Organizational closure system

Abstract

A tissue closure system is disclosed, one embodiment 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 to the proximal catheter section. A receiving member positioned within the deployment section can be configured between a thin form and a deployed form. Two or more anterior policy members and two or more posterior policy members can extend distally from first and second sides of the proximal catheter section. Two or more anterior policy members can be received into two or more openings along the first receiving section, and two or more posterior policy members can be received into two or more openings along the second receiving section.

Description

Technical Field

[0001] The present invention relates to methods and instruments for closing tissue sites. More particularly, the present invention relates to methods and instruments for percutaneously closing an opening along a blood vessel wall such as an artery or vein.

Background Art

[0002] When a percutaneous procedure using vascular access is completed, instruments such as an introducer sheath and an operable guide are removed from the blood vessel, leaving the puncture site open. To close the blood vessel opening to achieve hemostasis, various instruments and methods have been employed, such as compression, plugs, patches, metal fasteners, and suture application instruments that deploy sutures on both sides of the puncture site and tighten them to bring the two edges of the puncture site closer together. Suture-based instruments are preferred in the market because the two edges of the opening are closed in a manner that is closest to open surgery.

[0003] While such devices can be used effectively, their use is limited by the size of the puncture site, requiring multiple devices or being placed before the percutaneous procedure to ensure effective closure. For example, when the puncture site is relatively large, it may be necessary to use two devices: a first device, deployed and removed, and then a second device, to stop bleeding at the puncture site. Alternatively, a "pre-close" technique may be used, where sutures are placed while the puncture site is small, before the opening required for the introducer sheath and percutaneous procedure is enlarged. After the procedure is complete and the sheath is removed, one or more sutures are tightened and secured with one or more knots. In many cases, percutaneous procedures are emergencies such as aortic aneurysms, leaving no time for pre-placement of sutures, and the use of multiple devices is further hindered. Furthermore, there is an increased risk of damage or bacterial contamination of sutures remaining outside the patient's body during the percutaneous procedure, increasing the risk of post-procedure infection. This concern could lead to the selection of monofilament sutures, which have a smaller surface area than braided sutures but are less durable, or to the selection of more complex sutures.

[0004] In addition, such instruments are first introduced into the puncture site, then through the puncture site, and subsequently partially advanced into the blood vessel to be closed. A mechanism to facilitate the insertion of sutures into the tissue surrounding the opening is then usually deployed inside the blood vessel. However, depending on the size of the blood vessel and the relative size of the instrument, the introduction of the instrument into the blood vessel and the deployment of the mechanism may be hindered.

[0005] Furthermore, such devices may employ pre-tied knots supplied through the device to close and secure the puncture site. However, the use and supply of pre-tied knots can complicate the supply of sutures into and through the tissue, and further limit the flexibility in tissue fixation. Also, because the knot has a larger surface area, the risk of post-procedure bacterial contamination and infection increases when used with the pre-close method. Alternatively, such devices may require the use of another instrument or physician to tie the knot, which may delay tissue fixation. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, there is a need for instruments and methods for percutaneously closing large puncture sites along the blood vessel wall, where the suture is deployed into the tissue using a single instrument, pre-closing is not required, and the procedure is simplified. Furthermore, such instruments and methods are desired to minimize the risk of infection associated with suture damage or bacterial contamination. In addition, there is a need for instruments and methods that facilitate puncture closure regardless of the size of the blood vessel and utilize a simplified closure mechanism to achieve hemostasis. For these reasons, it is desirable to provide improved instruments, systems, and methods for suture-based tissue closure. These improved instruments and methods would be particularly beneficial if they overcome one or more of the aforementioned disadvantages and provide some or all of the advantages. [Means for solving the problem]

[0007] An instrument configured to close an opening in a tissue wall, such as an arterial or venous incision along a blood vessel wall, may include a slender catheter having a distal catheter section and a proximal catheter section configured to move or rotate relative to each other. The instrument may include a handle configured to be held by the operator (e.g., with one hand). A first actuation mechanism, such as a lever, sliding part, or other mechanism, may be incorporated along the handle to deploy a receiving member for receiving a needle member for insertion through the tissue site to be closed. A second actuation mechanism, such as a plunger or other mechanism, may also be incorporated along the handle to push or actuate the movement of the needle member from the proximal catheter section into the tissue, and to pull or tension a suture through the tissue via the instrument handle. An indicator, such as an opening lumen or other flush indicator, may also be incorporated into the handle, in which case the opening lumen may be in fluid communication through a lumen formed through the instrument and the proximal catheter section to receive a predetermined amount of blood, which can serve as an indicator to confirm that the instrument has been properly introduced and positioned in the blood vessel to be closed. In other embodiments, other alternative sensors or sensor mechanisms may be used to indicate that the instrument is properly positioned within the blood vessel, such as sensors utilizing pressure, conductivity, capacitance, temperature or heat, optical fibers, or flow rate. A scale on the instrument shaft may be used to inform the user of the blood vessel depth useful when tightening or locking sutures.

[0008] The proximal catheter section may extend distally from the handle and may be connected to the distal catheter section via a deployment section. This distal catheter section may extend further distally, and at its tip the instrument may terminate with a conical distal tip that is angled toward a relatively smaller distal end. This conical distal tip functions as a dilator, thereby allowing the instrument to be easily introduced and passed through tissue structures, including arterial or venous incisions. The conical distal tip may incorporate one or more lumens, either at the tip or along the side, for the passage of a guidewire, as desired.

[0009] The deployment section may include a support structure that extends from the proximal catheter section along two opposing members, forming a receiving region between the two opposing members. The support structure may be configured to extend linearly from the proximal catheter section, or it may include a curved or arc-shaped portion that curves the structure at an angle 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 section with a living hinge or other flexibility. The receiving region formed by the two opposing members of the support structure is configured to accommodate a receiving member that can rotate from a low-profile transport configuration to a deployed configuration. The receiving member may form two or more needle receiving openings for receiving the puncture tip of a needle deployed from a corresponding opening along the distal portion of the proximal catheter section.

[0010] Once the deployment section is properly positioned relative to the vascular opening to be closed, the first actuation mechanism is activated. The rotation of the receiving member can reposition the first receiving portion of the receiving member to receive one or more distally extending anterior tactile members that have advanced distally from the opening, and further reposition the second receiving portion of the receiving member to the second opposing side of the support structure to receive one or more distally extending posterior tactile members that have advanced distally from the opening along the second opposing side of the proximal catheter section. The operation of the second actuation mechanism may facilitate the distal advance of the needle member from the proximal catheter section.

[0011] These needle members (one or more anterior guide members and one or more posterior guide members) may be configured to advance one or more suture loops from the inner diameter or inner wall of the vessel, through the vessel wall, and out of the vessel, between each pair of needle members. In the case of two or more suture loops, the loops may be parallel along the inside of the vessel and intersect on the outside, or in yet another embodiment, the suture loops may intersect both inside and outside the vessel. As a result, the suture ends are stretched or tensioned at a position away from the puncture site (e.g., from outside the patient's body) to bring the tissue edges of the puncture site closer together without the need for a knot, and another instrument may be used to deploy a fixation device such as a cinch, ferrule, or clip, as will be described in more detail herein.

[0012] Because the proximal catheter segment forms an angle with respect to the tissue wall or vascular axis of the puncture site after insertion, the outer circumference of the instrument transition area becomes more elliptical or oblong relative to the tissue wall. The outer circumference indicates the region of the proximal catheter segment that forms an angle with respect to the tissue wall of the puncture site. As the width of the outer circumference along the longitudinal direction of the blood vessel decreases, the external shape and outer circumference of the instrument may expand in the transverse direction.

[0013] Because the protruding outer circumference forms an ellipse or oval shape, both edges of the puncture site can be relatively close to the outer surface of the angled proximal catheter section, and the ellipse or oval outer circumference may therefore be used in the catheter section to facilitate closure of the puncture site.

[0014] This instrument can be used near tissue openings such as arterial or venous incisions. Therefore, two or more separate sutures of different lengths can be pre-loaded into the instrument and used with a needle to deliver the sutures through the blood vessel wall, bringing the tissue edges closer together for hemostasis. This is possible without using pre-tied knots. Depending on the length of the sutures, they can be stored and deployed within the tissue using various methods of suture management.

[0015] In one embodiment, the suture may be pre-loaded in a lumen or space formed within the length of the proximal catheter section; in another embodiment, the suture may be pre-loaded in a lumen or space formed within the length of the distal catheter section. In yet another embodiment, the length of the suture may be contained within the proximal catheter section and then return distally through a lumen in the distal catheter section.

[0016] In one embodiment, the length of the suture is protected from tissue exposure during insertion of the instrument into the proximal or distal catheter compartment, and can be further protected by using a sliding sleeve, sheath, or other means. The sliding sleeve may incorporate a proximal interface member larger than the skin opening and can be used to improve hemostasis within and around the proximal catheter compartment.

[0017] In one embodiment, the length of the suture may be spread within the tissue to form a cross-stitch pattern below or above the puncture site along the blood vessel. In another embodiment, the length of the suture may be spread within the tissue to form a parallel suture pattern below or above the puncture site along the blood vessel.

[0018] As described herein, the tissue surrounding the puncture site may be oval or oval in shape to increase the penetration along the tissue between the needle member and the catheter casing. The puncture site may be formed by the instrument being at an angle to the blood vessel, but additional elements may be optionally incorporated to further increase or facilitate tissue reconstruction, especially for puncture sites that are particularly large relative to the transition diameter of the instrument.

[0019] To move the edges of the puncture sites along the sides of the instrument away from each other, so that both edges of the anterior and posterior puncture sites along the blood vessel are biased toward each other, one or more lateral expansion elements may be configured to extend from outside the proximal catheter section and / or distal catheter section and / or support structure. These lateral expansion elements may be configured to expand when actuated, for example, by a mechanism located on the handle.

[0020] As described herein, the instrument can be sized and used to position a suture loop for proximity to tissue openings such as arterial or venous incisions, without the need to place sutures before dilation of the opening with a prosthetic sheath or guide catheter, a technique commonly referred to as a “pre-close” procedure.

[0021] As described herein, a second instrument for suture capture and fixation may be used to fix the ends of each suture length after they have been deployed and transported through the tissue site to be closed for hemostasis following the use of the instrument described above.

[0022] A suture capture and fixation device according to one embodiment may include a handle having an operating mechanism for deploying or fixing an anchor to a captured suture. A slender shaft may extend from the handle and terminate at an opening at its distal end. The opening may partially penetrate the shaft and extend to a window formed along the side of the shaft adjacent to the distal end. A fixation anchor, such as a ferrule with a lumen, can be placed within the opening. A sliding element may be detachably arranged along the shaft or along the handle, and a wire may be coupled to the sliding element, extending along the device, passing through the window, through the fixation anchor, and distally through the opening, and the wire may form a snare loop that opens into an expansion loop.

[0023] During use, after the suture has been transported around the puncture site, the remaining suture ends can be passed through the snare loops. The sliding element is pulled proximal to the elongated shaft, thereby tensing the wire through the window and fixing anchor, causing the snare loop to tighten around the suture ends. When the sliding element is pulled further proximal, it contacts a tapering interface surface formed along the distal end of the handle, disengaging the sliding element from the shaft and moving away from the elongated shaft. As the snare loop is pulled further proximal to the fixing anchor and window, the suture ends caught in the loop are tensed as needed until they have completely passed through both the fixing anchor and the window.

[0024] While pressing the distal end of the shaft distally, tension can be applied proximal to the end of the suture while tightening the suture engaged through the tissue until the puncture site closes. By manipulating the length of such an instrument and suture, hemostasis can be evaluated before fixing the anchor member. Alternatively, a scale on the elongated shaft can be used to indicate the depth of the blood vessel to the user, corresponding to a scale on the suture transporter shaft. Once hemostasis and / or an appropriate depth have been evaluated, the fixing anchor is deformed, crimped, or otherwise tightened to fix the passing suture until the fixing anchor can no longer move. This deformation may be sufficient to simultaneously cut or terminate the end of the suture without requiring a separate cutting mechanism. Alternatively, with the fixing anchor crimped or tightened, the end of the suture can be simultaneously cut or trimmed by other means, and the shaft can be removed, leaving the fixed anchor with hemostasis achieved and the trimmed suture.

[0025] Since suture capture and fixation devices do not require knots or pre-tied knots, the fixation anchors that tighten the suture end and fix the tensioned suture to the tissue for hemostasis can include any number of deployable ferrules, clips, etc. A fixation anchor that can be deployed from the distal opening of the device shaft in a particular embodiment may include a ferrule, which can be sized in any number of configurations depending on the use case. The ferrule may also be sized to capture the suture end for complete closure, and such ferrule structures can be made from any number of materials, such as metal that can be deformed (e.g., compressed, crimped, etc.) on the suture, or polymer that can be heat-melted onto the suture for fixation. When the suture used is polymer, the ferrule partially melts together with part of the suture, providing a secure anchor.

[0026] The tissue closure device according to one aspect typically includes a deployment section coupled to a proximal catheter section, a distal catheter section pivotally coupled to the deployment section such that the distal catheter section is rotatable relative to the proximal catheter section, a receiving member disposed within the deployment section and having two or more openings along a first receiving portion and two or more openings along a second receiving portion, the receiving member being configurable between a thin form and a deployed form, two or more forward needle members that can extend distally from a first side of the proximal catheter section, and two or more rearward needle members that can extend distally from a second side of the proximal catheter section opposite the first side. The two or more forward needle members are receivable in the two or more openings along the first receiving portion when the receiving member is in the deployed form, and the two or more rearward needle members are receivable in the two or more openings along the second receiving portion.

