Surgical delivery device and method

Abstract

A surgical delivery device for delivering a patch to a surgical site, wherein the surgical delivery device comprises: a shaft having a proximal end and a distal end; a deployment subassembly at the shaft distal end, the deployment subassembly having a plurality of connection stations removably couplable to the patch, the deployment subassembly transitionable between a first configuration in which the patch is collapsed and a second configuration in which the patch is expanded; and a handle at the shaft proximal end, the handle including an actuator for effecting movement of the deployment subassembly between the first configuration and the second configuration.

Description

[0001] SURGICAL DELIVERY DEVICE AND METHOD

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application Nos. 63 / 467,593, filed on May 18, 2023 and 63,467,820, filed on May 19, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD OF THE INVENTION

[0005] The present invention, in some embodiments thereof, is directed to a surgical instrument and method for delivering a patch to a surgical site and, more particularly, but not exclusively, to a surgical instrument having a shaft and a deployment subassembly selectively couplable to a patch at a plurality of connection stations. The deployment subassembly may be effected to transition between a first configuration, in which the patch is collapsed, and a second configuration, in which the patch is expanded or spread out and can be applied at the surgical site.

[0006] BACKGROUND OF THE INVENTION

[0007] Various patch deployment devices are known in the art, including those disclosed in U.S. Patents Nos. 9,005,241; 8,888,811; and 8,906,045; and US Patent Application Publication No. 2011 / 0082479.

[0008] Rotator cuff injuries can result from various mechanisms, such as falls and direct impacts to the shoulder. The accepted treatment for a full thickness tear or a partial thickness tear greater than 50% involves reconnecting the tom tendon via sutures, with the surgeon sometimes positioning a sheet-like patch over the sutured area to strengthen the repair and try to prevent recurrent tears. Placement and attachment of the sheet-like patch in an arthroscopic procedure has been shown to be very difficult. Therefore, there is a significant need for improved surgical devices to aid in repairing the tendons within the existing arthroscopic surgical workflow. The proposed device and method aim to address the shortcomings of the current instruments.

[0009] SUMMARY OF THE INVENTION

[0010] Some exemplary embodiments are listed below (it should be noted that one or more features of some embodiments may be used in combination with one or more features of another embodiment): According to an aspect of some embodiments of the present invention there is provided a surgical delivery device for delivering a patch to a surgical site, wherein the surgical delivery device comprises: a shaft having a proximal end and a distal end; a deployment subassembly at the shaft distal end, the deployment subassembly having a plurality of connection stations removably couplable to the patch, the deployment subassembly transitionable between a first configuration in which the patch is collapsed and a second configuration in which the patch is expanded; and a handle at the shaft proximal end, the handle including an actuator for effecting movement of the deployment subassembly between the first configuration and the second configuration.

[0011] According to some embodiments of the invention, the shaft has a longitudinal axis; wherein the deployment subassembly includes a plurality of elongated rods each having a rod distal portion, each of the connection stations located at a respective rod distal portion, the rod distal portions each located at a first distance relative to the shaft longitudinal axis when in the first configuration, the rods distal portions configured to be moved to a second distance relative to the shaft longitudinal axis when in the second configuration, wherein the second distance is greater than the first distance.

[0012] According to some embodiments of the invention, the surgical delivery device includes a frame configured to extend around at most three sides of the patch.

[0013] According to some embodiments of the invention, the surgical delivery device is configured to be coupled to the patch at a single side of the patch only.

[0014] According to some embodiments of the invention, the shaft is flexible.

[0015] According to some embodiments of the invention, the shaft includes a bendable section, the bendable section bendable from a first configuration, at which the handle is positioned on the longitudinal axis, to a second configuration, at which the handle is at an angle relative to the longitudinal axis.

[0016] According to some embodiments of the invention, the angle is at most 45 degrees.

[0017] According to some embodiments of the invention, the bendable section includes an articulatable joint.

[0018] According to some embodiments of the invention, a cross-sectional profile of each the elongated rod is one of rectangular, circular, and elliptical.

[0019] According to some embodiments of the invention, the rods are positioned parallel to the longitudinal axis when the deployment subassembly is in the first configuration, the rods movable to be positioned at an angle to the longitudinal axis when the deployment subassembly is in the second configuration. According to some embodiments of the invention, the rods are positionable at a 90 degree angle to the longitudinal axis when the deployment subassembly is in the second configuration.

[0020] According to some embodiments of the invention, the device includes a plurality of pairs of rods, each pair of rods including first and second rods positioned on opposite sides of the longitudinal axis.

[0021] According to some embodiments of the invention, the device includes a plurality of rods positioned on a single side of the longitudinal axis.

[0022] According to some embodiments of the invention, each the connection station includes a clamp for removably coupling a portion of the patch thereto.

[0023] According to some embodiments of the invention, the deployment subassembly is transitionable to a third configuration, wherein each the clamp has a closed configuration when the deployment subassembly is in the first and second configurations, and wherein each the clamp has an open configuration when the deployment subassembly is in the third configuration.

[0024] According to some embodiments of the invention, each connection station includes an eyelet for removably attaching a portion of the patch thereto.

[0025] According to some embodiments of the invention, the rods are each located at a first distance relative to the shaft longitudinal axis when in the first configuration, the rods configured to be moved to a second distance relative to the shaft longitudinal axis when in the second configuration, wherein the second distance is greater than the first distance.

[0026] According to some embodiments of the invention, each the rod includes a plurality of connection stations for removably coupling a portion of the patch thereto.

[0027] According to some embodiments of the invention, each the connection station includes a barb for piercing the patch.

[0028] According to some embodiments of the invention, the device includes a push rod having a proximal end operably coupled to the handle, and a distal end coupled to the deployment subassembly, the push rod sized and configured to be slidably coupled to the shaft; wherein the push rod is axially translatable from a first orientation, in which the deployment subassembly is in the first configuration, to a second orientation, in which the deployment portion is in the second configuration.

[0029] According to some embodiments of the invention, when the device is in the first orientation, the push rod is axially translatable to the second orientation by distal movement of the push rod. According to some embodiments of the invention, when the device is in the first orientation, the push rod is axially translatable to the second orientation by proximal movement of the push rod.

[0030] According to some embodiments of the invention, each the elongated rod has an axial slit, wherein the surgical delivery device further comprises: a. a dorsal extension, extending distally from the shaft, the dorsal extension having a flat basal surface defining a dorsal slot sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the shaft, the ventral extension having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal pin, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit, defined in two of the elongated rods; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

[0031] According to some embodiments of the invention, the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of a pair of distal elongated rods, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated rods, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture, defined in the proximal end of the pair of distal elongated rods, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end, of the pair of proximal elongated rods, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the partially cylindrical ventral extension.

[0032] According to some embodiments of the invention, when the device is assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding proximal elongated rod, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated rod. According to an aspect of some embodiments of the present invention there is provided a method of delivering a patch to a target area, the method comprising: a. coupling the patch to a deployment subassembly of a surgical delivery device; b. Inserting the deployment subassembly, when in a first configuration in which the patch is collapsed, to the target area; c. at the target area, effecting transitioning of the deployment subassembly to a second configuration, in which the patch is expanded; and e. decoupling the patch from the surgical delivery device at the target area.

[0033] According to some embodiments of the invention, the coupling the patch to a deployment subassembly includes coupling each of a plurality of portions of the patch to an aperture defined in each of a plurality of elongated rods of the deployment assembly.

[0034] According to some embodiments of the invention, the coupling includes attaching a portion of the patch using a suture.

[0035] According to some embodiments of the invention, the coupling includes attaching a portion of the patch using jaws located at a distal portion of each of the plurality of elongated rods.

[0036] According to some embodiments of the invention, the surgical delivery device has a longitudinal axis, and wherein the patch is coupled to the deployment subassembly on a single side of the longitudinal axis.

[0037] According to some embodiments of the invention, the coupling includes attaching a portion of the patch using a plurality of barbs located along the plurality of elongated rods.

[0038] According to some embodiments of the invention, the decoupling includes pulling the deployment subassembly proximally and upward, thereby releasing the patch from the barbs and decoupling the patch from the surgical delivery device.

[0039] According to an aspect of some embodiments of the present invention there is provided a method of delivering a patch to a target area, the method comprising: a. coupling the patch to a deployment subassembly of a surgical delivery device; b. inserting the deployment subassembly, when in a first configuration in which the patch is collapsed, to the target area; c. at the target area, effecting transitioning of the deployment subassembly to a second configuration, in which the patch is expanded wherein, in the second configuration, the surgical delivery device does not interfere with stitching of the patch at the target area; and e. decoupling the patch from the surgical delivery device at the target area. According to an aspect of some embodiments of the present invention there is provided a surgical delivery device for delivering a patch to a tissue to be repaired at a surgical site, wherein the surgical delivery device comprises: a shaft having a distal end; and a deployment subassembly at the shaft distal end, the deployment subassembly having a plurality of connection stations removably couplable to the patch, the deployment subassembly transitionable between a first configuration in which the patch is collapsed and a second configuration in which the patch is expanded; wherein an area of the patch to be positioned over the tissue is defined between connection stations; wherein, when in the second configuration, the surgical delivery device does not overlap the area.

[0040] According to some embodiments of the invention, the shaft has a proximal end, and wherein the device includes a handle at the shaft proximal end, the handle including an actuator for effecting movement of the deployment subassembly between the first configuration and the second configuration.

[0041] According to an aspect of some embodiments of the present invention there is provided a surgical delivery device for delivering a patch to a surgical site, wherein the surgical delivery device comprises: a shaft having a proximal end and a distal end; a deployment subassembly at the shaft distal end, the deployment subassembly having a plurality of connectors removably couplable to the patch, the deployment subassembly transitionable between a first configuration in which the patch is collapsed, a second configuration in which the patch is expanded, and a third configuration in which the patch is released from the connectors; and a handle at the shaft proximal end, the handle including an actuator for effecting movement of the deployment subassembly among the first configuration, the second configuration, and the third configuration.

[0042] According to an aspect of some embodiments of the present invention there is provided a surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration and a deployment configuration, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and the push rod having a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having four elongated deployment plank members, operable to rotatably transition between the insertion configuration and the deployment configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to transition between the insertion configuration and the deployment configuration.

[0043] According to some embodiments of the invention, each elongated deployment plank member defines: a. a proximal end defining a proximal aperture and a distal end; b. an axial slit having a proximal end and a distal end; and c. a lateral protrusion defining an eyelet therein.

[0044] According to some embodiments of the invention, the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, the dorsal extension having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, the ventral extension having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal pin, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit, defined in two of the elongated deployment plank members; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

[0045] According to some embodiments of the invention, the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of a pair of distal elongated deployment plank members, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated deployment plank members, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture, defined in the proximal end of the pair of distal elongated deployment plank members, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture, defined in the proximal end, of the pair of proximal elongated deployment plank members, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the ventral extension.

[0046] According to some embodiments of the invention, when the device is assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding proximal elongated deployment plank members, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated deployment plank members.

[0047] According to some embodiments of the invention, the method comprises: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; and e. decoupling the patch at the target area.

[0048] According to some embodiments of the invention, the patch is a quadrilateral sheet, sized and configured to couple to the aperture defined in each of the pair of proximal elongated deployment plank members, and the pair of distal elongated deployment plank members.

[0049] According to an aspect of some embodiments of the present invention there is provided a surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration, a deployment configuration, and a decoupling configuration, wherein, in the decoupling configuration, the surgical delivery device is operable to decouple the patch from the deployment subassembly of the surgical delivery, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having four elongated deployment plank members, operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to reversibly transition between the insertion configuration, the deployment configuration, and the decoupling configuration.

[0050] According to some embodiments of the invention, each elongated deployment plank member is a resilient clamp defining a pair of jaws with: a. a common proximal end defining a proximal aperture and a split distal end; and b. an axial slit having a common proximal narrowed portion and a split distal narrowed portion.

[0051] According to some embodiments of the invention, the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

[0052] According to some embodiments of the invention, the common proximal narrowed portion of each elongated deployment plank member is narrower than each of the pair of proximal guiding pins, and the pair of distal guiding pins.

[0053] According to some embodiments of the invention, the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of a pair of distal elongated deployment plank members, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated deployment plank members, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the pair of distal elongated deployment plank members, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of the pair of proximal elongated deployment plank members, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the ventral extension.

[0054] According to some embodiments of the invention, when the device is assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of proximal elongated deployment plank members, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated deployment plank members.

[0055] According to some embodiments of the invention, upon translation of the push rod distally to the decoupling configuration, such that distal end of dorsal sliding rail, and ventral sliding rail respectively, each abuts the distal end of slits defined in dorsal extension and ventral extension respectively, each of the pair of proximal guiding pins and the pair of distal guiding pins are configured to frictionally engage common proximal narrowed portion of axial slit defined in each of the corresponding of proximal elongated deployment plank members, and the corresponding distal elongated deployment plank members, causing distal end to separate.

[0056] According to some embodiments of the invention, the method comprise: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; e. using the handle, transitioning the surgical delivery device to the decoupling configuration; and f. decoupling the patch at the target area.

[0057] According to some embodiments of the invention, each of the pair of proximal elongated deployment plank members, and the pair of distal elongated deployment plank members are configured to resiliently couple to the patch.

[0058] According to an aspect of some embodiments of the present invention there is provided a surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration and a deployment configuration, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having a pair of elongated bracket members and four elongated actuators, wherein the deployment subassembly being operable to transition between the insertion configuration and the deployment configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to transition between insertion configuration and deployment configuration.

[0059] According to some embodiments of the invention, each elongated bracket members, having a proximal end and a distal end, with an upper surface and a lower surface, each elongated bracket members further comprising a plurality of spurs extending basally and distally from the lower surface, and wherein each elongated bracket members further defines: a. a proximal aperture disposed adjacent to the proximal end; b. a distal aperture disposed distally to the proximal aperture respectively; c. a proximal opening disposed distally to the distal aperture; and d. a distal opening disposed proximally adjacent to the distal end of each elongated bracket members.

[0060] According to some embodiments of the invention, each of the four elongated actuators having a proximal end and a distal end, each of the four elongated actuators further having a proximal aperture defined adjacent to the proximal end, and a distal aperture defined adjacent the distal end, with an axial slit having a proximal end and a distal end.

[0061] According to some embodiments of the invention, the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two distal elongated actuators of the four elongated actuators; and e. a pair of proximal guiding pins disposed proximally to the pair of distal guiding pins, the pair of proximal guiding pins sized and configured to be accommodated in the axial slit defined in two proximal elongated actuators of the four elongated actuators.

[0062] According to some embodiments of the invention, the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of distal elongated actuators, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of proximal elongated actuators, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of distal elongated actuators, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of proximal elongated actuators, the dorsal sliding rail sized and configured to be accommodated in the ventral slot of the partially cylindrical dorsal extension.

[0063] According to some embodiments of the invention: a. the distal aperture of the pair of proximal elongated actuators is hingedly coupled to the proximal aperture of each elongated bracket members respectively; and b. the distal aperture of the pair of distal elongated actuators is hingedly coupled to the distal aperture of each elongated bracket members respectively.

[0064] According to some embodiments of the invention, when assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of proximal elongated actuators, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of distal elongated actuators.

[0065] According to some embodiments of the invention, the method comprises: a. using the surgical delivery device in the deployment configuration, and using the spurs, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; and e. pulling the elongated bracket members proximally and upward, thereby releasing the patch from the spurs and decoupling the patch at the target area.

[0066] According to some embodiments of the invention, the patch is a quadrilateral sheet, sized and configured to couple to the spurs extending basally and distally from the lower surface of each of elongated bracket members.

[0067] According to an aspect of some embodiments of the present invention there is provided a surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration, a deployment configuration, and a decoupling configuration, wherein, in the decoupling configuration, the surgical delivery device is operable to decouple the patch from the deployment subassembly of the surgical delivery, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having a pair of elongated deployment plank members, disposed proximally and distally on the same side of the shaft, operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to reversibly transition between the insertion configuration, the deployment configuration, and the decoupling configuration.

[0068] According to some embodiments of the invention, each elongated deployment plank member is a resilient clamp defining a pair of jaws with: a. a common proximal end defining a proximal aperture and a split distal end; and b. an axial slit having a common proximal narrowed portion and a split distal narrowed portion; c. a proximal ruler spanning a substantial length of proximal jaw with a proximally extending arcuate member, slidably coupled to a proximal facet of the proximal jaw.

[0069] According to some embodiments of the invention, the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. at least one proximal guiding pin, sized and configured to be accommodated in the axial slit defined in the proximally disposed elongated deployment plank member; and e. at least one distal guiding pin sized and configured to be accommodated in the axial slit defined in the distal elongated deployment plank member.

[0070] According to some embodiments of the invention, the common proximal narrowed portion of each elongated deployment plank member is narrower than each of the at least one guiding pin, and the at least one distal guiding pins.

[0071] According to some embodiments of the invention, the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the distally disposed elongated deployment plank member, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of the proximally disposed elongated deployment plank member, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the distally disposed elongated deployment plank member, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of the proximally disposed elongated deployment plank member, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension.

[0072] According to some embodiments of the invention, when the device is assembled, the at least one proximal guiding pin is each configured to be slidably accommodated in the axial slit defined in the proximally disposed elongated deployment plank member, and the at least one guiding pin is configured to be slidably accommodated in the axial slit defined in a corresponding distally disposed elongated deployment plank member.

[0073] According to some embodiments of the invention, upon translation of the push rod distally to the decoupling configuration, such that distal end of dorsal sliding rail, and ventral sliding rail respectively, each abuts the distal ends of slits, defined in dorsal extension and ventral extension respectively, each of the at least one proximal guiding pin and the at least one distal guiding pin are each configured to frictionally engage common proximal narrowed portion of axial slit defined in each of the corresponding of proximally disposed elongated deployment plank member, and the corresponding distally disposed elongated deployment plank member, causing jaws to separate.

[0074] According to some embodiments of the invention, the method comprises: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. At the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; e. using the handle, transitioning the surgical delivery device to the decoupling configuration; and f. Decoupling the patch at the target area.

[0075] According to some embodiments of the invention, the patch is a quadrilateral sheet, and wherein each of the proximally disposed elongated deployment plank member, and the distally elongated deployment plank member are configured to reversibly engage the patch on one side only.

