an eyelet and then through a one-way mechanism. [Figure 14] The two suture leads are shown passing through the string openings with the free ends passing through the one-way mechanism. [Figure 15] The eyelet of the collection loop is shown pulled tight against the one-way mechanism, closing the collection loop around the suture lead and creating tension in the suture lead and allowing adjustment prior to placement of the base receptacle. [Figure 16] Shown is the free end of the collection loop along with the other suture lead passing through the bottom of the base receptacle, which is positioned in a direction along the suture lead, leading to the bone contact and where the suture lead is tensioned before being secured. [Figure 17] 1A-1C illustrate examples of anatomical structures in which multiple sutures may be utilized to secure soft tissue to bone using instruments and systems according to the present disclosure. [Figure 18] FIG. 18 shows an enlarged view of a bone hole as shown in FIG. 17. [Figure 19] 1 shows a first view in a sequence illustrating the use of a bone anchor secured in a bone hole to secure one or more sutures using instruments and systems according to the present disclosure. [Figure 20] 19. Further figures in the sequence described with respect to FIG. [Figure 21] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Figure 22] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Figure 23] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Figure 24] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Diagram 25] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Figure 26] 20 shows the first diagram in the sequence described with respect to FIG. 19. [Figure 27] 18 shows a diagram of the anatomical structure described with respect to FIG. 17 with multiple sutures secured to bone via bone holes and bone anchors using instruments and systems according to the present disclosure. [Figure 28] 1 illustrates an alternative view of an anatomical structure in which multiple sutures may be utilized to secure soft tissue to bone using instruments and systems according to the present disclosure, where the sutures are passed through one hole, through another hole, through the cortical bone via a tunnel from the cortex through the cancellous bone utilizing a bone anchor. [Figure 29] 1 illustrates an alternative view of an anatomical structure in which multiple sutures may be utilized to secure soft tissue to bone using instruments and systems according to the present disclosure, where the sutures are passed through one hole, through another hole, through the cortical bone via a tunnel from the cortex through the cancellous bone (without utilizing a bone anchor). [Diagram 30] 29 shows a diagram of the anatomical structure described with respect to FIG. 28 with multiple sutures secured adjacent to bone using instruments and systems according to the present disclosure.

[0011] Reference numbers used in the specification and drawings: The following table provides a guide to the particular features described in the specification, which correspond to numbers numbered in the text or otherwise shown in the table. [Table 1]

[0012] Features and advantages of the general inventive concept will become apparent from the following description taken with reference to the accompanying drawings, including the drawings represented herein in the accompanying drawing set of the Brief Description below.

[0013] This disclosure describes exemplary embodiments in accordance with general inventive concepts and is not intended to limit the scope of the invention in any way. Indeed, the invention described herein is broader than, and is not limited to, the exemplary embodiments described herein, and terms used herein have their full ordinary meaning. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] This description describes exemplary embodiments in accordance with general inventive concepts and is not intended to limit the scope of the invention in any way. Indeed, the invention described herein is broader than, and is not limited to, the exemplary embodiments described herein, and terms used herein have their full ordinary meaning.

[0015] Herein, the general inventive concept will be described with occasional reference to exemplary embodiments of the present invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art that encompasses the general inventive concept. The terms described in this detailed description are merely for describing specific embodiments and are not intended to limit the general inventive concept.

[0016] As used herein, the singular forms "a," "an," and "the" are intended to include the plural unless the context clearly indicates otherwise. The term "proximal," as used in reference to any object, refers to the portion of the object closest to the operator of the object (or some other described point of reference), and the term "distal" refers to the portion of the object furthest from the operator of the object (or some other described point of reference). The term "operator," particularly in the context of providing health care, means and refers to any professional or paraprofessional who provides clinical care to a medical patient. More broadly, in the context of non-medical applications of the invention described herein, the term refers to a user of one or more components of the suture clamp assembly 9.

[0017] Unless otherwise indicated, all numbers expressing quantities, properties, and the like used in the present specification and claims should be understood to be modified in all cases by the term "about". Thus, unless otherwise indicated, the numerical properties described in the present specification and claims are approximations that may vary depending on the desired properties of the embodiments of the present invention. Although the numerical ranges and parameters setting forth the broad scope of the general inventive concept are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical values ​​inherently contain certain errors necessarily resulting from errors found in their respective measurements.

[0018] The term "proximal" as used in reference to any object refers to the portion of the object closest to the operator of the object (or some other described point of reference), and the term "distal" refers to the portion of the object furthest from the operator of the object (or some other described point of reference). "Clinical subject" refers to a human or other animal that is the subject of treatment with a bone fixation or bone reduction device in accordance with the present disclosure. With respect to any reference herein that may be made to a clinical subject, the term "medial" refers to a direction toward the central axis of the clinical subject (e.g., the spine), and the term "lateral" refers to a direction toward a side of the clinical subject. As used herein in the described and illustrated embodiments, the term "device" means and refers to any one of a suture, an assembly of suture clamp assembly 9, or one or more of parts thereof (the suture clamp assembly 9 may be referred to in the art as a clip), a fixation device, an anchor, and a suture. The term "system" refers to any combination of two or more of the devices. As specifically used herein, the term "lead" refers to the free end of a suture. Additionally, the term "method" refers to any one of a method of using a device or system and a surgical method or technique that utilizes a device or system.

