WO2025007002A1

WO2025007002A1 - Port closure device

Info

Publication number: WO2025007002A1
Application number: PCT/US2024/036177
Authority: WO
Inventors: Barry Stuart GREENE; Kalyna Sconzert; Ryan GIBBS; Gabriel OCHOA
Original assignee: Vicarious Surgical Inc.
Priority date: 2023-06-28
Filing date: 2024-06-28
Publication date: 2025-01-02

Abstract

A port closure device and method of suturing an incision are disclosed herein. In some embodiments, the device includes a plurality of bores through a conical tip for the passage of sutures into a fascia defect. The method includes exposing a notch of the device, retracting the device to capture fascia tissue, releasing the actuation mechanism, and inserting a suture through the device and the captured fascia tissue.

Description

PORT CLOSURE DEVICE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/523,756, filed June 28, 2023 and entitled “Port Closure Device,” the contents of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] Various surgical procedures require creation of an incision or incisions in the body to introduce surgical instruments. For example, a defect in the abdominal wall is created after removal of a trocar from a surgical site. Such a defect will result in a hernia if not surgically closed. The abdominal wall may be thick, preventing accurate fascial approximation.

SUMMARY OF THE INVENTION

[0003] The present disclosure provides a port closure device that enables an operator of the device to accurately and rapidly pass sutures through the abdominal wall with proper spacing between sutures and the edge of fascia tissue to securely approximate the edges of a fascial defect. In some embodiments, the port closure device enables sutures to bypass subcutaneous tissues, decreasing the risk of hernia.

[0004] According to an embodiment of the present disclosure, a port closure device is provided. The port closure device includes a base having a plurality of entry apertures disposed at a proximal portion of the port closure device and a shaft extending from the base. The shaft includes a plurality of bores extending through a wall of the shaft, each of the plurality of bores aligned with a respective one of the plurality of entry apertures. The port closure device also includes a conical tip moveably coupled to the shaft opposite the base. The conical tip includes a plurality of suture ports, each of the plurality of suture ports aligned with a respective one of the plurality of bores. The port closure device further includes an actuation mechanism configured to move the conical tip from a first position to a second position relative to the shaft to expose a notch between the conical tip and the shaft.

[0005] According to an embodiment of the present disclosure, a port closure device is provided. The port closure device includes a bifurcated base having a plurality of entry apertures disposed at a proximal portion of the port closure device and a bifurcated shaft having a first portion and a second portion and extending from the bifurcated base. The first portion of the bifurcated shaft being movably coupled to the second portion of the bifurcated shaft. The bifurcated shaft includes a plurality of bores extending through a wall of the bifurcated shaft, each of the plurality of bores aligned with a respective one of the plurality of entry apertures. The port closure device also includes a bifurcated conical tip having a first portion and a second portion. The first portion of the bifurcated conical tip being movably coupled to the first portion of the bifurcated shaft opposite the bifurcated base and the second portion of the bifurcated conical tip being moveably coupled to the second portion of the bifurcated shaft opposite the bifurcated base. The bifurcated conical tip includes a plurality of suture ports, each of the plurality of suture ports aligned with a respective one of the plurality of bores. The port closure device further includes an actuation mechanism configured to move the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip between a retracted position and an extended positon and to move the first portion of the bifurcated shaft and the second portion of the bifurcated shaft between a collapsed position and an expanded position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are employed. In the accompanying drawings, like reference numbers are used to identify like components, which may not be identical components. [0007] FIG. 1 depicts an exploded view of an example port closure device in accordance with some embodiments.

[0008] FIG. 2A is an example perspective view of a port closure device in an extender position in accordance with some embodiments.

[0009] FIG. 2B is an example perspective view of the port closure device of FIG. 2A in a retracted position.

[0010] FIG. 3 A depicts an example side view of a port closure device in accordance with some embodiments.

[0011] FIG. 3B depicts a rotated example side view of the port closure device of FIG. 3 A in accordance with some embodiments.

[0012] FIG. 4A depicts an example bottom view of a port closure device in accordance with some embodiments.

[0013] FIG. 4B depicts an example top view of a port closure device in accordance with some embodiments.

[0014] FIG. 4C depicts an example top view of a port closure device in accordance with some embodiments. [0015] FIG. 5A depicts an example side view of a base and shaft of a port closure device in accordance with some embodiments.

