Tissue closure system

Abstract

A tissue closure system is disclosed, one variation of which generally includes a handle, a proximal catheter section extending from the handle, a deployment section coupled to the proximal catheter section, and a distal catheter section pivotably coupled to the deployment section such that the distal catheter section is rotatable at an angle relative to the proximal catheter section. A receiver member positioned within the deployment section may be configured between a low profile configuration and a deployment configuration. Two or more anterior needle members and two or more posterior needle members may extend distally from the first side and the second side of the proximal catheter section. Two or more front needle members may be received into the two or more openings along the first receiver portion, and two or more rear needle members may be received into the two or more openings along the second receiver portion.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 495,454, filed April 11, 2023, which is incorporated herein by reference in its entirety. Invention Field

[0002] This invention relates to methods and apparatus for closing tissue regions. More specifically, this invention relates to methods and apparatus for percutaneously closing openings along the walls of blood vessels (such as arteries or veins). Background of the Invention

[0003] After completing a percutaneous procedure utilizing vascular access, instruments such as guide sheaths or manipulable guides are removed from the blood vessel, leaving the puncture site open. Various devices and methods have been employed to close the vascular opening for hemostasis, including compression devices, plugs, patches, metal clips, and suture application devices. Suture application devices are used to deploy sutures on the opposite side of the puncture and then tighten the sutures to approximate the edge of the puncture site. Suture-based devices are largely preferred in the market because the edges of the opening close in a manner most similar to open surgical techniques.

[0004] While these devices can be used effectively, they are limited by the size of the puncture site and may require multiple instruments or placement prior to the percutaneous procedure to achieve closure. For example, relatively large puncture sites may require two instruments, where the first device is deployed and removed, and then the second device is deployed and removed again to achieve hemostasis at the puncture site. Alternatively, a “pre-closure” technique may be necessary for smaller puncture sites, where one or more sutures are placed before the guide sheath and the opening dilation required for the percutaneous procedure. Then, after the procedure is completed and the sheath is removed, the sutures are tightened and secured with one or more knots or other methods. In many cases, percutaneous procedures are emergencies, such as aortic aneurysms, and there is no time for pre-placement of sutures, making the use of multiple devices a further obstacle. Furthermore, the risk of damage or bacterial contamination of sutures remaining outside the patient during percutaneous procedures increases, thus increasing the risk of postoperative infection. This risk may lead to the selection of monofilament sutures with a given design, which have a smaller surface area than braided sutures, but the result is less robust performance or increased complexity.

[0005] Additionally, this device is initially introduced and passed through the puncture site, then partially advanced into the blood vessel to be closed. A mechanism is then typically deployed inside the vessel to facilitate the placement of sutures into the tissue surrounding the opening. However, depending on the size of the blood vessel and the relative size of the device, the introduction of the device into the vessel and the deployment of the mechanism may be hindered.

[0006] Furthermore, such devices can employ pre-knotted knots, delivered by the device to close and secure the puncture site. However, the use and delivery of pre-knotted knots can complicate suture delivery into and through the tissue, further limiting flexibility in tissue fixation. The knots also contain a large surface area, increasing the risk of postoperative bacterial contamination and infection if used in a pre-closure method. Alternatively, such devices can be knotted by a separate device or by the physician, thus delaying tissue fixation.

[0007] Therefore, devices and methods for percutaneous closure of large puncture sites along the vessel wall are desired, wherein sutures can be deployed into the tissue using a single device without pre-closure, simplifying the procedure. Furthermore, such devices and methods are desired to minimize the risk of suture damage or infection associated with bacterial contamination. Additionally, devices and methods are desired that facilitate puncture closure regardless of vessel size and also utilize simplified closure mechanisms to achieve hemostasis. For the above reasons, improved devices, systems, and methods for suture-based tissue closure are desired. It would be particularly beneficial if these improved devices and methods provided some or all of the benefits while overcoming one or more of the disadvantages discussed above. Invention Overview

[0008] A variant of a device designed to close openings within tissue walls (such as arterial or venous incisions along the wall of a vessel) may include an elongated catheter having a distal and a proximal catheter segment configured to move or rotate relative to each other. The device may include a handle configured to be held by a practitioner (e.g., via a single hand). A first actuation mechanism, such as a lever, slider, or other mechanism, may be coupled along the handle for deploying a receiver member for receiving a needle member for insertion through the tissue area to be closed. A second actuation mechanism, such as a plug or other mechanism, may also be coupled along the handle for pushing or activating the needle member to move from the proximal catheter segment into the tissue, and for pulling or tensioning sutures through the tissue and through the device handle. An indicator, such as an open lumen or other flashing indicator, may also be coupled to the handle, wherein the open lumen is in fluid communication through a lumen defined by the device and the proximal catheter segment for receiving a volume of blood, and the open lumen can provide confirmation that the device has been properly introduced and positioned within the vessel to be closed. In other variations, alternative sensors or sensor mechanisms can be used to provide confirmation that the device has been properly positioned within the blood vessel. For example, sensors utilizing pressure, continuity, capacitance, temperature or heat, fiber optics, flow, etc., can be used. Markings on the device's axis can be used to inform the user of the blood vessel depth, which is useful when tightening and locking sutures.

[0009] The proximal catheter segment can extend distally from the handle, the deployment segment connects to the distal catheter segment, and the distal catheter segment can extend further distally, wherein the device can terminate at a tapered distal end, which is angled toward a relatively small distal end and can be used as a dilator to facilitate device access and passage through anatomical structures, including tissue, arterial incisions, or venous incisions. If desired, the tapered distal end can incorporate one or more lumens at the distal end or along the side that allows guidewire passage.

[0010] The deployment section may include a support structure extending from the proximal catheter section along two opposing members that define a receiving area between the two opposing members. The support structure may extend from the proximal catheter section in a straight configuration and may include curved or bowed portions that allow the structure to bend at an angle relative to the proximal catheter section. The distal catheter section may extend from the support structure via a hinged or pivotal attachment that allows the distal catheter section to rotate relative to the proximal catheter section. In other embodiments, the support structure may be formed as a continuous flexible structure, such as a movable hinge or other flexible section. The receiving area defined by the two opposing members of the support structure is sized to accommodate a receiver member that can rotate from its low-profile delivery configuration to its deployment configuration. The receiver member may define two or more needle receiving openings for receiving the puncture tip of a needle, the puncture tip of which can be deployed from corresponding openings along the distal portion of the proximal catheter section.

[0011] Once the deployment segment is properly positioned relative to the vascular opening to be closed, the first actuation mechanism can be activated. Rotation of the receiver member can reposition the first receiver portion of the receiver member to receive one or more distally extending anterior needle members advanced distally from the opening, and can further reposition the second receiver portion of the receiver member on the opposite second side of the support structure to receive one or more distally extending posterior needle members advanced distally from the opening along the opposite second side of the proximal catheter segment. Actuation of the second actuation mechanism can cause the needle members to advance distally from the proximal catheter segment.

[0012] These needle components (one or more anterior needle components and one or more posterior needle components) can be configured to advance one or more suture loops from the inner diameter or inner wall of the blood vessel and through the vessel wall between each pair of needle components to the outside of the vessel. For two or more suture loops, the loops can be parallel to the inside of the vessel and cross externally, or in another variation, the suture loops can cross both inside and outside the vessel. The resulting suture ends can be pulled or tensioned away from the puncture site (e.g., from outside the patient's body) to approach the tissue edge of the puncture site without any knots, and fixation devices such as bands, loops, clips, etc., can be deployed using separate instruments, as described in further detail herein.

[0013] Because the proximal catheter segment is angled relative to the tissue wall or vessel axis at the puncture site after insertion and placement, the periphery of the device transition area forms a shape closer to an oval or elliptical relative to the tissue wall. The periphery represents the area of ​​the angled proximal catheter segment relative to the tissue wall at the puncture site. With the periphery width decreasing along the longitudinal direction of the vessel length, the device outline and periphery can expand in the transverse direction.

[0014] Because the periphery of the projection forms an oval or elliptical shape, the edge of the puncture site can be relatively closer to the outer surface of the angled proximal catheter segment. Therefore, the oval or elliptical periphery allows the catheter segment to be used to promote closure of the puncture site.

[0015] Because this device can be used near tissue openings such as arterial or venous incisions, two or more separate suture segments can be preloaded within it and used with the needle component to deliver the suture through the vessel wall to approach the tissue edge for hemostasis. This can be achieved without any pre-knotted knots. Due to the length of the suture, it is possible to store and deploy the suture into the tissue using many different suture management variations.

[0016] In one variation, the suture may be preloaded within a lumen or space defined within the length of the proximal catheter segment, while in another variation, the suture may be preloaded within a lumen or space defined within the length of the distal catheter segment. In yet another variation, the suture segment may be stored within the proximal catheter segment and may be further returned distally through a lumen within the distal catheter segment.

[0017] In one variation, during insertion of the device into the proximal or distal catheter segment, the suture segment is protected from tissue exposure and can be further protected by using a sliding sleeve, sheath, or other device. The sliding sleeve may be combined with a proximal docking member that is larger than the opening in the skin and can be used to improve hemostasis within and around the proximal catheter segment.

[0018] In one variation, suture segments can be deployed into the tissue to create a cross-shaped suture pattern, which can be created along the blood vessel below or above the puncture site. In another variation, suture segments can be deployed into the tissue to create a parallel suture pattern, which can be created along the blood vessel below or above the puncture site.

[0019] As described herein, the tissue surrounding the puncture site can be configured in an oval or elliptical shape to increase the bite margin along the tissue between the needle assembly and the catheter exterior. While the puncture site can be configured by angulating the device relative to the blood vessel, additional features can be optionally incorporated to further enhance or facilitate tissue remodeling, particularly for puncture sites where the transition diameter relative to the device may be particularly large.

[0020] One or more lateral dilation elements may be configured to also extend from the outside of the proximal catheter segment and / or the distal catheter segment and / or the supporting structure, so as to force the edges of the puncture sites away from each other along the sides of the device, such that the edges of the puncture sites at the front and rear of the device push against each other along the edges of the blood vessels. These lateral dilation elements may be configured to extend when actuated by a mechanism located, for example, on a handle.

[0021] As described in this article, the device can be sized and used to place suture loops close to tissue openings, such as arterial or venous incisions, without requiring the sutures to be placed before the opening is dilated with a surgical sheath or guiding catheter (often referred to as a "pre-closure" technique).

[0022] As described herein, a second instrument for suture capture and fixation can be used to fix the ends of each suture segment after deployment and delivery through the tissue area to be closed, in order to achieve hemostasis after the use of the aforementioned device.

[0023] A variation of the suture capturing and securing device may include a handle having an actuation mechanism for deploying or securing an anchor to the captured suture. An elongated shaft may extend from the handle and terminate in an opening at its distal end. The opening may extend partially through the shaft and into a window defined along the side of the shaft near its distal end. A securing anchor, such as a loop having a cavity therethrough, may be positioned within the opening. A sliding element may be detachably positioned along the shaft or along the handle, and the suture may be coupled to the sliding element and extend along the device and through the window, through the securing anchor, and distally through the opening where the suture may form a loop leading to an expansion ring.

[0024] In use, the remaining suture ends after delivery around the puncture site can each pass through the snare. The sliding element can be pulled proximally along the elongated axis, causing the suture to be pulled through the window and the anchor, tightening the snare around the suture end. As the sliding element is pulled further proximally, it can abut against the tapered interface surface defined along the distal end of the handle, guiding the sliding element off-axis and away from the elongated axis. As the snare is pulled further proximally through the anchor and the window, the snareed suture end can be pulled through accordingly until the suture end has completely passed through both the anchor and the window.

[0025] When the distal end of the shaft is pushed distally, the suture tip can be tensioned proximally, simultaneously tightening the suture passing through the tissue junction until the puncture site is closed. This manipulation of the device and suture segment allows for assessment of hemostasis before the anchoring component is secured. Alternatively, markings on the elongated shaft (corresponding to markings on the suture delivery device shaft) can be used to inform the user of vascular depth. Once hemostasis and / or appropriate depth have been assessed, the anchoring component can be deformed, coiled, or otherwise tightened to secure the passing suture until the anchoring component can no longer be moved. This deformation can be sufficient to simultaneously cut or terminate the suture tip without requiring a separate cutting mechanism. Alternatively, in the case of coiling or tightening of the anchoring component, the suture tip can be simultaneously or otherwise cut or trimmed, and the shaft can be removed, leaving the anchoring component and the trimmed suture, achieving hemostasis.

[0026] Because suture capture and fixation devices eliminate the need for any knots or pre-knotted knots, fixation anchors that tighten the suture end and secure the taut suture to the tissue for hemostasis can include any number of deployable loops, clips, etc. A particular variant of a fixation anchor that can be deployed from a distal opening on the device shaft can include loops that can be sized in any number of configurations depending on the application. The loops can be sized to capture the suture end for closure, and such loop structures can be made of any number of materials, such as metals that can be deformed (e.g., compressed, coiled, etc.) on the suture or polymers that can be heat-melted on the suture for fixation. In cases where the suture used is a polymer, the loop can be partially melted along with a portion of the suture to achieve a secure anchor.