[0019] Referring now to the drawings, the present invention includes a suture clamp assembly 9 that securely holds one or more suture leads. Figures 1-3 and 8-10 show two alternative embodiments of the suture clamp assembly 9. Figures 5-7 show alternative views of a fixation device 30 that provides tensioning and locking functions. Figures 12-16 show the placement of a suture lead 18, including a one-way device 60 and a collection loop 53, illustrating a method for collecting and tensioning the suture lead 18 prior to placement of the suture clamp assembly 9. Also, Figures 17-29 further illustrate a method for collecting, tensioning, and securing a suture lead in a representative anatomical structure, namely, the shoulder joint, which is related to rotator cuff surgery. It will be understood by those skilled in the art that the devices, systems, and methods according to the present disclosure are suitable for other anatomical sites within the body where one or more suture leads may be tensioned for fixation of soft tissue to bone. Thus, the present invention is not limited to use for rotator cuff type repair of the shoulder, but may be utilized in any other anatomical site.

[0020] Referring again to the drawings, Figure 3 shows a first embodiment of the components of a clamp assembly according to the invention including a base receptacle 5 and a plug 7. In some embodiments, the suture clamp assembly 9 is preassembled or manufactured as one piece and assembled, and in use, the plug 7 is insertable into the through channel 1 of the base receptacle 5. In other embodiments, the suture clamp assembly 9 is provided unassembled. Referring now to Figure 4, there is shown a retainer 30 adapted with a distal mounting tip 34 to receive and retain the base receptacle of the suture clamp assembly 9 to allow one or more sutures to pass through the through channel 1.

[0021] In various embodiments, the complementary mating surfaces comprising the receiver and plug engagement features 12, 16 of the components of the clamp 9 may be selected from a series of circumferential grooves on the receptacle 5 and ribs on the plug 7, or a helical groove on the receptacle and threads on the plug 7. Of course, other configurations are possible. In various embodiments, the components interengage by a snap joint or threaded engagement between the complementary surfaces. The complementary surfaces generally lack sharp edges and angles to prevent severing of the suture passing therethrough, and are fitted with sufficient clearance to prevent binding and shearing of the suture.

[0022] 2, in one embodiment of the present invention, a base receptacle 5 and plug 7 are provided to hold one or more suture leads 18 from slipping. In one embodiment of the present invention, a base receptacle having a circular grooved inner surface 10, as shown in FIG 1, where the circular groove depicted here represents one embodiment of a receptacle engagement feature 12, and a plug 7 having a circular ribbed outer surface 14, as shown in FIG 2, where the circular rib depicted here represents one embodiment of a plug engagement feature 16, mate together to hold the suture leads 18 in place between the inner surface 10 and outer surface 14 of the base receptacle 5 and plug 7, respectively. The plug 7 is pushed through the base receptacle 5 into engagement with the receptor sheet 3 in the through channel 1 using a tool, which may be selected from the fixation tool 21 as shown in Figures 4-7, allowing the base receptacle 5 to expand around the plug 7, with each of the complementary engagement features 12, 16 interacting to lock the plug 7 in place within the base receptacle 5, securely maintaining the suture lead 18 and preventing the plug 7 from backing out of the base receptacle 5.

[0023] In another embodiment of the invention, a base receptacle 5 as shown in Figure 9 having a helically ribbed inner surface 10 and a plug 7 as shown in Figure 10 having a helically ribbed outer surface 14 mate together to hold a suture lead 18 in place between the inner surface 10 and outer surface 14 of the base receptacle 5 and plug 7, respectively. The plug 7 is threaded into the base receptacle 5 using a drive feature 40 on the plug 7 as shown in Figure 10, whereby the helical threads of the receptacle engagement feature 12 expand around the threads of the plug engagement feature 16, whereby the plug 7 is locked in place securing the suture lead 18 and preventing the plug 7 from backing out of the base receptacle 5. It will be appreciated that in various embodiments, the receptor engaging feature 12 may include structure such as male or female threads complementary to the plug engaging feature 16, as shown in Figures 8-10, or the receptor engaging feature 12 may include structure such as ridges or channels or grooves complementary to the plug engaging feature 16, as shown in Figures 1-3. In some embodiments, the respective receptor and plug engaging features 12, 16 may include a Morse taper type engagement (not shown). Thus, as shown in Figures 1-3 of the drawings, in one embodiment, the receptor engaging feature 12 includes a female groove complementary to a male rib forming the plug engaging feature 16 on the outer surface 14 of the plug 7. Also, in another embodiment, as shown in Figures 8-10 of the drawings, the receptor engaging feature 12 includes a female thread complementary to a male thread forming the plug engaging feature 16 on the outer surface 14 of the plug 7.