[0076] BRIEF DESCRIPTION OF THE SEVERAL VIEW OF THE DRAWINGS

[0077] The surgical delivery device disclosed herein will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings. Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0078] In the drawings:

[0079] FIG. 1A is a simplified pictorial illustration of a surgical delivery device, constructed and operative in accordance with an exemplary implementation thereof, shown in an insertion configuration;

[0080] FIG. IB is a simplified pictorial illustration of the surgical delivery device of Fig. 1A, shown in a deployment configuration, according to some embodiments;

[0081] FIG. 1C is a simplified enlargement view of a portion of the surgical delivery device of Figs. 1A and IB, according to some embodiments;

[0082] FIG. 2A is a simplified pictorial illustration of a surgical delivery device, constructed and operative in accordance with another exemplary implementation thereof, shown in an insertion configuration, according to some embodiments;

[0083] FIG. 2B is a simplified pictorial illustration of the surgical delivery device of Fig. 2A, shown in a deployment configuration, according to some embodiments;

[0084] FIG. 2C is a simplified enlargement view of a portion of the surgical delivery device of Figs. 2 A and 2B, according to some embodiments;

[0085] FIG. 3A is a simplified pictorial illustration of a surgical delivery device, constructed and operative in accordance with still another exemplary implementation thereof, shown in an insertion configuration, according to some embodiments;

[0086] FIG. 3B is a simplified pictorial illustration of the surgical delivery device of Fig. 3A, shown in a deployment configuration, according to some embodiments;

[0087] FIG. 3C is a simplified enlargement view of a portion of the surgical delivery device of Figs. 3A and 3B, according to some embodiments; FIG. 4A is a simplified enlarged partial pictorial illustration of a deployment subassembly coupled to a push rod, forming part of the surgical delivery device of Figs. 1A - 1C, shown in an insertion configuration, wherein some components have been omitted for clarity, according to some embodiments;

[0088] Fig. 4B is a simplified enlarged partial pictorial illustration of a deployment subassembly coupled to a push rod, forming part of the surgical delivery device of Figs. 2A - 2C, shown in an insertion configuration, wherein some components have been omitted for clarity, according to some embodiments;

[0089] FIG. 5A is a simplified enlarged partial sectional illustration of the cylindrical shaft, forming part of the surgical delivery device of Figs. 1A - 1C, according to some embodiments;

[0090] FIG. 5B is a simplified enlarged partial sectional illustration of the cylindrical shaft, forming part of the surgical delivery device of Figs. 2A - 2C, according to some embodiments;

[0091] FIG. 5C is a simplified enlarged partial sectional illustration of the cylindrical shaft, forming part of the surgical delivery device of Figs. 3A - 3C, according to some embodiments;

[0092] FIG. 6 is a simplified enlarged partial sectional illustration of a deployment subassembly coupled to a cylindrical shaft and to a push rod, forming part of the surgical delivery device of Figs. 1A - IB, shown in an insertion configuration, according to some embodiments;

[0093] FIG. 7A is a simplified enlarged partial sectional illustration of a deployment subassembly coupled to a cylindrical shaft and to a push rod, forming part of the surgical delivery device of Figs. 2 A - 2B, shown in an insertion configuration, according to some embodiments;

[0094] FIG. 7B is a simplified enlarged partial sectional illustration of a deployment subassembly coupled to a cylindrical shaft and to a push rod, forming part of the surgical delivery device of Figs. 2 A - 2B, shown in a decoupling configuration, according to some embodiments;

[0095] FIG. 7C is a simplified pictorial illustration of a surgical delivery device, constructed and operative in accordance with an alternative exemplary implementation thereof, having components similar to those of the surgical delivery device of Figs. 2A - 2B, shown in a deployment configuration;

[0096] FIG. 8A is a simplified enlarged partial sectional illustration of a deployment subassembly coupled to a cylindrical shaft and to a push rod, forming part of the surgical delivery device of Figs. 3 A - 3B, shown in a deployment configuration, according to some embodiments;

[0097] FIG. 8B is a simplified enlargement view of a portion of the deployment subassembly of the surgical delivery device of Figs. 3A - 3B, according to some embodiments; Fig. 8C is a simplified enlarged pictorial illustration of the deployment subassembly forming part of the surgical delivery device of Figs. 3 A -3B, shown in a deployment configuration, according to some embodiments;

[0098] FIG. 9 is a simplified pictorial illustration of a patch configured to be coupled to one of the deployment sub-assemblies of Fig. 4A, 4B, 7C, 8A, according to some embodiments;

[0099] FIG. 10A is a perspective view of a surgical delivery device similar to that shown in Fig. 3A, the device having a patch coupled thereto and positioned substantially above the device, according to some embodiments;

[0100] FIG. 10B is a perspective view of a surgical delivery device of similar to that shown in Fig. 1A, the device having a patch coupled thereto by sutures, according to some embodiments;

[0101] FIG. 11A is a perspective view of the surgical delivery device of Fig. 10B, the device having the patch attached thereto shown in a deployment configuration, according to some embodiments;

[0102] FIG. 1 IB is a top view of the surgical delivery device shown in Fig. 11 A, the device shown in a deployment configuration and having a patch attached thereto by sutures, according to some embodiments;

[0103] FIGs. 12A-B are sectional perspective views of a surgical delivery device having an alternative actuating mechanism, the device shown in respective insertion and deployment configurations, according to some embodiments;

[0104] FIG. 13A is a perspective view of the surgical delivery device of Fig. 3A-B, the surgical delivery device shown in an insertion configuration at a surgical site (enlarged to show detail), and the surgical delivery device having a patch coupled thereto, according to some embodiments;

[0105] FIG. 13B is a perspective view of the surgical delivery device of Fig. 13A, shown after insertion via a first incision at a surgical site, according to some embodiments;

[0106] FIG. 13C is a perspective view of the surgical delivery device of Fig. 13B, the device shown in a deployment configuration, and a patch attachment device inserted at a second incision at the surgical site (enlarged to show detail), according to some embodiments;

[0107] FIG. 13D is a perspective view of the surgical delivery device of Fig. 13B, after attachment of the patch at the surgical site, the surgical delivery device having been withdrawn from the first incision;

[0108] FIG. 14 is a perspective view of a surgical delivery device having a bendable shaft, according to some embodiments; and

[0109] FIG. 15 is a perspective view of a surgical delivery device having a shaft with a bendable portion, according to some embodiments. While the disclosure of the surgical delivery device disclosed herein, is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be further described in detail hereinbelow. It should be understood, however, that the intention is not to limit the disclosure to the particular exemplary implementations described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives. For example, dimensions of various components such as, for example, lengths and widths, may be modified to accommodate various sizes of patches. ..Additionally, the actuation method, by which the patch is opened / spread out by the device may include a trigger-like mechanism, as known in the art.

[0110] DETAILED DESCRIPTION

[0111] The present invention, in some embodiments thereof, is directed to a surgical instrument and method for delivering a patch to a surgical site and, more particularly, but not exclusively, to a surgical instrument having a shaft and a deployment subassembly selectively couplable to a patch at a plurality of connection stations. The deployment subassembly may be effected to transition between a first configuration, in which the patch is collapsed, and a second configuration, in which the patch is expanded or spread out and can be applied at the surgical site.

[0112] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways such as, for example, as discussed herein.

[0113] Provided herein are exemplary implementations of the surgical delivery device operable for delivering a patch to a surgical treatment area and method of use thereof. The device can be used for example in the repair of a torn tendon in a rotator cuff, according to some embodiments.

[0114] The accepted treatment for a full thickness tear or a partial thickness tear greater than 50% involves reconnecting the tom tendon via sutures, with the surgeon sometimes positioning a sheetlike patch over the sutured area to strengthen the repair and try to prevent recurrent tears. The disclosed surgical delivery device can be used in any arthroscopic or open surgery in the management of this pathology, or in any other procedure in which a patch is to be applied, according to some embodiments. These may include, for example, arthroscopic surgery of, for example, a rotator cuff, a patella, or an Achilles tendon; endoscopic or general surgery; and open or semi-open surgery anywhere a patch may be needed. An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the surgical delivery device may include a deployment subassembly having a plurality of elongated plank members such as, for example, rods or grippers or brackets, to which the patch may be releasably connected, prior to insertion of the device at the surgical site, according to some embodiments. After insertion of the device on which the patch has been coupled, the device in a collapsed configuration, via an incision at the surgical site, according to some embodiments, the device may be expanded over the surgical site, thereby spreading the patch over the surgical site, after which the patch may be attached to the tissue at the surgical site, for example, by suturing or by any other suitable method.

[0115] An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the patch may be introduced via an incision in a collapsed or folded configuration and thereafter intentionally / actively actuated, using an actuation mechanism operated by a user such as, for example, a surgeon, to expand or spread out over the surgical site by actuation of the device having a knob or roller- type actuator, according to some embodiments. This type of actuation mechanism may allow more control of the expansion / spreading of the patch than other deployment devices, wherein a device is actuated by expansion of a portion of the device due to being heated by the body of the patient or by simple release of elastic force of the device, according to some embodiments. Optionally, passive deployment of the patch may be achieved, for example, by utilizing a device including a portion formed of a shape memory material. Alternatively, passive deployment of the patch may be achieved by utilizing a device including a portion inserted in a stressed state into a cannula, the portion deployed from the cannula, thereby allowing the portion to revert to a relaxed state.

[0116] An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the surgical delivery device is couplable to portions of the patch in such a manner that access to specific portions of the patch are not blocked by the device. For example, by coupling the patch to lateral portions of the device such as, for example, axially extending components disposed on either side of a longitudinal axis of the device, access may be allowed to the top and / or bottom portions of the patch, according to some embodiments. Alternatively, by coupling the patch to distal and proximal portions of the device such as, for example, laterally extending components, access may be allowed to lateral portions of the patch, according to some embodiments. Such configurations may prevent mechanical interference between the surgical delivery device and a device for stitching or suturing or otherwise attaching the patch at the surgical site. An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the surgical delivery device may not overlap the patch, at least at the central portion of the patch. This may be affected by providing the surgical delivery device with brackets having connection stations for coupling the patch to the device, the brackets positionable laterally relative to a central portion of the patch, or a first bracket positioned proximally relative to a central portion of the patch and a second bracket positioned distally relative to the central portion of the patch. This may facilitate stitching or suturing or otherwise attaching the patch to the surgical site without mechanical interference by the device itself, according to some embodiments. Additionally, the surgical delivery device according to some embodiments may allow suturing or otherwise attaching the patch to the surgical site without the device itself blocking the view of the surgeon during the suturing, according to some embodiments.

[0117] An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the surgical delivery device may include a deployment subassembly including attachment members such as, for example, elongate rods or brackets having jaws or clips, for coupling a patch to the surgical delivery device, according to some embodiments. The jaws or clips may open automatically after the device has been expanded, and it is desired to release the patch from the device, thereby facilitating placement of the patch at the surgical site, according to some embodiments.

[0118] An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, the device having a deployment subassembly disposed on a single side of the device, i.e., proximal and distal elongated deployment plank members on one side only of a longitudinal shaft of the device shaft. Such an asymmetric configuration of the deployment subassembly may potentially allow for insertion of the surgical delivery device through a narrower working channel, since there may be no laterally protruding portions of the deployment subassembly at least on one of the sides of the shaft, according to some embodiments. Additionally, this configuration of the surgical delivery device may be useful for certain target areas that may require such geometry in which a patch may be deployed only on one side of the shaft, according to some embodiments. An aspect of some embodiments relates to a surgical delivery device for deployment of a patch at a surgical site, wherein the surgical delivery device may include a deployment subassembly including attachment members such as, for example, spurs or barbs or curved / L- shaped pegs, for coupling the patch to the surgical delivery device, according to some embodiments. The attachment members may be located, for example, on elongated brackets to be positioned on either side of the patch (when spread out). After the device has been expanded and the patch has been positioned at the surgical site, the device may be moved slightly proximally (or distally or laterally, depending on the attachment of the spurs / barbs / pegs to the patch) to release the patch from the device, according to some embodiments.

[0119] In addition, and as needed, the surgical delivery device disclosed can be used in other arthroscopic surgeries as well.

[0120] The term “coupled”, including its various forms such as “operably coupling”, "coupling" or "couplable", may refer to and may comprise any direct or indirect, structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection, according to some embodiments.

[0121] The term "slidably coupled" may be used in its broadest sense to refer to elements that are coupled in a way that permits one element to slide or translate with respect to another element. Additionally, the term “slidably” or “slidably coupled” may refer to movement of one surface (for example push rod 200) over, or within a second surface (for example, cylindrical shaft 100) while maintaining smooth continuous contact between the two surfaces, according to some embodiments. In some embodiments, the term “slidably coupled” may refer to a state in which two or more components are coupled to one another such that at least one of the components slides with respect to at least another component. Similarly; the terms “slide,” “slid” or “sliding” may be defined as moving, gliding or passing along or through a surface or a space, although continuous contact at each point along the path is not necessarily required.

[0122] In addition, for the purposes of the present disclosure, directional or positional terms such as “proximal”, “distal”, "top", "bottom", "upper," "lower," "side," "front," "frontal," "forward," "rear," "rearward," "back," "trailing," "above," "below," "left," "right," "radial ," "vertical," "upward," "downward," "outer," "inner," "exterior," "interior," "intermediate,", “apical”, “basal”, “dorsal”, “ventral” etc., are merely used for convenience in describing the various exemplary implementations of the present disclosure. Generally, the term “proximal” will be used herein to indicate closer to the user such as, for example, a surgeon, and “distal” will be generally used herein to indicate further from the user. “Dorsal” is generally used herein to indicate the upper side of the device when in position at a surgical site such as, for example, in the view in Fig. 10A, and “ventral” is generally used herein to indicate the lower side of the device when in position at surgical site (see, e.g., Fig. 10A). Other terms listed here are relative to the view shown in the relevant drawing(s). The term "engage" and various forms thereof, when used with reference to an engaging element, may refer in an exemplary implementation to the application of any forces that tend to hold together against inadvertent or undesired separating forces. It is to be understood, however, that engagement does not in all cases require an interlocking connection that is maintained against every conceivable type or magnitude of separating force. Further, the term "engaging element" may refer in another exemplary implementation to one or a plurality of coupled components, at least one of which may be configured for releasably engaging another element. Thus, this term encompasses both single part engaging elements and multi-part- assemblies.

[0123] The terms “first,” “second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms “a”, “an” and “the” herein do not denote a limitation of quantity, and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term.

[0124] Reference throughout the specification to “one exemplary implementation”, “another exemplary implementation”, “an exemplary implementation”, and so forth, means that a particular element (e.g., step, feature, structure, and / or characteristic) described in connection with the exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplary implementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0125] In the context of the disclosure, the term "operable" means the system and / or the device, or a certain element or step may be fully functional, sized, adapted and calibrated, comprises elements for, and meets applicable operability requirements to perform a recited function when activated, coupled, implemented, actuated, effected, or realized. In relation to systems, the term "operable" means the system may be fully functional and calibrated, having the necessary elements, as well as the mechanisms for, and meets applicable operability requirements to perform a recited function when executed by a user.

[0126] The term “abut” may refer in the context of the disclosure, to items that are in direct physical contact with each other, although the items may not be attached, secured, fused, glued, sewn, or welded together.

[0127] In the context of the disclosure, the term “accommodate” may refer to the ability of an accommodating element (e.g., axial bore 110 of the cylindrical shaft 100) to allow passage or retention of another element (e.g., push rod 200) at close tolerance, without substantial space for other elements or components.

[0128] Furthermore, in the context of the disclosure, the term "hinge" and its derivatives (e.g., “hinging element”) may refer to one or more parts which allow the second component to pivot with respect to the first component. Accordingly, "hingedly coupled" may indicate that the orientation of one component relative to the other can be varied. This may be because of a connecting region, which permits rotation, or because of a form of mechanical connection that may permit relative movement, for example a pivot or a hinge pin. There may be an intermediate portion, which may be hinged at respective spaced locations to the first and second portions, allowing a greater degree of hinging in one or more directions. Yet further, in the context of the disclosure, the term “slit” or “slot” maybe used interchangeably and may refer to a long narrow opening, groove, or passage along which another component may pass, slide, move.

[0129] A more complete understanding of the surgical delivery device configured to deliver a patch to a surgical treatment area, may be obtained by reference to the accompanying drawings. These figures (also referred to herein as “FIG.”) are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to necessarily indicate relative size, scale and dimensions of the devices or components thereof, and / or to define or limit the scope of the exemplary implementations. Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the exemplary implementations selected for illustration in the drawings, and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.

[0130] It may be noted that various components located on a first portion of a surgical delivery device as described herein may have similar or identical corresponding components located on a second portion of the surgical delivery device. In many cases, for simplicity, such first and second similar or identical or corresponding components may be indicated by the same base reference number, possibly with the addition of an apostrophe to one of the first and second components, to distinguish therebetween. For example, with reference to Fig. 4 A, there is shown a dorsal sliding rail 302 located on a dorsal portion of the deployment subassembly 300, and a corresponding ventral sliding rail 302’ located on a ventral portion of the deployment subassembly 300. It may be noted that, with regard to some components discussed herein that have counterpart components, which may be similar or identical or corresponding, the description may refer to only a first or a second of the two components and, in some instances, the drawings may include a reference number for only a first or a second of the two components, for the sake of clarity.

[0131] FIRST EMBODIMENT - DEVICE WITH ELONGATED PLANK MEMBERS

[0132] Reference is now made to Fig. 1A, which is a simplified pictorial illustration of a surgical delivery device shown with a handle, constructed and operative in accordance with an exemplary implementation thereof, shown in an insertion configuration and to Fig. IB, which is a simplified pictorial illustration of the surgical delivery device of Fig. 1A, shown in a deployment configuration and to Fig. 1C, which is a simplified enlargement view of a portion of the surgical delivery device of Figs. 1A and IB.

[0133] Surgical delivery device 10 may include a handle 500 having an actuator, as discussed herein, and a longitudinal shaft 100 having a plurality of elongated rods or planks 301 couplable to a patch 700 (Fig. 9), as discussed herein. Exemplary embodiments of device 10 are discussed hereinbelow.