[0027] A variation of an tissue closure device typically includes a handle having one or more actuation mechanisms, a proximal catheter segment extending from the handle, a deployment segment coupled to the proximal catheter segment, a distal catheter segment pivotally coupled to the deployment segment such that a distal catheter segment is rotatable relative to the proximal catheter segment, a receiver member positioned within the deployment segment and having two or more openings along a first receiver portion and two or more openings along a second receiver portion (wherein the receiver member can be configured between a low-profile configuration and a deployment configuration), and two or more anterior needle members extending distally from a first side of the proximal catheter segment and two or more posterior needle members extending distally from a second side of the proximal catheter segment opposite to the first side. When the receiver member is in the deployment configuration, two or more anterior needle members can be received into two or more openings along the first receiver portion, and two or more posterior needle members can be received into two or more openings along the second receiver portion.

[0028] A variation of the method for tissue closure typically includes advancing a distal catheter segment into and through an opening along the wall of a blood vessel, such that the distal catheter segment rotates about a deployment segment and is angled relative to a proximal catheter segment; deploying receiver components within the blood vessel from a low-profile configuration to a deployment configuration such that a first receiver portion and a second receiver portion abut against the wall of an adjacent opening; extending two or more anterior needle components distally from a first side of the proximal catheter segment; and extending two or more posterior needle components distally from a second side of the proximal catheter segment opposite to the first side, such that each of the needle components punctures through the wall of an adjacent opening; and receiving two or more anterior needle components into two or more openings along the first receiver portion; and receiving two or more posterior needle components into two or more openings along the second receiver portion.

[0029] A variation of a method for minimizing the risk of infection associated with tissue closure typically includes advancing a suture delivery catheter into and through an opening along the wall of a blood vessel, such that a distal catheter segment rotates about a deployment segment and is angled relative to a proximal catheter segment; deploying receiver components within the blood vessel from a low-profile configuration to a deployment configuration, such that a first receiver portion and a second receiver portion abut against the wall of an adjacent opening; extending two or more anterior needle components distally from a first side of the proximal catheter segment; and extending two or more posterior needle components distally from a second side of the proximal catheter segment opposite the first side, such that each of the needle components punctures through the wall of an adjacent opening; and receiving two or more anterior needle components along two or more of the first receiver portions. Two or more posterior needle members are received in two or more openings along the second receiver portion, such that two or more anterior needle members are received in corresponding connector members held in each of the two or more openings along the first receiver portion, and two or more posterior needle members are received in corresponding connector members held in each of the two or more openings along the second receiver portion. Two or more anterior needle members are retracted from the first receiver portion, and two or more posterior needle members are retracted from the second receiver portion, such that the first suture segment and the second suture segment are retracted proximally through the walls of adjacent openings, and the first suture segment and the second suture segment are secured with tissue fixation anchors that prevent movement of each suture segment without the use of knots.

[0030] A variation of a suture anchoring device may typically include a handle with an actuation mechanism, a shaft attached to the handle (where the shaft has a distal end that defines a distal opening and a window along one side of the shaft, such that the distal opening and the window communicate), a sliding element translatably positioned on the shaft, a tissue fixation anchor positioned within the distal opening and defining an anchoring cavity communicating with the window, and a thread connected to the distal portion of the sliding element and extending into the window and through the anchoring cavity, such that the thread exits the distal opening and forms a loop.

[0031] A variation of the method for anchoring sutures typically includes positioning one or more suture segments within a loop extending from a distal opening of an axis, retracting a sliding element proximally along the axis to reduce the size of the loop, and pulling one or more suture segments proximally into the distal opening, through an anchoring cavity of a tissue fixation anchor positioned within the distal opening, and pulling them out through a window defined along one side of the axis to position the distal opening of the axis near a tissue opening, while simultaneously tensioning one or more suture segments and deforming the tissue fixation anchor to secure one or more suture segments. Brief description of the attached diagram

[0032] Figure 1A and Figure 1B A perspective view of a variant of the device for actuating needle deployment is shown, which is used to deliver and / or capture suture segments when closing an opening in tissue.

[0033] Figure 2A and Figure 2B A perspective detail view shows the first actuation mechanism on the handle in its unactuated configuration and the corresponding deployment section held in its low-profile delivery configuration.

[0034] Figure 2C and Figure 2D A perspective detail view is shown of the first actuation mechanism on the handle in its actuation configuration and the corresponding deployment section in its deployment configuration.

[0035] Figures 3A-3C A perspective view of another variation of the device for actuating needle deployment is shown, which is used to deliver and / or capture suture segments when closing an opening in tissue.

[0036] Figures 4A-4C It shows the corresponding Figures 3A-3C Detailed perspective view of the sheath assembly translated on the proximal catheter segment and deployment segment.

[0037] Figure 5A A detailed perspective view of the sheathing components advancing distally on the deployment section is shown.

[0038] Figure 5B and Figure 5C Side and end perspective views of the sheath assembly in an unconstrained configuration are shown, such as when the sheath assembly is retracted over the proximal catheter segment.

[0039] Figure 5D and Figure 5E The image shows a sheath member in its constrained configuration when the sheath member is positioned on the deployment section and conforms to the features below.

[0040] Figure 6A A detailed side view is shown of the receiver component deployed from within the support structure in its low-profile configuration.

[0041] Figure 6B A detailed side view is shown of the distal catheter segment, which is pivotally or rotatably connected to the proximal catheter segment in a manner that is not collinearly aligned with each other.

[0042] Figure 6C A detailed side view is shown of the receiver components deployed relative to the distal and proximal catheter segments when positioned within the blood cavity.

[0043] Figure 7A detailed perspective view of a variant is shown, in which a flexible connector can connect the distal end of the support structure to the proximal end of the distal duct segment.

[0044] Figure 8A A detailed perspective view is shown of the transition region of the device that forms an oval or elliptical shape relative to the tissue wall.

[0045] Figure 8B A detailed perspective view is shown of the proximal catheter segment angled relative to the tissue wall at the puncture site after insertion and placement.

[0046] Figure 9A and Figure 9B Detailed perspective and side views of the receiving components not deployed within the receiving area of ​​the support structure are shown.

[0047] Figure 10A and Figure 10B A detailed perspective view shows the receiver component being rotated and pulled proximally into its deployment and angled configuration.

[0048] Figure 11A and Figure 11B Detailed side views and cross-sectional side views are shown of two front needle members and two rear needle members advancing distally from the opening until their distal ends are received within the corresponding openings in the receiver member.

[0049] Figure 11C Showing from Figure 7 A and Figure 7 Perspective view of the needle component of B.

[0050] Figure 12A and Figure 12B Detailed side view and cross-sectional side view show a variation of how suture segments can be preloaded within the proximal catheter segment of the device.

[0051] Figure 13 A detailed side view shows another variation of how suture segments can be preloaded within the distal catheter segment of the device.

[0052] Figure 14 A detailed side view shows another variation of how suture segments can be preloaded within the proximal and distal catheter segments of the device.

[0053] Figure 15 A detailed side view shows how suture segments can be preloaded within the proximal catheter section of the device and further arranged to produce another variation of the cross-stitch pattern.

[0054] Figure 16A and Figure 16BDetailed perspective top and bottom views of the deployment section are shown with the sheath assembly in its distal position, wherein the sheath assembly covers at least part or all of the deployment section.

[0055] Figure 17A and Figure 17B Detailed perspective top and bottom views are shown of the deployment section with the sheath assembly in its retracted proximal position, where the deployment section is exposed.

[0056] Figure 18A The suture channel is shown to illustrate the positioning of the suture segment outside the device.

[0057] Figure 18B It shows how the stitch segments are wired inside and through the device.

[0058] Figure 18C and Figure 18D This illustrates a variation in the wiring of suture segments within the distal ductal segment.

[0059] Figure 18E This illustrates how suture segments can be positioned within the length of a lumen or space defined within a distal catheter segment.

[0060] Figure 19A and Figure 19B The front and rear perspective views are shown, illustrating another variation in how the stitch segment can be wired outside the first and second receiver sections.

[0061] Figure 20A A top view shows the resulting cross-shaped suture pattern that can be produced below the puncture site along the blood vessel.

[0062] Figure 20B A top view shows the resulting parallel suture pattern that can be produced below the puncture site along the blood vessel.

[0063] Figure 20C Another variation is shown, in which the puncture site of a typical round opening in the vessel wall is compared with an oval or elliptical opening formed at an angle relative to the tissue surface through a proximal catheter segment.

[0064] Figure 21A An example of a suture segment with connecting members attached to each end of the suture segment is shown.

[0065] Figure 21B This illustrates an example of how a portion of a suture segment can be loosely held or how it can be held in place by some tension within the device.

[0066] Figure 22A and Figure 22BA modified side view and cross-sectional side view are shown, in which the end of the suture can be connected to the connecting member by one or more fingers or extension members.

[0067] Figure 23A and Figure 23B A side view and cross-sectional side view of another variation are shown, in which the tapered portion extending from the main body section can form a fixed engagement with the suture end.

[0068] Figure 24A and Figure 24B A side view and cross-sectional side view of another variation are shown, in which the tapered body, formed separately from the main body section, can be similarly fixed to the suture end and attached to the main body section.

[0069] Figure 25A and Figure 25B The illustration shows a side view of a variant of the suture terminal, which can be configured to have a widened portion.

[0070] Figure 26A and Figure 26B A perspective view of the connecting members is shown to illustrate how the tapered body can be attached to the body section via one or more weld points.

[0071] Figures 27A-27E A schematic diagram is shown to illustrate the steps involved in deploying the suture from the proximal wiring device location.

[0072] Figure 28 A detailed perspective view of the proximal catheter segment with an opening through which sutures can pass into the suture lumen or space is shown.

[0073] Figure 29A and Figure 29B The illustration shows a perspective view and an end view of a suture cavity feature, which includes an elastomeric component capable of applying compressive or frictional forces to the suture passing through it. Figure 29C A perspective detail of the suture cavity and an appropriately sized elastic tube is shown. The suture cavity can be terminated to open into a larger space, where the remaining portion of the suture segment can be stored. The elastic tube is used to hold the suture in a loaded configuration.

[0074] Figure 30A and Figure 30B A top view and a cross-sectional top view of another variation of the distal catheter segment are shown, which has one or more friction-inducing features along the segment junction for applying friction clamping or resistance to the suture.

[0075] Figures 31A to 31C Various cross-sectional shapes of the tensioning member are shown.

[0076] Figure 32A and Figure 32B Another variation of the suture tensioning mechanism is illustrated in detailed schematic side and perspective views. This suture tensioning mechanism is also positioned within the distal catheter segment to remove suture slack.

[0077] Figure 32C A schematic side view of another variation is shown, in which the flange body may alternatively be combined with one or more elastomeric support members configured to provide tension on the seams that loop around the column.

[0078] Figure 33A An example is schematically illustrated in which a push / pull member can be combined with an expansion member attached along the push / pull member.

[0079] Figures 33B-33D A variation of the dilator arms positioned distal to each other along the proximal duct segment is shown.

[0080] Figure 34A and Figure 34B A detailed side view of another variant of the device is shown, featuring proximal and distal catheter segments connected to each other via flexible sections.

[0081] Figures 35A to 35D A side view and perspective view of another variation are shown, in which the device may omit the distal catheter segment and instead incorporate a central axis.

[0082] Figure 36A and Figure 36B A perspective view of another variation of the device incorporating a central axis with a ramp section is shown.

[0083] Figure 37A and Figure 37B It shows the corresponding Figure 36A and Figure 36B A perspective view of the second receiver section.

[0084] Figure 38A and Figure 38B A perspective view of another variation of the device is shown, which incorporates a dual-receiver feature actuated or rotated via a ratchet mechanism, such as a rack and pinion mechanism.

[0085] Figure 39A A variation of the suture capture and fixation device is shown.

[0086] Figure 39B Another variation of the suture capture and fixation device is shown.

[0087] Figures 40A-40C A detailed perspective view of the suture ends of the suture exchange loop engagement is shown.

[0088] Figures 41A-41C A detailed perspective view of the fixed and trimmed suture ends is shown.

[0089] Figure 42A and Figure 42B Detailed perspective and side views of the suture exchange loop sliding element are shown.

[0090] Figure 43A A side view of a variant of the proximal duct segment incorporating scales along the outer surface is shown.

[0091] Figure 43B and Figure 43C A side view of another variation of the shaft of the suture capture and fixation device is shown, which incorporates a scale along the outer surface.

[0092] Figure 44 A perspective view of a modified shaft incorporating a scale is shown.

[0093] Figures 45A to 45D A detailed perspective view of the shaft and internal mechanisms is shown, with the outer wall of the shaft removed for clarity.

[0094] Figure 46A and Figure 46B Different perspective views of the base and the sliding blade element are shown.

[0095] Figures 47A-47E Perspective views of various ring embodiments are shown.