[0027] The tissue closure method according to one aspect typically includes rotating the distal catheter section about the deployment section and advancing the distal catheter section through an opening and into the opening along the wall of a blood vessel such that the distal catheter section forms an angle with respect to the proximal catheter section; deploying the receiving member within the blood vessel from a thin form to a deployed form such that the first receiving portion and the second receiving portion contact the wall adjacent to the opening; extending two or more forward needle members distally from a first side of the proximal catheter section and extending two or more rearward needle members distally from a second side of the proximal catheter section opposite the first side, thereby causing each needle member to pierce the wall adjacent to the opening; receiving the two or more forward needle members in the two or more openings along the first receiving portion and receiving the two or more rearward needle members in the two or more openings along the second receiving portion.

[0028] A method for minimizing the risk of infection associated with tissue closure in one aspect typically involves the steps of: advancing a suture transport catheter along the wall of a blood vessel into the opening, through the opening, such that the distal catheter section rotates around the unfolded section and the distal catheter section forms an angle with respect to the proximal catheter section; unfolding the receiving member from a thin form to an unfolded form within the blood vessel so that the first receiving section and the second receiving section contact the wall adjacent to the opening; extending two or more anterior tactile members distally from the first side of the proximal catheter section and extending two or more posterior tactile members distally from the second side of the proximal catheter section opposite the first side, thereby causing each needle member to puncture the wall adjacent to the opening; and extending two or more anterior and posterior tactile members distally. The method includes the steps of receiving two or more front policy members into two or more openings along a first receiving portion and receiving two or more rear policy members into two or more openings along a second receiving portion, such that the front policy members are received into corresponding connecting members held in each of two or more openings along a first receiving portion and the two or more rear policy members are received into corresponding connecting members held in each of two or more openings along a second receiving portion; retracting the two or more front policy members from the first receiving portion and retracting the two or more rear policy members from the second receiving portion, such that the first suture length and the second suture length are retracted proximally through the wall adjacent to the opening; and fixing the first suture length and the second suture length with tissue fixation anchors that prevent movement of the respective suture lengths without using knots.

[0029] A suture anchor device according to one aspect typically includes a handle having one or more actuating mechanisms, a shaft attached to the handle, the shaft having a distal tip forming a distal opening, and a window along a side of the shaft such that the distal opening and the window communicate, a sliding element movably disposed on the shaft, a tissue fixation anchor disposed within the distal opening and forming an anchor lumen that communicates with the window, and a wire connected to the distal portion of the sliding element and extending through the window and through the anchor lumen, whereby the wire exits the distal opening to form a snare loop.

[0030] A method of anchoring a suture according to one aspect typically includes the steps of disposing one or more lengths of suture within a snare loop extending from a distal opening of a shaft, retracting a sliding element proximally along the shaft such that the snare loop is reduced and the one or more lengths of suture are pulled proximally into the distal opening, through an anchor lumen of a tissue fixation anchor disposed within the distal opening, and out through a window formed along a side of the shaft, applying tension to the one or more lengths of suture and disposing the distal opening of the shaft adjacent to a tissue opening along a blood vessel wall, and deforming the tissue fixation anchor such that the one or more lengths of suture are secured.

Brief Description of the Drawings

[0031] [Figure 1A] Figures 1A and 1B are perspective views showing an instrument according to one aspect for actuating needle deployment to deliver and / or capture a length of suture when closing an opening in tissue. [Figure 1B] Figures 1A and 1B are perspective views showing an instrument according to one aspect for actuating needle deployment to deliver and / or capture a length of suture when closing an opening in tissue. [Figure 2A] ​​ [Figure 2B] Figures 2A and 2B are perspective views showing in detail the first operating mechanism on the handle in a non-operated configuration and the corresponding unfolded section maintained in a low-profile transport configuration. [Figure 2C] Figures 2C and 2D show perspective views illustrating in detail the first operating mechanism on the handle in the operating configuration and the corresponding deployment section in the deployed configuration. [Figure 2D] Figures 2C and 2D show perspective views illustrating in detail the first operating mechanism on the handle in the operating configuration and the corresponding deployment section in the deployed configuration. [Figure 3A] Figures 3A to 3C are perspective views showing another embodiment of an instrument for operating a needle deployment to transport and / or capture the length of suture when closing an opening in tissue. [Figure 3B] Figures 3A to 3C are perspective views showing another embodiment of an instrument for operating a needle deployment to transport and / or capture the length of suture when closing an opening in tissue. [Figure 3C] Figures 3A to 3C are perspective views showing another embodiment of an instrument for operating a needle deployment to transport and / or capture the length of suture when closing an opening in tissue. [Figure 4A] Figures 4A to 4C are perspective views showing in detail the sheath assembly positioned juxtaposed with the proximal catheter section and deployment section, corresponding to Figures 3A to 3C. [Figure 4B] Figures 4A to 4C are perspective views showing in detail the sheath assembly positioned juxtaposed with the proximal catheter section and deployment section, corresponding to Figures 3A to 3C. [Figure 4C] Figures 4A to 4C are perspective views showing in detail the sheath assembly positioned juxtaposed with the proximal catheter section and deployment section, corresponding to Figures 3A to 3C. [Figure 5A] Figure 5A is a detailed perspective view showing the sheath member that has advanced distally, covering the unfolded section. [Figure 5B]Figures 5B and 5C show a side view and an end perspective view of the sheath member in an unrestrained configuration, such as when the sheath assembly is retracted over the proximal catheter section. [Figure 5C] Figures 5B and 5C show a side view and an end perspective view of the sheath member in an unrestrained configuration, such as when the sheath assembly is retracted over the proximal catheter section. [Figure 5D] Figures 5D and 5E show the constrained form of the sheath member when it is positioned above the unfolded section and conforms to the lower element. [Figure 5E] Figures 5D and 5E show the constrained form of the sheath member when it is positioned above the unfolded section and conforms to the lower element. [Figure 6A] Figure 6A is a detailed side view showing the receiving member unfolded into a thin form from within the support structure. [Figure 6B] Figure 6B is a side view showing in detail how the distal catheter section and the proximal catheter section are pivotably or rotatably connected and are positioned non-parallel to each other. [Figure 6C] Figure 6C is a detailed side view showing the deployed receiving members for the distal and proximal catheter sections when positioned within the vascular lumen. [Figure 7] Figure 7 is a perspective view showing in detail one embodiment in which a flexible connector can connect the distal end of a support structure to the proximal end of a distal catheter section. [Figure 8A] Figure 8A is a perspective view showing in detail the instrument transition area, which is elliptical or oblong relative to the tissue wall. [Figure 8B] Figure 8B is a detailed perspective view showing the proximal catheter segment that forms an angle with respect to the tissue wall at the puncture site after insertion and placement. [Figure 9A] Figures 9A and 9B are perspective and side views, respectively, showing in detail the unextended bearing members within the bearing area of ​​the support structure. [Figure 9B]Figures 9A and 9B are perspective and side views, respectively, showing in detail the unextended bearing members within the bearing area of ​​the support structure. [Figure 10A] Figures 10A and 10B are perspective views showing in detail the state in which the receiving member is rotated, stretched proximal, and unfolded to form an angle. [Figure 10B] Figures 10A and 10B are perspective views showing in detail the state in which the receiving member is rotated, stretched proximal, and unfolded to form an angle. [Figure 11A] Figures 11A and 11B are side and side cross-sectional views, respectively, showing in detail two front guide members and two rear guide members advanced distally from the opening until their distal ends were received within the corresponding openings in the receiving member. [Figure 11B] Figures 11A and 11B are side and side cross-sectional views, respectively, showing in detail two front guide members and two rear guide members advanced distally from the opening until their distal ends were received within the corresponding openings in the receiving member. [Figure 11C] Figure 11C is a perspective view showing the needle member from Figures 11A and 11B. [Figure 12A] Figures 12A and 12B are a side view and a cross-sectional side view, respectively, illustrating in detail one embodiment of a method in which the length of the suture is pre-loaded within the proximal catheter section of the device. [Figure 12B] Figures 12A and 12B are a side view and a cross-sectional side view, respectively, illustrating in detail one embodiment of a method in which the length of the suture is pre-loaded within the proximal catheter section of the device. [Figure 13] Figure 13 is a side view detailing another embodiment of a method in which the length of the suture can be pre-loaded into the distal catheter section of the device. [Figure 14] Figure 14 is a side view detailing another embodiment of a method in which the length of the suture can be pre-loaded into the proximal and distal catheter sections of the device. [Figure 15]Figure 15 is a side view detailing another embodiment of a method in which the length of the suture thread may be pre-loaded within the proximal catheter section of the device and further arranged to form a cross-stitch pattern. [Figure 16A] Figures 16A and 16B show a detailed perspective top and bottom view of a deployment section having a sheath assembly located distally, where the sheath member covers at least part or all of the deployment section. [Figure 16B] Figures 16A and 16B show a detailed perspective top and bottom view of a deployment section having a sheath assembly located distally, where the sheath member covers at least part or all of the deployment section. [Figure 17A] Figures 17A and 17B are perspective top and bottom views, respectively, showing the deployment section in detail when it is in the proximal position where the sheath assembly is stored and the deployment section is exposed. [Figure 17B] Figures 17A and 17B are perspective top and bottom views, respectively, showing the deployment section in detail when it is in the proximal position where the sheath assembly is stored and the deployment section is exposed. [Figure 18A] Figure 18A shows a suture channel to illustrate that the length of the suture is located outside the instrument. [Figure 18B] Figure 18B shows how the length of the suture thread passes through the inside of the instrument. [Figure 18C] Figures 18C and 18D show one aspect of the routing of suture length within the distal catheter section. [Figure 18D] Figures 18C and 18D show one aspect of the routing of suture length within the distal catheter section. [Figure 18E] Figure 18E shows how the length of the suture can be positioned within the length of the lumen or space formed within the distal catheter compartment. [Figure 19A]Figures 19A and 19B are front and rear perspective views illustrating another embodiment of how the length of the suture thread may be routed outside the first and second receiving portions. [Figure 19B] Figures 19A and 19B are front and rear perspective views illustrating another embodiment of how the length of the suture thread may be routed outside the first and second receiving portions. [Figure 20A] Figure 20A is a top view showing the resulting cross-stitch pattern that may occur beneath the puncture site along a blood vessel. [Figure 20B] Figure 20B is a top view showing the resulting parallel suture pattern that may occur below the puncture site along the blood vessel. [Figure 20C] Figure 20C illustrates yet another aspect in which a typical circular opening puncture site in a blood vessel wall is compared to an elliptical or oblong opening formed by the angle of the proximal catheter segment with respect to the tissue surface. [Figure 21A] Figure 21A shows an example of the length of a suture with a connecting member attached to each end of the suture length. [Figure 21B] Figure 21B shows an example of how a portion of the suture length is held in place, sometimes loosely, and sometimes by tension within the instrument. [Figure 22A] Figures 22A and 22B are a side view and a side cross-sectional view showing one embodiment in which the end of a suture can be connected to a connecting member via one or more finger portions or extension members. [Figure 22B] Figures 22A and 22B are a side view and a side cross-sectional view showing one embodiment in which the end of a suture can be connected to a connecting member via one or more finger portions or extension members. [Figure 23A] Figures 23A and 23B are a side view and a side cross-sectional view showing yet another embodiment in which a portion extending from the main body section, which tapers towards the tip, can form a fixing engagement portion with the end of the suture thread. [Figure 23B]Figures 23A and 23B are a side view and a side cross-sectional view showing yet another embodiment in which a portion extending from the main body section, which tapers towards the tip, can form a fixing engagement portion with the end of the suture thread. [Figure 24A] Figures 24A and 24B are a side view and a side cross-sectional view showing yet another embodiment in which a body tapering to a tip, formed separately from the main body section, can similarly be fixed to the suture end and attached to the main body section. [Figure 24B] Figures 24A and 24B are a side view and a side cross-sectional view showing yet another embodiment in which a body tapering to a tip, formed separately from the main body section, can similarly be fixed to the suture end and attached to the main body section. [Figure 25A] Figures 25A and 25B are side views showing one embodiment of a suture end that may be configured to have a widened portion. [Figure 25B] Figures 25A and 25B are side views showing one embodiment of a suture end that may be configured to have a widened portion. [Figure 26A] Figures 26A and 26B are perspective views illustrating connecting members that illustrate how a body that tapers towards the tip is attached to a body section via one or more weld points. [Figure 26B] Figures 26A and 26B are perspective views illustrating connecting members that illustrate how a body that tapers towards the tip is attached to a body section via one or more weld points. [Figure 27A] Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment from a proximal-routed instrument position. [Figure 27B] Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment from a proximal-routed instrument position. [Figure 27C] Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment from a proximal-routed instrument position. [Figure 27D]Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment from a proximal-routed instrument position. [Figure 27E] Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment from a proximal-routed instrument position. [Figure 28] Figure 28 is a detailed perspective view of a proximal catheter section having an opening through which a suture can pass into the suture lumen or space. [Figure 29A] Figures 29A and 29B are perspective and end views showing a suture lumen element that includes an elastomer element capable of applying compressive force or friction to a perforated and routed suture. [Figure 29B] Figures 29A and 29B are perspective and end views showing a suture lumen element that includes an elastomer element capable of applying compressive force or friction to a perforated and routed suture. [Figure 29C] Figure 29C is a perspective view detailing a suture lumen that can be terminated to open into a larger space where the remaining length of the suture can be accommodated, and an appropriately sized elastomer tube for gripping the suture in its loaded form. [Figure 30A] Figures 30A and 30B are a top view and a top cross view, respectively, showing a distal catheter section in another embodiment having one or more friction-inducing elements incorporated along the section to provide friction grip or resistance to the suture. [Figure 30B] Figures 30A and 30B are a top view and a top cross view, respectively, showing a distal catheter section in another embodiment having one or more friction-inducing elements incorporated along the section to provide friction grip or resistance to the suture. [Figure 31A] Figures 31A to 31C show various cross-sectional shapes of tension-applying members. [Figure 31B] Figures 31A to 31C show various cross-sectional shapes of tension-applying members. [Figure 31C] Figures 31A to 31C show various cross-sectional shapes of tension-applying members. [Figure 32A] Figures 32A and 32B are schematic side and perspective views, respectively, detailing another embodiment of a suture tensioning mechanism positioned within the distal catheter section to remove suture slack. [Figure 32B] Figures 32A and 32B are schematic side and perspective views, respectively, detailing another embodiment of a suture tensioning mechanism positioned within the distal catheter section to remove suture slack. [Figure 32C] Figure 32C is a schematic side view illustrating yet another embodiment in which the flanged body may instead incorporate one or more elastomer support members configured to apply tension to sutures wound in a loop around the support column. [Figure 33A] Figure 33A schematically shows an example in which a pressing / tensioning member can incorporate an extension member attached along the pressing / tensioning member. [Figure 33B] Figures 33B to 33D show the configuration of the expansion arms, which are positioned on opposite sides along the distal end of the proximal catheter section. [Figure 33C] Figures 33B to 33D show the configuration of the expansion arms, which are positioned on opposite sides along the distal end of the proximal catheter section. [Figure 33D] Figures 33B to 33D show the configuration of the expansion arms, which are positioned on opposite sides along the distal end of the proximal catheter section. [Figure 34A] Figures 34A and 34B are side views showing in detail another embodiment of the device having a proximal catheter section and a distal catheter section connected to each other via a flexible section. [Figure 34B] Figures 34A and 34B are side views showing in detail another embodiment of the device having a proximal catheter section and a distal catheter section connected to each other via a flexible section. [Figure 35A] Figures 35A to 35D are side and perspective views showing yet another embodiment of the device in which the distal catheter section is omitted and replaced with a central shaft. [Figure 35B] Figures 35A to 35D are side and perspective views showing yet another embodiment of the device in which the distal catheter section is omitted and replaced with a central shaft. [Figure 35C] Figures 35A to 35D are side and perspective views showing yet another embodiment of the device in which the distal catheter section is omitted and replaced with a central shaft. [Figure 35D] Figures 35A to 35D are side and perspective views showing yet another embodiment of the device in which the distal catheter section is omitted and replaced with a central shaft. [Figure 36A] Figures 36A and 36B are perspective views showing a further different embodiment of the fixture incorporating a central shaft having a lamp section. [Figure 36B] Figures 36A and 36B are perspective views showing a further different embodiment of the fixture incorporating a central shaft having a lamp section. [Figure 37A] Figures 37A and 37B are perspective views showing the second receiving section corresponding to Figures 36A and 36B. [Figure 37B] Figures 37A and 37B are perspective views showing the second receiving section corresponding to Figures 36A and 36B. [Figure 38A] Figures 38A and 38B are perspective views showing a device in yet another embodiment that incorporates a dual bearing element that acts or rotates via a ratchet mechanism such as a rack and pinion mechanism. [Figure 38B] Figures 38A and 38B are perspective views showing a device in yet another embodiment that incorporates a dual bearing element that acts or rotates via a ratchet mechanism such as a rack and pinion mechanism. [Figure 39A] Figure 39A shows a suture capture and fixation device according to one embodiment. [Figure 39B] Figure 39B shows a suture capture and fixation device in a different embodiment. [Figure 40A] Figures 40A to 40C are perspective views showing in detail the suture ends engaged by the suture exchange snare loop. [Figure 40B] Figures 40A to 40C are perspective views showing in detail the suture ends engaged by the suture exchange snare loop. [Figure 40C] Figures 40A to 40C are perspective views showing in detail the suture ends engaged by the suture exchange snare loop. [Figure 41A] Figures 41A to 41C are perspective views showing in detail the fixation and trimming of suture ends. [Figure 41B] Figures 41A to 41C are perspective views showing in detail the fixation and trimming of suture ends. [Figure 41C] Figures 41A to 41C are perspective views showing in detail the fixation and trimming of suture ends. [Figure 42A] Figures 42A and 42B are perspective and side views, respectively, showing the suture replacement snare sliding element in detail. [Figure 42B] Figures 42A and 42B are perspective and side views, respectively, showing the suture replacement snare sliding element in detail. [Figure 43A] Figure 43A is a side view showing the proximal catheter division in one configuration in which a scale is incorporated along the outer surface. [Figure 43B] Figures 43B and 43C are side views showing a shaft of another embodiment of a suture capture and fixation device with a scale incorporated along its outer surface. [Figure 43C] Figures 43B and 43C are side views showing a shaft of another embodiment of a suture capture and fixation device with a scale incorporated along its outer surface. [Figure 44] Figure 44 is a perspective view showing a shaft in one configuration with a scale incorporated into it. [Figure 45A] Figures 45A to 45D are perspective views showing the shaft and internal mechanism in detail, with the outer wall of the shaft removed for clarity. [Figure 45B] Figures 45A to 45D are perspective views showing the shaft and internal mechanism in detail, with the outer wall of the shaft removed for clarity. [Figure 45C]Figures 45A to 45D are perspective views showing the shaft and internal mechanism in detail, with the outer wall of the shaft removed for clarity. [Figure 45D] Figures 45A to 45D are perspective views showing the shaft and internal mechanism in detail, with the outer wall of the shaft removed for clarity. [Figure 46A] Figures 46A and 46B are different perspective views showing the base and the sliding blade element. [Figure 46B] Figures 46A and 46B are different perspective views showing the base and the sliding blade element. [Figure 47A] Figures 47A to 47E are perspective views showing ferrules in various embodiments. [Figure 47B] Figures 47A to 47E are perspective views showing ferrules in various embodiments. [Figure 47C] Figures 47A to 47E are perspective views showing ferrules in various embodiments. [Figure 47D] Figures 47A to 47E are perspective views showing ferrules in various embodiments. [Figure 47E] Figures 47A to 47E are perspective views showing ferrules in various embodiments. [Figure 48] Figure 48 is a side cross-sectional view showing a ferrule incorporating a releasable plug member. [Figure 49A] Figures 49A and 49B are perspective and cross-sectional views, respectively, of a ferrule in another embodiment incorporating a plug member. [Figure 49B] Figures 49A and 49B are perspective and cross-sectional views, respectively, of a ferrule in another embodiment incorporating a plug member. [Figure 50] Figure 50 is a side perspective cross-sectional view showing a ferrule incorporating a plug member according to one embodiment. [Modes for carrying out the invention]

