SURGICAL DEVICES AND METHODS FOR ACHILLES TENDON REPAIR

Abstract

An Achilles tendon repair that provides a minimally invasive surgical procedure that requires at least two medical devices comprising: at least one fascial elevator separator and at least one suture passer elevator separator with a paddle guide that assist with repair of Achilles tendons wherein a fascial elevator separator paddle guide that has a U-shaped portion at a distal end provides separation of a Paratenon from an Achilles tendon and also provides a surgical plane along a designated length of the Achilles tendon that eliminates a possibility of damage to either the Sural Nerve or Saphenous Vein. The suture passer elevator separator also provides for precise placement of multiple locking sutures along the medial and lateral free edge if the Achilles tendon which allows even tensioning of the surgical repair.

Claims

1. At least three medical devices for minimally invasive tendon repair comprising; (i) one or more fascial elevator separator(s) comprising a U-shaped paddle guide portion attached to a distal portion of a cylindrical rod and a proximate handle attached to said cylindrical rod wherein said one or more fascial elevator separator(s) and U-shaped paddle guide portion separate a membrane-like areolar structure known as a Paratenon from an Achilles tendon; (ii) one or more suture passer elevator separators that maintain separation of said Paratenon from said Achilles tendon and comprises a hollow cylindrical rod with an axial and radial axis with an attached distal U-shaped paddle guide and with an inverted suture grasping and firing mechanism, wherein a set of jaws and a needle is positioned such that said set of jaws and needle enter one or more fascial elevator separator(s) prepared surgical plane for one or more sutures and/or fiber tapes wherein said needle fires and passes through a superficial portion of a tendon to a deep portion of said tendon; and wherein said set of jaws are located along said axial axis of said hollow cylindrical rod shaped shaft in a position between a proximate trigger-handle and directly underneath said distal U-shaped paddle guide thereby said U-shaped paddle guide maintains separation and guides a free edge of an Achilles tendon into a set of jaws of said suture passer elevator separator that controls position and penetration of said sutures deployed for said tendon repair and; (iii) at least one suture shuttle passer that is deployed to complete said tendon repair.

2. The one or more fascial elevator separator(s) of claim 1, wherein a U-shaped paddle guide portion of said one or more fascial elevator separator(s) provides separation of a Paratenon from an Achilles tendon and also provides a surgical plane along a designated length exterior to said Achilles tendon so that one or more modified suture passers allow for passage of said sutures from a ruptured end of said Achilles tendon in a proximal portion of the Achilles tendon above a zone of injury toward a knee with passing of free ends of proximal looped locking sutures in a sub-paratenonous manner, through a distal stump to a calcaneus suture bone anchor, so that eventual passage of two or more sutures and/or fiber tapes with said suture passer elevator separator of a locking stitch along a medial and lateral free edge of said tendon occurs to preserve blood flow and lubricity to and of said Achilles tendon and eliminates possibility of damage to a Sural Nerve and a saphenous vein.

3. The one or more suture passer elevator separators of claim 1, wherein said one or more suture passer elevator separators includes an apparatus with both said set of jaws are graspers and include a needle passer capable of passing said one or more sutures/fiber tapes for said one or more suture passer elevator separators located within and attached to a hollow cylindrical rod shaped shaft so that said U-shaped paddle guide of said suture passer elevator separator also acts as a fascial separator of said Paratenon and said Achilles tendon and maintains said separation prior to and during passage of said suture/fiber tape along said channel provided by said one or more fascial elevator separator(s) and paddle guide and wherein said suture passer elevator separator with said set of jaws/graspers and said needle passer are positioned such that said suture/fiber tape is passed from a superficial portion to a deep portion of and along said Achilles tendon.

4. The one or more fascial elevator separator(s) of claim 1, wherein said one or more fascial elevator separator(s) is a paratenon fascial elevator separator that utilizes a U-shaped paddle guide portion with demarcation lines along a shaft of said one or more fascial elevator separator(s) to assist with proper placement of a surgical plane that separates a Paratenon from said Achilles tendon and directs initial placement of said suture/fiber tape along a length of said Achilles tendon as a repair operation proceeds.