[0096] Figure 48 A cross-sectional side view of a collar incorporating a releasable plug component is shown.

[0097] Figure 49A and Figure 49B Perspective and cross-sectional perspective views of another ring variant incorporating a plug component are shown.

[0098] Figure 50 A cross-sectional perspective side view of a collar incorporating a variation of a plug component is shown. Detailed description of the invention

[0099] A device designed to close openings within tissue walls (such as arterial or venous incisions along the wall of a blood vessel) may include an elongated catheter having a distal and a proximal catheter segment configured to move or rotate relative to each other. The distal and / or proximal catheter segments may be used to deploy several retractable needles that can be used to capture and / or tighten segments of sutures to close the arterial or venous incision.

[0100] exist Figure 1A and Figure 1BThe perspective view shows a variation of this device, illustrating an example of actuating needle deployment to deliver and / or capture suture segments. Figure 1A A device 10 with a handle 12 is shown, the handle 12 being configured to be held by a practitioner (e.g., via one hand). A first actuation mechanism 14, such as a lever, slider, or other mechanism, may be coupled along the handle 12 for deploying a receiver member for receiving a needle member for insertion through a region of tissue to be closed. A second actuation mechanism 16, such as a plug 16, or other mechanism, may also be coupled along the handle 12 for pushing or activating the needle member from the proximal catheter segment 20 and into the tissue, and for pulling or tensioning sutures through the tissue and through the device handle 12, as described in further detail herein. An indicator 18, such as an open lumen 18 or other flashing indicator, may also be coupled to the handle 12, wherein the open lumen 18 is in fluid communication through a lumen defined by the device and the proximal catheter segment 20 for receiving a volume of blood, the open lumen providing confirmation that the device has been properly introduced and positioned within the vessel to be closed. In addition, markings 28, as shown, can be provided along the proximal catheter segment 20, the distal catheter segment 22, and / or both segments 20, 22, to inform the user of the depth of the blood vessel below the skin surface, which may be useful when tightening and locking sutures. Markings 28 can be marked relative to the distance of the receiver component. Once deployed within the blood vessel, the receiver component is already positioned within the vessel along the tissue wall adjacent to the opening, thus providing a reference against which markings 28 can be used to indicate the depth of the blood vessel from the skin surface.

[0101] The proximal catheter segment 20 can extend distally from the handle 12, and the deployment segment 24 connects to the distal catheter segment 22, which can extend further distally. The device can terminate at a tapered distal end 26, which is angled toward a relatively small distal end and can be used as a dilator to facilitate device entry and passage through an arterial or venous incision. If desired, the tapered distal end 26 can incorporate one or more lumens at the distal end or along the side that allows guidewire passage.

[0102] Figure 1B The device is illustrated in which a first actuation mechanism 14 is pulled or otherwise activated, and a second actuation mechanism 16 is advanced or pushed relative to a handle 12 to deploy a needle and a rotating receiver platform positioned along a deployment section 24.

[0103] Receiver and needle deployment Figure 2A A detailed view of the first actuation mechanism 14 on the handle 12 in its unactuated configuration is shown, and... Figure 2BThe deployment section 24 is shown, illustrating how it is maintained in its low-profile delivery configuration. The deployment section 24 may include a support structure 30 extending from the proximal catheter section 20 along two opposing members that define a receiving area between them. The support structure 30 may extend from the proximal catheter section 20 in a straight configuration and may include a curved or bowed portion that bends the structure 30 at an angle relative to the proximal catheter section 20, as further described herein. The distal catheter section 22 may extend from the support structure 30 via a hinged, pivotal, or flexible attachment 34 that allows the distal catheter section 22 to be easily rotated about a predetermined rotation angle relative to the proximal catheter section 20. The receiving area 32 defined by the two opposing members of the support structure 30 is sized to receive a receiver member 36, which can be received from... Figure 2B The low-profile delivery configuration shown is rotated to the deployment configuration described below. The distal portion of the receiver member 36 may define two or more needle receiving openings 38 for receiving the distal puncture tip 40 of the needle, which may be deployed from the respective opening 40 along the distal portion of the proximal catheter segment 20.

[0104] Once deployment segment 24 has been properly positioned relative to the opening of the blood vessel to be closed, the first actuation mechanism 14 can be activated, such as Figure 2C As illustrated, the mechanism 14 can be pulled to rotate about the handle 12 to reconfigure the receiver member 36 from its low-profile delivery configuration to its deployment configuration, wherein the receiver member 36 can rotate at an angle between two opposing members relative to the support structure 30. Rotation of the receiver member 36 can reposition the first receiver portion 36' of the receiver member 36 to receive two distally extending front needle members 42A, 42B advanced distally from the opening 40, and rotation of the receiver member 36 can further reposition the second receiver portion 36' of the receiver member on the opposing second side of the support structure 30 to receive two distally extending rear needle members (hidden in this figure) advanced distally from the opening along the opposing second side of the proximal conduit section 20. Actuation of the second actuation mechanism 16 can cause the needle members to be advanced distally from the proximal conduit section 20 into the receiver member receiver position 36, as shown.

[0105] In this variant, device 10 is shown as having two anterior needle members 20 deployable along a first side of the proximal catheter segment 20 and two posterior needle members deployable along a second side of the proximal catheter segment 20 opposite to the first side, for a total of four needle members. These four needle members can be configured to advance two suture loops between two needle members (e.g., between two adjacent needle members along the first side, between two opposing needle members between the first and second sides, and / or between two opposing needle members forming a crossing or angled configuration, etc.). The resulting suture ends can be pulled or tensioned proximally away from the puncture site (e.g., from outside the patient's body) to facilitate access to the tissue edge of the puncture site without knotting, and a separate instrument can be used to deploy fixation devices, such as bands, loops, clips, etc., as described further in detail herein.

[0106] In other variations, a device may be used that employs more than two needle members on either side or both sides of the device 10. Alternatively, other variations may include a device having more needle members on one side than on the opposite second side, depending on the desired closure of the tissue opening.

[0107] By using two suture loops, clinical outcomes for tissue closure can be improved because both loops can serve to approach the tissue edges and improve overall hemostasis. Furthermore, the device 10 can be proportionally adjusted to accommodate various sizes of tissue puncture diameters for tissue closure and / or can provide devices of various sizes for closure of different tissue puncture diameters. For example, a first-sized device can be provided to close puncture diameters, for example, in the range of 10Fr-18Fr, and a relatively larger second-sized device can be provided to close puncture diameters, for example, in the range of 18Fr-30Fr, and so on. Therefore, the diameter of the distal catheter segment can be in any range, for example, 14Fr-24Fr (such as 20Fr), while the diameter of the proximal catheter segment can be in any range, for example, 10Fr-30Fr.

[0108] Another variation of the device 11 is in Figures 3A-3C The perspective view illustrates an embodiment similar to the one described above, but including a deployment section 25, which is configured to be continuous and flexible along its length. This deployment section 25 allows the distal catheter section 22 to bend or flex relative to the proximal catheter section 20 during insertion into the blood vessel without requiring a separate hinge or pivoting mechanism.

[0109] Additionally, the sheath assembly 27 can be slidably positioned along the proximal catheter segment 20, as shown, wherein the sheath assembly 27 may have a sheath member 29 and a proximal abutment member 31 attached to the proximal portion of the sheath member 29. The sheath member 29 may have a minimum thickness profile that allows the sheath member 29 to slide on the deployment segment 25 and the suture segment, such as... Figure 3A As shown, during introduction and delivery into the patient, the suture is protected by preventing any displacement of the suture and preventing contact with the skin or tissue that may increase the risk of infection. The sheath member 29 may also have a smooth, low-profile outer surface to ensure that the deployment segment 25 and the suture can be introduced into the blood vessel without damaging any surrounding tissue, while ensuring that the leading edge of the sheath member 29 remains non-protruding.

[0110] The proximal mating member 31 can be attached to the proximal end of the sheath member 29 and can be configured to facilitate the retraction or advancement of the sheath member 29, such as... Figure 3B As shown, or by a user using two or more fingers, for example with one hand, or by contacting the abutment surface with the sheath member 29, wherein the sheath member 29 can retract through the surrounding tissue as the device 11 is further advanced into the blood vessel. Therefore, the sheath member 29 can have a length that is sized to cover the deployment section 25 but is less than the length of the proximal catheter section 20. The inner diameter of the sheath member 29 can therefore be equal to or approximate the circumference of the proximal catheter section 20, for example, 10-30 Fr or 20 Fr in one embodiment. The sheath member 29 can be thermoformed to achieve a curved profile shape and / or the sheath member 29 can be formed in a straightened configuration and reshaped by sliding the sheath member 29 along the proximal catheter section 20 and the deployment section 25. The proximal abutment member 31 can also be formed to present a curved or arcuate interface along its distal surface for non-invasive abutment contact with tissue. The proximal docking member 31 may also be sized to be larger than the opening in the skin and be angled or otherwise shaped, such as spherical, to allow use under pressure to improve hemostasis within and around the proximal catheter segment 20. The underside of the angled or shaped proximal docking member may also be constructed with felt, swabs, or other similar devices to improve hemostatic performance.

[0111] Once the device 11 has been introduced and desiredly positioned within the blood vessel, and the sheath assembly 27 has been properly retracted, the first actuation mechanism 14 coupled along the handle 12 can be actuated to deploy the receiver component 36, as shown. Figure 3C As shown.

[0112] Figures 4A-4C It shows the correspondence as described above. Figures 3A-3C Detailed perspective view of the sheath assembly 27 translated on the proximal catheter segment 20 and deployment segment 25. (See attached image) Figure 4AAs shown, the sheath member 29 can be positioned such that the entire deployment section 25 is covered by the sheath member 29. For example... Figure 4B As shown, once the sheath assembly 27 retracts proximally along the proximal conduit section 20, the entire deployment section 25 may be exposed by the sheath member 29. The sheath assembly 27 can retract proximally until the proximal mating member 31 abuts the handle 12. The receiver member 36 may also be exposed for deployment, as described herein. Figure 4C As shown.

[0113] like Figure 5A As shown in the detailed perspective view, deployment section 25 is shown with a sheath member 29 extending distally over deployment section 25. The leading edge of sheath member 29 can be positioned just distal to deployment section 25, for example, about 0.10 cm to 0.16 cm, to guide the transition and protect the suture as it crosses from the distal portion of the device into the deployment position secured within receiver member 36 without negatively impacting the flexibility of deployment section 25. Alternatively, sheath member 29 can extend fully over the entire exposed suture segment, such that sheath member 29 can extend partially over distal catheter section 22. In this position, the underlying suture can be completely covered and protected from any external contact (e.g., contact with the skin surface) before sheath member 29 retracts.

[0114] Figures 5B-5E A perspective side view and a front view of the sheath assembly 27 removed from the device 11 are shown. Figure 5B and Figure 5C The illustration shows the sheath member 29 in an unconstrained configuration, for example, when the sheath assembly 27 is retracted over the proximal catheter segment 20. Figure 5D and Figure 5E The illustration shows the sheath member 29 in its constrained configuration when it is located on the deployment section 25 and abuts the features below, while enclosing the receiver member 36 and the undeployed seam.

[0115] Figure 6A The illustration shows how receiver component 36 can be deployed from within support structure 30 from its low-profile configuration. As receiver component 36 rotates, first receiver portion 36' can rotate upward and away from support structure, while second receiver portion 36" can rotate downward and away from support structure until it is aligned in a corresponding manner with the first opening 38' defined along the first receiver portion 36' to receive a needle component advanced distally from the first opening 40 along the first side of the proximal conduit segment 20, and the second opening 38" defined along the second receiver portion 36" is aligned in a corresponding manner to receive a needle component advanced distally from the second opening 52 along the second side of the proximal conduit segment 20.

[0116] As previously described, the support structure can extend distally from the proximal catheter segment 20 in a straight configuration along the proximal support structure 30', and the intermediate portion 50 can be bent or arched along the support structure, such that the distal portion 30' of the support structure can extend at a bending angle relative to the proximal catheter segment 20, such that the hinged or pivotal attachment 34 is out of plane relative to the proximal support structure 30' and the proximal catheter segment 20. The distal catheter segment 22 is pivotally or rotatably connected to the hinged or pivotal attachment 34, such that when the distal catheter segment 22 is straightened, the distal catheter segment 22 and the proximal catheter segment 20 are not collinear with each other, but can extend parallel to each other at a distance, as... Figure 6B As shown. This offset between the longitudinal axis 54 of the proximal catheter segment 20 and the longitudinal axis 64 of the distal catheter segment 22 helps to accommodate the receiver member 36 and also helps the distal catheter segment 22 to bend and further guide into the lumen when initially introduced into the blood vessel, while minimizing trauma to the tissue wall by reducing the forces exerted on the tissue during catheter introduction and advancement through the puncture site. Additionally and / or alternatively, portions of the device 10 (e.g., the distal catheter segment 22, the deployment segment 24, and / or the proximal catheter segment 20) may optionally be lubricated, for example with a hydrophilic coating or other lubricating additives.