[0032] A device configured to close an opening in a tissue wall, such as an arterial or venous incision along a blood vessel wall, may include a slender catheter having a distal catheter section and a proximal catheter section configured to move or rotate relative to one another. Either the distal catheter section or / or the proximal catheter section can be used to deploy multiple retractable needles that can be used to capture and / or tighten a length of suture for closing the arterial or venous incision.

[0033] The perspective views of Figures 1A and 1B show one embodiment of such an instrument, which illustrates an example for activating needle deployment to deliver and / or capture the length of suture. Figure 1A shows an instrument 10 having a handle 12 configured to be held by a practitioner (e.g., with one hand). A first actuation mechanism 14, such as a lever, sliding part, or other mechanism, may be incorporated along the handle 12 to deploy a receiving member for receiving a needle member for insertion through the tissue site to be closed. A second actuation mechanism 16, such as a plunger 16 or other mechanism, may also be incorporated along the handle 12 to push or actuate the movement of the needle member from the proximal catheter section 20 into the tissue, and to pull or tension the suture through the tissue via the instrument handle 12. An indicator 18, such as an opening lumen 18 or other flush indicator, may also be incorporated into the handle 12, in which case the opening lumen 18 can be fluidly connected through a lumen formed through the instrument and the proximal catheter section 20 to receive a predetermined amount of blood, which can serve as an indicator to confirm that the instrument has been properly introduced and positioned within the blood vessel to be closed. Furthermore, to inform the user of the depth below the skin surface where the blood vessel is located, marked scales 28 may be provided along the proximal catheter section 20, the distal catheter section 22, and / or both sections 20, 22, as shown in the figure, which can be useful when tightening or securing sutures. The scales 28 may be indicated as a distance to the receiving member. Once positioned within the blood vessel, the receiving member is already positioned within the blood vessel along the tissue wall adjacent to the opening, and therefore the scales 28 are marked to indicate the depth of the blood vessel from the skin surface.

[0034] The proximal catheter section 20 may extend distally from the handle 12 and may be connected to the distal catheter section 22 via the deployment section 24. This distal catheter section 22 may extend further distally, and at its tip the instrument may terminate with a conical distal tip 26 that is angled toward a relatively smaller distal end. This conical distal tip 26 functions as a dilator, thereby allowing the instrument to be easily introduced and passed through tissue, arterial incision, or venotomy. The conical distal tip 26 may incorporate one or more lumens for the passage of a guidewire, as desired, either at the tip or along the side.

[0035] Figure 1B illustrates the device in which the first actuation mechanism 14 is pulled or otherwise actuated, the second actuation mechanism 16 advances or is pushed relative to the handle 12 to deploy the needle, and the rotating receiving platform is positioned along the deployment section 24.

[0036] Deployment of the receiving section and needle

[0037] Figure 2A is a detail view showing a first actuation mechanism 14 on the handle 12 in a non-actuated state, and Figure 2B illustrates an embodiment in which the deployment section 24 is held in a low-profile transport configuration. The deployment section 24 may include a support structure 30 extending from the proximal catheter section 20 along two opposing members, forming a receiving region 32 between the two opposing members. The support structure 30 may be configured to extend linearly from the proximal catheter section 20, as further described herein, or may include a curved or arc-shaped portion that curves the structure 30 at an angle to the proximal catheter section 20. The distal catheter section 22 may extend from the support structure 30 via a hinged, pivotal, or flexible mounting portion 34, thereby allowing the distal catheter section 22 to easily rotate about a predetermined rotation angle relative to the proximal catheter section 20. The receiving region 32, formed by two opposing members of the support structure 30, is sized to receive a receiving member 36 that can rotate from a thin transport configuration as shown in Figure 2B to a deployed configuration as described below. The distal portion 36 of the receiving member may form two or more needle receiving openings 38 for receiving the distal puncture tip of a needle deployed from a corresponding opening 40 along the distal portion of the proximal catheter section 20.

[0038] Once the deployment section 24 is properly positioned relative to the vascular opening to be closed, the first operating mechanism 14 is activated, as shown in the example in Figure 2C, and tension is applied so that the mechanism 14 rotates around the handle 12, thereby reconfiguring the receiving member 36 from a thin transport configuration to a deployed configuration in which the receiving member 36 rotates at an angle to the support structure 30 between two opposing members. The rotation of the receiving member 36 may cause the first receiving portion 36' of the receiving member to be repositioned and receive two distally extending anterior guidance members 42A and 42B that advance distally from the opening 40. Furthermore, rotation of the receiving member 36 may cause the second receiving portion 36" of the receiving member to be repositioned to the second side opposite the support structure 30, and may receive two posterior tactile members (not shown in this figure) extending distally along the second side opposite the proximal catheter section 20, which advance distally from the opening. Activation of the second actuation mechanism 16 may cause the needle member to advance from the proximal catheter section 20 to the distal end of the needle member within the receiving position 36 of the receiving member, as shown.

[0039] In this embodiment, the instrument 10 is shown to have a total of four needle members: two anterior tactile members deployable along a first lateral portion of the proximal catheter section 20, and two posterior tactile members deployable along a second lateral portion of the proximal catheter section 20 opposite to the first lateral portion. These four needle members may be configured to advance two suture loops between two needle members (e.g., between two adjacent needle members along the first lateral portion, between two opposing needle members between the first and second lateral portions, and / or between two opposing needle members forming an intersecting or angled configuration). As a result, the suture ends are pulled or tensioned proximal to a position spaced away from the puncture site (e.g., from outside the patient's body) to easily bring both edges of the puncture site tissue closer together without the need for knots, and another instrument may be used to deploy a fixation device such as a cinch, ferrule, or clip, as will be described in more detail herein.

[0040] In other embodiments, an instrument can be used that has two or more needle members on either one or both sides of the instrument 10. Alternatively, in other embodiments, an instrument may have more needle members on one side than on the opposite second side, depending on the desired closure of the tissue opening.

[0041] By using two suture loops, both edges of the tissue are brought closer together by the loops, improving overall hemostasis and potentially improving the clinical outcome of the closure site. Furthermore, the instrument 10 can be sized to accommodate various tissue puncture diameters to achieve tissue closure, and / or instruments of various sizes can be provided to close different tissue puncture diameters. For example, a first-size instrument may be provided to close puncture diameters in the range of, for example, 10 to 18 Fr, and a relatively larger second-size instrument may be provided to close puncture diameters in the range of, for example, 18 to 30 Fr. Thus, the diameter of the distal catheter section may be in the range of 14 to 24 Fr, for example, 20 Fr, while the diameter of the proximal catheter section may be in the range of, for example, 10 to 30 Fr.

[0042] Figures 3A to 3C show perspective views of the device 11 in a different embodiment, which is similar to the one described above but includes an unfolding section 25 configured to be continuous and flexible along its length. This unfolding section 25 allows the distal catheter section 22 to bend and flex relative to the proximal catheter section 20 during intravascular insertion without requiring a separate hinged or pivot mechanism.

[0043] In addition, the sheath assembly 27 may be slidably positioned along the proximal catheter section 20, as shown in the figure, and the sheath assembly 27 may have a sheath member 29 and a proximal interface member 31 attached to the proximal part of the sheath member 29. As shown in Figure 3A, the sheath member 29 may have a thin minimum thickness that allows it to slide over the length of the deployment section 25 and the suture during insertion and transport into the patient's body, thereby protecting the suture by preventing it from falling out and preventing contact with skin and tissue, thereby preventing an increased risk of infection. The sheath member 29 may also have a smooth, thin outer surface so as to ensure that the leading edge of the sheath member 29 does not obstruct and so that the deployment section 25 and the suture can be introduced into the blood vessel without damaging the surrounding tissue.

