Suture tensioning devices, systems and methods

Abstract

Embodiments relate to a suture tensioning device for tensioning a suture operably engaged at a soft tissue repair site. In some examples, the suture tensioning device includes a housing having a wide proximal receiving end and a narrow distal end configured to snugly receive a finger, and a suture tensioning mechanism configured to fixedly receive one or more suture portions of corresponding suture ends of a suture extending from a tissue reporting site within the body distal end to an exterior of the body distal end and terminating in the suture tensioning mechanism. The device can further include a suture coupling element for fixedly coupling the one or more suture portions to a tension adjustment mechanism and an adjustment device configured to controllably adapt the tension of the suture.

Description

Detailed Description of the Invention

[0001] (background) Severed or ruptured tendons, as well as other soft tissues including ligaments, tendons, and sometimes bone fragments connected to them, can cause significant pain and, in some cases, loss of movement, leading to disability. Techniques for repairing severed tendons include suturing the ends of the severed tendon together.

[0002] One of the most widely established suturing techniques is the Kessler repair, or its modifications, in which opposing cut ends of a tendon or ligament are sutured together in a specific configuration.

[0003] BRIEF DESCRIPTION OF THE DRAWINGS The figures illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0004] For simplicity and clarity of illustration, elements shown in the figures are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity of presentation. Furthermore, reference numerals may be repeated among the figures to indicate corresponding or similar elements. Reference to previously presented elements is implied without necessarily further citation to the figure or description in which they appear. The number of elements shown in the figures should not be construed as limiting in any way and is for illustrative purposes only. The figures are listed below.

[0005] 1A-1E show various perspective views of an upper suture tensioning device according to some embodiments.

[0006] 2A-2C show various perspective views of an upper suture tensioning device operably engaging a finger, according to some embodiments.

[0007] 3A-3D show various perspective views of a lower suture tensioning device according to some embodiments.

[0008] FIG. 4 illustrates a lower suture tensioning device that is operably engaged with a finger, according to some embodiments.

[0009] (Detailed explanation) Possible postoperative complications associated with suturing together the ends of a severed tendon include incomplete or poor healing of the injury due to insufficient connection of the two tendon ends, gaping at the repair site, local edema, and peritendon adhesions, all of which can result in physical disabilities such as reduced hand movement and lack of grip strength, as well as decreased strength and ability in other parts of the body.

[0010] The healing process of tendons, ligaments, and soft tissues is achieved through a biological response in which cells at the injury site attempt to repair the damaged tissue by creating a tissue matrix. Approximation of the damaged tissue is key to proper healing, and force transmission and tissue stretching facilitate these processes. Furthermore, accurate and optimal placement of sutures, along with optimal alignment and contact of the injured tendon or ligament ends, are key to timely and optimal healing.

[0011] Because decreased mobility and / or grip strength may not necessarily be directly related to decreased suture tension, but may be related to, for example, local edema and / or peritendon adhesions, repeated tension measurements can provide an indication of whether decreased mobility and / or grip strength is due to decreased suture tension.

[0012] Embodiments relate to a suture tensioning device configured to post-operatively measure the amount of tension applied to sutures attached to a soft tissue repair site, such as a tendon, during patient rehabilitation to objectively assess the success of the repair procedure and detect post-operative complications.

[0013] Embodiments of the suture tensioning device are configured to allow for feedback-based suture tensioning, for example, allowing for incremental tensioning of the suture to promote internal healing (also referred to as intrinsic healing) of the tendon and slow down external healing, resulting in reduced external scarring.

[0014] In some examples, a suture tensioning device may be employed to determine whether re-tensioning of the suture filament is necessary. The suture filament tensioning device may be configured to allow re-tensioning of the suture filament under a selected imaging modality (e.g., ultrasound imaging) while providing tension feedback. In this manner, gap reduction can be correlated with the tension that needs to be applied to reach a desired gap reduction.

