JP2013509974A - Tissue suturing device, transfer device and system, kit and method therefor - Google Patents

Abstract

  The invention relates to a tissue suturing device, a transfer device and system, a kit and a method therefor. The tissue suturing device can achieve tissue suturing instead of compression, and can be rapidly deployed by an introducing device or from outside the body.

Description

This application is a priority of US Provisional Patent Application No. 61 / 280,896, filed November 9, 2009, whose title is “Bioabsorbable Plug Tissue Closure Systems”. Claiming the right and filed on April 9, 2010, the name of the tissue is “suture device, transfer device and system, kit, and method therefor (Tissue Closure Devices, Device and Systems for Delivery, Kits and Methods Thefor), which is a continuation-in-part of US patent application Ser. No. 12 / 757,275, claiming priority to said US patent application. Is 20 US provisional patent application filed on April 9, 2009 with the title "Introducer Sheath Adapter for the Medical Delivery of a Medical Device" No. 61 / 212,296, filed Sep. 21, 2009, US provisional patent application 61/277, entitled “Tissue Closure Device Systems and Methods”, whose title is “Tissue Closure Device Systems and Methods”. No. 359 and a US provisional filed on November 9, 2009 with the title “Bioabsorbable Plug Tissue Closure Systems” Patent application 61 / 280,896 claiming priority and filed on December 3, 2008 with the title "Guided tissue cutting device, method and method of use, and kit for it (Guided Tissue) (Cutting Devices, Methods, of Use and Kits Thefor) ", which is a continuation-in-part of US patent application Ser. No. 12 / 327,655, which was issued on October 31, 2008. This is a continuation application of US patent application Ser. No. 12 / 263,322, filed on the date and entitled “Vascular Closure Devices, Systems, and Methods of Use”. , Said US patent application Ser. No. 12/26. No. 61, filed on Dec. 3, 2007, the title of which is “Guided Tissue Cutting Device and Method of Use”. No./005,435 and a US priority patent filed on August 26, 2008 with the title "Tissue Suturing Devices, Systems and Methods of Use (Systems and Methods of Use)" US patent application Ser. No. 10 / 183,396, claiming priority of application 61 / 190,100 and filed on June 28, 2002, now US Pat. No. 6,726,696. This is a continuation-in-part application, said US patent application Ser. Is a continuation of part of US patent application Ser. No. 10 / 127,714, filed on Apr. 23, 2002, whose title is “Arterytomy Devices and Techniques”. Patent application No. 60 / 286,269, filed April 24, 2001 and entitled “Percutaneous Vessel Access Suture Device and Method”. And patent application No. 6 filed on June 25, 2001 with the title "Percutaneous Vessel Access Suture Device and Method". No. 300/892 and filed on June 28, 2001, the name of the invention is “Percutaneous Vessel Access Suture Device and Method (Hemostatic Patch or Collar) [Percutaneous Vessel Access Device and Method (Hemostatic Patchor)” Collar)] ”claims the priority of patent application 60 / 302,255, the disclosure of which is incorporated herein by reference in its entirety. Form.

The present invention relates generally to medical devices and techniques, and more specifically to cardiovascular tissue suturing devices, systems, techniques and kits.

In most cardiology and imaging medicine processes, catheters are inserted through arterial introducers into arteries such as femoral arteries. Once such a process is complete, the physician removes the catheter from the introducer and then removes the introducer from the opening or incision or arteriotomy into the lumen in the blood vessel. The physician must then limit the amount of blood that is drained through the arteriotomy or prevent blood from being drained in order for the patient to be discharged. Physicians currently use many methods for suturing arteriotomy, such as local compression, sutures, collagen plugs, adhesives, gels, foams, clips, and similar materials.

In performing local compression, the physician pushes the blood vessel down so that the arteriotomy is naturally clotted. However, such a method takes considerable time and requires the patient to remain in the hospital for observation without moving. In addition, blood clots at the holes may be removed. The time required for local compression can be significantly increased depending on the amount of heparin, glycoprotein IIb / IIA antagonist or other anticoagulant used in the process described above. Sutures and collagen plugs are process variable, require time for vascular suturing and require a separate deployment device. Adhesives, gels, foams and clips have negative cost factors, require complex deployment processes, and process variability.

An aspect of the present disclosure relates to a suturing device. The suturing device comprises a flexible distal cap; one or more radially extending elements positioned proximally; between the flexible distal cap and one or more radial extending elements A stem that is positioned can be provided, and the flexible distal cap can be formed toward an axis. In at least some configurations, the flexible distal cap includes a substantially flat distal surface and a substantially flat proximal surface, a substantially flat distal surface and a substantially concave proximal surface, substantially A flat distal surface and a substantially convex proximal surface; a substantially convex distal surface and a substantially flat proximal surface; a substantially convex distal surface and a substantially convex proximal surface; A substantially convex distal surface and a substantially concave proximal surface; a substantially concave distal surface and a substantially flat proximal surface; a substantially concave distal surface and a substantially concave proximal surface; and It is configured to have at least one of a substantially concave distal surface and a substantially convex proximal surface. Further, the flexible distal cap has at least one of a uniform thickness section on the cross section or a thickness section variable on the cross section. In some configurations, the proximal surface of the flexible distal cap has at least one of an anchoring protrusion, a nib, or a rib. The flexible distal cap is also configured to have a shape selected from circular, triangular, egg (oval), ovoid, oval, square and dish-shaped. The flexible distal cap shape can have a rounded edge. Further, the stem is positioned on the proximal face of the flexible distal cap in at least one of the central and non-central areas. A proximally accessible stem bore is further provided. In addition, the clip can be positioned within the proximal bore. The proximally accessible stem bore also includes at least one inner screw along the inner surface, a parallel wall along its length, a non-parallel wall along its length, and a bore at a location along its length. At least one of an inner undercut and a bent bore along its length. Further, the bore is configured to extend from the proximal end of the device to the proximal end of the flexible distal cap. As can be appreciated, a wide variety of configurations for the stem are possible. Some configurations include cross-sectional profile shapes selected from the group including, for example, squares, triangles, arrowheads, trapezoids, rectangles, J-shapes, Y-shapes, hooks and bulbs. The stem has an opening positioned proximally therethrough, one or more outer features suitably configured to achieve stem anchoring in the body, a stem starting from its proximal end One or more slots along at least a portion of its length parallel to the longitudinal axis, a configuration allowing opening away from the longitudinal axis from its proximal end, a clasp, socket, breakable A proximal end suitably configured to form a flexible stem, a tearable stem, and / or a flexible distal end, the stem being in releasable communication with the tether. . In addition, a tether is provided. The tether is one or more of a wire, a spring, a screw, a ribbon, and a tube. The wire may be at least one of a bent wire, a curved wire, a corrugated wire, and a spiral wire.

Another aspect of the present disclosure relates to a transfer capsule. The transfer capsule comprises a cartridge body; a tapered distal tip; a compressible section; a transparent section; a lumen extending therethrough, the transparent section being suitable for housing a suturing device and containing the suturing device Configured as follows. The transfer capsule may also include a valve, one or more concave features positioned proximally on the outer surface of the cartridge body, one or more undercuts positioned distally, and external to the cartridge body. It is preferably configured to include a side opening, a one-way snap feature, an undercut central bore, and / or a central opening that is preferably configured to receive a plunger. At the position where the transfer capsule houses the plunger, the transfer capsule is further configured to allow the plunger to move in the first axial direction and to resist movement in a second axial direction different from the first axial direction. . One or more collets are further provided.

Yet another aspect of the present disclosure relates to a tissue suture transfer system. The tissue suture transfer system comprises an introducer, a tissue suture transfer cartridge; a guide and seal assembly; and a plunger, the introducer suitable for releasable coupling with a tissue suture transfer cartridge at a proximal end. The tissue suture transfer cartridge is preferably configured to be releasably coupled with a guide and seal assembly at a proximal end, and the plunger includes an introducer, a tissue suture transfer cartridge, and a guide and Each seal assembly is preferably configured to advance through the lumen. In at least some configurations, the flexible distal cap includes a substantially flat distal surface and a substantially flat proximal surface, a substantially flat distal surface and a substantially concave proximal surface, and substantially flat. Distal surface and substantially convex proximal surface, substantially convex distal surface and substantially flat proximal surface, substantially convex distal surface and substantially convex proximal surface, substantially An upper convex distal surface and a substantially concave proximal surface, a substantially concave distal surface and a substantially flat proximal surface, a substantially concave distal surface and a substantially concave proximal surface, and substantially It is configured to have at least one of an upper concave distal surface and a substantially convex proximal surface. Further, the flexible distal cap has at least one of a uniform thickness section on the cross section or a thickness section variable on the cross section. In some configurations, the proximal surface of the flexible distal cap has at least one of an anchoring protrusion, nib or rib. The flexible distal cap is also configured to have a shape selected from circular, triangular, egg-shaped, oval, elliptical, square and dish-shaped. The flexible distal cap shape has a rounded edge. Further, the stem is positioned on the proximal surface of the flexible distal cap in at least one of the central and non-central regions. A proximally accessible stem bore is further provided. Further, the clip can be positioned within the proximal bore. The proximally accessible stem bore also has an internal thread along the inner surface, a parallel wall along its length, a non-parallel wall along its length, and a position in the bore along its length. One or more of an undercut and a bent bore along its length. Further, the bore is configured to extend from the proximal end of the device to the proximal end of the flexible distal cap. As can be appreciated, a wide variety of configurations for the stem are possible. Some configurations include cross-sectional profile shapes selected from the group including, for example, squares, triangles, arrowheads, trapezoids, rectangles, J-shapes, Y-shapes, hooks and bulbs. The stem has an opening positioned proximally therethrough, one or more outer features suitably configured to achieve stem anchoring in the body, a stem starting from its proximal end One or more slots along at least a portion of its length parallel to the longitudinal axis, a configuration allowing opening away from the longitudinal axis from its proximal end, clasp, socket, breakable stem, A tearable stem and / or a proximal end suitably configured to form at least one flexible distal end may be further provided, the stem being in releasable communication with the tether. The In addition, a tether is provided. The tether is one or more of a wire, a spring, a screw, a ribbon, and a tube. The wire may be at least one of a bent wire, a curved wire, a corrugated wire, and a spiral wire. The transfer capsule may also include a valve, one or more concave features positioned proximally on the outer surface of the cartridge body, one or more undercuts positioned distally, and external to the cartridge body. It is preferably configured to include a side opening, a one-way snap feature, an undercut central bore, and / or a central opening that is preferably configured to accommodate a plunger. At the position where the transfer capsule houses the plunger, the transfer capsule is also configured to allow the plunger to move in the first axial direction and to resist movement in a second axial direction different from the first axial direction. . One or more collets are further provided.

Yet another aspect of the present disclosure relates to a method for suturing a wound or a method for suturing tissue. Suitable methods include assembling a tissue suturing system comprising a guide and seal assembly, a suturing device transfer capsule, and an introducing device; inserting the assembled wound suturing system through the skin; distal to the tubular sheath of the introducing device Centering the animal vessel with the tip; and inserting a plunger into the proximal opening with the guide and seal assembly; advancing the plunger through the guide and seal assembly and into the suturing device transfer capsule; Coupling the suturing device at the tip; advancing the suturing device into the tapered tip and reducing the suturing device profile in at least one plane; beyond the distal tip of the tubular sheath of the introducer Advancing the suturing device within; and the proximal surface of the suturing device faceplate is animal blood Step retracting the system into contact with the inner surface; comprising the step of decoupling the suturing device from the inside of the introducer. Further, the method includes at least one of drawing a tether coupled to the proximal end of the suturing device and releasing a tether coupled to the proximal end of the suturing device.

Yet another aspect relates to a kit for a percutaneous process comprising a suturing device transfer capsule containing a suturing device; an introducer device; a guide and seal assembly; and a plunger. The kit includes one or more needles, hypotubes, guide wires, electrode wires, intravenous wires, vascular introducers, catheters, laparoscopes, endoscopes, trocars and cannulas, for transfer to tissue. One or more articles selected from the group consisting of compounds, and / or a pair of scissors, scalpel, swab, syringe, tourniquet, lubricant, needle, snare, preservative, and It further includes one or more articles selected from the group comprising euphoric agents. Suitable compounds include, for example, one or more of sclerosants, antibiotics, and anti-inflammatory agents.

Incorporation by reference All publications, patents and patent applications mentioned in this specification are included by reference with each individual publication, patent or patent application and are specifically indicated individually. Are incorporated herein by reference to the same extent as they are.

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description of the illustrative embodiments that follow and the accompanying drawings in which the principles of the invention are used. The drawings are as follows.

1 is a perspective view of an embodiment of a vascular suturing system. FIG.

1 is a perspective view of an embodiment of a vascular suture clip that is an open or pre-deployed structure. FIG.

FIG. 3 is a perspective view of the clip of FIG. 2 in a closed or unfolded configuration.

FIG. 3 is a side view of the clip of FIG. 2 in an open configuration.

FIG. 3 is a side view of the clip of FIG. 2 in a closed configuration.

FIG. 3 is a bottom view of the clip of FIG. 2 in a closed configuration.

FIG. 6 is a perspective view of a deployment instrument preloaded with a vascular suture clip.

FIG. 8 is an enlarged view of the distal end of the deployment instrument of FIG. 7.

FIG. 8 is a perspective view of an inner tubular member portion of the deployment device of FIG. 7.

FIG. 10 is a side view of the inner tubular member of FIG. 9.

FIG. 10 is a distal end view of the inner tubular member of FIG. 9.

FIG. 8 is a perspective view of an outer tubular member portion of the deployment device of FIG. 7.

FIG. 13 is a distal end view of the outer tubular member of FIG.

FIG. 13 is a side view of the outer tubular member of FIG. 12.

FIG. 13 is an enlarged side view of an intermediate portion of the outer tubular member of FIG. 12.

FIG. 13 is another enlarged side view of the intermediate portion of the outer tubular member of FIG. 12.

FIG. 8 is a perspective view of a pressure element of the deployment device of FIG. 7.

FIG. 8 is a perspective view of the deployment instrument of FIG. 7 loaded onto a blood vessel introduction device inserted into a patient's blood vessel.

FIG. 8 is a perspective view of the deployment instrument of FIG. 7 advanced over the vascular introducer until its distal end abuts the vessel wall.

FIG. 20 is an enlarged view of the deployment instrument of FIG. 19 showing the pressurizing element in an initial relaxed position.

FIG. 8 is a perspective view of the deployment instrument of FIG. 7 with the pressure element fully advanced.

FIG. 22 is an enlarged view of the deployment instrument of FIG. 21 showing the pressure element fully advanced.

FIG. 8 is an enlarged side view of the deployment instrument of FIG. 7 in a partially deployed state showing the antler of a clip that penetrates the vessel wall.

FIG. 8 is a perspective view of the deployment instrument of FIG. 7 in a partially deployed state.

FIG. 25 is an enlarged view of the distal end of the deployment instrument of FIG. 24.

FIG. 25 is an enlarged bottom view of the proximal end of the deployment device of FIG. 24, showing the handle coupled to the stop element.

FIG. 25 is a side view of the proximal end of the deployment instrument of FIG. 24, showing the handle coupled to the stop element.

FIG. 25 is a side view of the deployment instrument of FIG. 24, shown in a partially deployed state after the blood vessel introduction device has been retracted.

FIG. 28 is a side view of the proximal end of the deployment device of FIG. 27, showing how the stop element can be overcome.

FIG. 8 is a perspective view of the deployment instrument of FIG. 7 in a fully deployed configuration.

FIG. 8 is a side view of the deployment instrument of FIG. 7, showing a vascular suture clip for suturing an arteriotomy, shown in a fully deployed configuration.

FIG. 8 is a side view of the deployment instrument of FIG. 7 showing the deployment device being removed from the patient following deployment.

FIG. 4 is a side view showing a blood vessel suturing process using a removable clip, showing a deployment instrument that advances over the blood vessel introduction device.

It is drawing which shows the expansion | deployment instrument removed after expand | deploying a clip, and is a side view which shows the process of FIG.

FIG. 34 is a side view showing the blood vessel suturing process of FIG. 33, showing the blood vessel suturing clip removed from the patient after hemostasis.

It is a perspective view of a clip loading mechanism.

FIG. 37 is a perspective view of the clip loading mechanism of FIG. 36 fully inserted into the distal end of the deployment instrument.

FIG. 37 is a perspective view of a pusher tool configured to pair with a vascular suture clip to fully advance the clip over the distal end of the deployment instrument and across the clip loading mechanism of FIG.

FIG. 39 is a perspective view of the pusher tool of FIG. 38 with the clip fully advanced over the distal end of the deployment instrument.

It is a bottom view of a slidable tissue cutter.

FIG. 41 is a perspective view of the slidable tissue cutter of FIG. 40.

FIG. 41 is a bottom view of a frame that can constitute the first component of the slidable tissue cutter of FIG. 40.

FIG. 43 is a distal end view of the frame of FIG. 42.

FIG. 6 is a perspective view of a slidable tissue dilator.

FIG. 45 is a distal end view of the slidable tissue dilator of FIG. 44.

FIG. 45 is a side view of the slidable tissue dilator of FIG. 44.