5. The one or more suture passer elevator separators of claim 1, wherein said suture passer elevator separator also includes demarcation lines along a length of a solid cylindrical rod shaft that directs a proper position of suture/fiber tape for said suture passer elevator separators placement during said repair operation.

6. The one or more suture passer elevator separators of claim 1, wherein said solid cylindrical rod shaft is a working shaft that is at least 30 cm in length.

7. The one or more suture passer elevator separators of claim 1, wherein said suture passer elevator separator provides an ability for said suture/fiber tape for said suture passer elevator separators to be accepted that can be completely balanced by equal tensioning of said suture/fiber tape for said suture passer elevator separators on both sides of said Achilles tendon and eliminates bunching and allows for centralization of said tendon inside jaws of said for said suture passer elevator separators during an operative process to repair said tendon.

8. The one or more suture passer elevator separators of claim 7, wherein said suture passer elevator separator provides at least 3 locking double sutures that allow equal tensioning of said double sutures for repair and stabilization of said Achilles tendon in both a medial and lateral direction on each side of said Achilles tendon and also provides for reconnection of torn portions of said Achilles tendon and wherein said double locking sutures remain subparatenonous to and away from said Sural Nerve and/or said saphenous vein.

9. The one or more suture passer elevator separators of claim 3, wherein positioning of said apparatus is in opposition to other suture passers in that said apparatus with said set of jaws that acts as graspers and said needle of said suture passer elevator separator is positioned 180 degrees in opposition to other suture passers and allows a thickness equivalent of two sutures/fiber tapes to be passed from a superficial to a deep position of said Achilles tendon.

10. The one or more suture passer elevator separators of claim 1, wherein said one or more suture passer elevator separators also have a first jaw member and a second jaw member extending from a distal end of said cylindrical hollow shaft, said first jaw member having a suture capturing aperture that is a working movable jaw whereas a channel is for a fixed jaw that allows loading of one or more sutures/fiber tapes through a channel wherein said first jaw member is moveable relative to said second jaw member with a working shaft provided by said hollow cylindrical rod along a length of said one or more suture passer elevator separators that includes a curvature that is inverted by 180 degrees from that of other commonly known suture passers and provides a fascial separator U-shaped paddle guide that is guided along an Achilles tendon and; wherein said fascial separator U-shaped paddle guide elevates and separates a Paratenon from said Achilles tendon and centralizes said Achilles tendon inside a set of jaws provided by said suture one or more suture passer elevator separators.

11. The one or more suture passer elevator separators of claim 10, further comprising a moveable handle to manipulate movement of said first jaw member and said second jaw member.

12. The one or more suture passer elevator separators of claim 10, wherein a transverse opening of a tissue penetrating member comprises a hook defining a curved surface that faces towards a distal end of said suture passer elevator separator that also functions as a suture passing device.

13. The one or more suture passer elevator separators of claim 10, wherein a needle that is utilized by said one or more suture passer elevator separators is primarily non-hollow and wherein said needle can also be hollow.

14. The one or more suture passer elevator separators of claim 10, wherein said second jaw member comprises a transverse channel for pre-loading the device with a length of two sutures and/or fiber tapes for said one or more suture passer elevator separators and wherein said distal portion of said needle comprises Nitinol.

15. The one or more suture passer elevator separators of claim 10, wherein said first jaw member comprises said suture capturing member disposed within an opening of said first jaw member for capture of a length of two sutures and/or fiber tapes for said one or more suture passer elevator separators.

16. The one or more suture passer elevator separators of claim 10, wherein a distal end of said first jaw member is angularly laterally offset by a first position and wherein a distal end of said second jaw member is angularly laterally offset by a second position, different from said first position.

17. The one or more suture passer elevator separators of claim 10, wherein an angle of offset of said first jaw member and said second jaw member relative to a longitudinal axis of said cylindrical rod is at least 45 degrees and wherein a cross section of a tissue penetrating member is substantially circular.

18. The one or more suture passer elevator separators of claim 16, wherein, in said second position, a tissue penetrating member is defined by at least one curved portion having a first radius of curvature greater than or equal to three (3) times a thickness of said tissue penetrating member.

19. The one or more suture passer elevator separators of claim 16, wherein, in said first position, a tissue penetrating member is defined by at least one curved portion having a second radius of curvature selected to be larger than a first radius of curvature.