[0134] It may be noted that the planks 301 may be oriented substantially perpendicularly relative to the device longitudinal axis 12 when the device is in an open configuration and may be oriented substantially axially when the device is in a closed configuration, according to some embodiments. It may also be noted that the planks 301 may extend distally from the dorsal sliding rail 302 and the ventral sliding rail 302’ (discussed further herein), as seen most clearly in Fig 4A.

[0135] A surgical delivery device 10 for delivering a patch is seen in Figs. 1A and IB. According to some embodiments, the surgical delivery device 10 may define a longitudinal axis 12 and may be configured to transition between an insertion configuration and a deployment configuration. It is noted that the surgical delivery device is operative for insertion through the arthroscopic work channel along with the patch when disposed in the insertion configuration and may be operative for releasing the patch within the surgical treatment area when disposed in the deployment configuration, according to some embodiments.

[0136] According to some embodiments, shaft 100 and / or elongated planks 301 (may be formed of any medical grade metal or polymer, and may be of any suitable length and diameter. For example, shaft 100 may be from 5-200mm in length and from 3- 16mm in diameter. The dimensions of plank members 301 depend on the specific implementation of the surgical delivery device 10, such as, for example, the size of the patch 700 to be delivered to a surgical site. Components of alternative embodiments discussed herein may be formed of similar materials and components thereof may have similar dimensions, depending on the specific implementation. In an exemplary implementation, the patch may be made of a biodegradable material and may be of any size and shape suitable for the specific surgical procedure, according to some embodiments. Particularly, the patch may be formed as a sheet of material having a quadrilateral shape, according to some embodiments.

[0137] A patch, as discussed herein with regard to any of the embodiments described or shown in the drawings, may refer to any patch made of biological material or synthetic material such as, for example, a BioBrace® implant (Conmed Corporation), a Regeneten® Bioinductive implant (Smith & Nephew), an ArthroFLEX® allograft, (Arthrex, Inc.), etc. While dimensions of patches vary greatly, depending on the manufacturer, a patch may commonly be from O.l-33mm in thickness. A patch used in accordance with any of the embodiments discussed herein may be placed over a tear or partial tear, for example, of a tendon in a rotator cuff. The tom tissue may then grow into the patch, adding thickness above the degenerated portion of the tissue. This may reduce stress from the degenerated portion of the tissue, thereby facilitating healing of the tissue.

[0138] While the patch shown and described herein may appear to be of a rectangular shape, it will be appreciated by persons skilled in the art that, optionally, a patch of any suitable size and shape such as, for example, round or oval, may be used, depending on the size, shape, and location of the tear in the tissue, and depending on preference of the surgeon.

[0139] It is seen in Figs. 1A & IB that the surgical delivery device 10 may include a generally cylindrical shaft 100 arranged along the longitudinal axis 12, the shaft 100 having a proximal end 101 and a distal end 102, according to some embodiments. The cylindrical shaft 100 may be configured to be operably coupled to a handle 500 adjacent the shaft proximal end 101, as seen specifically in Fig. 1A, according to some embodiments. In accordance with this exemplary implementation, the cylindrical shaft 100 may be fixedly coupled to the handle 500. It is noted that the cylindrical shaft 100 may define an axial bore 110 extending along the longitudinal axis 12, according to some embodiments.

[0140] According to some embodiments, the surgical delivery device 10 is configured to be actuated by a user, to effect opening of the device. This may provide a potential advantage in allowing the user to have better control over opening and closing of the device, with corresponding folding and unfolding / spreading out of the patch. Additionally, this may potentially allow the patch to resist deformation after deployment, before being released from the device, according to some embodiments.

[0141] According to some embodiments, actuation of the device and opening / spreading out of the patch may be effected by any suitable means such as, for example, by incorporating a push rod 200 into the device, as discussed herein. It is noted that a push rod 200 such as, for example, as shown in Fig. 4 A, may be arranged along the longitudinal axis 12 and may have a proximal end 1

[0142] 201 and a distal end 202 (see e.g., Fig. 6), according to some embodiments. The proximal end 201 of the push rod 200 may be configured to be operably coupled to the handle 500, and the distal end 202 of the push rod 200 may be sized and configured to be accommodated in, and slidably coupled with respect to the axial bore 110 of the cylindrical shaft 100, according to some embodiments.

[0143] It is noted that, according to some embodiments, the handle 500 in accordance with an exemplary implementation may be arranged along the longitudinal axis 12, the handle having a proximal end 501, a distal end 502 and gripping protrusions 503, operable to engage, for example, sutures, such as, for example, sutures which may be utilized to attach a patch to the device (see, e.g. Fig. 10B), the sutures extending proximally toward the handle 500, and the gripping protrusions 503 may be formed adjacent the handle distal end 502 or at an intermediate location along the longitudinal extent of the handle 500. Handle 500 may be formed of any suitable material such as, for example, plastic, stainless steel, or aluminum. Gripping protrusions 503 are discussed further herein, with regard to Figs. 11A-B. The gripping protrusions 503 may be omitted in accordance with another exemplary implementation. According to some embodiments, the handle may define an axial bore 507 and an actuator 504 may be configured to be accommodated within the axial bore 507 of the handle 500 and slidably coupled with respect thereto. The actuator 504 in exemplary implementation may have a roller or knob 505 formed thereon, which protrudes laterally from the outer surface of the handle 500 through an opening 506 formed in the handle 500. It should be appreciated by a person skilled in the art that any type of handle may be used in accordance with an alternative exemplary implementation, such as a flat handle or the like.

[0144] It is further noted that the proximal end 201 (Fig. 4B) of the push rod 200 may be operably coupled to the actuator 504 of the handle 500, according to some embodiments. In an exemplary implementation, the proximal end 201 of the push rod 200 may be fixedly coupled to the actuator 504, so that the push rod 200 can be axially translated along the longitudinal axis 12 following manipulation of the knob 505 by the user such as, for example, by rotation or axial movement of the roller or knob 505. Specifically, according to some embodiments, axial rolling of the knob 505 in a distal direction may be configured to cause slidable axial displacement of the push rod 200 relative to the cylindrical shaft 100. Alternatively, according to some embodiments, axial rolling (or, optionally, sliding of an actuator knob / slider) of the knob 505 in a proximal direction may be configured to cause slidable axial displacement of the push rod 200 relative to the cylindrical shaft 100. Such an embodiment is discussed further herein, with regard to Figs. 12A-B. Optionally, the knob 505 may be configured to lock in one of a number of positions such as, for example, corresponding to when the patch is folded (e.g., as shown in Fig. 10A), partly unfolded, or open / spread out (e.g., as shown in Fig. 11 A).

[0145] It is further seen in Figs. 1A & IB that a deployment subassembly 300 (a portion of which is shown in more detail in Fig. 4B) may be configured to be operably coupled to the distal end 202 of the push rod 200 and to the cylindrical shaft 100, according to some embodiments. In accordance with this exemplary implementation, the deployment subassembly 300 may have a plurality such as, for example, four, elongated deployment members 301 such as, for example, elongated planks or rods or bars or brackets or the like, including a pair of proximal plank members and a pair of distal plank members. The deployment subassembly 300 may be operable to rotatably transition between the insertion configuration and the deployment configuration, according to some embodiments, upon axial slidable translation of the push rod 200 relative to the cylindrical shaft 100 following manipulation of the knob 505 of handle 500 by the user. Use of device 10 with a patch 700 (Fig. 9) will be discussed further with reference to Fig. 10B.

[0146] While, in the embodiments shown, the patch deployment members are shown as being elongated planks 301 (Fig. 1C) or 310 (Fig. 2C) or elongated bracket members 320 (Fig. 3A), it will be appreciated by person skilled in the art that, optionally, the deployment members may have any suitable configuration such as, for example, arcuate, for example, corresponding to the shape of a circular or elliptically- shaped patch, according to some embodiments.

[0147] While, in the embodiments shown, various components such as, for example, the elongated deployment plank members 301 (Fig. 1C), 310 (Fig. 2C), and 321 (Fig. 8B), and the elongated bracket members 320 (Fig. 3B) are each shown as having a rectangular cross-sectional profile, it should be noted that this is for illustrative purposes only. Similarly, in the embodiments shown, the shaft 100 is shown as having a circular cross-sectional profile. However, it will be appreciated by persons skilled in the art that, alternatively, any of the various components described herein may have any suitable cross-sectional profile that can withstand the forces involved in opening / closing the device at the surgical site and inserting the device via an incision at the surgical site.

[0148] Other cross-sectional profiles that may be suitable for components of the surgical delivery device, according to some embodiment, may be for example, rectangular, circular or elliptical, depending on the location of the surgical site and preference of the surgeon.

[0149] Optionally, the deployment subassembly 300 and / or the shaft 100 may be deployed via a cannula to be introduced at the surgical site, or via an endoscope, a thoracoscope, etc. Optionally, the device may have a flexible portion or a bendable portion such as, for example, a flexible or bendable shaft, as discussed further herein with regard to Figs. 14-15. Optionally, the shaft may be utilized for the delivery of flexible or bendable delivery tools (not shown).

[0150] SECOND EMBODIMENT - DEVICE WITH JAW-LIKE PLANK MEMBERS

[0151] Reference is now made to Fig. 2A, which is a simplified pictorial illustration of a surgical delivery device shown with a handle, constructed and operative in accordance with another exemplary implementation thereof, shown in an insertion configuration and to Fig. 2B, which is a simplified pictorial illustration of the surgical delivery device of Fig. 2 A, shown in a deployment configuration and to Fig. 2C, which is a simplified enlargement view of a portion of the surgical delivery device of Figs. 2A and 2B.

[0152] Surgical delivery device 20 may include a handle 500 having an actuator, as discussed herein, and a longitudinal shaft 100 having a plurality of elongated rods or planks 310 couplable to a patch 700 (Fig. 9), as discussed herein. Exemplary embodiments of device 20 are discussed hereinbelow.

[0153] It may be noted that the planks 310 may be oriented substantially perpendicularly relative to the device longitudinal axis 12 when the device is in an open configuration and may be oriented substantially axially when the device is in a closed configuration, according to some embodiments. It may also be noted that the planks 310 may extend distally from the dorsal sliding rail 302 and the ventral sliding rail 302’ (discussed further herein), as seen most clearly in Fig 4B.

[0154] A surgical delivery device 20 for delivering a patch, according to some embodiments, is seen in Figs. 2A - 2C. The surgical delivery device 20 may define a longitudinal axis 12 and may be configured to transition between an insertion configuration, a deployment configuration and a decoupling configuration, according to some embodiments. It is noted that the surgical delivery device may be operative for insertion through the arthroscopic work channel along with the patch when disposed in the insertion configuration, operative for deploying the patch at the surgical target area when disposed in the deployment configuration and may be operative for releasing the patch within the surgical target area when disposed in the decoupling configuration, according to some embodiments.

[0155] In an exemplary implementation, the patch may be made of a biodegradable material and may be of any size and shape suitable for the specific surgical procedure. Particularly, the patch may be formed as a sheet of material having a quadrilateral shape, according to some embodiments.

[0156] It may be seen in Figs. 2A & 2B that, according to some embodiments, the surgical delivery device 20 may include a generally cylindrical shaft 100 arranged along the longitudinal axis 12, the shaft having a proximal end 101 and a distal end 102. The cylindrical shaft 100 may be configured to be operably coupled to a handle 500 adjacent the shaft proximal end 101, according to some embodiments. In accordance with this exemplary implementation, the cylindrical shaft 100 may be fixedly coupled to the handle 500. It may be noted that the cylindrical shaft 100 may define an axial bore 110 extending along the longitudinal axis 12, according to some embodiments.

[0157] It may be noted that a push rod 200 may be arranged along the longitudinal axis 12 and may have a proximal end 201 and a distal end 202 (see e.g., Figs. 4B and Figs. 7A & 7B), according to some embodiments. The proximal end 201 of the push rod 200 may be configured to be operably coupled to the handle 500, and the distal end 202 of the push rod 200 may be sized and configured to be accommodated in, and slidably coupled with respect to the axial bore 110 of the cylindrical shaft 100, according to some embodiments.

[0158] It may be noted that the handle 500, in accordance with an exemplary implementation, may be arranged along the longitudinal axis 12 and may have a proximal end 501, a distal end 502 and gripping protrusions 503, operable to engage, for example, sutures, and may be formed adjacent the handle distal end 502 or at an intermediate location along the longitudinal extent of the handle 500. The gripping protrusions 503 may be omitted in accordance with another exemplary implementation. According to some embodiments, the handle may define an axial bore 507 and an actuator 504 may be configured to be accommodated within the axial bore 507 of the handle 500 and slidably coupled with respect thereto. The actuator 504 in exemplary implementation may have a knob 505 formed thereon, which protrudes laterally from the outer surface of the handle 500 through an opening 506 formed in the handle 500. It is appreciated by a person skilled in the art that any type of handle may be used in accordance with an alternative exemplary implementation, such as flat handle or the like.

[0159] It may be seen in Fig. 2A that, according to some embodiments, demarcations (5021, 5022, 5023) may be provided on the handle 500, indicating the axial position of the push rod 200 relative to the cylindrical shaft 100. According to some embodiments, when the knob 505 is aligned with demarcation 5021, the surgical delivery device 20 may be disposed in the insertion configuration. When the push rod 200 is translated axially distally relative to the cylindrical shaft 100, the knob 505 may be aligned with demarcation 5022 and the surgical delivery device 20 may be disposed in the deployment configuration, according to some embodiments. When the push rod 200 is further translated axially distally relative to the cylindrical shaft 100, the knob 505 may be aligned with demarcation 5023 and the surgical delivery device 20 may be disposed in the decoupling configuration, according to some embodiments, as discussed further herein. It may be further noted that, according to some embodiments, the proximal end 201 of the push rod 200 may be operably coupled to the actuator 504 of the handle 500. In exemplary implementation, the proximal end 201 of the push rod 200 may be fixedly coupled to the actuator 504, so that the push rod 200 can be axially translated along the longitudinal axis 12 following manipulation of the knob 505 by the user. Specifically, axial displacement of the knob 505 in a distal direction may be configured to cause slidable axial displacement of the push rod 200 relative to the cylindrical shaft 100, according to some embodiments.

[0160] It may be further seen in Figs. 2A & 2B that a deployment subassembly 300 (Fig. 4B) may be configured to be operably coupled to the distal end 202 of the push rod 200 and to the cylindrical shaft 100, according to some embodiments. In accordance with this exemplary implementation, the deployment subassembly 300 may have four elongated deployment plank members 310, including a pair of proximal plank members and a pair of distal plank members. The deployment subassembly 300 shown in Figs. 2A - 2C, 4B, 5B, 7A and 7B may be operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration upon axial slidable translation of the push rod 200 relative to the cylindrical shaft 100, following manipulation of the knob 505 of handle 500 by the user, according to some embodiments. Specifically, the device 20 may be transitioned from a first configuration, in which the patch 700 is folded while being retained by the jaws 3106, 3106’; to a second configuration, in which the patch 700 is open / spread out by the device 20, while still being retained by the jaws 3106, 3106’; and to a third configuration, in which the jaws 3106, 3106’ are caused to release the patch 700.

[0161] Optionally, the surgical delivery device 20 may be configured such that there are at least three predetermined positions of the knob 505, these positions corresponding to an orientation of the device in which the patch 700 is folded; an open / spread out orientation of the device, in which the patch is open / spread out at the surgical site; and a release orientation, at which the already open / spread out patch is released from the jaws 3106, 3106’ of device 20.

[0162] THIRD EMBODIMMENT-DEVICE WITH ELONGATED BRACKET MEMBERS

[0163] Reference is now made to Fig. 3A, which is a simplified pictorial illustration of a portion of a surgical delivery device 30 for delivering a patch, constructed and operative in accordance with still another exemplary implementation thereof, shown in an insertion configuration; to Fig. 3B, which is a simplified pictorial illustration of the surgical delivery device of Fig. 3 A, shown in a deployment configuration; and to Fig. 3C, which is a simplified enlargement view of a portion of the surgical delivery device of Figs. 3A and 3B. According to some embodiments, the surgical delivery device 30 may define a longitudinal axis 12 and may be configured to transition between an insertion configuration and a deployment configuration. It is noted that the surgical delivery device 30 may be operative for insertion through the arthroscopic work channel along with the patch when disposed in the insertion configuration and may be operative for deploying the patch at the surgical target area when disposed in the deployment configuration, according to some embodiments.

[0164] In an exemplary implementation, the patch may be made of a biodegradable material and may be of any size and shape suitable for the specific surgical procedure. Particularly, the patch may be formed as a sheet of material having a quadrilateral shape, according to some embodiments. Exemplary patches are discussed herein.

[0165] Surgical delivery device 30 may include a handle 500 having an actuator, as discussed herein, and a longitudinal shaft 100 having a pair of elongated brackets or rods 320 couplable to a patch 700 (Fig. 9), as discussed herein. Exemplary embodiments of device 30 are discussed hereinbelow.

[0166] It may be seen in Figs. 3 A & 3B that the surgical delivery device 30 may include a generally cylindrical shaft 100 arranged along the longitudinal axis 12, the shaft having a proximal end 101 and a distal end 102, according to some embodiments. The cylindrical shaft 100 may be configured to be operably coupled to a handle (not shown) adjacent the shaft proximal end 101, according to some embodiments. In accordance with this exemplary implementation, the cylindrical shaft 100 may be fixedly coupled to the handle. It may be noted that the cylindrical shaft 100 may define an axial bore extending along the longitudinal axis 12, according to some embodiments.

[0167] It may be noted that, according to some embodiments, a push rod 200 may be arranged along the longitudinal axis 12, the push rod 200 having a proximal end 201 and a distal end 202 (see e.g., Fig. 8A). The proximal end 201 of the push rod 200 may be configured to be operably coupled to the handle, and the distal end 202 of the push rod 200 may be sized and configured to be accommodated in, and slidably coupled with respect to the shaft axial bore 110, according to some embodiments.

[0168] It may be noted that the handle in accordance with an exemplary implementation may be arranged along the longitudinal axis 12 and may include a proximal end, a distal end and gripping protrusions, operable to engage, for example, sutures, similar in structure and / or function to corresponding components illustrated in Figs. 1A and 2A. The gripping protrusions may be omitted in accordance with another exemplary implementation. The handle may define an axial bore and an actuator configured to be accommodated within the axial bore of the handle, according to some embodiments. The actuator may be similar in structure and / or function to a corresponding component illustrated in Figs. 1A and 2A, according to some embodiments.