[0015] According to some embodiments, a suture tensioning device may include a housing in the form of a hollow socket having, for example, a wide proximal receiving end for receiving a body part and a narrow distal end. The housing may be configured to receive a body part, which may be a body end, such as a portion of a toe, having a major longitudinal axis. The housing may be at least partially adaptable around or configured for mating engagement with the body end. The body end may be that of a mammal, such as a human.

[0016] In some examples, the socket may be a partially open socket having an arcuate open cross-section. The narrow distal end of the socket may be configured to conformably restrain axial movement of the body end in a distal direction. In some examples, the narrow distal end may be a closed end in the shape of a cap, for example, having a generally circular or arcuate cross-section.

[0017] In the context of the present disclosure, without limitation, the term "distal" refers to the end of the device that is located further away from the soft tissue repair site, and the term "proximal" refers to the end of the device that is located closer to the soft tissue repair site, for example, during normal use of the suture tensioning device.

[0018] The suture tensioning device can further include a suture tensioning mechanism. The suture tensioning mechanism can be configured to fixedly receive at least one distal end of the suture. The suture can extend from a soft tissue repair site (e.g., a tendon repair site) within the patient's body, exit the patient's body end, e.g., via a distal tip, or at any site at the body end (e.g., the distal tip of the patient's toe) where sufficient soft tissue exists to surround the exteriorized suture filament, and terminate outside the patient's body at the suture tensioning mechanism.

[0019] In some embodiments, the suture tensioning device can include a suture coupling element (e.g., a suture snare, a through-hole) for fixedly coupling a distal portion of the suture filament to the tensioning mechanism. In some instances, the suture coupling element can be part of the suture tensioning mechanism.

[0020] The suture tensioning mechanism can further include an adjustment device that allows for controllably tensioning the suture filament by applying tension in a distal direction relative to the soft tissue repair site. The adjustment device can include an actuator, such as a wheel, knob, or slider, operably engaged by a user of the suture tensioning device that allows for selectively increasing or decreasing the tension applied to the suture. The user can be a medical professional or a patient.

[0021] In some embodiments, the adjustment device can be configured to selectively allow incremental, stepwise increases or decreases in the applied tension. For example, the adjustment device can include an actuator having a serrated surface formed by a plurality of adjacent teeth and a flexible tab configured to protrude into a detent between every two adjacent teeth. The flexible tab tends to restore a nominal positional relationship to the teeth and is configured to be resiliently deflectable in at least one direction in response to movement of the teeth relative to the tab.

[0022] In some embodiments, the actuator of the adjustment device may be configured as a gear, while in other embodiments, the actuator of the adjustment device may be configured as a rack.

[0023] In some embodiments, the adjustment device can be configured as a ratchet configured to increase suture tension by default, preventing undesired decreases in suture tension. For example, the actuator can include a geared wheel and a biased pawl configured to engage the teeth of the gear. The wheel and pawl are configured such that the wheel can rotate only in a first direction to apply tension to the suture.

[0024] The suture tensioning mechanism can include a tension meter operably coupled to the suture and / or the adjustment device. The tension meter can be implemented electronically and / or mechanically. For example, the tension meter can include a mechanical energy storage device configured to measure the tension in the suture. The tension meter can provide an output indicative of a measurement of the tension experienced by the suture.

[0025] The soft tissue repair site may be characterized based on the measured or sensed suture tension applied to the suture.

[0026] In some embodiments, the suture tension adjustment device can include a communications module configured to output (e.g., transmit via wired or wireless means) a signal encoding data related to the sensed suture tension to one or more computerized platforms. The computerized platforms can include multi-function mobile communications devices, also known as "smartphones," personal computers, laptop computers, tablet computers, servers (which may be associated with one or more servers or storage systems and / or services related to a business or enterprise, including, for example, file hosting services, cloud storage services, online file storage providers, peer-to-peer file storage or hosting services, and / or cyberlockers), personal digital assistants, workstations, wearable devices, handheld computers, and / or notebook computers.