20. A medical device kit for Achilles tendon repair comprising: one or more fascial elevator separator(s) comprising a U-shaped paddle guide portion attached to a distal portion of a cylindrical rod and a proximate handle of said cylindrical rod wherein said one or more fascial elevator separator(s) and U-shaped paddle guide portion(s) separate a membrane-like areolar structure known as a Paratenon from an Achilles tendon; one or more suture passer elevator separators that are tool(s) that maintain separation of said Paratenon from said Achilles tendon and are comprised of a hollow cylindrical rod with an axial and radial axis to which is attached a distal U-shaped paddle guide with an inverted suture grasping and firing mechanism that is not inverted when compared with other suture passers; one or more large curved suture shuttle passers; two or more suture bone anchors; a drill that accommodates various sizes of suture bone anchors; a length of sutures and/or fiber tape(s) that ensure completion of said Achilles tendon repair.

21. The medical device kit of claim 20, wherein said kit and components of said kit are utilized for repair of quadriceps and patella tendons.

22. The medical device kit of claim 20, wherein said one or more suture passer elevator separators includes a camera that is located and mounted on an outer portion of said hollow cylindrical rod in order to provide a more accurate determination of where sutures are to be utilized along either a lateral or medial length portion of said Achilles tendon to ensure direct visualization of suture placement and repair.

23. A method for repairing Achilles tendons comprising: preparing a patient for and administering anesthesia and placing said patient in a prone position on an operating room table followed by palpation of said Achilles tendon rupture for locating defects and ends of a tendon tear and/or rupture, wherein a transverse incision is made just proximal to a palpable defect through only a dermis of said patient so that this action is followed by a blunt dissection advanced through subcutaneous tissues while ensuring protection of a Sural Nerve and saphenous vein, wherein said nerve and vein lie just lateral to said Achilles tendon, so that once a paratenon is identified it is sharply incised transversely exposing torn ends of said tendon and surrounding hematoma and wherein said hematoma is evacuated and any frayed torn ends of said tendon are removed without damaging healthy tendon and wherein said proximal end of said tendon is grabbed with at least one Kochers-clamp forceps so that applying tension allows for control of said tendon and so that a paddle guide is passed along both a medial and lateral edge of said Achilles tendon thereby creating a soft tissue surgical plane to stage a suture passer utilizing suture/fiber tape to be passed subparatenonously thereby also preserving vascularity and tendon gliding properties of said Achilles tendon, wherein said suture passer also includes a paddle guide portion that is placed into said surgical plane so that said curved shaped paddle guide portion and an inverted suture grasping and firing mechanism which is a portion of a suture passer elevator separator and guides a side of said ruptured tendon into opened jaws of said suture passer allowing proper placement of at least three locking loop stitches wherein a suture passer needle is loaded with sutures and/or fiber tapes and said paddle guide portion of said suture passer is passed up one side of said tendon to an appropriate depth and wherein said at least three locking loop stitches are then passed equally along each side of said tendon with said fiber tape and/or suture so that with said fiber tape is properly placed, applying tension to a proximal segment of said tendon for at least 5 minutes occurs, bringing said Achilles tendon out to its original length and ensuring equal and balanced tensioning on both sides of said tendon, and; wherein attention is next directed to both sides of a heel bone just proximal to insertion of said Achilles tendon, wherein two vertical incisions are made on each side of said tendon allowing for dissection to be performed taken down to a bone portion of said heel bone and wherein a calcaneus is then drilled to an appropriate depth depending on size of said suture anchor chosen and a large-curved suture shuttle passer is then placed from a heel incision through a distal tendon stump and into a transverse surgical site so that said curved suture shuttle passer is used to pull one or more proximal suture tapes through a distal Achilles tendon to each of said surgical incision sites on each side of said heel bone wherein an appropriate sized bone suture anchor is loaded with ends of sutures and/or fiber tapes and fixed to said calcaneus so that final surgical repair allows tensioned bringing torn ends of said tendon together wherein said bone suture anchor is locked into place securing sutures and/or fiber tapes into said calcaneus without use of a knot and said paratenon is then sutured back together maintaining its vascularity for tendon healing and proper tendon gliding.

