Suture tensioning devices, systems, and methods

Abstract

Embodiments relate to a suture tensioning device for tensioning a suture operably engaged with a soft tissue repair site. In some examples, a suture tensioning device includes a housing having a wide proximal receiving end and a narrow distal end, where the housing is configured to closely receive a finger / toe; and a suture tensioning mechanism configured to fixedly receive one or more suture portions extending from a tissue repair site within the body limb tip out of the body limb tip to terminate at a corresponding suture end of the suture of the suture tensioning mechanism. The device may further include a suture coupling element for fixedly coupling the one or more suture portions with the tensioning mechanism; and an adjustment device configured to controllably adjust the tension on the suture.

Description

Background Art

[0001] A ruptured or torn tendon, as well as other soft tissues (including ligaments and tendons), and bone fragments that may be attached to it, can cause severe pain and, in some cases, impaired mobility and disability. Techniques for repairing a ruptured tendon include suturing techniques used to connect the two ends of the ruptured tendon.

[0002] One suturing method that has established itself as one of the most widely used methods is the Kessler repair or a modification thereof, in which opposing ruptured ends of a tendon or ligament are sutured together in a specific configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The drawings generally illustrate, by way of example but without limitation, various implementations discussed in this document.

[0004] For simplicity and clarity of illustration, the elements shown in the drawings are not necessarily drawn to scale. For example, for clarity, the size of some elements may be exaggerated relative to other elements. In addition, reference numerals may be repeated between the drawings to indicate corresponding or similar elements. References to previously presented elements are implied without further reference to the drawings or descriptions in which they appear. The number of elements shown in the drawings is for illustrative purposes only and should not be construed as limiting. The drawings are listed below.

[0005] Figures 1A-1E Various views of an upper suture tensioning device are shown according to some embodiments.

[0006] Figure 2A-2C Various views of an upper suture tensioning device operably engaged with a digit are shown according to some embodiments.

[0007] Figures 3A-3D Various views of a lower suture tensioning device are shown according to some embodiments.

[0008] Figure 4 A lower suture tensioning device operably engaged with a finger / toe is shown according to some embodiments. DETAILED DESCRIPTION

[0009] Postoperative complications associated with suture connection of the two ends of a ruptured tendon include incomplete or no healing of the injury due to inadequate connection of the two tendon ends, gapping at the repair site, local edema, and adhesions around the tendon, all of which may lead to limb disabilities such as reduced hand movement or lack of grip strength, or reduced strength and ability in other areas of the body.

[0010] The process of tendon or ligament or soft tissue healing is achieved through a biological response, in which cells in the injured area repair the damaged tissue while forming a tissue matrix. Approximation of the damaged tissue is key to proper healing, and the transmission of forces and appropriate movement of the tissue can enhance these processes. In addition, the correct and optimal placement of suture materials and ensuring optimal alignment and contact of the ends of the damaged tendon or ligament are key to timely and optimal healing.

[0011] Since impaired mobility and / or reduced grip may not always necessarily be directly associated with reduced suture tension, but may be related to, for example, local edema and / or peri-tendon adhesions, repeated measurements of tension may indicate whether impaired mobility and / or reduced grip are due to reduced suture tension.

[0012] Embodiments are directed to suture tensioning devices configured to postoperatively measure the amount of tension applied to a suture coupled to a repair site of soft tissue, such as a tendon, during a patient's recovery period to objectively assess the success of the repair surgery and detect postoperative complications.

[0013] Embodiments of the suture tensioning device allow for feedback-based suture tensioning and, for example, are configured to enable gradual tensioning of the suture to enhance internal healing of the tendon (also known as: intrinsic healing) to slow external healing, which may manifest itself as a reduction in external scarring.

[0014] In some examples, a suture tensioning device may be used to determine whether the suture wire needs to be re-tensioned. The suture wire tensioning device can be configured to allow the suture wire to be re-tensioned under a selected imaging modality (e.g., ultrasound imaging) while providing tension feedback. In this way, the gap reduction can be associated with the tension that needs to be applied to achieve the desired gap reduction.

