WO2020014191A1

WO2020014191A1 - Flexible/articulating delivery device for ligation of tissue

Info

Publication number: WO2020014191A1
Application number: PCT/US2019/040946
Authority: WO
Inventors: Jason Sperling
Original assignee: Corfigo, Inc.
Priority date: 2018-07-09
Filing date: 2019-07-09
Publication date: 2020-01-16

Abstract

Disclosed herein are ligation tool delivery devices, including suture delivery devices. Further disclosed is a suture delivery device having a tubular body that is conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture to a target tissue in a patient, a lumen defined within the tubular body, and an opening in fluidic communication with the lumen and having a diameter that is narrower than an outer diameter of the slipknot of the suture being delivered.

Description

FLEXIBLE/ ARTICULATING DELIVERY DEVICE FOR LIGATION OF TISSUE

Cross-Reference to Related Application(s)

[001] This application claims the benefit under 35 U.S.C. § 1 19(e) to U.S. Provisional

Application 62/695,253, filed July 9, 2018 and entitled “Flexible/Articulating Device for Ligation of Tissue,” which is hereby incorporated herein by reference in its entirety.

Field of the Invention

[002] The various embodiments herein relate to medical devices, and more specifically to ligation devices, and even more specifically to delivery devices for delivery a ligation device to a target tissue, and related systems and methods.

Background of the Invention

[003] The left atrial appendage is an outpouching of the left atrium heart chamber. It has a reservoir function and is hormonally active but also is a site of morbidity related to stroke and embolism. Its muscle is highly trabeculated and when stasis of blood flow occurs, such as in heart rhythm disturbances such as atrial fibrillation or atrial flutter, blood clots may form within the appendage. The left atrial appendage is the source of embolic stroke in up to 95% of cases when stroke is a consequence of atrial fibrillation. It is a very common medical problem in developed countries with aging populations, and is growing year over year. Multiple methods have been used to excise, exclude or ligate the left atrial appendage during open-heart surgery, and more recently using minimally invasive techniques and devices. One benefit of external (in contrast to transvenous) ligation of the left atrial appendage is elimination of electrical signals that originate within it, which can be additive to ablation procedures that aim to restore normal heart rhythm.

[004] Devices to aid left atrial appendage ligation from the outside of the heart (epicardially) have usually been designed for use in open heart surgery, or when access to the appendage is achieved using a generally linear trajectory. Since the left atrial appendage resides within a space called the pericardium (heart sac), it can be accessed as long as the heart sac itself is entered. One disadvantage of known ligation devices is that their delivery methods and actuation have not been designed to navigate multiple curves around delicate heart structures in order to approach the appendage atraumatically but effectively. The left atrial appendage itself is susceptible to trauma and bleeding could be lethal. Also, incomplete ligation of the appendage can result in residual thrombogenic portions of the appendage still able to contribute to clot formation and stroke.

[005] There is a need in the art for an improved device for external (non-transvenous) ligation of certain tissues, including the left atrial appendage.

Brief Summary of the Invention

[006] Discussed herein are various delivery devices for delivering a ligation device to a target tissue, including devices such as flexible or pre-shaped devices that can conform to a non linear delivery path. [007] In Example 1 , a suture delivery device comprises a tubular body comprising of a plurality of segments, wherein each of the plurality of segments is rotatably coupled to at least one other segment, wherein each of the plurality of segments comprises a segment lumen defined therein, a tubular body lumen defined by and extending along a length of the tubular body, wherein each of the segment lumens comprises a portion of the tubular body lumen, and an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture.

[008] Example 2 relates to the device according to Example 1 , wherein the opening is defined in one of the plurality of segments, wherein the one of the plurality of segments is disposed at the distal end of the tubular body.

[009] Example 3 relates to the device according to Example 1 , wherein each of the plurality of segments is rotatably coupled to at least one other segment via a ball and socket coupling.

[010] Example 4 relates to the device according to Example 1 , wherein each of the plurality of segments comprises a male coupling portion and a female coupling portion, wherein each of the plurality of segments is coupleable to at least one other segment via the male and female coupling portions.

[011] Example 5 relates to the device according to Example 1 , wherein each of the plurality of segments can articulate in a first plane but can only articulate minimally in a second plane that is transverse to the first plane.

[012] Example 6 relates to the device according to Example 1 , wherein the tubular body is constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient.