[0044] The proximal interface member 31 may be provided as an attachment at the proximal end of the sheath member 29 and may be configured to facilitate the retraction or advancement of the sheath member 29, as shown in Figure 3B. This retraction or advancement may be performed by the user, for example, using two or more fingers of one hand, or the sheath member 29 may be retracted by the surrounding tissue as the sheath member 29 contacts a tissue surface and the instrument 11 advances further into the blood vessel. Thus, the sheath member 29 may have a length large enough to cover the deployment section 25 but shorter than the length of the proximal catheter section 20. The inner diameter of the sheath member 29 may be equal to or approximate the circumference of the proximal catheter section 20, for example, 10 to 30 Fr or 20 Fr in one embodiment. The sheath member 29 may be thermoformed to obtain a curved outer shape, and / or the sheath member 29 may be formed linearly and reshaped by sliding along the proximal catheter section 20 and the deployment section 25. The proximal interface member 31 may also be formed to exhibit a curved or arc-shaped interface surface along its distal side for non-traumatic contact with tissue. The proximal interface member 31 may also be set to a size larger than the skin opening and may be angled or otherwise shaped, such as spherical, so that it can be used to compress and improve hemostasis in and around the proximal catheter section 20. The lower surface of the angled or shaped proximal interface member may also be constructed of felt, cotton thread, or other similar means to improve hemostatic performance.

[0045] Once the instrument 11 is introduced into the blood vessel, positioned in the desired location, and the sheath assembly 27 is properly retracted, the first actuation mechanism 14, which is incorporated along the handle 12, can be activated to deploy the receiving member 36, as shown in Figure 3C.

[0046] Figures 4A to 4C are perspective views showing in detail the sheath assembly 27 positioned juxtaposed with the proximal catheter section 20 and the deployment section 25, corresponding to Figures 3A to 3C described above. As shown in Figure 4A, the sheath member 29 may be positioned so as to cover the entire deployment section 25. As shown in Figure 4B, once the sheath assembly 27 is retracted proximal along the proximal catheter section 20, the entire deployment section 25 may be exposed by the sheath member 29. The sheath assembly 27 can be retracted proximal until the proximal interface member 31 abuts against the handle 12. The receiving member 36 may also be exposed for deployment, as described herein and shown in Figure 4C.

[0047] As shown in the detailed perspective view of Figure 5A, the deployment section 25 is shown with the sheath member 29 advanced distally over the deployment section 25. The leading edge of the sheath member 29 may be positioned immediately distal to the deployment section 25 to guide a transition of, for example, about 0.10 to 0.16 cm, in order to protect the suture from the distal end of the device to the deployment position attached within the receiving member 36 without adversely affecting the flexibility of the deployment section 25. Alternatively, the sheath member 29 may be fully extended over the entire length of the exposed suture, thereby partially extending over the distal catheter section 22. In this position, the sheath member 29 can completely cover the suture beneath it and protect it from external contact (such as contact with the skin surface) before being retracted.

[0048] Figures 5B to 5E are a side perspective view and a front view showing the sheath assembly 27 removed from the instrument 11. Figures 5B and 5C illustrate the sheath member 29 in an unrestrained configuration, such as when the sheath assembly 27 is pulled back onto the proximal catheter section 20. Figures 5D and 5E show the restraint configuration of the sheath member 29 when it is positioned above the deployment section 25, conforming to the shape of the underlying layer and enclosing the receiving member 36 and the undeployed suture.

[0049] Figure 6A is a side view showing in detail how the receiving member 36 unfolds from its thin form inside the support structure 30. As the receiving member 36 rotates, the first receiving portion 36' may rotate upward and away from the support structure, and the second receiving portion 36" may rotate downward and away from the support structure, until the first opening 38' formed along the first receiving portion 36' aligns to receive the needle member that has advanced distally from the first opening 40 along the first side of the proximal catheter section 20, and the second opening 38" formed along the second receiving portion 36" aligns to receive the needle member that has advanced distally from the second opening 52 along the second side of the proximal catheter section 20.

[0050] As described above, the support structure extends linearly distally from the proximal catheter section 20 along the proximal support structure 30', and may be curved or arc-shaped at the intermediate section 50, so that the distal portion of the support structure 30'' extends at a curved angle with respect to the proximal catheter section 20, so that the hinged or pivotable mounting section 34 is out of plane with respect to the proximal support structure 30' and the proximal catheter section 20. The distal catheter section 22 is pivotably or rotatably connected to the hinged or pivotable mounting section 34, so that the distal catheter section 22 is linear, the distal catheter section 22 and the proximal catheter section 20 are not collinear with each other, as shown in Figure 6B, but instead are spaced apart from each other. They can extend parallel to each other. This misalignment between the longitudinal axis 54 of the proximal catheter section 20 and the longitudinal axis 64 of the distal catheter section 22 helps to accommodate the receiving member 36 and also helps to bend when the distal catheter section 22 is first introduced into the blood vessel and then directed again into the vascular lumen, thereby minimizing damage to the tissue wall by reducing the force applied to the tissue while the catheter is introduced and advanced from the puncture site. In addition and / or alternatively, parts of the instrument 10, such as the distal catheter section 22, the deployment section 24, and / or the proximal catheter section 20, may be optionally treated for lubrication, for example, with a hydrophilic coating or other lubricating additive(s).

[0051] The hinged or pivoted mounting section 34 allows the distal catheter section 22 to be easily bent for vascular introduction, and the hinged or pivoted mounting section 34 allows the distal catheter section 22 to rotate within a predetermined range of motion. The distal catheter section 22 may rotate around the hinged or pivoted mounting section 34 with respect to the longitudinal axis 54 of the proximal catheter section 20. For example, the distal catheter section 22 may rotate up to +55 degrees at a positive angle 60, or up to -10 degrees at a negative angle 62. The range of motion can be varied by increasing or decreasing both or one of the angles to allow for flexibility in use without compromising the integrity and / or usability of the instrument. In other embodiments, the support structure may be formed as a structure with continuous flexibility, such as a living hinge or other flexible section.

[0052] As the distal catheter section 22 is advanced into the blood vessel through the puncture site, the rigidity of the components and their columnar strength may help to push the distal catheter section 22 into the blood vessel, and the offset axis may also help to gently press the distal catheter section 22 against the inner wall of the blood vessel. Once positioned in place, the distal catheter section 22 can be rotated at an angle of 66 degrees, for example, around 45 degrees, relative to the proximal catheter section 20, as shown in the side view of Figure 6C. To maintain the connection between the proximal catheter section 20 and the distal catheter section 22, an internal flexible spinous projection or connecting element may extend between the two sections through the support structure 30.

[0053] As shown in the figure, when the receiving member 36 is deployed from its thin form to its deployed form inside the blood vessel, the receiving member 36 may be ready to receive the needle member. However, the height of the deployed instrument can be adjusted to ensure sufficient space inside the blood vessel. The height is expressed as the distance between the plane 68 (indicating the upper end of the receiving member 36 when it is in contact with the inner wall of the blood vessel) and the plane 70 (indicating the base of the distal catheter section 22 which forms an angle). Various elements can be adjusted accordingly, for example, by the length of the support structure 30, the deployment angle between the proximal catheter section 20 and the distal catheter section 22, and by changing the shape of the bottom of the interface of the distal catheter section 22, chamfering, contouring, trimming, etc. Therefore, the height can be any range between 5 and 20 mm, for example, depending on various factors such as the size of the instrument 10, the size of the puncture site, and the size of the blood vessel to be closed (i.e., the inner diameter).

[0054] As described herein, the connection between the proximal catheter section 20 and the distal catheter section 22 may be joined to each other via a hinged or pivot mechanism, but in other embodiments, the connection may be achieved by a flexible structure that does not need to be bent or curved by a hinged or pivot mechanism, but instead may be bent or curved via a flexible joint. Figure 7 is a perspective view detailing one embodiment in which a flexible connector 72 can connect the distal end of a support structure 30 to the proximal end of the distal catheter section 22. The flexible connector 72 may be formed of an elastic member, which allows either end to bend or flex while maintaining a continuous structure, such as when the distal catheter section 22 is angled away from the vessel wall to move further distally within the vessel without applying excessive force to the vessel.

[0055] In one embodiment, the flexible connector 72 may be formed of an elastomer polymer formed to extend from the distal end of the support structure 30. Mounting elements 74, such as struts, shoulders, and projections, are formed to protrude from the distal end of the support structure 30 and can serve as mounting points that reinforce the connection between the support structure 30 and the flexible connector 72. Furthermore, a rigidity-granting member 76 can be incorporated, which can extend at least partially into the flexible connector 72 or throughout the entire flexible connector 72, thereby increasing the rigidity of the connection and allowing for more material connection between the flexible connector 72 and the support structure 30. In one embodiment, the rigidity-granting member 76 may be integrally provided with the support structure 30 so as to extend distally from the support structure 30 over which the flexible connector 72 may be formed. In other embodiments, the rigidity-granting member 76 can be incorporated as a separate component from the support structure 30, but it can be attached to the support structure 30 by insertion, overmolding, bonding, mechanical fasteners, etc.

[0056] In either case, the rigidity-imparting member 76 may be formed to have a continuous, smooth surface, or it may be formed to have a plurality of protrusions or elements. In other embodiments, the rigidity-imparting member 76 may be formed to have a plurality of through-holes that function to reduce the rigidity of the member 76, and further, the material of the connector 72 may be allowed to flow into the through-holes during manufacturing to facilitate secure attachment between the flexible connector 72 and the support structure 30. The rigidity-imparting member 76 may be formed to have a flat, ribbon-like outer shape, thereby allowing directional bending and deflection in a first plane (e.g., vertical direction) between the proximal catheter section 20 and the distal catheter section 22, while resisting deflection in a transverse plane (e.g., left-right direction), and maintaining the pushability and conformability of the distal catheter section 22 into the patient's body.

[0057] As shown in the detailed perspective view of Figure 8B, the proximal catheter section 20 forms an angle 66 with respect to the tissue wall of the puncture site after insertion. Therefore, as shown in the detailed perspective view of Figure 8A, the outer circumference 80 of the instrument transition area forms a more elliptical or oblong shape with respect to the tissue wall. The outer circumference 80 indicates the region of the proximal catheter section 20 that forms an angle with respect to the tissue wall of the puncture site. By reducing the width of the outer circumference 80 along the longitudinal direction of the blood vessel, the external shape of the instrument and the outer circumference 80 can be expanded in the transverse direction. Thus, for example, in the case of an instrument external shape with a circumference equivalent to 20 Fr, the outer circumference 80 is substantially wider than, for example, 3 mm in the transverse direction (extending transversely with respect to the length of the blood vessel) and smaller than, for example, 3 mm in the longitudinal direction along the length of the blood vessel.

[0058] Because the protruding outer circumference 80 forms an ellipse or oval shape, both edges of the puncture site can be relatively close to the outer surface of the proximal catheter section 20, which forms an angle, and the ellipse or oval outer circumference 80 may therefore be used to allow the catheter section to be easily closed to the puncture site. This also makes it possible to make the receiving member 36 smaller, and furthermore, it is possible to use this instrument in relatively small blood vessels. For example, the distance between the center of each deployed needle member 42A, 42B, 82A, and 82B received in the corresponding openings 38' and 38'' of the receiving portion 36' and 36'' of the receiving member, and the free edge of the tissue relative to the outer wall of the proximal catheter section and / or support structure 30 can be considered the occlusal margin of the amount of tissue grasped by the needle member. This occlusal margin can be increased intrinsically because the outer circumference 80 is ellipse. In one example, for an instrument outer shape having a circumference equivalent to, for example, 20 Fr, the resulting occlusal margin may be in the range of, for example, 1.0 to 2.5 mm, or for example, 2.25 mm.

[0059] A more detailed explanation of the deployment of the bearing member is shown in the perspective and side views detailed in Figures 9A and 9B. As shown, the bearing member 36 can be seen in a low-profile transport configuration, maintaining a state in which the bearing member 36 is not deployed within the bearing area 32 of the support structure 30. The first bearing portion 36' and opening 38' are visible exposed along the first side of the support structure 30, but the bearing member maintains a low-profile configuration that does not obstruct.

[0060] The operation of the pressing / tensioning member 84, such as a rod, located inside the proximal catheter section 20 (optionally, it may be actuated via the first actuation mechanism 14 and / or the second actuation mechanism 16) can be used to press to maintain the thin form of the receiving member 36, or to tension to unfold the receiving member 36, as shown in the detailed perspective view of Figure 10A. When the receiving member 36 is deployed, it may rotate as indicated by the rotational arrow 86' and be pulled proximal as indicated by the directional arrow 86'' until it contacts the distal end of the proximal catheter section 20 in a configuration that makes the receiving member 36 deployable, as shown in the detailed perspective view of Figure 10B. The inner wall of the support structure 30 may have one or more guides or rails 88 formed symmetrically along each of the support, allowing the receiving member 36 to rotate to its deployed position. These guides or rails 88 may also provide a path for movement, so that when the pressing / tensioning member 84 is activated again to reconfigure the receiving member 36 into a thin configuration after suture transport, the pressing / tensioning member 84 pushes the receiving member 36 distally along the guides or rails 88, thereby allowing the receiving member 36 to rotate back to the transport configuration shown in Figures 9A and 9B.

[0061] Once the receiving member 36 is properly deployed and positioned against the inner wall of the blood vessel surrounding the puncture site, the needle member is then deployed distally from the proximal catheter section 20. Figure 11A shows a detailed side view, and Figure 11C shows a perspective view, which in one embodiment shows the two anterior tactile members 42A and 42B advancing distally from the opening 40 until their distal ends are received within the corresponding first opening 38' when activated by a second actuation mechanism 16 located on the handle 12. Similarly, the two rear guide members 82A and 82B can be advanced distally from the opening 52 until their distal ends are received within the corresponding openings 38. The operation of the two rear guide members 82A and 82B may be simultaneous with the operation of the two front guide members 42A and 42B, but in other embodiments, the operation can be arbitrarily staggered. Once each needle member exits the openings 40 and 52, it can be advanced linearly to move along a straight path. Alternatively, once each needle member exits the corresponding openings 40 and 52, it can be advanced linearly to move along a slightly curved path. That is, the two front guide members 42A and 42B exit the opening 40 As they exit (for example, by a curved exit lumen), they curve slightly and move slightly radially outward from the surface of the proximal catheter section 20, and the two posterior guide members 82A, 82B also curve slightly as they exit (for example, by a curved exit lumen) and move similarly radially outward, so that their movement paths branch off from the movement paths of the two anterior guide members 42A, 42B. The angle and length of each needle member can be determined by the desired occlusal margin relative to the tissue surrounding the puncture site. In one embodiment, as discussed herein, the occlusal margin can be targeted to, for example, 1.0 to 2.5 mm or 2.25 mm.