[0016] FIG. 5B depicts an example side view of the port closure device of FIG. 5 A with a conical tip in accordance with some embodiments.

[0017] FIG. 6 depicts an example cross-sectional view of a port closure device in accordance with some embodiments.

[0018] FIG. 7 depicts an example perspective view of a base and shaft of a port closure device in accordance with some embodiments.

[0019] FIG. 8A depicts an example side view of a conical tip and a notch of a port closure device in accordance with some embodiments.

[0020] FIG. 8B depicts an example perspective view of the conical tip and the notch of the port closure device of FIG. 8 A.

[0021] FIG. 9A depicts an example actuation mechanism and an example cap in accordance with some embodiments.

[0022] FIG. 9B depicts the actuation mechanism and cap of FIG. 9A situated within a port closure device.

[0023] FIG. 10 depicts an example actuation mechanism attached to a conical tip and a notch in accordance with some embodiments.

[0024] FIG. 11 A depicts an example cross-sectional view of a port closure device in a retracted position in accordance with some embodiments.

[0025] FIG. 1 IB depicts an example cross-sectional view of the port closure device of FIG. 11 A in an extended position.

[0026] FIG. 12 depicts a flowchart of suturing a defect with a port closure device in accordance with some embodiments.

[0027] FIG. 13 depicts an example front view of a port closure device with a bisected shaft and conical tip in accordance with some embodiments.

[0028] FIG. 14 depicts an example top view of a port closure device with a bisected shaft in accordance with some embodiments.

[0029] FIG. 15A depicts an example front view of a port closure device in an extended and expanded position in accordance with some embodiments.

[0030] FIG. 15B depicts an example side view of the port closure device of FIG. 15A in an extended and collapsed position.

[0031] FIG. 16A depicts an example bottom view of a port closure device in a retracted and collapsed position in accordance with some embodiments. [0032] FIG. 16B depicts an example bottom view of the port closure device of FIG. 16A in an extended and expanded position.

[0033] FIG. 17A depicts an example cross-sectional view of a port closure device in a collapsed position in accordance with some embodiments.

[0034] FIG. 17B depicts an example cross-sectional view of the port closure device of FIG. 17A in an expanded position in accordance with some embodiments.

[0035] FIG. 18 depicts a flowchart of suturing a defect with a port closure device in accordance with some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

[0036] While various embodiments have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the embodiments disclosed herein. It may be understood that various alternatives to the embodiments described herein may be employed.

[0037] As used in the specification and claims, the singular form “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0038] The standard of care for surgical operations requires closure of ports over ten millimeters in diameter. Conventional suture guides are shaped in a manner to result in a suture trajectory that includes subcutaneous tissue and a variable amount of fascia. When subcutaneous tissues are included in fascial closure, the subcutaneous tissues may render the fascial closure with inaccurate tension, resulting in sub-optimal healing and a higher hernia rate.

[0039] In some embodiments, the present disclosure provides a port closure device having a plurality of bores extending parallel to a longitudinal axis of the device and an exposable notch portion that extends egress suture ports past fascia tissue, allowing for more accurate suture passage and avoiding subcutaneous tissues. This configuration enables more accurate placement of sutures through fascia tissue. An operator of a port closure device as taught herein may more accurately adjust the tension of the sutures to approximate fascia without strangulating the fascia and surrounding tissue.

[0040] In some embodiments, the present disclosure provides a port closure device having a plurality of bores extending through a bifurcated shaft of the device. The bifurcated shaft being movable into an expanded position moving fat and tissue surrounding a fascia tissue defect. This configuration enables the plurality of bores to be more accurately positioned relative to the defect in the fascia tissue, such that when an operator of the port closure device passes a suture through one of the plurality of bores, the defect in the fascia tissue can be sutured without strangulating the fascia and surrounding tissue.

[0041] In the following description, numerous specific details are set forth regarding the system and method of the present disclosure and the environment in which the system and method may operate, in order to provide a thorough understanding of the disclosed subject matter. It will be apparent to one skilled in the art, however, that the disclosed subject matter may be practiced without such specific details, and that certain features, which are well known in the art, are not described in detail in order to avoid complication and enhance clarity of the disclosed subject matter. In addition, it will be understood that any examples provided below are merely illustrative and are not to be construed in a limiting manner, and that it is contemplated by the present inventors that other systems, apparatuses, and/or methods can be employed to implement or complement the teachings of the present disclosure and are deemed to be within the scope of the present disclosure.