[013] Example 7 relates to the device according to Example 1 , wherein each of the plurality of segments are tubular segments.

[014] In Example 8, a suture delivery device comprises a tubular body constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient, a lumen defined by and extending along a length of the tubular body, and an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture.

[015] Example 9 relates to the device according to Example 8, wherein the tubular body is constructed and arranged to conform to at least two curves of the delivery path.

[016] Example 10 relates to the device according to Example 9, wherein the at least two curves are of opposing polarities.

[017] Example 1 1 relates to the device according to Example 8, wherein the tubular body is steerable from a proximal end of the tubular body. [018] Example 12 relates to the device according to Example 8, wherein the tubular body comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body.

[019] Example 13 relates to the device according to Example 12, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

[020] Example 14 relates to the device according to Example 8, wherein the tubular body comprises of a plurality of segments, wherein each of the plurality of segments is rotatably coupled to at least one other segment.

[021] Example 15 relates to the device according to Example 14, wherein each of the plurality of segments is rotatably coupled to at least one other segment via a ball and socket coupling.

[022] Example 16 relates to the device according to Example 14, wherein each of the plurality of segments comprises a male coupling portion and a female coupling portion, wherein each of the plurality of segments is coupleable to at least one other segment via the male and female coupling portions.

[023] Example 17 relates to the device according to Example 16, wherein each of the plurality of segments can articulate in a first plane but can only articulate minimally in a second plane that is transverse to the first plane.

[024] Example 18 relates to the device according to Example 8, wherein a portion of the loop or slipknot is radio-opaque.

[025] Example 19 relates to the device according to Example 8, wherein the suture is non absorbable.

[026] Example 20 relates to the device according to Example 8, further comprising a suture cutting device associated with the tubular body.

[027] Example 21 relates to the device according to Example 20, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

[028] Example 22 relates to the device according to Example 14, wherein each of the plurality of segments are tubular segments.

[029] In Example 23, a suture delivery device comprises a tubular body constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient, a lumen defined by and extending along a length of the tubular body, an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture, and a steering mechanism associated with the tubular body.

[030] Example 24 relates to the device according to Example 23, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

[031] In Example 25, a suture delivery device comprises a tubular body constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient, a lumen defined by and extending along a length of the tubular body, an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture, a steering mechanism associated with the tubular body, and a suture cutting device associated with the tubular body.

[032] Example 26 relates to the device according to Example 25, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

[033] Example 27 relates to the device according to Example 25, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

[034] Example 28 relates to the device according to Example 1 , further comprising a suture cutting device associated with the tubular body.

[035] Example 29 relates to the device according to Example 28, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

[036] Example 30 relates to the device according to Example 1 , further comprising a steering mechanism associated with the tubular body.

[037] Example 31 relates to the device according to Example 30, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

[038] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[039] FIG.1 is a side view of a known suture loop/snare with a pre-tied slipknot. [040] FIG. 2 is a side view of a pusher device with a snare disposed therethrough, according to one embodiment.

[041] FIG. 3 is a side view of a pusher device with a double curve and a snare disposed therethrough, according to one embodiment.

[042] FIG. 4A is a side view of a pusher segment, according to one embodiment.

[043] FIG. 4B is a side view of a pusher device with three pusher segments, according to one embodiment.

[044] FIG. 5 is a side view of a segmented pusher device disposed through an access cannula, according to one embodiment.

[045] FIG. 6 is a side view of a pusher segment, according to another embodiment.

[046] FIG. 7 A is a perspective view of a segmented pusher device, according to one embodiment.

[047] FIG. 7B is an aerial view of the segmented pusher device of FIG. 7A.

[048] FIG. 8A is a side view of a pusher device having a steering mechanism and a suture cutting device, according to another embodiment.

[049] FIG. 8B is another side view of the pusher device of FIG. 8A in which the distal portion has been urged into a curved configuration, according to one embodiment.

Detailed Description

[050] The various embodiments disclosed or contemplated herein relate to a delivery system or device configured to navigate a curved or non-linear path to deliver a standard slipknot suture and use that suture to ligate tissue. In certain specific embodiments, a delivery device is described that delivers a standard slipknot suture to ligate a patient’s left atrial appendage. Ligation of other tissues is also contemplated. It is further contemplated according to certain embodiments that the device and method embodiments disclosed or contemplated herein can be used to perform a ligation procedure in conjunction with an exterior heart wall ablation procedure. That is, any of the various ligation device embodiments can be inserted into and positioned within the patient’s chest cavity via the same approach as the ablation device.