[0027] In some embodiments, the device and / or system may be configured to limit the tension that the suture can be subjected to so that the suture is not subjected to excessive tension to avoid applying excessive force to the tissue repair site.

[0028] In some embodiments, the device and / or system may be configured to record or record the tension experienced by the suture, along with a timestamp, and optionally, along with clinical information related to grip force, motion span, and / or the like.

[0029] This can be accomplished both through professional guidance and determining the desired time, repetition rate, number of repetitions, their method, and their timing. The device and / or system may enable targeting of desired values ​​during correct rehabilitation and subsequently ensuring patient compliance with the desired rehabilitation protocol—when performed with or without supervision. In some examples, the system may include outputs (e.g., one or more visual and / or audio outputs) to provide the user with indications regarding rehabilitation progress and / or compliance.

[0030] Those skilled in the art know that as tendon or tissue healing progresses, the forces acting on the suture itself may decrease. Data from various cases will be collected and used to evaluate changes and differences in repair strength within individuals, between individuals, and between toes. These findings can then be interpreted to develop and differentiate rehabilitation protocols tailored to specific patients. For example, accelerated rehabilitation for young, non-smoking professional athletes may be recommended, while slower rehabilitation may be discontinued for older, unhealthy smokers.

[0031] Although embodiments of the device are disclosed with respect to operative engagement with a finger, this should not be construed as limiting in any way. Accordingly, embodiments of the device may also be operatively engageable with the Achilles tendon, patellar tendon, and / or other soft tissue, including ligaments and / or tendons, and potentially bone fragments connected thereto, which can cause significant pain and, in some cases, loss of movement and disability.

[0032] 1A-1E and 2A-2C. In some embodiments, upper suture tensioning device 1000 may include upper housing 1100 in the form of a hollow socket having, for example, a wide proximal receiving end and a narrow distal end for the body part. Upper housing 1100 may be configured to receive a body part, which may be a body end, such as a portion of toe 500 having a longitudinal axis Z.

[0033] In some examples, the upper housing 1100 can be a partially open socket having an arcuate open cross-section. The narrow distal end of the socket can be configured to form-fittingly constrain axial movement of the body end in the distal direction. In some examples, the narrow distal end can be a closed end in the shape of a cap, for example, having a generally circular or arcuate cross-section.

[0034] Upper suture tensioning device 1000 may further include upper suture tensioning mechanism 1200. Upper suture tensioning mechanism 1200 may be configured to fixedly receive at least one distal end of suture 600. Suture 600 may extend from a soft tissue repair site (e.g., a tendon repair site) within a patient's body, exit the patient's body end through a distal tip of the body end (e.g., a distal tip of a patient's finger), and terminate at upper suture tensioning mechanism 1200 outside the patient's body.

[0035] In some embodiments, the upper suture tensioning mechanism 1200 may include a suture coupling element 1300 for fixedly coupling a distal portion of the suture to the tensioning mechanism.

[0036] The upper suture tensioning mechanism 1200 can further include an adjustment device 1400 that allows the suture to be controllably tensioned by applying a tensioning force distally to the soft tissue repair site.

[0037] The adjustment device 1400 can include at least one actuator 1410, such as a wheel, knob, or slider, operably engageable by a user of the suture tensioning device 1000, and a resiliently deflectable tab 1420 operably engaging the actuator 1410 to allow the tension applied to the suture to be selectively, e.g., incrementally, increased or decreased. In some examples, the adjustment device 1400 can include multiple actuators configured such that each wheel can be rotated independently of the other wheels to selectively tension different ends of the suture.

[0038] In the following discussion, without being limiting, it is shown that the actuators are implemented as wheels.

[0039] In some embodiments, the actuator 1410 may include a geared wheel and a deflectable tab 1420 configured to engage each detent formed by two adjacent teeth of the gear. In some examples, the wheel and pawl are configured such that the actuator 1410 may be rotatable only in a first direction to provide tension on the suture, thereby implementing a ratchet configuration.