[0062] With each needle member deployed, as shown in Figure 11C, each needle member can penetrate the blood vessel wall at its own individual position. Each needle member may have its own puncture tip 94" (which may optionally be spiny) that is received in a corresponding opening 38" along a receiving portion 36" as shown in the detailed partial side cross-sectional view of Figure 11B. Each opening 38" may form a conical portion 90" that tapers towards the tip to facilitate insertion of the puncture tip 94" into the opening 38" so as to insert the puncture tip 94" into a corresponding connecting member 92" that is releasably fixed within the opening 38" The connecting member 92" may be configured as a tubular receiving member having an inner diameter set to a size that receives and fixes the puncture tip 94" so that when the puncture tip 94" is withdrawn proximally from the opening 38" the connecting member 92" is withdrawn or released from the opening 38" together with the tip 94" The inner diameter of the connecting member 92" can optionally incorporate elements such as projections that enable the connecting member 92" to be fixed to the puncture tip 94". The needle members can be set to a size such as having a diameter in the range of 0.5 to 1.0 mm, and the outer diameter of each corresponding connecting member can be set to a size that does not exceed the outer diameter of each corresponding needle member so that the connecting portion can be smoothly removed through the needle penetration site without getting caught in the tissue.

[0063] As described above, each needle member may include its own puncture tip, and each receiving opening along the receiving portion may also incorporate its own coupling member for engaging with the corresponding needle member.

[0064] Any of these receiving and needle deployment modes may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the suture management, suture transport, tissue management, alternative instrument embodiments, or suture capture and fixation elements described herein.

[0065] Suture management

[0066] When the instrument 10 is used to bring tissue openings, such as arterial or venous incisions, two separate sutures of independent lengths may be pre-loaded within the instrument 10 and used with a needle member to transport the sutures through the blood vessel wall, or the deployed sutures may be used to bring the two edges of the tissue together for hemostasis (as described in further detail herein). This is possible without using a knot in the suture. Depending on the length of the suture, the suture can be stored and deployed within the tissue using various forms of suture management.

[0067] 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, monofilamental, coated, uncoated, etc. The same type of suture can be used for individual suture loops in a single instrument. Alternatively, different types of sutures may be used in a single instrument, with two or more suture loops deployed, thereby deploying different types of sutures in a single instrument for tissue closure.

[0068] Figure 12A is a side view detailing one embodiment in which the suture 102 can be pre-loaded into a lumen or space 104 formed within the length of the proximal catheter section 20. Each of the connecting members 92', 92'' at opposite ends of the receiving member can be joined to one another via a suture 102 of its own length. As shown in the side section of Figure 12B, the connecting member 92' positioned within the opening 38' of the first receiving portion 36' may have its distal end 100' joined to the first end of the suture 102. The length of the suture 102 can be routed through a defined lumen through the receiving member 36 so that the suture 102 passes proximal to the receiving member 36 and enters a lumen or space 104 within the proximal catheter section 20. The length of this suture 102 is contained within the proximal catheter section 20 and can then return distally through the lumen formed through the receiving member 36 toward the second connecting member 92'', with the second end of the suture 102 being joined to the distal end 100'' of the second connecting member 92''. Similarly, a second length suture, independent of the suture 102, may be pre-loaded into the space or lumen within the proximal catheter section 20, such that its first and second ends are attached to corresponding connecting members positioned in corresponding openings along the first receiving portion 36' and the second receiving portion 36''.

[0069] As the two anterior and two posterior policy members are deployed through the tissue and received by the corresponding opening and connecting members, each of the puncture tips of each needle member can engage with the connecting member and subsequently be pulled proximal to pull the connecting member and suture end proximal through the punctured tissue opening. The length of each suture ranges, for example, from 30 to 75 cm or more, depending on the depth of the tissue opening to be closed from the skin surface and the embodiment of the instrument used.

[0070] Since the suture 102 remains within the instrument and is inserted and deployed directly into the tissue without unnecessary contact, the risk of the suture 102 coming into contact with the skin surface or other tissues (as in percutaneous procedures) is avoided, and the risk of bacterial contamination being entangled or drawn into the punctured tissue by the suture 102 is reduced. Furthermore, since no knot is used, the risk of bacterial contamination is further reduced or completely avoided after the procedure.

[0071] Figure 13 illustrates another embodiment in which the length of the suture may be housed in a lumen or space 104' formed in the distal catheter section 22 rather than in the proximal catheter section 20. As shown, the end of each suture length may still be attached to the opposite connecting member, but the suture length may pass through a lumen and / or slot formed in the receiving member, or pass outside the device into a lumen or space 104' in the distal catheter section 22.

[0072] Figure 14 shows yet another embodiment in which the ends of each suture length are similarly attached to the connecting members on each opposite side, but the first portion 102' of the suture length 102 may be housed in the lumen or space 104 within the proximal catheter section 20, and the second portion 102'' of the same suture length 102 may be housed in the lumen or space 104' within the distal catheter section 22. In this way, the suture length 102 passes through or along the support structure 30 and can provide an extra suture length if an extra suture length is needed or desired (for example, by doubling the suture length 102 to 40 to 100 cm or more). Furthermore, such an arrangement simplifies the drawing out of the suture loop and ensures that any detached suture remains within the device during deployment. In addition, this arrangement can also prevent suture breakage during suture deployment.

[0073] Figure 15 illustrates yet another embodiment in which the ends of each suture length may be configured to cross in order to form a cross-stitch pattern across the puncture site. Rather than one end of one suture length 102 being connected to connecting members positioned opposite each other along the first receiving section 36' and the second receiving section 36”, both ends of one suture length 102 may be attached to connecting members positioned opposite and adjacent to each other along the first receiving section 36' and the second receiving section 36” as shown. This crossing can be achieved by crossing the connecting members at either the first receiving section 36' or the second receiving section 36” and the suture length can be housed in either the proximal catheter section 20, the distal catheter section 22, or both.

[0074] In an embodiment of the device in which the length of the suture 102 is routed and / or housed within the distal catheter section 22, the suture 102 extends from the respective receiving sections 36', 36'' and passes along or through one or more corresponding suture channels 106, 108 formed along the flexible connector and / or the proximal portion of the distal catheter section 22. Figures 16A and 16B are perspective top and bottom views detailing the deployment section 25 with a sheath assembly 27 in a distal position where the sheath member 29 covers at least part or all of the deployment section 25. Figures 17A and 17B are perspective top and bottom views detailing the deployment section 25 with the sheath assembly 27 in a retracted proximal position and the deployment section 25 exposed.

[0075] Figures 16A and 17A show that the suture channel 106 may extend from a common channel and be formed to branch into, for example, two separate channels, and the suture 102 from the first receiving portion 36' may extend along channel 106 and route to a lumen inside the distal catheter section 22. Figures 16B and 17B illustrate how the suture channel 108 may extend parallel to the deployment section 25, and the suture 102 from the second receiving portion 36'' may extend along channel 108 and similarly route to a lumen inside the distal catheter section 22. When the sheath member 29 is positioned over the deployment section 25, the lengths of the sutures positioned in the suture channels 106, 108 are covered and protected from coming loose or coming into contact with tissue surfaces such as the skin surface during insertion and advancement into the tissue.

[0076] Figure 18A illustrates a suture channel 106 for reference, for comparison, as shown in Figure 18B, to show how the length of the suture is routed and passes through the inside of the instrument. As shown, each end 102T of the suture 102 may be attached to a corresponding connecting member housed in a first receiving section 36', a second receiving section 36'', or a corresponding opening 38 along both the first receiving section 36' and the second receiving section 36'', depending on the suture style used. In this embodiment, the length of the suture 102 is housed in a lumen or space 104' formed within the distal catheter section 22 (as shown in Figure 13 or Figure 14), and the remaining end 102E located opposite each end 102T of each suture length may be routed through the suture channel 106 and extend toward a corresponding connecting member housed in each opposite opening 38 opposite to the location where the end 102T is connected. In this embodiment, the end 102T may be coupled to the corresponding connecting member in the second receiving section 36'', and the opposite end 102E may be coupled to the corresponding connecting member in the first receiving section 36'. The remaining length of the suture may be routed in the lumen or space 104' such that the approximately midpoint 102M of the length of the individual suture is positioned proximal within the distal catheter section 22, as shown in the figure. This midpoint 102M, for example, about plus or minus 5 cm in length, along with, for example, about 0 to 3 cm in length, is the portion of the suture that is expected to remain in the patient's body after fixation, as will be described in more detail herein. Depending on the length of the distal catheter section 22, the length of the suture 102 within the device may range, for example, from 15 cm to 90 cm.

[0077] Figures 18C and 18D illustrate one aspect of the routing of suture lengths from Figure 18B within the distal catheter section 22, showing how each suture length is routed within the lumen or space 104' and routed back towards the proximal end so that the central portion 102M is located proximal within the catheter 22. Figure 18C shows both catheter lengths, while Figure 18D shows one suture length for clarity. Figure 18E illustrates how the suture lengths are positioned within the length of the lumen or space 104' formed within the distal catheter section 22.

[0078] Figures 19A and 19B are front and rear perspective views illustrating another embodiment of how the length of the suture may be routed outside the first receiving portion 36' and the second receiving portion 36”. In this embodiment, only one length of suture 102 is shown for clarity, illustrating how this suture is routed so as to be contained within the lumen or space 104' of the distal catheter section 22. The first end of the suture is coupled to one of the openings 38' along the first receiving portion 36' and passed through the lumen or space 104' of the distal catheter section 22. It is visible that the second end of the suture extends from one of the openings 38” along the second receiving portion 36” and may pass around, move around, pass through, or loop around a projection or shoulder 106” (such as a cleat or bearing element) that allows for easy management of the suture during transport and deployment.

[0079] As described herein, the ends of each suture length may be positioned directly beside each other to create a straight stitch, or be positioned beside and diagonally to each other to create a cross-stitch pattern within adjacent tissue openings, in order to join them in the corresponding openings between the first receiving portion 36' and the second receiving portion 36''.

[0080] Figure 20A is a top view showing a cross-stitch pattern that may occur along a blood vessel 110 having a puncture diameter 112 below the puncture site PN. The illustrated cross-stitch pattern may result from an embodiment of the instrument 10 described in Figure 15 above. With the instrument inserted through the puncture site PN having a diameter 112, advancing the anterior guide members 42A, 42B creates openings 114, 116 through the tissue wall, and the posterior guide members 82A, 82B may create openings 118, 120 shown in the tissue. The resulting suture loops can be formed to intersect each other on the puncture site PN. The distance 122 between adjacent openings 114 and 116 and between opening 118 and 120, the distance 124 between opposing adjacent openings 114 and 120, and the angle 126 between the openings and the midline of the blood vessel 110 can be controlled or adjusted by adjusting the corresponding distance between the needle members.

[0081] Figure 20B is a top view showing a parallel suture pattern that may occur above the puncture site PN along a blood vessel 110 having a puncture diameter of 130.

[0082] The illustrated parallel suture patterns may result from the configuration of the instrument 10 described in Figures 12 to 14 above, in which each suture loop extends between opposing needle members, such as between needle member 42A and needle member 82A, and between needle member 42B and needle member 82B. The resulting suture loops can be formed to extend longitudinally parallel to each other along the blood vessel over the puncture site PN. The distance 132 between adjacent openings 114 and 116 and between opening 118 and 120, the distance 134 between opposing adjacent openings 114 and 120, and 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.

[0083] Figure 20C illustrates yet another embodiment in which a typical circular opening puncture site PN in the blood vessel wall is compared to an elliptical or oblong opening PN' formed by the angle of the proximal catheter section 20 with respect to the tissue surface, as further illustrated in Figure 8A. As shown, when the distance 138 between opposing needle members remains the same, the occlusal margin between the insertion position of the needle member and the exposed edge of the puncture site PN' may be relatively larger than in the case of a circular puncture site PN. By utilizing an elliptical shape, the instrument 10 can reduce its thickness along one axis (transverse to the length of the blood vessel) and increase its thickness along the other axis (along the length of the blood vessel). By promoting engagement with one axis of the opening PN', both edges can be controlled to improve closure.

[0084] Any of these suture management methods may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the receiving and needle deployment, suture delivery, tissue management, alternative instrument embodiments, or suture capture and fixation elements described herein.

[0085] Suture transport

[0086] By using two anterior guide members and two posterior guide members, two suture lengths independent of each other can be used between each pair of needle members, as described herein. As shown in Figure 21A, each end of each suture length 102 may incorporate a connecting member 92', 92'' attached to the corresponding connecting members 100', 100''. As described herein, each suture length may be in the range of, for example, 40 to 75 cm or more, and each connecting member 92', 92'' is detachably fixed in the corresponding opening along the receiving member 36, while the remainder of the suture length may be located in a lumen or space within the proximal catheter section 20, the distal catheter section 22, or both.

[0087] As shown in Figure 21B, a portion 140 of the suture length 102 may be loosely held or held by some tension 144 (tension spring, spool, etc.), while the remainder is made into a loop 142 within the instrument. The suture length may be prevented from binding to or wrapping around itself during suture deployment, as long as the lumen or space 104' in which the suture is held is of an appropriate size. The suture holding lumen or space may incorporate some tension-applying mechanism to keep the undeployed suture released in a controlled manner, and the suture lumen itself does not need to have a specific shape or cross-section.