[0117] Because the hinged or pivoting attachment 34 facilitates bending of the distal catheter segment 22 for vascular introduction, it allows the distal catheter segment 22 to rotate within a predetermined range of motion. The distal catheter segment 22 can rotate about the hinged or pivoting attachment 34 relative to the longitudinal axis 54 of the proximal catheter segment 20. For example, the distal catheter segment 22 can rotate at a positive angle of 60 up to any angle of +55 degrees or greater, or at a negative angle of 62 up to any angle of -10 degrees or less. The range of motion can be altered by increasing or decreasing either of the angles to allow for flexibility without compromising device integrity and / or usability. In other embodiments, the support structure can be formed as a continuous flexible structure, such as a movable hinge or other flexible segments.

[0118] As the distal catheter segment 22 is advanced through the puncture site and into the blood vessel, the rigidity of the components and their column strength help propel the distal catheter segment 22 into the vessel, while the offset axis helps the distal catheter segment 22 gently push against the inner wall of the vessel. Once in place, the distal catheter segment 22 can rotate relative to the proximal catheter segment 20 at an angle of 66 degrees (e.g., approximately 45 degrees), as... Figure 6C As shown in the side view. To maintain the connection between the proximal catheter segment 20 and the distal catheter segment 22, an internal flexible ridge or connecting element can extend between the two segments via a support structure 30.

[0119] As shown in the figure, when the receiver component 36 is deployed from its low-profile configuration to its deployment configuration inside the blood vessel, the receiver component 36 can be prepared to receive the needle component. However, to ensure sufficient space is available within the blood vessel, the height of the deployed device can be adjusted. The height is expressed as the distance between plane 68 (which represents the top of the receiver component 36 when it is placed against the inner wall of the blood vessel) and plane 70 (which represents the angled base of the distal catheter segment 22). Various features can be adjusted accordingly, such as the length of the support structure 30, the deployment angle between the proximal catheter segment 20 and the distal catheter segment 22, and the bottom of the interface of the distal catheter segment 22 can be reshaped, beveled, contoured, trimmed, etc. Therefore, the height can be in any range between, for example, 5 mm and 20 mm, depending on various factors such as the size of the device 10, the size of the puncture site, and the size (i.e., inner diameter) of the blood vessel to be closed.

[0120] As described herein, the connection between the proximal catheter segment 20 and the distal catheter segment 22 can be achieved via a hinge or pivot mechanism, while in other variations, the connection can be achieved via a flexible structure that does not require bending or turning via a hinge or pivot mechanism, but can be bent or turned via a flexible connector. Figure 7 A detailed perspective view of a variant is illustrated, in which the flexible connector 72 connects the distal end of the support structure 30 to the proximal end of the distal catheter segment 22. The flexible connector 72 may be formed of an elastic member that allows either end to bend or flex while maintaining structural continuity, for example, when the distal catheter segment 22 can be angled away from the vessel wall to move further distally into the vessel without exerting excessive force on the vessel interior.

[0121] In one variation, the flexible connector 72 may be formed of an elastomeric polymer to extend distally from the support structure 30. Attachment features 74, such as clamps, shoulders, protrusions, etc., may be formed to project distally from the support structure 30 to provide attachment points to enhance the connection between the support structure 30 and the flexible connector 72. Furthermore, a reinforcing member 76 may be incorporated to extend at least partially within or completely through the flexible connector 72 to enhance the rigidity of the connection and allow for further material attachment between the flexible connector 72 and the support structure 30. In one variation, the reinforcing member 76 may be integrated with the support structure 30 to extend distally from the support structure 30, and the flexible connector 72 may be formed on the support structure 30. In other variations, the reinforcing member 76 may be incorporated as a component separate from and attached to the support structure 30, for example, through insertion, overmolding, adhesion, mechanical fasteners, etc.

[0122] In either case, the reinforcing member 76 may be formed with a continuous smooth surface, or it may be formed with multiple protrusions or features. In other variations, the reinforcing member 76 may be formed with multiple through-holes that reduce the rigidity of the member 76 and may further allow material of the connector 72 to flow into the through-holes during manufacturing to facilitate a secure attachment between the flexible connector 72 and the support structure 30. The reinforcing member 76 may also be formed with a flat, strip-like profile that allows directional bending or deflection between the proximal catheter segment 20 and the distal catheter segment 22 within a first plane (e.g., vertically), but resists deflection in a transverse plane (e.g., laterally), while maintaining the maneuverability and trackability of the distal catheter segment 22 into the patient's body.

[0123] Because the proximal catheter segment 20 forms an angle of 66° with respect to the tissue wall at the puncture site after insertion and placement, such as Figure 8B As shown in the detailed perspective view, the periphery 80 of the transition region of the device forms a more oval or elliptical shape relative to the tissue wall, such as Figure 8A A detailed perspective view is shown. Perimeter 80 represents the area of ​​the angled proximal catheter segment 20 relative to the tissue wall at the puncture site. As the width of perimeter 80 decreases along the longitudinal direction of the vessel length, the device profile and perimeter 80 can expand in the transverse direction. Thus, for a device profile having, for example, an equivalent circumference of 20 Fr, perimeter 80 is effectively wider than, for example, 3 mm in the transverse direction (extending laterally relative to the vessel length) and effectively less than, for example, 3 mm in the longitudinal direction along the vessel length.

[0124] Because the projected periphery 80 forms an oval or elliptical shape, the edge of the puncture site can be relatively closer to the outer surface of the angled proximal catheter segment. Therefore, the oval or elliptical periphery allows the catheter segment to facilitate closure of the puncture site. This also allows for a smaller receiver component 36, which further enables the device to be used in relatively small blood vessels. For example, the distance between the center of each deployed needle component 42A, 42B and 82A, 82B receiving tissue within the corresponding openings 38' and 38" of the receiver component portions 36' and 36" and the free edge abutting the outer wall of the proximal catheter segment and / or support structure 30 can be considered as the bite edge of the amount of tissue purchased by the needle component. This bite edge can be substantially increased due to the oval periphery 80. In one example, for a device profile with an equivalent periphery of, for example, 20Fr, the resulting bite edge can be in the range of, for example, 1.0 mm to 2.5 mm, or in one example, it can be, for example, 2.25 mm.

[0125] exist Figures 9A-9BA more detailed description of the receiver component deployment is shown in the detailed perspective and side views. As shown, the receiver component 36 can be seen in its low-profile delivery configuration, where the receiver component 36 is not yet deployed within the receiving region 32 of the support structure 30. The first receiver portion 36' and the opening 38' can be seen exposed along the first side of the support structure 30 while the receiver component remains non-protruding and low-profile.

[0126] The actuation of a push / pull member 84, such as a rod, located inside the proximal catheter segment 20 (and optionally actuated via a first actuation mechanism 14 and / or a second actuation mechanism 16), can be pushed to maintain the low-profile configuration of the receiver member 36 or pulled to deploy the receiver member 36, as... Figure 10A As shown in the perspective detail view. When the receiver component 36 is deployed, the receiver component 36 can be rotated as indicated by rotation arrow 86' and simultaneously pulled proximally as indicated by direction arrow 86" until the receiver component 36 is adjacent to the distal end of the proximal duct segment 20 in its deployment and angled configuration, as shown. Figure 10B As shown in the detailed perspective view. The inner wall of the support structure 30 may define one or more guides or tracks 88 symmetrically arranged along each of the supports, along which the receiver member 36 may travel and rotate to its deployment position. These guides or tracks 88 provide a path of travel such that when the push / pull member 84 is actuated again to reconfigure the receiver member 36 back to its low profile configuration after suture delivery, the push / pull member 84 may be pushed to cause the receiver member 36 to travel distally along the guides or tracks 88, allowing it to rotate back to its deployment position. Figures 9A-9B The delivery configuration is shown in the figure.

[0127] Once the receiver component 36 has been properly deployed and positioned against the internal vessel wall around the puncture site, the needle component can then be deployed distally from the proximal catheter segment 20. Figure 11A A detailed side view is shown. Figure 11CThis illustrates how, in one variation, the two front needle members 42A, 42B can be advanced distally from opening 40 until their distal ends are received within the respective opening 38', when actuated by, for example, a second actuation mechanism 16 located on handle 12. Similarly, the two rear needle members 82A, 82B can be advanced distally from opening 52 until their distal ends are received within the respective opening 38'. Actuation of the two rear needle members 82A, 82B can occur simultaneously with actuation of the two front needle members 42A, 42B, while in other variations, actuation can optionally alternate. Each needle member can be advanced linearly to travel along a straight path once exiting openings 40, 52. Alternatively, each needle member can be advanced linearly to travel along a slightly curved path once exiting the respective openings 40, 52, such that the two front needle members 42A, 42B may be slightly curved as they exit opening 40. For example, by means of a curved exit cavity, the two posterior needle components 82A, 82B may also be slightly curved (e.g., by means of a curved exit cavity) as they exit opening 52, so that they also travel slightly radially away from the surface of the proximal catheter segment 20, such that their paths of travel diverge from the paths of the two anterior needle components 42A, 42B. The angle and length of each needle component can be determined by the desired bite edge relative to the tissue surrounding the puncture site. In one variation, the bite edge can be targeted to any size, such as 1.0 mm–2.5 mm or 2.25 mm, as discussed herein.

[0128] With each needle component deployed, each needle component can penetrate the blood vessel wall at its own discrete location, such as... Figure 11C As shown. Each needle component may have its own puncture tip 94 (which may optionally be barbed), which is received in each corresponding opening 38” along the receiver portion 36”, as Figure 11BA detailed partial cross-sectional side view is shown. Each of the openings 38” may define a tapered conical portion 90” to receive the puncture tip 94” into the opening 38”, such that the puncture tip 94” is inserted into a corresponding connecting member 92”, which is releasably secured within the opening 38”. The connecting member 92” may be configured as a tubular receiving member with an inner diameter sized to receive and secure the puncture tip 94” to the puncture tip 94”, such that retracting the puncture tip 94” proximally from the opening 38” can pull or release the connecting member 92” together with the tip 94” from the opening 38”. The inner diameter of the connecting member 92” may optionally incorporate features such as protrusions that allow the connecting member 92” to be secured to the puncture tip 94. The needle members may be sized to have a diameter in the range of, for example, 0.5 mm to 1.0 mm, and the outer diameter of each corresponding connecting member may be designed not to exceed the outer diameter of each corresponding needle member to ensure that the connection can be smoothly removed through the needle penetration site without getting stuck in the tissue.

[0129] As described above, each needle component may include its own puncture tip, and each receiving opening along the receiver may also be coupled with its own connecting component for engagement with the corresponding needle component.

[0130] Any of these receiver and needle deployment variations can be used in any number of combinations or embodiments with any of the device features described herein, including any of the suture management, suture delivery, tissue management, alternative device embodiments, or suture capture and fixation features described herein.

[0131] suture management Because device 10 can be used near tissue openings such as arterial or venous incisions, two separate suture segments, independent of each other, can be preloaded within device 10 and used with the needle component to deliver the suture through the vessel wall. The deployed suture can be used to approach tissue edges for hemostasis (as described further in detail herein). This can be accomplished without any suture knots. Due to the length of the suture, it can be stored and deployed into the tissue using many different suture management variations.

[0132] The sutures used in any of the described embodiments may include any number of different types of sutures, such as polymeric, metallic, absorbable, non-absorbable, braided, monofilament, coated, uncoated, etc. A single device may use the same type of suture for each individual suture loop. Alternatively, different types of sutures may be used in a single device, wherein two or more suture loops are deployed, such that the different suture types are deployed by the single device for tissue closure.

[0133] Figure 12AA detailed side view of a variant is shown, wherein suture 102 may be preloaded within a lumen or space 104 defined within the length of the proximal catheter segment 20. Each of the connecting members 92', 92" at opposite ends of the receiver member may be connected to each other via suture 102 of its own length. Figure 12B As shown in the partial cross-sectional side view, the connecting member 92' located within the opening 38' of the first receiver portion 36' may have its distal end 100', which is connected to the first terminal of the suture 102. This suture 102 may be wired through a cavity defining the receiver member 36, such that the suture 102 passes proximally through the receiver member 36 and enters the lumen or space 104 within the proximal catheter segment 20. This suture 102 may be stored within the proximal catheter segment 20 and may further return distally through the cavity defining the receiver member 36 and toward the second connecting member 92'", wherein the second terminal of the suture 102 may be connected to the distal end 100' of the second connecting member 92'. Similarly, a second length of suture, independent of the suture 102, may have its first and second terminals attached to corresponding connecting members, each positioned within its respective opening along the first receiver portion 36' and the second receiver portion 36', such that the second length of suture is also preloaded within the space or lumen within the proximal catheter segment 20.

[0134] When the two anterior needle components and two posterior needle components are deployed through the tissue and received into their respective openings and connecting components, each puncture end of each needle component can engage the connecting component, and then the connecting component can be pulled proximally to pull the connecting component and the suture end proximally back through the punctured tissue opening. Each suture segment can be in any range, for example, 30 cm to 75 cm or greater, depending on the depth from the skin surface of the tissue opening to be closed and the embodiment of the device used.