[0040] In some embodiments, the suture coupling element 1300 may be implemented as a through-hole extending through the wheel 1400 .

[0041] In some embodiments, the adjustment device 1400 can be configured as a ratchet configured to increase suture tension by default, preventing undesired decreases in suture tension. For example, the actuator can include a geared wheel and a deflectable tab configured to engage the teeth of the gear. The wheel and pawl are configured such that the wheel can rotate only in a first direction to tension the suture.

[0042] 3A-3D and 4. In some embodiments, the lower suture tensioning device 2000 can include a lower housing 2100 in the form of a hollow socket having, for example, a wide proximal receiving end for a body part and a narrow distal end. The lower housing 2100 can be configured to receive a body part that can be a body end, such as a portion of a toe 500 having a longitudinal axis Z.

[0043] In some examples, the lower housing 2100 can be a partially open socket having an arcuate open cross-section. The narrow distal end of the socket can be configured to form-fittingly constrain axial movement of the body end in the distal direction. In some examples, the narrow distal end can be a closed end in the shape of a cap, for example, having a generally circular or arcuate cross-section.

[0044] The lower suture tensioning device 2000 may further include a lower suture tensioning mechanism 2200. The lower suture tensioning mechanism 2200 may be configured to fixedly receive a distal end of at least one suture 600. The suture 600 may extend from a soft tissue repair site (e.g., a tendon repair site) within the patient's body, exit the patient's body end through a distal tip of the body end (e.g., a distal tip of the patient's finger), and terminate at the lower suture tensioning mechanism 2200 outside the patient's body.

[0045] In some embodiments, the lower suture tensioning mechanism 2200 may include a suture coupling element 2300 (eg, a through-hole, a suture snare) for fixedly coupling a distal portion of the suture to the tensioning mechanism.

[0046] The lower suture tensioning mechanism 2200 can further include an adjustment device 2400 that allows the suture to be controllably tensioned by applying a tensioning force distally to the soft tissue repair site.

[0047] In some embodiments, the adjustment device 2400 can include an actuator 2410, such as a wheel, knob, or slider, and a resiliently deflectable tab 2420 that operably engages the actuator 1410 so as to selectively, e.g., incrementally, increase or decrease the tension applied to the suture.

[0048] In some embodiments, the suture coupling element 1300 may be implemented as a through-hole extending through the wheel 1400 .

[0049] (Other Examples) Example 1 relates to a suture tensioning device for tensioning a suture operably engaged at a soft tissue repair site, the suture tensioning device comprising:

[0050] A housing having a wide proximal receiving end and a narrow distal end, the housing configured to snugly receive a finger.

[0051] A suture tensioning mechanism configured to fixedly receive one or more suture portions of corresponding suture ends of a suture extending from a tissue reporting site within the body end to the body and terminating in the suture tensioning mechanism.

[0052] a suture coupling element for fixedly coupling the one or more suture portions to the tensioning mechanism;

[0053] An adjustment device configured to controllably adapt the tension on the suture.

[0054] Example 2 includes the subject matter of Example 1, and optionally, the adjustment device comprises an actuator operably engageable by a user of the suture tensioning device to selectively increase or decrease the tension applied to the suture.

[0055] Example 3 includes the subject matter of any one or more of Examples 1-2, optionally, the adjustment device is configured as a ratchet for tensioning the suture to prevent undesired reduction in suture tension.

[0056] Example 4 includes the subject matter of any one or more of examples 2-3, optionally, wherein the tensioning mechanism includes:

[0057] Wheel with gears.

[0058] A biased pawl configured to mesh with the teeth of a gear.

[0059] The wheels and pawls are configured so that the wheels can only rotate in one direction by default.

[0060] Example 5 includes the subject matter of any one or more of Examples 1-4, and optionally a tension meter operably coupled to the suture and / or the adjustment device to provide an output indicative of tension applied to the suture.