FIG. 12 is a perspective view of another embodiment of a vascular suture clip having an open structure.

FIG. 47B is a perspective view of the vascular suture clip of FIG. 47A in a closed configuration.

FIG. 47B is a bottom view of the vascular suture clip of FIG. 47A in a closed configuration.

FIG. 47B is a side view of the vascular suture clip of FIG. 47A in a closed configuration.

FIG. 12 is a perspective view of another embodiment of a vascular suture clip having an open structure.

FIG. 48B is a perspective view of the vascular suture clip of FIG. 48A in a closed configuration.

FIG. 12 is a perspective view of another embodiment of a vascular suture clip having an open structure.

FIG. 49B is a perspective view of the vascular suture clip of FIG. 49A in a closed configuration.

FIG. 12 is a perspective view of another embodiment of a vascular suture clip having an open structure.

FIG. 50B is a perspective view of the vascular suture clip of FIG. 50A in a closed configuration.

FIG. 12 is a perspective view of another embodiment of a vascular suture clip having an open structure. FIG. 51B is a perspective view of the vascular suture clip of FIG. 51A in a closed configuration. FIG. 51B is a side view of the vascular suture clip of FIG. 51A in an open configuration. FIG. 51B is a side view of the vascular suture clip of FIG. 51A in a closed configuration. FIG. 51B is a top view of the vascular suture clip of FIG. 51A in a closed configuration.

FIG. 6 is a circuit diagram of a circuit that uses direct resistive element heating to heat the tissue surrounding the arteriotomy.

FIG. 5 is a circuit diagram of a circuit that uses ohmic tissue heating to heat tissue surrounding an arteriotomy.

FIG. 6 is a distal end view of another embodiment of an inner tubular member that can form a component of a deployment device.

FIG. 55 is a proximal end view of the inner tubular member of FIG. 54.

FIG. 12 is a perspective view of another embodiment of a deployment device for use with a vascular suture plug. FIG. 56B is a perspective view of the deployment instrument of FIG. 56A with a pre-loaded vascular suture plug. FIG. 56B is a perspective view of the deployment instrument of FIG. 56A after the vascular suture plug has been deployed.

FIG. 56B is a side view of the deployment instrument of FIG. 56B advanced over a vascular introducer inserted into a patient's blood vessel.

FIG. 58 is a side view of the deployment instrument of FIG. 57 positioning the distal end of the vascular suture plug relative to the arteriotomy.

FIG. 58 is a side view of the deployment instrument of FIG. 57 holding the plug against the arteriotomy after removing the blood vessel introduction device.

FIG. 58 is a side view of the deployment device of FIG. 57 showing an exposed portion of the plug that begins to expand.

FIG. 58 is a side view of the deployed plug as the deployment tool of FIG. 57 is removed.

FIG. 62 is a side view of the deployed plug of FIG. 61 continuing to expand.

FIG. 62 is a side view of the deployed plug of FIG. 61 beginning to be absorbed by the patient's body.

FIGS. 64A through 64H illustrate various embodiments and suturing systems for a locking mechanism. FIG. 64A is an external view of the system and a cross-sectional view of the external surface taken along line BB. FIG. 64B is an external view of the system and a cross-sectional view of the external surface taken along line BB. FIG. 64C is an enlarged view of a cross section of the proximal section of the system shown in FIG. 64B. FIG. 64D is an enlarged view of the distal end of the device. FIG. 64E is an enlarged view of a cross section of the proximal end of the device. FIG. 64F is an enlarged view of a cross section of the proximal end of the device. 2 illustrates various embodiments and a suturing system for a locking mechanism. 2 illustrates various embodiments and a suturing system for a locking mechanism.

65A to 65G are drawings showing a transfer capsule. FIG. 65A is an incision. FIG. 65B is an outer side view. FIG. 65C is a cross-sectional view taken along line CC. It is drawing which shows a transfer capsule. FIG. 65E is a view of the distal barrel end as viewed from below. FIG. 65F is a cross-sectional view taken along line FF. FIG. 65G is a cross-sectional view shown with a direction indicator for pressurization.

FIG. 3 is a proximal cross-sectional view of a transfer system showing an embodiment of a mechanism that couples a portion of the transfer system with another portion. FIG. 3 is a proximal cross-sectional view of a transfer system showing an embodiment of a mechanism that couples a portion of the transfer system with another portion. FIG. 3 is a proximal cross-sectional view of a transfer system showing an embodiment of a mechanism that couples a portion of the transfer system with another portion. FIG. 3 is a proximal cross-sectional view of a transfer system showing an embodiment of a mechanism that couples a portion of the transfer system with another portion.

67A-67E illustrate a plug deployment system in use with currently available introducers. Fig. 2 illustrates a plug deployment system in use with currently available introduction devices. FIG. 67C is an enlarged view. FIG. 6 is a cross-sectional view of the proximal end. Fig. 2 illustrates a plug deployment system in use with currently available introduction devices.

FIG. 68A is an external view of a plug deployment system used with other introducer devices currently available. FIG. 68B is an external view of a plug deployment system used with other introducer devices currently available.

FIG. 69A is an exterior view of another plug deployment system for use with other currently available introduction devices. FIG. 69B is an external view of another plug deployment system for use with other currently available introduction devices.

70 to 70G are external views showing the plug transfer capsule. FIG. 70B shows a longitudinal section taken along line BB. FIG. 70C is a view of the distal end portion as viewed from below. FIG. 70D is an external view of the transfer capsule collet. FIG. 70E is a cross-sectional view taken along the line FF before machining. FIG. 70F shows after machining to form fingers or legs. FIG. 70G is a drawing of the proximal barrel as viewed from below.

71A to 71C are views showing a collet cartridge insert. FIG. 71A is an external view. FIG. 71B is a cross-sectional view taken along line BB. FIG. 71C is a view of the barrel as viewed from below from the proximal end.

72A to 72E are diagrams showing a capsule structure, and FIG. 72A is a side perspective view. FIG. 72B is a cross-sectional view in the longitudinal direction of the BB line. FIG. 72C is a view of the barrel as viewed from below from the distal end. FIG. 72D is a side view. FIG. 72E is a view of the barrel from below at the proximal end.

73A to 73E are drawings showing other capsule structures, and FIG. 73A is a perspective shade view. FIG. 73B is a longitudinal sectional view taken along line BB. FIG. 73C is a view of the distal end portion as viewed from below. FIG. 73D is a drawing showing a cross section with shading. FIG. 73E is a view of the proximal end portion as viewed from below.

74A to 74D are drawings showing a plunger grip, and FIG. 74A is a perspective view. FIG. 74B is a side sectional view taken along line BB. FIG. 74C is a side view. FIG. 74D is a cross-sectional view of the distal end portion as viewed from below.

75A to 75C are drawings showing another plunger grip structure, and FIG. 75A is a proximal shadow view of the plunger grip. FIG. 75B is a side sectional view taken along line BB. FIG. 75C is a view of the distal end portion as viewed from below.

It is drawing which shows a tether line structure. It is drawing which shows a tether line structure.

It is drawing which shows the other tether line structure. It is drawing which shows the other tether line structure.

78A to 78E are drawings showing the tip of the plunger, and FIG. 78A is a perspective view. FIG. 78B is a longitudinal sectional view taken along line BB. FIG. 78C is a view from the proximal end. FIG. 78D is a view from the distal end. FIG. 78E is a cross-sectional view of the plunger tip and plunger.

79A to 79J are views showing two plug structures, and FIG. 79A is a perspective view of the first structure. FIG. 79B is a top view from the distal end. FIG. 79C is a bottom view from the proximal end. FIG. 79D is a side view. FIG. 79E is a cross-sectional view of the EE line in the longitudinal direction. FIG. 79F is a perspective view of the second structure. FIG. 79G is a top view from the distal end. FIG. 79H is a side view. FIG. 79I is a bottom view from the proximal end. FIG. 79J is a longitudinal sectional view taken along line EE.

6 is a drawing showing a locking structure and a plug that operate in a state in which a stem portion of the plug is removably communicated with a plate. 6 is a drawing showing a locking structure and a plug that operate in a state in which a stem portion of the plug is removably communicated with a plate. 6 is a drawing showing a locking structure and a plug that operate in a state in which a stem portion of the plug is removably communicated with a plate.

81A-81N are diagrams illustrating additional plug pair structures employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem. FIG. 6 is a drawing showing a further plug pair structure employing wires, variably configured longitudinal openings in the stem, hooks, clasps, and vertical openings through the stem.

FIG. 6 is a diagram illustrating a releasable plug structure that is separated or torn along a stem. FIG. 6 is a diagram illustrating a releasable plug structure that is separated or torn along a stem.

83A to 83D are views showing a tether type plug structure including a ball or a radiopaque marker. 1 is a drawing showing a tethered plug structure with a ball or radiopaque marker. 1 is a drawing showing a tethered plug structure with a ball or radiopaque marker. 1 is a drawing showing a tethered plug structure with a ball or radiopaque marker.

84 to 84D are views showing a tether type plug structure having a ball and socket connecting portion. It is drawing which shows a tether type plug structure with a ball and socket connection part. It is drawing which shows a tether type plug structure with a ball and socket connection part. It is drawing which shows a tether type plug structure with a ball and socket connection part.

FIGS. 85A to 85R are diagrams showing variations of plug stems having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes. 6 is a diagram illustrating a deformation of a plug stem having a wide variety of geometric shapes.

86 to 86E are diagrams showing plugs having a petal structure. 2 is a diagram illustrating a plug having a petal structure. 2 is a diagram illustrating a plug having a petal structure. 2 is a diagram illustrating a plug having a petal structure. 2 is a diagram illustrating a plug having a petal structure.

1 is a diagram showing a disk structure for a face plate of a plug. 1 is a diagram showing a disk structure for a face plate of a plug.

FIGS. 88-88F illustrate alternative disk structures for the plug faceplate. 6 shows an alternative disk structure for a plug faceplate. 6 shows an alternative disk structure for a plug faceplate. 6 shows an alternative disk structure for a plug faceplate. 6 shows an alternative disk structure for a plug faceplate. 6 shows an alternative disk structure for a plug faceplate.

89A to 89G are views showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs. 1 is a diagram showing a disk structure having ribs and nibs.

90A to 90E are drawings showing a hemostatic plug capsule structure. It is drawing which shows the hemostatic plug capsule structure. It is drawing which shows the hemostatic plug capsule structure. It is drawing which shows the hemostatic plug capsule structure. It is drawing which shows the hemostatic plug capsule structure.

91A to 91I are views showing a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure. It is drawing which shows a stem and capsule pair structure.

92A through 92T are diagrams illustrating the interaction and operation of system components when a vascular suturing device is deployed using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed. 2 is a diagram illustrating the interaction and operation of system components when deploying a vascular suturing device using a system as disclosed.

93A to 93D are drawings showing a plug having a snap action geometric structure. 2 shows a plug having a snap action geometry. 2 shows a plug having a snap action geometry. 2 shows a plug having a snap action geometry.

94A to 94D are views showing another example of a plug having a snap action geometric structure. 6 is a view showing another example of a plug having a snap action geometric structure; 6 is a view showing another example of a plug having a snap action geometric structure; 6 is a view showing another example of a plug having a snap action geometric structure;

95A to 95C are drawings showing a plug having a self-intersecting geometric structure. 2 is a diagram showing a plug having a self-intersecting geometric structure. 2 is a diagram showing a plug having a self-intersecting geometric structure.

It is drawing which shows the vascular access stitching | suture part.

97A through 97E are diagrams illustrating the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location. FIG. 6 shows the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location. FIG. 6 shows the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location. FIG. 6 shows the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location. FIG. 6 shows the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location.

The following description provides examples of specific embodiments for purposes of illustration. The claimed invention is not limited to these examples. Further, although examples have been presented in connection with vascular sutures, the present invention also has a wide range of applications for other types of tissue sutures. US Pat. No. 7,025,776, which is hereby incorporated by reference in its entirety and is incorporated by reference to Houser, et al., Instead of features of the embodiments disclosed herein, Alternatively, a variety of additional vascular suturing devices and methods are disclosed that have features for use in combination with this feature.

As will be appreciated by those skilled in the art, the components of the vascular suturing system described herein include 6 to 22 French and an introducer device dimensioned to any size within this range. Dimensions are determined. Alternatively, the introduction device is sized at less than 6 French and / or greater than 22 French. The scope is presented merely for purposes of illustration and is intended to facilitate understanding of the present disclosure. Additional values presented for illustrative purposes only are included in Table 1.

I. Vascular Suturing System Referring to FIG. 1, a vascular suturing system 100 generally comprises a vascular suturing device such as a clip 102 or a plug and a deployment or advancement instrument 104. A plug or suturing device may also refer to a sealing device, an implant, a vascular access suturing device, an arteriotomy suturing device, a vascular suturing device, and a tissue suturing device. As shown, the clip 102 is loaded onto the distal end 105 of the deployment instrument 104. The deployment instrument 104 is slidably attached to or advanced along and generally guided by the vascular introducer 108 or other tubular medical device such as a catheter inserted into the blood vessel 18. The In certain embodiments, the narrow hole in the skin initially formed for insertion of the vascular introducer device 108 is inflated or expanded by the slidable guided tissue cutter 106 to deploy the deployment device 104 to the body. A percutaneous hole 12 that is large enough to easily allow the passage of.

The deployment instrument 104 is guided by the tube section 110 of the vascular introducer 108 through the percutaneous hole 12 until the arteriotomy position 14 is reached. The deployment instrument 104 is configured to deploy the vascular suture clip 102 to suture the arteriotomy 114. The deployment instrument 104 can be retracted at this time.

(A) Deployment instruments A variety of deployment instruments are shown and described herein. Those skilled in the art will appreciate that modifications to the disclosed structures can be made without departing from the scope of the present disclosure.

Returning to FIG. 8, a more detailed view of the distal end 105 of the deployment device 104 in FIG. 1 is shown, but the deployment device is deployed to accommodate the clip 102 and generally deployed. It is configured to hold this clip in an open structure. In the illustrated embodiment, the antler 126a, 126b is substantially parallel to the central axis of the inner tubular member 154, and the distal ends 127a, 127b of the antler 126a, 126b are remote from the inner tubular member 154. Is substantially aligned with the distal end 165. In other embodiments, the distal ends 127a, 127b of the antler 126a, 126b extend slightly beyond the distal end 165 of the inner tubular member 154. Alternatively, deployment instrument 104 is in its initial configuration with distal ends 127a, 127b of antlers 126a, 127b spaced a predetermined distance proximally from distal end 165 of inner tubular member 154. In the meantime, clip 102 will be located more proximally. As will be described in more detail below, the inner diameter of the base 120 of the clip 102 is positioned proximate to or in contact with the outer diameter of the distal end 165 of the inner tubular member 154. The outer diameter of the base 120 of the clip 102 is positioned proximate to or in contact with the inner diameter of the distal end 173 of the outer tubular member 156. . The restoring force exerted by the antler 126a, 126b in a radially inwardly open configuration increases the friction between the inner surface of the clip 102 and the outer surface of the inner tubular member 154, thereby generally reducing the clip 102. The inner tubular member 154 and the outer tubular member 156 cannot easily slide away from their positions.

The distal end 173 of the outer tubular member 156 includes an inner shelf or countersink 174 that houses and is configured adjacent to the base 120 of the clip 102. As described in more detail below, when the assembled deployment instrument 104 is advanced to the tissue suturing position and the inner tubular member 154 is axially retracted proximally from the outer tubular member 156, it is distally moved. A reaction force is applied to the base 120 of the clip 102 by the countersink 174, thereby preventing the clip 102 from moving further proximally. When the distal end 165 of the inner tubular member 154 moves proximally past the base 120 of the clip 102, the contact or adjacent relationship between the clip 102 and the inner tubular member 154 and the outer tubular member 156 is obstructed; Clip 102 is released from deployment instrument 104. In certain embodiments, the countersink 174 may be used to allow the outer tubular member 156 to be unable to contact all or part of the clip 102 or to protect all or part of the clip 102 during advancement prior to deployment. Tolerate. In other embodiments, the countersink 174 can be omitted and the distal most surface of the outer tubular member 156 can be configured to contact the base 120 to eliminate force or to remove the clip 102 from the deployment instrument 104. Allow.

9 to 11 are views showing an example of the inner tubular member 154 separated from the outer tubular member 156 before the structure shown in FIGS. 7 and 8 is assembled. Inner tubular member 154 forms an inner lumen 166 configured to receive a tubular medical device, such as vascular introducer 108. The elongated slot 162 allows the medical professional to tilt at least a portion of the deployment device 104 far from the proximal portion of the vascular introducer 108 without the deployment device 104 generally leaving the tube section 110. And allows axial separation from the proximal portion. For example, refer to FIG. These structures allow the medical professional to position the deployment device 104 out of the path while the desired adjustment or diagnostic process is taking place. In the presented embodiment, the axial groove 160 extends along the length of the outer surface of the inner tubular member 154 and is formed on the inner surface of the outer tubular member 156 (see FIG. 13). Configured to be paired with Such a paired structure can avoid rotation of the inner tubular member 154 relative to the outer tubular member 156 and helps align the elongated slot 162 of the inner tubular member 154 and the elongated slot 170 of the outer tubular member 156.

