US2015088192A1PendingUtilityA1

Tissue tensioning devices and related methods

44
Assignee: UNIV WAKE FOREST HEALTH SCIENCESPriority: Nov 10, 2009Filed: Dec 2, 2014Published: Mar 26, 2015
Est. expiryNov 10, 2029(~3.3 yrs left)· nominal 20-yr term from priority
A61B 17/29A61B 17/2833A61B 2090/064A61B 17/2812
44
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Claims

Abstract

Surgical devices configured to apply and hold a defined pre-set or pre-load tension to target tissue, such as, for example, a blood vessel, tendon or ligament during a surgical procedure.

Claims

exact text as granted — not AI-modified
That which is claimed is: 
     
         1 . A surgical device for rotator cuff repair surgeries, comprising:
 a soft-tissue grasper configured to releaseably engage and pull rotator cuff tendon associated with a rotator cuff repair; and   a tension measurement device in communication with the grasper whereby tension applied to the rotator cuff tendon by the grasper is measured,   wherein the soft-tissue grasper has or is attached to an elongate shaft that extends in a direction away from tissue grasping prongs associated with the soft tissue grasper, and wherein the tension measurement device comprises a housing with a resilient member, the housing holding a portion of the elongate shaft so that the elongate shaft, the housing and the resilient member cooperate to provide a defined tension to a rotator cuff tendon.   
     
     
         2 . The surgical device of  claim 1 , wherein the device is configured to hold the rotator cuff tendon at the target pre-load tension and hold the tendon at this pre-load tension while a physician attaches the tendon to local bone. 
     
     
         3 . The device of  claim 2 , further comprising an arm mounting member configured to support the soft tissue grasper and releasably hold the surgical device on an arm of a patient while allowing the tissue grasper to pivot relative to the arm mounting member. 
     
     
         4 . The device of  claim 1 , wherein the tissue grasper has an elongate shaft that extends in a direction away from tissue grasping prongs associated with the tissue grasper, the device further comprising a housing with a resilient member, the housing holding a portion of the shaft so that the shaft, the housing and the resilient member cooperate to provide a defined tension to the rotator cuff tendon. 
     
     
         5 . A method of repairing a rotator cuff injury, comprising:
 providing a device with a tissue grasper and a tension measurement device;   pulling a detached torn rotator cuff down from a retracted intrabody position using the tissue grasper;   measuring tension applied to the rotator cuff during the pulling step using the tension measurement device; then   maintaining a desired defined pre-load tension on the pulled rotator cuff using the device while affixing the rotator cuff to local bone.   
     
     
         6 . A method according to  claim 5 , further comprising:
 mounting the device to a patient prior to the pulling and measuring steps; and   slidably extending, retracting and pivoting the tissue graspers while the device is mounted to the patient, wherein the measuring step is carried out at least twice before the maintaining step, so that at least two different tension measurements are taken with the arm in at least two different positions.   
     
     
         7 . A surgical device, comprising:
 tissue graspers;   a tension measurement device in communication with the tissue graspers; and   a tissue elongation guide in communication with the tissue graspers to measure elongation of tissue held by the tissue graspers.   
     
     
         8 . The device of  claim 7 , further comprising a circuit in communication with the tension measurement device configured to generate an audible and/or visual output when a target pre-load is met or exceeded. 
     
     
         9 . The device of  claim 7 , wherein the tissue graspers are in communication with a releasably lockable gimble that can allow a user to pivot and lock the tissue graspers into a desired orientation. 
     
     
         10 . The device of  claim 7 , further comprising a circuit in communication with the tissue elongation guide and the tension measurement device, the circuit configured to: (a) monitor the measured tension; (b) generate an output to a user when a target pre-load tension is approached, met and/or exceeded; and (c) measure tissue stiffness using data from the measured tension and data from the tissue elongation guide. 
     
     
         11 . A method of repairing a tissue injury, comprising:
 providing a device with a tissue grasper and a tension measurement device;   pulling tissue from a retracted intrabody position using the tissue grasper;   measuring tension applied to the tissue during the pulling step using the tension measurement device; then   maintaining a desired defined pre-load tension on the pulled tissue using the device while affixing the tissue to local structure.   
     
     
         12 . A method according to  claim 11 , further comprising:
 mounting the device to a patient prior to the pulling and measuring steps; and   slidably extending, retracting and pivoting the tissue graspers while the device is mounted to the patient, wherein the measuring step is carried out at least twice before the maintaining step, so that at least two different tension measurements are taken with the limb in at least two different positions.   
     
     
         13 . A method according to  claim 11 , further comprising measuring tissue elongation of the pulled tissue using the device. 
     
     
         14 . The device of  claim 10 , further comprising a limb mounting member configured to releasably attach to a limb of a patient and hold the surgical device on the limb of a respective patient. 
     
     
         15 . The device of  claim 14 , wherein the tissue grasper is pivotably attached to the limb mounting member and is able to rotate longitudinally and transversely relative to the limb mounting member. 
     