[0015] According to some embodiments, a suture tensioning device can include a housing, for example, a housing in the shape of a hollow receiving cavity, having a narrow distal end and a wide proximal receiving end for receiving a body part. The housing can be configured to receive a body part, which can be an extremity, such as a portion of a finger / toe having a main longitudinal axis. The housing can be configured to at least partially fit around or fitably engage with the extremity. The extremity can be a mammal, such as a human extremity.

[0016] In some examples, the receiving cavity can be a partially open receiving cavity with an arched, open cross-section. The narrow distal end of the receiving cavity can be configured to restrict axial movement of the limb end in a distal direction in a form-fitting manner. In some examples, the narrow distal end can be a closed end, shaped like a cap, for example, with a generally circular cross-section or an arched cross-section.

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

[0018] The suture tensioning device may further include a suture tensioning mechanism. The suture tensioning mechanism may be configured to fixedly receive at least one distal end of the suture. The suture may extend from a soft tissue repair site (e.g., a tendon repair site) within the patient's body, for example, via the distal end of a limb end or from any area with sufficient soft tissue to surround the suture filament exiting the body (e.g., the distal end of a patient's finger / toe), and terminate outside the patient's body at the suture tensioning mechanism.

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

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

[0021] In some embodiments, the adjustment device can be configured to selectively allow the applied tensioning force to be gradually and stepwise increased or decreased. 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 each two adjacent teeth. The flexible tab is configured to tend to restore a nominal positional relationship relative to the teeth and to allow elastic deflection 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. In some 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 that is configured to increase the tension of the suture by default and prevent unnecessary reduction of the tension of the suture. For example, the actuator can include a gear with teeth and a biased pawl that is configured to engage with the teeth of the gear. The wheel and the pawl are configured so that the wheel can only rotate in a first direction to achieve tensioning of the suture.

[0024] The suture tensioning mechanism may include a tension meter operably coupled to the suture and / or the adjustment device. The tension meter may be implemented electronically and / or mechanically. For example, the tension meter may include a mechanical energy storage device configured to estimate the tension of the suture. The tension meter may provide an output indicating the tension to which the suture is subjected as measured.

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

[0026] In some embodiments, the suture tensioning device may include a communication module configured to output (e.g., transmit in a wired or wireless manner) a signal encoding data related to the sensed suture tension to one or more computerized platforms. The computerized platform may include a multi-function mobile communication device (also referred to as a "smartphone"), a personal computer, a laptop computer, a tablet computer, a server (which may involve one or more servers or storage systems and / or services associated with a business or corporate entity, including, for example, a file hosting service, a cloud storage service, an online file storage provider, a peer-to-peer file storage or hosting service, and / or a cyberlocker), a personal digital assistant, a workstation, a wearable device, a handheld computer, and / or a laptop computer.

[0027] In some embodiments, a device and / or system can be configured to define the tension to which a suture can be subjected to avoid over-tensioning of the suture and thereby avoid applying excessive forces at a tissue repair site.

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

[0029] This can be done with the guidance of a professional who determines the required time, repetition rate, number of repetitions, and how and when. The device and / or system can allow the required values ​​to be set during the correct rehabilitation period and then ensure that the patient adheres to the required rehabilitation regimen - when performed with or without supervision. In some instances, the system can include outputs (e.g., one or more visual and / or auditory outputs) for providing the user with indications of rehabilitation progress and / or compliance.

[0030] It is known in the art that as a tendon or tissue heals, the forces acting on the suture itself may weaken. Data accumulated from different cases will be collected and used to evaluate the variation and differences in the accumulation of repair strength within the same individual, between individuals, and between fingers / toes to allow for the interpretation of these findings and for the establishment and differentiation of rehabilitation programs tailored to certain patients. For example, an accelerated rehabilitation program for a young, non-smoking professional athlete and a paused, slower rehabilitation program for an older, unhealthy smoker.