The proximal end of the inner tubular member 154 includes a handle 164 that can be grasped by a medical professional, for example, to retract the inner tubular member 154 during deployment. The handle is generally configured to be handled by the user and so that the user can achieve movement or actuation of the distal end in response to the user's control over the handle. As shown, the handle 164 may be circular with a flat lower end to facilitate easy delatching of the stop mechanism during full deployment, as will generally be described below. Other shapes and structures may be used. The upper portion of the handle 164 includes a cut portion 350 that is aligned with and merges with the elongated slot 162. The lower portion of the handle 164 includes a recess 169 to accommodate the tab 172 of the outer tubular member 156. The distal end of the handle 164 includes a substantially flat distal surface 354. The distal surface 354 is configured to be adjacent the proximal edge of the tube section of the outer tubular member 156 to prevent excessive insertion of the inner tubular member 154 into the outer tubular member 156. Proximal surface 167 of handle 164 is substantially flat and is configured to adjoin stop 175 on tab 172 during partial deployment. The lower portion of the handle 164 includes an angular surface 362.

12 to 16 are views showing an example of the outer tubular member 156 separated from the inner tubular member 154 before the structure shown in FIGS. 7 and 8 is assembled. Outer tubular member 156 forms an inner lumen 171 configured to receive inner tubular member 154. The elongated slot 170 extends along the length of the outer tubular member 156 to provide access to the interior of the inner lumen 171. The elongated slot 170 of the outer tubular member 156 is configured to be aligned with the elongated slot 162 of the inner tubular member 154. The distal end of the outer tubular member 156 includes one or more slots 176 to provide side access to the clip 102 while the deployment instrument 104 is in its initial configuration.

A fixed structure or movement restriction structure, such as tab 172, extends from the proximal end of outer tubular member 156. Tab 172 includes a stop surface 175 configured to be adjacent to proximal surface 167 on handle 164 during partial deployment, as described in more detail below. Tab 172 includes two tapered arms 181 surrounding window portion 177 to facilitate assembly of deployment instrument 104, as will be described further below. Tab 172 may also be recessed, deteriorated, or include hinge portion 186 to facilitate folding. In certain embodiments, the tab 172 can be relatively rigid except for the degraded portion 186. In certain embodiments, the folding of tab 172 is configured to occur substantially at degraded portion 186. In certain embodiments, tab 172 is relatively long. For example, the tab 172 can be at least about 20 mm. Long tab 172 facilitates handling by medical professionals. The long tab 172 can also increase the leverage added by the medical professional to fold.

The deployment device includes, in one example, a vacuum structure with a pressure taper 178 formed on the flexible tab 188 of the pressure element 158 and the outer surface of the outer tubular member 156. The outer tubular member 156 also includes a vacuum structure such as an axial protrusion 185 extending from the proximally located outer surface. Although other configurations are possible, as presented, the axial protrusions 185 can be located at opposite positions substantially opposite the elongated slot 170. A ramp or unidirectional tapered locking portion 184 extends from the axial protrusion 185. A generally annular stop 182 extends from the outer surface of the outer tubular member 156. The outer surface of the outer tubular member 156 also includes a pressure taper 178. The pressure taper 178 ends with a substantially flat surface 180. The surface 180 can contact the annular stop 182 adjacent to the annular stop 182. As shown in FIG. 16, the outer tubular member 156 includes two pressure tapers 178 located on the substantially circular outer tubular member 156 in positions that are substantially diametrically opposed to each other. Also, as shown, the pressure taper 178 is positioned at approximately the same circumferential distance from the elongated slot 170 and the axial protrusion 185. Other structures are possible.

FIG. 17 provides a detailed view of the pressure element 158, which in some embodiments is a ring-shaped element configured to be received on the outer surface of the outer tubular member 156. It can be. In certain embodiments, as illustrated, the pressure element 158 can be a separate element from the outer tubular member 156. In other embodiments, the pressure element 158 is integrally formed with the outer tubular member 156. As will be described in more detail below, the pressurizing element 158 is used to ensure the application of sufficient and not excessive pressure by the medical professional to safely initiate deployment of the clip 102. The pressure element 158 includes a cutout portion 195 that is aligned with the elongated slot 162 of the inner tubular member 154 and the elongated slot 170 of the outer tubular member 156. The recess 190 is configured to pair with the axial protrusion 185 of the outer tubular member 156 to maintain the pressurizing element 158 in proper alignment. The inner surface of the pressure element 158 includes one or more flexible tabs 188. The flexible tab 188 is configured to align with and advance over the pressure taper 178 of the outer tubular member 156.

During assembly of the deployment instrument 104, the pressure element 158 can be advanced over the proximal end of the outer tubular member 156 and over the unidirectional tapered locking portion 184. The recessed portion 190 and / or the locking portion 184 are configured to be folded or temporarily deformed sufficiently to allow these processes. Alternatively, the locking portion 184 or other locking means is formed on or secured to the outer tubular member 156 after positioning of the pressure element 158. The tapered locking portion 184 prevents the pressure element 158 from moving too far in the proximal direction relative to the outer tubular member 156. The inner tubular member 154 is then inserted into the inner lumen 171 of the outer tubular member 156 from the proximal end of the outer tubular member. When the inner tubular member 154 is inserted into the outer tubular member 156, the inner side 183 (see FIG. 11) of the lower portion of the handle 164 adjacent to the recess 169 begins to contact the tapered arm 181 of the tab 172. Subsequent advancement of the inner tubular member 154 causes the surface 183 to apply an inward force against the arm 181 distally. Window 177 allows arm 181 to elastically bend inward until handle 164 is advanced distal to stop 175. The inner tubular member 154 can then be further advanced until the distal surface of the handle 354 contacts the proximal edge of the tube section of the outer tubular member 156.

In another example of a deployment instrument that forms part of a suturing system or kit, a vascular suturing system 600 is shown in FIGS. 64A-64E. Vascular suturing system 600 is preferably configured to further provide three parts in communication with each other: plunger 610, capsule 630, and introducer 650. Plunger 610 further includes a deployment plunger 612, a guide and seal assembly 614. The deployment plunger 612 is a cylindrical rod or a substantially cylindrical rod configured to be received within an opening formed in the guide and seal assembly 614. The plunger 612 is configured to be movable in at least one direction along the central axis A. The plunger can terminate with a plunger tip 620 that can be removed in some configurations.

Suture device capsule 630 is coupled with a plunger at proximal end 70 and an introducer at distal end 80. The suturing device capsule 630 includes a deployment cartridge body 632 and a compressible section 634. In some configurations, the suturing device capsule 630 is suitably configured to snap into at least a portion of the introducer cap.

The introduction device 650 is suitable for accommodating a part of the capsule 630. The concave nose 646 of the capsule 630 is positioned to align within the opening of the introducer bore to minimize cocking of the suturing device 670 during deployment. A central opening 656 is provided through which a clip, plug or suturing device 670 received within the capsule 630 proceeds during deployment. In such a configuration, a hemostasis valve 652 is provided on the introducer that holds the suturing device 670 in place within the capsule during transport.

Once the introducer, capsule 630 and plunger are assembled, the components are not separated during use. These features prevent unintentional disassembly once the clip, plug or suturing device 670 is deployed within the blood vessel. For example, if the overall deployment assembly and introducer are not retracted as a single unit, the clip, plug or suturing device 670 is detached from the plunger. This results in the clip, plug or suturing device 670 being deployed into the blood vessel without being properly placed at the position of the arteriotomy. As shown in FIG. 64C, the capsule 630 is snapped across the introducer 650 at its proximal end, and the capsule 630 is snapped within the introducer at its proximal end. When the plunger 610 is fully positioned on the capsule 630, an additional flange on the distal end 80 of the arm or cap 616 extends from the plunger 610 sandwiched in a pawl 636 provided on the outer surface 631 of the capsule 630. 675 is provided.

Each component is configured to provide a one-way snap feature, as shown in more detail in FIGS. 64E through 64H. 64E and 64F, the plunger grip 610 is snapped onto the capsule 630 and the system is provided with the illustrated internal locking feature, but the proximal end 70 of the introducer 650 is radially away from the axis A. And then extends so as to bend along an axis parallel to axis A, or along an axis substantially parallel to axis A, to the distal end 80 of capsule 630. It is combined with the outer side surface of and is paired. Capsule 630 features a tapered tip 636 at its distal end 80 that is further provided with an undercut configured to be sandwiched within the inner recess of the introducer.

Examples of external locking features are shown in more detail in FIGS. 64G and 64H. In connection with the previous illustration, the plunger grip 610 is snapped onto the capsule 630. At the location where the external locking feature is provided, the proximal end of the introducer 650 further comprises a finger 660 sandwiched in a groove 642 formed on the outer surface 631 of the capsule 630, and the capsule 630 is disposed therein. A flange to be sandwiched is provided.

The tissue clips and plugs described in more detail below are deployed using the system by providing a clip, plug or suturing device 670 within the capsule 630, for example, as shown in FIGS. 65A-65G. . Capsule 630 has a tubular outer surface 631 having a first diameter at proximal end 70 and a smaller diameter at distal end 80. As can be understood by those skilled in the art, the tubular capsule can adopt various cross-sectional structures including circular, egg-shaped, polygonal, D-shaped and the like. For illustrative purposes, dimensions are presented for circular cross-sectional shapes to provide context for the relevant size and volume. In addition, the size is changed according to the size of the introduction device used. One skilled in the art will appreciate that the introduction device can vary from 8 French to 20 French (and values within this range). Thus, the dimensions are proportional to the French dimensions of the introducer. Thus, for example, the normal diameter of the first diameter is about 4 mm to 25 mm, more preferably about 8 mm, or any value within this range with a tolerance of about 1/100 mm. A typical diameter range for the second diameter is from about 1 mm to about 3 mm, more desirably about 2 mm, or any value within this range with a tolerance of about 1/100 mm. The full length range of the capsule is from about 12 mm to about 50 mm, or up to 100 mm, more preferably about 35 mm, or any value within this range with a tolerance of about 1/100 mm. Capsule 630 comprises a generally intermediate length transparent tubular section 640 through which the presence of a clip, plug or suturing device is observed, and the clip, plug or suturing device 670 contained within capsule 630 is deployed. Through this, fluid flow can be observed through this. As illustrated in cross section along the longitudinal axis A, the capsule body 632 includes a proximal end 70, a distal end 80 and an intermediate section. Openings 638, 638 'are provided in both the proximal and distal body sections. As shown, a valve 648 is provided. The suturing device 670 is positioned inside the capsule 630 where the capsule body 632 is configured so that a user can view the clip, plug or suturing device 670 within the capsule body 632. The concave nose 646 of the plunger grip 610 is snapped onto the capsule 630 and the system is provided with the illustrated internal locking feature, while the proximal end 70 of the introducer 650 is near its diameter. The distal end 70 and the distal end 80 are tapered along their lengths so that they are not substantially identical. Further, the elongated aperture 638 'within the nose 646 can also vary in diametrical plane along its length. A tapered tip 646 at the distal end is configured to inflate the hemostasis valve 652 within the introducer 650 to open the valve at least temporarily, thereby allowing the distal end of the plunger 612 to The clip, plug or suturing device 670 can be advanced through the valve without removing the clip, plug or suturing device from the end or potentially damaging the clip, plug or suturing device 670. Changing the cross-section of the elongate opening within the nose 654 through which the clip, plug or suturing device 670 progresses during deployment, such that when the clip, plug or suturing device 670 is advanced forward, the clip, plug or The suturing device 670 is thus manipulated to achieve a reduced profile. The see-through chamber allows fluids such as blood to flow, thereby ensuring that the proper position of the introducer sheath is achieved. Capsule 630 is also configured to include a guide for insertion of a tool to contact and advance clip, plug or suturing device 670. In the structure shown here, the legs of the clip, plug or suturing device 670 are positioned to rest on the edge of the bore on the distal end section.

Still referring to FIGS. 66A-66D, additional structure of capsule 630 and plunger assembly configured to provide disassembly is illustrated. The illustrated structure is preferably configured to prevent unintentional separation of the deployment assembly from the introducer once the clip, plug or suturing device extends completely into the blood vessel. Some structures are suitably configured to allow intentional disregard by the physician if necessary. In conjunction with the previous structure, the vascular suturing system 600 is preferably configured to further provide three parts in communication with each other: a plunger 610, a capsule 630, and an introducer 650. Plunger 610 further includes a deployment plunger 612 and a guide and seal assembly 614. The deployment plunger 612 is a cylindrical rod or a substantially cylindrical rod configured to be received within an opening formed in the guide and seal assembly 614. The plunger 612 is configured to be movable in the first direction and the second direction along the central axis A. The plunger 610 is sandwiched across the proximal end 70 of the capsule 630 and snapped onto the proximal end. Alternatively, an internal locking feature can be provided, where the male section of plunger 610 slides into a pair of female recesses at the proximal end of capsule 630, as shown in FIG. 66D. Locked in place. In some structures, no separate seal is provided. Instead, hemostasis is achieved by the suturing device itself when the suturing device is sealed within the capsule. Therefore, it is optional to prepare a separate seal with any structure among these structures.

Further aspects of the deployment system are the introducer system available from Cordis (FIGS. 67 and 69) and the introducer system available from St. Jude Medical (FIG. 68). And can be used with a variety of commercially available introduction device systems. As shown in FIGS. 67A-67E, 68A and 68B, and FIGS. 69A and 69B, each system 600 includes a plunger 610, a transfer capsule 630 combined with the plunger 610, a plunger tube 618, a collet cartridge insert. 623, a transfer cap collet 621, a bioabsorbable suturing device 670, a tether 662, and a tether traction element 664. As shown in FIGS. 68 and 69, a plunger tip 613 is also provided. Introducing devices illustrated herein are typically in the range of about 120 mm to about 170 mm in length, or have a tolerance of about 1/100 mm at any value within this range. The plunger tube is typically 15 mm to 50 mm longer than the length of commercially available introducers, and is thus configured to be paired with a deployment system configured to operate with a 120 mm introducer, for example. For example, in length, it includes a plunger of about 135 mm to about 170 mm or any length within this range and has an internal diameter of about 1.0 mm to about 2.4 mm (for a 6 French introducer). The system allows for easy and easy non-surgical suturing of dialysis vascular access locations (eg, including tubular organs and / or grafts) that are no longer usable due to occlusion or other reasons. Composed.

A suitable structure for the transfer capsule 630 is shown in more detail in FIGS. 70A-70F. The transfer capsule 630 has an outer diameter of about 4 mm to 12 mm at its distal end 80 and an outer diameter of about 3 mm to about 11 mm at its proximal end, or about any value within this range. Has a tolerance of 1 / 100mm. If the device is manufactured in bulk, the distal tip and capsule are configured as a single component. Proximal end 70 has an opening through which the guide assembly is sandwiched (as shown in FIG. 64 above) and has an opening through which a deployment plunger that can be advanced when pushing the suturing device into the transfer position. The distal end 80 has a smaller outer diameter to facilitate coupling with the introducer (which is sandwiched around the outer surface 631 of the capsule 630 until it reaches the wall). From FIG. 70C, a view of the barrel of the capsule 630 from below from the distal end 80, the central opening 644 can be seen, and the bottom surface 649 formed from the counterbore features a sidewall and a base surface. . The transfer capsule collet 621 shown in FIGS. 70D and 70E has a first diameter in the range of about 3 mm to about 4 mm, or a diameter having a tolerance of about 1/100 mm at any value within this range. Have a diameter, or have a second diameter in the range of about 2.7 mm to about 3.0 mm, or have a second diameter with a tolerance of about 1/100 mm at any value within this range. The inner diameter of the opening ranges from about 1.5 mm to about 1.9 mm at its proximal end and ranges from about 1.3 mm to about 1.7 mm at its distal end, or any within this range With a tolerance of about 1/100 mm. From FIG. 70F, the outer taper of the outer surface of the collet 621 from the proximal end (wider) to the distal end (narrower) is a value of about 0.4 ° to about 8 °, more preferably about 5 °. Or have any value within this range.

A collet cartridge insert 623 is shown in FIGS. 71A-71C. The collet cartridge insert is a cylindrical clamp formed with a slot that is inserted into the tapered interior of the transfer capsule to hold the capsule. The collet cartridge insert has a cylindrical profile with an opening extending along axis A. This opening has a tapered dimension as shown in FIG. 71B. 71C is an end view from the distal end 80 of the collet cartridge insert. Typically, the collet has a first outer diameter at the proximal end 70 and a second outer diameter at the distal end 80. The first outer diameter is in the range of about 4.4 mm to about 5.0 mm, or has a tolerance of about 1/100 mm at any value within this range, and the second outer diameter is about 4.7 mm. Or a tolerance of about 1/100 mm at any value within this range. The inner diameter of the opening ranges from about 3.3 mm to about 3.9 mm at its proximal end and ranges from about 1.5 mm to about 1.8 mm at its distal end, or any within this range With a tolerance of about 1/100 mm. Does the outer taper of the inner opening of the collet cartridge insert from the proximal end (wider) to the distal end (narrower) have a value of about 0.4 ° to about 8 °, more preferably about 5 ° With any value in this range.