     
         16 . The device of  claim 14 , wherein the limb mounting member comprises an elongate body with a plurality of straps extending transversely therefrom. 
     
     
         17 . The device of  claim 15 , further comprising a slidably adjustable mounting arm with a slot that is lockably attached to the limb mounting member to allow for vertical adjustment of the tissue grasper. 
     
     
         18 . The device of  claim 15 , wherein the limb mounting member has a longitudinal axis, and wherein the device further comprises an upper platform that extends transversely to the longitudinal axis of the limb mounting member, the upper platform having opposing first and second end portions, wherein the first end portion resides above and is rotatably attached to an upper end portion of the limb mounting member, and wherein the tissue grasper is slidably held by the upper platform so as to be able to retract and extend in a lengthwise direction of the upper platform. 
     
     
         19 . The device of  claim 18 , further comprising a housing slidably mounted to the upper platform, wherein the upper platform comprises a slot that extends in a lengthwise direction whereby the housing is able to slidably translate back and forth in the slot. 
     
     
         20 . The device of  claim 19 , wherein the device further comprises an axially extending threaded member with an external handle with the threaded member comprising a portion that resides inside the housing, and wherein the threaded member is able to threadably retract and extend in a lengthwise direction relative to the upper platform in response to rotation of the handle. 
     
     
         21 . The device of  claim 7 , wherein the tissue grasper has a first tissue-contacting end portion and an opposing spaced apart second end portion, the device further comprising:
 an elongate member attached to the second end portion of the tissue grasper;   a housing configured to allow the elongate member to slidably extend and retract therefrom; and   a resilient member residing in the housing in communication with the elongate member, wherein the resilient member is configured to cooperate with the housing and elongate member to apply an adjustable tensile force to target issue held by the tissue grasper.   
     
     
         22 . The device of  claim 21 , wherein the resilient member comprises a coil spring that compresses against the housing, and wherein the elongate member is a shaft and is configured to extend through a channel defined by the coil spring. 
     
     
         23 . The device of  claim 14 , wherein the device is configured to allow the limb of the patient to move into or through different positions while the limb mounting member remains in position on the patient. 
     
     
         24 . The device of  claim 18 , wherein the upper platform is attached to the limb mounting member using a gimble that resides between the upper platform and limb mounting member to allow the tissue grasper. 
     
     
         25 . The device of  claim 14 , further comprising a slidably adjustable mounting arm with a slot that is lockably attached to the limb mounting member to allow for vertical adjustment of the tissue grasper. 
     
     
         26 . The device of  claim 14 , wherein the limb mounting member has a concave contour. 
     
     
         27 . The device of  claim 7 , wherein the tissue grasper has a pair of cooperating outer prongs with anti-slip surfaces that pivotably close together in parallel relationship in front of a pivot attachment of the prongs to trap soft tissue therebetween for pulling trapped soft tissue outwardly, and wherein the tension measurement device comprises an elongate shaft that extends in a longitudinal direction to be longitudinally aligned with lower shaft of the tissue grasper. 
     
     
         28 . A surgical device, comprising:
 a tissue grasper having a first tissue-contacting end portion and a lower shaft with a longitudinally opposing spaced apart second end portion; and   a tension measurement device in communication with the tissue grasper whereby tension applied to tissue by the tissue grasper is measured,   wherein the tissue grasper has a pair of cooperating outer prongs with anti-slip surfaces that pivotably close together in parallel relationship in front of a pivot attachment of the prongs to trap soft tissue therebetween for pulling trapped soft tissue outwardly, and wherein the tension measurement device comprises an elongate shaft that extends in a longitudinal direction to be longitudinally aligned with the second end portion of the lower shaft of the tissue grasper.   
     
     
         29 . The device of  claim 28 , further comprising a limb mounting member configured to support the tissue grasper and releasably hold the surgical device on a limb of a patient, wherein the device is configured to allow the limb of the patient to move into or through different positions while the limb mounting member remains in position on the patient. 
     
     
         30 . The device of  claim 28 , wherein the tissue grasper has an upper shaft that is pivotably attached to the lower shaft to provide the pivot attachment of the prongs, and wherein the upper shaft has a second end portion that allows a user to push against the upper shaft to close the prongs together, and wherein the elongate shaft of the measurement device extends a distance longitudinally away from the prongs of the tissue grasper, the tension measurement device further comprising:
 a housing configured to allow the elongate member to slidably extend and retract therefrom; and   a resilient member residing in the housing in communication with the elongate member, wherein the resilient member is configured to cooperate with the housing and elongate member to apply an adjustable tensile force to target issue held by the tissue grasper.   
     
     
         31 . The device of  claim 30 , wherein the resilient member comprises a coil spring that compresses against the housing, and wherein the elongate member is a shaft and is configured to extend through a channel defined by the coil spring.

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