[0061] Example 6 includes the subject matter of Example 5 and, optionally, a communications module configured to output signals encoding data regarding suture tension sensed by the tensiometer to one or more computerized platforms.

[0062] Example 7 includes a suture tensioning device according to any one or more of the preceding claims, comprising a belt or strap externally connectable to a body part of a patient and to which a suture filament emanating from a suture site may be connected, the suture tensioning device further comprising:

[0063] A suture tensioning mechanism configured to fixedly receive one or more suture portions of corresponding suture ends of a suture extending from a tissue reporting site within the body end to an exterior of the body end and terminating in the suture tensioning mechanism.

[0064] a suture coupling element for fixedly coupling the one or more suture portions to the tensioning mechanism;

[0065] An adjustment device configured to controllably adapt the tension on the suture.

[0066] Example 8 includes the subject matter of example 7, optionally comprising an actuator operably engageable by a user of the suture tensioning device to enable selectively increasing or decreasing tension applied to the suture.

[0067] Example 9 includes the subject matter of Examples 7-8 or more, optionally, the adjustment device is configured as a ratchet for tensioning the suture to prevent undesired reduction in tensioning of the suture.

[0068] Example 10 includes the suture tensioning device subject matter of any one or more of Examples 7-9, optionally, wherein the tensioning mechanism includes:

[0069] Wheel with gears.

[0070] A biased pawl configured to mesh with the teeth of a gear.

[0071] The wheels and pawls are configured so that the wheels can only rotate in one direction by default.

[0072] Example 11 includes the subject matter of any one or more of Examples 7-10, and optionally further includes:

[0073] A tension meter operably coupled to the suture and / or the adjustment device and providing an output indicative of the tension applied to the suture.

[0074] Example 12 includes the subject matter of Example 11 and, optionally, the following subject matter:

[0075] A communications module configured to output signals encoding data regarding the suture tension sensed by the tensiometer to one or more computerized platforms.

[0076] Example 13 relates to a suture tension monitoring and evaluation system and includes:

[0077] Suture tensioning device.

[0078] One or more computerized platforms configured to receive signals encoding data regarding the tension in the suture sensed by the tensiometer.

[0079] Example 14 includes the subject matter of Example 13 and, optionally, an imaging device for imaging the suture repair site to determine one or more characteristics of the soft tissue repair site.

[0080] The system is configured to determine one or more adjustment parameter values ​​of the displacement device based on one or more characteristics of the soft tissue repair site.

[0081] Example 15 includes the subject matter of example 14 and, optionally, a motion driver configured to adjust one or more actuators of the displacement device based on one or more adjustment parameter values.

[0082] Example 16 includes the subject matter of example 15, optionally wherein the one or more actuators are automatically, semi-automatically, or manually adjustable via a motion driver.

[0083] Example 17 relates to a method for repairing severed soft tissue, such as tendons, in a mammalian body extremity, the method comprising the steps of:

[0084] Joining the opposite ends of the severed soft tissue with a suture so that the ends of the suture are external to the mammalian body.

[0085] Operatively engaging the body end with a suture tensioning device.

[0086] Operatively coupling the suture ends to a suture tensioning device and tensioning the suture with the suture tensioning device.

[0087] Recording the tension on the suture.

[0088] In some embodiments, the adjustment device can be configured as a ratchet configured to increase suture tension by default, preventing undesired decreases in suture tension. For example, the actuator can include a geared wheel and a biased pawl configured to engage the teeth of the gear. The wheel and pawl are configured such that the wheel can rotate only in a first direction to apply tension to the suture.

[0089] In the specification and claims of this application, the words "comprise," "include," and "have," and forms thereof, do not necessarily limit the members of a list with which the word may be associated. Furthermore, in the event of a conflict between this application and a document incorporated by reference, it is hereby intended that the present application shall control.