[0024] According to various embodiments of the suture clamp assembly 9, the base receptacle 5 and plug 7 are each configured with a complementary tapered profile such that the tapered plug 7 fits within a complementary tapered receiver seat within the base receptacle 5. It will be appreciated that in other embodiments, the base receptacle 5 and plug 7 may each be cylindrical rather than tapered, or may be configured with a complementary profile that includes both cylindrical and frustoconical or tapered portions.

[0025] In various embodiments, the base receptacle 5 includes a through channel 1 opening into the receptor sheet 3 at its upper end 4 and also includes a lower end 6, where a through channel 1 adapted for passage of a suture lead is formed between the upper end 4 and the lower end 6, where the receptor sheet 3 is adapted to receive and retain the plug 7 within the base receptacle 5 without passing beyond the lower end 6. In some embodiments, the receptor sheet 3 is a continuous channel through the base receptacle 5 as shown in the drawings, and in some embodiments, the receptor sheet 3 is sized to retain the plug 7, narrowing and sized to allow passage of the suture through the base receptacle from between the lower end 6 and the upper end 4, but otherwise preventing further passage of the plug 7 beyond the receptor sheet 3.

[0026] According to various embodiments, the receptor sheet 3 of the base receptacle 5 includes edges at one or both of the upper and lower ends 4, 6 that feature scalloped or other circumferential recesses for the sutures that pass through the base receptacle to prevent compression and possible damage when the suture clamp assembly 9 contacts the bone during tensioning.

[0027] According to some embodiments, the components of the suture clamp assembly 9 are made of implant grade plastics such as PEEK or PMMA. This material selection provides a generally lightweight device that can be utilized to secure sutures without bone insertion. Of course, other materials such as other implant grade polymers, carbon fiber, ceramics, metals, and combinations thereof may be utilized. In accordance with some applications of the suture clamp assembly 9, it is desirable for the material to be radiolucent, and therefore only materials that are radiolucent are selected. In some embodiments, radiopaque materials may be beneficial to ensure the ability to locate by x-ray after the surgical site is closed. Of course, in some embodiments, the radiopaque materials may include radiopaque markers / visual indicators, for example, using tantalum or other materials.

[0028] The present invention also includes a fixation device, shown in Figures 4-7, which allows multiple suture leads 18 to be tensioned and then locked simultaneously, for example, by fixation with a suture clamp assembly 9. The mechanisms allowing for insertion of the suture clamp assembly 9, tensioning of the suture leads, and final locking are all incorporated into a single device. The device includes a mounting tip 34, a trigger 22, a handle 20 having a rack 36, a carriage assembly 23 including a pinion knob 30, a tension ring 28, and a ratchet 38, and an upper slide 24.

[0029] According to an exemplary surgical method according to the present disclosure, the system of the present invention is utilized to secure several suture leads without the use of knots or substantially without the use of a minimal number of bone anchors.

[0030] According to the method, referring now to FIG. 11, multiple sutures are utilized to repair and adjust the anatomical arrangement of soft tissue, e.g., rotator cuff soft tissue, with each suture being secured in or through bone. Thus, each of the multiple sutures may be secured to the bone, for example, in an alignment as shown in FIG. 17, and each suture may be secured at one end to an anchor secured to the bone leaving a free end or lead, or may be passed through a bone channel or tunnel connecting holes penetrating the cortical bone into the cancellous bone, leaving two free leads, one in each bone hole. Further, according to the method, all or a subset of each suture lead is captured in a collecting loop of a collecting suture, and after use of a fixation device, the collected suture leads are tensioned and then clamped against the bone and fixed in place with a clamping assembly. In some examples, all of the free suture leads may be collected and captured in a single collecting loop and then fixed with a single clamping assembly. Also, in still other examples, two or more subsets of the free suture leads may be collected and captured in a single collection loop and then secured with a single clamp assembly. In some examples, the collection suture is one of multiple sutures secured to the bone. In some other examples, the collection suture includes a one-way mechanism and is attached to a bone anchor that is inserted into a bone hole. The collection suture includes a lead end that is actuated by pulling, applying tension that draws the collected suture lead into the loop and clamps against the bone. In some examples, the lead end of the collection suture may pass through the loop and be clamped.

[0031] It will be understood that the various steps according to the method shown in Figure 11 may be performed in any order. Thus, according to Figure 11, the following steps may be modified as described below. It will be understood that the method includes the following steps, including or excluding any steps shown, and that there may be other steps that may be utilized, such as, for example, manual adjustment of tensioning of the suture lead, crossing of sutures between holes prior to collection and fixation, etc.