The distal tip 654 of the transfer capsule 630 is shown in more detail in FIGS. 72A-72E. The distal tip 654 of the transfer capsule 630 has a stem with an opening 636 extending therethrough. The stem is also referred to as a core, column, vertical section, middle section, center, post or shaft without departing from the scope of the present disclosure. The aperture is diametrically and has a tolerance of about 3.8 mm to about 4.2 mm at its proximal end, more preferably about 4.02 mm, or about 1/100 mm at any value within this range; Along the tapered tip 638 is about 2.4 mm to about 2.6 mm, or more preferably about 2.51 mm, or down with a diameter having a tolerance of 1/100 mm at any value within this range. Tapered. The length of the distal tip ranges from about 4.0 mm to about 25.0 mm, more preferably about 18 mm, or has a tolerance of about 1/100 mm at any value within this range. In some structures, a length greater than 35 mm is appropriate. The outer diameter of the transfer capsule distal tip is about 3.0 mm to about 4.0 mm, more preferably 3.2 mm, or has a tolerance of about 1/100 mm at any value within this range. The outer diameter may be up to 35 mm or more in some cases. The outer diameter of the widest section ranges from about 4.5 mm to about 10.0 mm, more preferably about 5.7 mm, or has a tolerance of about 1/100 mm at any value within this range. . In some constructions, the widest section is up to 35 mm or even larger. The outer diameter of the proximal section is in the range of about 4.5 mm to about 10.0 mm, more preferably about 5.7 mm, or has a tolerance of about 1/100 mm at any value within this range. Inner tapered section 634 is located near proximal end 70. The distal tip has an intermediate body with a radius that is greater than the radius of the neck. A proximal section is provided that is larger than the distal tip but has a smaller radius than the intermediate body. The transparent proximal module section of transfer capsule 630 is illustrated in further detail in FIGS. 73A-73E. This transparent section has a body with an opening 637 therethrough. The body provides an outer diameter sized so that it can be coupled with the distal end 80 of the plunger at its proximal end 70 and at the proximal end of the transfer mechanism at its distal end 80. It is configured to provide an outer diameter that is sized to be mated with end 70. As shown, the outer diameter of the proximal end 70 is larger than the diameter of the intermediate section but smaller than the diameter of the distal section. The opening at the distal end 80 is sufficiently large so that the proximal end 70 of the transfer mechanism is sandwiched within the recess adjacent the distally facing surface. The proximal end 70 of the opening has a diameter that is flared when reaching the proximal end 70 of the module.

The capsule contains a sealing element or vascular suturing device and protects the device from damage during the deployment process. As a result of the structure of the capsule, the capsule also begins to reduce the cross-sectional diameter of the vascular suturing device prior to the vascular suturing device entering the introducer. The capsule achieves a reduction in the cross-sectional diameter of the vascular suturing device, for example, by deflecting a radially extending section of the vascular suturing device. The capsule also facilitates confirmation that the introducer sheath is positioned within the target vessel due to the presence of blood visible within the capsule.

Plunger grip 610 is shown in FIGS. 74A-74D. Plunger grip 610 is configured to provide a variable outer surface that facilitates coupling by a user. The proximal end 70 has a knob shape that tapers into a narrower neck before widening at its distal end 80. A central lumen 622 is provided along part of its length along axis A, but ends before the proximal end 70. A vertical opening is provided near the distal end 80 that communicates with the central lumen. The vertical opening can be, for example, a threaded hole for use with a set screw to allow adjustment of the overall length of the plunger. The length of the plunger grip is about 12 mm to about 45 mm, or more preferably 25 mm, or has a tolerance of about 1/100 mm at any value within this range. The outer diameter of the plunger grip ranges from about 3.0 mm to about 12 mm along its length, more desirably about 10 mm in its widest section, about 6 mm in its narrowest section, or An arbitrary value within the range has a tolerance of about 1/100 mm. The concave central portion of the plunger has, in particular, a variable outer diameter along its length ranging from about 5 mm to about 20 mm in length, more preferably from about 7 mm to about 15 mm, or within this range. An arbitrary value has a tolerance of about 1/100 mm. Although these features are optional, this improves the physician's grip at the proximal end. The central lumen is for coupling with a plunger rod or tube.

A variation of the plunger grip is illustrated in FIGS. 75A-75C. As shown, the plunger grip 610 does not have a concave section along its length. The plunger grip comprises a central lumen 622 having a first inner diameter and a second inner diameter, the length of which is about 10 mm to about 35 mm, more preferably about 16 mm, or about 1/100 mm at any value within this range. Have a tolerance of. Whether the first inner diameter of the lumen is in the range of about 6.3 mm to about 7.7 mm, or more preferably about 7 mm, while the outer diameter of the plunger grip is in the range of about 7.6 mm to about 8.9 mm. More desirably, it is about 8 mm, or has a tolerance of about 1/100 mm at any value within this range. The second inner diameter is about 1.2 mm to about 1.8 mm, or more preferably 1.6 mm, or has a tolerance of about 1/100 mm at any value within this range. The lumen length of the first inner diameter section is in the range of about 5.0 mm to about 7.6 mm, more preferably about 6.4 mm, or any value within this range has a tolerance of about 1/100 mm. While the length of the lumen of the second inner diameter section is in the range of about 7.6 mm to about 11.4 mm, more preferably about 9.4 mm, or any value within this range of about 1/100 mm. Has tolerance.

A tether line 672 is employed in some structures of the system. Tethers also include leashes, temporary or removable plugged mechanisms, sutures, threads, wires, lines, containment members, containment elements, stabilization elements and capture elements without departing from the scope of the present disclosure Also called. Tethers are bioabsorbable, biodegradable, or otherwise degraded in the body. Suitable tether line structures are illustrated in FIGS. 76A and 76B and FIGS. 77A and 77B. The tether line 672 may be a continuous loop, as shown in FIG. 76A, or a wire forming the tether 674, as shown in FIGS. 81A-81D. In some structures as shown in FIGS. 68 and 69, the plunger tip 662 is employed without a tether line. A suitable structure for the plunger tip is illustrated in FIGS. 78A-78E. Plunger tip 662 includes a tapered proximal end 70 that is adapted to snap into a pair of recesses 676 as shown in FIG. 79E at the proximal end of the vascular suture and It has a round distal tip 80. 68, 69 and 78E show the plunger tip in the plunger stem. The total length of the plunger tip is, for example, about 7.6 mm to about 11.4 mm, or more preferably about 9.5 mm, or has a tolerance of about 1/100 mm at any length within this range. . The proximal end has a first diameter of about 1.02 mm to about 1.27 mm, more preferably about 1.14 mm, or a trapezoidal cross section having a tolerance of about 1/100 mm at any diameter within this range. 664. Over a length of about 0.76 mm to about 1.02 mm, more preferably about 0.89 mm, the trapezoidal cross section is about 1.02 mm to about 1.27 mm, more preferably 1.14 mm, or any range within this range The diameter of the one having a tolerance of about 1/100 mm is widened. A narrowed middle neck section 666 follows that is similar in diameter to the proximal end of the trapezoidal section and has a length of about 0.76 mm to about 1.02 mm, more preferably about 0.89 mm. The diameter of the main body 668 of the plunger tip is about 1.77 mm to about 2.29 mm, more preferably about 1.98 mm, or a tolerance of about 1/100 mm at any diameter within this range. Have. With reference to FIG. 78C looking at the plug from the proximal end, one can see the three variable diameters at the proximal end of the trapezoidal cross section, the wider diameter of the trapezoidal section and the main body. The diameter of the narrowing middle neck is not seen. After the main body 668, the stem section 665 is about 3.05 mm to about 4.32 mm, more preferably about 4.04 mm from the proximal end to the distal end, or any range within this range The value narrows over a length having a tolerance of about 1/100 mm. Stem section 665 terminates distally with the formation of bulbous end 667. The diameter of the bulb-type end is about 1.02 mm to about 1.17 mm, or more preferably about 1.14 mm, or has a tolerance of about 1/100 mm at any value within this range. As can be seen from the distal end shown in FIG. 78D, the diameter of the bulbous end can be seen and the main body can be seen. As can be seen by reviewing FIG. 78E, the plunger is sandwiched within the opening at the distal end of the plunger stem 618, which is connected to the handle at its proximal end.

(B) Tissue clips, plugs and other suturing devices The tissue clips, plugs and other suturing devices disclosed herein are transported into the animal body, for example, for the purpose of suturing an artery. The situation is disclosed. However, other examples are possible as will be appreciated by those skilled in the art. For example, clips, plugs and other suturing devices do not require transport by a transport system as an alternative to compression to stop bleeding, but rather are transported in the field in trauma-trauma such as stab or gun injury. The dimensions are determined. A variety of elements are utilized with the suturing device on the outer or inner surface including, but not limited to, edges, ridges, flanges, wings, pedals, radial extension members, and horizontal protrusions. Any discussion of any such elements can also refer to other elements disclosed.

FIG. 2 is a perspective view of an embodiment of the clip 102 in an open or pre-deployed configuration. Clip 102 includes a base portion 120. The base portion 120 is generally or completely annular, thereby forming a partial or complete circle. In some embodiments, as shown, the base portion 120, which is continuous or substantially continuous circular along its upper edge, can be one or both of an open structure and a closed structure, It can provide greater strength and resistance to bending or bending. The generally circular base portion 120 allows the antler 126a, 126b to move or bend between the open and closed structures during transition, while the shape or orientation of the base portion 120 changes substantially. resist. The height 135 of the base portion 120 is selected to achieve the desired degree of rigidity or flexibility.

Fingers 122 and 124 can be configured to support a plurality of tissue binding elements, such as antlers 126 a, 126 b, and extend from base portion 120. In some embodiments, as shown, the fingers 122 and fingers 124 are positioned, for example, in a substantially opposing arrangement, but the fingers 122 are substantially on the generally circular base portion 120 from the fingers 124. The position is set at a position facing the opposite side. As described below, a plurality of different locations and structures can be utilized.

In the example illustrated in FIG. 2, each finger 122, 124 comprises three antler angles, one central antler 126a and two outer antlers 126b. The outer antler 126b may be substantially the same length from each tip 127b to each joint comprising the front surface 134 of each finger 122, 124. In some embodiments, the front surface 134 may be open and substantially perpendicular to the antler 126a, 126b and substantially parallel to the plane of the base portion 120. In general, the surface 134 can act as a substantially round stop to prevent excessive insertion of the clip 102 into the vessel wall 16. In some embodiments, the length 133 of the central antler 126a is slightly larger than the length 132 of the outer antler 126b. These length differences allow for leverage and force along the center line that bisects the base portion 120 between two opposing central antlers 126a to help draw the opposing sides of the tissue split together. Can be increased.

In some embodiments, the lengths 132, 133 are selected such that the antler 126a, 126b penetrates through the average thickness of the vessel wall 16 into the interior region of the vessel 18, but cannot penetrate completely. . For example, the length 132 can be about 1 mm or more, or about 4 mm or less, and the length 133 can be about 1 mm or more, or about 5 mm or less. In some embodiments, the length 132 is about 3 mm and the length 133 is about 3 mm. In other embodiments, the antler 126a, 126b is configured to penetrate the vessel wall, but generally contacts the vessel wall 17 on the opposite side of the vessel 18 or penetrates the vessel wall. Not long enough. The length of the antler 126a, 126b is generally greater than the height 135 of the base portion 120. In the presented embodiment, fingers 122 and 124 are symmetric about a central axis. In other embodiments, fingers 122, 124 are also asymmetric and may include a different number or structure of tissue binding elements.

The fingers 122, 124 include one or more easily bent regions 125, such as a narrowed region, a bay, an articulated joint or a window portion, as shown. The size, shape and placement of the easily bent region 125 is adjusted to help achieve the desired size of suturing force for the clip 102. As presented, the contour of the easily bendable region 125 is gradual to avoid further trauma to the vessel wall. In some embodiments, the upper edge 129 of the easily bent region 125 is positioned to be aligned with the lower edge 131 of the base portion 120 to maintain the desired height 135 of the base portion 120. The As presented, the width of the easily bent region is less than the height 135 of the base portion 120.

FIG. 3 is a perspective view of the clip 102 in a closed or unfolded configuration. Clip 102 is desirably biased in a closed configuration. As shown in FIGS. 1 and 2, the clip 102 is temporarily kept open or pre-deployed by the deployment device 104 until it is restored to the same structure as shown in FIG. 3 after being deployed. The Clip 102 is configured to automatically close upon deployment to suture the arteriotomy. In certain embodiments, closure of the clip 102 is accomplished by a change in the bending region 400. In some embodiments, the size, shape and / or orientation of other portions of the clip 102 remain substantially unchanged between the pre-deployed state and the deployed state.

FIG. 4 is a side view of the clip 102 in an open configuration. The respective heights 135, 136, 401 of the base portion 120, the support portion 141, and the easily bent region 125 have a plurality of different values depending on the specific application of the clip 102 and other design preference conditions. Further, these heights 135, 136, 401 may be constant and may vary in some embodiments. For example, the height 135 of the base portion 120 is greater than or equal to about 0.5 mm, or less than or equal to about 2 mm, and the height 136 of the support portion 141 is greater than or equal to about 0.5 mm, or about 4 mm. The height 401 of the easily bent region 125 is less than or equal to about 0.2 mm, or less than about 2 mm, or has a tolerance of about 1/100 mm for any dimension within this range. . In some embodiments, the height 135 of the base portion 120 is about 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1 .3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm or 2.0 mm. In some embodiments, the height 136 of the support 141 is about 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1 .3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3 .8 mm, 3.9 mm, or 4.0 mm, or have a tolerance of 1/100 mm for any dimension within this range. In some embodiments, the height 401 of the easily bent region 125 is about 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm,. 9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm or 2.0mm, or this An arbitrary value within the range has a tolerance of about 1/100 mm. In some embodiments, the height 135 is about 1 mm, the height 136 is about 2 mm, and the height 401 is about 0.8 mm. Other suitable heights are also used.

As shown in FIGS. 2-4, the height 136 of the support 141 of the fingers 122 and 124 is less than the length 133 of the central antler 126a (eg, less than about 80%). This allows the base portion 120 of the clip 102 to be positioned relatively close to the outer surface of the vessel wall 16 when the clip 102 is attached. In some embodiments, the support 141 may or may not have different dimensions (eg, antlers 126a, 126b are attached directly to the base portion 120). In other embodiments, the height 136 is substantially the same as the length 133 of the central antler 126a or greater than the length 133. The support 141 includes a side 143 with a loose profile as shown to eliminate the possibility that the support 141 will penetrate / penetrate the vessel wall 16 or cause trauma to the vessel wall 16. In the presented embodiment, the outer surface of the support 141 is curved [eg, similar in curvature to the outer surface of the base portion 120]. In some embodiments, the outer surface of the support 141 is flat or shaped differently than the outer surface of the base portion 120.

FIG. 5 is a side view of clip 102 in a closed configuration. In the deployed state, the clip 102 can form an angle θ 130 between the edge or central axis line at the fingers 122, 124 and the surface or edge 131 around the base portion 120. The angle θ 130 is selected to assist in easy removal of the clip 102 and determination of the applied suturing force in embodiments using temporary stitching, as further described below. The angle θ 130 is also selected to assist in determining the total penetration depth by the branch angles 126a, 127b into the vessel wall 16. For example, the smaller the corner, the more generally penetrates shallower, and the larger the corner, the more generally penetrates deeper. In some embodiments, the angle θ 130 can be greater than or equal to about 30 ° or less than about 70 °. In some embodiments, the angle θ 130 is about 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, or 70 °, or any range within this range. Has a tolerance of 1/100 ° to the angle. In a specific example, the angle θ 130 can be about 50 °. Other suitable angles can also be used. In some embodiments, as presented, the bending region 400 can be bent while other structures remain substantially unchanged or remain intact.

FIG. 6 is a bottom view of clip 102 in a closed configuration. As presented, opposing pairs of antlers 126a, 126b are in contact with each other in a closed configuration or in close proximity to each other [eg, the approximate thickness 137 of each antler 126a, 126b. Within the same length as]. In other embodiments, the antler 126a, 126 need not be configured to move in close proximity to each other in a closed configuration. In some embodiments, the base portion 120 has a side thickness 138 that is / is greater than or equal to about 0.1 mm, or less than or equal to about 0.5 mm. In some embodiments, the base portion 120 has a tolerance of about 1/100 mm for about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, or 0.5 mm or any dimension within this range. It has a side thickness 138. In some embodiments, the base portion 120 has a side thickness 138 of about 0.2 mm. As presented, in some embodiments, every portion of the clip 102 can generally share the same thickness. This thickness also varies between various portions of clip 102 in appropriate circumstances. For example, referring to FIG. 4, the antler 126a, 126b has a thickness 137 that is less than the thickness 138 of the base portion 120 to facilitate penetration of the vessel wall 16.