[0169] It may be further noted that, according to some embodiments, the proximal end 201 of the push rod 200 may be operably coupled to the actuator of the handle. In exemplary implementation, the proximal end 201 of the push rod 200 may be fixedly coupled to the actuator, so that the push rod 200 can be axially translated along the longitudinal axis 12 following manipulation of the knob by the user. Specifically, axial displacement of the knob in a distal direction may be configured to cause slidable axial displacement of the push rod 200 relative to the cylindrical shaft 100, according to some embodiments.

[0170] It may be further seen in Figs. 3A - 3C that, according to some embodiments, a deployment subassembly 300 may be operably coupled to the distal end 202 of the push rod 200 and to the cylindrical shaft 100. In accordance with this exemplary implementation, the deployment subassembly 300 may include a pair of elongated rods or planks or bracket members 320, 320’, and four elongated actuators 321.

[0171] It may be noted that the bracket members 320, 320’ may be oriented axially when the device is in an open configuration and when the device is in a closed configuration, according to some embodiments. It may also be noted that the bracket members 320, 320’ may extend distally from the elongated actuators 321, as seen most clearly in Figs. 3A-B.

[0172] The deployment subassembly 300 shown in Figs. 3A - 3C and 8A - 8C may be operable to transition between the insertion configuration and the deployment configuration upon axial slidable translation of the push rod 200 relative to the cylindrical shaft 100 following manipulation of the knob 505 of handle 500 by the user, according to some embodiments. Use of device 30 with a patch 700 (Fig. 9) will be discussed further with reference to Fig. 10A.

[0173] It may be noted that, in the embodiment shown and discussed above, the surgical delivery device 30 is shown as having elongated bracket members 320, 320’ which are to be disposed on either side of a patch (see, e.g., Fig. 12B). This may facilitate placement of a patch and stitching (or otherwise attaching) of the patch at the surgical site without mechanically interfering with operation of a stitching device and / or without interfering with the view of the surgeon during the procedure. However, it will be appreciated by persons skilled in the art. that, the elongated bracket members 320, 320’ may be positioned laterally, relative to the device longitudinal axis 12, as shown in Fig. 3B. Such a configuration may be preferred in a surgical procedure such as, for example, wherein a tear in a tissue presents in a direction parallel to the device longitudinal axis 12. Alternatively, a surgical delivery device according to some embodiments, may be provided with elongated bracket members, a first positioned distal to the patch and a second positioned proximal to the patch. Such a configuration may be preferred such as, for example, in a surgical procedure wherein a tear in a tissue presents in a direction transverse to the device longitudinal axis 12.

[0174] FOURTH EMBODIMENT - DEVICE WITH PLANKS ON ONE SIDE ONLY

[0175] Reference is now made to Fig. 7C, which is a simplified pictorial illustration of the surgical delivery device 40, constructed and operative in accordance with an alternative exemplary implementation thereof similar to the surgical delivery device of Figs. 2A - 2C, shown in a deployment configuration

[0176] According to some embodiments, the surgical delivery device 40 may define a longitudinal axis 12 and may be configured to transition between an insertion configuration, a deployment configuration and a decoupling configuration. It may be noted that, according to some embodiments, the surgical delivery device may be operative for insertion through the arthroscopic work channel along with the patch when disposed in the insertion configuration, operative for deploying the patch at the surgical target area when disposed in the deployment configuration and may be operative for releasing the patch within the surgical target area when disposed in the decoupling configuration.

[0177] In an exemplary implementation, the patch may be made of a biodegradable material and may be of any size and shape suitable for the specific surgical procedure. Particularly, the patch may be formed as a sheet of material having a quadrilateral shape, according to some embodiments.

[0178] It may be seen in Fig. 7C that, according to some embodiments, the surgical delivery device 40 may include a generally cylindrical shaft 100 arranged along the longitudinal axis 12, the shaft having a proximal end 101 and a distal end 102. The cylindrical shaft 100 may be configured to be operably coupled to a handle 500 adjacent the shaft proximal end 101, according to some embodiments. In accordance with this exemplary implementation, the cylindrical shaft 100 may be fixedly coupled to the handle 500, and may define an axial bore 110 extending along the longitudinal axis 12, according to some embodiments.

[0179] It is noted that, according to some embodiments, a push rod 200 (shown more clearly in the embodiment of Fig. 4B) may be arranged along the longitudinal axis 12 and may have a proximal end 201 and a distal end 202. The proximal end 201 of the push rod 200 may be configured to be operably coupled to the handle 500, and the distal end 202 of the push rod 200 may be sized and configured to be accommodated in, and slidably coupled with respect to the axial bore 110 of the cylindrical shaft 100, according to some embodiments. It may be noted that, according to some embodiments, the handle 500 in accordance with an exemplary implementation may be similar in structure and function to the handle illustrated in any of the embodiments previously discussed herein and may include gripping protrusions 503, operable to engage, for example, sutures, and formed adjacent the handle distal end 502or at an intermediate location along the longitudinal extent of the handle 500. The gripping protrusions 503 may be omitted in accordance with another exemplary implementation. The handle may define an axial bore 507 and an actuator 504 may be configured to be accommodated within the axial bore 507 of the handle 500 and slidably coupled with respect thereto, according to some embodiments. The actuator 504 in exemplary implementation may have a knob 505 formed thereon, which protrudes laterally from the outer surface of the handle 500 through an opening 506 formed in the handle 500, according to some embodiments. It is appreciated by a person skilled in the art that, according to some embodiments, any type of handle may be used in accordance with an alternative exemplary implementation, such as flat handle or the like.

[0180] It may be seen in Fig. 7C that, according to some embodiments, demarcations (5021, 5022, 5023) may be provided on the handle 500, and may indicate the axial position of the push rod 200 relative to the cylindrical shaft 100. When the knob 505 is aligned with demarcation 5021, the surgical delivery device 20 may be disposed in the insertion configuration, according to some embodiments. When the push rod 200 is translated axially distally relative to the cylindrical shaft 100, the knob 505 may be aligned with demarcation 5022 and the surgical delivery device 20 may be disposed in the deployment configuration, according to some embodiments. When the push rod 200 is further translated axially distally relative to the cylindrical shaft 100, the knob 505 may be aligned with demarcation 5023 and the surgical delivery device 20 may be disposed in the decoupling configuration, wherein the jaws 3106 are opened to release the patch 700, according to some embodiments.

[0181] It is further noted that, according to some embodiments, the proximal end 201 of the push rod 200 may be operably coupled to the actuator 504 of the handle 500. In an exemplary implementation, the proximal end 201 of the push rod 200 may be fixedly coupled to the actuator 504, so that the push rod 200 can be axially translated along the longitudinal axis 12 following manipulation of the knob 505 by the user. Specifically, axial displacement of the knob 505 in a distal direction may be configured to cause slidable axial displacement of the push rod 200 relative to the cylindrical shaft 100, according to some embodiments.

[0182] It may be further seen in Fig. 7C that, according to some embodiments, a deployment subassembly 300 may be configured to be operably coupled to the distal end 202 of the push rod 200 and to the cylindrical shaft 100. In accordance with this exemplary implementation, the deployment subassembly 300 may have a pair of elongated deployment plank members 310, including a single proximal plank member and a single distal plank member, disposed proximally and distally on the same side of the shaft 100. The deployment subassembly 300 shown in Fig. 7C may be operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration upon axial slidable translation of the push rod 200 relative to the cylindrical shaft 100 following manipulation of the knob 505 of handle 500 by the user, according to some embodiments. It may be noted that, according to some embodiments, the handle 500 having a distal end 502 coupled to the proximal end 101 of the cylindrical shaft 100 may be operable to translate the push rod 200 axially, causing the deployment subassembly 300 to reversibly transition between insertion configuration, deployment configuration, and decoupling configuration.

[0183] It may be noted that the device 40 of Fig. 7C is shown as having being provided with elongated plank members 310 on a single side of the device. Alternatively, a device accordingly to some embodiments may be provided with elongated plank members 301 (Fig. 1C) on a single side of the device. Alternatively, a device according to some embodiments may be provided with elongated plank members having spurs or barbs or pegs, as discussed herein with regard to the embodiment of Fig. 3B. Such an embodiment may facilitate release of the patch from the device, after deployment of the patch at the surgical site, as discussed herein with regard to Figs. 13C-D.

[0184] It may be further noted that device 40, according to some embodiments, may be suitable for use with a patch 700 that has sufficient structural stiffness such that it will remain open / spread out when retained on a single side of the patch only, as discussed herein.

[0185] INTERNAL MECHANISM OF THE SURGICAL DEPLOYMENT DDEVICE

[0186] Reference is now additionally made to Fig. 4A, which is a simplified enlarged partial pictorial illustration of the deployment subassembly 300 coupled to the push rod 200 and omitting the cylindrical shaft 100, for clarity, according to some embodiments. The deployment subassembly 300, shown in an insertion configuration, may form part of the surgical delivery device 10 of Figs. 1A - 1C, according to some embodiments. Reference is also made to Fig. 5A, which is a simplified enlarged partial sectional illustration of the cylindrical shaft 100, forming part of the surgical delivery device 10 of Figs. 1 A - 1C and to Fig. 6, which is a simplified enlarged partial sectional illustration of the deployment subassembly 300 coupled to the cylindrical shaft 100 and to the push rod 200, all forming part of the surgical delivery device 10 of Figs. 1A - 1C, shown in an insertion configuration, according to some embodiments. It is particularly seen in Figs. 1A and IB that, according to some embodiments, the cylindrical shaft 100 may have a partially cylindrical dorsal extension 103, extending distally from a distally facing shoulder 1020 (see e.g., Fig. 5A) of the cylindrical shaft 100, the dorsal extension 103 having a flat basal surface defining a dorsal slot (or slit) 1030 sized and configured to slidably accommodate a first portion of the deployment subassembly 300, the dorsal extension 103 having distal end 1021. The dorsal slot 1030 may define a dorsal slot length L.

[0187] The cylindrical shaft 100 may also have a partially cylindrical ventral extension 104 (see e.g., Fig. 5A), extending distally from a distally facing shoulder 1020 of the cylindrical shaft 100, the ventral extension 104 having a flat apical surface defining a ventral slit or slot 1040 sized and configured to slidably accommodate a second portion of the deployment subassembly 300, and the ventral extension 104 having a distal end 1022, according to some embodiments. The ventral slit may define a ventral slit length L, that may be equal to dorsal slot 1030 length L, according to some embodiments.

[0188] It may be noted that, according to some embodiments, in an exemplary implementation, the dorsal extension 103 and the ventral extension 104 may be symmetric about the longitudinal axis 12. The dorsal slot 1030 and the ventral slit 1040 may extend axially in parallel to longitudinal axis 12, according to some embodiments.

[0189] The flat basal surface and the flat apical surface may be separated by a gap 115 (see e.g., in Fig. 1A) configured to accommodate a portion of the deployment subassembly 300, according to some embodiments.

[0190] The cylindrical shaft 100 may have an axial bore 110, which extends along the longitudinal axis 12 from the proximal end 101 of the cylindrical shaft 100 to the distally facing shoulder 1020, located adjacent the dorsal extension 103 and the ventral extension 104, according to some embodiments.

[0191] It may be particularly seen in Fig. 1C that, according to some embodiments, each elongated deployment plank member 301 may define a proximal end 3010 defining a proximal aperture 3015 and a distal end 3011, an axial slit 3102 having a proximal end 3016 and a distal end 3017; and a lateral protrusion 3013 defining an eyelet 3014 therein. The function of the eyelets 3014 will be discussed further herein, with regard to Figs. 11A-B.

[0192] It may be seen in Fig. 5A that, according to some embodiments, the cylindrical shaft 100 may have a distal pin 1001 disposed distally spanning a gap 115 formed by the basal flat surface of the partially cylindrical dorsal extension 103, and the flat apical surface of the partially cylindrical ventral extension 104. The cylindrical shaft 100 further may have a pair of proximal guiding pins 1003, 1003’ sized and configured to be accommodated in the axial slit 3102, defined in two of the elongated deployment plank members 301, according to some embodiments. The cylindrical shaft 100 also may have a pair of distal guiding pins 1004, 1004’ sized and configured to be accommodated in the axial slit 3102 defined in two of the elongated deployment plank members 301, according to some embodiments. Optionally, instead of the surgical delivery device being provided with proximal guiding pins 1003, 1003’ and distal guiding pins 1004, 1004’, which fit in slits 3012 (Fig. 1C) or slits 3102 (Fig. 2C), the shaft may be provided with guides with guides and the plank members may be provided with corresponding protrusions, according to some embodiments.

[0193] As particularly seen in Fig. 6, the push rod 200 may be slidably accommodated within the axial bore 110 of the cylindrical shaft 100 and may be configured to axially translate relative to the cylindrical shaft 100 and between the pins 1002 and 1002’, according to some embodiments.

[0194] It may be particularly seen in Figs. 1A - 1C, Fig. 4A and Fig. 6 that, according to some embodiments, the deployment subassembly 300 may include a dorsal sliding rail 302, having a proximal end 3020 defining a proximal aperture 3022 hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021 defining a distal aperture 3023 hingedly coupled to the aperture 3015 defined in the proximal end 3010 of a pair of distal elongated deployment plank members 301. The dorsal sliding rail 302 may further define an intermediate aperture 3025 hingedly coupled to the aperture 3015 defined in the proximal end 3010 of a pair of proximal elongated deployment plank members 301, according to some embodiments. The dorsal sliding rail 302 may be sized and configured to be accommodated in the dorsal slot 1030 of the partially cylindrical dorsal extension 103 of the cylindrical shaft 100, according to some embodiments. The deployment subassembly 300 may further include a ventral sliding rail 302’, having a proximal end 3020’ defining a proximal aperture 3022’ hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021’ defining a distal aperture 3023’ hingedly coupled to the aperture 3015, defined in the proximal end 3010 of the pair of distal elongated deployment plank members 301, according to some embodiments. The ventral sliding rail 302’ may further define an intermediate aperture 3025’ hingedly coupled to the aperture 3015, defined in the proximal end 3010, of the pair of proximal elongated deployment plank members 301, according to some embodiments. The ventral sliding rail 302’ may be sized and configured to be accommodated in the ventral slit 1040 of the partially cylindrical ventral extension 104 of the cylindrical shaft 100, according to some embodiments.

[0195] It may be noted, as particularly seen in Fig. 6, that, according to some embodiments, when the deployment subassembly 300 is assembled onto the cylindrical shaft 100, the pair of proximal guiding pins 1003, 1003’ may be each configured to be slidably accommodated in the axial slit 3102 defined in a corresponding proximal elongated deployment plank members 301, and the pair of distal guiding pins 1004, 1004’ may be each configured to be slidably accommodated in the axial slit 3102 defined in a corresponding distal elongated deployment plank members 301.

[0196] It is a particular feature of this exemplary implementation that, according to some embodiments, the handle 500 may be operable to axially translate the push rod 200 distally relative to the cylindrical shaft 100, thereby translating the dorsal sliding rail 302 and the ventral sliding rail 302’ distally, which in turn may cause transitioning of the surgical delivery device 10 from the insertion configuration to the deployment configuration.

[0197] It is specifically noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 10, the proximal plank members 301 may be generally disposed at an acute angle relative to each other. Also, the distal plank members 301 may be generally disposed at an acute angle relative to each other, according to some embodiments. It is noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 10, the angle between the proximal plank members 301 and the angle between the distal plank members 301 can be minimized to an extent in which the entire deployment subassembly 300, aside from the eyelets 3014, may be laterally accommodated within the cylindrical shaft 100, such that, aside from the eyelets 3014, the proximal plank members 301 and the distal plank members 301 do not extend radially outwardly from the outer circumference of the cylindrical shaft 100. In accordance with another exemplary implementation, the proximal plank members 301 and the distal plank members 301 may extend radially outwardly from the outer circumference of the cylindrical shaft 100 to a minimal extent (due to the lateral extension of eyelets 3014) in the insertion configuration, according to some embodiments.

[0198] Fig. IB shows the surgical delivery device 10 in a deployment configuration, in which the push rod 200 has been translated axially distally relative to the cylindrical shaft 100 following manipulation of the handle 500 by the user, according to some embodiments. Once the push rod 200 has been axially translated distally relative to the cylindrical shaft 100, it may cause axial distal translation of the dorsal and ventral sliding rails 302, 302’ (seen most clearly in Fig. 4A) of the deployment subassembly 300, according to some embodiments. Distal translation of the dorsal and ventral rails 302, 302’ in turn may cause rotational displacement of the proximal plank members 301 about an axis extending through apertures 3025 and of the distal plank members 301 about an axis extending through apertures 3023, thereby rotatably transitioning the surgical delivery device 10 from insertion configuration to deployment configuration, according to some embodiments. In the deployment configuration of the surgical delivery device 10 the proximal plank members 301 may be disposed generally transversely to the longitudinal axis 12, on either side of the shaft 100, according to some embodiments. Similarly, distal plank members 301 may be disposed generally transversely to the longitudinal axis 12, on either side of shaft 100, according to some embodiments.

[0199] The push rod 200 may be translated axially by operation of the handle 500 by the user, and particularly by operation of the actuator 504, which may be fixedly coupled with the push rod 200, according to some embodiments.

[0200] It may be noted that, according to some embodiments, any additional number of plank members may be added in accordance with another exemplary implementation.

[0201] It may be noted that, according to some embodiments, the knob 505 of the handle 500 may be disposed proximally in the insertion configuration of the surgical delivery device 10 and may be generally translated distally to the deployment configuration of device 10, as specifically seen from the comparison of Figs. 1A and IB.

[0202] It may be specifically seen in Figs. 1A and IB that, according to some embodiments, the dorsal and ventral rails 302, 302’ may be slidably accommodated within the respective dorsal and ventral slits 1030 and 1040 of the cylindrical shaft 100.

[0203] As particularly seen in Fig. 6, the proximal plank members 301 may be rotatably transitioned from insertion configuration to deployment configuration upon axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the proximal guiding pins 1003, 1003’ within slits 3102, according to some embodiments. It may be further noted that, according to some embodiments, the distal plank members 301 may be rotatably transitioned from insertion to deployment configuration upon axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the distal guiding pins 1004, 1004’ within slits 3102.