[0042] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.

[0043] Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from the context, all numerical values provided herein are modified by the term “about.”

[0044] Like numerical identifiers are used throughout the figures to refer to the same elements. [0045] FIG. 1 depicts an exploded view of an example port closure device 100 in accordance with some embodiments. FIG. 2A and 2B are an example perspective view of the port closure device 100 in accordance with some embodiments in an extended position and a retracted position, respectively. The device 100 includes a base 110 having a plurality of entry apertures 112 and is disposed at a proximal portion of the port closure device 100. The circular shape of the base 110 depicted in the Figures is merely illustrative. Base 110 may be provided in a variety of shapes.

[0046] The device 100 includes a shaft 120 extending distally from the base 110. The shaft 120 may be sufficiently long to bypass subcutaneous fat of a subject. For example, the shaft 120 may be at least fifty millimeters in length. In some embodiments, the outer diameter of the shaft 120 may be approximately the same diameter as the defect to be treated. For example, a surgeon may select an appropriately sized device 100 prior to repairing the surgical defect. In some embodiments, an appropriately sized device 100 may be provided with a trocar of substantially similar diameter to the shaft 120 to repair the defect created for entry of the trocar. In some embodiments, the outside diameter of the shaft 120 and/or trocar may be eighteen millimeters. In some embodiments, the shaft 120 may be tapered having a conical cross sectional shape that is wider near the base 110. In some embodiments, the shaft 120 has a circular or elliptical cross sectional shape.

[0047] The shaft 120 may include a plurality of bores 122 extending through a wall of the shaft 120 as depicted in FIG. 6. In some embodiments, each of the plurality of bores 122 is aligned with a respective one of the plurality of entry apertures 112. In some embodiments, the number of bores 122 corresponds to the number of entry apertures 112. The shaft 120 may include between two to six bores 122. In some embodiments, the shaft 120 includes four bores 122. In some embodiments, the shaft 120 includes six bores 122.

[0048] The device 100 includes a conical tip 130 moveably coupled to the shaft 120 opposite the base 110. The conical tip 130 may include a plurality of suture ports 132 as depicted in FIG. 4A. In some embodiments, each of the plurality of suture ports 132 is aligned with a respective one of the plurality of bores 122. In some embodiments, the plurality of suture ports 132 are angled outwardly with respect to a center axis 125 of the shaft 120 to guide a needle or suture through the conical tip 130. In some embodiments, the bores 122 are parallel to the center axis 125 of the shaft 120. FIG. 5A depicts a side view of the base 110 and the shaft 120 and FIG. 5B depicts the conical tip 130 in a retracted position relative to the shaft 120. As discussed herein with respect to FIGS. 13-17B, in some embodiments, the shaft 120 is bifurcated into two halves along the center axis 125. The bifurcation allows each portion of the shaft 120 to move laterally with respect to the center axis 125 while the conical tip 130 is advanced. In these embodiments, the lateral movement of the shaft 120 may direct a needle or suture through the conical tip 130 farther out the center axis 125 to repair a larger defect.

[0049] The device 100 may include an actuation mechanism 150, for example, a biasing member such as a spring is configured to move the conical tip 130 from a first position to a second position, for example from a retracted position to an extended position, relative to the shaft 120 to expose a notch 140 between the conical tip 130 and the shaft 120. In some embodiments, the actuation mechanism 150 is held in place by a cap 160. As can be seen in FIGS. 11 A and 1 IB, the cap 160 may be situated within the base 110 and may be pressed into the shaft 120. In some embodiments a push rod 142 may be disposed in the shaft 120 between the notch 140 and the cap 160 to impart movement of the cap 160 to the notch 140 and the conical tip 130. In some embodiments, a shaft of the push rod 142 extends through a central portion of the actuation mechanism 150.