[0088] Next, turning to the attachment of the suture end to the corresponding connecting member, the suture end can be attached to the connecting member via various attachment mechanisms. Figures 22A and 22B are a side view and a cross-sectional view showing one embodiment in which the end of the suture 102 can be attached to the connecting member via one or more finger portions or extension members 103 (e.g., three or four finger portions) extending from the main body, which may also form one or more projections 101 formed on the circumference of the main body. One or more projections 101 may extend radially inward to ensure engagement with the needle tip of the front guide members 42A, 42B and / or rear guide members 82A, 82B as it advances into the main body section. The finger portions or extension members 103 can ensure engagement by pressing or crushing the suture end radially inward.

[0089] Figures 23A and 23B are side and side cross-sectional views showing yet another embodiment in which a tapering portion 107 extending from the main body section 105 can form a fixed engagement portion with the suture end (e.g., via a sewn-in). Figures 24A and 24B are side and side cross-sectional views showing yet another embodiment in which a tapering body 111, formed separately from the main body section 109, can similarly be fixed to the suture end and can also be attached to the main body section 109 (e.g., via mechanical attachment, welding, adhesive, etc.).

[0090] In another embodiment, Figures 25A and 25B are side views showing one embodiment of a suture end that may be configured to have a widened portion 113, for example, a molten portion, a knotted portion, or a heated portion, or additional mechanical elements. Inserting this widened portion 113 into the connecting member can enhance secure engagement with the connecting member. Figures 26A and 26B are perspective views showing embodiments of a connecting member from Figures 24A and 24B to illustrate a method in which a body 111 that tapers towards the tip is attached to a body section 109 via one or more weld points.

[0091] Figures 27A to 27E are schematic diagrams illustrating the steps involved in suture deployment to illustrate how suture length may be transported during suture deployment into tissue. One suture length 102 is shown for clarity, but a second suture length may be deployed parallel from a second pair of needle members to create a parallel suture pattern or cross-stitch pattern as described herein, or any other desired pattern. Furthermore, a different number of needle members may be used, as further described herein.

[0092] As shown in the illustrative side view of Figure 27A, after the distal catheter section 22 is introduced through the puncture site and positioned at an angle within the blood vessel 110 relative to the proximal catheter section 20, the receiving member may be operated to rotate from its thin form to its deployed form, for example by the operation of the first actuation mechanism 14, as shown in the figure. With the receiving member deployed, the receiving member is stretched against the inner wall of the blood vessel adjacent to the puncture site, and the anterior tactile members 42A, 42B and posterior tactile members 82A, 82B are advanced from the proximal catheter section 20, so that, for example by pushing down the second actuation mechanism 16, the respective puncture tips can pass through the tissue adjacent to the puncture site through the corresponding entry points 114, 116 and 118, 120.

[0093] The occlusal margin between the outer surface of the instrument and the entry points 114, 116 and 118, 120 is visible, and the puncture tip of each needle member is advanced until it is received in the corresponding opening, with the anterior tactile members 42A, 42B being received in the corresponding connecting members in the first receiving section 36', and the posterior tactile members 82A, 82B being received in the corresponding connecting members in the second receiving section 36''. The length 102 of the suture is visible in this embodiment as being pre-loaded in the lumen or space within the proximal catheter section 20.

[0094] With the puncture tip engaged with the corresponding connecting member, each needle member can be pulled proximal to the receiving member, for example by tension of the second actuating member 16, as shown in Figure 27B, so that the connecting member is pulled from the corresponding receiving portion 36', 36''. Each needle member, together with the engaged connecting member, is pulled proximal (indicated by the directional arrow 150) and outward from the blood vessel 110 through the entry points 114, 116 and 118, 120, thereby pulling the attached end of the suture length 102 through the receiving portions 36', 36'' of the receiving member and also through the entry points 114, 116 and 118, 120.

[0095] As the suture length 102 continues to be pulled proximal 156, the suture length 102 housed within the proximal catheter section 20 (and / or distal catheter section 22 in other embodiments) may be pulled out from the storage lumen or space 104 until the suture 102 is detached from the instrument 10, until the final remainder of the suture 154 is drawn into the blood vessel 110, as shown in Figure 14C. With the end of the suture length 102 located outside the blood vessel 110 and the patient's body, the end can be cut or trimmed from the connecting member to release the suture length 102 from the needle member with which the connecting member is engaged. The receiving member can then be rotated back to its thin form, as shown in Figure 27D, and the instrument 10 can be pulled back proximal 158 through the puncture site, as shown in Figure 27E, with only the suture length 102 passing through the entry points 114, 116 and 118, 120.

[0096] The proximal end of the suture length 102 can be tensioned from outside the patient's body so that both edges of the puncture site move closer together along the blood vessel wall. With the puncture site closed by the suture length 102, the sutures can be tightened and secured together to maintain hemostasis at the puncture site. Then, as will be described in more detail herein, the ends of each suture length can be secured using a second instrument for suture capture and fixation.

[0097] Various mechanisms may be used to release the suture in a controlled manner to prevent premature release and potential entanglement of the suture as the suture length is drawn out from the suture storage lumen or space 104 in the proximal catheter section 20 and / or distal catheter section 22.

[0098] One such mechanism is shown in the detailed perspective view of Figure 28, which shows a proximal catheter section 22 having an opening 162 through which a suture 160 (shown in the cross-stitch configuration of Figure 15) can pass through the distal lumen on the central axis of the proximal instrument section. A suture lumen described herein and referred to as lumen 164 may incorporate a friction element 166, such as a narrowed section or passage made of a material such as silicone, as shown in the perspective and end views of Figures 29A and 29B, which can apply light tension to the suture 102, preventing the suture from being wound out of the instrument in an uncontrollable manner during deployment. The friction element 166 may be used with a suture lumen or space in either the proximal catheter section 20, the distal catheter section 22, or any other suture lumen for suture management.

[0099] Another embodiment is shown in the detailed perspective view of Figure 29C, in which the suture lumen 164 may be terminated to open into a larger space in which the remaining length 102 of the suture can be accommodated. The amount of friction applied to the suture length 102 can be changed by changing the length of the suture lumen 164 itself. The length of the suture maintained outside the suture lumen 164 may provide some nominal resistance to prevent the suture 102 from being pulled out prematurely.

[0100] Figures 30A and 30B are a top view and a top cross view showing a distal catheter section 22 in another embodiment having one or more friction-inducing elements incorporated along the section 22 to impart friction grip or resistance to the suture housed within the distal catheter section 22. In this embodiment, the suture length is routed through its corresponding suture channels 106 and / or 108 (described herein), and the suture length can come into contact with one or more suture tension-applying members 161 positioned in the corresponding channels or grooves 163 to form a tension-applying point 159 between the suture length and the tension-applying members 161 to impart friction to the suture. The frictional grip ensures that the length of the underlying suture is reliably retained during transport and storage. However, when the instrument is in use, the suture is pulled out to pass through the suture channels 106 and / or 108, and the tension-applying members 161 ensure that the suture is reliably deployed in a controlled manner.

[0101] In the illustrated embodiment, two tension-applying members 161 are provided, configured as O-rings spaced apart from each other along the length of the distal catheter section 22. The tension-applying members 161 may be spaced apart from each other, for example, in the range of 0 to 2.5 cm. Furthermore, one tension-applying member 161 may be used, or two or more tension-applying members 161 may be used. In addition, although the tension-applying members 161 are illustrated as O-rings, other features, such as C-shaped clamps or partial rings, may be used instead.

[0102] The cross-sectional shape of the tension-applying member 161 can also be changed in any number of ways, as long as it makes proper contact with the suture thread beneath it. Figure 31A shows a tension-applying member 165 having a polygonal cross-section 165. Figure 31B shows a tension-applying member 167 having a circular cross-section 165, and Figure 31C shows a tension-applying member 169 having a rectangular or square cross-section 165. Various materials can be used for the tension-applying member, such as nitrile, silicone, and other elastomer materials.

[0103] In another embodiment, a flange tensioning rod may be incorporated into the distal catheter section 22 to apply tension to the suture contained within the lumen or space 104' and to remove slack in the suture that has spread during use. The suture may be wrapped around the flange tensioning rod one or more times, and the flange tensioning rod may be designed to break or snap at a specific load expected when the suture is pulled out during tissue closure procedures. In yet another suture tensioning mechanism, Figures 32A and 32B are schematic side and perspective views detailing another embodiment of a suture tensioning mechanism positioned within the distal catheter section 22 to remove slack in the suture. The suture 102 may be wrapped around a support 175 extending between two support members 173 attached to a flanged body 171. The spring or biasing element 177 can apply tension to the flanged body 171 such that the length of the suture 102 maintains tension by the support 175 pulling on the suture 102. In other embodiments, as shown in Figure 32B, the spring or biasing element 177 may be omitted entirely, and tension can be applied using the support 175 with the flanged body 171 alone. Figure 32C shows a schematic side view of yet another embodiment, in which the flanged body 171 may instead incorporate one or more elastic support members 173', which are configured by their elastic properties to apply tension to the suture 102 looped around the support 175, and are shown in an extended or elongated form when tension is applied by the suture 102. The support 175 and / or support members 173' may preferentially break once a threshold tension is reached.

[0104] Any of these suture delivery methods may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the receiving and needle deployment, suture management, tissue management, alternative instrument embodiments, or suture capture and fixation elements described herein.

[0105] organization management

[0106] As described herein, the tissue surrounding the puncture site may be elliptical or oblong in size of larger arterial or venous incisions (i.e., 10 Fr and 20 Fr or larger, depending on the size of the instrument used) in order to maintain or increase the occlusal margin along the tissue between the needle member and the catheter sheath. The puncture site may be formed by the instrument being at an angle to the blood vessel, but additional elements may be optionally incorporated to further increase or facilitate tissue reconstruction, especially for puncture sites that are particularly large relative to the transition diameter of the instrument.

[0107] To move the edges of the puncture sites along the sides of the instrument 10 away from each other, so that the anterior and posterior edges of the instrument 10 along the blood vessel are biased toward each other, one or more lateral expansion elements may be configured to extend from outside the proximal catheter section 20 and / or distal catheter section 22 and / or support structure 30. These lateral expansion elements may be configured to extend when actuated by a mechanism located, for example, on the handle 12.

[0108] Figure 33A schematically shows an example in which a pressing / tensioning member 170 (such as a pressing / tensioning member 84 as described herein) may incorporate an expansion member 176, such as a tapering or conical element, attached along the pressing / tensioning member 170. The pressing / tensioning member 170 can be actuated to deploy the receiving member as described above, and can also be moved to receive the expansion member 176 into a receiving channel 174 formed by one or more mutually separable expansion arms 172. When the pressing / tensioning member 170 is tensioned or stretched, the proximal movement of the expansion member 176 biases the expansion arms 172 to actuate and move away from each other, thereby causing the expansion arms 172 to extend away from the outer surface of the catheter section or support structure and to contact and press against adjacent tissue. When tension is applied to or the tension is pulled of the pressing / tensioning member 170, the proximal movement of the expansion member 176 may be configured such that the movement of the expansion member 176 occurs simultaneously or in stages relative to the movement of the receiving portion XX.

[0109] Figure 33B illustrates one embodiment in which the extension arms 178', 178'' are positioned opposite each other along the distal end of the proximal catheter section 20. When activated, the arms 178', 178'' can move distally along a fixed curved track or guide that, for example, urges the arms 178', 178'' to advance radially away from the outer surface of the instrument. Contacted tissue can be forcibly pulled away from the side of the instrument 10, and the remaining portion of the tissue edge can be pushed into an elliptical or oblong shape.

[0110] Figure 33C illustrates another embodiment in which the extension arms 180', 180'' may be formed into a ribbon-like shape such that when compressed distally, the arms 180', 180'' bend or pivot around the corresponding fixed pivot points 182', 182'', as shown in the figure.

[0111] Figure 33D shows yet another embodiment in which the extension arms 184', 184'' may be formed of members that are pushed out orthogonal or transversely during operation.

[0112] Any of these tissue control methods may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the receiving and needle deployment, suture management, suture transport, alternative instrument embodiments, or suture capture and fixation elements described herein.

[0113] Alternative device embodiment

[0114] Apart from the embodiments of the device described herein, further embodiments may be implemented. Figures 34A and 34B are side views detailing one embodiment having a proximal catheter section 190 and a distal catheter section 192, which are connected to each other via a flexible section 196, thereby allowing the proximal catheter section 190 to rotate at an angle of 198 relative to the distal catheter section 192. The receiving member 194 may be positioned in a thin form within the extension of the distal catheter section 192. Rather than rotating into its deployed form, the receiving member 194 may be pulled proximal to the distal catheter section 192 and exposed via an operating member 200, such as a pressing / tensioning rod, which is slidably positioned within the proximal catheter section 190, and aligned in a predetermined position.

[0115] After the receiving member 194 is positioned in the deployed position, the anterior tactile member 202 and the posterior tactile member 204 are deployed from the proximal catheter section 190 and can contact the corresponding openings along the receiving member 194.

[0116] Figures 35A to 35D are side and perspective views showing yet another embodiment in which the device may omit the distal catheter section. Instead, a central shaft 212 may be slidably positioned within the proximal catheter section 210. The central shaft 212 may include a first receiving section 214 and a second receiving section 216 opposite the first receiving section 214, each receiving section may be rotatably coupled to an internal fixing element 218 via a hinged or pinned connector 220. Once the central shaft 212 is introduced into the blood vessel and advanced, the first receiving section 214 and the second receiving section 216 may be maintained in a low profile configuration, as shown in Figure 35A. Furthermore, when the central shaft 212 is properly positioned, the internal fixing element 218 may be pressed, stretched, rotated, or otherwise actuated to rotate both the first receiving portion 214 and the second receiving portion 216 into their deployed configuration, as shown in Figures 35B and 35C. The internal fixing element 218 is shown having a bar connection, but in other embodiments it may include a cable, wire, or other mounting element. Figure 35D shows a perspective view of the first receiving portion 214 and the second receiving portion 216 deployed, where each opposing connecting member within each opening may have its own suture loops 222, 224, as described herein.