[051] Known slipknot devices for soft tissue ligation utilize a relatively straight and substantially rigid (non-flexible) delivery device (also referred to herein as a“pusher”). Such devices cannot navigate a pathway with aggressive bends, arcs or curves to reach the target tissue with an indirect trajectory. In contrast, the various device and system embodiments disclosed or contemplated herein are constructed to navigate curves and bend in multiple directions while still being capable of actuating a pre-tied slipknot. More specifically, the various implementations herein relate to a delivery device or system that can assume the curves of an anatomical space (such as, for example, the pericardium and the heart that occupies it) during delivery. Certain embodiments relate to a unitary delivery tube, while others relate to a segmented device and still others relate to a delivery device disposed through a delivery cannula.

[052] One exemplary embodiment of a delivery device (also referred to as a “pusher device” or“pusher”) 20 according to one embodiment is depicted in FIG. 2. The device 20 is a flexible elongate tube 20 having a lumen 22 defined through the length of the tube 20 such the lumen 22 can receive a suture such as the suture 10 as shown. In one implementation, the diameter of the opening of the lumen 22 at the distal end of the tube 20 is smaller than the diameter of the slipknot 14 on the suture 10 such that the slipknot 14 cannot enter into or be positioned within the lumen 22. The delivery device 20, according to one implementation, can be used to deliver a standard slipknot suture, such as the suture 10 depicted in FIG. 1 . According to one embodiment, the suture 10 is a commercially-available Endoloop®.

[053] The known suture 10 as shown in FIG. 1 (along with FIGS. 2 and 3 as well) has a standard loop (also referred to as a“snare”) 12 disposed at a distal end of the suture 10 and a known, pre-tied slipknot 14 that slidably couples the loop 12 to the suture 10. It is understood in the art that the known slipknot 14 can be used to increase or decrease the size of the loop 12 by moving the slipknot 14 along the length of the suture 10, thereby making it possible to position the loop 12 over and around a target tissue, decrease the size of the loop 12 by tightening the slipknot 14, and thereby ligate the target tissue. In certain embodiments, the loop 12 or slipknot 14, or a portion thereof, or a portion of the suture 10 adjacent to or associated with the slipknot 14, can be radiopaque to facilitate medical procedures using fluoroscopy. Any suture 10 used with any of the embodiments herein can have any of these characteristics.

[054] Another delivery device embodiment 30 is depicted in FIG. 3. The device 30 in this implementation is an elongate tube 30 with a predetermined or preformed curved shape as shown. The curved shape of the tube 30 makes it possible for the pusher 30 to navigate turns or curved portions of a delivery path that known delivery devices cannot. In one embodiment, the pusher 30 with the preformed curves can be used to navigate the curves of a patient’s heart and the small space in the pericardial sac. Alternatively, the pusher 30 can be used to navigate any number of curved or non-straight pathways in a human body. It should also be noted that the various components in FIG. 3 with the same or similar components are substantially similar to the corresponding components in FIG. 2, such that the tube 30 has a lumen 32 configured to receive a suture such as the suture 10 as shown and in a similar manner as described above with respect to the pusher device 20.

[055] In use, either of the delivery devices 20, 30 (or any other delivery device embodiment disclosed or contemplated herein) can be used in the following fashion. The pusher 20, 30 with the suture (such as suture 10) disposed therein is positioned within the desired pathway to the target tissue and urged forward toward the target tissue. In certain embodiments, the target tissue is the left atrial appendage. One known pathway to the left atrial appendage, according to one embodiment, is via an access tube (not shown) positioned through a small incision below the breastbone and into the space surrounding the heart. In certain embodiments, this access tube (not shown), so positioned, can also be used to perform an ablation procedure on an external wall of the heart either before or after the ligation procedure. Alternatively, the target tissue can be any tissue within a patient to be ligated, and the pathway can be any straight or non-straight pathway that can be used to deliver the pusher device 20, 30 to the target tissue. At this point, the slipknot 14 of the suture 10 is disposed on the suture 10 such that the loop 12 is large enough to be positioned around the target tissue, and the delivery device 20, 30 and suture 10 are advanced distally together such that the loop 12 can maintain that desired diameter.