[0032] As one of the first steps, multiple sutures are anchored to the bone in the surgical area using one or a combination of a single suture anchored in the bone hole with an anchor and one or more sutures anchored by passing through a tunnel between the upper and lower bone holes.

[0033] Provide collection sutures.

[0034] One or more suture leads from the plurality of sutures are threaded through a collection loop formed in a collection suture, which may be any one of the plurality of sutures secured in the bone hole or the collection suture may include a one-way mechanism and be attached to a bone anchor that is inserted into the bone hole.

[0035] Optionally, the free lead end of the collection suture is threaded through the collection loop; this can be done at any time with another suture lead or just prior to final tightening of the collection loop.

[0036] Optionally, the tension of each individual suture lead is manually adjusted to achieve a desired tension.

[0037] The following steps may be performed in any order.

[0038] The collecting suture is pretensioned and the collecting loop is actuated to collect and pull the suture lead towards the bone.

[0039] At least a plurality of suture leads are threaded through the suture guides of the fixation device.

[0040] Optionally, the free lead end of the collection suture is threaded through a suture guide of the fixation device.

[0041] At least a plurality of suture leads are threaded through receptacles in the clamp assembly.

[0042] Optionally, the free lead end of the collection suture is threaded through a receptacle in the clamp assembly.

[0043] Optionally, the tension of each individual suture lead is manually adjusted to achieve a desired tension.

[0044] The following steps may be performed in any order.

[0045] The receptacle of the clamp assembly is secured to the fixture.

[0046] The plug of the clamp assembly is secured to the fixture.

[0047] The following steps may be performed in any order.

[0048] The fixed receptacle of the clamp assembly is positioned adjacent to the bony anatomical structure to establish the final location of the suture lead placement for fixation with the clamp assembly.

[0049] Each suture lead is guided into engagement with a suture tensioning carriage.

[0050] Next,

[0051] The following steps may be performed in any order.

[0052] The suture tensioning carriage is activated, tensioning all of the suture leads.

[0053] Optionally, the tension of each individual suture lead is manually adjusted to achieve a desired tension.

[0054] Next,

[0055] Optionally, the tension of each individual suture lead is manually adjusted to achieve a desired tension.

[0056] Final tension is applied to the collection suture to actuate the collection loop and securely clamp the suture leads adjacent the bone.

[0057] The retainer is actuated to orient the plug of the clamp assembly into engagement with the receptacle.

[0058] The following steps may be performed in any order.

[0059] The fastener is disengaged from contact with the clamp assembly receptacle.

[0060] The fixation device is disengaged from contact with the suture lead.

[0061] Cut off the suture lead.

[0062] A more specific description of each step shown in FIG. 11 is provided below with specific reference to the drawings.

[0063] Referring again to the drawings, Figure 12 depicts a one-way mechanism 60 that allows the collecting suture 54 to be pulled in one direction and resist pulling in the other direction. Examples of one-way mechanisms 60 include, but are not limited to, knots tied in a manner that allows the suture to be pulled freely in one direction, such as a slip knot, where the same knot would tighten around the suture and not allow it to slip in the opposite direction. Other suitable examples of one-way mechanisms 60 include structures that receive the suture, including mechanical springs, poles or gripping arms that compress and grip the suture when pulled in one direction, and allow it to move freely in the other direction.

[0064] Referring again to the drawings, FIG. 13 shows a collection loop 53 formed to capture and secure one or more suture leads 18, the collection loop 53 including a loop portion 54 of the collection suture 41, a collection suture lead 42 (which is the loose end of the collection suture 41), a loop portion 54 of the collection suture 41, an eyelet portion 50 including an eyelet portion 52 and an eyelet opening 51. The collection loop 53 is created by threading the suture lead 42 of the collection suture 41 through the eyelet 50. The collection loop 53 forms a string, lasso, snare, or other similar fiber collecting structure that can collect together a bundle of sutures, such as one or more suture leads 18. FIG. 14 shows the suture lead 18 passing through the collection loop 53. FIG. 15 shows the lead 42 of the collection suture 51 pre-tensioned to bring the eyelet 50 into contact with a one-way mechanism 60 (e.g., a knot or other structure as described herein). This causes the collection loop 53 to close around the suture lead 18. The tension of each of the individual suture leads 18 and the collection suture lead 41 can be adjusted as needed. Figure 16 shows that the suture leads 18, 41 pass through a generally ring shaped representation of a suture clamp 90 (which may be, for example, a suture clamp assembly 9 as shown in Figures 1-3). 18-26 show enlarged views of the bone hole shown in FIG. 17 and include successive views in a sequence illustrating the use of a bone anchor 100 (generally represented as a rectangle, which may be selected from a variety of known anchors, as designed herein) secured to the bone hole 76 to secure one or more sutures 18 using instruments and systems according to the present disclosure; as noted above, the securing method shown in FIGS. 12-16 further includes the use of a suture anchor 100 secured to a collecting suture 41 to provide enhanced fixation to the bone prior to application of a clamp assembly 90 (represented as a general clamp having a generally rectangular shape in the series of drawings represented in FIGS. 18-26, and as a ring in the series of drawings represented in FIGS. 12-16).