24. The method for repairing Achilles tendons of claim 23, wherein subcutaneous and dermal sutures are placed according to one or more surgeons' preferences.

25. The method for repairing Achilles tendons of claim 23, wherein said patient's wound is dressed and a posterior splint or cast is applied with an ankle in equines and wherein said sutures and/or fiber tapes may be biodegradable so that said sutures and/or fiber tapes need not be removed post Achilles repair and wherein bone marrow aspirate and/or use of PRP (platelet rich plasma) that provides progenitor stem cells from a patient undergoing said method wherein said platelets and/or cells are soaked into a patch prior to wrapping said patch around a rupture site of said tendon thereby providing a bioavailable and biocompatible collagen matrix that accelerates full recovery of said Achilles tendon.

26. The method for repairing Achilles tendons of claim 23, wherein said appropriate depth of said suture passer needle loaded with sutures and/or fiber tape is in a range of 70 to 80 centimeters.

27. The method for repairing Achilles tendons of claim 23, wherein said appropriate depth of drilling said calcaneus is 15 to 25 millimeters and is dependent on a size of said bone suture anchor chosen.

28. The method for repairing Achilles tendons of claim 23, further comprising passing said suture passer elevator separator with said suture and/or fiber tape through an open incision.

29. The method for repairing tendons of claim 23, further comprising preloading said suture passer elevator separator with one or more sutures and/or fiber tapes so that a thickness of said sutures and/or fiber tapes is twice that an original thickness of said sutures and/or fiber tapes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:

[0052] FIG. 1A illustrates a side view of an exemplary angled suture passer of this disclosure with the jaws in a closed position;

[0053] FIG. 1B illustrates the suture passer of FIG. 1A with the jaws grasping tissue and the needle extending through the tissue;

[0054] FIG. 2A illustrates a top view of the suture passer of FIG. 1B with the tissue removed;

[0055] FIG. 2B illustrates the underside of a suture passer with the jaws in an open position and the needle in a retracted configuration;

[0056] FIG. 3 illustrates a elevator fascial separator with paddle guide for Paratenon sheath separation and elevation;

[0057] FIG. 4A illustrates a suture passer elevator separator equipped with a paddle guide that provides a paratenon/deep fascia elevator;

[0058] FIG. 4B illustrates the suture passer elevator separator with paddle guide positioned on a lateral border along the Achilles tendon;

[0059] FIG. 5 illustrates a completed Achilles tendon repair, in accordance with the present disclosure.

[0060] FIG. 6 is illustrative of an example of a suture shuttle passer as described herein and known in the art.

DETAILED DESCRIPTION

[0061] In the description that follows, common components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale, and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.

[0062] As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “substantially” are used represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. “Comprise,” “include,” and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. “And/or” is open-ended and includes one or more of the listed parts and combinations of the listed parts.