[0135] Because the suture 102 remains within the instrument and is deployed directly against the tissue without any unnecessary contact, it avoids contact between the suture 102 and the skin surface or other tissues (such as in percutaneous surgery), reducing any risk of bacterial contamination being trapped or aspirated by the suture 102 into the punctured tissue. Furthermore, the additional risk of postoperative bacterial contamination is further reduced or completely avoided due to the elimination of the use of a knot.

[0136] Figure 13 Another variation is illustrated in which the suture segments can be stored within a cavity or space 104', defined within the distal catheter segment 22 rather than the proximal catheter segment 20. As shown, the ends of each suture segment can still be attached to the opposite connecting member, but the suture segments can pass through cavities and / or slots defined within the receiver member, or they can extend outside the device and enter the cavity or space 104' within the distal catheter segment 22.

[0137] Figure 14 Another variation is shown in which the terminal of each suture segment can be similarly attached to each opposing connecting member, but the first portion 102' of suture segment 102 can be stored within a lumen or space 104 within the proximal catheter segment 20, and the second portion 102' of the same suture segment 102 can be stored within a lumen or space 104' within the distal catheter segment 22. In this way, if additional suture length is needed or desired, suture segment 102 can pass through or along the support structure 30 to provide additional suture segments (e.g., suture segment 102 doubled to 40-100 cm or greater). Furthermore, this arrangement simplifies suture loop payout, ensuring that any suture outside the body remains within the device during deployment. Additionally, this arrangement prevents suture breakage during suture deployment.

[0138] Figure 15 Another variation is shown in which the ends of each suture segment can be configured to cross in order to form a cross-shaped suture pattern across the puncture site. Instead of attaching the end of a suture segment 102 to connecting members positioned opposite and adjacent to each other along the first receiver portion 36' and the second receiver portion 36" as shown, the end of a suture segment 102 can be attached to connecting members directly opposite each other along the first receiver portion 36' and the second receiver portion 36" as shown. This crossing can be achieved by crossing the connecting members on either the first receiver portion 36' or the second receiver portion 36" and the suture segments can be stored in either or both of the proximal catheter segment 20 and the distal catheter segment 22.

[0139] In a variation of the device, segments of suture 102 are wired and / or stored within the distal catheter segment 22. Suture 102 may extend from each respective receiver portion 36', 36" and travel along or through one or more respective suture channels 106, 108, which are defined along the proximal portion of the flexible connector and / or the distal catheter segment 22. Figure 16A and Figure 16B The illustration shows detailed perspective top and bottom views of the deployment section 25 with the sheath assembly 27 in its distal position, wherein the sheath member 29 covers at least part or all of the deployment section 25, and Figure 17A and Figure 17B The illustration shows a detailed perspective top and bottom view of the deployment section 25 with the sheath assembly 27 in its retracted proximal position, where the deployment section 25 is exposed.

[0140] Figure 16A and Figure 17AThe illustration shows how the suture channel 106 can be defined as extending from a common channel and branching into, for example, two separate channels, wherein the suture 102 from the first receiver portion 36' can extend along the channel 106 and be routed into the lumen of the distal catheter segment 22. Figure 16B and Figure 17B The illustration shows how the suture channel 108 can extend parallel to the deployment section 25, such that the suture 102 from the second receiver portion 36” can extend along the channel 108 and similarly be routed into the lumen of the distal catheter section 22. When the sheath member 29 is located on the deployment section 25, the suture segments located within the suture channels 106, 108 can remain covered and protected during insertion and advancement within the tissue to prevent displacement or contact with tissue surfaces, such as the skin surface.

[0141] Figure 18A The diagram illustrates suture channel 106, used as a reference for how suture segments are routed inside and through the device, such as... Figure 18B As shown, for comparison. As illustrated, the ends 102T of the suture 102 can each be attached to a corresponding connecting member contained within each corresponding opening 38 along either the first receiver portion 36', the second receiver portion 36', or both the first receiver portion 36' and the second receiver portion 36', depending on the type of suture used. In this variation, the length of the suture 102 is stored within a lumen or space 104' defined within the distal catheter segment 22 (e.g., as shown in…). Figure 13 or Figure 14 As shown), the remaining terminals 102E opposite to each terminal 102T of each suture segment can be routed through the suture channel 106 to extend toward a corresponding connecting member contained in each opposite opening 38 opposite to the opening to which the terminal 102T is attached. In this variant, terminal 102T may be attached to a corresponding connecting member within the second receiver portion 36”, and the opposite terminal 102E may be attached to a corresponding connecting member within the first receiver portion 36’. The remaining portions of the suture segments can be routed within the lumen or space 104’ such that the approximately central portion 102M of each individual suture segment is positioned proximally within the distal catheter segment 22, as shown. For example, this central portion 102M, approximately + / - 5 cm, together with a trimmed length of, for example, approximately 0-3 cm, is the portion of the suture intended to remain in the patient’s body after fixation, as described further in detail herein. Depending on the length of the distal catheter segment 22, the length of the suture 102 within the device can range in length from, for example, 15 cm to 90 cm.

[0142] Figure 18C and Figure 18D The illustration shows the source Figure 18BA variation of the suture segment routing within the distal catheter segment 22 is illustrated to show how each corresponding suture segment can be routed into the lumen or space 104' and then travel proximally back through the lumen, allowing the central portion 102M to be positioned proximally within the catheter 22. For clarity, Figure 18C Two catheter segments were shown, while Figure 18D A single suture segment is shown. Figure 18E This illustrates how the suture segment can be positioned within the length of the lumen or space 104' defined within the distal catheter segment 22.

[0143] Figure 19A and Figure 19B A front and rear perspective view is shown, illustrating another variation of how a suture segment can be routed outside the first receiver portion 36' and the second receiver portion 36'. In this variation, a single suture segment 102 is illustrated for clarity only, and it shows how the suture can be routed for storage within the lumen or space 104' of the distal conduit segment 22. The first end of the suture can be attached within any opening 38' along the first receiver portion 36' and pass into the lumen or space 104' of the distal conduit segment 22. A second end of the suture can be seen extending from any opening 38' along the second receiver portion 36' and can surround, encircle, pass through, or loop around the protrusion or shoulder 106 (e.g., a splint or support feature), facilitating suture management during delivery and deployment.

[0144] As described herein, the end of each suture segment can be positioned to connect within each opening between the first receiver portion 36' and the second receiver portion 36" to generate a straight suture in the tissue opening to be approached, either directly across each other or across each other and diagonally opposite each other to generate a cross suture pattern.

[0145] Figure 20A The illustration shows a top view of the resulting cross-shaped suture pattern produced below a puncture site PN having a puncture diameter 112 along blood vessel 110. The cross-shaped suture pattern shown can be derived from the above... Figure 15 This is a variation of the device 10. When the device is inserted through a puncture site PN having a diameter of 112, the advancement of the anterior needle members 42A, 42B can result in openings 114, 116 through the tissue wall, and the advancement of the posterior needle members 82A, 82B can result in openings 118, 120 as shown in the tissue. The resulting suture loops can be formed to cross each other at the puncture site PN. The distances 122 between adjacent openings 114, 116 and adjacent openings 118, 120, and the distance 124 between opposite and adjacent openings 114 and 120, as well as the angle 126 between the opening and the midline of the blood vessel 110, can be controlled or adjusted by adjusting the corresponding distances between the needle members.

[0146] Figure 20B The illustration shows a top view of the resulting parallel suture pattern that can be produced above a puncture site PN with a puncture diameter of 130 along the blood vessel 110.

[0147] The parallel stitching pattern shown can be derived from Figure 12 above. Figure 14 A variation of the device 10 is produced in which each suture loop can extend between opposing needle members, for example, between needle members 42A and 82A and between needle members 42B and 82B. The resulting suture loops can be formed to extend longitudinally parallel to each other along the blood vessel and above the puncture site PN. The distances 132 between adjacent openings 114, 116 and adjacent openings 118, 120, and the distance 134 between opposing and adjacent openings 114 and 120, as well as the angle 136 between the opening and the midline of the blood vessel 110, can be controlled or adjusted by adjusting the corresponding distances between the needle members.

[0148] Figure 20C Another variation is shown, in which the puncture site PN, a typical round opening in the vessel wall, is compared with an oval or elliptical opening PN' formed at an angle relative to the tissue surface through the proximal catheter segment 20, as shown. Figure 8A As further illustrated, when the distance 138 between the opposing needle components remains constant, the bite between the insertion positions of the needle components relative to the exposed edge of the puncture site PN' may result in a larger bite than that of a circular puncture site PN. The oval profile allows the device 10 to reduce thickness along one axis (transverse to the vessel length) while increasing thickness along another axis (along the vessel length). Facilitating engagement with one axis of the opening PN' allows for edge control to improve closure.

[0149] Any of these suture management variations can be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture delivery, tissue management, alternative device embodiments, or suture capture and fixation features described herein.

[0150] suture delivery By using two front needle components and two rear needle components, two independent suture segments can be used between each pair of needle components, as described in this article. Figure 21AAs shown, each terminal of each suture segment 102 can be coupled with connecting members 92', 92'", to attach 100', 100'" to each corresponding connecting member. As described herein, each suture segment can be in a range of, for example, 40cm-75cm or greater, and when each connecting member 92', 92'" is removably secured within each corresponding opening along receiver member 36, the remainder of the suture segment can be positioned in a lumen or space within proximal catheter segment 20, distal catheter segment 22, or both proximal catheter segment 20 and distal catheter segment.

[0151] like Figure 21B As shown, a portion 140 of the suture segment 102 can be loosely held or held by some tension 144 (e.g., a tension spring, a spool, etc.), while the remainder can be looped 142 within the device. As long as the cavity or space 104' in which the suture is held is appropriately sized, the suture segment can be prevented from sticking or tangling during suture deployment. The suture holding cavity or space can be combined with some tensioning mechanism to hold undeployed suture release in a controlled manner, and the suture cavity itself does not need to be of any particular shape or cross-section.

[0152] The focus now shifts to the attachment of the suture end and its corresponding connecting component, which can be attached to the connecting component via various attachment mechanisms. Figure 22A and Figure 22B A modified side view and cross-sectional side view are shown, wherein the end of the suture 102 can be coupled to a connecting member (e.g., three or four fingers) via one or more fingers or extension members 103 extending from a body segment. The body segment may also define one or more protrusions 101 defined above the circumference of the body segment. One or more protrusions 101 may extend radially inward to securely engage with the needle tips of the anterior needle members 42A, 42B and / or the posterior needle members 82A, 82B upon advancement into the body segment. The fingers or extension members 103 may be pushed or contracted radially inward at the suture end to create a secure engagement.

[0153] Figure 23A and Figure 23B A further variation of the side view and cross-sectional side view is shown, wherein the tapered portion 107 extending from the body section 105 can (e.g., via die forging) form a fixed engagement with the seam end. Figure 24A and Figure 24B A side view and a cross-sectional side view of another variation are shown, in which the tapered body 111, which is formed separately from the body section 109, can also be similarly fixed to the seam end and attached to the body section 109 (e.g., via mechanical attachment, welding, bonding, etc.).

[0154] In another variation, Figure 25A and Figure 25B The illustration shows a side view of a variant of the suture terminal, which may be configured to have a widened portion 113, such as a melting, knotting, or heating portion, or additional mechanical features. This widened portion 113 may be inserted into a connecting member to enhance a secure connection with the connecting member. Figure 26A and Figure 26B Showing from Figure 24A and Figure 24B A perspective view of a variant of the connecting member, illustrating how the tapered body 111 can be attached to the body section 109 via one or more weld points.

[0155] To illustrate how suture segments are delivered during suture deployment into the tissue. Figures 27A-27E A schematic diagram is shown to illustrate the steps involved in suture deployment. For clarity, a single suture segment 102 is shown; however, a second suture segment can be deployed parallel to the second pair of needle members to produce parallel or cross-stitch patterns as described herein, or any other pattern as required. Furthermore, alternative numbers of needle members can be used, as further described herein.

[0156] like Figure 27A As shown in the illustrative side view, after the distal catheter segment 22 has been introduced through the puncture site and positioned at an angle relative to the proximal catheter segment 20 into the vessel 110, the receiver member can be actuated to rotate from its low-profile configuration to its deployment configuration, for example, by actuation of the first actuation mechanism 14. With the receiver member deployed, it can be pulled against the vessel wall adjacent to the puncture site, and the anterior needle members 42A, 42B and the posterior needle members 82A, 82B can be advanced from the proximal catheter segment 20 such that their respective puncture tips pass through the tissue adjacent to the puncture site via their respective entry points 114, 116 and 118, 120, for example, by pressing the second actuation mechanism 16.

[0157] The interlocking edges between the outer surface of the device and the entry points 114, 116 and 118, 120 can be seen, and the puncture ends of each needle component are advanced until they are received in their respective openings. The anterior needle components 42A, 42B are received in their respective connecting members within the first receiving portion 36', and the posterior needle components 82A, 82B are received in their respective connecting members within the second receiving portion 36'. In this variant, the suture segment 102 can be considered as preloaded within the lumen or space of the proximal catheter segment 20.