[0204] In accordance with this exemplary implementation, the method of delivering the patch 700 (see e.g., Fig. 9) to a target area, implemented with the surgical delivery device 10 may include the following steps: a) using the surgical delivery device 10 in the deployment configuration, releasably coupling the patch 700 to the deployment subassembly 300; (b) using the handle 500, transitioning the surgical delivery device 10 to the insertion configuration; (c) inserting the surgical delivery device 10 to the target area; (d) at the target area, using the handle 500 to transition the surgical delivery device 10 to the deployment configuration; and (e) decoupling the patch 700 at the target area, according to some embodiments. Further details of the method, according to some embodiments, are discussed herein, with reference to Figs. 13A-D.

[0205] It may be noted that, according to some embodiments, the patch 700 may be configured to be coupled to the deployment subassembly 300. Specifically, the patch 700 may be formed as a sheet having a quadrilateral shape, which may be sized and configured to be coupled to the eyelets 3014 of the lateral protrusions 3013, 3013’ of each of the distal plank members 301 of the deployment subassembly 300 of the surgical delivery device 10, according to some embodiments.

[0206] Reference is now made to Fig. 4B, which is a simplified enlarged partial pictorial illustration of the deployment subassembly 300 coupled to the push rod 200 , forming part of the surgical delivery device 20 of Figs. 2 A - 2C, shown in an insertion configuration, according to some embodiments. It should be noted that, according to some embodiments, the cylindrical shaft 100, shown in Figs. 2A-C has been omitted for clarity. Reference is additionally made to Fig. 5B, which is a simplified enlarged partial sectional illustration of the cylindrical shaft 100, forming part of the surgical delivery devices 20 of Figs. 2A - 2C and to Fig. 7A, which is a simplified enlarged partial sectional illustration of the deployment subassembly 300 coupled to the cylindrical shaft 100 and to the push rod 200, all forming part of the surgical delivery device 20 of Figs. 2A - 2C, shown in an insertion configuration and to Fig. 7B, which is a simplified enlarged partial sectional illustration of the deployment subassembly 300 coupled to the cylindrical shaft 100 and to the push rod 200, all forming part of the surgical delivery device 20 of Figs. 2A - 2C, shown in a decoupling configuration, according to some embodiments.

[0207] It may be particularly seen in Fig. 2B that, according to some embodiments, the cylindrical shaft 100 may have a partially cylindrical dorsal extension 103, extending distally from a distally facing shoulder 1020 (see e.g., Fig. 5B) of the cylindrical shaft 100, having a flat basal surface defining a dorsal slot 1030 sized and configured to slidably accommodate a first portion of the deployment subassembly 300, the dorsal extension 103 having a distal end 1021. The dorsal slot 1030 may define a dorsal slot length L.

[0208] According to some embodiments, the cylindrical shaft 100 also may have a partially cylindrical ventral extension 104 (see e.g., Fig. 5B), extending distally from a distally facing shoulder 1020 of the cylindrical shaft 100, the ventral extension 104 having a flat apical surface defining a ventral slit 1040 sized and configured to slidably accommodate a second portion of the deployment subassembly 300, the ventral extension 104 having a distal end 1022. The ventral slit 1040 may have a ventral slit length L that may be equal to the length L of dorsal slot 1030, according to some embodiments.

[0209] It may be noted that, according to some embodiments, in an exemplary implementation, the dorsal extension 103 and the ventral extension 104 may be symmetric about the longitudinal axis 12. The dorsal slot 1030 and the ventral slit 1040 may extend axially in parallel to longitudinal axis 12, according to some embodiments. The flat basal surface and the flat apical surface may be separated by a gap 115 (see e.g., in Fig. 2A) configured to accommodate a portion of the deployment subassembly 300, according to some embodiments.

[0210] The cylindrical shaft 100 may have an axial bore 110, which extends along the longitudinal axis 12 from the proximal end 101 of the cylindrical shaft 100 to the distally facing shoulder 1020, located adjacent the dorsal extension 103 and the ventral extension 104, according to some embodiments.

[0211] It may be particularly seen in Fig. 2C that, according to some embodiments, each elongated deployment plank member 310 may be formed as a resilient clamp defining a pair of jaws 3106, 3106’ (or, optionally, clips or tweezer-like clamps) with a common proximal end 3100 defining a proximal aperture 3105. The jaws 3106, 3106’ have a split distal end 3101 and an axial slit 3102 having a common proximal narrowed portion 3103 and a split distal narrowed portion 3104, according to some embodiments.

[0212] It may be seen in Fig. 5B that, according to some embodiments, the cylindrical shaft 100 may have a distal pin 1001 that may span gap 115 formed by between the partially cylindrical dorsal extension 103 and the partially cylindrical ventral extension 104. The cylindrical shaft 100 further may have a pair of proximal guiding pins 1003, 1003’ each sized and configured to be accommodated in the axial slit 3102, defined in one of the proximal elongated deployment plank members 310, according to some embodiments. The cylindrical shaft 100 yet further may have a pair of distal guiding pins 1004, 1004’ sized and configured to be accommodated in the axial slit 3102 defined in two of the distal elongated deployment plank members 310, according to some embodiments.

[0213] In an exemplary implementation, the common proximal narrowed portion 3103 of each elongated deployment plank member 310 may be narrower than each of the pair of proximal guiding pins 1003, 1003’ and the pair of distal guiding pins 1004, 1004’ of the cylindrical shaft 100, according to some embodiments.

[0214] As particularly seen in Figs. 7A & 7B, according to some embodiments, the push rod 200 may be slidably accommodated within the axial bore 110 of the cylindrical shaft 100 and may be configured to be axially translated relative to the cylindrical shaft 100 and between the pins 1002 and 1002’. It may be noted that in device 20, pins 1002, 1002’ may be omitted, as they have no importance in the function of device 20, according to some embodiments.

[0215] It is particularly seen in Figs. 2A - 2C, Fig. 4B and Figs. 7A & 7B that, according to some embodiments, the deployment subassembly 300 may include a dorsal sliding rail 302, having a proximal end 3020 defining a proximal aperture 3022 hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021 defining a distal aperture 3023 hingedly coupled to the aperture 3105 (Fig. 2C) defined in the proximal end 3100 of each of a pair of distal elongated deployment plank members 310. The dorsal sliding rail 302 may further define an intermediate aperture 3025 hingedly coupled to the aperture 3105 defined in the proximal end 3100 of each of a pair of proximal elongated deployment plank members 310. The dorsal sliding rail 302 may be sized and configured to be accommodated in the dorsal slot 1030 of the partially cylindrical dorsal extension 103 of the cylindrical shaft 100, according to some embodiments. The deployment sub assembly 300 may further include a ventral sliding rail 302’, having a proximal end 3020’ defining a proximal aperture 3022’ hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021’ defining a distal aperture 3023’ hingedly coupled to the aperture 3105 defined in the proximal end 3100 of each of the pair of distal elongated deployment plank members 310, according to some embodiments. The ventral sliding rail 302’ may further define an intermediate aperture 3025’ hingedly coupled to the aperture 3105 defined in the proximal end 3100 of each of the pair of proximal elongated deployment plank members 310, the ventral sliding rail 302’ sized and configured to be accommodated in the ventral slot 1040 (Fig. 5B) of the partially cylindrical ventral extension 104 of the cylindrical shaft 100, according to some embodiments.

[0216] It may be noted, as particularly seen in Figs. 7A & 7B, that, according to some embodiments, when the deployment subassembly 300 may be assembled onto the cylindrical shaft 100, the pair of proximal guiding pins 1003, 1003’ may be each configured to be slidably accommodated in the axial slit 3102 defined in a corresponding one of a pair of proximal elongated deployment plank members 310, and the pair of distal guiding pins 1004, 1004’ may be each configured to be slidably accommodated in the axial slit 3102 defined in a corresponding one of a pair of distal elongated deployment plank members 310 of the deployment subassembly 300.

[0217] It is a particular feature of this exemplary implementation that, according to some embodiments, the handle 500 is operable to axially translate the push rod 200 distally relative to the cylindrical shaft 100, thereby translating the dorsal sliding rail 302 and the ventral sliding rail 302’ distally, which in turn may cause transitioning of the surgical delivery device 20 from the insertion configuration (indicated at demarcation 5021) shown in Figs. 2A & 7A to the deployment configuration (indicated at demarcation 5022) and thereafter to the decoupling configuration (indicated at demarcation 5023), shown in Figs. 2B & 7B.

[0218] In an exemplary implementation, upon translation of the push rod 200 distally to the decoupling configuration (indicated at demarcation 5023), such that distal ends 3021, 3021’ of dorsal sliding rail 302, and ventral sliding rail 302’, respectively, abut the distal ends 1032, 1042, of slits 1030, 1040, defined in partially cylindrical dorsal extension 103 and partially cylindrical ventral extension 104, respectively of the cylindrical shaft 100, as seen particularly in Figs. 2B and 5B, according to some embodiments. Each of the pair of proximal guiding pins 1003, 1003’ and the pair of distal guiding pins 1004, 1004’ may be configured to frictionally engage common proximal narrowed portion 3103 of axial slit 3102 defined in a corresponding proximal elongated deployment plank member 310 and a corresponding distal elongated deployment plank member 310, respectively, thereby causing the distal end 3101 of each plank member 310 to separate, as shown in Fig. 7B, thus allowing decoupling of the patch 700 (see e.g., Fig. 8) from the deployment subassembly 300, according to some embodiments.

[0219] It may be noted that, according to some embodiments, the jaws 3106, 3106’ may be typically made of resilient material. In the context of the disclosure, the term “resilient material” refers to the ability of such a material to readily deform upon the application of pressure, as well as its ability to generally spring back to its original shape when such pressure is removed, according to some embodiments. It may be noted that, according to some embodiments, device 20 is configured such that, when no pressure is applied, jaws 3106, 3106’ of plank member 310 are disposed generally slightly apart from each other as shown, for example, in Fig. 2B. The jaws 3106, 3106’ may be closed, for example, as shown in Fig. 2C, when pressure is applied thereto, as discussed herein.

[0220] It may be specifically noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 20, the proximal plank members 310 may be generally disposed at an acute angle relative to each other. Also, the distal plank members 310 may be generally disposed at an acute angle relative to each other.

[0221] It may be noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 20 shown in Figs. 2 A & 7 A, the angle between the proximal plank members 310 and the angle between the distal plank members 310 can be minimized to an extent in which the entire deployment subassembly 300 is laterally accommodated within the cylindrical shaft 100, such that the proximal plank members 310 and the distal plank members 310 do not extend radially outwardly from the outer circumference of the cylindrical shaft 100. In accordance with another exemplary implementation, the proximal plank members 310 and the distal plank members 310 extend radially outwardly from the outer circumference of the cylindrical shaft 100 to a minimal extent in the insertion configuration, according to some embodiments.

[0222] Fig. 2B shows the surgical delivery device 20 in a decoupling configuration, in which the push rod 200 has been translated axially distally relative to the cylindrical shaft 100 following manipulation of the handle 500 by the user, according to some embodiments. Once the push rod 200 is axially translated distally relative to the cylindrical shaft 100, it may cause axial distal translation of the dorsal and ventral sliding rails 302, 302’ of the deployment subassembly 300, according to some embodiments. Distal translation of the dorsal and ventral rails 302, 302’ in turn may cause rotational displacement of the proximal plank members 310 about an axis extending through apertures 3025 and of the distal plank members 310 about an axis extending through apertures 3023, thereby rotatably transitioning the surgical delivery device 20 from insertion configuration to deployment configuration, according to some embodiments. In the deployment configuration of the surgical delivery device 20 the proximal plank members 310 may be disposed generally transversely to the longitudinal axis 12, on either side of shaft 100, according to some embodiments. Similarly, distal plank members 310 may be disposed generally transversely to the longitudinal axis 12, on either side of shaft 100, according to some embodiments.

[0223] The push rod 200 may be translated axially by operation of the handle 500 by the user, and particularly by operation of the actuator 504, which may be fixedly coupled with the push rod 200, according to some embodiments.

[0224] It may be noted that any additional number of plank members may be added in accordance with another exemplary implementation.

[0225] It may be noted that the knob 505 of the handle 500 may be disposed proximally in the insertion configuration of the surgical delivery device 20 and may be generally translated distally to the deployment and decoupling configurations thereof, as specifically seen from the comparison of Figs. 2A and 2B, according to some embodiments.

[0226] It may be specifically seen in Figs. 2A and 2B that the dorsal and ventral rails 302, 302’ are optionally slidably accommodated within the respective dorsal and ventral slits 1030 and 1040 of the cylindrical shaft 100, according to some embodiments. Alternatively, dorsal and ventral rails 302, 302’ may be retained within the shaft 100 such as, for example, by being disposed within longitudinal grooves within the shaft 100 or adjacent the shaft 100.

[0227] As particularly seen in Figs. 7A & 7B, the proximal plank members 310 may be rotatably transitioned from insertion configuration to deployment configuration upon axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the proximal guiding pins 1003, 1003’ within slits 3102 of proximal plank members 310, according to some embodiments. It may be further noted that, according to some embodiments, the distal plank members 310 may be rotatably transitioned from insertion to deployment configuration upon axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the distal guiding pins 1004, 1004’ within slits 3102 of distal plank members 310.

[0228] It may be noted that, according to some embodiments, in an exemplary implementation, at least one of the jaws 3106, 3106’ typically may have a gripping geometry such as, for example, a textured surface, serrations on an inner surface of one of the jaws 3106, 3106’, or a serrated inner surface configured to intermesh with the corresponding serrated inner surface of the other jaw to provide for appropriated holding of the patch 700 by the resilient clamp during insertion and prior to deployment thereof onto the target area.

[0229] As discussed herein, according to some embodiments, device 20 has at least three (and optionally more) actuatable states, namely, a first state in which the patch is folded; a second state, in which the patch is unfolded / open / spread out; and a third state, in which the patch is released from the device 20.

[0230] In accordance with this exemplary implementation, the method of delivering the patch 700 (see e.g., Fig. 9) to a target area, implemented with the surgical delivery device 20 may include the following steps: a) using the surgical delivery device 20 in the deployment configuration, releasably coupling the patch 700 to the deployment subassembly 300; (b) using the handle 500, transitioning the surgical delivery device 20 to the insertion configuration; (c) inserting the surgical delivery device 20 to the target area; (d) at the target area, and using the handle 500, transitioning the surgical delivery device 20 to the deployment configuration; and (e) decoupling the patch 700 at the target area.

[0231] It may be noted that, according to some embodiments, the patch 700 may be configured to be coupled to the deployment subassembly 300. Specifically, the patch 700 may be formed as a sheet having a quadrilateral shape, and each of the pair of proximal elongated deployment plank members 310, and the pair of distal elongated deployment plank members 310 may be configured to be resiliently coupled to the patch 700, according to some embodiments.

[0232] Returning now to Fig. 7C, there is shown a simplified pictorial illustration of the surgical delivery device 40 shown with the handle 500, constructed and operative in accordance with an alternative exemplary implementation thereof, in a deployment configuration, according to some embodiments.

[0233] The surgical delivery device 40 may be similar in most respects to surgical device 20, which is shown in Figs. 2A - 2C, 4B, 5B, 7A and 7B, but the deployment subassembly 300 of device 40 may be asymmetric and may have a pair of elongated deployment plank members 310, disposed proximally and distally on the same side of the cylindrical shaft 100, according to some embodiments. Alternatively, device 40 may be provided with a single plank member 310 and a single plank member 301 (having an eyelet 3014), such that a patch such as, for example, a triangular patch, may be coupled to the device 40.

[0234] This asymmetric configuration of the deployment subassembly may allow for insertion of the surgical delivery device 40 through narrower working channels, since there may be no laterally protruding portions of the deployment subassembly 300 at least on one of the sides of the cylindrical shaft 100, according to some embodiments. Additionally, certain target areas require such geometry in which the patch 700 may be deployed only on one side of the cylindrical shaft and this may be provided by the surgical delivery device 40 having the entire deployment subassembly 300 configured to extend laterally from a single side of the cylindrical shaft 100, according to some embodiments.

[0235] According to some embodiments, each elongated deployment plank member 310 of the deployment subassembly 300 of the surgical delivery device 40 may be a resilient clamp defining a pair of jaws 3106, 3106’ with a common proximal end 3100 defining a proximal aperture 3105 and a split distal end 3101; and an axial slit 3102 having a common proximal narrowed portion 3103 and a split distal narrowed portion 3104. Optionally, a proximal ruler 3118 spanning a substantial length of proximal jaw 3106’ of proximal plank member 310, with a proximally extending arcuate member 3110, may be slidably coupled to a proximal facet of the proximal jaw 3106’.

[0236] It may be noted that, according to some embodiments, the cylindrical shaft 100 of the surgical delivery device 40 may be similar in all respects to the cylindrical shaft 100 of the surgical delivery device 20 of Figs. 2A - 2C. The cylindrical shaft 100 may include a partially cylindrical dorsal extension 103, extending distally from the distal end 102 of the cylindrical shaft 100, the dorsal extension 103 having a flat basal surface defining a dorsal slot 1030 sized and configured to slidably accommodate a first portion of the deployment subassembly 300, dorsal extension 103 having distal end 1021, according to some embodiments. The cylindrical shaft 100 may further include a partially cylindrical ventral extension 104, extending distally from the distal end 102 of the cylindrical shaft 100, the ventral extension 104 having a flat apical surface defining a ventral slit 1040 sized and configured to slidably accommodate a second portion of the deployment subassembly 300, and the ventral extension 104 having a distal end 1022, according to some embodiments. The cylindrical shaft 100 may further include a distal pin 1001, disposed distally spanning the gap 115 formed by the basal flat surface of the partially cylindrical dorsal extension 103, and the flat apical surface of the partially cylindrical ventral extension 104, according to some embodiments. The cylindrical shaft 100 may optionally further include at least one proximal guiding pin 1003, sized and configured to be accommodated in the axial slit 3102 defined in the proximally disposed elongated deployment plank member 310; and at least one distal guiding pin 1004 sized and configured to be accommodated in the axial slit 3102 defined in the distal elongated deployment plank member 310, according to some embodiments. It may be noted that, according to some embodiments, the common proximal narrowed portion 3103 of each proximal elongated deployment plank member 310 may be narrower than each of the at least one guiding pin 1003 and the common proximal narrowed portion 3103 of each distal elongated deployment plank member 310 may be narrower than each of the at least one distal guiding pin 1004.