[0063] Referring now to FIG. 1A, there is shown a side view of a suture passer elevator separator [100], wherein a first plane is defined as parallel to the longitudinal axis A and parallel to the view shown such that the direction B is perpendicular to the first plane. A second plane is also defined and relied upon (later in this discussion) that is also parallel to the longitudinal axis, and perpendicular to the first plane, and best shown in FIG. 2A. The suture passer elevator separator [100] has an elongate shaft [120] extending from a handle (not shown). The working shaft has a length of 30 to 35 cm with depth markings along the shaft for precise suture [125] placement along edges of the tendon. The increased length allows the hand mechanism to be extended beyond the heel portion during the procedure. A lumen [110] extends through the shaft [120]. A distal end of the shaft [120] may curve downward to terminate in a distally-extending upper jaw [140]. Alternatively, upper jaw [140] may be a separate element (not shown), coupled to and extending distally from a distal end of the shaft [120], and may be coupled so as to be fixedly attached to the stationary jaws. Upper fixed jaw [140] may define an upward curve at the proximal end so as to define an opening or gap [190] at the proximal end of the jaw between the two facing surfaces of the upper fixed and lower working jaw ([140] and [160] respectively). This provides clearance for tissue disposed therein to be grasped. Upper fixed jaw [140] may comprise an elongate body with an elongate channel [145] disposed therein, and as shown in FIG. 1A, the jaw defines a first curve along the first plane, curving initially away from longitudinal axis at the proximal end, curving back towards and across the longitudinal axis at the tip or distal end [130]. This first curve along the first plane aids to keep the distal tips of the two jaws [140, 160] closer together and also aids in reducing stresses by allowing some curvature on a needle [180] retained within the elongate channel (shown in dotted lines on FIG. 1A) and described in more detail below. This first curve also aids in directing the needle [180] as it extends towards the lower working jaw [160]. A substantially linear lower working jaw [160] is attached to the shaft [120] such that the lower working jaw [160] and the upper fixed jaw [140] may be biased in the closed position, as shown. In working examples, the lower working jaw [160] may pivot about a longitudinal axis (A) relative to the shaft [120] (as shown) or, alternatively, the connection between the upper fixed jaw [140] and the lower working jaw [160] may be a reciprocating or cam system wherein the lower working jaw [160] is movable relative to the upper fixed jaw [140]. A length of the lower jaw [160] is selected such that it extends distally beyond the upper jaw [140]. In examples, the diameter of the suture passer [100] is at least 4-8 mm in diameter or is otherwise selected to allow for the internal working mechanism to operate. The upper fixed jaw [140] also includes a transverse channel [115] (best seen in FIGS. 1B and 2B) for initial retention of at least two lengths of two sutures [125] therethrough in preparation for stitching the sutures/fiber tapes [125] simultaneously through soft tissue and subsequently capturing the sutures [125].

[0064] A tissue receiving area [190] is defined between the upper fixed jaw [140], the lower working jaw [160], and the distal end of the shaft [120]. Jaws are shaped such that the tissue receiving area [190] is larger towards the proximal end of the jaws as a relief for tissue disposed therein, while still maintaining a smaller distance between the two jaws towards the distal ends of jaws, adjacent the channel [115] to aid in a reliable suture capture during operation. Here, a width of the distal end [150] of the lower working jaw [160] is selected to be larger than a width of the distal end [130] of the upper fixed jaw [140], such that the upper fixed jaw [140] is housed within opposing upwardly extending protrusions or teeth [170] of the lower working jaw [160] when the suture passer [100] is in the closed position. The location of the teeth helps to enclose and control the tissue within the jaws, while not overly compressing the tissue that the needle [180] has to penetrate through, making the action of the needle [180] more reliable for guiding and stabilizing. Notably, in the closed position, the teeth [170] do not block the channel [115] in the upper fixed jaw [140] so that the suture passer [100] can be passed effectively through a surgical incision when in the closed position. Teeth [170] are distally spaced from the channel [115].

[0065] In various examples, not shown, the handle is an in-line type handle. The handle may include an opening for accommodating a user's fingers and is shown in FIGS. 4A and 4B. In alternative examples, the handle does not include such an opening, and the user's fingers simply fit around the handle. The handle may also include one or more actuators to open/close the lower working jaw [160] relative to the upper fixed jaw [140] and/or to extend/retract the needle [180]. For example, the actuator(s) may be in the form of a thumb activated slider which may be moved distally toward from the handle to activate the suture passer [100]. The needle passes from the fixed upper jaw (140) to the lower working jaw (160). The actuator may be biased by suitable means, such as a spring, to default to a closed/retracted position when an application force is removed, for example, when a user removes pressure from a finger or thumb. Here the needle [180] could be shifted between positions to grab two sutures to be passed simultaneously through the Achilles tendon. The preference is to use two portions of a single 2 mm fibertape suture [125] simultaneously, allowing for the sutures [125] to be applied in a loop locking stitch to the border of the tendon through a single entrance into the surgical incision site. Fibertape sutures are a wider suture construct than the #2 standard round suture and reduce tissue cut-through when surgically repairing poor quality torn Achilles tendon tissues.