The base portion 120 can form an outer diameter and an inner diameter. For example, the outer diameter can be about 3 mm or more, or about 7 mm or less, and the inner diameter can be about 2.5 mm or more, or about 6.5 mm or less. In some embodiments, the outer diameter is about 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, or 7.0 mm. . In some embodiments, the inner diameter is about 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, or 6.5 mm, or this It has a tolerance of about 1/100 mm for any dimension within the range. In some embodiments, the outer diameter is about 5.3 mm and the inner diameter is about 4.8 mm. Other suitable diameters can also be used. Different sized clips are used to account for different anatomical dimensions, depending on the particular tissue compression or suturing case in which the clip is used, and such as differences in vessel wall 16 thickness or diameter. In some cases, a plurality of differently sized clips 102 are provided to allow for variability and increased tolerances for health care professionals to eliminate trauma and increase the appropriate suturing force for a particular patient. It is done. Further, the clip dimensions are also selected to accommodate the tubular medical device through which the advancing clip passes. In embodiments performing arteriotomy sutures, the inner diameter of the clip must be large enough to be advanced over standard commercial introducers.

As shown in FIG. 6, the antler can have a straight edge 145 to form an interior angle α 405. The interior angle α 405 is selected to help adjust the insertion force required to cause the branch angles 126a, 126b to retract from the vessel wall 16 or to penetrate the branch angles 126a, 126b into the vessel wall. In some embodiments, the interior angle α 405 may be greater than or equal to about 3 ° or less than about 15 °. In some embodiments, the interior angle α 405 is about 3 °, 4 °, 5 °, 6 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12 °, 13 °, 14 °, or 15 °. Or have a tolerance of 1/100 ° for any value within this range. In some embodiments, the interior angle α 405 can be about 9 °. Other suitable angles can also be used. The width of the tips 127a, 127b of the antler 126a, 126b can also be adjusted to determine the required insertion force. In particular embodiments, the width of the tips 127a, 127b can be greater than or equal to about 0.03 mm or less than or equal to about 0.09 mm. In certain embodiments, the width of the tips 127a, 127b is about 0.03, 0.04, 0.05, 0.06, 0.07, 0.08 or 0.09 mm, or within this range Has a tolerance of about 1/100 mm for any dimension. In a particular embodiment, the width of the tips 127a, 127b can be about 0.06 mm. Other suitable tip widths can also be used. In particular embodiments, the edges of the antler 126a, 126b may be curvilinear, form segments, or form different angles at various portions. In certain embodiments, the antler 126a, 126b includes barbs, protrusions or other elements configured to resist retraction from the vessel wall 16. The barb is sized to provide sufficient resistance to prevent accidental removal of the clip 102 during partial deployment of the clip 102, as will be described in further detail below. Or configured. In certain embodiments, the resistance provided by the barbs is also small enough to allow atraumatic removal of the clip 102.

In embodiments where the base portion 120 is substantially circular, the arc 406 corresponds to the width around the fingers 122 and 124. In the presented embodiment, the arc 406 is subtended to an angle of about 90 °. In some embodiments, arc 406 can / can be an angle greater than about 60 ° relative to the arc, or can be an angle less than about 90 ° relative to the arc. In some embodiments, arc 406 can be at an angle of about 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, or 90 ° with respect to the arc, or any value within this range. An angle with a tolerance of 1/100 ° can be made to the arc. Other suitable angles can also be used. The arc 403 corresponds to the width around the window portion 125. In some embodiments, the arc 403 can be at an angle between the angle greater than about 15 ° and the angle less than about 30 ° relative to the arc. In some embodiments, the arc 403 is about 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °. An angle of 28 °, 29 ° or 30 ° can be with respect to the arc, or an angle with a tolerance of 1/100 ° with respect to any angle within this range. In certain embodiments, arc 403 can be about half or less in length of arc 406. Corresponding portions of fingers 122 and 124 adjacent window portion 125 have a width formed by arcs 402 and 404. Arc 139 corresponds to the separation distance between finger 122 and finger 124. In the presented embodiment, arc 139 is at an angle of about 90 ° to the arc. In some embodiments, the arc 139 can / can be an angle greater than about 60 ° relative to the arc, or can be an angle less than about 90 ° relative to the arc. In some embodiments, arc 139 can be at an angle of about 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, or 90 ° with respect to the arc, or any angle within this range. An angle with a tolerance of 1/100 ° to the arc can be made. Other angles can also be used. In some embodiments, as presented, the shape and / or orientation of the base portion substantially or entirely when transitioned between an open or pre-deployed state and a closed or deployed state. Do not change.

FIG. 7 is a perspective view of the deployment instrument 104 with the clip 102 attached to its distal end in an open or pre-deployed position. The structure illustrated in FIG. 7 is the initial or starting structure before the deployment instrument 104 is inserted into the patient. The deployment device 104 with the preloaded clip 102 is provided to the physician in a package sterilized with such a general structure. In certain embodiments, the deployment instrument 104 is comprised of three basic components: an inner tubular member 154, an outer tubular member 156, and a pressurizing element 158.

FIGS. 47A-47D illustrate another embodiment of a vascular suture clip 350. As shown, the clip 350 is similar in many respects to the clip 102 except as described below. The main difference between clip 350 and clip 102 is that the placement of fingers 252 and 254 on clip 350 is asymmetric, i.e., the number of branch angles 256 and 258 on each side is not the same. For example, as shown, the first finger 252 includes three antlers 256. The second finger 254 includes two branch angles 258. Branch angle 256 and branch angle 258 are offset from each other and configured to entangle when clip 350 is in the closed configuration, as shown in FIGS. 47B-47D. In some applications, these entangled structures can provide certain advantages over the structure of clip 102. For example, fingers 252 and 254 attempt to force the opposing tissue sides to be pulled across each other, thereby applying more pressure on the tissue and suturing arteriotomy 114 more completely. Composed. In addition, these entangled structures are between the edge 253 or surrounding surface of the base portion 251 and the edge or central axis line at the fingers 252 254 for the fingers 252 254 of a given length in some embodiments. A smaller angle θ 259 is formed. In some embodiments, the angle θ 259 can be greater than or equal to about 10 °, or can be less than or equal to about 50 °. In some embodiments, the angle θ 259 is about 10 °, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, or 50 °, or any range within this range. Tolerance of 1/100 ° to the value. In a specific example, the angle θ 259 can be about 30 °. Other suitable angles can also be used. In the example illustrated in FIG. 47C, fingers 252 and 254 do not contact each other when clip 350 is in its closed or deployed configuration. In other embodiments, fingers 252 and 254 are configured to contact each other in the deployed configuration. For example, the antler 258 is configured to rest on the front surface 253 of the finger 252. The antler 256 is configured to rest on the front surface 255 of the finger 254.

48A and 48B illustrate another embodiment of a vascular suture clip 260. Clip 260 is similar to other clips disclosed herein except as described below. Clip 260 includes three symmetrical fingers 262 extending from an annular base 261. As shown, the fingers 262 are evenly spaced around the periphery of the base 261. Each finger 262 includes two antlers 264. The distal end of the antler 264 is configured to fit when the clip 260 is in its closed configuration as illustrated in FIG. 48B.

49A and 49B illustrate another embodiment of a vascular suture clip 270. FIG. The clip 270 includes three symmetrical fingers 272 that are evenly spaced around the periphery of the annular base 271. Clip 270 is similar in many respects to clip 260. The main difference between the clip 270 and the clip 260 is that when the clip 270 has a closed structure, the branch angle 274 of the clip 270 is configured such that the branch angles 274 of adjacent fingers overlap.

50A and 50B illustrate another embodiment of a vascular suture clip 280. FIG. Clip 280 is similar to other clips disclosed herein. The clip 280 includes three fingers 284 that are substantially uniformly spaced around the periphery of the annular base 281. Each finger 282 includes two branch angles 284 that are offset to one side from the central portion of the finger 282. These structures allow the fingers to bend more greatly in a closed structure without overlap.

51A through 51E illustrate another embodiment of a vascular suture clip 290. FIG. Clip 290 is similar to other clips disclosed herein except as described below. Clip 290 includes six fingers 292 that are uniformly spaced around the periphery of base portion 291. In some embodiments, each finger 292 includes only one antler 294. The antler 294 is configured to fold in a flat structure, best seen in FIG. 49D. These structures cause clip 290 to have a relatively low internal profile. Antlers 294 are not configured to contact each other when clips 290 are in their closed configuration. In other embodiments, the antler 294 is configured to meet at or near a central point or other point. Antler 294 includes a distal most portion 295 and a second more proximal portion 296. The most distal portion 295 forms a first interior angle that is less than the interior angle formed by the proximal portion 296. These structures impart a relatively “sharp” tip to the antler 294 and facilitate initial penetration of the antler with respect to the vessel wall 16. The base portion has a height 298. As shown, the height 298 is relatively small and can be, for example, about 1/5 or less of the radius formed by the annular base portion 291. The relatively small height 298 ensures that the clip 290 has a relatively low external profile when implanted.

The clip 290 can be configured to be coupled to tissue on virtually every side of the arteriotomy to provide a more complete circumferential suture. In certain embodiments, it is further desirable to use these clips 290 for permanent implantation and other clips for temporary implantation. For example, the use of just two opposing fingers facilitates removal. The use of just two opposing fingers advantageously produces a simple and predictable “pinching” type of suturing action.

In certain embodiments, heat is used to facilitate suturing the arteriotomy 114. FIG. 52 shows a circuit 500 that uses direct resistive element heating to heat the tissue surrounding the arteriotomy 114. In certain embodiments, the selected tissue surrounding the arteriotomy is heated at a temperature of about 40 ° C. or less, about 40 ° C. to 45 ° C., or greater than about 45 ° C. In certain embodiments, the selected tissue surrounding the arteriotomy is about 35 ° C, 36 ° C, 37 ° C, 38 ° C, 39 ° C, 40 ° C, 41 ° C, 42 ° C, 43 ° C, 44 ° C, 45 ° C, It is heated at a temperature of 46 ° C., 47 ° C., 48 ° C., 49 ° C., or 50 ° C., or at a temperature having a tolerance of about 1/100 ° C. for any value within this range. Other suitable temperatures can also be used. At these temperatures, the tissue that is pressed together by the vascular suture clip undergoes a cellular change that tends to fuse the tissue together to suture the arteriotomy.

Other clip variations are possible. Tissue compression is deformed by adjusting one or more of the constituent attributes of a plurality of tissue binding elements such as element length, width, thickness, angle, number, and position. The proximal edge of the clip is straight, sinusoidal, notched, keyed, combined, or have other suitable configurations. The geometry of the proximal edge is paired with the contact surface of the advancement and deployment device. The clip is made of one or more of tubing, sheets, wires, strips, bands, rods, combinations thereof, or other suitable materials.

56A-56C illustrate a further embodiment of a vascular suturing system. In one embodiment, the bioabsorbable inflatable plug 310 is loaded onto the distal end of the plug deployment instrument 300. The plug deployment instrument 300 includes an inner tubular member 302 with a handle 306 and an outer tubular member 304 with a handle 308. The proximal end 312 of the plug 310 is received by the distal end of the outer tubular member 304. The intermediate stop 314 of the plug 310 can have an outer diameter that is larger than either the proximal end 312 or the distal end 316 and is received relative to the distal end of the outer tubular member 304. The As shown, the stop 314 has a generally circular geometric shape. However, other suitable shapes or geometric shapes can be used. For example, in certain embodiments, the stop 314 has a flared or tapered shape, an X shape, an inverted T shape, a combination thereof, or any other suitable shape or geometric shape. . In certain embodiments, the stop 314 is formed with slots or ribbons to bend easily during advancement. The proximal end 312 is relatively long to facilitate plug kinking (long long g), as described below. In certain embodiments, the proximal end 312 can / can have a length that is greater than or equal to about twice the length of the distal end 316, or about five times the length of the distal end 316. It can have the above length. The plug 310 includes a deployment tool 300 and a longitudinal channel 318 that allows the plug 310 to advance over the tubular medical device in a manner similar to that described above with respect to the deployment instrument 104. Inner tubular member 306 can be advanced distally by applying pressure to handle 306 and / or pulling handle 308 proximally. Stop means such as a removable element secured to the outer tubular member 302 between the handle 306 and the handle 308 can maintain the separation of the handle 306 and the handle 308 until the medical professional is ready to begin deployment. . Once the medical professional has confirmed proper placement of the distal end of the deployment instrument 300, the stopping means can be overcome, for example, by removing a removable element to initiate deployment. The distal end of the inner tubular member 306 freely pushes the plug 310 out of the outer tubular member 304 for deployment. The deployment tool 300 can be configured so that the plug 310 is fully deployed when the handle 306 and handle 308 are assembled together.

The inflatable plug 310 is a material that expands or expands when the material is exposed to fluids such as blood or subcutaneous fluid, or other fluids added by the physician to cause the material to expand, for example. Manufactured entirely or entirely. These materials include hydrophilic gels (hydrogels), regenerated cellulose, polyethylene vinyl acetate (PEVA), as well as composites and combinations thereof, and other biocompatible inflatable or expandable material combinations. Including. Upon deployment, the inflatable plug 310 can expand to occlude the longitudinal channel 318 and seal the arteriotomy. In certain embodiments, the plug 310 is partially or wholly made of a lyophilized hydrogel, such as, for example, polyethylene glycol (PEG) or other polymer carrier. The polymer used in the carrier can contain a group of chemicals that can be hydrolyzed to degrade, thereby allowing degradation in situ. Hydrophilic polymeric materials suitable for use in forming the hydrogel include poly (hydroxyalkyl methacrylate), poly (electrolyte composite), poly (vinyl acetate) crosslinked with hydrolyzable bonds, N inflatable with water -Vinyl lactam polysaccharide, natural gum, agar, agarose, sodium alginate, carrageenan, fucoidan, far selelain, laminaran, hypnea, eucheuma, gum arabic, gucci gum, karaya gum, taracanto gum, locust bean gum, arabino These include hydrophilic colloids such as galactan, pectin, amylopectin, gelatin, carboxymethylcellulose gum or alginate gum cross-linked with polyols such as polypropylene glycol. Various constitutive formulas of known hydrogels are described in U.S. Pat. No. 3,640,741 granted to Ettes, U.S. Pat. No. 3,865,108 granted to Hartop, and Denzinger. U.S. Pat. No. 3,992,562 granted to Denzinger et al., U.S. Pat. No. 4,002,172 granted to Manning et al., U.S. patent granted to Arnold No. 4,014,335, U.S. Pat. No. 4,207,893 granted to Michael and a shared polymer handbook published by Chemical Rubber Company in Cleveland, Ohio, edited by Scott and Roff And disclosed in the above patents and published literature in connection with hydrogels. Loose disclosure of which is incorporated herein by reference.

An example of a method for using the plug deployment device 300 and plug 310 will now be described with reference to FIGS. The deployment instrument 300 loaded with the plug 310 is advanced over the previously provided tubular medical device 108 as shown in FIG. 57 until the distal end 316 abuts the vessel wall 16. In certain embodiments, the distal end 316 is housed within the arteriotomy 114 as shown. In other embodiments, the distal end 316 is received against the outer surface of the vessel wall 316. The intermediate portion 314 is configured to act as a stop to prevent excessive insertion of the plug 310 into the blood vessel. The introducer sheath is removed from the blood vessel as shown in FIG.

As shown in FIG. 60, deployment device 300 is held in place against vessel wall 116 while the exposed portion of plug 310 begins to expand. Such expansion is initiated or accelerated by various events such as contact with blood and / or subcutaneous fluid. In certain embodiments, the enlargement of the distal end 316 helps to secure the plug 310 in place within the arteriotomy 114. Expansion of the plug 310 tends to occlude the longitudinal channel 318, thereby sealing the arteriotomy 114 or tending to partially or totally fill the arteriotomy. Alternatively or additionally, channel 318 is occluded by kinking of proximal portion 312. Once the plug 310 is secured to the vessel wall 116, the deployment device 300 is removed as shown in FIG. Adipose tissue already displaced by the deployment instrument 300 begins to fill with the tissue region. These tissues can thereby apply pressure to the proximal portion 312, which tends to kink or occlude the proximal portion. Patient movement and / or externally or internally applied pressure is also used to kink the proximal portion 312. As shown, deploying plug 310 at an acute angle relative to the vessel wall also increases the kinking tendency of proximal portion 312. In certain embodiments, the inner surface of the longitudinal channel 318 is configured to adhere to itself when one region contacts another region. For example, in certain embodiments, the inner surface of the longitudinal channel 318 is coated with an adhesive or other suitable coating to assist in the closure of the longitudinal channel 318. In certain embodiments, the adhesive or coating is configured to prevent adhesion to the deployment device 300 or not to adhere to the deployment device. FIG. 62 shows an embodiment of the plug 310 deployed in a fully expanded state. Plug 310 can be wholly or partially bioabsorbable. In certain embodiments, the plug 310 is configured to be completely absorbed by the patient's body after about 4 weeks. Other suitable times are also used. FIG. 63 shows the plug 310 in a partially dissolved state.

The inflatable plug 310 is shielded from inadvertent contact with fluid (blood, saline, etc.) by a removable wrapper or dissolvable coating prior to insertion into the body. The inflatable plug 310 can include a relatively rigid outer coating that begins to dissolve when exposed to a fluid, such as blood, thereby reducing the positioning time of the plug 310 within the arterial incision of a medical professional. provide. In some embodiments, the plug is configured to advance directly over the tubular medical device 108 and the deployment device 300 is replaced with a pusher device. In certain embodiments, the plug can include a longitudinal slit or helix to attach the plug to the tubular medical device or deployment instrument from the side. In certain embodiments, the deployment device also includes a slot that allows attachment from the side.