[056] Once the delivery device 20, 30 has delivered the loop 12 to the target tissue, the user (such as, for example, a surgeon) manipulates the proximal end of the delivery device 20, 30 to position the loop 12 at the distal end of the device 20, 30 around the target tissue. Once the loop 12 is positioned as desired, the user advances the delivery device 20, 30 distally while maintaining the position of the suture 10, thereby causing the distal end of the tube 20, 30 to urge the slipknot 14 in a distal direction in relation to the suture 10, thereby causing the slipknot 14 to“tighten” the loop 12 such that the loop 12 closes or tightens around the target tissue as the diameter of the loop 12 decreases. This continues until the loop 12 is closed sufficiently tight around the target tissue. At this point, the delivery device 20, 30 is retracted proximally out through the access tube (not shown), leaving the suture 10 positioned therein. A known device (not shown) for cutting the tail of the suture 10 can then be inserted through the access tube (not shown) to cut the suture 10 just proximal of the cinched loop 12, thereby leaving only the loop 12 cinched around the target tissue. The cutting device (not shown) and the access tube (not shown) can then both be retracted out of the chest cavity of the patient.

[057] According to certain embodiments, the procedure involves the delivery of at least two sutures 1 and thus the placement of at least two loops 2 around the target tissue. In fact, in certain versions of those embodiments, the first suture 10 is inserted through the device 20, 30 and positioned as desired around or in contact with the target tissue to grasp or otherwise manipulate the tissue and thereby more easily direct the second loop 12 over the target tissue and positioned as desired.

[058] A further delivery device 40 is depicted in FIGS. 4A and 4B, according to another embodiment. This device 40 has a segmented elongate member (also referred to herein as a“tube”) 42 as best shown in FIG. 4B that is made up of two or more individual, mateable segments (also referred to as“vertebrae,”“blocks,” or“units”) 44 as best shown in FIG. 4A. That is, the tube 42 of FIG. 4B has two or more segments 44 that mate or otherwise couple with each other to create a segmented tube 42 when coupled together as shown. Returning to FIG. 4A, each segment 44 has a distal portion (also referred to as a“head” or“male” portion) 46 and a proximal portion (also referred to as a“tail” or“female” portion) and a lumen 50 defined therethrough that is sized to receive a suture (such as suture 10). The proximal portion includes a pair of coupling projections (also referred to as “mating projections,”“coupling arms,”“mating arms,” or“grasping arms”) 48 that define an opening (also referred to as a“coupling opening” or“void”) 52 therebetween that is in fluid communication with the lumen 50.

[059] Returning to FIG. 4B, the tube 42 is made up of multiple segments 44. In this embodiment, only three segments 44 are shown. Flowever, it is understood that the tube 42 can be made up of any number of segments 44 ranging from two to at least 100. Alternatively, the tube 42 can have any number of segments 44 necessary to create a tube 42 having the desired length for delivering the suture (such as suture 10) to the target tissue. Each of the segments 44 is coupled to at least one other segment 44 as shown, with the distal portion 46 of each segment being sized and shaped to couple to and articulate with the proximal portion of another segment 44. More specifically, in this particular embodiment, the rounded distal head 46 of one segment 44 can be jointedly coupled to the proximal portion of another segment 44 by positioning the head 46 between the two coupling projections 48 in the opening 52 such that the two segments 44 are coupled together in an articulated fashion. The connection of the two segments 44 aligns the lumens 50 in each segment such that both lumens 50 are in fluid communication with each other when the two segments 44 are coupled.

[060] In addition, the coupling of the segments 44 as depicted and described herein create a pusher 40 that has sufficient axial stiffness to urge a suture (such as suture 10) along a pathway to a target tissue while also allowing for radial rotation or articulation between the segments 44 such that the pusher 40 can bend or otherwise navigate through curves in the pathway. More specifically, in this specific embodiment, the two proximal projections 48 of the distally positioned segment 44 couple to the distal portion 46 of the proximally positioned segment 44 such that the proximal segment 44 cannot move lengthwise in relation to the distal segment 44 but can rotate in relation to the distal segment 44. That is, the two segments 44 are coupled together such that there is little or no axial movement between the two segments 44 but the coupling allows for radial movement therebetween. As such, each of the segments 44 in the elongate segmented tube 42 articulates with the two other segments 44 to which it is coupled while still allowing for passage of a suture (such as suture 10) therethrough via the lumens 50 and delivery of the suture to the target tissue.