[0158] When the puncture tip is engaged with the corresponding connecting member, each needle member can be pulled proximally away from the receiver member, such that the connecting members are pulled from their respective receiver portions 36', 36" as... Figure 27BAs shown, for example, by pulling the second actuating member 16. Each of the needle members, together with the engaging connecting member, is pulled proximally through entry points 114, 116 and 118, 120 (as indicated by directional arrow 150) and outward of the blood vessel 110, such that the attachment terminal of the suture segment 102 is pulled through receiver member portions 36', 36" and also through entry points 114, 116 and 118, 120.

[0159] As suture segment 102 continues to tighten proximally 156, the suture segment 102 stored in the proximal catheter segment 20 (and / or in other variations in the distal catheter segment 22) can be pulled out from the storage cavity or space 104 until the last remaining portion 154 of the suture is pulled downward into the vessel 110, as... Figure 14 As shown in C, until the suture 102 is no longer affected by the device 10. With the end of the suture segment 102 located outside the blood vessel 110 and the patient, the end can be cut or trimmed from the connecting member to release the suture segment 102 from the needle member engaged with the connecting member. The receiver member can then rotate back into its low-profile configuration, as shown in Figure C. Figure 27D As shown, the device 10 can be pulled back 158 proximally through the puncture site, leaving only the suture segment 102 passing through the entry points 114, 116 and 118, 120, as... Figure 27E As shown.

[0160] The proximal end of suture segment 102 can be tensioned from outside the patient's body, causing the edges of the puncture site to approach each other along the vessel wall. With the puncture site closed by suture segment 102, the sutures can be tightened and secured relative to each other to maintain hemostasis at the puncture site. A second instrument for suture capture and fixation can then be used to secure the ends of each suture segment, as described further in detail herein.

[0161] When the suture segment is pulled out from the suture storage cavity or space 104 within the proximal catheter segment 20 and / or the distal catheter segment 22, various mechanisms can be used to loosen the suture in a controlled manner to prevent premature suture loosening and potential tangling.

[0162] exist Figure 28 The perspective view shows such a mechanism, illustrating the proximal duct segment 22 with an opening 162, and suture 160 (in Figure 15 (As shown in the cross-stitch variation) the distal cavity on the central axis of the proximal device section can pass through this opening 162. The suture cavity described herein and shown as cavity 164 can be combined with friction feature 166, for example, utilizing a narrow segment or channel of a material such as silicone, as Figures 29A-29BAs shown in the perspective and end views, it can apply slight tension to the suture 102, thereby preventing the suture from uncontrollably winding outside the device during deployment. The friction feature 166 can be used with a suture lumen or space in the proximal catheter segment 20, a suture lumen or space in the distal catheter segment 22, or any other suture lumen for suture management.

[0163] exist Figure 29C The perspective detail shows another variation in which the suture cavity 164 can terminate to open into a larger space where the remainder of the suture segment 102 can be stored. The length of the suture cavity 164 itself can vary to alter the amount of friction applied to the suture segment 102. The suture segment held outside the suture cavity 164 can provide some nominal resistance to the suture 102 to prevent premature pull-out.

[0164] Figure 30A and Figure 30B A top view and a cross-sectional top view of another variation of the distal catheter segment 22 are shown, which has one or more friction-inducing features joined along segment 22 for applying frictional clamping or resistance to the sutures housed within the distal catheter segment 22. In this variation, as suture segments are routed through their respective suture channels 106 and / or 108 (as described herein), they may contact one or more suture tensioning members 161, which are positioned within corresponding channels or recesses 163 to create a tension point 159 between the suture segment and the tensioning member 161 to apply frictional contact to the suture. Frictional clamping ensures that the underlying suture segment remains fixed during transport and storage. However, when the device is in use, the suture segment can be withdrawn to pass through the suture channels 106 and / or 108, and the tensioning member 161 ensures that the suture segment is deployed in a controlled manner.

[0165] The illustrated variant shows two tensioning members 161 configured as O-rings separated from each other along the length of the distal catheter segment 22. The tensioning members 161 can be separated from each other within a distance range of, for example, 0-2.5 cm. Furthermore, a single tensioning member 161 can be used, or alternatively, more than two tensioning members 161 can be used. Additionally, when the tensioning member 161 is illustrated as an O-ring, other features such as C-clamps, partial rings, etc., can be used alternatively.

[0166] The cross-sectional shape of the tensioning member 161 can also vary in any number of configurations, as long as they provide proper contact with the underlying seam. Figure 31A A tensioning member 165 with a polygonal cross-section 165 is shown. Figure 31B A tensioning member 167 with a circular cross-section 165 is shown, and Figure 31CA tensioning member 169 with a rectangular or square cross-section 165 is shown. The material of the tensioning member can also be varied, for example, an elastomer material such as nitrile, silicone, etc.

[0167] In another variation, a flange tensioner may be incorporated within the distal catheter segment 22 to apply tension to the suture contained within the lumen or space 104' to eliminate any suture slack that may have spread during use. The suture may be wound around the flange tensioner once or more, and the flange tensioner may be designed to break or fail under a specific load during suture withdrawal in the course of a tissue closure procedure. In yet another suture tensioning mechanism, Figure 32A and Figure 32B Another variation of the suture tensioning mechanism is shown in detailed schematic side and perspective views, also positioned within the distal conduit segment 22 to eliminate suture slack. The suture 102 can loop around a post 175 extending between two support members 173 attached to a flanged body 171. A spring or biasing element 177 can provide tension on the flanged body 171, holding the suture segment 102 under tension by pulling the suture 102 through the post 175. In other variations, the spring or biasing element 177 can be omitted entirely, and the post 175 with the flanged body 171 can be used alone to provide tension, such as... Figure 32B As shown. Figure 32C A schematic side view of another variation is shown, in which the flanged body 171 is alternatively combined with one or more elastomeric support members 173', which are configured to provide tension on the stitching 102 looping around the post 175 by means of the elastomeric properties of the support members. The one or more elastomeric support members 173' are illustrated in a stretched or elongated configuration when tension is applied by the stitching 102. The post 175 and / or the support members 173' may fail preferentially once a threshold tension is reached.

[0168] Any of these suture delivery variations can be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture management, organization management, alternative device embodiments, or suture capture and fixation features described herein.

[0169] Organizational Management As described herein, the tissue surrounding the puncture site can be configured in an oval or elliptical shape to maintain or enhance the bite edge along the tissue between the needle assembly and the catheter exterior in larger arterial or venous incision sizes (i.e., 10 Fr or greater and 20 Fr or greater, depending on the size of the device used). While the puncture site can be configured by the device being angled relative to the vessel, additional features can be optionally incorporated to further enhance or facilitate tissue remodeling, particularly for puncture sites where the transition diameter relative to the device may be particularly large.

[0170] One or more lateral dilator elements may be configured to also extend from the outside of the proximal catheter segment 20 and / or the distal catheter segment 22 and / or the support structure 30, so as to force the edges of the puncture sites away from each other along the sides of the device 10, such that the edges of the puncture sites at the front and rear of the device 10 are pushed toward each other along the edges of the blood vessels. These lateral dilator elements may be configured to extend when actuated by a mechanism located, for example, on the handle 12.

[0171] Figure 33A An example is schematically illustrated in which a push / pull member 170 (e.g., push / pull member 84 as described herein) may be combined with an expansion member 176, such as a conical or tapered feature attached along the push / pull member 170. The push / pull member 170 may be actuated to deploy a receiver member, as previously described, and it may also move the expansion member 176 to be received within a receiver channel 174 defined by one or more expansion arms 172 that are separable from each other. When the push / pull member 170 is tensioned or pulled, the proximal movement of the expansion member 176 may force the expansion arms 172 to actuate and move away from each other, such that the expansion arms 172 extend away from the outer surface of the catheter segment or support structure to contact and push adjacent tissue. When the push / pull member 170 is tensioned or pulled, the proximal movement of the expansion member 176 may be configured such that the movement of the expansion member 176 relative to the receiver XX occurs simultaneously or in stages.

[0172] Figure 33B The illustration shows a variant in which dilating arms 178', 178" are positioned on opposite sides of each other along the distal end of the proximal duct segment 20. Upon actuation, arms 178', 178" can move distally, for example, along a fixed, curved track or guide that can cause arms 178', 178" to advance radially away from the outer surface of the device. The contacted tissue can be forced away from the side of the device 10 to cause the remaining area of ​​the tissue edge to enter an oval or elliptical configuration.

[0173] Figure 33CAnother variation is illustrated in which the expansion arms 180', 180” can be formed into a strip configuration, wherein the arms 180', 180” can bend or pivot about the corresponding fixed pivot points 182', 182” when compressed distally, as shown in the figure.

[0174] Figure 33D Another variation is shown, in which the expansion arms 184, 184” can be formed by components that extend orthogonally or laterally upon actuation.

[0175] Any of these organizational management variations can be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture management, suture delivery, alternative device embodiments, or suture capture and fixation features described herein.

[0176] Alternative device embodiments In addition to the device variations described herein, further variations may be implemented. Figure 34A and Figure 34B A detailed side view of such a variant is shown, having a proximal catheter segment 190 and a distal catheter segment 192, which are connected to each other via a flexible segment 196 that allows the proximal catheter segment 190 to rotate relative to the distal catheter segment 192 at an angle 198. A receiver member 194 can be positioned in its low-profile configuration within an extension of the distal catheter segment 192. Instead of rotating to its deployment configuration, the receiver member 194 can be pulled proximally from the distal catheter segment 192, exposed and aligned in place via an actuation member 200, such as a push / pull rod slidably positioned through the proximal catheter segment 190.

[0177] After the receiver component 194 has been positioned in its deployment location, the anterior needle component 202 and the posterior needle component 204 can be deployed from the proximal catheter segment 190 and contact the corresponding openings along the receiver component 194.

[0178] Figures 35A-35D A further variation of the side and perspective views is shown, in which the distal catheter segment may be omitted. Alternatively, the central axis 212 is slidably positioned through the proximal catheter segment 210. The central axis 212 may include a first receiver portion 214 and a second receiver portion 216 opposite to the first receiver portion 214, wherein each receiver portion may be rotatably coupled to the internal fixation element 218 via a hinged or pin connector 220. When the central axis 212 is introduced and advanced into the blood vessel, the first receiver portion 214 and the second receiver portion 216 may be maintained in a low-profile configuration, such as... Figure 35AAs shown, and with the central axis 212 properly positioned, the internal fixing element 218 can be pushed, pulled, rotated, or otherwise actuated to rotate the first receiver portion 214 and the second receiver portion 216, as... Figure 35B and Figure 35C As shown. The internal fixing element 218 is illustrated as having a rod connector, but other variations may include cables, wires, or other attachment features. Figure 35D A perspective view of the first receiver portion 214 and the second receiver portion 216 already deployed is shown, wherein each opposing connecting member within each opening may have its own stitch loops 222, 224, as described herein.

[0179] Figures 36A-36B and Figures 37A-37B Various perspective views of another variation of the device are illustrated. In this variation, the proximal conduit portion 230 may similarly include a central shaft 232, which is coupled to a fixed ramp portion 234 having an angled or tapered surface. Upon actuation, the first receiver portion 236 can be pushed distally or the central shaft 232 can be pushed proximally, such that when the first receiver portion 236 contacts the ramp portion 234 and slides on and rotates about the hinged coupling 238, the first receiver portion 236 is forced to move upward and away from the central shaft 232, as... Figure 36A and Figure 36B As shown. Simultaneously, the second receiver portion 240 can be rotated around the hinged connector 242 when pushed or induced by the pin element 243, as correspondingly... Figure 37A and Figure 37B As shown.

[0180] Figures 38A-38B Various perspective views of another variation of the device are shown, incorporating a dual-receiver feature that can be actuated or rotated via a ratchet mechanism such as a rack and pinion mechanism. This variation can similarly incorporate a central shaft 256 having a first receiver portion 252 and an opposing second receiver portion 254, each rotatably coupled to a proximal catheter segment 250. The central shaft 256 may define multiple protrusions (e.g., rack configurations) on both sides facing each corresponding receiver portion 252, 254, and the receiver portions 252, 254 may also incorporate a circular pinion configuration. Once the central shaft 256 has been properly advanced and positioned within the blood vessel, it can be pulled proximally to actuate the rack and pinion of the receiver portions 252, 254, causing the receiver portions 252, 254 to rotate into their deployment configuration.

[0181] Any of these alternative device variations can be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture management, suture delivery, tissue management, or suture capture and fixation features described herein.

[0182] Thread capture and fixation As described herein, a second instrument for suture capture and fixation can be used to fix the ends of each suture segment after deployment and delivery through the tissue area to be closed, in order to achieve hemostasis using the aforementioned device.