[0050] FIG. 3 A depicts an example side view of the port closure device 100 and FIG. 3B depicts a rotated example side view of the port closure device 100. FIGs. 3 A and 3B illustrate that the notch 140 may have a rectangular cross sectional shape. In other words, the notch 140 may be thinner in one dimension than another dimension. In some embodiments, the notch may have a different cross section, for example circular, triangular, etc. The shape of the notch 140 may match the shape of a fascial defect to be treated. The defect may be smaller in one dimension than another due to the profile of a trocar used within the defect and/or materials and/or tissue passed in or out of the defect.

[0051] FIG. 4A depicts an example bottom view of the port closure device 100 having four suture ports 132. In some embodiments, the bottom of the port closure device 100 includes more than four suture ports 132, for example, six suture ports or more. In some embodiments, the spacing and arrangement of the suture ports 132 provide proper spacing between sutures. FIG. 4B depicts an example top view of the port closure device 100 having six entry apertures 112. In some embodiments, the base 110 having six entry apertures 112 eliminates the need to rotate the device 100 between inserting and retrieving a suture through the device 100. FIG. 4C depicts an example top view of the port closure device 100 having four entry apertures 112. The port closure device 100 may, or may not, include a cap 160 and the actuation mechanism 150 if the device 100 has four or six entry apertures 112.

[0052] FIG. 7 depicts a perspective view of the base 110 and the shaft 120 of the port closure device 100. The bores 122 may be situated around a recess 124. The recess 124 may be configured to receive the notch 140. In a retracted position, the notch 140 sits within the recess 124. In an extended position, the notch 140 is actuated from the recess 124 out of the shaft 120. [0053] FIG. 8A depicts a side view of the conical tip 130 and the notch 140 and FIG. 8B is a perspective view thereof. The notch 140 may be attached to a proximal end of the conical tip 130. The notch does not interfere with the suture ports 132. In other words, a suture may be passed through bores 122 and into the suture ports 132. In some embodiments, the plurality of suture ports 132 are angled outwardly with respect to a center axis 125 of the shaft 120 to guide a needle or suture through the conical tip 130 to a suitable location for suturing a defect in the fascia. The shaft 120 may be of sufficient length to situate the conical tip 130 past layer(s) fatty tissue and into fascia tissue, enabling passage of a suture from a suture port 132 directly into fascia.

[0054] FIG. 9A depicts the actuation mechanism 150 and the cap 160 in accordance with some embodiments. In some embodiments, the actuation mechanism 150 is a spring. The cap 160 may hold the spring within the shaft 120 as depicted, for example, in FIG. 9B. The cap may be held in place by a shoulder 152 situated within the shaft 120. In some embodiments, another shoulder 154 maintains a lower end of the actuation mechanism 150 in position within the shaft 120. When the spring is compressed, the notch 140 may be exposed in an extended position as depicted in FIG. 1 IB. When released, the notch 140 contracts back into the shaft 120 in a retracted position as depicted in FIG. 11 A. FIG. 10 depicts the actuation mechanism 150 attached to the conical tip 130 and the notch 140 in accordance with some embodiments.

[0055] FIG. 12 depicts a flowchart of a method 200 for suturing a defect with a port closure device 100 in accordance with some embodiments. At Step 202, a port closure device 100 is inserted into an incision such that the base 110 of the port closure device 100 is adjacent to an outer surface of the incision. In other words, the base 110 does not enter the incision.

[0056] At Step 204, the actuation mechanism 150 is engaged to expose the notch 140. The notch 140 may be actuated via depression of the actuation mechanism 150. For example, a surgeon may engage the cap 160 to compress the actuation mechanism 150, moving the device 100 to an extended position in which the notch 140 is actuated out of the shaft 120.

[0057] At Step 206, the port closure device 100 may be retracted with the notch 140 exposed, capturing fascia tissue in the notch 140. In some embodiments, the shaft 120 is partially withdrawn from the incision/defect to capture the fascia tissue. The fascia tissue may be captured by the wide proximal end of the conical tip 130.

[0058] At Step 208, the actuation mechanism 150 is released, for example, pressure is removed from the cap 160, to form a seal between the port closure device 100 and the captured fascia tissue. The seal prevents gases from escaping the incision. When the actuation mechanism 150 is released, the notch 140 is retracted.

[0059] At Step 210, a suture may be inserted into a first entry aperture 112 and through the port closure device 100 and captured fascia tissue. The sutures may be inserted through one or more layers of fascia tissue. The suture is inserted through a first suture port 132. In some embodiments, the device 100 is rotated after insertion of the suture. For example the device 100 may be rotated approximately ninety or one-hundred and eighty degrees. In some embodiments, the port closure deice 100 remains in a fixed position (i.e., without rotation) as the sutures are inserted and retrieved.