[061] It is understood that the segments 44 as described above and the additional segments according to the additional embodiments disclosed below or otherwise contemplated herein are not limited to a specific shape or configuration. That is, so long as the segment has the components or features as described herein, the segment can have any known shape.

[062] Another embodiment of a pusher system 60 is depicted in FIG. 5. In this embodiment, the system 60 has an articulated delivery device 62 that can be positioned within a cannula 64 and delivered to the target tissue 66 via the cannula 64. In this specific implementation, the cannula 64 has a preformed curvature as shown. Further, the cannula 64 also has a first or distal imaging device 68A at the distal end of the cannula 64 and a second or proximal imaging device 68B at the proximal end of the cannula 64. According to one embodiment, the imaging devices 68A, 68B are video imaging devices such as video cameras.

[063] The delivery device 62 has multiple segments or vertebrae 70 positioned adjacent to and articulated with respected to each other in a manner similar to the delivery device 40 discussed above, with each segment 70 having a distal portion 72 and two proximal attachment projections 74. The segments 70 articulate with one another such that the pusher 62 can bend and curve to take on the shape of cannula 64 that it is positioned within and as it passes therethrough. Further, each of the segments 70 has a lumen (not shown) defined therethrough that is similar to the lumen 22 discussed above such that the suture 10 can pass through each of the segments 70. In addition, like the device embodiment 40 discussed above, the segments 70 of this delivery device 62 can be tensioned axially along the suture 10 in order to urge the slipknot 14 distally and thereby actuate (narrow) the loop 12.

[064] In this implementation as shown in FIG. 5, the loop 12 has been positioned over the target tissue 66. According to one specific embodiment, the target tissue 66 is the left atrial appendage. In use, the user can be aided by the imaging devices 68A, 68B, which can be coupled to an external video screen or viewing device that is visible to the user.

[065] Another embodiment of a single segment 80 of a delivery device is depicted in FIG. 6.

In one embodiment, this segment has the same or similar components as the segment 44, 70 embodiments discussed above, including, for example, a distal end 84 of the segment 80 and a lumen 86 defined therethrough. In addition, one difference is that this segment 80 has proximal coupling projections 82 that allow for the coupled segments 80 to articulate in one radial direction while preventing them from articulating in the other. More specifically, as shown in the figure, the positioning and structure of the two coupling projections (or“paddles”) 82 are such that any segment (not shown) disposed between the two projections 82 and thereby coupled to the segment 80 would be rotatable in a radial direction as shown by arrow A in relation to the segment 80, but would not be rotatable in the radial direction depicted as arrow B, which is transverse in relation to arrow A. In other words, the paddles 82 prevent rotation of the proximally coupled segment (not shown) in the direction depicted as arrow B but does allow rotation in the transverse direction depicted by arrow B.

[066] FIGS. 7 A and 7B depict a delivery device 100 that is made up of segments 102 substantially similar to the segment 80 depicted in FIG. 6. In this embodiment, in addition to each having a lumen 1 10 similar to the segment lumens described above, the various segments 102 each have a distal (or“head”) portion 104 that is coupled to the paddles 106 of the immediately distal segment 102 such that each proximal segment 102 is coupled to and rotatable in relation to the immediately adjacent distal segment 102 as shown. More specifically, as discussed above, the paddles 106 of each segment 102 allow for the proximally coupled segment 102 to rotate in one radial direction but restricts the segment 102 from rotating in the other, transverse radial direction. Flence, as shown in FIG. 7A, the segments 102 of the segmented tube 108 can rotate in relation to each other in one radial direction that is parallel to the paper on which the figure is printed such that the tube 108 can be curved along that plane as shown. Flowever, the paddles 106 of the segments 102 prevent rotation of the segments 102 in the transverse plane, thereby preventing the segmented tube 108 from bending in that plane.

[067] FIG. 7B, in contrast, is an aerial view of the delivery device 100 such that the tube

108 cannot bend in the plane parallel to the paper on which the figure is printed. In other words, the paddles 106 restrict the rotation of the segments 1 02 such that the segments 102 cannot rotate in that plane, which is depicted graphically in the figure via the arrows C that represent that the segments 102 cannot rotate in the directions represented by those arrows C. As such, this device 100 embodiment has two or more segments 102 that allow the device 1 00 to rotate in one radial direction but cannot rotate in the other, transverse radial direction. Put another way using layman’s terms, the device 100 can be formed into curves up-and-down but cannot be formed into curves side-to-side.