[0031] Although embodiments of the present device are disclosed for operable engagement with a finger / toe, this should in no way be construed as limiting. Thus, embodiments of the present device can also be operable to engage the Achilles tendon, patellar tendon, and / or other soft tissues (including ligaments and / or tendons), as well as bone fragments that may be attached thereto, which can cause severe pain and, in some cases, affect movement and lead to disability.

[0032] Reference now Figures 1A-1E and Figure 2A-2C In some embodiments, upper suture tensioning device 1000 can include upper housing 1100, e.g., a housing in the shape of a hollow receptacle having a narrow distal end and a wide proximal receiving end for a body part. Upper housing 1100 can be configured to receive a body part, which can be a limb extremity, such as a portion of a finger / toe 500 having a longitudinal axis Z. The term "upper" refers to a configuration in which upper housing 1100 engages posteriorly with finger / toe 500.

[0033] In some examples, the upper housing 1100 can be a partially open receiving cavity with an arched, open cross-section. The narrow distal end of the receiving cavity can be configured to restrict axial movement of the limb end in the distal direction in a shape-fitting manner. In some examples, the narrow distal end can be a closed end, shaped like a cap, for example, with a generally circular cross-section or an arched cross-section.

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

[0035] In some embodiments, the upper suture tensioning mechanism 1200 can 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 may further include an adjustment device 1400 that allows the suture to be controllably tensioned by applying a tensioning force in a distal direction relative to the soft tissue repair site.

[0037] Adjustment device 1400 may include at least one actuator 1410, such as a wheel, knob, or slider, which can be operably engaged by a user of suture tensioning device 1000, and a resiliently deflectable tab 1420, which is operably engaged with actuator 1410 to allow selective increase or decrease (e.g., gradually) of tension applied to the suture. In some examples, adjustment device 1400 may include multiple actuators configured such that each wheel can be rotated independently of the other wheels to selectively pull different ends of the suture.

[0038] In the discussion that follows, and not to be construed as limiting, the actuators are shown as being implemented as wheels.

[0039] In some embodiments, the actuator 1410 can include a gear having teeth and a deflectable tab 1420 configured to engage each brake formed by two adjacent teeth of the gear. In some examples, the wheel and pawl are configured such that the actuator 1410 can only be rotated in a first direction to achieve tensioning of the suture, thereby implementing a ratchet configuration.

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

[0041] In some embodiments, the adjustment device 1400 can be configured as a ratchet that is configured to increase the tension of the suture by default and prevent unnecessary reduction of the tension of the suture. For example, the actuator can include a gear with teeth and a deflectable tab that is configured to engage with the teeth of the gear. The wheel and the pawl are configured so that the wheel can only be rotated in a first direction to achieve tensioning of the suture.

[0042] Reference now Figures 3A-3D and Figure 4 In some embodiments, the lower suture tensioning device 2000 can include a lower housing 2100, for example, a housing in the shape of a hollow socket having a narrow distal end and a wide proximal receiving end for a body part. The lower housing 2100 can be configured to receive a body part, which can be a limb end, such as a portion of a finger / toe 500 having a longitudinal axis Z. The term "lower" refers to a configuration in which the lower housing 2100 engages the finger / toe 500 anteriorly.

[0043] In some examples, the lower housing 2100 can be a partially open receiving cavity with an arched, open cross-section. The narrow distal end of the receiving cavity can be configured to restrict axial movement of the limb end in the distal direction in a shape-fitting manner. In some examples, the narrow distal end can be a closed end, shaped like a cap, for example, with a generally circular cross-section or an arched 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 at least one distal end of the suture 600. The suture 600 may extend from a soft tissue repair site (e.g., a tendon repair site) inside the patient's body, exit the patient's limb end via a distal end of the limb end (e.g., a distal end of a patient's finger / toe), and terminate outside the patient's body at the lower suture tensioning mechanism 2200.