[0066] Turning now to FIG. 1B, it can be seen that a curved needle [180] for passing the sutures [125] through soft tissue [122], such as Achilles tendon tissue, is configured to be axially movable within and extendable from the lumen [110] of the shaft [120] and a needle [180] in the upper fixed jaw [140], such that the needle tip [126] may be moved from a retracted position, wherein the needle [180] is withdrawn or shielded from the tissue receiving area [190], to an extended position, wherein the needle [180] is displaced through an opening in the lower working jaw [160] and through the soft tissue [122]. The needle [180] may be housed along a portion of the upper jaw [140] in the first position with the needle tip adjacent to and slightly retracted from the transverse channel [115]. The upper fixed jaw [140] may comprise a channel [145] shown in FIG. 1A—along its length for housing and sheltering the needle [180] in the first position, the channel having a distal ramp [141] (FIG. 2B) adjacent the transverse channel [115] of the upper fixed jaw [140] so as to direct the needle [180] towards the transverse channel [115] to reliably pick up the lengths of sutures [125] disposed within the transverse channel [115]. Since the needle [180] is curved in its unstressed configuration (described later), which defines the needle trajectory as it extends out of the channel [145], the ramp [141] is not considered a means for significantly altering the extended trajectory of the needle, merely a local control surface to aid in reliable suture capture near channel [115]. As the needle extends and is released to its resting state, the needle is shown in FIG. 1B to curve approximately perpendicular to the longitudinal axis A and potentially even in a proximal direction. It follows therefore that a ramp [141] may not be necessary and no ramp or an open distal end [130] of the upper jaw [140] may suffice. Counter to this, should the needle [180] be produced without a preformed curve as disclosed, a ramp [141] or bumper may be required to induce a needle trajectory, which would predominantly extend linearly from the ramp [141] and not continue to curve approximately perpendicular to the longitudinal axis A and potentially in a slight proximal direction as shown in FIG. 1B. As shown in FIG. 1B, the needle tip [126] is more proximally disposed relative to the suture channel [115]. This curved trajectory keeps the needle tip [126] close to the lower working jaw [160] rather than extending away from it, which helps to reduce injury that the needle tip [126] may cause to the tissue as it moves through and away from the lower working jaw [160]. A housing may be used which has a covered portion [142] to better grasp tissue and protect the needle [180]. Housing [140] may be curved, along the first plane discussed earlier relative to FIG. 1A to better guide the needle [180] and improve engagement reliability with a suture capture aperture of lower working jaw [160]. A covered portion [142] may help retain the preformed needle [180] within the housing.

[0067] Further at least a distal portion of the needle [180] is comprised of a super-elastic material, such as nitinol, and has a generally circular cross-section. A circular cross section provides some added lateral stiffness and helps the needle [180] retain its path as it extends through the tissue and lower working jaw [160]. The needle itself [180] may be substantially hollow or substantially non-hollow. The needle [180] may be tapered and may have a length of smaller diameter or non-circular cross section adjacent the distal tip of the needle and a length of larger diameter proximally extending therefrom. This may allow for easier insertion though the suture capture aperture [134], described below. The super-elastic nature of the material allows the needle [180] to be disposed in a generally linear configuration relative to its preformed shape while placed in the retracted position so as to be readily conformed to the housing within the upper fixed jaw [140], and then returns to a form closer to the preformed, curved configuration during the displacement of the needle [180] from the retracted to the extended position.

[0068] In the fully extended position of the needle [180], the sutures or fiber tapes [120] that have been drawn through the tissue [122] forms a suture/tape portion [121] which protrudes from and is disposed above the lower working jaw [160]. In our example, the suture/tape portion [121] may form a looped configuration.

[0069] Still referring to FIG. 1B, the lower working jaw [160] may be actuated by the handle to move to a closed position to enable the suture passer [100] to immobilize and stabilize the tissue [122] between the lower working jaw [160] and the upper fixed jaw [140]. With the tissue [122] grasped between the lower working jaw [160] and the upper fixed jaw [140], the needle [180] may be deployed by actuation of the needle deployment member or trigger in the handle to the extended position. The needle [180] is advanced axially toward the distal end of the suture passer [100] such that a transverse opening [124] of the needle [180], which may be in the form of a distally facing hook. As the needle [180] is advanced in a generally distal direction through the Achilles tendon passing the suture back toward its resting state followed by retraction. The protrusions or teeth [170] assist in retaining the tissue [122] within the tissue receiving area [190] as the needle [180] advances through the soft tissue [122]. In order to aid in maintaining a reliable needle [180] and thereby suture trajectory though the tissue, the needle cross section is preferably a circular cross section, and the target tissue is kept stabilized within the grasping mechanism so that the needle is easily passed through the tissue.