[068] According to another implementation, the delivery device 120 can be an elongate steerable tube 120 as depicted in FIGS. 8A and 8B. The device 120 in this implementation has an elongate tubular body 122 with a lumen 124 defined therethrough such that a suture such as suture 10 can be received therein in a similar manner as described above with respect to the various other delivery device embodiments. It should also be noted that the various similar components in FIGS. 6A and 6B are substantially similar to the corresponding components as described above and depicted in previous figures. However, unlike previous implementations, this delivery device 120 has an integrated steering system 126 that includes a moveable tension line 128 that is fixedly attached at its distal end to a distal portion of the tubular body 122, which in this specific embodiment is called the “tensioning area” 130. In this implementation, the tension line 128 is fixedly attached to the tubular body 122 at the tensioning area 130 via fixation nodes 132 that fixedly attach the line 128 to the tubular body 122. The tension line 128 also has a sliding handle (also referred to herein as a“knob”) 134 fixedly coupled to the proximal end of the tension line 128 and slideably coupled to a proximal portion of the tubular body 122 such that a user can urge the sliding knob 134 proximally to urge the tension line 128 proximally and thereby“steer” the distal portion of the tubular body 122 as described in additional detail below.

[069] It is understood that the steering system 126 can be incorporated into any embodiment disclosed or contemplated herein. Further, it is understood that other steering mechanisms or structures can be incorporated into the device 120 or any other embodiment herein.

[070] In use, as best shown in FIG. 8B, a user can urge the slideable knob 134 proximally to cause the distal portion of the tubular body 122 to curve. That is, the user can“steer” the delivery device 120 to navigate the device 120 through multiple curves around delicate organs and other tissue structures. When the knob 134 is urged proximally, the tension line 128 is urged proximally, which urges the tensioning area 130 proximally. Because the distal portion is somewhat flexible, the pulling of the tensioning area 130 in the proximal direction causes the distal portion of the tubular body 122 to curve toward the side of the body 122 on which the tension line 128 and tensioning area 130 are disposed as best shown in FIG. 8B. In certain embodiments, the tension line 128 and/or the distal portion of the tubular body 122 is tensioned or otherwise configured to be continuously urged into the straight configuration as depicted in FIG. 8A. As such, the user must urge the knob 134 proximally to cause the distal portion of the body 122 to curve as shown in FIG. 8B, and if the user releases the knob 134, the distal portion of the body 122 will return to its substantially straight configuration as shown in FIG. 8A.

[071] Returning to FIG. 8A, according to another implementation, this tubular body 122 (or any other delivery device embodiment herein) has a suture cutting device 140. The cutting device 140 has a cutting mechanism 142, an actuation button 144, and an actuation line 146 coupling the actuation button 144 to the cutting component 142. In accordance with one embodiment, the cutting component 142 is a set of clippers, shears, or scissors. Alternatively, any known cutting component 142 can be incorporated herein. The cutting mechanism 142 is disposed adjacent to the lumen 124 such that actuation of the cutting mechanism 142 causes the mechanism to cut any suture 10 disposed through the lumen 124. In use, the user can depress the actuation button 144 to actuate the cutting mechanism 142 to cut the suture 10 disposed through the lumen 124 of the delivery device 120.

[072] In the exemplary embodiment as shown in FIG. 8A, the cutting component 142 is disposed along the length of the tubular body 122 at a point that is proximal to the distal end thereof as shown. Alternatively, the cutting component 142 can be disposed at any point along the length of the tubular body 122. For example, in one specific alternative implementation, the cutting component 142 can be disposed at or near the distal end of the tubular body 122.

[073] It is understood that the suture cutting device 140 or a similar mechanism or structure can be incorporated into any embodiment disclosed or contemplated herein. For example, the suture cutting device 140 can be incorporated into any of the segmented embodiments herein, such that the cutting component is disposed within or otherwise attached to one of the segments of the segmented device. Further, it is understood that other suture cutting mechanisms or structures can be incorporated into the device 120 or any other embodiment herein.