[0237] In exemplary implementation, the deployment subassembly 300 may include a dorsal sliding rail 302, having a proximal end 3020 defining a proximal aperture 3022 hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021 defining a distal aperture 3023 hingedly coupled to the aperture 3105 defined in the proximal end 3100 of the distally disposed elongated deployment plank member 310, according to some embodiments. The dorsal sliding rail 302 may further define an intermediate aperture 3025 hingedly coupled to the aperture 3105 defined in the proximal end 3100 of the proximally disposed elongated deployment plank member 310, according to some embodiments. The dorsal sliding rail 302 may be sized and configured to be accommodated in the dorsal slot 1030 of the partially cylindrical dorsal extension 103 of the cylindrical shaft 100, according to some embodiments.

[0238] The ventral sliding rail 302’ may have a proximal end 3020’ defining a proximal aperture 3022’ hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3021’ defining a distal aperture 3023’ hingedly coupled to the aperture 3105’ defined in the proximal end 3100’ of the distally disposed elongated deployment plank member 310, according to some embodiments. The ventral sliding rail 302’ may further define an intermediate aperture 3025’ hingedly coupled to the aperture 3105’ defined in the proximal end 3100’ of the proximally disposed elongated deployment plank member 310, according to some embodiments. The ventral sliding rail 302’ may be sized and configured to be accommodated in the ventral slot 1040 of the partially cylindrical ventral extension 104 of the cylindrical shaft 100, according to some embodiments.

[0239] It may be noted that, according to some embodiments, when the deployment subassembly 300 is assembled onto the cylindrical shaft 100, each of the at least one proximal guiding pin 1003 may be configured to be slidably accommodated in the axial slit 3102 defined in the proximally disposed elongated deployment plank member 310, and the at least one guiding pin 1004 may be configured to be slidably accommodated in the axial slit 3102 defined in a corresponding distally disposed elongated deployment plank member 310.

[0240] It may be noted that, according to some embodiments, upon translation of the push rod 200 distally to the decoupling configuration (indicated at demarcation 5023), such that distal end 3021, 3021’ of dorsal sliding rail 302, and ventral sliding rail 302’ respectively, each abuts the distal end 1032, 1042, of slits 1030, 1040, defined in partially cylindrical dorsal extension 103 and partially cylindrical ventral extension 104, respectively, each of the at least one proximal guiding pin 1003 and the at least one distal guiding pin 1004 may be configured to frictionally engage a common proximal narrowed portion 3103 of axial slit 3102 defined in each of the corresponding of proximally disposed elongated deployment plank member 310, and the corresponding distally disposed elongated deployment plank member 310, causing jaws 3106, 3106’ to separate thus allowing decoupling of the patch 700 (see e.g., Fig. 8) from the deployment subassembly 300.

[0241] It may be noted that, according to some embodiments, the jaws 3106, 3106’ may typically be made of resilient material. In the context of the disclosure, the term “resilient material” refers to the ability of such a material to readily deform upon the application of pressure, as well as its ability to generally spring back to its original shape when such pressure is removed.

[0242] It is noted that, according to some embodiments, in the surgical delivery device 40 shown in Fig. 7C, when in the insertion configuration (not shown), the angle between the proximal plank member 310 and the longitudinal axis 12, as well as the angle between the distal plank member 310 and the longitudinal axis 12 can be minimized to an extent in which substantially the entire deployment subassembly 300, aside from the portion coupled to the patch such as, for example, the jaws distal end 3101, may be laterally accommodated within the cylindrical shaft 100, such that the proximal plank member 310 and the distal plank member 310 do not substantially extend radially outwardly from the outer circumference of the cylindrical shaft 100, aside from, for example, the jaws distal end 3101. In accordance with another exemplary implementation, the proximal plank member 310 and the distal plank members 310 extend radially outwardly from the outer circumference of the cylindrical shaft 100 to a minimal extent in the insertion configuration. Optionally, a significant portion of the plank members 310 may extend radially outwardly from the outer circumference of the shaft 100.

[0243] Fig. 7C shows the surgical delivery device 40 in a decoupling configuration, according to some embodiments, in which the push rod 200 has been translated axially distally relative to the cylindrical shaft 100 following manipulation of the handle 500 by the user. .According to some embodiments, once the push rod 200 is axially translated distally relative to the cylindrical shaft 100, it may cause axial distal translation of the dorsal and ventral sliding rails 302, 302’ of the deployment subassembly 300. Distal translation of the dorsal and ventral rails 302, 302’ in turn may cause rotational displacement of the proximal plank member 310 about an axis extending through apertures 3025 and 3025’, and rotational displacement of the distal plank member 310 about an axis extending through apertures 3023 and 3023’, thereby rotatably transitioning the surgical delivery device 40 from insertion configuration to deployment configuration, according to some embodiments. In the deployment configuration of the surgical delivery device 40 the proximal plank member 310p and the distal plank member 310d may be disposed generally transversely to the longitudinal axis 12, according to some embodiments.

[0244] The push rod 200 may be translated axially by operation of the handle 500 by the user, and particularly by operation of the actuator 504, which may be fixedly coupled with the push rod 200, according to some embodiments.

[0245] It may be noted that, according to some embodiments, any additional number of plank members may be added on the same side of the cylindrical shaft 100 in accordance with another exemplary implementation.

[0246] It may be noted that, according to some embodiments, the knob 505 of the handle 500 may be disposed proximally in the insertion configuration of the surgical delivery device 40 and may be generally translated distally to the deployment and decoupling configurations thereof.

[0247] With regard to the embodiment of Fig. 7C, the dorsal and ventral rails 302, 302’ may be slidably accommodated within the respective dorsal and ventral slits 1030 and 1040 of the cylindrical shaft 100, according to some embodiments.

[0248] As particularly seen in Fig. 7C, according to some embodiments, the proximal plank member 310 has been rotatably transitioned from insertion to deployment configuration by axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the proximal guiding pins 1003, 1003’ within slits 3102 of proximal plank member 310. It is further noted that, according to some embodiments, the distal plank members 310 has been rotatably transitioned from insertion to deployment configuration by axial displacement of the dorsal and ventral rails 302, 302’ due to slidable insertion of the distal guiding pins 1004, 1004’ within slits 3102 of distal plank member 310.

[0249] It is noted that in an exemplary implementation, each one of the jaws 3106, 3106’ typically may have a serrated inner surface configured to intermesh with the corresponding serrated surface of the other jaw to provide for appropriated holding of the patch 700 by the resilient clamp during insertion and prior to deployment thereof onto the target area.

[0250] In accordance with this exemplary implementation, the method of delivering the patch 700 (see e.g., Fig. 9) to a target area, implemented with the surgical delivery device 40 may include the following steps: a) using the surgical delivery device 40 in the deployment configuration, releasably coupling the patch 700 to the deployment subassembly 300; (b) using the handle 500, transitioning the surgical delivery device 20 to the insertion configuration; (c) inserting the surgical delivery device 40 to the target area; (d) at the target area, using the handle 500, transitioning the surgical delivery device 40 to the deployment configuration; and (e) decoupling the patch 700 at the target area.

[0251] It is noted that, according to some embodiments, the patch 700 may be configured to be coupled to the deployment subassembly 300. Specifically, the patch 700 may be formed as a sheet having a quadrilateral shape and each of the proximally disposed elongated deployment plank members 310, and the distally elongated deployment plank members 310 may be configured to reversibly engage the patch 700 on one side only, according to some embodiments.

[0252] THIRD EMBODIMENT - ELONGATED BRACKET MEMBERS WITH BARBS / SPURS

[0253] It should be noted that, in the embodiments discussed above, with regard to Figs. 1A and 2 A, each of the surgical delivery devices 10 and 20 is configured to provide support to a surgical patch 700 at proximal and distal locations along the lateral portions of the patch. With reference to the surgical delivery device 30 discussed herein, it should be noted that support may be provided to the patch at multiple locations along the lateral sides of the patch, as discussed herein with regard to device 30.

[0254] Reference is now made to Figs. 3A-3C, which illustrate a surgical delivery device 30 according to some embodiments, and to Fig. 5C, which is a simplified enlarged partial sectional illustration of the cylindrical shaft 100, forming part of the surgical delivery device 30 of Figs. 3A - 3C, according to some embodiments. Reference is additionally made to Fig. 8A, which is a simplified enlarged partial sectional illustration of the deployment subassembly 300 coupled to the cylindrical shaft 100 and to the push rod 200, all forming part of the surgical delivery device 30 of Figs. 3A - 3C, shown in a deployment configuration, according to some embodiments. Reference is also made to Fig. 8B, which is a simplified enlargement view of a portion of the deployment subassembly 300 of the surgical delivery device 30 of Figs. 3A - 3C and to Fig. 8C, which is a simplified enlarged pictorial illustration of the deployment subassembly 300 to be coupled to a portion of the push rod 200, all forming part of the surgical delivery device 30 of Figs. 3A - 3C, shown in a deployment configuration, according to some embodiments.

[0255] It is particularly seen in Figs. 3A-B and 8A-B that, according to some embodiments, each of elongated bracket members 320, 320’, has a proximal end 3200, 3200’ and a distal end 3201, 3201’, with the bracket members 320, 320’ each having an upper surface 3202, 3202’ and a lower surface 3203, 3203’. Each of elongated bracket members 320, 320’ further may have a plurality of tissue holders such as, for example, barbs or claws or spurs 3208, 3208’ extending basally and in a same direction from the lower surface 3203, 3203’, respectively, according to some embodiments. For example, the spurs 3208, 3208’ may extend basally and distally from the lower surface 3203, 3203’, or may extend basally and proximally from the lower surface 3203, 3203’, or may extend basally and to the right or left (in the sense of the view of the embodiment shown in Fig. 3B). Alternatively, instead of or in addition to spurs 3208 on bracket members 320, 320’, a patch 700 may be coupled to device 30 using sutures (not shown). Optionally, bracket members 320, 320’ may be provided with openings for facilitating attachment of the patch 700 to the device 30 using sutures.

[0256] Additionally, each of elongated bracket members 320, 320’ may define a proximal aperture 3204, 3204’ disposed adjacent to the respective proximal end 3200, 3200’, a distal aperture 3205, 3205’ disposed distally to the respective proximal aperture 3204, 3204’, a proximal opening 3206, 3206’ disposed distally to the distal aperture 3205, 3205’, respectively; and a distal opening 3207, 3207’ disposed adjacent to the respective distal end 3201, 3201’ of elongated bracket members 320, 320’, according to some embodiments. According to some embodiments, openings 3206 and 3207 may be optionally utilized for attachment of a patch 700 to the device 30 with sutures (not shown). Openings 3206 and 3207 may be omitted, according to some embodiments.

[0257] In an exemplary implementation, each of four elongated actuators 321 may have a proximal end 3211 and a distal end 3212, according to some embodiments. Each of the four elongated actuators 321 further may have a proximal aperture 3213 defined adjacent to the proximal end 3211, and a distal aperture 3214 defined adjacent the distal end 3212, with an axial slit 3215 having a proximal end 3216 and a distal end 3217, according to some embodiments, as specifically seen in Fig. 8B.

[0258] While the embodiment shown in Figs. 3A-B may include elongated bracket members 320, 320’ which extend axially, a patch attached to such a device 30 may be positioned between the axially disposed elongated bracket members 320, 320’, according to some embodiments. Alternatively, according to some embodiments (not shown), optionally, a pair of elongated bracket member may be positioned perpendicularly relative to the device longitudinal axis 12, with a first bracket member positioned proximally to the patch and a second bracket member positioned distally to the patch 700, such that the patch may be held between the two laterally positioned bracket members.

[0259] It is noted that, according to some embodiments, the cylindrical shaft 100, as specifically seen in Fig. 5C, may have a partially cylindrical dorsal extension 103 (see Fig. 3A), extending distally from a distally facing shoulder 1020 (see e.g., Fig. 5C) of the cylindrical shaft 100, the dorsal extension 103 having a flat basal surface defining a dorsal slot 1030 which may be sized and configured to slidably accommodate a first portion of the deployment subassembly 300, the dorsal extension 103 having distal end 1021. The dorsal slot 1030 may define a dorsal slit length

[0260] L.

[0261] According to some embodiments, the cylindrical shaft 100 also may have a partially cylindrical ventral extension 104 (see e.g., Fig. 5C), extending distally from a distally facing shoulder 1020 of the cylindrical shaft 100, the ventral extension 104 having a flat apical surface defining a ventral slit 1040 sized and configured to slidably accommodate a second portion of the deployment subassembly 300, and the ventral extension 104 having a distal end 1022. The ventral slit may define a ventral slit length L, that may be equal to the length of dorsal slot 1030, according to some embodiments.

[0262] It may be noted that in an exemplary implementation, the dorsal extension 103 and the ventral extension 104 may be symmetric about the longitudinal axis 12. The dorsal slot 1030 and the ventral slit 1040 may extend axially in parallel to longitudinal axis 12.

[0263] The flat basal surface of dorsal extension 103 and the flat apical surface of ventral extension 104 may be separated by a gap 115 (see e.g., in Fig. 3A) configured to accommodate a portion of the deployment subassembly 300, according to some embodiments.

[0264] The cylindrical shaft 100 may have an axial bore 110 (Fig. 5C), which may extend along the longitudinal axis 12 from the proximal end 101 of the cylindrical shaft 100 to the distally facing shoulder 1020, located adjacent the dorsal extension 103 and the ventral extension 104, according to some embodiments.

[0265] It may be seen in Fig. 5C that, according to some embodiments, the cylindrical shaft 100 may have a distal pin 1001 that may span gap 115 formed between the basal flat surface of the partially cylindrical dorsal extension 103, and the flat apical surface of the partially cylindrical ventral extension 104. The shaft 100 may have a pair of distal guiding pins 1004, 1004’ sized and configured to be accommodated in the axial slit defined in two distal elongated actuators 321 of the four elongated actuators 321; and a pair of proximal guiding pins 1005, 1005’ disposed proximally to the pair of distal guiding pins 1004, 1004’. The pair of proximal guiding pins 1005, 1005’ may be sized and configured to be accommodated in the axial slit defined in two proximal elongated actuators 321 of the four elongated actuators 321, according to some embodiments.

[0266] As particularly seen in Fig. 8A, according to some embodiments, the push rod 200 may be slidably accommodated within the axial bore 110 of the cylindrical shaft 100 and may be configured to be axially translated relative to the cylindrical shaft 100.

[0267] It may be particularly seen in Figs. 3 A and 8 A - 8C that, according to some embodiments, the deployment subassembly 300 may include a dorsal sliding rail 322, having a proximal end 3220 defining a proximal aperture 3224 hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3221 defining a distal aperture 3225 hingedly coupled to the proximal aperture 3213 defined in the proximal end 3211 of the pair of distal elongated actuators 321. It may be noted that, according to some embodiments, the dorsal sliding rail 322 may further define an intermediate aperture 3226 hingedly coupled to the proximal aperture 3213 defined in the proximal end 3211 of the pair of proximal elongated actuators 321. The dorsal sliding rail 322 may be sized and configured to be accommodated in the dorsal slot 1030 of the partially cylindrical dorsal extension 103, according to some embodiments.

[0268] The deployment subassembly 300 may further have a ventral sliding rail 322’, having a proximal end 3220’ defining a proximal aperture 3224’ hingedly coupled to the distal end 202 of the push rod 200, and a distal end 3221’ defining a distal aperture 3225’ hingedly coupled to the proximal aperture 3213 defined in the proximal end 3211 of the pair of distal elongated actuators 321, according to some embodiments. It may be noted that, according to some embodiments, the ventral sliding rail 322’ may further define an intermediate aperture 3226’ hingedly coupled to the proximal aperture 3213 defined in the proximal end 3211 of the pair of proximal elongated actuators 321. The ventral sliding rail 322’ may be sized and configured to be accommodated in the ventral slot 1040 of the partially cylindrical ventral extension 104, according to some embodiments.

[0269] It may be specifically seen in Figs. 8A-B that, according to some embodiments, the distal aperture 3214 of each of the pair of proximal elongated actuators 321 may be hingedly coupled to the proximal aperture 3204, 3204’ of the elongated bracket members 320, 320’, respectively; and the distal aperture 3214 of the pair of distal elongated actuators 321 may be hingedly coupled to the distal aperture 3205, 3205’ of elongated bracket members 320, 320’, respectively.

[0270] It may be noted, as particularly seen in Figs. 3A, 3B and 8A, that, according to some embodiments, when the deployment subassembly 300 is assembled onto the cylindrical shaft 100, the pair of proximal guiding pins 1005, 1005’ may be each configured to be slidably accommodated in the axial slits 3215 defined in one of a corresponding pair of proximal elongated actuators 321, and the pair of distal guiding pins 1004, 1004’ may be each configured to be slidably accommodated in the axial slits 3215 defined in one of a corresponding pair of distal elongated actuators 321.

[0271] It is a particular feature of this exemplary implementation that, according to some embodiments, the handle 500 may be operable to axially translate the push rod 200 distally relative to the cylindrical shaft 100, thereby translating the dorsal sliding rail 322 and the ventral sliding rail 322’ distally, which in turn may cause transitioning of the surgical delivery device 30 from the insertion configuration shown in Fig. 3A to the deployment configuration and thereafter to the decoupling configuration shown in Figs. 8 A and 8C.

[0272] In exemplary implementation, upon translation of the push rod 200 distally to the decoupling configuration, such that distal ends 3221, 3221’ (see Fig. 8C) of dorsal sliding rail 322 and ventral sliding rail 322’ each abuts the respective distal end 1032, 1042, of respective dorsal slit 1030 and ventral slit 1040, defined in partially cylindrical dorsal extension 103 and partially cylindrical ventral extension 104, respectively, of the cylindrical shaft 100, as seen particularly in Fig. 3B, according to some embodiments.

[0273] It may be specifically noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 30, the actuators 321 may be generally disposed at an acute angle relative to each other and the bracket members 320 320’ may be generally disposed in parallel to each other, as seen in Fig. 3A.