[0065] For example, as shown in Fig. 11, in a surgical technique using the clamping and fixation instruments of the present invention, one or more suture leads 18 are secured to or passed through tunnels in the bone tissue of the shoulder, for example, as depicted in Fig. 17 showing examples of bone holes 72, 76. The sutures are then passed through the soft tissue to be repaired and / or fixed, and then collected for tensioning and fixation by fixation using one or a combination of bone anchor and clamp assembly 9 devices in accordance with the present disclosure. The clamp and anchor devices are used in place of all or substantially all knots that would otherwise be utilized to secure the tension and fix the suture leads.

[0066] In use, the fixation tool 21 is utilized to tension the suture leads 18 and secure and fix the clamp assembly 9 to the suture leads 18. Thus, once the suture leads are collected and initially drawn towards the bone by pre-tensioning the collection suture 41, the sutures 18 and the base receptacle 5 of the suture clamp assembly 9 according to the present disclosure are secured on the mounting tip 34 at the distal end of the fixation tool 30, and the suture leads 18 pass through the clamp assembly 9 and loosely pass through the slot 29 on the tension ring 28 of the carriage assembly 23. The mounting tip 34 is seated against the bone tissue by placing the clamp in the desired final position. The carriage assembly 23 can then be moved to apply tension to the suture leads 18. To move the carriage assembly 23, the pinion knob 30 is rotated. This causes the carriage assembly 23 to move along the rack 36 in a proximal direction along the long axis of the fixture 21 toward the rear handle 20 (and toward the user of the fixture 21), as shown in FIG. 7. The pinion knob 30 includes a tension dial that provides an indication of the force to be applied to move the carriage assembly 23 to the next notch of the rack 36. The ratchet 38 holds the carriage assembly 23 in place and maintains tension on the suture lead 18 so that they may be locked. To lock the suture lead, the trigger 22 is pulled toward the rear handle 20. This causes the upper slide 24 to move toward the distal end of the fixture. The plug inserter 26, at the distal end of the fixture 21 and opposite the mounting tip 34, is positioned to engage the drive feature 40 of the plug 7 and move along the long axis of the fixture 21 to introduce the plug 7 into the through channel 1 of the base receptacle 5. Actuation of the upper slide 24 thus drives the slide distally along the long axis of the fixation device, exerting a force on the proximal end 12 of the plug 7, threading the plug 7 into the through channel 2 and causing the outer surface 14 of the plug 7 to contact the inner surface 10 of the base receptacle 5 and seat the plug 7 within the receptor seat 3, engaging the complementary engaging features 14, 16 of the base receptacle 5 and plug 7, thereby compressing the suture leads 18 and locking them into position in compression between the plug 7 and base receptacle 5.The fixation device 21 is used to perform some of the steps of the exemplary method shown in FIG. 11, thereby providing final fixation of the suture lead without the need for many or any hand tied knots.

[0067] Referring again to the drawings, FIGS. 27-30 show in the context of the shoulder anatomy including an example of the humerus of a possible final fixation configuration for suturing utilizing the systems, devices and methods of the present invention.

[0068] FIG. 27 shows a multiple anchor suture without a bone tunnel where the leads are all collected with a loop of collecting suture and secured to a central anchor in a bone hole and then locked in tension with a generally depicted clamp assembly 90.

[0069] FIG. 28 shows multiple anchor sutures passing through a bone tunnel where the leads are all collected with a loop of collecting suture and secured to anchors positioned laterally within the bone hole and then locked in tension with a generally depicted clamp assembly 90.

[0070] FIG. 29 shows the lead split into two subgroups, each group all collected with a loop of collecting suture and locked in tension with a generally represented clamp assembly 90, multiple anchor sutures through the bone tunnels and a single anchor suture coming from the top center.

[0071] FIG. 30 shows a multiple anchor suture arrangement including two sutures passing through each of two bone tunnels where the lead is split into two sub-groups, each group all collected with a loop of collecting suture and locked in tension with a generally depicted clamp assembly 90.

[0072] It should be understood that the logic underlying the alignment of holes and sutures is such that any of a variety of arrangements are possible (1) for use with clamps only, and (2) for use with clamps 90 and anchors 100, and sutures may be secured in either lateral or not necessarily lateral anchor holes. It will be further understood that, according to the present disclosure, there are no particular limitations or requirements regarding the site of tissue within the body in which the present invention may be utilized, and while the figures and description provide the shoulder as an example, other sites such as the knee, hip, and other large and small bones would benefit from the use of the present invention. Furthermore, the examples and figures do not limit in any way the number, placement, size, and placement of bone holes and tunnels that may be utilized to secure sutures to bone.