[074] In summary, each of the various delivery device embodiments disclosed or contemplated herein is shaped to or can conform to the curved or non-linear path for delivery of the ligation device. Further, it is understood that each of the various implementations herein can be inserted through an access sheath or tube that can have a predetermined curved shape such that any delivery device embodiment disclosed or contemplated herein can be inserted through the access sheath without impacting or altering the predetermined shape thereof.

[075] Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

Claims What is claimed is:

1 . A suture delivery device comprising:

(a) a tubular body comprising of a plurality of segments, wherein each of the plurality of segments is rotatably coupled to at least one other segment, wherein each of the plurality of segments comprises a segment lumen defined therein ;

(b) a tubular body lumen defined by and extending along a length of the tubular body, wherein each of the segment lumens comprises a portion of the tubular body lumen; and

(c) an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture.

2. The device of claim 1 , wherein the opening is defined in one of the plurality of segments, wherein the one of the plurality of segments is disposed at the distal end of the tubular body.

3. The device of claim 1 . wherein each of the plurality of segments is rotatably coupled to at least one other segment via a ball and socket coupling.

4. The device of claim 1 , wherein each of the plurality of segments comprises a male coupling portion and a female coupling portion, wherein each of the plurality of segments is coupleable to at least one other segment via the male and female coupling portions.

5. The device of claim 1 , wherein each of the plurality of segments can articulate in a first plane but can only articulate minimally in a second plane that is transverse to the first plane.

6. The device of claim 1 , wherein the tubular body is constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient.

7. The device of claim 1 , wherein each of the plurality of segments are tubular segments.

8. A suture delivery device comprising: (a) a tubular body constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient;

(b) a lumen defined by and extending along a length of the tubular body; and

9. The device of claim 8, wherein the tubular body is constructed and arranged to conform to at least two curves of the delivery path.

10. The device of claim 9, wherein the at least two curves are of opposing polarities.

1 1 . The device of claim 8, wherein the tubular body is steerable from a proximal end of the tubular body.

12. The device of claim 8, wherein the tubular body comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body.

13. The device of claim 12, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

14. The device of claim 8, wherein the tubular body comprises of a plurality of segments, wherein each of the plurality of segments is rotatably coupled to at least one other segment.

15. The device of claim 14, wherein each of the plurality of segments is rotatably coupled to at least one other segment via a ball and socket coupling.

16. The device of claim 14, wherein each of the plurality of segments comprises a male coupling portion and a female coupling portion, wherein each of the plurality of segments is coupleable to at least one other segment via the male and female coupling portions.

17. The device of claim 16, wherein each of the plurality of segments can articulate in a first plane but can only articulate minimally in a second plane that is transverse to the first plane.

18. The device of claim 8, wherein a portion of the loop or slipknot is radio-opaque.

19. The device of claim 8, wherein the suture is non-absorbable.

20. The device of claim 8, further comprising a suture cutting device associated with the tubular body.

21 . The device of claim 20, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

22. The device of claim 14, wherein each of the plurality of segments are tubular segments.

23. A suture delivery device comprising:

(a) a tubular body constructed and arranged to be conformable to a non-linear delivery path while having sufficient axial rigidity to be capable of delivering a ligation suture having a slipknot and loop to a target tissue in a patient;

(b) a lumen defined by and extending along a length of the tubular body;

(c) an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture; and

(d) a steering mechanism associated with the tubular body.

24. The device of claim 23, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

25. A suture delivery device comprising:

(b) a lumen defined by and extending along a length of the tubular body;

(c) an opening defined at a distal end of the tubular body, wherein the opening is in fluidic communication with the lumen, and further wherein the opening has a diameter that is narrower than an outer diameter of a slipknot of a ligation suture;

(d) a steering mechanism associated with the tubular body; and (e) a suture cutting device associated with the tubular body.

26. The device of claim 25, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.

27. The device of claim 25, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

28. The device of claim 1 , further comprising a suture cutting device associated with the tubular body.

29. The device of claim 28, wherein the suture cutting device comprises an actuation button, an actuation line operably coupled to the actuation button, and a cutting mechanism operably coupled to the actuation line.

30. The device of claim 1 , further comprising a steering mechanism associated with the tubular body.

31 . The device of claim 30, wherein the steering mechanism comprises an integrated tensioning mechanism operably coupled to a distal portion of the tubular body, wherein the integrated tensioning mechanism comprises a tension line operably coupled to the distal portion of the tubular body and a slidable handle coupled to a proximal end of the tension line.