[0183] exist Figure 39A The perspective view shows a variation of the suture capturing and securing device, illustrating a handle 260 with an actuation mechanism 262 for deploying or securing an anchor to the captured suture. An elongated shaft 266 extends from the handle 260 and terminates at an opening 268 at its distal end. The opening 268 may extend partially through the shaft 266 and into a window 270 defined along one side of the shaft 266 near its distal end. The window 270 is positioned proximally from the distal end of the shaft 266 by a distance 294, which can be measured from the distal end to the center of the window 270 and may range from, for example, 0.5 cm to 5 cm. A securing anchor 272 (such as a collar with a cavity passing through it) may be positioned within the opening 268. The sliding element 264 can be detachably positioned along the axis 266 or along the handle 260, and the line 274 can be coupled to the sliding element 264 and extend along the device and into the window 270, through the fixed anchor 272 and distally through the opening 268, wherein the line 274 can form a loop 276, which opens into an expansion ring for joining seams.

[0184] The thread 274 and the stitch loop 276 can be formed from any number of materials (such as stainless steel, nitinol, nylon, thermoplastic, stitching, etc.) in any number of construction forms (such as braiding, cable, or monofilament, etc.). In addition, the fixing anchor 272 contained in the distal opening can be positioned at a distance of, for example, 3 mm or less from the outer surface of the distal end.

[0185] exist Figure 39BThe perspective view shows another variation of the suture capturing and securing device, which illustrates a handle 260 with an actuation mechanism 262 and an elongated shaft 280 extending from the handle 260. In this variation, the suture loop sliding element 284 can be located near the distal end of the shaft 280, close to a window 282 defined along one side of the shaft 280. As described above, the window 282 can be positioned a distance 294 from the distal end of the shaft 280 toward the proximal end, the distance 294 being measured from the distal end to the center of the window 282, wherein the distance 294 can be in any range, for example, from 0.5 cm to 3.5 cm. The window 282 itself can be suitably sized to accommodate the passage of up to eight suture segments (e.g., four end suture ends 278, which fold over themselves when pulled proximal through the window 282), wherein the length of the window 282 along the length of the shaft 280 can be in any range, for example, from 2 mm to 10 mm, and the width of the window 282 transverse to the length of the shaft 280 can be in any range, for example, from 1 mm to 4 mm. The sewing loop sliding element 284 can be formed as a protrusion or tab, such as an annular tab, which provides the feature of easy gripping and pulling with one hand. A line 292 can be attached to the distal portion of the sewing loop sliding element 284 and extends distally through window 282, through a retaining anchor 272 held therein, and extends distally through an opening, wherein line 292 can form a sewing loop loop 286. Both the sewing loop sliding element 284 and the elongated shaft 280 can have features that hold the two elements in a desired relative position. Such features also facilitate a removable fixed connection between the two components until use.

[0186] In use, the terminal suture ends 278 retained after suture delivery around the puncture site can each pass through the suture loop 286. The suture loop sliding element 284 can then be pulled from or along the elongated shaft 280 towards the proximal side 290, causing the suture 292 to be pulled through the window 282 and the fixed anchor 272, thereby tightening the suture loop 286 around the suture ends 278. As the suture loop sliding element 284 is pulled further proximal, it can abut against the tapered mating surface 288 defined at the distal end of the handle 260, causing the suture loop sliding element 284 to be pushed upward and disengaged from the elongated shaft 280.

[0187] Prior to the suture capture and fixation procedure, the suture loop sliding element 284 and suture loop collar 286 can be preloaded onto the elongated shaft 280, making the suture capture and fixation device immediately usable. If additional fixation anchors 272 are required for tissue closure, multiple suture capture and fixation devices can be used, or additional suture loop sliding elements 284, suture loop collars 286, and fixation anchors 272 can be loaded onto the same elongated shaft 280 as many times as required to deploy the additional fixation anchors 272.

[0188] Figures 40A-40C The illustration shows a detailed perspective view of the seam end 278 being joined by the seam loop 286, as shown. Figure 40A As shown, when the sewing loop 286 is pulled further proximally through the fixed anchor 272 and the window 282, the looped sewing end 278 can be pulled through accordingly, as shown. Figure 40B As shown, until the end of the suture 278 completely passes through both the fixing anchor 272 and the window 282, as Figure 40C As shown.

[0189] As the distal end of shaft 280 is advanced distally to the puncture site, the suture tip 278 can be tensioned proximally, simultaneously tightening the suture passing through the tissue junction until the edge of the puncture site approaches or closes, such as Figure 41A As shown. Once the puncture site is tensioned and closed, as indicated by arrow 296, pulling the suture proximally allows the user to assess hemostasis before finalizing suture fixation and trimming. Once hemostasis has been assessed, the anchor 272 can deform, coil, or otherwise tighten to secure the passed suture 278 until the anchor 272 can no longer move, for example, by actuating the clamping mechanism within the distal end of the shaft 280 via the actuation mechanism 262 on the handle 260 to deform or coil the anchor 272 around the suture. In the case of the anchor 272 coiling or tightening, the suture end 278 can be cut or trimmed, as... Figure 41B As shown, shaft 280 can be removed, leaving the fixing anchor 272 and the trimmed sutures to achieve hemostasis, as... Figure 41C As shown. In some embodiments, the suture end can be trimmed simultaneously with attachment of the anchor 272 by a built-in cutter driven by the same actuation mechanism 262. The suture can be trimmed such that the tail of the suture extending proximally from the loop member is cut flush with or cut to a desired length (e.g., 0-30 mm or greater) above the end of the anchor 272. Figure 41C As shown, instead of requiring a knot for each suture segment, two (or more) suture segments or loops are secured with a single anchor.

[0190] Figure 42A and Figure 42B Detailed perspective and side views of the sewn loop sliding element 284 are shown to illustrate additional features that can be combined. The sliding element 284 is shown defining an annular tab 302, which allows a user to grasp the sewn loop sliding element 284 with a single finger or hand. A thread 292 can be seen attached to the distal portion of the sliding element 284, extending distally into a window 282, passing through a retaining anchor 272 contained within a distal opening at the end of the shaft 280, and extending from the distal opening to form a loop 286. The sewn loop sliding element 284 defines an open channel through which the shaft 280 is slidably engaged, allowing the sliding element 284 to be translated proximally on the outside of the shaft 280 and removably secured. The shaft 280 may be configured with a keyed or angled cross-sectional profile to ensure that the sliding element 284 remains aligned and / or synchronized relative to the elongated shaft during proximal translation. In this variation, shaft 280 is shown as having an outer profile 300 of a hexagonal shape along its length. While the outer profile 300 can be configured with any number of different cross-sectional areas (e.g., triangles, squares, rectangles, pentagons, etc.), as long as they facilitate the alignment of sliding element 284 on shaft 280. Instead of a keyed cross-sectional surface, shaft 280 can alternatively incorporate guides, tracks, or longitudinal protrusions that are bonded along sliding element 284 to the corresponding receiving channel. Such longitudinal protrusions can also be used to ensure the alignment of sliding element 284 relative to shaft 280 during proximal translation of sliding element 284.

[0191] The proximal surface of the sliding element 284 can also be configured as an inclined or angled surface 304, such as... Figure 42B As shown, it can correspond to a tapered mating surface 288 defined along the distal end of the handle 260, so that the sliding element 284 can be released from the outside of the shaft when pulled proximally.

[0192] Additionally, the sliding element 284 may incorporate a protrusion or shoulder 306 extending from it for engaging a corresponding pawl or groove defined along the shaft 280. In this variation, the protrusion or shoulder 306 may extend distally from the sliding element 284 on a flexible member. During delivery, the engagement between the protrusion or shoulder 306 and the shaft 280 secures the sliding element 284 in place on the shaft 280. Pulling the sliding element 284 easily releases the protrusion or shoulder 306 from the shaft 280.

[0193] As described above, the proximal catheter segment 20 (and / or the distal catheter segment 22) may include graduations 28 on the outer surface of the catheter to provide a visual indication of the depth of the vessel to be closed relative to the surface of the tissue or skin T, such as Figure 43AAs shown in the figure, the scale 28 can be angled (e.g., at 30-45 degrees relative to the skin surface) or straight relative to the longitudinal axis of the proximal duct segment 20. Figure 43B The illustration shows how the axis 280 of the suture capture and fixation device can also be combined with a scale 311 to similarly provide a visual indication of the insertion depth relative to the tissue surface or skin T, as shown. In this variation, as shown, the scale 311 can be configured in a transverse (or linear) configuration relative to the longitudinal axis of the axis 280, or the scale can be an angled scale 311' (e.g., at 30-45 degrees relative to the skin surface), as shown. Figure 43C As shown.

[0194] In the proximal catheter segment 22 or axis 280, the initial distance between the initial graduation mark and the receiver member 36 or the inner surface of the blood vessel may be, for example, 10 mm, and each subsequent graduation mark may be spaced at a uniform distance (e.g., 5 mm-10 mm).

[0195] Figure 44 A perspective view of a variant of the shaft 280 including scale 311 is shown, wherein each scale mark may be spaced apart from each other, for example, by 5 mm or 10 mm. A loop 286, a window 282, and a sliding element 284 are also shown.

[0196] Now, the focus has shifted to an internal suture cutting mechanism. Figure 45A and Figure 45B A detailed perspective view of shaft 280 and its internal mechanisms is shown, with the outer wall of shaft 280 removed for clarity. Figure 45AAs shown, when the suture end 278 enters and passes through the distal end of the shaft 280 and exits the window 282, the fixing anchor 272 can be seen positioned between the deformable platforms 303, which have one or more lateral protrusions positioned at the distal end of the cantilever member 307, which has a tapered mating surface. A receiving platform 305, also having one or more lateral protrusions arranged complementary to the deformable platform 303, can be seen positioned relative to the deformable platform 303. The suture 278 can pass through a suture cavity 301 extending between the distal end of the shaft 280 and the window 282. A suture exit port 319 with a cutting mating window 321 can be fixedly positioned within the suture cavity 301 such that the cutting mating window 321 of the exit port 319 is aligned with the window 282, allowing the suture end 278 to pass through the interior of the suture exit port 319 and exit through the cutting mating window 321 and the corresponding window 282. The slidable blade element 313, extending from the base 317 and terminating at the cutting edge 315, can be slidably positioned within the suture cavity 301 such that when the instrument is actuated, for example by the actuation handle 262, the actuating mechanism can push the base 317 to slide the cutting edge 315 distally over the cutting docking windows 321 and 278 to correspondingly cut the suture end 278.

[0197] The perspective and side views of the instrument axis 280 are further illustrated. Figure 45C and Figure 45D As shown, when the base 317 and the cutting edge 315 are translated distally, the translation pusher 309 can be pushed distally such that the tapered mating surface 311 at the distal end of the pusher 309 can contact the cantilever member 307, which is then forced upward (in the lateral direction). This lateral movement can push the deformable platform 303 toward the receiving platform 305, thereby deforming the anchor 272 positioned between the lateral protrusions of both the deformable platform 303 and the receiving platform 305. Thus, in a single actuation, the mechanism can fix the anchor 272 and the trimmed suture end 278 to release the anchor 272 onto the adjacent tissue. The length of the suture between the anchor 272 and the trimming position (trimming length) can be, for example, in the range of about 0-3 cm, and represents the suture expected to remain in the patient's body after anchor fixation and suture cutting.

[0198] Figure 46A and Figure 46BDifferent perspective views of the base 317 and the sliding blade element 313 are shown. In the variant shown, the blade element 313 is illustrated as having a curved surface approaching the inner circumference of the shaft 280, but in other variants, the blade element 313 can be shaped into other configurations. Furthermore, while the cutting edge 315 can be a tapered cutting element, other variants can also be used, which can be combined with alternative energy delivery mechanisms to cut the suture, such as heating elements, rotating elements, etc.

[0199] Any variation of the suture deployment and delivery mechanism may be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture management, suture delivery, tissue management, or suture anchoring features described herein.

[0200] Thread anchoring Because the suture capture and fixation device eliminates the need for any knots or pre-knotted knots, the fixation anchor that tightens the suture end and secures the tensioned suture to the tissue for hemostasis can include any number of deployable loops, clips, etc. A particular variant of the fixation anchor that can be deployed from the distal opening of the device shaft 280 can include loops that can be sized in any number of configurations depending on the application. The loops can be sized to capture the suture end 278 to complete the closure, and such loop structures can be made of any number of materials, such as metals that can be deformed (e.g., compressed, curled, etc.) on the suture or polymers that can be heat-melted on the suture for fixation. In the case where the suture used is a polymer, the loop can be partially melted along with a portion of the suture to achieve a secure anchor.

[0201] exist Figure 47A A variation of the loop is shown in the perspective view, illustrating a loop with a tubular portion 310 defining a lumen 314 for receiving suture passage. The distal end of the loop may include a flared or enlarged shoulder or sill 312, which can help position and secure the loop within the distal opening of the axis 280. Once the suture has passed through the lumen 314 and is tensioned, the tubular portion 310 may deform or coil (or heat-melt) the suture to prevent its movement. The tubular portion 310 may optionally be rolled, angled, or flattened relative to the vessel wall, such that the trimmed end of the suture near or at the opening of the lumen 314 is configured with a low profile for patient comfort.