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

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

[0047] In some embodiments, the adjustment device 2400 may include an actuator 2410, such as a wheel, knob, or slider, and a resiliently deflectable tab 2420 that is operably engaged with the actuator 1410 to allow for selectively increasing or decreasing (e.g., gradually) the tension applied to the suture.

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

[0049] Additional Examples:

[0050] Embodiment 1 relates to a suture tensioning device for tensioning a suture operably engaged with a soft tissue repair site, the suture tensioning device comprising:

[0051] a housing having a wide proximal receiving end and a narrow distal end, wherein the housing is configured to snugly receive a finger / toe;

[0052] a suture tensioning mechanism configured to fixedly receive one or more suture portions of a suture extending from a tissue repair site within the body extremity to outside the body extremity to terminate at respective suture ends of the suture of the suture tensioning mechanism;

[0053] a suture coupling element for fixedly coupling one or more suture portions to the tensioning mechanism; and

[0054] An adjustment device is configured to controllably adjust the tension on the suture.

[0055] Embodiment 2 includes the subject matter of Embodiment 1 and optionally wherein the adjustment device comprises an actuator operably engageable by a user of the suture tensioning device and allowing for selective increase or decrease of tension applied to the suture.

[0056] Embodiment 3 includes the subject matter of any one or more of Embodiments 1-2, and optionally wherein the adjustment device is configured as a ratchet for tensioning the suture and preventing unnecessary reduction in suture tension.

[0057] Embodiment 4 includes the subject matter of any one or more of Embodiments 2 to 3, and optionally, wherein the tensioning mechanism comprises:

[0058] a gear having teeth; and

[0059] an offset pawl configured to mesh with the teeth of the gear,

[0060] Therein, the wheel and pawl are configured such that the wheel can only rotate in one direction by default.

[0061] Embodiment 5 includes the subject matter of any one or more of Embodiments 1-4 and, optionally, a tensiometer operably coupled to the suture and / or the adjustment device for providing an output indicative of tension applied to the suture.

[0062] Example 6 includes the subject matter of Example 5 and, optionally, a communication module configured to output a signal encoding data related to suture tension sensed by the tensiometer to one or more computerized platforms.

[0063] Embodiment 7 includes the suture tensioning device of any one or more of the preceding claims, comprising a belt or strap that can be externally coupled to a body part of a patient and to which suture filaments emanating from a suture site can be connected, the suture tensioning device further comprising:

[0064] a suture tensioning mechanism configured to fixedly receive one or more suture portions of a suture extending from a tissue repair site within the body extremity to outside the body extremity to terminate at respective suture ends of the suture of the suture tensioning mechanism;

[0065] a suture coupling element for fixedly coupling one or more suture portions to the tensioning mechanism; and

[0066] An adjustment device is configured to controllably adjust the tension on the suture.

[0067] Example 8 includes the subject matter of Example 7 and optionally wherein the adjustment device comprises an actuator operably engageable by a user of the suture tensioning device and allowing for selective increase or decrease of tension applied to the suture.

[0068] Example 9 includes the subject matter of any one or more of Examples 7-8, and optionally wherein the adjustment device is configured as a ratchet for tensioning the suture and preventing unnecessary reduction in suture tension.

[0069] Embodiment 10 includes the subject matter of the suture tensioning device of any one or more of Embodiments 7 to 9, and optionally, wherein the tensioning mechanism comprises:

[0070] a gear having teeth; and

[0071] an offset pawl configured to mesh with the teeth of the gear,

[0072] Therein, the wheel and pawl are configured such that the wheel can only rotate in one direction by default.

[0073] Embodiment 11 includes the subject matter of any one or more of Embodiments 7 to 10, and optionally, further includes:

[0074] A tension meter is operably coupled to the suture and / or the adjustment device for providing an output indicative of tension applied to the suture.