[0060] At Step 212, the suture is pulled through a second suture port 132, the captured fascia tissue and a second entry aperture 112. The suture may be inserted, and may be pulled, by a needle. The needle may be inserted through the entry aperture 112, bore 122, and suture port 132 to insert or retrieve the suture.

[0061] In some embodiments, the device 100 is discarded after use.

[0062] FIGS. 13-17B illustrate an embodiment of the disclosed port suture device having a bifurcated shaft and base allowing the shaft and the base to move laterally with respect to the center axis 125’.

[0063] FIG. 13 depicts a front view of an example port closure device 100’ having a bifurcated shaft 120’ in accordance with some embodiments. FIG. 14 is an example top view of the port closure device 100’ illustrating a bifurcated base 110’ in accordance with some embodiments. The device 100’ including a base 110’ having a plurality of entry apertures 112’ disposed at a proximal portion of the port closure device 100’. The device 100’ can also include a shaft 120’ bisected into a first portion 120a and a second portion 120b, the first portion of the shaft 120a and the second portion of the shaft 120b extending distally from the base 110’. The first portion of the shaft 120a and the second portion of the shaft 120b may be similar in size, shape, or function to the shaft 120. In some embodiments, the first portion of the shaft 120a may be movably coupled to the second portion of the shaft 120b by a hinge 126’. The hinge 126 may be a butt hinge, a flag hinge, a living hinge, or another type of rotating coupling. In some embodiments, the shaft 120’, including the first portion of the shaft 120a and the second portion of the shaft 120b, may be tapered having a variable diameter which is wider near the base 110’. [0064] Each of the first portion of the shaft 120a and the second portion of the shaft 120b may include a plurality of bores 122’ extending through a respective wall of the first portion of the shaft 120a and the second portion of the shaft 120b as depicted in dashed lines in FIG. 13. In some embodiments, each of the plurality of bores 122’ is aligned with a respective one of the plurality of entry apertures 112’. In further embodiments, the number of bores 122’ corresponds to the number of entry apertures 112’.

[0065] In some embodiments, the port closure device 100’ also includes a conical tip 130’ bisected into a first portion 130a and a second portion 130b, the first portion of the conical tip 130a is movably coupled to the first portion of the shaft 120a opposite the base 110’ and the second portion of the conical tip 130b is movably coupled to the second portion of the shaft 130b opposite the base 110’. In some embodiments, the first portion of the conical tip 130a and the second portion of the conical tip 130b are attached to a respective post 146, the respective post 146 being disposed in and extendable out of the first portion of the shaft 120a and the second portion of the shaft 120b. In some embodiments, the post 146 or at least a portion thereof may have a rectangular cross sectional shape, being thinner in one dimension than another dimension. In some embodiments, the post 146 may have a different cross section, for example circular, triangular, etc. The shape of the post 146 or at least a portion of the post may match the shape of a fascial defect to be treated. For example, the post can have a rectangular cross section in the proximity of the conical tip and have a circular cross section that extends from the rectangular cross section to a terminal end. As another example the post can have a rectangular cross section in the proximity of the conical tip that extends to a terminal end. The defect may be smaller in one dimension than another due to the profile of a trocar used within the defect and/or materials and/or tissue passed in or out of the defect. In some embodiments, a portion of the post 146 adjacent to the conical tip 130’ and between the wide proximal end of the conical tip 130’ and the distal end of the shaft 120’ when the conical tip 130’ is in the extended position may be defined as a notch, the notch may be similar to the notch 140.

[0066] The first portion of the conical tip 130a and the second portion of the conical tip 130b may each include a plurality of suture ports 132’. In some embodiments, the plurality of suture ports 132’ are angled outwardly with respect to a center axis 125’ of the shaft 120’ to guide a needle or suture through the conical tip 130’.