[0090] The various features and steps described above, and other known equivalents to each such feature or step, can be mixed and matched by those skilled in the art to perform methods according to the principles described herein. While this disclosure has been provided in the context of specific embodiments and examples, those skilled in the art will recognize that the disclosure extends beyond the specifically described embodiments to other alternative embodiments and / or uses, and obvious modifications and equivalents thereof. Accordingly, the disclosure is not intended to be limited by the specific disclosure of embodiments herein.

[0091] As used herein, unless otherwise specified, adjectives such as "substantially" and "about" modifying a condition or relationship characteristic of a feature or characteristic of an embodiment of an apparatus are understood to mean that the condition or characteristic is defined within a tolerance range that is acceptable for the operation of the embodiment for its intended use.

[0092] Unless otherwise specified, the terms "about" and / or "approximately" in relation to a magnitude or numerical value may mean within an inclusive range of -10% to +10% of the respective magnitude or numerical value.

[0093] Unless otherwise specified, the terms "about" or "approximately" mean at or near a location or portion of an object relative to another part or region of the object.

[0094] Positional terms used herein, such as "upper," "lower," "right," "left," "bottom," "below," "lowered," "low," "top," "above," "elevated," "high," "vertical," and "horizontal," and grammatical variations thereof, do not indicate that a component referred to as "below" is actually "below" another component, or that a component referred to as "above" is actually "above" another component, since, for example, such orientation, components, or both, may be flipped, rotated, moved in space, positioned in an oblique orientation or position, positioned horizontally or vertically, or similarly altered. Accordingly, it will be understood that the terms "below," "below," "above," and "above" may be used herein for illustrative purposes only, to illustrate the relative positions or placement of particular components, to indicate first and second components, or both.

[0095] "Coupling with" means "coupled" either indirectly or directly.

[0096] As used herein, unless otherwise specified, the use of ordinal adjectives such as "first," "second," etc., merely indicates that different instances of similar objects are being referred to and does not imply that the objects so described must be in a predetermined order, chronologically, sequentially, and / or otherwise.

[0097] The description of various embodiments of the present device has been presented for purposes of explanation and is not intended to be exhaustive or limiting of the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein has been selected to best explain the principles of the embodiments, practical applications or technical improvements over technology found in the marketplace, or to enable those skilled in the art to understand the embodiments disclosed herein. [Brief explanation of the drawings]

[0098] [Figure 1A] 10A-10C illustrate various perspective views of an upper suture tensioning device according to some embodiments. [Figure 1B] 10A-10C illustrate various perspective views of an upper suture tensioning device according to some embodiments. [Figure 1C] 10A-10C illustrate various perspective views of an upper suture tensioning device according to some embodiments. [Figure 1D] 10A-10C illustrate various perspective views of an upper suture tensioning device according to some embodiments. [Figure 1E] 10A-10C illustrate various perspective views of an upper suture tensioning device according to some embodiments. [Figure 2A] 10A-10C illustrate various perspective views of an upper suture tensioning device operably engaging a finger, according to some embodiments. [Figure 2B] 10A-10C illustrate various perspective views of an upper suture tensioning device operably engaging a finger, according to some embodiments. [Figure 2C] 10A-10C illustrate various perspective views of an upper suture tensioning device operably engaging a finger, according to some embodiments. [Figure 3A] 10A-10C illustrate various perspective views of a lower suture tensioning device according to some embodiments. [Figure 3B] 10A-10C illustrate various perspective views of a lower suture tensioning device according to some embodiments. [Figure 3C] 10A-10C illustrate various perspective views of a lower suture tensioning device according to some embodiments. [Figure 3D]10A-10C illustrate various perspective views of a lower suture tensioning device according to some embodiments. [Figure 4] 14 illustrates a lower suture tensioning device operably engaging a finger, according to some embodiments.