Vascular suturing devices positively influence the treatment at and / or near the deployment position of the device and are integrated into the structure forming the device, integrated into the coating, or both It includes one or more coatings, materials, compounds, substances, drugs, therapeutic agents, etc. that are to be integrated. Anti-thrombotic material, anti-proliferative material, or other coating may be present at or near the attachment point of the vascular suturing device within the body, thrombus (acute and / or chronic), hyperplasia, platelet aggregation, or other The intention is to prevent negative reactions. Coatings, materials, compounds, substances, drugs, therapeutic agents, etc. can be used per se or are included in the carrier as in a polymer matrix, starch or other suitable material or method. The coating can be a liquid, gel, film, uncured form, partially cured form, cured form, combinations thereof, or other suitable form.

A further configuration of the suturing device, ie, clip, plug or suturing device 670, is shown in FIGS. 79A-79E. The clip, plug, or suturing device 670 includes a plate section, wing or petal at the first end, a core, stem, vertical section, intermediate section, long neck section that is a post or shaft, and a radial extension member, wing A set of flanges 675 that are petals or horizontal protrusions and extend from the neck at opposite ends. As shown, the faceplate is triangular and has three petal shapes at its distal end (end within the wound), which meet towards the center at a central point along the faceplate, Extends outward. The petal is also a projecting section with scoring, which in any configuration helps to bend the faceplate towards the inner axis A during deployment. In addition, a few or more petals that are scored or projecting are provided. Furthermore, the shape of the face plate results in a change in the number of petals used on the surface. The clip, plug or suturing device 670 further comprises an opening or bore 676 that passes through at least a portion of the long neck section or stem 672. A horizontal groove is provided around the core to reduce bleeding and reinforce the seal. The plug is also coated with lubricating oil to help contact the vessel opening and to reduce the force required to advance the plug through the capsule and introducer sheath tube or into the target point Is done. The wound or blood vessel contact surface varies in thickness, profile and geometry, and the intermediate plug core or stem varies in thickness, profile, geometry and / or any other manner. Furthermore, the intermediate plug section is at least partially free. Furthermore, any surface of the plug is soft, textured, patterned, grooved, or configured to achieve at least one of these combinations. The plug includes at least one of a hole, a notch, a void, a recess, a groove, a slot, a bay, a recessed section, or any other desired structure. The plug section is made of a single part or multiple parts. If another part is used, the other part may be fixed or movable. For example, the plug is configured such that the outer vascular contact moves toward the inner vascular contact, thereby contacting the blood vessel (and compressing the blood vessel if necessary). The movable outer vascular contact may include one or more and / or one-way or bi-directional latches in one or both of bumps or protrusions between the core (column) and the outer vascular contact. Configured to maintain its position relative to the vessel wall and / or the inner vessel contact area by any suitable technique, including a custom insert or optimal between the inner vessel contact portion and the outer vessel contact portion Enables integrated plug-in. The plug includes at least one of a radially extending inner vascular element and a radially extending outer vascular element. The outer vascular element can be located at any point on the center [eg, axis A] of the plug or any point on the core and does not need to be in direct or close contact with the outer vessel wall. When deployed (when unrestrained), the inner vascular member and one or more vertical cores, the upper end of the core expands from a constrained or deflected position during advancement with the tubular medical device. It can be moved to an open position within the larger cross section (both independently or in combination).

The triangular plate section or face plate 680 is preferably configured for placement on the inner surface of the tissue layer to be sealed, with the long neck 672 extending through the wound and two or more flanges 675 against the wound. Located outwardly proximal to the deployment device. The face plate is configured to be flat on the proximal side and convex on the rear side. The face plate is scored along its rear face so that the face plate easily follows a low profile configuration for transfer. The stem or core can be linear, curved, inclined or a combination thereof. In addition, the stem serves for contact and / or attachment of the plug to the blood vessel. Furthermore, the device is substantially straight during deployment or advancement through the introducer sheath and moves to other structures when it is no longer constrained within a tubular medical device (device such as an introducer sheath). . The devices and systems are configured to provide a partial or complete suture device for securing an implantable device, such as a ventricular assist device. The rotator and / or pawl is integrated into the system for forward advancement of the final plunger to ensure that the plug is fully deployed and the sheath is ready to retract.

For illustration from the point of view of the device being transferred in situ, a suitable configuration of the plug disclosed herein is in the range of about 3.81 mm to about 5.08 mm, more preferably about 4. Provide a length with a tolerance of about 1/100 mm at 4.39 mm or any value within this range. The length of the bore is from about 2.92 mm to about 3.94 mm, more preferably about 3.43 mm, or any value within this range with a tolerance of about 1/100 mm. The bore width has a tolerance of about 0.76 mm to about 1.27 mm, desirably about 1.00 mm, or any value within this range, about 1/100 mm. The stem of the plug between the cap and the flange 675 has a tolerance of about 1/100 mm at a range of about 3.30 mm to about 3.81 mm, more preferably about 3.48 mm or any value within this range. The overall diameter of the device has a tolerance of about 3.81 mm to about 4.57 mm, more preferably 4.27 mm or any value within this range of about 1/100 mm. Although the shape should not necessarily be circular, these values represent, for example, the diameter of a two-dimensional circle surrounding the faceplate or flange 675. The device is used outside the body (eg, it can be larger in size to be used to cure external wounds instead of compression).

A further configuration of the suturing device, ie, clip, plug, or suturing device 670 is shown in FIGS. 79F-79J. The clip, plug, or suturing device 670 has a plate section, wing or petal at the first end and attaches to a long neck section that is a core, stem, vertical section, middle section, post or shaft, and tether line. Providing a proximal bail or loop 675 'extending from the neck at the opposite end for the tether, where the tether forms a loop through the bale and is pulled outward through the loop 675' when the tether loop is cut. The clip, plug or suturing device 670 further comprises an opening or bore 676 that passes through at least a portion of the long neck section or stem 672.

The clip, plug, or suturing device 670 is combined and deployed with, for example, a removable tether. The use of the tether allows confirmation of proper placement and sealing of the seal and reduces unintentional manipulation of the deployed clip, plug or suturing device 670. The tether is, for example, a screw, a wire and / or a coil. Tethers are composed of surfaces, polymers, metals, metal alloys, and are soft, semi-rigid, rigid, or vary in stiffness. The tether is preformed using, for example, nitinol or any suitable material including silk, metal, or metal alloy or polymer. The preformed tether is configured to hold the plug during deployment and is then drawn outwardly away from the plug, thereby separating from the plug and retracting from the body. Further, the tether includes at least one soft section that is / is another component or is included in the configuration of the plug and is configured to be separated from the plug at a particular section. In some configurations, the tether is separated from the plug by pulling, pushing, twisting, or a combination thereof, or by any other separation mechanism. Further, as shown in some embodiments of the present specification, the tether is configured to be separable by a soft region, strength of the tether, adhesion strength between the tether and the plug, or a combination thereof.

As shown in FIGS. 80A-80C, the clip, plug or suturing device 670 is foldable with a distal end 80 sandwiched within an opening on the proximal end 70 of the clip, plug or suturing device 670. A clip, plug or suturing device 670 is configured to be attached to a tether or wire 674 that folds the clip, plug or suturing device 670 at its proximal end 70 when pulled. The transfer system and wire 674 are now retracted through the transfer device, and the entire transfer system is completely uncoupled, allowing the clip, plug or suturing device 670 to be deployed in the field. 81A through 81N show other removable configurations, in which a tether or wire 674 is used to confirm proper placement and placement of the clip, plug, or suturing device 670. . As shown in FIG. 81A, the folded wire 674 is routed through a central bore 676 with a clip, plug, or suturing device 670. The wire 674 is configured such that the force required to strengthen the wire and pull the wire through the bore 676 is the same as the mold release force. As shown in FIG. 81B, the wire 674 can be configured to recoil far from the central axis A when the wire 674 is proximal toward the user and pulled away from the clip, plug, or suturing device 670. In FIG. 81C, wire 674 is configured to have a corrugated bend to engage the apex of the bend with a sidewall 678 of tubular channel 678 'formed in clip, plug or suturing device 670. The distal end 80 of the wire 674 is in a semi-permanent configuration such that force is required to decouple the wire 674 from the clip, plug or suturing device 670 and to retract the wire through the channel. Coupled with the plug face plate 680. As shown in FIG. 81D, the channel comprises a groove or well in which a bend in the wire forming the pawl 636 extends inward. The suture line is used as shown in FIG. 81E. The suture line 674 is configured to be uncoupled from the clip, plug or suturing device 670 as shown. Other configurations include, for example, a folded wire 674 configuration as shown in FIG. 81F, where the helical coiled wire 674 is configured to decrease in outer diameter when tension is applied. . FIG. 81G illustrates a bore or channel 678 that is zigzag or folded with a clip, plug or suturing device 670 through which the stressed wire 674 is positioned. The stressed wire 674 must thereby be zigzag-shaped or folded through a folded bore or channel 678. In FIG. 81H, the wire 674 is configured to represent a long sigmoidal curve with a sharp tip that goes in the opposite direction (eg, towards the distal end 80). As shown in FIGS. 81E through 81H, a portion of the line 674 extends through the distal surface of the cap 680 and can take a variety of configurations, parallel or coiled to the surface of the cap 680.

Other concepts include, for example, the concept of a tethered clip, plug, or suturing device 670, where, for example, a tether 674 in the form of a loose screw forms a clip, plug, or suturing device 670 as shown in FIG. 81I. Through the opening 679 on the proximal end 70 of the. Alternatively, the proximal end 70 of the clip, plug or suturing device 670 can be in the form of a safety pin clasp as shown in FIG. 81J that is hinged to release the tether 674. Pincher clasps can be used similarly as shown in FIG. 81K or can be snap-and-ball sockets as shown in FIG. 81L. A molded-in break point is also used to break the break point shown thicker when tension is applied from the proximal end 70, as shown in FIG. 81M. In other configurations, ribbon sections are used as shown in FIG. 81N.

A further release concept is illustrated in FIGS. 82A and 82B. The configuration shown in FIG. 82A depends on a section that extends excessively from the soft point due to the stem length of the suturing device 670. Excessive stretching is combined with a twisting action that causes the stem 672 to snap due to its length. In some configurations, as shown in FIG. 82B, a tear notch is provided that separates the stem 672 using a tearing motion, the stem being clipped, plugged or sutured while being torn along the tear notch at this time. Release device 670. The cutter is used in combination with a tether tube 678 '. As can be appreciated by those skilled in the art, radiopaque markers, such as tungsten balls, are employed to allow the suturing device to be viewed on an X-ray monitor or other imaging device. The radiopaque marker is positioned to be part of the disrupted portion of the plug so that it can be removed when no more plug is needed for treatment or when it is desirable to place the marker in place.

Tethered clips, plugs or suturing devices 670 are also contemplated. As the tether type clip, plug or suturing device 670, for example, a ball and socket structure as shown in FIG. 83A can be used. In these configurations, a molded ball is provided on the plug stem. The molded ball socket has one or more splits. When opened, the split forms a finger that can be easily opened for release of the ball in the socket. As shown in FIG. 83B, the tether line 674 is provided in combination with the tether tube 682. The tether tube restrains a finger formed by a molded ball socket and restrains the finger from the opening. This maintains a firm grip on the ball until the tether line 674 and tube 682 are withdrawn. When the tether tube and line are withdrawn, the ball retracts as well, as shown in FIGS. 83C and 83D. These configurations represent very high grip accuracy on the plug through the tether line until the user slides the tether tube 682 from the end.

In other configurations, a tethered clip, plug or suturing device 670 is used with a ball and socket tether tube 682-tether line 674 as shown in FIG. 84A. The ball is positioned to be fixed relative to the end of the ball and tether tube 682. The configuration of the release button 684 is used to lock the tether tube 682 in place, and movement of the tether tube 682 along the axis A is interrupted when one or more buttons reach the pawl 636. As shown in FIG. 84B, the tether tube 682 is retracted past the end of the clip, plug or suturing device 670, for example, when the release button is pressed. The diameter of the configuration has a tolerance of about 1.0 mm to about 2.5 mm, more preferably about 1.5 to 2.0 mm, or about 1/100 mm at any value within this range. In the snip-off configuration shown in FIGS. 84C and 84D, the tether tube 682 moves to the button stop 684 similar to the configuration shown in FIG. 84A and then near the proximal end 70. Sniped at the cutting line.

In addition to the structures shown in FIGS. 79-84, various clip, plug or suturing device 670 profiles are also contemplated. As shown in FIG. 85A, the suturing device 670 can have a faceplate 680 or a circular or substantially round disc at the distal end 80, at which time the stem 672 protrudes from the proximal surface of the disc. . The stem 672 is a stem for position determination, centering, and / or anchoring. As will be appreciated by those skilled in the art, the stem 672 has a variety of configurations as shown in more detail in FIGS. 85B-85R. The stem 672 is configured to have a square or rectangular cross-section as shown in FIG. 85B, where the cross-section can be a variety of cross-sections along its vertical axis with respect to what is shown (eg, Circular, square, etc.) and can have a triangular cross-section as shown in FIG. 85C in three dimensions, eg, pyramid or conical, and an arrowhead shaped stem is shown in FIG. 85D; Suitable for accommodating paired balls, having a concave proximal surface as shown in FIG. 85E with the same three-dimensional considerations already described, and having a convex proximal surface as shown in FIG. 85F An arrow shaped stem combination with a concave surface is shown in FIG. 85G, for example, a stem with a vertical opening through the stem to accommodate the wire is shown in FIG. 85H. The distal A stem having a tapered flange 675 of which is shown in FIG. 85I, stem formed into trapezoid, it has a wide edge that is located set proximally its narrow edge is adjacent to the disc portion of the suturing device. In other configurations, the stem is molded as a cross-section hook with a round hook as shown in FIG. 85K or as a catch as shown in FIG. 85L. In addition, as part of a pawl 636 system as shown in FIG. 85M, it is advantageous to use a channel that is open to accommodate a pair of elements with protrusions or widening heads as shown in FIG. 85N. Is. A variety of screw configurations are also employed for the stem 672 as shown in FIGS. 85O and 85P. The standard screw of the stem 672 is used as shown in FIG. As an alternative, the inner thread in the bore of stem 672 is used as shown in FIG. 85P. A bi-stable geometry is also used as shown in FIGS. 85Q and 85R.

The suturing device is also configured to provide an inner petal as shown in FIGS. 86A-86E. The stem 672 having such a configuration has a small diameter of less than 1 mm for both selective suture selections. Various stem choices are included on both sides of the skirt or distal sealing surface to illustrate ribs and nibs. As shown in FIG. 86A, the stem 672 has a bulbous section with a diameter larger than the small diameter of the stem along its length. Alternatively, the neck may be any value less than 1 mm or up to 10 mm, as shown in FIG. 86B, but the end with a flat disc 680 at its proximal end 70 communicates with the suture 674. As shown in FIGS. 86C and 86D, the suturing device 670 is pushed in place with the disk 680 configured to allow the outer edge to move towards the central axis A when the suturing device 670 is pushed through the wound. For example, it is temporarily opened in the blood vessel with a disk that applies pressure to the blood vessel wall to maintain its position. As shown in FIG. 86E, the suturing device 670 is configured to include a hollow plunger that rests under the cap of the suturing device. Various configurations of disks are employed, and post configurations on the surface of the disks are employed without departing from the scope of the disclosure, as can be understood by reviewing FIGS. 87A and 87B, and FIGS. 88A-88F. The As shown in FIGS. 87A and 87B, the suturing device 670 includes a disk 680 that is substantially flat when viewed from the side and substantially circular when viewed from the end, at which time the post or stem 672. And / or the tether or suture 674 is centered on the disk 680. As shown in FIGS. 88A-88F, the disk 680 can be circular, triangular, egg-shaped, oval, square, triangular, and long (with wings). Usually such a shape can have a more rounded edge, for example a square or triangular shape will be rounded at the corner as shown in FIG. 88B. Further, the corners are bent inward toward the center point, for example, so that the triangular shape is closer to a Y shape as shown in FIG. 88C. Furthermore, as shown in FIGS. 88D to 88F, for example, a flat profile, a concave profile, a convex profile, a flat shape at one corner, and a convex or concave profile at the opposite corner. Angular profiles are employed with or without an inner chamber as shown in FIG. 88E. In some configurations, one or more surfaces are ribbed to facilitate anchoring of the suturing device in the field, as shown in FIGS. 88F and 89A-89G illustrating embodiments deployed in the field. And nibs 686 are provided. A nib 686 on the proximal surface is coupled to the inner surface of the blood vessel to prevent retraction of the suturing device 670 when the suturing device 670 is inserted into a blood vessel, for example, and minimizes suturing device movement in the field. Or prevent the suturing device from moving.