[0067] FIGS. 15A depicts the port closure device 100’ in an extended and expanded position in accordance with some embodiments. In some embodiments, the first portion of the shaft 120a and the second portion of the shaft 120b are movable between a collapsed position (illustrated in FIGS. 13, 15B and 16A) and an expanded position (illustrated in FIGS. 15A, and 16B). A push rod 142’ may be conically shaped or have a conically shaped portion, for example, a wedge 144 to actuate the first portion of the shaft 120a and the second portion of the shaft 120b between the collapsed and expanded position. The push rod 142’ may extend out of the base 110’ with the conical or wedge portion being disposed between the first portion of the shaft 120a and the second portion of the shaft 120b. In some embodiments, as illustrated in FIGS. 17A and 17B, the sides of the wedge 144 engage a respective internal surface of the first portion of the shaft 120a and the second portion of the shaft 120b such that as the push rod 142’ and the wedge 144 are depressed, the first portion of the shaft 120a and the second portion of the shaft 120b are moved laterally outward with respect to the center axis 125’ from the collapsed position to the expanded position, rotating away from each other via the hinge 126. As the push rod 142’ and the wedge 144 are retracted the first portion of the shaft 120a and the second portion of the shaft 120b are moved inwardly relative to the center axis 125’ from the expanded position to the collapsed position.

[0068] In some embodiments, the push rod 142’ may include a cap 160’, on an end of the push rod 142’ opposite the conical tip 130’ to facilitate actuating the push rod 142’. In some embodiments, the device 100’ may include an actuation mechanism 150’, for example a biasing member such as a spring, configured to move the push rod 142’ and the wedge 144 from a first position to a second position, relative to the shaft 120’ to move the first portion of the shaft 120a and the second portion of the shaft 120b between the collapsed position and the expanded position. In some embodiments, the actuation mechanism 150’ is held in place by the cap 160’. In some embodiments, the actuation mechanism 150’ is disposed around at least a portion of the push rod 142’.

[0069] In some embodiments, the sides of the wedge 144 engages a portion of the respective post 146 connected to the first portion of the conical tip 130a and the second portion of the conical tip 130b. In this way, when the push rod 142’ and the wedge 144 are depressed, the first portion of the conical tip 130a and the second portion of the conical tip 130b are moved from a retracted position to an extended position and the first portion of the shaft 120a and the second portion of the shaft 120b are moved laterally outward with respect to the center axis 125’ from the collapsed position to the expanded position. In some embodiments, the first portion of the shaft 120a and the second portion of the shaft 120b are moved between the collapsed position to the expanded position simultaneously as the first portion of the conical tip 130a and the second portion of the conical tip 130b are moved between the retracted position and the extended position. In some embodiments, the first portion of the shaft 120a and the second portion of the shaft 120b are moved between the collapsed position to the expanded position independently of the first portion of the conical tip 130a and the second portion of the conical tip 130b being moved between the retracted position and the extended position.

[0070] In some embodiments, a pin 148 on each of the respective posts 146 moves in a respective slot 128 in each respective portion of the shaft 120’, for example, the first portion of the shaft 120a (a similar pin 148 and slot 128 may be arranged in a similar manner on second portion of the shaft 120b and the respective post 146 associated therewith). As the portion of the conical tip 130a, 130b moves between the retracted position and the extended position, the respective pins 148 slide in the respective slots 128 to prevent over extension of the portion of the conical tip 130a, 130b. In some embodiments, the first portion of the conical tip 130a and the second portion of the conical tip 130b may be moved between the retracted position and the extended position via the pin 148. In some embodiments, the pin 148 extends transversely through the respective post 146 into an interior of the shaft 120’ and the wedge 144 may engage a portion of the respective pin 148 connected to the respective post 146. In this way, when the push rod 142’ and the wedge 144 are depressed, the first portion of the conical tip 130a and the second portion of the conical tip 130b are moved from a retracted position to an extended position via the pin 148.

[0071] In some embodiments, a flexible sheath or other flexible cover may be provided. The flexible sheath may be used to cover at least a portion of the shaft 120’ or the conical tip 130’ to help create a seal of the fascia defect when the port closure device 100’ is inserted into an incision. The seal may be airtight or semi-airtight to prevent gas, for example, carbon dioxide, from escaping through the fascia defect. In some embodiments, the flexible sheath may act as a biasing member, biasing the first portion of the shaft 120a and the second portion of the shaft 120b into the collapsed position.