[0073] In some embodiments, a suture locking system is provided comprising an implantable clamping assembly including a base receptacle and a plug insertable into the base receptacle, each of the receptacle and plug having complementary surfaces that match to secure the plug in the base receptacle, the contact surfaces upon mating providing a suitable interface for securing one or more sutures passed therebetween; and a fixation device having a distal end and a proximal end engageable with the one or more sutures, the fixation device comprising a distal retention end, a trigger, a rear handle including a rack, a carriage assembly including a pinion knob, a suture tension ring, a ratchet, and an upper slide, the fixation device in use being configured to lock the sutures in place at the distal end of the device. the at least one suture is passed through the clamp assembly and loosely through a tension ring on the carriage, the distal end of the instrument is seated against tissue, the carriage assembly is moved to apply tension to the at least one suture, the pinion knob is rotated along the rack causing the carriage assembly to move toward the rear handle according to a force selected on the pinion knob, a ratchet holds the carriage assembly in place holding the at least one suture in tension, and upon actuation of a trigger toward the rear handle an upper slide is moved toward the distal end of the instrument applying a force to an upper portion of a plug provisionally placed in the upper end of the base receptacle, the force passing the plug through the receptor seat compresses the at least one suture lead in place to lock the suture and clamp assembly.

[0074] In some embodiments, the suture locking system includes a collecting suture formed in a collecting loop to collect one or more sutures that have passed through the through channel. In some embodiments, the collecting loop includes an eyelet through which the collecting suture passes to pull together the sutures that have passed through the through channel. In some embodiments, the suture locking system includes a one-way device arranged and positioned to apply tension to the collecting suture in a single direction. In some embodiments, the suture locking system includes a receptacle including a top and bottom end, an outer surface, and a through channel from the top and bottom ends, the through channel including a receptor sheet. In some embodiments, the base receptacle and the tapered plug each include a complementary receptor sheet and plug engagement feature to hold the tapered plug in the tapered receptor sheet and hold one or more sutures that have passed through the through channel by their compression between the complementary receptor sheet and plug engagement feature. In some embodiments, the suture locking system includes a one-way device arranged and positioned to apply tension to the collecting suture in a single direction. In some embodiments, one or both of the base receptacle and tapered plug of the implantable clamping assembly are formed from radiolucent plastic. In some embodiments, the tapered receiver sheet and tapered plug each include a taper angled between 0.5 degrees and 10 degrees. In some embodiments, the base receptacle includes an opening to the receiver sheet at its upper end and a suture passage at its lower end, the receiver sheet adapted to receive and hold the plug within the base receptacle without passage beyond the lower end. In some embodiments, the receiver sheet is a continuous channel through the base receptacle, the receiver sheet sized to hold the plug and narrowing from the lower end to a distal suture channel sized to receive sutures passed through the base receptacle from the upper end through the lower end, but otherwise preventing further passage of the plug beyond the receiver sheet.In some embodiments, the complementary mating surfaces of the base receptacle and tapered plug may be selected from a series of circumferential grooves on the receptacle and ribs on the plug, and helical grooves on the receptacle and threads on the plug. In some embodiments, the base receptacle and tapered plug interengage with a snap joint or threaded engagement between the complementary surfaces. In some embodiments, the complementary surfaces of the base receptacle and tapered plug generally lack sharp edges and angles to prevent severing of sutures passed therethrough, and are matched with sufficient clearance to prevent binding and shearing of sutures. In some embodiments, the receiver seat of the base receptacle includes edges at one or both of its upper and lower ends that are characterized by scalloped or other circumferential recesses for sutures passed through the base receptacle, preventing compression and possible damage when the clamp assembly contacts bone during tensioning.

[0075] In some embodiments, a locking system is provided that includes an implantable clamp assembly comprising: an implantable clamp assembly, the implantable clamp assembly including a base receptacle including upper and lower ends, an exterior surface, and a through channel from the upper and lower ends, the through channel including a tapered receiver sheet and a tapered plug, each of the base receptacle and the tapered plug including a complementary receiver sheet and plug engaging feature for retaining the tapered plug within the tapered receiver sheet and retaining one or more sutures passed through the through channel by compression thereof between the complementary receiver sheet and plug engaging feature; and a fixation device having distal and proximal ends engageable with the base receptacle and one or more sutures of the clamp assembly, the fixation device including a distal retention end, a trigger, a rear handle including a rack, a carriage assembly including a pinion knob, a suture tension ring, and a ratchet. and an upper slide, wherein the fixation instrument, in use, is secured to a base receptacle secured to a distal end of the instrument, at least one suture passes through the clamp assembly and loosely passes through a tension ring of the carriage, the distal end of the instrument is seated against tissue, the carriage assembly is moved to apply tension to the at least one suture, the pinion knob is rotated along the rack causing the carriage assembly to move toward the rear handle according to a force selected on the pinion knob, the ratchet holds the carriage assembly in place and holds the at least one suture in tension, and upon actuation of a trigger toward the rear handle the upper slide is moved toward the distal end of the instrument applying a force to an upper portion of a plug provisionally placed in the upper end of the base receptacle, which force passes the plug through a receptor seat and compresses the at least one suture lead in place to lock the suture and clamp assembly.