The suturing device is also configured to have a snap action geometry. 93A to 93D and 94A to 94D show a plug having a snap action geometry. The snapping geometry is integrated into any clip, plug or suturing device, including any other embodiment mentioned elsewhere in this specification. Clips, plugs or other suturing devices have one or more protruding or radially extending surfaces. For example, the plug / sealing element includes a radial extension member, a flexible cap, a flange, a wing, a finger, a skirt, a ridge, a faceplate, a round disc or a protrusion. Any description of any form of protruding or radially extending surface is applicable to any other type of protruding or radially extending surface. In some examples, the plug is molded into a convex or concave shape and is then deflected to the opposing shape. 93A to 94D are diagrams showing examples of a plug 930 including a circular disk 932. FIG. Plug features apply to discs of any shape. 93B to 93D are side views of the plug in various states. The plug represents a petal structure with a skirt 932 and a stem 934. The plug represents a neutral state, a maximum deformed state, and an excessively extended state. The neutral state is a convex or concave shape, and the plug is deflected to an opposing shape. For example, as shown in FIGS. 93B to 93D, the neutral state is a convex shape. The plug is deflected into a concave shape. In another example, as shown in FIGS. 94B to 94D, the neutral state is a concave shape. The plug is deflected into a convex shape.

In an embodiment of the invention having an overcenter and snap action geometry, the plug 940 has a petal geometry along with a skirt 942 and a stem 944. A petal geometry passes through a given shape with maximum total deformation energy when deflected to another shape, and then the total deformation energy is further reduced as a result of additional deflections (depending on the design geometry) The target structure is molded into a predetermined structure so as to follow the following. The geometry remains (A) deflected, but reduces the force required to cause further deflection to the final state, or (B) once the petal reduces its maximum total deformation energy geometry If deflected too far, additional force supplied from the outside continues to be deflected to the final deflection geometry (by releasing the stored deformation energy), with no additional external deflection force applied. Maintain its shape without (this is the second metastable position).

Providing a snapping geometry to the suturing device skirt can provide advantages over a flat skirt. For example, the snap action geometry advantageously increases the amount of force required to reversely fold the skirt. The force applied to the flat skirt can bend or distort the material, which does not provide great resistance in full folding. The primary resistance, if present, can be due to the material or any rib thickness. With a snapping geometry, the force required to fold the skirt back in one direction is significantly increased compared to a flat skirt. The material at the outer rim of the snap-action geometric skirt should be stretched by folding the rim from a smaller diameter to a larger diameter (eg, when the skirt is in maximum deformation). Once the maximum deformation state is passed, the skirt can move to a predetermined position (popping) so that it swells as it swells (or vice versa). This can provide resistance to any initial or temporary force while the plug is anchored.

Another advantage is that when the plug is deployed, it can be snapped together with a recessed structure, which is closer to the shape of the inner wall of the blood vessel (eg, artery) than when the skirt is flat. It can be done. This can improve the ability of the suturing device to seal, i.e. to the blood vessel.

The suturing device is also configured to have a self-intersecting geometry. 95A to 95C show a plug having a self-intersecting geometric structure. The self-intersecting geometry may be integrated into any clip, plug or suturing device, including any other embodiment mentioned elsewhere in this specification. 95A to 95C are views showing an example of a plug 950 including a circular disk 952. FIG. Plug features apply to discs of any shape. A side view of a plug 950 comprising a skirt 952 and a stem 954 is shown. The plug represents a first state in which a section of the skirt forms a convex shape with a foldable feature 956 that is folded in a first direction. The plug has a relatively straight structure in the section of the skirt, where the foldable feature 956 represents a second state that is substantially unfolded. The plug also has a concave skirt section, where the foldable feature 956 represents a third state that is folded in the second direction. The second direction can be the reverse of the first direction. The foldable feature has a geometric structure that can limit the degree to which the foldable feature can be folded in the second direction.

In an embodiment of the invention having a self-intersecting geometry, the plug 950 has a petal geometry comprising a skirt 952 and a stem 954. The plug geometry is configured such that when deflected in one direction, the geometry is open and does not repeat with other areas of the skirt, or repeats minimally. If configured to have very thin sections (as shown), these sections can form a natural position to be bent with minimal applied external force. Such a natural position is a foldable feature. In some embodiments, the foldable feature or thin section is located between one or more protrusions 958, ribs, or other forms of geometry that can contact each other. In some embodiments, the protrusions can form a radial pattern. In some embodiments, the protrusions can form a flower shape with one or more central protrusions 958a and one or more surrounding protrusions 958b. Any number of central protrusions are provided. The size of the protrusion or the angle of the protrusion can determine the angle at which the protrusion can begin to intersect itself.

When a deflection force is applied in the opposite direction, the geometric structure touches between two regions of the surface at some point (calculated precisely), which further increases the geometric structure Cause an increase in the force required to deflect. The applied force against the deflection curve represents a sudden change in slope at the point where the geometry starts to intersect itself. Figures 89A and 89C illustrate other ways in which a self-intersecting geometry can be achieved (e.g., with discontinuous concentric ribs). The helix can also provide further examples of self-intersecting geometric structures. In some embodiments, the self-intersecting geometric shape represents a flower shape.

Providing a self-intersecting geometry in the skirt of the suturing device can advantageously provide flexibility / deflection in one direction while resisting deflection in the opposite direction (ie, Stiffen). The suturing device skirt is free to fold in one direction without intersecting geometry, but is limited in flexibility in the opposite direction (the direction with its own intersecting geometry). Such a structure allows the plug skirt to be easily deflected rearward while the plug is advanced through the introducer sheath. Once the plug is advanced past the end of the introducer sheath, the self-intersecting geometry can limit the reverse deflection so that the plug is drawn from the blood vessel as the introducer sheath is retracted from the body. Can resist being done. The self-intersecting geometric structure can allow flexibility or deflection of a predetermined and predictable size.

Any clip, plug or suturing device described herein can be a single piece. For example, the skirt and stem are formed from a single part. The stem and any other radially extending member / sealing element are formed in one piece. The radial extension member is deflected during deployment and is again expanded / deflected when the suturing device is no longer restrained off the distal end of the introducer sheath.

(C) Guided tissue cutter FIGS. 40-42 illustrate a tissue opening widener, such as a slidable guided tissue cutter 106, used in the vascular suturing system 100 in certain embodiments. An example is illustrated. After completing the desired medical process, the medical professional can temporarily attach the tissue cutter 106 by clipping the tissue cutter to the tube section 110 of the vascular introducer 108, as shown in FIG. At this time, the tissue cutter 106 can be slidably advanced along the blood vessel introducer sheath 108. The cutter 106 is configured to make an accurate depth and width incision at the location of the percutaneous opening 12 using the sharp distal end 203 of the blade 202. In general, the cutter 106 moves the edge 203 of the blade 202 at a specific orientation and distance from the tube 110 for the deployment instrument 104 to be consistent and to allow an entry point that is easily sized. Set the position. A shelf, such as a mechanical stop 208, can ensure that the incision required to facilitate entry of the deployment instrument 104 does not become deeper. Using the existing introducer sheath 108 as a guide for the slidable tissue cutter 106 helps to ensure proper placement of the incision. After the incision, the slidable tissue cutter 106 is removed from the side of the blood vessel introduction device.

FIGS. 41 to 43 are views showing an example of a frame portion 200 that can form a component of the slidable tissue cutter 106. In certain embodiments, the knife blade 202 is secured to the frame portion 200. In other embodiments, the cutter 106 can / can use a special blade or is formed of a single piece. As shown, the slidable tissue cutter 106 includes two blades 202 positioned on lateral sides, such as at diametrically opposed positions. In other embodiments, a single blade or more than two blades are used. In certain embodiments, the cutting surface of each blade 202 is fixed and configured to cut tissue without requiring interaction with the second cutting surface. In other embodiments, dynamic blades are used.

The slidable tissue cutter 106 includes a channel 206 having a partial circumferential cross-sectional geometry as shown in FIG. The geometry allows the cutter 106 to be easily and temporarily attached to the tubular medical device with a “snap-on” feature, and facilitates removal of the cutter 106 once the desired tissue has been cut. Enable. In other embodiments, the slidable tissue cutter can utilize two pairs of parts that are clamped together or snapped to facilitate temporary attachment and removal. In a preferred embodiment, channel 206 is sized to be compatible with any commercially available introducer sheath. The end 208 of the frame portion 200 acts as a mechanical stop to control the depth of the incision. In some embodiments, the handle portion 204 extends past the end of the channel 206 to facilitate medical professional handling at a predetermined distance from the sharp edge 203. Advantageously, these configurations do not require an increase in the length 205 of the channel 206 and facilitate instrument control for medical professionals. Most commercially available vascular introducers are 11 to 13 cm in length. Once inserted into the patient's blood vessel, the exposed portion of the introducer tube section is relatively small. Therefore, it is desirable to limit the size of the tube section occupied by the attached cutter, thereby reducing the length 205 of the channel 206. The proximal end of the handle portion 204 is used to increase the space between the tube 110 and the cutter 106 to improve passive access and manipulation, and the deployment instrument 104 is provided with a generally short exposed length of the tube 110. Flared outward as shown to be positioned as close as possible to the axial direction. The side edges of the cutter 106 are tapered as shown.

The frame 200 includes a recess 210 that is sized to accommodate the female blade 202. The recess 210 is not used to cut tissue, but is used to shield a portion of the blade 202. The knife blade 202 is fixed to the frame 200 by one or more of various known methods such as friction fitting, mechanical force insertion, ultrasonic welding, adhesive, screw, clamp, and the like. As shown, the knife blades 202 are configured to form an angle slightly inward relative to each other. Such a configuration ensures that the blade 202 cuts tissue immediately adjacent to the percutaneous opening 12. In other embodiments, the knife blade 202 is oriented in a substantially parallel configuration. In some embodiments, the blade 202 is adjustable so that the medical professional can adjust / can adjust one or more of the incision depth, width, and angle, or of various size cutters 106. Collections are provided for various applications. In certain embodiments, the slidable tissue cutter 106 is configured to cut only the patient's skin. Adipose tissue located under the skin generally moves away from the direction of the deployment device 104 with minimal resistance. This eliminates the need for deeper incisions in some embodiments.

The cutter 106 is made of the following materials: nylon, polyamide, polycarbonate (for example, Makrolon (registered trademark)), acrylonitrile butadiene styrene (ABS), polyester, polyethylene terephthalate (PET), polyetheretherketone (PEEK ^™ ), polyimide. , Polymers including superelastic / shape memory polymers, and spring steel, stainless steel, nickel titanium alloy (Nitinol), 17-7PH, cobalt-chromium-nickel alloy (Elgiloy®), and nickel with chromium and iron Manufactured from one or more of the metals including the base alloy (Inconel®). Other suitable materials are also used. In embodiments using the “snap-on” feature, the frame 200 is sufficiently flexible that the channel wall can be folded outward to accommodate the tubular medical device 108. The slidable cutter 106 may be entirely used in one or more of the following methods: casting, laminating, machining, molding (injection or other methods), sintering, stereolithography. Or partially manufactured. Other suitable methods are also used. Advantageously, the slidable tissue cutter 106 is so low in cost as to be constructed and manufactured disposable. In other embodiments, the tissue cutter 106 is configured for subsequent sterilization and repeated use. A further advantage of the slidable tissue cutter 106 is that it is easier to use than a handheld scalpel and can implement higher tolerances and is less dependent on the technical and technical focus of a medical professional.

(D) Guided tissue dilator FIGS. 44-46 illustrate an example of a slidable guided tissue dilator 220 used in the vascular suturing system 100 in a specific embodiment. Tissue dilator 220 is configured to expand the tissue region in front of deployment instrument 104 and moves through an opening in the skin. Tissue dilator 220 is generally tube shaped and is configured to snap and uncouple to an existing introducer sheath. Dilating the tissue prior to advancement of the deployment instrument 104 creates a temporary path through the tissue, which further facilitates advancement of the deployment instrument 104 forward relative to the vessel wall 116. After dilating the tissue region, the tissue dilator 220 is removed from the introducer sheath periphery while sliding backward therefrom.

Tissue dilator 220 includes an elongated tubular portion 223 having a channel 222. Tubular portion 223 includes a tapered distal end 226 to facilitate insertion of tissue dilator 220 through percutaneous opening 12. The tissue dilator 220 includes a base 221 having a handle portion 224 that extends past the end of the channel 222. As shown, the surface of the handle 224 is positioned in a plane that is substantially parallel to the longitudinal axis of the tubular portion 223. In other embodiments, the handle 224 is positioned at a suitable angle, for example, at an angle of at least about 90 °. The handles forming the corners advantageously cause the surface perpendicular to the direction of the applied force to be pushed. When using the cutter 106, the end 228 of the base 221 can act as a mechanical stop to limit the depth of the incision. The medical professional advances the tissue dilator 220 until the tissue dilator distal end 226 is subjected to resistance of the vessel wall 116. When using the cutter 106, the channel 222 may have a partial circumferential cross-sectional geometry that causes the introducer sheath or other medical device to “snap on” the channel. In other embodiments, the tissue dilator can utilize two pairs of parts that are clamped together or snapped together to facilitate temporary attachment and removal. In the illustrated embodiment, the tubular section 223 includes a distal section 230 and a proximal section 232. Distal section 230 has a cross section around a portion larger than proximal section 232. In other embodiments, the tubular section 223 is substantially uniform along its length. Tissue dilator 220 is manufactured with materials and methods similar to those described above with reference to tissue cutter 106.

(E) Heating system Heat is used with any of the previously described vascular suture clips, such as clip 102, for example. A power source 502 such as an RF power source is provided. Other suitable power sources such as a DC power source are used. Power supply 502 is coupled to resistive element 508 through conductors 504 and 506. Clip 102 functions as a resistive element 508 of the circuit. In certain embodiments, only a portion of clip 102 functions as a resistive element. The clip 102 is treated, for example, with a resistive coating to increase its resistance. The increased resistance reduces the power level required to cause a certain amount of heating. In certain embodiments, a portion of the clip 102 is covered with a thermally and / or electrically insulative coating. The portion of clip 102 that remains uncovered is configured to transfer thermal energy to the tissue to be heated. In certain embodiments, only the antler or the distal portion of the antler is configured to transfer thermal energy to the tissue. Conductors 504 and 506 include wires made from a suitable electrically conductive material such as copper-coated steel. In certain embodiments, leads 504 and 506 can also function as tethering elements to allow removal of clip 102. Conductors 504 and 506 are covered with an insulating cover or coating. A thermocouple 512 is attached to the clip to monitor the temperature of the clip and / or surrounding tissue. The recorded temperature is provided to user display 510 and / or controller 514. The controller 514 allows the medical professional to adjust the amount of power transferred to the resistance element 508. In certain embodiments, the delivered power can be less than about 2W, about 2-50W, or greater than 50W. In particular embodiments, the delivered power is about 2W, 3W, 4W, 5W, 6W, 7W, 8W, 9W, 10W, 11W, 12W, 13W, 14W, 15W, 16W, 17W, 18W, 19W, 20W, 21W. 22W, 23W, 24W, 25W, 26W, 27W, 28W, 29W, 30W, 31W, 32W, 33W, 34W, 35W, 36W, 37W, 38W, 39W, 40W, 41W, 42W, 43W, 44W, 45W, 46W 47W, 48W, 49W, or 50W, or any wattage between these values. Other suitable wattages are also used. A medical professional can maintain the tissue at a desired temperature during a specified time. In some embodiments, the heat is applied to the tissue during a period of about 30 seconds or less, or during a period exceeding 30 seconds. Other suitable times are also used.

Following the application of heat, the leads 504 and 506 are disconnected from the clip 102 in a number of ways. For example, twisting, cutting or other manipulation action is used to remove the conductor. In embodiments that use temporary or removable clips, leads 504, 506 are used as primary or backup tethering elements to remove clip 102 after hemostasis. In particular embodiments, the leads 504, 506 are coupled to the clip 102 through spot welding, mechanical mating, soldering, combinations thereof, or other suitable methods. Conductors 504, 506 may be a variety of different materials, such as copper, platinum, stainless steel, or composite materials (eg, platinum and silver combined by a tube forming process filled with copper-coated steel or drone), etc. Made of material. In certain embodiments, leads 504, 506 include composite signal wires that use silver as the inner core, for example, to better transmit radio frequency or DC energy. The conductors 504, 506 are made in a circular, elliptical, rectangular (flat shape) or other geometric shape that depends on the space available on the clip 102. Conductors 504, 506 are covered or jacketed with an insulating material such as polyimide, polyamide, polyurethane, polyester, nylon, or other suitable material.

In certain embodiments, the special tip can be inserted through the skin and in contact with the suturing device and / or tissue, for example, a Bobby Instrument [i.e., Bobby Medical Corporation. To standard electro-medical tools such as Digital Electro-Medical Generators and Accessories manufactured by Corporation. In certain embodiments, alternative heating means are provided to heat adjacent tissue and / or clips, including, for example, ultrasonic energy, microwave energy, and the like.