Claims

1. 1. A suture tensioning device for tensioning a suture operably engaged at a soft tissue repair site, comprising: a housing having a wide proximal receiving end and a narrow distal end, the housing configured to snugly receive a finger; a suture tensioning mechanism configured to fixedly receive one or more suture portions of corresponding suture ends of a suture extending from a tissue reporting site within the body distal end to an exterior of the body distal end and terminating in the suture tensioning mechanism; a suture coupling element for fixedly coupling the one or more suture portions to the tensioning mechanism; an adjustment device configured to controllably adapt the tension on the suture; A suture tensioning device comprising:

2. 10. The suture tensioning device of claim 1, wherein the adjustment device includes an actuator operably engaged by a user of the suture tensioning device to selectively increase or decrease tension applied to the suture.

3. 3. The suture tensioning device of claim 1, wherein the adjustment device is configured as a ratchet for tensioning the suture to prevent undesired reduction in suture tension.

4. the tensioning mechanism comprising: a geared wheel; a biased pawl configured to mesh with the teeth of the geared wheel; The suture tensioning device of claim 2 or 3, wherein the wheel and pawl are configured such that the wheel is rotatable in only one direction by default.

5. 5. The suture tensioning device of claim 1, further comprising a tension meter operably coupled to the suture and / or the adjustment device to provide an output indicative of tension applied to the suture.

6. The suture tensioning device of claim 5, further comprising a communications module configured to output signals encoding data regarding the suture tension sensed by the tensiometer to one or more computerized platforms.

7. The suture tensioning device according to claim 5 or 6, one or more computerized platforms configured to receive signals encoding data regarding the suture tension sensed by the tensiometer.

8. and further comprising an imaging device for imaging the suture repair site to determine one or more characteristics of the soft tissue repair site. The suture tension monitoring and evaluation system of claim 7 , wherein the system is configured to determine one or more adjustment parameter values ​​of the displacement device based on the one or more characteristics of the soft tissue repair site.

9. The suture tension monitoring and evaluation system of claim 8 comprising a motion driver configured to adjust the one or more actuators of the displacement device based on the adjustment parameter value.

10. The suture tension monitoring and evaluation system of claim 9, wherein the one or more actuators are automatically, semi-automatically, or manually adjustable through the motion driver.

11. a belt or strap externally connectable to a patient's body part and to which a suture filament emanating from the suture site can be connected; a suture tensioning mechanism configured to fixedly receive one or more suture portions of corresponding suture ends of a suture extending from a tissue reporting site within the body distal end to an exterior of said body distal end and terminating in the suture tensioning mechanism; a suture coupling element for fixedly coupling the one or more suture portions to the tensioning mechanism; and an adjustment device configured to controllably adapt the tension on the suture.

12. 12. The suture tensioning device of claim 11, wherein the adjustment device includes an actuator operably engaged by a user of the suture tensioning device to selectively increase or decrease tension applied to the suture.

13. 13. The suture tensioning device of claim 11 or 12, wherein the adjustment device is configured as a ratchet for tensioning the suture to prevent undesired reduction in suture tension.

14. the tensioning mechanism comprising: a geared wheel; a biased pawl configured to mesh with the teeth of the geared wheel; 14. The suture tensioning device of any one of claims 11 to 13, wherein the wheel and pawl are configured such that the wheel can rotate in only one direction by default.

15. 15. The suture tensioning device of claim 11, further comprising a tension meter operably coupled to the suture and / or the adjustment device to provide an output indicative of tension applied to the suture.

16. The suture tensioning device of claim 15, further comprising a communications module configured to output signals encoding data regarding the suture tension sensed by the tensiometer to one or more computerized platforms.

17. 1. A method of repairing severed soft tissue, such as a tendon, in a mammalian body extremity, comprising: connecting the opposite ends of the severed soft tissue with a suture such that the end of the suture is external to the mammal; operably engaging the body end with a suture tensioning device according to any one of claims 1 to 12; operatively coupling the suture ends to the suture tensioning device and tensioning the suture with the suture tensioning device; and recording the tension on the suture.

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