[0117] Figures 36A and 36B and 37A and 37B are various perspective views showing the device in yet another embodiment. In this embodiment, the proximal catheter portion 230 may also include a central shaft 232 incorporating a fixed ramp portion 234 having a surface that is angled or tapers towards the tip. When activated, as shown in Figures 36A and 36B, the first receiving portion 236 is biased distally or the central shaft 232 is biased proximally, causing the first receiving portion 236 to contact and slide against the ramp portion 234 and rotate around the hinged connector 238, thereby forcing the first receiving portion 236 to move upward away from the central shaft 232. Simultaneously, as shown in the corresponding Figures 37A and 37B, the second receiving portion 240 may be pushed or urged by a pin element 243 to rotate around the hinged connector 242.

[0118] Figures 38A and 38B are various perspective views showing an instrument in yet another embodiment incorporating a dual receiving element that acts or rotates via a ratchet mechanism such as a rack and pinion mechanism. This embodiment may also incorporate a central shaft 256 having a first receiving portion 252 and a second receiving portion 254 on the opposite side, respectively, which are rotatably coupled to a proximal catheter section 250. The central shaft 256 may have multiple projections (e.g., rack configurations) formed on both sides facing each receiving portion 252, 254, and may also incorporate a circular pinion configuration. Once the central shaft 256 has advanced properly and is positioned in the blood vessel, the central shaft 256 can be pulled proximal to activate the rack and pinion engagement with the receiving portions 252, 254, and the receiving portions 252, 254 can be rotated in an deployed configuration.

[0119] Any of these alternative instrument embodiments may be used in any number of combinations or embodiments with any of the instrument elements described herein, including any of the receiving and needle deployment, suture management, suture transport, tissue management, or suture capture and fixation elements described herein.

[0120] Capture and fixation of sutures

[0121] As described herein, a second instrument for suture capture and fixation may be used to fix both ends of each suture length after it has been deployed and delivered through the tissue site to be closed for hemostasis using the instrument described above.

[0122] Figure 39A is a perspective view showing one embodiment of a suture capture and fixation device, illustrating a handle 260 having an operating mechanism 262 for deploying or fixing an anchor to a captured suture. A long shaft 266 extends from the handle 260 and terminates at its distal end with an opening 268. The opening 268 may partially penetrate the shaft 266 and extend to a window 270 formed along the side of the shaft 266 close to the distal end. The window 270 may be located at a distance 294 proximal to the distal end of the shaft 266, where this distance 294 is measured from the distal end to the center of the window 270, and may be in the range of, for example, 0.5 cm to 5 cm. A fixing anchor 272, such as a ferrule with lumens, can be placed within the opening 268. The sliding element 264 is detachably positioned along the shaft 266 or along the handle 260, and the wire 274 is coupled to the sliding element 264 and extends along the instrument, passing through the window 270, through the fixing anchor 272, and distally through the opening 268, so that the wire 274 can form a snare loop 276 that opens into an expanding loop for engaging a suture.

[0123] The wire 274 and suture snare loop 276 can be made of any number of materials, such as stainless steel, nitinol, nylon, thermoplastic, suture, etc., and can be formed in any number of configurations, such as braided, cable-like, or single-filament. Furthermore, the fixing anchor 272 housed within the distal opening may be positioned within the distal end at a distance of, for example, 3 mm or less from the outer surface of the distal end.

[0124] Figure 39B is a perspective view showing another embodiment of a suture capture and fixation device, in which a handle 260 has an operating mechanism 262 and a long shaft 280 extends from the handle 260. In this embodiment, the suture snare sliding element 284 may be located near the distal end of the shaft 280, proximal to a window 282 formed along the side of the shaft 280. Similarly, the window 282 may be located at a distance 294 proximal to the distal end of the shaft 280, where the distance 294 is measured from the distal end to the center of the window 282, and this distance 294 may be in the range of, for example, 0.5 cm to 3.5 cm. The window 282 itself may be sized to accommodate the length of up to eight sutures (for example, four suture ends 278 that are folded back when pulled proximally through the window 282), the length of the window 282 along the length of the shaft 280 may range from, for example, 2 mm to 10 mm, and the width of the window 282 transversely to the length of the shaft 280 may range from, for example, 1 mm to 4 mm. The suture snare sliding element 284 may be formed as a projection or tab, such as a ring tab, that provides an element that can be easily grasped and pulled with one hand. The wire 292 is attached to the distal part of the suture snare sliding element 284 and extends distally through the window 282, and may extend distally through an opening through a fixed anchor 272 held inside, through which the wire 292 can form a suture snare loop 286. Both the suture snare sliding element 284 and the elongated shaft 280 may have elements for holding the two elements in a desired relative position to each other. Such elements also allow for a secure and easy, detachable connection between the two parts until use.

[0125] During use, the remaining suture ends 278 after transporting the suture around the puncture site can be passed through the suture snare loops 286. The suture snare sliding element 284 may then be detached from the elongated shaft 280 or pulled proximal 290 along it, thereby pulling the wire 292 through the window 282 and the fixing anchor 272, and fastening the suture snare loops 286 around the suture ends 278. If the suture snare sliding element 284 is pulled further proximal, it may be pushed upward away from the elongated shaft 280 and come into contact with the tapering interface surface 288 formed along the distal end of the handle 260.

[0126] Prior to suture capture and fixation, the suture snare sliding element 284 and suture snare loop 286 may be pre-loaded onto the elongated shaft 280, thereby enabling the suture capture and fixation device to be quickly used. If additional fixation anchors 272 are required for tissue closure, multiple suture capture and fixation devices may be used, or additional suture snare sliding elements 284, suture snare loops 286, and fixation anchors 272 may be loaded onto the same elongated shaft 280 as many times as necessary to deploy the additional fixation anchors 272.

[0127] Figures 40A to 40C are perspective views showing in detail a configuration in which the suture end 278 is engaged by the suture snare loop 286, as shown in Figure 40A. As the suture snare loop 286 is pulled further proximal through the fixing anchor 272 and the window 282, the suture end 278 on the snare may also be pulled accordingly, as shown in Figure 40B, until the suture end 278 has completely passed through both the fixing anchor 272 and the window 282, as shown in Figure 40C.

[0128] As shown in Figure 41A, the suture end 278 may be pulled proximal as the distal end of the shaft 280 advances distally towards the puncture site, applying tension and tightening the engaged suture through the tissue until both edges of the puncture site are brought close together or closed. Once the puncture site is tensioned and closed, the suture is pulled proximal as indicated by arrow 296, allowing the user to evaluate hemostasis before finally fixing and trimming the suture. Once hemostasis is evaluated, the suture 278 passing through may be fixed by deforming, crimping, or otherwise tightening the fixing anchor 272 until it is no longer possible for the fixing anchor 272 to move, for example, by activating the actuation mechanism 262 on the handle 260 to activate the clamping mechanism in the distal end of the shaft 280, thereby deforming or crimping the fixing anchor 272 against the suture. With the fixing anchor 272 crimped or tightened, the suture end 278 can be cut or trimmed, as shown in Figure 41B, and the shaft 280 can be removed, leaving the fixing anchor 272 and trimmed suture, with hemostasis achieved, as shown in Figure 41C. In some embodiments, the suture end can be trimmed simultaneously with the installation of the fixing anchor 272 by a built-in cutter driven by the same actuation mechanism 262. The suture trimming can be carried out so that the tail portion of the suture protruding proximally from the ferrule component is cut to a length coplanar or of a desired length, for example, 0 to 30 mm or more above the end of the fixing anchor 272. As illustrated in Figure 41C, two (or more) suture lengths or loops are secured by one fixing anchor, in contrast to requiring one knot for each suture length.

[0129] Figures 42A and 42B are perspective and side views, respectively, detailing the suture snare sliding element 284 to illustrate additional elements that may be incorporated. The sliding element 284 is shown to form a ring tab 302, which allows the user to grasp the suture snare sliding element 284 with one finger or one hand. The wire 292 is shown to be attached to the distal end of the sliding element 284, so that the wire 292 extends distally into the window 282, passes through a fixing anchor 272 contained within the distal opening at the end of the shaft 280, and exits the distal opening to form a snare loop 286. The suture snare sliding element 284 forms an open channel into which the shaft 280 slidably engages, so that the sliding element 284 moves proximal to the outside of the shaft 280 and is detachably fixed. The shaft 280 may be configured to have a aligning or angled cross-sectional shape so that the sliding element 284 remains reliably aligned and positioned with respect to the elongated shaft during proximal movement. In this embodiment, the shaft 280 is shown to have a hexagonal outer shape 300 along the length of the shaft 280, however, the shaft outer shape 300 may be configured to have any number of different cross-sectional areas (e.g., triangles, squares, rectangles, pentagons, etc.) as long as they facilitate the alignment of the sliding element 284 with the shaft 280. Instead of a aligning cross-section, the shaft 280 may also incorporate a guide or rail or longitudinal projection aligned with a corresponding receiving channel along the sliding element 284. Such a longitudinal projection also functions to reliably align the sliding element 284 with respect to the shaft 280 during proximal movement of the sliding element 284.

[0130] The proximal surface of the sliding element 284 may also be configured as an inclined or angled surface 304, as shown in Figure 42B, which can correspond to a tapered interface surface 288 formed along the distal end of the handle 260, allowing the sliding element 284 to easily detach from the outer surface of the shaft when pulled proximal.

[0131] In addition, the sliding element 284 may further incorporate a projection or shoulder 306 extending from the sliding element 284 to engage with a corresponding retaining or groove formed along the shaft 280. In this embodiment, the projection or shoulder 306 may extend distally from the sliding element 284 on a flexible member. During transport, the engagement between the projection or shoulder 306 and the shaft 280 may fix the position of the sliding element 284 on the shaft 280. When the sliding element 284 is stretched, the projection or shoulder 306 can simply be separated from the shaft 280.

[0132] As described above, the proximal catheter section 20 (and / or distal catheter section 22) may include a scale 28 on the outer surface of the catheter to visually indicate the depth of the vessel to be closed relative to the surface of the tissue or skin T, as shown in Figure 43A. The scale 28 may be angled (e.g., 30 to 45 degrees relative to the skin surface) or linear with respect to the longitudinal axis of the proximal catheter section 20, as shown. Figure 43B illustrates that the shaft 280 of a suture capture and fixation device may also incorporate a scale 311 to similarly provide a visual indication of the insertion depth relative to the tissue surface or skin T. In this embodiment, the scale 311 may be configured transversely (or linearly) with respect to the longitudinal axis of the shaft 280, as shown, or it may be an angled scale 311' (e.g., 30 to 45 degrees relative to the skin surface), as shown in Figure 43C.

[0133] In either the proximal catheter section 22 or the shaft 280, the first marking may be at an initial distance of, for example, 10 mm from the receiving member 36 or the inner surface of the blood vessel, and subsequent markings may be at equal intervals of, for example, 5 to 10 mm.

[0134] Figure 44 is a perspective view illustrating a shaft 280 in one embodiment incorporating a scale 311, where the marks on each scale may be, for example, 5 mm or 10 mm apart from each other. A snare loop 286, a window 282, and a sliding element 284 are also shown.

[0135] Next, turning our attention to the internal suture cutting mechanism, Figures 45A and 45B are perspective views showing the shaft 280 and the internal mechanism in detail, with the outer wall of the shaft 280 removed for clarity. As shown in Figure 45A, the suture end 278 is passed through the distal end of the shaft 280 and may exit through the window 282, and the fixing anchor 272 is shown to be positioned between deformation platforms 303 having one or more transverse projections located at the distal end of a cantilever arm member 307 having an interface surface that tapers towards the tip. Also shown is a receiving platform 305 having one or more transverse projections configured to be complementary to the deformation platforms 303, positioned opposite the deformation platforms 303. The suture 278 can pass through a suture lumen 301 extending between the distal end of the shaft 280 and the window 282. The suture exit port 319, having a cutting interface window 321, may be fixedly positioned within the suture lumen 301, so that the cutting interface window 321 of the exit port 319 aligns with window 282, allowing the suture end 278 to pass through the inside of the suture exit port 319 and exit to the outside through the cutting interface window 321 and the corresponding window 282. A slidable blade element 313 extending from the base 317 and terminating with a cutting blade 315 is slidably positioned within the suture lumen 301, so that when the instrument is operated, for example by the operation of the handle 262, the pressing mechanism presses against the base 317, causing the cutting blade 315 to slide distally over the cutting interface window 321 and window 278, shearing the suture end 278 as appropriate.

[0136] As shown in Figures 45C and 45D, which further show perspective and side views of the instrument shaft 280, as the base 317 and cutting blade 315 move distally, the moving pressing portion 309 is biased distally, so that the interface surface 311 of the distal end of the pressing portion 309, which tapers towards the tip, contacts the cantilever arm member 307 and may then be forcibly biased upward (transversely). This transverse movement may also press the deformation platform 303 toward the receiving platform 305, thereby deforming the fixed anchor 272 located between the transverse projections of both the deformation platform 303 and the receiving platform 305. Thus, in a single operation, the mechanism can fix the anchor 272 while simultaneously trimming the end of the suture 278 and releasing the fixed anchor 272 onto the nearby tissue. The length of the suture between the fixing anchor 272 and the trimmed position (trim length) can be, for example, in the range of approximately 0 to 3 cm, and represents the suture that is expected to remain in the patient's body after anchor fixation and suture cutting.

[0137] Figures 46A and 46B are different perspective views showing the base 317 and the slidable blade element 313. In the illustrated embodiment, the blade element 313 is shown having a curved surface that approximates the inner circumference of the shaft 280, but in other embodiments, the blade element 313 may have a different shape. Furthermore, the cutting edge 315 may be a cutting element that tapers towards the tip, but other embodiments can also be used that incorporate an alternative energy supply mechanism for cutting sutures, such as a heating element, a rotating element, etc.

[0138] Any embodiment of the suture deployment and transport mechanism may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the receiving and needle deployment, suture management, suture transport, tissue management, or suture anchor fixing elements described herein.