[0075] Embodiment 12 includes the subject matter of embodiment 11, and optionally,

[0076] A communication module is configured to output a signal encoding data related to suture tension sensed by the tensiometer to one or more computerized platforms.

[0077] Embodiment 13 relates to a suture tension monitoring and assessment system, comprising:

[0078] Suture tensioning device

[0079] One or more computerized platforms are configured to receive a signal encoding data related to suture tension sensed by the tensiometer.

[0080] Embodiment 14 includes the subject matter of embodiment 13 and optionally, an imaging device for imaging the suture repair site for determining one or more characteristics of the soft tissue repair site, and

[0081] Therein, 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.

[0082] Embodiment 15 includes the subject matter of Embodiment 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.

[0083] Embodiment 16 includes the subject matter of Embodiment 15 and optionally wherein one or more actuators are automatically, semi-automatically, or manually adjustable via a motion drive.

[0084] Example 17 relates to a method for repairing ruptured soft tissue (such as a tendon at the end of a mammalian limb), the method comprising:

[0085] connecting the opposite ends of the disrupted soft tissue using a suture such that the ends of the suture are outside the body of the mammal;

[0086] operably engaging the limb end with a suture tensioning device;

[0087] operably coupling the suture ends to a suture tensioning device to allow the suture to be tensioned using the device; and

[0088] The tension applied to the suture was recorded.

[0089] In some embodiments, the adjustment device can be configured as a ratchet that is configured to increase the tension of the suture by default and prevent unnecessary reduction of the tension of the suture. For example, the actuator can include a gear with teeth and a biased pawl that is configured to engage with the teeth of the gear. The wheel and the pawl are configured so that the wheel can only rotate in a first direction to achieve tensioning of the suture.

[0090] In the specification and claims of the present application, the words "comprise", "include", and "have" and each of their forms are not necessarily limited to the members of the list with which these words are associated. In addition, if there is an inconsistency between the present application and any document incorporated by reference, the present application shall control.

[0091] Those of ordinary skill in the art may mix and match the various features and steps described above and other known equivalents of each such feature or step to perform methods according to the principles described herein. Although the present disclosure is provided in the context of certain embodiments and examples, it will be appreciated by those skilled in the art that the present disclosure extends beyond the specifically described embodiments to other alternative embodiments and / or uses and obvious modifications and equivalents thereof. Therefore, the present disclosure is not intended to be limited by the specific disclosure of the embodiments herein.

[0092] In the discussion, unless otherwise stated, adjectives such as "substantially" and "about" modifying a condition or relational characteristic of one or more features of an embodiment of the device should be understood to mean that the condition or characteristic is defined within an acceptable tolerance for the operation of the embodiment for the intended application.

[0093] Unless otherwise stated, the terms 'about' and / or 'approximately' with respect to a magnitude or value may imply an inclusive range of -10% to +10% of the corresponding magnitude or value.

[0094] Unless otherwise indicated, the terms 'about' or 'approximately' imply being at or within a region of an object, or being close to a location or portion of an object relative to another portion or region of an object.

[0095] Positional terms that may be used herein, such as "upper", "lower", "right", "left", "bottom", "below", "lower", "top", "above", "elevated", "high", "vertical", and "horizontal", and grammatical variations thereof, do not necessarily indicate, for example, that a "bottom" component is below a "top" component, or that a "below" component is actually "below" other components, or that a "top" component is actually "above" other components, as these directions, components, or both may be flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified. Therefore, it should be understood that the terms "bottom", "below", "top", and "above" herein are used for exemplary purposes only to illustrate the relative positioning or placement of certain components to indicate a first and a second component, or both.

[0096] "Link" means either an indirect or direct "link".

[0097] As used herein, unless otherwise specified, the use of ordinal adjectives "first," "second," etc. to describe similar objects merely indicates different instances of the similar objects referred to and is not intended to imply that the objects described must be in a given order, time, ranking, and / or in any other manner.