[0202] The tubular portion 310 may define a cavity 314 with a smooth inner wall, but such as Figure 47B Other variations of the ferrule can be incorporated with the threaded channel 316. Alternatively, the ferrule cavity 314 can be incorporated with one or more protrusions 318 extending inwardly into the cavity 314, such as... Figure 47CThe loop is shown to further enhance the bond between the loop and the seam when deformed or curled.

[0203] Figure 47D and Figure 47E A perspective view of an additional collar variation is shown, which includes a spherical tubular portion 320 for removing any hard edges from the implant. The spherical collar may also define a split or open channel 322 along the length of the tubular portion to facilitate curling or contraction of the collar on the suture. Figure 47D Variations also show a shoulder or sill 312 including a flared or enlarged opening, while Figure 47E The shoulder 312 has been omitted.

[0204] In other variations, the ferrule cavity may incorporate a secondary feature serving as a plug or impact member, which fills the gap within the ferrule to further secure it to the suture. This secondary feature can be made of various materials, such as compressible biocompatible plastics (non-absorbable or absorbable).

[0205] Figure 48 A modified partial cross-sectional side view is shown, in which the loop tubular portion 310 may optionally be coupled with a plug 320 (e.g., an elastomer) having a tapered surface that can press against the suture 278 passing through the cavity. Specifically, the tapered surface can help secure the suture against the edge of the loop, as shown. The plug 320 may also include a pull tab 322 feature that allows a user to grasp the pull tab 322 and pull the plug 320 out of the loop for suture release or repositioning.

[0206] Figure 49A and Figure 49B The illustration shows a perspective view and a cross-sectional perspective view of another variation, in which the plug 330 defining the plug cavity 332 can be fully inserted through the loop cavity, allowing the suture to pass directly through the plug cavity 332 itself. The plug cavity 332 may also define a tapered cavity that narrows at the proximal end of the plug cavity 332, thereby enhancing the curl of the suture.

[0207] Figure 50 A further variation of the cross-sectional perspective view is shown, in which a plug 340 can be introduced into the proximal cavity opening of the ferrule. The plug 340 may include an enlarged proximal end 342 for engaging with the ferrule opening and an enlarged distal feature 344 sized for entry into the ferrule cavity 314. When the suture passes through the ferrule cavity 314, both the distal feature 344 and the proximal end 342 of the plug can facilitate suture fixation within the ferrule cavity 314 when the plug 340 is pushed into the ferrule cavity 314.

[0208] Any of these variations of suture capture and fixation features may be used in any number of combinations or embodiments with any of the device features described herein, including any of the receiver and needle deployment, suture management, suture delivery, tissue management, or alternative device embodiments described herein.

[0209] The applications of the apparatus and methods discussed above are not limited to those described, but can include any number of suture delivery and tissue fixation applications. Modifications to the above-described components and methods for carrying out the invention, combinations of possible different variations, and variations of various aspects of the invention, as will be apparent to those skilled in the art, are all within the scope of the claims.

Claims

1. A tissue closure device, comprising: A handle having one or more actuation mechanisms; A proximal catheter segment extending from the handle; A deployment section, the deployment section being connected to the proximal catheter section; A distal catheter segment, which is connected to the deployment segment, allows the distal catheter segment to rotate at an angle relative to the proximal catheter segment. A receiver component, positioned within the deployment section and having two or more openings along a first receiver portion and two or more openings along a second receiver portion, wherein the receiver component is configurable between a low-profile configuration and a deployment configuration; Two or more anterior needle components and two or more posterior needle components, the two or more anterior needle components being extendable distally from a first side of the proximal catheter segment, and the two or more posterior needle components being extendable distally from a second side of the proximal catheter segment opposite to the first side. When the receiver component is in the deployment configuration, the two or more front pin components are able to receive into the two or more openings along the first receiver portion, and the two or more rear pin components are able to receive into the two or more openings along the second receiver portion.

2. The device according to claim 1, wherein, The proximal catheter segment defines one or more suture cavities therein.

3. The device according to claim 1, wherein, The proximal catheter segment defines an opening corresponding to each of the two or more anterior needle members and the two or more posterior needle members.

4. The device according to claim 1, wherein, The deployment section defines a receiving area for holding the receiver component within the low-profile configuration.

5. The device according to claim 1, wherein, The deployment section defines a curved or arcuate profile such that the longitudinal axis of the distal catheter section is offset relative to the longitudinal axis of the proximal catheter section.

6. The device of claim 1, further comprising a coupling member held within each of the two or more openings along the first receiver portion and along the second receiver portion.

7. The device according to claim 6, wherein, Each connecting member is configured to receive an opening at the puncture tip from the corresponding needle member in a fixed engagement manner.

8. The device according to claim 6, wherein, Each connecting component is attached to the end of the stitch segment.

9. The device of claim 6, further comprising a first suture connected to a first connecting member and a second connecting member, the first connecting member being held within a first opening along the first receiver portion, and the second connecting member being held within a second opening along the second receiver portion.

10. The device of claim 9, further comprising a second suture connected to a third connecting member and a fourth connecting member, the third connecting member being held within a third opening along the first receiver portion, and the fourth connecting member being held within a fourth opening along the second receiver portion.

11. The device of claim 1, further comprising one or more tissue dilation elements configured to extend laterally from the proximal duct segment.

12. The device of claim 1, further comprising a suture anchoring device configured to receive a segment or more of sutures deployed from the tissue closure device and to secure a tissue anchoring member around the segment or more of sutures.

13. The device according to claim 12, wherein, Two or more suture segments are secured with a single tissue fixation anchor.

14. The device of claim 1, further comprising a sheath assembly slidably positioned along the proximal catheter segment, the sheath assembly having a sheath member and a proximal docking member.

15. The device according to claim 14, wherein, The sheath member is configured to fit the deployment section such that the receiver member in the low-profile configuration is enclosed within the sheath member.

16. A method for tissue closure, comprising: The distal catheter segment is advanced into and through an opening along the wall of the blood vessel, such that the distal catheter segment is rotated about the deployment segment and is angled relative to the proximal catheter segment. Within the blood vessel, the receiver components are deployed from a low-profile configuration to a deployment configuration such that a first receiver portion and a second receiver portion abut against the wall adjacent to the opening; Two or more anterior needle members extend distally from a first side of the proximal catheter segment, and two or more posterior needle members extend distally from a second side of the proximal catheter segment opposite to the first side, such that each of the needle members pierces through the wall adjacent to the opening; and The two or more front needle members are received into two or more openings along the first receiver portion, and the two or more rear needle members are received into two or more openings along the second receiver portion.

17. The method according to claim 13, wherein, Advancing the distal catheter segment includes advancing the distal catheter segment into and through an arterial or venous incision.

18. The method according to claim 16, wherein, Advancing the distal catheter segment includes sliding a sheath member proximally along the proximal catheter segment as the distal catheter segment is advanced, such that the deployment segment is exposed by the proximal retraction of the sheath member.

19. The method according to claim 18, wherein, Sliding the sheath member proximally includes contacting the tissue surrounding the opening via a proximal docking member as the distal catheter segment is advanced into and through the opening.

20. The method of claim 16, wherein, Deploying the receiver component includes triggering an actuation mechanism on a handle coupled to the proximal catheter segment.

21. The method according to claim 16, wherein, Deploying the receiver component also includes maintaining the proximal duct segment at an angle relative to the distal duct segment, such that the tissue area around the opening forms an oval or elliptical shape.

22. The method according to claim 16, wherein, Extending distally includes extending the two or more front needle members from the first side along a curved or angled path, and extending the two or more rear needle members from the second side along a curved or angled path.

23. The method according to claim 16, wherein, Receiving includes receiving the two or more front needle members into corresponding connecting members held within each of the two or more openings along the first receiver portion, and receiving the two or more rear needle members into corresponding connecting members held within each of the two or more openings along the second receiver portion.

24. The method of claim 16, further comprising retracting the two or more front needle members from the first receiver portion and retracting the two or more rear needle members from the second receiver portion, such that the first suture segment and the second suture segment are retracted proximally through the wall adjacent to the opening.

25. The method of claim 24, further comprising trimming the first suture segment and the second suture segment from each of the needle components.

26. The method of claim 25, further comprising tensioning the first suture segment and the second suture segment such that the opening along the wall of the blood vessel is approached and closed.

27. The method of claim 26, further comprising advancing a tissue fixation anchor along the first suture segment and the second suture segment.

28. The method of claim 27, further comprising securing the tissue fixation anchor to the first suture segment and the second suture segment.

29. A method for minimizing suture-based infection risk associated with tissue closure, comprising: The suture delivery catheter is advanced into and through an opening along the wall of the blood vessel, such that the distal catheter segment rotates about the deployment segment and is angled relative to the proximal catheter segment. Within the blood vessel, the receiver components are deployed from a low-profile configuration to a deployment configuration such that a first receiver portion and a second receiver portion abut against the wall adjacent to the opening; Two or more anterior needle members extend distally from a first side of the proximal catheter segment, and two or more posterior needle members extend distally from a second side of the proximal catheter segment opposite to the first side, such that each of the needle members pierces through the wall adjacent to the opening; and The two or more front needle members are received into two or more openings along the first receiver portion and the two or more rear needle members are received into two or more openings along the second receiver portion, such that the two or more front needle members are received into corresponding connecting members held within each of the two or more openings along the first receiver portion, and the two or more rear needle members are received into corresponding connecting members held within each of the two or more openings along the second receiver portion; The two or more front needle members are retracted from the first receiver portion and the two or more rear needle members are retracted from the second receiver portion, such that the first suture segment and the second suture segment are retracted proximally through the wall adjacent to the opening; as well as The first and second suture segments are secured using tissue fixation anchors, which prevent each of the suture segments from moving without knots.

30. The method according to claim 24, wherein, The first and second suture segments are prevented from contacting the tissue as they are advanced into and through the wall.

31. The method according to claim 24, wherein, Advancing the distal catheter segment includes holding the first suture segment and the second suture segment within a sheath member that is slidably positioned above the deployment segment.

32. The method of claim 31, further comprising sliding the sheath member proximally along the proximal catheter segment as the distal catheter segment is advanced, such that the deployment segment is exposed by the proximal retraction of the sheath member.

33. The method according to claim 32, wherein, Sliding the sheath member proximally includes contacting the tissue surrounding the opening via a proximal docking member as the distal catheter segment is advanced into and through the opening.

34. A suture anchoring device, comprising: A handle having an actuation mechanism; A shaft attached to the handle, wherein the shaft has a distal end that defines a distal opening and a window along one side of the shaft, such that the distal opening and the window communicate with each other; A sliding element, which is capable of being translatably positioned on the shaft; An organization fixation anchor is positioned within the distal opening and defines an anchor cavity communicating with the window; and A line, which is connected to the distal portion of the sliding element and extends into the window and through the anchor cavity, such that the line exits the distal opening and forms a loop.

35. The apparatus according to claim 34, wherein, The handle defines a tapered mating surface, and the shaft is attached to the handle at the tapered mating surface.

36. The apparatus according to claim 34, wherein, The shaft defines a cross-sectional area, which is keyed and corresponds to a channel defined along the sliding element.

37. The apparatus according to claim 34, wherein, The sliding element defines an annular protrusion.

38. The apparatus according to claim 34, wherein, The sliding element also includes a protrusion for maintaining the position of the sliding element on the shaft.

39. The apparatus according to claim 34, wherein, The window is defined near the distal opening.

40. The apparatus according to claim 34, wherein, The line can retract proximally via the sliding element, causing the size of the loop to decrease and pass proximally through the distal opening, the anchor cavity, and the window.

41. The device of claim 34 further includes a section or more of suture capable of being positioned within the loop.

42. The apparatus according to claim 34, wherein, The tissue fixation anchor includes a collar that can deform to contract.

43. A method for anchoring a suture, comprising: Position one or more sections of suture within a loop extending from the distal opening of the shaft; The sliding element is retracted proximally along the axis, causing the loop to decrease in size and pulling one or more segments of suture proximally into the distal opening, through the anchor cavity of the tissue fixation anchor located within the distal opening, and out through a window defined along one side of the axis. Position the distal opening of the shaft near the tissue opening along the vessel wall while tensioning one or more suture segments; and The tissue anchor is deformed to fix one or more suture segments.

44. The method of claim 43, further comprising trimming one or more segments of suture above the tissue fixation anchor.

45. The method according to claim 43, wherein, Locating one or more suture segments includes locating the one or more segments extending from a tissue region adjacent to the tissue opening.

46. ​​The method according to claim 43, wherein, Retracting proximally involves pulling the sliding element until it is released from the axis.

47. The method according to claim 43, wherein, Tightening one or more segments of suture includes tightening until the tissue opening is opened to achieve hemostasis.

48. The method according to claim 43, wherein, Deformation of the tissue fixation anchor includes curling the anchor cavity along one or more suture segments.

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