[0274] It may be noted that, according to some embodiments, in the insertion configuration of the surgical delivery device 30 shown in Fig. 3 A, the angle between the actuators 321 can be minimized to an extent in which the entire deployment subassembly 300 may be laterally accommodated within the cylindrical shaft 100, such that the actuators 321 do not extend radially outwardly from the outer circumference of the cylindrical shaft 100. In accordance with another exemplary implementation, the actuators 321 extend radially outwardly from the outer circumference of the cylindrical shaft 100 to a minimal extent in the insertion configuration.

[0275] Fig. 3B shows the surgical delivery device 30 in a deployment configuration, in which the push rod 200has been translated axially distally relative to the cylindrical shaft 100 following manipulation of the handle 500 by the user, according to some embodiments. Once the push rod 200 has been axially translated distally relative to the cylindrical shaft 100, it may cause axial distal translation of the dorsal and ventral sliding rails 322, 322’ of the deployment subassembly 300, according to some embodiments. Distal translation of the dorsal and ventral rails 322, 322’ in turn may cause rotational displacement of the distal actuators 321 about an axis extending through apertures 3225 and of the proximal actuators 321 about an axis extending through apertures 3226, thereby rotatably transitioning the surgical delivery device 30 from insertion configuration (Fig. 3A) to the deployment configuration (Fig. 8C), according to some embodiments. In the deployment configuration of the surgical delivery device 30 the proximal actuator 321 located on each side of the longitudinal axis 12 may be disposed generally in parallel to the distal actuator 321 located on the same side of the longitudinal axis, according to some embodiments. Additionally, according to some embodiments, the proximal actuator 321 located on a first side of the longitudinal axis may be disposed at obtuse angle relative to the proximal actuator 321 located on a second side of the longitudinal axis. According to some embodiments, the proximal actuators 321 and distal actuators 321 may be disposed generally transversely to the longitudinal axis 12.

[0276] The push rod 200 may be translated axially by operation of the handle 500 by the user, and particularly operation of the actuator 504, which may be fixedly coupled with the push rod 200. It may be noted that any additional number of actuators 321 may be added in accordance with another exemplary implementation, according to some embodiments.

[0277] It may be noted that, according to some embodiments, the knob 505 of the handle 500 may be disposed proximally in the insertion configuration of the surgical delivery device 30 and may be generally translated distally to the deployment configurations thereof.

[0278] It may be specifically seen in Figs. 3A and 3B that, according to some embodiments, the dorsal and ventral sliding rails 322, 322’ may be slidably accommodated within the respective dorsal and ventral slits 1030 and 1040 of the cylindrical shaft 100.

[0279] As particularly seen in Figs. 8A & 8C, the proximal actuators 321 may be rotatably transitioned from insertion configuration to deployment configuration upon axial displacement of the dorsal and ventral rails 322, 322’ due to slidable insertion of the proximal guiding pins 1005, 1005’ within slits 3215 of the proximal actuators 321, according to some embodiments. It may be further noted that, according to some embodiments, the distal actuators 321 may be rotatably transitioned from insertion configuration to deployment configuration upon axial displacement of the dorsal and ventral rails 322, 322’ due to slidable insertion of the distal guiding pins 1004, 1004’ within slits 3215 of the distal actuators 321.

[0280] PROCESS OF DEPLOYMENT OF A PATCH AT A SURGICAL SITE AND ADDITIONAL OPTIONAL FEATURES

[0281] With reference to Fig. 10A there is shown, in a perspective view, a surgical delivery device 30 similar to that shown in Fig. 3A, the device having a patch 700 removably coupled thereto by projections 3208, 3208’ such as, for example, spurs or barbs or curved or L-shaped pegs, the patch 700 positioned, for example, substantially above the device 30, according to some embodiments. It is seen that, according to some embodiments, in the insertion configuration shown, wherein the bracket members 320, 320’ may be adjacent each other, the patch 700 may be folded over and positioned above the device 30 so that the device 30 together with the patch 700 may be in a configuration narrow enough to be inserted into an incision at or near a surgical site (see, for example, Fig. 13A). Alternatively, according to some embodiments, the patch 700 may be folded over and positioned below the device 30, in the view shown in Fig. 10A, so that the device 30 together with the patch 700 may be in a configuration narrow enough to be inserted into an incision at or near a surgical site (see, for example, Fig. 13A). Optionally, the surgical delivery device 30, together with a patch 700 coupled thereto, may be housed in a cannula prior to being inserted via an incision at or near the surgical site.

[0282] With reference to Fig. 10B there is shown, in a perspective view, a surgical delivery device 10 similar to that shown in Fig. 1A, the device having a patch 700 removably coupled thereto by sutures 3500 extending through eyelets 3014, the patch 700 positioned substantially below the device 30, in particular below ventral extension 104, according to some embodiments. It is seen that, according to some embodiments, in the insertion configuration shown, wherein the elongated deployment plank members 301 may be substantially parallel to the device longitudinal axis 12, the patch 700 may be folded over and positioned below the device 10, so that the device 10 together with the patch 700 may be in a configuration narrow enough to be inserted into an incision at or near a surgical site (see, for example, Fig. 13A).

[0283] With additional reference to Figs. 11A-B there is shown the surgical delivery device 10 of Fig. 10B, the device 10 having a patch 700 attached thereto by a plurality of sutures 3500 each of which extends through an opening 3508 in the patch 700 and through an eyelet 3014 in an elongated deployment plank member 301, according to some embodiments. In particular, according to some embodiments, for each of the corners of the patch 700, a suture 3500 portion 3502 may be threaded over a first surface 702 of the patch 700 toward an eyelet 3014, pass through the eyelet 3014, wrap around an edge 704 of the patch 700 (such as, for example, the patch distal edge 704 shown) extend a short distance along a second surface 706 of the patch, pass through opening 3508 in the patch, pass back through eyelet 3014, and extend along surface 702. The free ends 3510 of suture 3500 may extend proximally toward the device handle 500, such that they will extend outside the body when the patch is inserted via an incision at or near the surgical site, according to some embodiments.

[0284] Optionally, according to some embodiments, suture free ends 3510 may be wrapped around gripping protrusions 503, for example as discussed herein, for example, with regard to Fig. 1A, or may be wrapped around a bobbin or other winding device (not shown), or may be held by a surgeon during the surgical procedure. It will be appreciated by persons skilled in the art that, optionally, any other threading of sutures 3500 may be utilized to removably attach the patch 700 to the device 10, according to some embodiments. Optionally, according to some embodiments, the sutures 3500 may be removed by the surgeon after a few stitches / sutures / other attachment means have been inserted to attach the patch 700 to tissue (see, for example, injured tendon 6004 in Fig. 13A) surgical site. The surgical delivery device, according to embodiments discussed herein, has been described as being configured to effect deployment of a patch 700, for example, by pushing a pushrod 200. Optionally, deployment of the patch 700 may be effected by pulling of a rod, or by pulling of a wire or other component attached to the deployment subassembly. A potential advantage of such a configuration is that the surgical delivery device may include a flexible / bendable shaft or a shaft having a bendable joint (discussed further with regard to Figs. 14-15).

[0285] Figs. 12A-B are sectional perspective views of a surgical delivery device 50 having an alternative actuating mechanism, the device shown in respective insertion and deployment configurations, according to some embodiments. Device 50 may include various components similar in structure and function to those of device 30, and will not be described again herein. However, device 50 may include a roller or knob or other actuator 505 attached to a proximal end 510 of a rod or wire 512, the rod 512 attached to a deployment subassembly, similar to that discussed hereinbefore, except that the deployment subassembly may be caused to transition from a closed configuration to an open configuration by proximal movement of the knob 505, and vice versa. Specifically, the device has a first orientation (Fig. 12A), at which the knob 505 is in a forward position, the rod 512 is in a distally positioned orientation, and the deployment subassembly is in a closed configuration in which the patch 700 is collapsed. The knob 505 may be moved proximally such as, for example,, to the position shown in Fig. 12B, such that the deployment subassembly is in an open configuration (Fig. 12B), at which the patch 700 may be unfolded or spread out, according to some embodiments. Device 30 may be transitioned from the first orientation to the second orientation by axial movement of the knob 505 in a proximal direction, i.e., in the direction of arrow 508, according to some embodiments.

[0286] A surgical delivery device in accordance with any of the embodiments described herein and / or shown in the accompanying drawings may be provided with at least one resilient member such as, for example, a spring, to facilitate transition of the device from an open configuration to a closed configuration, and / or to facilitate transition of the device from a closed configuration to an open configuration.

[0287] It may be noted that, according to some embodiments, the surgical delivery device has been generally described herein as being actuated during a surgical procedure such as, for example, an arthroscopic procedure. However, it will be appreciated by persons skilled in the art that optionally, according to some embodiments, the surgical delivery device may be operated outside the body such as, for example, when checking operation of the device and / or when checking the effect of opening / closing of the device on flexibility of a patch. Other instances of operation of the surgical delivery device, as discussed herein, will be apparent to those skilled in the art.

[0288] Fig. 13A is a perspective view of the surgical delivery device 30 of Fig. 3A-B, the device shown in an insertion configuration, according to some embodiments, at a surgical site 6000 (enlarged to show detail) at which a tendon 6004 has a tear / partial tear or other injury. Optionally, according to some embodiments, the surgical delivery device or a distal portion thereof containing the patch 700 may be housed in a cannula for insertion at a surgical site, optionally, to prevent inadvertent trauma at the surgical site. It may be noted that, the surgical delivery device or distal portion thereof containing the patch 700 is sized and configured to be disposed substantially within the shaft, as discussed herein, which may allow it to be housed inside a cannula for insertion at or near a surgical site. Additionally, due to the configuration of the shaft 100 such as, for example, having a circular cross-sectional profile, as discussed herein, at least the shaft portion of the device, together with the patch coupled thereto, may be easily inserted into and deployed from a cannula. In the insertion configuration shown, the surgical delivery device 30 may have a patch 700 coupled thereto by barbs 3208, as discussed herein, according to some embodiments. Device 30 is shown in the first configuration, according to some embodiments, in which patch 700 is collapsed such that it is narrow enough to be inserted via a first access point or port or incision 6002 at the surgical site 6000.

[0289] With additional reference to Fig. 13B, according to some embodiments, after insertion of the distal end of device 30 via the first incision 6002 at the surgical site 6000, a second incision 6006 may be made (or may have been made prior to insertion of the device 30 via first incision 6002), and a repairing device 6008 such as, for example, a stitching device, a suturing device, a tissue-to-bone stapler or anchoring device, or other repair device may be inserted via a second access point or port or incision 6006 to affect attachment of the patch 700 to the tendon 6004. Optionally, repairing device 6008 may be inserted via first incision 6002.

[0290] With additional reference to Fig. 13C, there is shown a perspective view of the surgical delivery device of Fig. 13B, the device shown in a deployment configuration, i.e., after actuation of the device, as discussed herein, to spread the patch 700 over the tendon 6004, according to some embodiments. According to some embodiments, after insertion of the repairing device 6008 via second incision 6006, the repairing device may affect attachment of the patch 700 to the tendon 6004, for example, by application of a plurality of staples or hooks 6010 or another attachment component. Suitable staples or hooks or other attachment components may be formed of any suitable material such as, for example, PLA (polylactic acid), PLGA [poly(lactic-co-glycolic acid)], or PEEK (polyether ether ketone), according to some embodiments. The number and location of the hooks 6010 inserted may depend on various factors such as, for example, the specific injury to the tendon 6004 and the technique selected by the surgeon, according to some embodiments.

[0291] With additional reference to Fig. 13D, according to some embodiments, after deployment of the patch 700, the surgical delivery device 30, according to some embodiments, may be manipulated such as, for example, by moving it slightly proximally, to dislodge the barbs 3208 from the patch 700, thereby separating the device 30 from the patch 700, after which the device 30 may be transitioned to the first configuration, at which the elongated bracket members 320, 320’ may be moved toward each other, for example, to their positions in Fig. 3A. Thereafter, the surgical delivery device 30 may be removed from the surgical site via first incision 6002. After the surgeon has inserted sufficient sutures or hooks or other attachment components to attach the patch 700 at the surgical site, the repair device 6008 may be removed from the surgical site, optionally, after a particular number of hooks have been inserted to attach the patch 700 at the surgical site 6000, Alternatively, the surgical delivery device 30 may remain in position, coupled to the patch 700, at the surgical site, until suturing (or insertion of hooks or other attachment components) has been completed or until enough sutures have been inserted to ensure that the patch 700 will remain in position, and then the patch 700 may be released from the surgical delivery device 30, after which the device 30 may be removed, as discussed herein. Thereafter, the repair device 6008 may be removed from the surgical site via the second incision 6006, according to some embodiments.

[0292] As shown in Fig. 13D, according to some embodiments, the patch 700 will remain in place on the tendon 6004, being held in place by the hooks (or sutures, or other attachment means). As discussed herein, the provision of a patch at the site of a tear / partial / other injury to the tendon 6004 may allow healing of the surgical site and / or may prevent the recurrence of additional tears.

[0293] Optionally, according to some embodiments, the above-described method of repairing a tendon 6004 may be performed using a separate viewing device such as, for example, an endoscope, optionally inserted at the surgical site via a third incision (not shown), or using an endoscope located on the stitching / suturing device 6008 or located on the surgical delivery device 30. According to some embodiments, this may allow the surgeon to have a better view of the surgical site while stitching / suturing / attaching the patch 700 to the tendon 6004.

[0294] With reference to Fig. 14 there is shown a surgical delivery device 60 having a bendable shaft 62, according to some embodiments. Various components of device 60 are similar or identical in function and structure to those of, for example, device 10, and will not be described again herein. It should be noted that the pushrod 200 (see Fig. 4A) of device 60 is flexible such that it will bend with bending of shaft 62. The provision of a bendable shaft 62 may facilitate the insertion of the deployment subassembly 300 at a surgical site by allowing the surgeon to manipulate the device 60 while holding the handle at an angle relative to the direction of insertion. The shaft 62 is bendable to an angle of up to about 45 degrees in any direction. Optionally, handle 500 is provided with an actuator 66 such as, for example, a pullwire for bending shaft 62. Alternatively, device 60 may be provided with an actuator in the form of a joystick connected to a mechanism (not shown) associated with the shaft 62, for bending the shaft 62. Such an actuator / joystick having a plurality of predetermined stopping states, each corresponding to an orientation of the shaft such as, for example, the orientation shown in Fig. 14. Optionally, the shaft 62 is bendable during the surgical procedure, after the deployment subassembly has been inserted via the first incision 6002 (Fig. 13 A) at the surgical site.

[0295] With reference to Fig. 15 there is shown a surgical delivery device 70 including a bendable shaft 72 having a bendable portion 74, according to some embodiments. Various components of device 70 are similar or identical in function and structure to those of, for example, device 30, and will not be described again herein. It should be noted that the pushrod 200 (see also Fig. 8A) of device 70 is bendable such that it will bend with bending of bendable portion 74 of shaft 72. The provision of a bendable shaft 72 may facilitate the insertion of the deployment subassembly 300 at a surgical site by allowing the surgeon to manipulate the device 70 while holding the handle at an angle relative to the direction of insertion. The shaft 72 is bendable to an angle of up to about 45 degrees, either above or below the horizontal, in the sense of the view shown in Fig. 15. Optionally, handle 500 is provided with an actuator (not shown) for bending shaft 72 at bendable portion 74, the actuator having at least three predetermined stopping states, each corresponding to an orientation of the shaft 72 such as, for example, the orientations shown in Fig. 15. Optionally, the shaft 72 is bendable at the bendable portion 74 during the surgical procedure, after the deployment subassembly has been inserted via the first incision 6002 (Fig. 13A) at the surgical site.

[0296] In accordance with this exemplary implementation, the method of delivering the patch 700 (see e.g., Fig. 9) to a target area, implemented with the surgical delivery device 30 includes the following steps: a) using the surgical delivery device 30 in the deployment configuration, and using the spurs 3208, coupling the patch 700 to the deployment subassembly 300; (b) using the handle 500, transitioning the surgical delivery device 30 to the insertion configuration; (c) inserting the surgical delivery device 30 to the target area; (d) at the target area, using the handle 500 to transition the surgical delivery device 30 to the deployment configuration; and (e) pulling the elongated bracket members 320, 320’ proximally and upward, thereby releasing the patch 700 from the spurs 3208, 3208’ and decoupling the patch 700 at the target area.

[0297] It may be noted that, according to some embodiments, the patch 700 may be configured to be releasably coupled to the deployment subassembly 300. Specifically, the patch 700 may be a sheet having a quadrilateral shape, which may be sized and configured to couple to the spurs 3208, 3208’ extending basally and distally from the lower surface 3203 of each of elongated bracket members 320, 320’ of the deployment subassembly 300 of the surgical delivery device 30.

[0298] While in the foregoing specification the surgical delivery device of any of the embodiments shown and discussed herein has been described in relation to certain exemplary implementations, and many details are set forth for the purpose of illustration, it will be apparent to those skilled in the art that the disclosure of the alignment methods, implementable using the systems disclosed herein, may be suitable for additional implementations and that certain of the details described in this specification and more fully delineated in the following claims can be varied considerably without departing from the basic principles disclosed herein.

[0299] It is expected that during the life of a patent maturing from this application many relevant delivery devices and / or patches will be developed and the scope of the terms delivery device and patch is intended to include all such new technologies a priori.

[0300] As used herein the term “about” refers to ± 10 %.

[0301] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

[0302] The term “consisting of’ means “including and limited to”.

[0303] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0304] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a component" or "at least one component" may include a plurality of component, including at least one assembly thereof.

[0305] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0306] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0307] As used herein the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0308] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition

[0309] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0310] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0311] It is the intent of the Applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A surgical delivery device for delivering a patch to a surgical site, wherein the surgical delivery device comprises: a shaft having a proximal end and a distal end; a deployment subassembly at said shaft distal end, said deployment subassembly having a plurality of connection stations removably couplable to the patch, said deployment subassembly transitionable between a first configuration in which the patch is collapsed and a second configuration in which the patch is expanded; and a handle at said shaft proximal end, said handle including an actuator for effecting movement of said deployment subassembly between said first configuration and said second configuration.