[0070] FIG. 2A illustrates the suture passer elevator separator [100] of FIG. 1B in a bottom surface view. The suture capture member [134] may be in the form of a removable cartridge or may be an integrated structural component of the lower working jaw [160]. A further detailed description and examples of suture capture members can be found in U.S. Pat. No. 9,211,118, the complete disclosure of which is incorporated herein by reference. In examples, the suture capture aperture [134] is comprised of high-temper, spring steel material and capable of capturing 2 sutures/tapes through the opening.

[0071] In one embodiment, the angulated grasping jaws, lower working jaw [160] and upper fixed jaw [140], are laterally angled or curve away from the longitudinal axis (A) of the shaft [120] along the second plane. As viewed from above, the lower working jaw [160] and the upper fixed jaw [140] may be angled either to the left (as shown) or to the right, from 45 up to 90 degrees from the longitudinal axis (A) of the shaft [120]. For other devices that target alternative areas of the patient, larger or smaller angles and offsets are envisioned, and generally speaking, this angle and lateral offset may be any non-zero value that improves target tissue access through a curved space, given the procedure and patient anatomy. In alternative embodiments (not shown) each jaw may have a slightly different angled offset from each other, so as to be staggered and potentially adjust for an altered path of the needle [180] as it extends through the tissue [122]. Needle [180] may continue along a reliable trajectory along the longitudinal axis; however, it may be laterally offset relative to a suture capture aperture [128].

[0072] Returning now to FIGS. 1A-2A, in operation, the user (e.g., surgeon) may insert the suture passer elevator separator [100] mechanism through a minimally invasive incision. Generally, the suture passer elevator separator [100] mechanism is preloaded with sutures [125] (FIG. 1A). The suture [125] may be a grabbed by a suture passer elevator separator mechanism (as shown in more detail in FIGS. 2A and 2B) with a suture [125] attached, or it may be a suture [125] or a fiber tape that has already been positioned within the upper fixed jaw [140]. Once the suture passer elevator separator [100] is near the tissue [122] to be sutured/taped, the suture passer elevator separator [100] is actuated so that the tissue [122] may be positioned between the upper fixed jaw [140] and the lower working jaw [160]. This target tissue [122] is grasped at a location offset from the working axis of the suture passer elevator separator [100], the distal end of the suture passer, having a curved or angled portion so as to better access this target tissue [122]. Once the target tissue [122] is stabilized the needle [180] should then be actuated to pass the suture through the stabilized tendon. With the needle tip [126] and the sutures [125] drawn through soft tissue [122], the actuation of the needle [180] continues until the needle [180] advances into and through the opening [136] in the lower working jaw [160] (FIG. 2A). Concurrently, the needle [180] and the sutures [125] are also directed through the aperture [128] of the suture capture member [134].

[0073] In summary a major difference between a current conventional suture passer and that designed and created by necessity to perform the minimally invasive Achilles repair operation herein described is that the present disclosure describes a suture passer that provides an inverted position of the mechanism used to allow for the necessary operation of the entire instrument. In accomplishing this task, the suture passer mechanism of the suture passer elevator separator has an angular capacity to pass sutures at an angle of from 45 up to 90 degrees from the longitudinal axis (A). Using this unconventional modified suture passer elevator separator together with the described and shown in FIGS. 3, 4A and 4B below, it is possible to provide an operation that avoids essentially all the pitfalls of any previously known methods to repair the Achilles and other ruptured/torn tendons.

[0074] FIG. 3 is a schematic representation of a fascial elevator separator and paddle guide [300] for a paratenon separation from the Achilles tendon thereby preserving vascularity and mobility of the tendon to minimize potential damage during operative repair for minimally invasive Achilles tendon repair. The fascial elevator separator and paddle guide [300] is a specially designed Paratenon fascial elevator to separate and isolate the Achilles tendon in order to create a surgical plane/pathway/channel for the suture passer elevator separator [100], thereby protecting the Paratenon and surrounding tissue from injury. The Paratenon is a highly vascularized tissue, having visceral and parietal layers but no true tendon sheath. The paratenon produces a lubricating fluid which allows for the tendon to glide, thus preventing friction. The paddle guide [200] allows the paratenon to maintain vascularity to the tendon for healing and maintenance of motion during and post operation. Although the Achilles tendon does not have a true tendon sheath, the paddle guide [200] can be also used on tendons having a sheath, such as the quadriceps tendon and patella tendon.