[0098] The description of various embodiments of the present device is given for the purpose of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terms used herein are selected to best explain the principles of the embodiments, practical applications, or technical improvements over technologies found on the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A suture tensioning device for tensioning a suture operably engaged with a soft tissue repair site, the suture tensioning device comprising: a housing having a wide proximal receiving end and a narrow distal end, wherein the housing is configured to snugly receive a finger / toe; a suture tensioning mechanism configured to fixedly receive one or more suture portions extending from a tissue repair site within the body extremity to outside the body extremity to terminate at respective suture ends of the suture of 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 is configured to controllably adjust the tension on the suture.

2. The suture tensioning device according to claim 1, wherein: The adjustment device includes an actuator that is operably engageable by a user of the suture tensioning device and allows for selectively increasing or decreasing tension applied to the suture.

3. A suture tensioning device according to any one or more of the preceding claims, wherein: The adjustment device is configured as a ratchet for tensioning the suture and preventing unnecessary reduction of suture tension.

4. The suture tensioning device according to claim 2 or claim 3, wherein: The tensioning mechanism comprises: a gear having teeth; and an offset pawl configured to mesh with the teeth of the gear, Wherein the wheel and the pawl are configured such that the wheel can rotate in only one direction by default.

5. The suture tensioning device of any one or more of the preceding claims, further comprising a tension meter operably coupled to the suture and / or the adjustment device for providing an output indicative of the tension applied to the suture.

6. The suture tensioning device according to claim 5, further comprising: A communication module is configured to output a signal encoding data related to suture tension sensed by the tensiometer to one or more computerized platforms.

7. Suture tension monitoring and assessment system, including: A suture tensioning device according to claim 5 or claim 6, and One or more computerized platforms are configured to receive a signal encoding data related to suture tension sensed by the tensiometer.

8. The suture tension monitoring and assessment system of claim 7, further comprising an imaging device for imaging a suture repair site for determining one or more characteristics of the soft tissue repair site, and in, 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 assessment 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 assessment system of claim 9, wherein: The one or more actuators may be automatically, semi-automatically or manually adjustable by the motion drive.

11. A suture tensioning device, comprising: a belt or strap that can be externally coupled to a body part of a patient and to which suture filaments emanating from a suture site can be connected, the suture tensioning device further comprising: a suture tensioning mechanism configured to fixedly receive one or more suture portions extending from a tissue repair site within the body extremity to outside the body extremity to terminate at respective suture ends of the suture of 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 is configured to controllably adjust the tension on the suture.

12. The suture tensioning device of claim 11, wherein: The adjustment device includes an actuator that is operably engageable by a user of the suture tensioning device and allows for selectively increasing or decreasing tension applied to the suture.

13. The suture tensioning device according to any one or more of claims 11 to 12, wherein: The adjustment device is configured as a ratchet for tensioning the suture and preventing unnecessary reduction of suture tension.

14. The suture tensioning device according to any one or more of claims 11 to 13, wherein: The tensioning mechanism includes: a gear having teeth; and an offset pawl configured to mesh with the teeth of the gear, Wherein the wheel and the pawl are configured such that the wheel can rotate in only one direction by default.

15. The suture tensioning device according to any one or more of claims 11 to 14, further comprising: A tension meter is operably coupled to the suture and / or the adjustment device for providing an output indicative of tension applied to the suture.

16. The suture tensioning device of claim 15, further comprising: A communication module is configured to output a signal encoding data related to suture tension sensed by the tensiometer to one or more computerized platforms.

17. A method for repairing ruptured soft tissue, such as a tendon at the end of a mammalian limb, the method comprising: connecting opposite ends of the severed soft tissue using a suture such that ends of the suture are outside the body of the mammal; operatively engaging the limb extremity with a suture tensioning device according to any one or more of claims 1 to 12; operably coupling the suture end to the suture tensioning device to allow tensioning of the suture using the device; and The tension applied to the suture was recorded.

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