[0139] Suture anchor fixation

[0140] Since the suture capture and fixation device does not require knots or pre-tied knots, the fixation anchor that tightens the suture end and fixes the tensioned suture to the tissue for hemostasis may include any number of deployable ferrules, clips, etc. A fixation anchor that can be deployed from the distal opening of the device shaft 280 in a particular embodiment may include a ferrule, which may be sized in any number of configurations depending on the use case. The ferrule may also be sized to capture the suture end 278 for complete closure, and such a ferrule structure may be made from any number of materials, such as metal that can be deformed (e.g., compressed, crimped, etc.) on the suture, or polymer that can be heat-melted onto the suture for fixation. When the suture used is polymer, the ferrule partially melts together with part of the suture to provide a secure anchor.

[0141] Figure 47A is a perspective view illustrating one embodiment of a ferrule, which has a tubular portion 310 that forms a lumen 314 for receiving a suture. The distal end of the ferrule may include a flared or enlarged shoulder or shelf portion 312 that helps to fix the ferrule in place within the distal opening of the shaft 280. Once the suture is passed through the lumen 314 and tension is applied, the tubular portion 310 can be deformed or compressed (or thermally melted) to the suture to prevent it from moving. The tubular portion 310 can be arbitrarily curved, angled, or flattened relative to the vessel wall so that the trimmed end 314 of the suture near or at the opening of the lumen is thin for patient comfort.

[0142] The tubular portion 310 may form a lumen 314 having a smooth inner wall, but other embodiments, such as the ferrule in Figure 47B, may incorporate a threaded channel 316. Alternatively, the ferrule lumen 314 may incorporate one or more projections 318 extending inward from the lumen 314, as shown in the ferrule in Figure 47C, to further enhance the ferrule's engagement with the suture when deformed or crimped.

[0143] Figures 47D and 47E are perspective views showing an additional ferrule configuration including a ball-shaped tubular portion 320 for removing the hard edges of the graft. The ball-shaped ferrule may also form a split or open channel 322 along the length of the tubular portion to facilitate crimping or crushing of the ferrule during suturing. The configuration in Figure 47D also shows the inclusion of a flared or enlarged shoulder or shelf portion 312, although Figure 47E omits the shelf portion 312.

[0144] In yet another embodiment, the ferrule lumen may incorporate a secondary element that functions as a plug or abutment member, such a secondary element may be used to fill the gap within the ferrule to further secure the ferrule to the suture. Such secondary elements can be formed from a variety of materials, such as compressible biocompatible plastics (non-absorbable or absorbable).

[0145] Figure 48 is a partial side cross-sectional view showing one embodiment in which a plug 320 (e.g., elastomer) having a tapered tip that presses against the suture 278 passing through the lumen can be optionally incorporated into the ferrule tubular portion 310. In particular, the tapered tip helps to secure the suture against the edge of the ferrule, as shown in the figure. The plug 320 may further include a pull tab 322 element, which allows the user to grasp the tab 322 and pull the plug 320 out of the ferrule for suture release or repositioning.

[0146] Figures 49A and 49B show a perspective view and a cross-sectional perspective view of another embodiment in which the plug 330 forming the plug lumen 332 may be inserted entirely through a ferrule lumen so that the suture can be passed directly through the plug lumen 332 itself. The plug lumen 332 may also form a lumen that tapers towards the tip, narrowing at the proximal end of the plug lumen 332, to improve the compression of the suture.

[0147] Figure 50 is a perspective cross-sectional view showing yet another embodiment in which the plug 340 may be introduced into the proximal lumen opening of the ferrule. The plug 340 may include an enlarged proximal end 342 for engaging with the ferrule opening and an enlarged distal element 344 set to a size for entering the ferrule lumen 314. With the suture threaded through the ferrule lumen 314, the distal element 344 and the proximal end 342 of the plug together facilitate the fixation of the suture within the ferrule lumen 314 when the plug 340 is pushed into the ferrule lumen 314.

[0148] Any of these suture capture and fixation elements may be used in any number of combinations or embodiments with any of the elements of the instrument described herein, including any of the receiving and needle deployment, suture management, suture transport, tissue management, or alternative instrument embodiments described herein.

[0149] The uses of the apparatus and methods described above are not limited to those described and may include any number of suture transport and tissue fixation applications. Modifications of the assemblies and methods described above for carrying out the present invention, combinations between different possible embodiments, and variations of embodiments of the present invention that are obvious to those skilled in the art are intended to be included in the claims.

Claims

1. A tissue closure device, A handle having one or more operating mechanisms, A proximal catheter section extending from the handle, The deployment section is connected to the proximal catheter section, The distal catheter section is connected to the deployment section so that it can rotate at a predetermined angle relative to the proximal catheter section, A receiving member arranged within the unfolded section and having two or more openings along a first receiving portion and two or more openings along a second receiving portion, wherein the receiving member can be configured between a thin form and an unfolded form, Two or more anterior guiding members that can extend distally from the first side of the proximal catheter section, and two or more posterior guiding members that can extend distally from the second side of the proximal catheter section opposite to the first side, Equipped with, A tissue closure device in which, when the receiving member is in the deployed state, the two or more front policy members can be received into the two or more openings along the first receiving portion, and the two or more rear policy members can be received into the two or more openings along the second receiving portion.

2. The device according to claim 1, wherein the proximal catheter section forms one or more suture lumens inside.

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

4. The apparatus according to claim 1, wherein the unfolded section forms a receiving region for holding the receiving member in the thin form.

5. The device according to claim 1, wherein the unfolded section is curved or forms an arc-shaped outer shape such that the longitudinal axis of the distal catheter section is offset from the longitudinal axis of the proximal catheter section.

6. The apparatus according to claim 1, further comprising a coupling member held inside each of the two or more openings along the first receiving portion and the two or more openings along the second receiving portion.

7. The device according to claim 6, wherein each connecting member forms an opening configured to securely receive the puncture tip from the corresponding needle member.

8. The device according to claim 6, wherein each connecting member is connected to the end of the suture thread.

9. The device according to claim 6, further comprising a suture of a first length connected to a first connecting member held in a first opening along the first receiving portion and a second connecting member held in a second opening along the second receiving portion.

10. The device according to claim 9, further comprising a suture of second length connected to a third connecting member held in a third opening along the first receiving portion and a fourth connecting member held in a fourth opening along the second receiving portion.

11. The device according to claim 1, further comprising one or more tissue expansion elements configured to extend transversely from the proximal catheter section.

12. The apparatus according to claim 1, further comprising a suture anchor device configured to receive one or more sutures of one or more lengths deployed from the tissue closure device and to fix tissue fixation anchors around the one or more sutures of one or more lengths.

13. The device according to claim 12, wherein two or more sutures of different lengths are fixed with a single tissue fixation anchor.

14. The device according to claim 1, further comprising a sheath assembly slidably disposed along the proximal catheter section, wherein the sheath assembly comprises a sheath member and a proximal interface member.

15. The apparatus according to claim 14, wherein the sheath member is configured to conform to the deployment section such that the receiving member in the thin form is surrounded within the sheath member.

16. A method for closing down an organization, The distal catheter section rotates around the deployment section, and the distal catheter section is advanced along the wall of the blood vessel into the opening, through the opening, so that the distal catheter section forms an angle with respect to the proximal catheter section. The steps include unfolding the receiving member from a thin form to an expanded form within the blood vessel such that the first receiving portion and the second receiving portion contact the wall adjacent to the opening, Steps include extending two or more anterior tactile members distally from a first side of the proximal catheter section, and extending two or more posterior tactile members distally from a second side of the proximal catheter section opposite the first side, such that each needle member punctures the wall adjacent to the opening, and extending the anterior and posterior tactile members distally. The steps include receiving the two or more front policy members into two or more openings along the first receiving portion, and receiving the two or more rear policy members into two or more openings along the second receiving portion, Methods for organizational closure, including those mentioned above.

17. The method according to claim 13, wherein the step of advancing the distal catheter section includes advancing the distal catheter section into the arterial incision or venotomy through the arterial incision or venotomy.

18. The method according to claim 16, wherein the step of advancing the distal catheter section includes advancing the distal catheter section such that the deployment section is exposed by the proximal retraction of the sheath member, and sliding the sheath member proximal to the proximal catheter section.

19. The method according to claim 18, wherein the step of sliding the sheath member proximal to the distal catheter section is to advance the distal catheter section into the opening through the opening and to contact the tissue surrounding the opening via the proximal interface member.

20. The method according to claim 16, wherein the step of deploying the receiving member includes the step of activating the operating mechanism of a handle coupled to the proximal catheter section.

21. The method according to claim 16, wherein the step of unfolding the receiving member further includes the step of holding the proximal catheter section at an angle to the distal catheter section such that the tissue area around the opening forms an ellipse or oblong shape.

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

23. The method according to claim 16, wherein the receiving step includes receiving the two or more front policy members into corresponding coupling members held in each of the two or more openings along the first receiving portion, and receiving the two or more rear policy members into corresponding coupling members held in each of the two or more openings along the second receiving portion.

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

25. The method according to claim 24, further comprising the step of trimming the first suture length and the second suture length from each of the needle members.

26. The method according to claim 25, further comprising the step of applying tension to the first suture length and the second suture length so that the opening along the wall of the blood vessel approaches and closes.

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

28. The method according to claim 27, further comprising the step of fixing the tissue fixation anchor to the length of the first suture and the length of the second suture.

29. A method for minimizing the risk of infection caused by sutures during tissue closure, The distal catheter section rotates around the deployment section, and the suture transport catheter is advanced along the wall of the blood vessel into the opening, through the opening, so that the distal catheter section forms an angle with respect to the proximal catheter section. The steps include unfolding the receiving member from a thin form to an expanded form within the blood vessel such that the first receiving portion and the second receiving portion contact the wall adjacent to the opening, Steps include extending two or more anterior tactile members distally from a first side of the proximal catheter section, and extending two or more posterior tactile members distally from a second side of the proximal catheter section opposite the first side, such that each needle member punctures the wall adjacent to the opening, and extending the anterior and posterior tactile members distally. The steps include receiving the two or more front policy members into the two or more openings along the first receiving portion, and receiving the two or more rear policy members into the two or more openings along the second receiving portion, such that the two or more front policy members are received into corresponding coupling members held in each of the two or more openings along the first receiving portion, and the two or more rear policy members are received into corresponding coupling members held in each of the two or more openings along the second receiving portion, The steps include: retracting the two or more front guide members from the first receiving portion and retracting the two or more rear guide members from the second receiving portion so that the lengths of the first and second sutures are retracted proximally through the wall adjacent to the opening; The steps include fixing the length of the first suture and the length of the second suture with tissue fixation anchors that prevent the length of each suture from shifting without knots, A method to minimize the risk of infection caused by sutures during tissue closure, including [mention specific method / method here].

30. The method according to claim 24, wherein the length of the first suture and the length of the second suture are prevented from coming into contact with tissue within the wall as they advance through the wall.

31. The method according to claim 24, wherein the step of advancing the distal catheter section includes the step of holding the first suture length and the second suture length within a sheath member that covers and is slidably disposed over the deployed section.

32. The method according to claim 31, further comprising the steps of advancing the distal catheter section and sliding the sheath member proximal to the proximal catheter section, such that the deployment section is exposed by the proximal retraction of the sheath member.

33. The method according to claim 32, wherein the step of sliding the sheath member proximal to the distal catheter section is to advance the distal catheter section into the opening through the opening and to contact the tissue surrounding the opening via the proximal interface member.

34. A suture anchor device, A handle having one or more operating mechanisms, A shaft attached to the handle, the shaft having a distal end that forms a distal opening, and a window along the side of the shaft such that the distal opening and the window communicate with each other, A sliding element movably disposed on the shaft, A tissue-fixing anchor is disposed within the distal opening and forms an anchor lumen that communicates with the window, A wire connected to the distal portion of the sliding element and extending through the window and the anchor lumen, thereby causing the wire to exit the distal opening and form a snare loop, A suture anchoring device equipped with [specific features].

35. The apparatus according to claim 34, wherein the handle has an interface surface that becomes thinner towards the tip of the shaft to which it is attached to the handle.

36. The apparatus according to claim 34, wherein the shaft forms a cross-sectional region aligned to correspond to a channel formed along the sliding element.

37. The apparatus according to claim 34, wherein the sliding element forms a ring tab.

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

39. The apparatus according to claim 34, wherein the window is formed in close proximity to the distal opening.

40. The apparatus according to claim 34, wherein the wire is retractable via the sliding element so that the snare loop is reduced and passes proximal to the distal opening, the anchor lumen, and the window.

41. The device according to claim 34, further comprising one or more sutures of a length that can be positioned within the snare loop.

42. The apparatus according to claim 34, wherein the tissue fixation anchor includes a ferrule that is deformable by crushing.

43. A method for anchoring sutures, The steps include placing one or more lengths of suture thread within the snare loop extending from the distal opening of the shaft, The steps include: retracting the sliding element proximal along the shaft so that the snare loop shrinks and the suture of one or more lengths is pulled proximal through the distal opening, through the anchor lumen of the tissue fixation anchor located in the distal opening, and out through a window formed along the side of the shaft; The steps include applying tension to the suture of one or more lengths and positioning the distal opening of the shaft close to a tissue opening along the blood vessel wall, The steps include: deforming the tissue fixation anchor so that one or more sutures of the aforementioned lengths are fixed; A method of securing sutures, including [specific method / technique].

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

45. The method according to claim 43, wherein the step of positioning one or more lengths of sutures includes the step of positioning one or more lengths of sutures extending from a portion of tissue adjacent to the tissue opening.

46. The method according to claim 43, wherein the step of retracting the sliding element proximally includes the step of stretching the sliding element until the sliding element is released from the shaft.

47. The method according to claim 43, wherein the step of applying tension to one or more sutures of one or more lengths includes applying tension until hemostasis is achieved from the tissue opening.

48. The method according to claim 43, wherein the step of deforming the tissue fixation anchor includes the step of crimping the anchor lumen onto one or more lengths of suture thread.

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