[0076] In some embodiments, a method for surgically repairing a rotator cuff injury includes selecting an implantable clamp assembly including a base receptacle including upper and lower ends, an outer surface, and a through channel from the upper and lower ends, the through channel including a tapered receiver sheet and a tapered plug, each of the base receptacle and the tapered plug including a complementary receiver sheet and plug engaging feature for retaining the tapered plug within the tapered receiver sheet and retaining one or more sutures passed through the through channel by compression thereof between the complementary receiver sheet and plug engaging feature; and selecting suture leads from at least two suture anchors implanted in tissue adjacent the rotator cuff, the suture leads from at least two suture anchors implanted in tissue adjacent the rotator cuff, the suture leads from at least two suture anchors implanted in tissue adjacent the rotator cuff on an inner surface of the rotator cuff. and at least one of two suture leads resulting from a suture anchor on the lateral surface of the rotator cuff, wherein the two or more anchors are characterized as one of hard and soft, and each of the two or more anchors is selected from a single lead suture and a double lead suture; passing the two or more suture leads through a through channel of a clamp assembly; contacting a base receptacle of the claim assembly against the tissue surface to tension the suture leads; assembling the clamp assembly by inserting a plug into a tapered receptor seat and locking the tensioned sutures in the clamp assembly.

[0077] In some embodiments, the method further includes collecting a group of suture leads at a fixed point within the bone prior to passing two or more suture leads through a through channel of the clamp assembly, the collecting including passing the group of suture leads through a collection loop formed from the collection sutures and a unidirectional mechanism arranged and positioned to tension the collection sutures in a single direction. In some embodiments, the method further includes pre-tensioning the collection loop to pull the leads to the bone surface. In some embodiments, the clamp assembly is pre-assembled prior to passing the sutures through the through channel.

[0078] Although various inventive aspects, concepts, and features of the general inventive concept are described and illustrated herein in the context of various exemplary embodiments, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the general inventive concept. Furthermore, although various alternative embodiments (e.g., alternative materials, structures, configurations, methods, devices and components, alternatives in terms of formation, fit, and function, etc.) may be described herein with respect to various aspects, concepts, and features of the invention, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or later developed.

[0079] Those skilled in the art may readily adopt one or more of the aspects, concepts, or features of the present invention into additional embodiments and uses within the scope of the general inventive concept, even if such embodiments are not expressly disclosed herein. In addition, while some features, concepts, or aspects of the present invention may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are required or necessary unless expressly stated. Furthermore, while exemplary or representative values ​​and ranges may be included to aid in the understanding of the present disclosure, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if expressly stated. Furthermore, while various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the invention, such identification is not intended to be exclusive, rather, there may be aspects, concepts, and features of the invention that are fully described herein without being expressly identified as such or as part of a particular invention. The description of an exemplary method or process is not limited to the inclusion of all steps as required in all cases, nor in the order in which the steps are presented such that they are interpreted as required or necessary unless expressly stated. Additionally, although disclosed benefits, advantages, and solutions to problems have been described with reference to specific embodiments, these are not intended to be construed as essential or required to the present invention.

Claims

1. 1. A suture locking system comprising: a) an implantable clamping assembly comprising a base receptacle and a plug insertable into the base receptacle, the base receptacle and the plug each having complementary surfaces that interfit to secure the plug within the base receptacle, the complementary surfaces, when interfitted, providing an interface for securing one or more sutures passed therebetween; b) a fixation device having a distal end and a proximal end, engageable with the base receptacle of the clamp assembly and one or more sutures and configured to tension and lock the sutures to the clamp assembly, the fixation device comprising: an attachment tip for holding and securing the base receptacle of the clamp assembly and for collecting and securing one or more sutures; and a plug in septor, the attachment tip and the plug in septor being disposed in series along a longitudinal axis of the fixation device defined from the distal end to the proximal end, the fixation device further comprising a carriage assembly comprising a tension ring for securing the one or more sutures, the carriage assembly being adapted to move along the longitudinal axis of the fixation device from the proximal end to the distal end.