[0075] FIG. 4A provides a suture passer elevator tool [400] equipped with both the ability to provide for maintaining separation of the paratenon from the Achilles tendon via an elevator equipped with a paddle guide [405] and passing sutures during the repair operation. This suture passer elevator tool [400] includes a paddle like portion that includes a fascial separator (paddle) guide along the length of the shaft placed appropriately [405] as shown. The fascial separator guide portion [405] guides the free edge of the Achilles tendon into the awaiting open jaws of the suture passer portion for proper suture [125] placement along the border of the tendon both medially and laterally. For all of the description above and within this disclosure, the suture passer elevator tool [400] must be placed directly behind the paratenon fascial separator to ensure that the surrounding paratenon tissue is either minimally damaged or left completely undamaged. The position of the suture passer elevator tool [400] on the medial [410] and lateral [420] borders of the Achilles tendon [440] is best shown as provided in FIG. 4B. Here the placement of the fascial separator (paddle) guide [405] portion together with the suture passer portion [415] on the tendon is more clearly shown. The suture passer with elevator tool [400] is shown used along the medial border [410] of the Achilles tendon [440}. Either the same tool which can be rotated to the lateral border [420] or a separate tool can be used to accomplish the same function along the lateral border [420] as is shown along the medial border [410].

[0076] FIG. 5 illustrates a completed channel-assisted minimally invasive Achilles tendon repair [400] having loop locking stitches [425] provided by fibertape(s) as a construct along the medial border [410] and lateral border [420] of the Achilles tendon [440]. The repair is completed using a pair of three (3) to five (5) Loop Locking Stitches per Girth Hitch above the zone of injury [430] for even and balanced tensioning of the tendon during the tendon repair. A larger, curved modified suture passer (shown as 100) design is necessary to allow for the sutures/fiber tapes to be passed through the distal stump of the Achilles tendon to be eventually secured to the calcaneus [450] (heel bone). In this manner, which has also never before been accomplished for an Achilles tendon repair operation, it is possible to provide intra-tendinous sutures [435] through the end of the tendon tear thereby securing the sutures using a knotless suture-anchor technique [460]. This keeps the fibertape(s) mainly within the Achilles tendon [440] avoiding any adhesions and any possible risk of infection. The use of the Suture-Anchor technique has shown a 116% lower displacement and a 45% greater load to failure versus Suture-Only repair, while leaving no palpable tied knots at the incision site. Suture-Anchor augmented repairs performed on Achilles tendon ruptures with a short distal stump are bio-mechanically stronger than Suture-Only repairs as earlier published (Boin, M., et al., The Orthopedic Journal of Sports Medicine, January 2017).

[0077] As the needle [180] is passed during repair from the superficial fixed upper jaw [140] to the deeper working lower jaw [160] as a result of using the three tools developed for this operation and another critical feature of this disclosure, it has become possible to completely avoid medial injury to the Sural Nerve, Saphenous Vein, and Posterior Tibial Nerve. The completed procedure is achieved through a 3 cm transverse incision and results in no proximal bunching of the tendon, and greater suture fixation and tensioning of repair.

[0078] FIG. 6 illustrates an example of a conventional and commercially available suture shuttle passer (600) that is utilized to complete the non-invasive tendon surgical repair as described above. This conventional suture shuttle passer (600) can be supplied in a kit with the other two (2) tools; [0079] (i) the fascial elevator separator and [0080] (ii) the suture passer elevator separator or separately; [0081] depending on the needs of the surgeon or an offering by those manufacturing the devices. [0082] The suture shuttle passer (600) as shown and deviations thereof is available and known to those of skill in the art.

[0083] While this disclosure has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present application as defined by the appended claims. Such variations are intended to be covered by the scope of this present application. As such, the foregoing description of examples of the present application is not intended to be limiting, the full scope rather being conveyed by the appended claims.