[0072] FIG. 18 depicts a flowchart of a method 300 for suturing a defect with a port closure device 100’ in accordance with some embodiments. At Step 302, the port closure device 100’ is inserted into an incision such that the base 110’ of the port closure device 100’ is adjacent to an outer surface of the incision. In other words, the base 110’ does not enter the incision. The shaft 120’ and conical tip 130’ are inserted into the incision and the conical tip 130’ is inserted past the defect to be sutured into a cavity below the defect.

[0073] At Step 304, the cap 160’ may be engaged, depressing the push rod 142’ and the wedge 144 to move the first portion of the shaft 120a and the second portion of the shaft 120b into the expanded position. When in the expanded position, the portions of the shaft 120a, 120b may spread the fat and tissue over the fascia tissue thereby exposing the fascia tissue to be sutured. Further, when in the expanded position, the portions of the shaft 120a, 120b may angle the bores 122 away from the defect in the fascia tissue to be sutured for suitable placement of the sutures to close the defect in the fascia. In some embodiments, the bores 122 may be positioned about ten millimeters away from the defect. In some embodiments, the bores 122 may be positioned between eight and twelve millimeters away from the defect. Controlling the position of the bores 122 relative to the defect in the fascia tissue to be sutured may be desirable since if the suture is too tight the tissue may die and if the suture is too loose the defect may not heal properly.

[0074] At Step 306, the conical tip 130’, including the first portion of the conical tip 130a and the second portion of the conical tip 130b, is moved into the extended position. The conical tip 130’ is extended further into the cavity below the defect to be sutured, exposing the wide proximal end of the conical tip 130’ and the respective post 146 connected to the first portion of the conical tip 130a and the second portion of the conical tip 130b. In some embodiments, Step 304 and Step 306 occur simultaneously and the push rod 142’ and the wedge 144 move the shaft 120’ into the expanded position and the conical tip 130’ into the extended position via the same actuation.

[0075] At Step 308, conical tip 130’, including the first portion of the conical tip 130a and the second portion of the conical tip 130b, is moved into the retracted position, capturing fascia tissue between the wide proximal end of the conical tip 130’ and the distal end of the shaft 120’ forming a seal between the port closure device and the captured fascia tissue. In some embodiments, the shaft 120’ is partially withdrawn from the incision/defect to facilitate capture of the fascia tissue. The capturing of the fascia tissue between the shaft 120’ and the conical tip 130’ forms a seal preventing gases from escaping the incision.

[0076] At Step 310, a suture may be inserted into a first entry aperture 112’ and through the port closure device 100’ and captured fascia tissue. The suture may be inserted through one or more layers of fascia tissue. The suture is inserted through a first suture port 132’. In some embodiments, the device 100’ is rotated after insertion of the suture. For example the device 100’ may be rotated approximately ninety or one-hundred and eighty degrees. In some embodiments, the shaft 120’ is further expanded or collapsed after insertion of the suture to adjust the position or angle of the bores 122’ or the suture ports 132’. In some embodiments, the port closure deice 100’ remains in a fixed position (i.e., without rotation) as the sutures are inserted and retrieved. [0077] At Step 312, the suture is pulled through a second suture port 132’, the captured fascia tissue and a second entry aperture 112’. The suture may be inserted, and may be pulled, by a needle. The needle may be inserted through the entry aperture 112’, bore 122’, and suture port 132’ to insert or retrieve the suture.

[0078] In some embodiments, the device 100’ is discarded after use.

[0079] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It may be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A port closure device, comprising: a base having a plurality of entry apertures disposed at a proximal portion of the port closure device; a shaft extending from the base, the shaft including a plurality of bores extending through a wall of the shaft, each of the plurality of bores aligned with a respective one of the plurality of entry apertures; a conical tip moveably coupled to the shaft opposite the base, the conical tip including a plurality of suture ports, each of the plurality of suture ports aligned with a respective one of the plurality of bores; and an actuation mechanism configured to move the conical tip from a first position to a second position relative to the shaft to expose a notch between the conical tip and the shaft.

2. The device of claim 1, wherein the plurality of suture ports are angled with respect to a center axis of the shaft to guide a needle or suture through the conical tip.

3. The device of claim 1, wherein the actuation mechanism is a spring.

4. The device of claim 1, wherein the shaft is tapered having a wider diameter proximal to the base.

5. The device of claim 1, further comprising a rod connected to the notch, extending though the shaft, and extending out of the base, the rod is operatively connected to the actuation mechanism.