2. the fixation tool further comprises a distal holding end with the mounting tip, a trigger, a handle, a carriage assembly with a pinion knob, the tension ring, the rack, and the ratchet, and an upper slide with the plug inserter at its distal end; the one or more sutures and the base receptacle are secured to the mounting tip, the one or more sutures are threaded through the base receptacle and loosely threaded through a slot above the tension ring of the carriage assembly, the carriage assembly is movable by rotating the pinion knob to move the carriage assembly along the rack toward the handle to apply tension to the one or more sutures, the ratchet holds the carriage assembly in place, 2. The suture locking system of claim 1, wherein tension is maintained on one or more sutures to lock the one or more sutures in place, and the trigger is pulled toward the handle to lock the one or more sutures in place, and pulling the trigger moves the top slide toward a distal end of the fixation instrument, and moving the top slide applies a force to the plug that seats the plug in the base receptacle and locks the one or more sutures in place between the plug and the base receptacle.

3. 2. The suture locking system of claim 1, wherein, in use, the fixation device is secured to the base receptacle at the distal end of the fixation device, one or more sutures pass through the clamp assembly and loosely pass through the tension ring of the carriage assembly, the carriage assembly is configured to be moved to apply tension to the one or more sutures, a pinion knob is configured to be rotated along a rack to move the carriage assembly toward a rear handle according to a force selected on the pinion knob, a ratchet holds the carriage assembly in place and holds the one or more sutures in tension, and a trigger is configured, when actuated toward the rear handle, to move an upper slide toward the distal end of the fixation device and apply a force to an upper portion of the plug provisionally placed in an upper end of the base receptacle, the force passing the plug through a receptor seat to compress one or more suture leads in place and lock the one or more sutures and the clamp assembly.

4. The suture locking system of claim 1 further comprising a collection suture comprising a free end including a lead and a collection end including a collection loop.

5. The suture locking system of claim 4 , wherein the collection loop includes an eyelet through which a lead end of the one or more sutures can pass to tighten the collection loop.

6. a unidirectional device arranged and positioned to tension the one or more sutures in a single direction, the unidirectional device being a slip knot; 6. The suture locking system of claim 5, wherein the slip knot is a knot tied such that the lead end of the collection loop is free to pull in one direction and can be tightened around one or more sutures to prevent the lead end from slipping in the other direction.

7. The suture locking system of claim 1 , wherein the base receptacle comprises upper and lower ends, an exterior surface, and a through channel from the upper and lower ends, the through channel including a receiver sheet.

8. 6. The suture locking system of claim 5, wherein the base receptacle and the plug each include a complementary receiver sheet and a plug engagement feature selected from grooves, ribs, and male and female threads to retain a tapered plug within the tapered receiver sheet and to retain the one or more sutures passed through the through channel by compression thereof between the complementary receiver sheet and the plug engagement feature.

9. The suture locking system of claim 1 , wherein one or both of the base receptacle and the plug of the implantable clamp assembly are formed from a radiolucent plastic.

10. The suture locking system of claim 8, wherein the receiver sheet and the plug each include an angled taper of between 0.5 degrees and 10 degrees.

11. 2. The suture locking system of claim 1, wherein the base receptacle receiver seat includes edges at one or both of its upper and lower ends characterized by scalloped or other circumferential recesses for the one or more sutures passed through the base receptacle to prevent compression and possible damage when the clamp assembly contacts bone during tensioning.

12. 11. A medical device comprising: a retainer for tensioning and locking a plurality of sutures, the retainer having a distal end and a proximal end, engageable with a base receptacle of the clamp assembly and the plurality of sutures for tensioning and locking the plurality of sutures with a clamp assembly, the retainer comprising: a mounting tip for holding and securing the base receptacle of the clamp assembly and for collecting and securing the plurality of sutures; and a plug in septum, the mounting tip and the plug in septum being disposed in series along a longitudinal axis of the retainer defined from the distal end to the proximal end, the retainer further comprising: a carriage assembly comprising a tension ring for securing the plurality of sutures, the carriage assembly adapted to translate between proximal and distal along the longitudinal axis of the retainer.

13. 13. The medical device of claim 12, wherein the fixation instrument further comprises: a distal holding end with the mounting tip; a trigger for locking a plurality of sutures; a handle; a carriage assembly comprising a pinion knob that is rotated to move the carriage assembly, the tension ring, a rack along which the carriage assembly moves by rotating the pinion knob, and a ratchet that holds the carriage assembly in position and holds the plurality of sutures in tension; and an upper slide with the plug inserter at its distal end.

14. 14. The medical device of claim 13, wherein, in use, the fixation tool is secured to the base receptacle at the distal end of the fixation tool, at least one suture of the plurality of sutures passes through the clamp assembly and loosely passes through the tension ring of the carriage assembly, the carriage assembly is configured to be moved to apply tension to the at least one suture, a pinion knob is configured to be rotated along a rack to move the carriage assembly toward a rear handle according to a force selected on the pinion knob, a ratchet holds the carriage assembly in place and holds the at least one suture in tension, and a trigger, when actuated toward the rear handle, moves an upper slide toward the distal end of the fixation tool and applies a force to an upper portion of a plug provisionally placed in an upper end of the base receptacle, the force passing the plug through a receptor seat and compressing the at least one suture in place to lock the at least one suture and the clamp assembly.

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