2. The surgical delivery device according to claim 1, wherein said shaft has a longitudinal axis; wherein said deployment subassembly includes a plurality of elongated rods each having a rod distal portion, each of said connection stations located at a respective rod distal portion, said rod distal portions each located at a first distance relative to said shaft longitudinal axis when in said first configuration, said rods distal portions configured to be moved to a second distance relative to said shaft longitudinal axis when in said second configuration, wherein said second distance is greater than said first distance.

3. The surgical delivery device according to claim 1, wherein said surgical delivery device includes a frame configured to extend around at most three sides of the patch.

4. The surgical delivery device according to claim 1, wherein said surgical delivery device is configured to be coupled to the patch at a single side of the patch only.

5. The surgical delivery device according to claim 1, wherein said shaft is flexible.

6. The surgical delivery device according to claim 1, wherein said shaft includes a bendable section, said bendable section bendable from a first configuration, at which said handle is positioned on said longitudinal axis, to a second configuration, at which said handle is at an angle relative to said longitudinal axis.

7. The surgical delivery device according to claim 6, wherein said angle is at most 45 degrees.

8. The surgical delivery device according to claim 6, wherein said bendable section includes an articulatable joint.

9. The surgical delivery device according to claim 1, wherein a cross-sectional profile of each said elongated rod is one of rectangular, circular, and elliptical.

10. The surgical delivery device according to claim 2, wherein said rods are positioned parallel to said longitudinal axis when said deployment subassembly is in said first configuration, said rods movable to be positioned at an angle to said longitudinal axis when said deployment subassembly is in said second configuration.

11. The surgical delivery device according to claim 10, wherein said rods are positionable at a 90 degree angle to said longitudinal axis when said deployment subassembly is in said second configuration.

12. The surgical delivery device according to claim 11, including a plurality of pairs of rods, each pair of rods including first and second rods positioned on opposite sides of said longitudinal axis.

13. The surgical delivery device according to claim 11, including a plurality of rods positioned on a single side of said longitudinal axis.

14. The surgical delivery device according to claim 1, wherein each said connection station includes a clamp for removably coupling a portion of the patch thereto.

15. The surgical delivery device according to claim 14, wherein said deployment subassembly is transitionable to a third configuration, wherein each said clamp has a closed configuration when said deployment subassembly is in said first and second configurations, and wherein each said clamp has an open configuration when said deployment subassembly is in said third configuration.

16. The surgical delivery device according to claim 1, wherein each said connection station includes an eyelet for removably attaching a portion of the patch thereto.

17. The surgical delivery device according to claim 2, wherein said rods are each located at a first distance relative to said shaft longitudinal axis when in said first configuration, said rods configured to be moved to a second distance relative to said shaft longitudinal axis when in said second configuration, wherein said second distance is greater than said first distance.

18. The surgical delivery device according to claim 17, wherein each said rod includes a plurality of connection stations for removably coupling a portion of the patch thereto.

19. The surgical delivery device according to claim 18, wherein each said connection station includes a barb for piercing the patch.

20. The surgical delivery device according to claim 1, including a push rod having a proximal end operably coupled to said handle, and a distal end coupled to said deployment subassembly, said push rod sized and configured to be slidably coupled to said shaft; wherein said push rod is axially translatable from a first orientation, in which said deployment subassembly is in said first configuration, to a second orientation, in which said deployment portion is in said second configuration.

21. The surgical delivery device according to claim 20, wherein when in said first orientation, said push rod is axially translatable to said second orientation by distal movement of said push rod.

22. The surgical delivery device according to claim 20, wherein when in said first orientation, said push rod is axially translatable to said second orientation by proximal movement of said push rod.

23. The surgical delivery device of claim 20, wherein each said elongated rod has an axial slit, wherein said surgical delivery device further comprises: a. a dorsal extension, extending distally from the shaft, the dorsal extension having a flat basal surface defining a dorsal slot sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end;b. a ventral extension, extending distally from the shaft, the ventral extension having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal pin, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit, defined in two of the elongated rods; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

24. The surgical delivery device of claim 23, wherein the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of a pair of distal elongated rods, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated rods, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture, defined in the proximal end of the pair of distal elongated rods, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end, of the pair of proximal elongated rods, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the partially cylindrical ventral extension.

25. The surgical delivery device of claim 24, wherein, assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding proximal elongated rod, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated rod.

26. A method of delivering a patch to a target area, the method comprising: a. coupling the patch to a deployment subassembly of a surgical delivery device; b. Inserting the deployment subassembly, when in a first configuration in which the patch is collapsed, to the target area;c. at the target area, effecting transitioning of the deployment subassembly to a second configuration, in which the patch is expanded; and e. decoupling the patch from the surgical delivery device at the target area.

27. The method of claim 26, wherein said coupling the patch to a deployment subassembly includes coupling each of a plurality of portions of the patch to an aperture defined in each of a plurality of elongated rods of the deployment assembly.

28. The method of claim 27, wherein said coupling includes attaching a portion of the patch using a suture.

29. The method of claim 26, wherein said coupling includes attaching a portion of the patch using jaws located at a distal portion of each of the plurality of elongated rods.

30. The method of claim 29, wherein the surgical delivery device has a longitudinal axis, and wherein the patch is coupled to the deployment subassembly on a single side of the longitudinal axis.

31. The method of claim 26, wherein said coupling includes attaching a portion of the patch using a plurality of barbs located along said plurality of elongated rods.

32. The method of claim 31, wherein said decoupling includes pulling the deployment subassembly proximally and upward, thereby releasing the patch from the barbs and decoupling the patch from the surgical delivery device.

33. A method of delivering a patch to a target area, the method comprising: a. coupling the patch to a deployment subassembly of a surgical delivery device; b. inserting the deployment subassembly, when in a first configuration in which the patch is collapsed, to the target area; c. at the target area, effecting transitioning of the deployment subassembly to a second configuration, in which the patch is expanded wherein, in said second configuration, the surgical delivery device does not interfere with stitching of the patch at the target area; and e. decoupling the patch from the surgical delivery device at the target area.

34. A surgical delivery device for delivering a patch to a tissue to be repaired at a surgical site, wherein the surgical delivery device comprises: a shaft having a distal end; and a deployment subassembly at said shaft distal end, said deployment subassembly having a plurality of connection stations removably couplable to the patch, said deployment subassembly transitionable between a first configuration in which the patch is collapsed and a second configuration in which the patch is expanded; wherein an area of the patch to be positioned over the tissue is defined between connection stations; wherein, when in said second configuration, said surgical delivery device does not overlap the area.

35. The surgical delivery device according to claim 34, wherein said shaft has a proximal end, and wherein said device includes a handle at said shaft proximal end, said handle including an actuator for effecting movement of said deployment subassembly between said first configuration and said second configuration.

36. A surgical delivery device for delivering a patch to a surgical site, wherein the surgical delivery device comprises: a shaft having a proximal end and a distal end; a deployment subassembly at said shaft distal end, said deployment subassembly having a plurality of connectors removably couplable to the patch, said deployment subassembly transitionable between a first configuration in which the patch is collapsed, a second configuration in which the patch is expanded, and a third configuration in which the patch is released from said connectors; and a handle at said shaft proximal end, said handle including an actuator for effecting movement of said deployment subassembly among said first configuration, said second configuration, and said third configuration.

37. A surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration and a deployment configuration, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore;b. a push rod having a proximal end operably coupled to a handle, and said push rod having a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having four elongated deployment plank members, operable to rotatably transition between the insertion configuration and the deployment configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to transition between the insertion configuration and the deployment configuration.

38. The surgical delivery device of claim 37, wherein each elongated deployment plank member defines: a. a proximal end defining a proximal aperture and a distal end; b. an axial slit having a proximal end and a distal end; and c. a lateral protrusion defining an eyelet therein.

39. The surgical delivery device of claim 38, wherein the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, the dorsal extension having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, the ventral extension having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal pin, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit, defined in two of the elongated deployment plank members; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

40. The surgical delivery device of claim 39, wherein the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedlycoupled to the aperture defined in the proximal end of a pair of distal elongated deployment plank members, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated deployment plank members, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture, defined in the proximal end of the pair of distal elongated deployment plank members, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture, defined in the proximal end, of the pair of proximal elongated deployment plank members, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the ventral extension.

41. The surgical delivery device of claim 30, wherein, assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding proximal elongated deployment plank members, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated deployment plank members.

42. A method of delivering the patch to a target area, implemented with the surgical delivery device of claim 41, comprising: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; and e. decoupling the patch at the target area.

43. The method of claim 42, wherein the patch is a quadrilateral sheet, sized and configured to couple to the aperture defined in each of the pair of proximal elongated deployment plank members, and the pair of distal elongated deployment plank members.

44. A surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration, a deployment configuration, and a decoupling configuration, wherein, in the decoupling configuration, the surgical delivery device is operable to decouple the patch from the deployment subassembly of the surgical delivery, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having four elongated deployment plank members, operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to reversibly transition between the insertion configuration, the deployment configuration, and the decoupling configuration.

45. The surgical delivery device of claim 44, wherein each elongated deployment plank member is a resilient clamp defining a pair of jaws with: a. a common proximal end defining a proximal aperture and a split distal end; and b. an axial slit having a common proximal narrowed portion and a split distal narrowed portion.

46. The surgical delivery device of claim 45, wherein the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension;d. a pair of proximal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members; and e. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two of the elongated deployment plank members.

47. The surgical delivery device of claim 46, wherein the common proximal narrowed portion of each elongated deployment plank member is narrower than each of the pair of proximal guiding pins, and the pair of distal guiding pins.

48. The surgical delivery device of claim 47, wherein the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of a pair of distal elongated deployment plank members, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of a pair of proximal elongated deployment plank members, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the pair of distal elongated deployment plank members, the ventral sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of the pair of proximal elongated deployment plank members, the ventral sliding rail sized and configured to be accommodated in the ventral slot of the ventral extension.

49. The surgical delivery device of claim 48, wherein, assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of proximal elongated deployment plank members, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding distal elongated deployment plank members.

50. The surgical delivery device of claim 49, wherein upon translation of the push rod distally to the decoupling configuration, such that distal end of dorsal sliding rail, and ventralsliding rail respectively, each abuts the distal end of slits defined in dorsal extension and ventral extension respectively, each of the pair of proximal guiding pins and the pair of distal guiding pins are configured to frictionally engage common proximal narrowed portion of axial slit defined in each of the corresponding of proximal elongated deployment plank members, and the corresponding distal elongated deployment plank members, causing distal end to separate.

51. A method of delivering the patch to a target area, implemented with the surgical delivery device of claim 50, comprising: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; e. using the handle, transitioning the surgical delivery device to the decoupling configuration; and f. decoupling the patch at the target area.

52. The method of claim 51, wherein each of the pair of proximal elongated deployment plank members, and the pair of distal elongated deployment plank members are configured to resiliently couple to the patch.

53. A surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration and a deployment configuration, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having a pair of elongated bracket members and four elongated actuators, wherein the deployment subassembly being operable to transition between the insertion configuration and the deployment configuration; andd. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to transition between insertion configuration and deployment configuration.

54. The surgical delivery device of claim 53, wherein each elongated bracket members, having a proximal end and a distal end, with an upper surface and a lower surface, each elongated bracket members further comprising a plurality of spurs extending basally and distally from the lower surface, and wherein each elongated bracket members further defines: a. a proximal aperture disposed adjacent to the proximal end; b. a distal aperture disposed distally to the proximal aperture respectively; c. a proximal opening disposed distally to the distal aperture; and d. a distal opening disposed proximally adjacent to the distal end of each elongated bracket members.

55. The surgical delivery device of claim 54, wherein each of the four elongated actuators having a proximal end and a distal end, each of the four elongated actuators further having a proximal aperture defined adjacent to the proximal end, and a distal aperture defined adjacent the distal end, with an axial slit having a proximal end and a distal end.

56. The surgical delivery device of claim 49, wherein the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. a pair of distal guiding pins sized and configured to be accommodated in the axial slit defined in two distal elongated actuators of the four elongated actuators; and e. a pair of proximal guiding pins disposed proximally to the pair of distal guiding pins, the pair of proximal guiding pins sized and configured to be accommodated in the axial slit defined in two proximal elongated actuators of the four elongated actuators.

57. The surgical delivery device of claim 56, wherein the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of distal elongated actuators, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of proximal elongated actuators, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of distal elongated actuators, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the proximal aperture defined in the proximal end of the pair of proximal elongated actuators, the dorsal sliding rail sized and configured to be accommodated in the ventral slot of the partially cylindrical dorsal extension.

58. The surgical delivery device of claim 57, wherein: a. the distal aperture of the pair of proximal elongated actuators is hingedly coupled to the proximal aperture of each elongated bracket members respectively; and b. the distal aperture of the pair of distal elongated actuators is hingedly coupled to the distal aperture of each elongated bracket members respectively.

59. The surgical delivery device of claim 58, wherein, assembled, the pair of proximal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of proximal elongated actuators, and the pair of distal guiding pins are each configured to be slidably accommodated in the axial slit defined in a corresponding pair of distal elongated actuators.

60. A method of delivering the patch to a target area, implemented with the surgical delivery device of claim 59, comprising: a. using the surgical delivery device in the deployment configuration, and using the spurs, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration;c. inserting the surgical delivery device to the target area; d. at the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; and e. pulling the elongated bracket members proximally and upward, thereby releasing the patch from the spurs and decoupling the patch at the target area.

61. The method of claim 60, wherein the patch is a quadrilateral sheet, sized and configured to couple to the spurs extending basally and distally from the lower surface of each of elongated bracket members.

62. A surgical delivery device defining a longitudinal axis for delivering a patch, the surgical delivery device configured to transition between an insertion configuration, a deployment configuration, and a decoupling configuration, wherein, in the decoupling configuration, the surgical delivery device is operable to decouple the patch from the deployment subassembly of the surgical delivery, wherein the surgical delivery device comprises: a. a shaft operably coupled to a handle having a distal end and a proximal end, the shaft defining an axial bore; b. a push rod having a proximal end operably coupled to a handle, and a distal end, the push rod sized and configured to be accommodated in, and slidably coupled to the axial bore of the shaft; c. a deployment subassembly, operably coupled to the distal end of the push rod and to the shaft, the deployment subassembly having a pair of elongated deployment plank members, disposed proximally and distally on the same side of the shaft, operable to rotatably transition between the insertion configuration, the deployment configuration, and the decoupling configuration; and d. the handle having a distal end coupled to the proximal end of the shaft, operable to translate the push rod axially, causing the deployment subassembly to reversibly transition between the insertion configuration, the deployment configuration, and the decoupling configuration.

63. The surgical delivery device of claim 62, wherein each elongated deployment plank member is a resilient clamp defining a pair of jaws with: a. a common proximal end defining a proximal aperture and a split distal end; and b. an axial slit having a common proximal narrowed portion and a split distal narrowed portion;c. a proximal ruler spanning a substantial length of proximal jaw with a proximally extending arcuate member, slidably coupled to a proximal facet of the proximal jaw.

64. The surgical delivery device of claim 63, wherein the shaft further comprises: a. a dorsal extension, extending distally from the distal end of the shaft, having a flat basal surface defining a dorsal slit sized and configured to slidably accommodate a first portion of the deployment subassembly, and having distal end; b. a ventral extension, extending distally from the distal end of the shaft, having a flat apical surface defining a ventral slit sized and configured to slidably accommodate a second portion of the deployment subassembly, and having a distal end; and c. a distal column, disposed distally spanning a gap formed by the basal flat surface of the dorsal extension, and the flat apical surface of the ventral extension; d. at least one proximal guiding pin, sized and configured to be accommodated in the axial slit defined in the proximally disposed elongated deployment plank member; and e. at least one distal guiding pin sized and configured to be accommodated in the axial slit defined in the distal elongated deployment plank member.

65. The surgical delivery device of claim 64, wherein the common proximal narrowed portion of each elongated deployment plank member is narrower than each of the at least one guiding pin, and the at least one distal guiding pins.

66. The surgical delivery device of claim 65, wherein the deployment subassembly comprises: a. a dorsal sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the distally disposed elongated deployment plank member, the dorsal sliding rail further defining an intermediate aperture hingedly coupled to the aperture defined in the proximal end of the proximally disposed elongated deployment plank member, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension; and b. a ventral sliding rail, having a proximal end defining a proximal aperture hingedly coupled to the distal end of the push rod, and a distal end defining a distal aperture hingedly coupled to the aperture defined in the proximal end of the distally disposed elongated deployment plank member, the dorsal sliding rail further defining an intermediate aperture hingedly coupledto the aperture defined in the proximal end of the proximally disposed elongated deployment plank member, the dorsal sliding rail sized and configured to be accommodated in the dorsal slot of the dorsal extension.

67. The surgical delivery device of claim 66, wherein, assembled, the at least one proximal guiding pin is each configured to be slidably accommodated in the axial slit defined in the proximally disposed elongated deployment plank member, and the at least one guiding pin is configured to be slidably accommodated in the axial slit defined in a corresponding distally disposed elongated deployment plank member.

68. The surgical delivery device of claim 67, wherein upon translation of the push rod distally to the decoupling configuration, such that distal end of dorsal sliding rail, and ventral sliding rail respectively, each abuts the distal ends of slits, defined in dorsal extension and ventral extension respectively, each of the at least one proximal guiding pin and the at least one distal guiding pin are each configured to frictionally engage common proximal narrowed portion of axial slit defined in each of the corresponding of proximally disposed elongated deployment plank member, and the corresponding distally disposed elongated deployment plank member, causing jaws to separate.

69. A method of delivering the patch to a target area, implemented with the surgical delivery device of claim 68, comprising: a. using the surgical delivery device in the deployment configuration, coupling the patch to the deployment subassembly; b. using the handle, transitioning the surgical delivery device to the insertion configuration; c. inserting the surgical delivery device to the target area; d. At the target area, and using the handle, transitioning the surgical delivery device to the deployment configuration; e. using the handle, transitioning the surgical delivery device to the decoupling configuration; and f. Decoupling the patch at the target area.

70. The method of claim 69, wherein the patch is a quadrilateral sheet, and wherein each of the proximally disposed elongated deployment plank member, and the distally elongated deployment plank member are configured to reversibly engage the patch on one side only.

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