6. The device of claim 5, where in the actuation mechanism is disposed around at least a portion of the rod.

7. The device of claim 1, wherein when the conical tip is in the first position the notch is disposed in the shaft and when the conical tip is in the second position the notch is exposed.

8. A method of suturing an incision, comprising: inserting a port closure device according to claim 1 into an incision such that the base of the port closure device is adjacent to an outer surface of the incision; actuating the actuation mechanism to expose the notch; retracting the port closure device with the notch exposed capturing fascia tissue in the notch; releasing the actuation mechanism to form a seal between the port closure device and the fascia tissue; inserting a suture into a first entry aperture and through the port closure device and captured fascia tissue; and pulling the suture through the captured fascia tissue and a second entry aperture.

9. The method of claim 8, further comprising rotating the port closure device between the steps of inserting a suture and pulling the suture.

10. A port closure device, comprising: a bifurcated base having a plurality of entry apertures disposed at a proximal portion of the port closure device; a bifurcated shaft having a first portion and a second portion and extending from the bifurcated base, the bifurcated shaft including a plurality of bores extending through a wall of the bifurcated shaft, each of the plurality of bores aligned with a respective one of the plurality of entry apertures, the first portion of the bifurcated shaft being movably coupled to the second portion of the bifurcated shaft; a bifurcated conical tip having a first portion and a second portion, the first portion of the bifurcated conical tip being movably coupled to the first portion of the bifurcated shaft opposite the bifurcated base and the second portion of the bifurcated conical tip being moveably coupled to the second portion of the bifurcated shaft opposite the bifurcated base, the bifurcated conical tip including a plurality of suture ports, each of the plurality of suture ports aligned with a respective one of the plurality of bores; and an actuation mechanism configured to move the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip between a retracted position and an extended position and to move the first portion of the bifurcated shaft and the second portion of the bifurcated shaft between a collapsed position and an expanded position.

11. The device of claim 10, wherein when the first portion of the bifurcated shaft and the second portion of the bifurcated shaft are moved into the expanded position, the first portion of the bifurcated shaft and the second portion of the bifurcated shaft move laterally away from a center axis of the bifurcated shaft.

12. The device of claim 10, wherein when the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip are moved into the extend position, the first portion of the bifurcated conical tip extends away from the first portion of the bifurcated shaft exposing a first notch and the second portion of the bifurcated conical tip extends away from the second portion of the bifurcated shaft exposing a second notch.

13. The device of claim 10, wherein the first portion of the bifurcated shaft is movably coupled to the second portion of the bifurcated shaft by a hinge.

14. The device of claim 13, wherein the hinge is a living hinge.

15. The device of claim 10, wherein when the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip are moved into the extended position the first portion of the bifurcated shaft and the second portion of the bifurcated shaft are moved into the expanded position.

16. The device of claim 10, wherein the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip are movable between the retracted position and the extended position independent of the position of the first portion of the bifurcated shaft and the second portion of the bifurcated shaft.

17. The device of claim 10, wherein the first portion of the bifurcated shaft and the second portion of the bifurcated shaft are moveable between the collapsed position and the expanded position independent of the position of the first portion of the bifurcated conical tip and the second portion of the bifurcated conical tip.

18. The device of claim 10, further comprising a first slot in the first portion of the bifurcated shaft; a second slot in the second portion of the bifurcated shaft; a first pin connected to the first portion of the bifurcated conical tip is movable in the first slot, guiding the movement of the first portion of the bifurcated conical tip; and a second pin connected to the second portion of the bifurcated conical tip is movable in the second slot, guiding the movement of the second portion of the bifurcated conical tip.

19. The device of claim 18, wherein the first pin prevents the first portion of the bifurcated conical tip from overextending and the second pin prevents the second portion of the bifurcated conical tip from over extending.

20. The device of claim 10, wherein the actuation mechanism includes a wedge disposed between the first portion of the bifurcated shaft and the second portion of the bifurcated shaft; wherein when the actuation mechanism is actuated, the wedge engages a respective internal surface of the first portion of the bifurcated shaft and the second portion of the bifurcated shaft moving the first portion of the bifurcated shaft and the second portion of the bifurcated shaft into the expanded position.