FIG. 53 shows a circuit that uses ohmic tissue heating to heat the tissue. A power supply 502 is provided, such as a radio frequency (RF) or direct current (DC) power supply. A power source 502 is coupled to the active electrode 524 through a conductor 526. Clip 102 functions as active electrode 524. As an alternative, only a portion of the clip 102 functions as the active electrode 524. For example, in certain embodiments, only one or more of the clip horns or a portion of the clip horn such as the most distal portion functions as the active electrode 524. In certain embodiments, the remaining portion 524 of the clip is covered with an electrically insulating cover or coating. The second conductor 528 connects the power source 502 to the indifferent electrode 522. The indifferent electrode 522 is, for example, an electrode plate applied to a patient's skin or an indifferent ground pad having a large surface area. The indifferent electrode 522 is placed on the patient's back, thigh, or other location. The indifferent electrode 522 is applied to the part of the patient's skin facing the percutaneous opening. The power source 502 applies a voltage difference across the active electrode 524 and the indifferent electrode 522 to allow current to flow through the sandwiched tissue, thereby heating the tissue. Heat is generally concentrated in the tissue adjacent to the active electrode 524. Controller 514 allows the medical professional to adjust the amount of power delivered.

In other embodiments (not shown), the first portion of the clip acts as the first electrode and the second portion of the clip acts as the second electrode. The first part and the second part of the clip are electrically insulated from each other. For example, a first finger or a part of the first finger such as one or more antlers acts as the first electrode, and a second finger or a part of the second finger acts as the second electrode. The power source applies a voltage difference across the first electrode and the second electrode so that a current flows between the electrodes and heats the sandwiched tissue.

Electroformable suturing devices are also used to confirm contact between the suturing device and the tissue surface by comparing the impedance between the electrode element and the return path (indifferent electrode or second electrode). When the electrode surface is simply or primarily in contact with blood, the measured impedance is substantially greater than the impedance when a small or substantial portion of the electrode surface contacts the tissue.

54 and 55 illustrate another embodiment of an inner tubular member 154 'that can form a component of a deployment device. The inner tubular member 154 'is similar to the inner tubular member 154 described above. The main difference between the inner tubular member 154 'and the inner tubular member 154 is that it includes a recessed portion 550 on the handle 164'. The connecting channel 552 is relatively thin and allows access from the outer surface of the handle 164 to the inside of the recessed portion 550. The recess portion 550 houses the proximal end of the suture line 234. For example, the proximal end of the suture line 234 may be tied to the portion 554 of the handle 164 'and may form a loop around the portion. The removable clip is implanted using the process described above. Prior to removal of the deployment instrument, the suture 234 is removed from the portion 554 of the handle 164 '. After hemostasis, the proximal end of suture 234 can be grasped to retract the blood vessel and clip from the patient.

II. Using and deploying clips and / or plugs In certain embodiments, the distal end of the inner tubular member has at least one section with a larger circumferential diameter, or (forward during deployment). Flared to deflect the clip antlers outwardly (while moving to), when the clip is advanced forward for greater tissue compression and sealing (when there is no section of increased diameter) Capture more tissue). The distal end of the inner tubular member also has at least one bump disposed around the circumference, or an enlarged portion that is not a circumferential portion, such as a raised surface. Such a structure is used to open or deflect only a portion of the clip antlers outwardly during advancement and deployment, or to deflect some more than others.

In certain embodiments, the deployment instrument is configured to deploy the clip by advancing the outer tubular member distally relative to the inner tubular member instead of retracting the inner tubular member proximally. A pressurizing element or other pressure sensing means is secured to the inner tubular member, such as at the proximal end of the inner tubular member.

In certain embodiments, inhalation is used to temporarily attach a deployment device to the vessel wall and / or to ensure contact with the desired tissue. The deployment device is configured for local inhalation and / or remote inhalation. In certain embodiments, a long inhalation tube or lumen may be / can be secured to the deployment device or may be located within the deployment device. The inhalation tube comprises an opening at or near the distal end of the deployment device, and a syringe, valve, or other inhalation device may be attached / formed or integrally formed Includes a valve or fitting [eg, Luer fitting, etc.] at the proximal end or at the side of the tool. In certain embodiments, local inhalation is achieved without sticking to an external vacuum source. Local inhalation is accomplished, for example, using a syringe or other device operated by the physician to deflate the air, thereby providing the desired inhalation. At this time, a suction tube containing a vacuum is used to maintain the suction state, or a luer lock or stopcock is used to close the lumen. In certain embodiments, a remote vacuum suction system is attached to the vacuum line. The remote vacuum inhalation system comprises means for limiting the degree of vacuum / inhalation that can be formed to prevent trauma to tissue adjacent to the distal inhalation port.

A slidable tissue cutter uses heat to cut the skin and / or other tissue by causing the leading edge to be an electrode and attaching at least one electrical lead to the electrode. Direct resistance element heating or ohmic tissue heating is used. Biocompatible materials (eg gold, platinum, platinum / iridium, stainless steel, nitinol and other suitable materials) are used for the electrodes and connected to the appropriate (eg electrical and biocompatible) conductors Is done. One wire is connected to the RF power source for heating the ohmic tissue. The other leads are connected to a ground pad located on the patient's body and to a power source. Both wires from the power supply are connected to electrodes for direct heating of the resistive element.

In certain embodiments, the cutting element of the slidable tissue cutter is configured to cut tissue or to cut and remove tissue. In some cutting and removal embodiments, the cutting element is a circular blade, a diagonal blade, a cornered blade or other blade. The slidable tissue cutter includes, but is not limited to, skin, fatty ligament, cartilage, bone or blood vessel, and is configured and used to cut any body tissue. The cutting element is of any desired type, including thermal types (laser, RF, etc.), chemical types, ultrasonic types, combinations thereof or other types.

Hereinafter, an example of a method using the deployment tool 104 and the clip 102 will be described. FIG. 18 shows the deployment instrument 104 in an initial configuration loaded into a vascular introducer 108 inserted into a patient's blood vessel 118. The deployment instrument 104 may also be used with other medical devices such as, for example, tubular or long dilators, trocars, endoscopes, catheters, guidewires, needles, tubes, sheaths, combinations thereof, or other devices. Configured. The tubular medical device 108 is first inserted through the inner diameter of the deployment instrument 104 loaded with the clip 102. The tubular medical device 108 is inserted through the skin and into the desired blood vessel 118 using any of a number of known methods such as, for example, the Seldinger method. The desired adjustment or diagnostic process takes place at this time. The deployment device 104 temporarily moves to the side as shown so as not to interfere with such a medical process. For example, the deployment instrument 104 moves toward the posterior or proximal end of the introducer sheath 108 as shown in FIG. Slots 162 and 170 (see FIGS. 7 and 12) facilitate such positioning.

Referring to FIGS. 19 and 20, the deployment instrument 104 is advanced forward along the introducer sheath through the percutaneous opening 12 until the distal end 105 of the deployment instrument 104 contacts the vessel wall 116. In such a state, along the pressure sensing structure outside the outer tubular member 156, the pressurizing element 158 is present in its initial unadvanced structure, as shown in FIG. In certain embodiments, a dilator that has already been removed or a new dilator, or other long member, is placed on the inner lumen of the vascular introducer device 108 to provide mechanical support and resistance to the kinking of the introducer device 108. Inserted. The reinsertion of the dilator thereby facilitates advancement of the deployment instrument 104 relative to the introducer device 108.

Referring to FIGS. 21 and 22, the pressurizing element 158 will be manually advanced distally until it reaches the stop 182, which may be deployed between the deployment instrument 104 and the vessel wall 116. Inform the medical professional that a suitable force is applied to start. FIG. 22 is an enlarged view of the pressure element 158 in its fully advanced configuration. As the pressurizing element 158 is advanced distally, the flexible tab 188 is bent more greatly as the pressurizing taper 178 is fully advanced. Accordingly, advancing the pressurizing element 158 requires a greater applied force. The pressure taper 178 is flared outward until it reaches a generally flat surface 180. The stop 182 generally prevents the pressurizing element 158 from advancing beyond this point from the distal end. The amount of applied force required to fully advance the pressure element 158 is one of the number, size, width and stiffness of the tab 188, the angle of inclination of the pressure taper 178, and the height of the surface 180. It is adjusted by changing the above. In certain embodiments, deployment instrument 104 requires a force of at least about 10 ounces to safely initiate deployment of clip 102. Thus, in certain embodiments, the pressure element 158 can require a force of at least about 10 ounces to be fully advanced. In other embodiments, deployment instrument 104 requires a force of about 3 ounces to about 64 ounces to safely initiate deployment of clip 102. In some embodiments, a force of less than about 3 ounces is required. In other embodiments, the deployment instrument 104 may include about 3 ounces of force, about 4 ounces of force, about 5 ounces of force, about 6 ounces of force, about 7 ounces to safely initiate deployment of the clip 102. , About 8 ounces, about 9 ounces, about 10 ounces, about 11 ounces, about 12 ounces, about 13 ounces, about 14 ounces, about 15 ounces About 16 ounces force, about 17 ounces force, about 18 ounces force, about 19 ounces force, about 20 ounces force, about 21 ounces force, about 22 ounces force, about 23 ounces force, about 24 ounce force, about 25 ounce force, about 26 ounce force, about 27 ounce force, about 28 ounce force, about 29 ounce force, about 30 ounce force, about 31 ounce force, about 32 ounce force About 33 ounces, about 34 ounces, about 35 ounces, about 6 ounces, about 37 ounces, about 38 ounces, about 39 ounces, about 40 ounces, about 41 ounces, about 42 ounces, about 43 ounces, about 44 ounces , About 45 ounces, about 46 ounces, about 47 ounces, about 48 ounces, about 49 ounces, about 50 ounces, about 51 ounces, about 52 ounces About 53 ounces force, about 54 ounces force, about 55 ounces force, about 56 ounces force, about 57 ounces force, about 58 ounces force, about 59 ounces force, about 60 ounces force, about Tolerance of 1/100 ounce as a force of 61 ounces, force of about 62 ounces, force of about 63 ounces, or force of about 64 ounces, or any force within about 100 ounces, or any force within this range Requires force measured at. In certain embodiments, the deployment device is configured to generate an audible “click” sound when the pressurizing element 158 is fully advanced, or otherwise generate an auditory signal, a view signal, or a tactile signal. The

In some embodiments, other pressure sensing structures such as pressure gauges or force gauges are used to verify proper pressure application. The deployment device can use a spring instead of or in addition to the tapered element. The first end of the spring is fixed to the slidable element. The second end is attached to a distal point on the outer tubular member. The slidable element is used to compress the spring, thereby applying a force to the outer tubular member. Further included is a combination or other means for verifying sufficient contact and pressure between the deployment instrument and the blood vessel. In certain embodiments, the deployment instrument comprises a grasping tool configured to assist in securing the distal end of the deployment instrument to the blood vessel. In certain embodiments, a medical professional can observe blood reflux through a channel or window in the deployment device after removal of the tubular medical device to confirm proper placement in the blood vessel. Blood is allowed to flow through the central channel of the deployment device. In certain embodiments, a transparent channel or transparent tubular section 640 is provided to accommodate blood flow. One or more sensors are provided to verify proper placement and / or pressure.

FIG. 23 shows the deployment instrument 104 together with the clip 102 in a partially deployed configuration. In the partially deployed state, the antler 126a, 126b can open the vessel wall 16, and the clip 102 remains attached to the deployment device 104 in an open configuration. The medical professional partially deploys clip 102 by initiating retraction of inner tubular member 154. The medical professional can maintain a suitable pressure with the pressure element 158 while retracting the inner tubular member 154 [eg, pressure is sufficient to maintain the pressure element 158 in its fully advanced configuration. ]. Handle 164 is used to retract inner tubular member 154. For example, a medical professional can apply pressure distally to the pressure element 158 with one hand, while the remaining hand can partially retract the handle 164. A ridge or countersink 174 on the outer tubular member 156 prevents the clip 102 from retracting with the inner tubular member 154. Thus, as the inner tubular member 154 retracts, the antler 126a, 126b begins to extend past the distal end 165 of the inner tubular member 154. The continuous application of pressure to the pressurizing element 158 [and thereby the outer tubular member 156] generally applies a force to the antler 126a, 126b to open the vessel wall 16. In certain embodiments, the pressurizing element 158 includes means for making the inner tubular member 154 non-retractable unless the pressurizing element 158 is fully advanced and until the pressurizing element is fully advanced.

24 to 29 show an example of a method for realizing partial expansion. FIG. 24 shows a perspective view of the deployment instrument 104 in the partially deployed state, and FIG. 25 is an enlarged view of the distal end portion 105 of the deployment instrument 104 in the partially deployed state. The handle 164 can be retracted until the proximal surface 167 of the handle 164 contacts the stop 175, thereby preventing further retraction, as generally shown in FIGS. The stop 175 generally prevents a medical professional from fully deploying the clip in advance and ensures that the clip 102 is partially deployed to the appropriate depth. The stop 175 is configured such that the handle 164 can travel a well-known limited distance 179. In embodiments where the tips 127a, 127b of the antler 126a, 126b are initially aligned with the distal end 165 of the inner tubular member 154, the distance 179 corresponds to the insertion depth of the antler into the vessel wall 16. it can. In certain embodiments, the distance 179 is / is about 0.5 mm or more, or is about 4 mm or less. In particular embodiments, the distance 179 is about 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2. 7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, Or has a tolerance of 1/100 mm at 4.0 mm or for any dimension within this range. In a particular embodiment, distance 179 is about 2 mm. Other suitable distances are also used. The distance 179 depends on the specific example and the clip used.

With the clip 102 partially deployed at the vessel wall 16, the tubular medical device 108 does not need to guide the deployment instrument 104 to the arteriotomy so that the tubular medical device 108 is shown in FIG. So as to be removed from the blood vessel 18. Removal of the tubular medical device 108 prior to full deployment prevents the clip 102 from being closed over the tubular medical device 108. Partial deployment of the clip 102 helps to more accurately position the deployment instrument 104 while the tubular medical device 108 is removed, and to temporarily secure the deployment instrument in place.

Once the tubular medical device 108 is removed from the blood vessel, the stop 175 can be overcome by folding the tab 172 in the direction of the arrow 189 shown in FIG. It becomes possible. Accordingly, the tab 172 can act as a release element, thereby allowing the stop 175 to be overcome. The recessed or soft portion 186 of the tab 172 can be easily folded. The flat bottom portion and the angled surface 352 of the handle 164 can reduce the degree to which the tab 172 is required to be bent to get over the stop 175. In some embodiments where the deployment device 104 is configured to be disposable, the tab 175 is configured to be snapped out. Other suitable stopping means and methods of overcoming this stopping means are used.

With reference to FIGS. 30 and 31, the medical professional can remove the inner tubular member until force is removed from the clip 102 or the clip is advanced past the distal end 105 of the deployment instrument 104. Continue to retract 154. The opposing fingers 122, 124 of the clip 102 are folded inward to bring together the sides of the vascular tissue from the outer surface of the vessel to suture the arteriotomy 114 as shown in FIG. Arteriotomy sutures are not necessary, but complete mechanical sutures of the aperture can be achieved as a result. Instead, in this situation, the term “suture” refers to any hemostasis enhancement. Thus, in certain embodiments, the sides of the vascular tissue should not necessarily contact. In general, the sides of the vascular tissue gather closer together to reduce the size of the opening 114 in the blood vessel 118, thereby facilitating hemostasis.

FIG. 32 shows the deployment instrument 104 retracted after successful deployment of the clip 102. Clip 102 is biocompatible and may be configured for permanent implantation. This allows the patient to be discharged after successful clip deployment and hemostasis confirmation in certain embodiments.

In some embodiments, the vascular suturing system 100 is completely or substantially external to the vessel in that the deployment instrument or suturing device need not penetrate into the inner region of the blood vessel 118. This can reduce or eliminate the amount of foreign material introduced in contact with the patient's bloodstream, thereby reducing the risk of infection, clogging, or other complications. For example, in certain embodiments, a rear support is not required during clip deployment. In some systems, the use of a posterior support is disadvantageous because a portion of the deployment tool or suturing device needs to be positioned in the blood vessel during or after deployment. If a posterior support element is used inside the blood vessel, complex mechanisms can be required to facilitate its removal after deployment. Safe deployment of clips that do not require a back support can be achieved by applying a controlled amount of external pressure through the use of partial deployment techniques as described above, and through a pressure element or other pressure sensing means. It becomes easy. In addition, the use of clips with antlers that are appropriately sized to prevent excessive insertion also facilitates deployment without a rear support.

The system 100 described above is already compatible with standard commercially available introduction devices used in standard vascular adjustment or diagnostic processes. This eliminates the need to purchase and use special and costly additional equipment or other equipment, and eliminates the need to change the manner in which the adjustment or diagnostic process takes place, thereby reducing the risks involved. .

33 to 35 show an example of a method for temporarily transplanting the clip 102. In certain embodiments, the vascular suture clip 102 can be removed and configured for temporary implantation as shown in FIG. In embodiments using temporary sutures, one or more suture lines 234 or other suitable tethering means are secured to the clip 102 and positioned along the outer surface of the outer tubular member 156 prior to insertion. The suture 234 can be tied to the clip 102, attached to the window portion 125, or some other manner, or looped through other openings provided in the clip 102 for such purposes. In certain embodiments, clip 102 and deployment instrument 104 are provided to a medical professional with suture 234 attached. In other embodiments, the suture 234 is attached by a medical professional prior to use. A slot 176 (see FIG. 8) at the distal end 173 of the outer tubular member 156 facilitates access to the clip 102 to secure the suture 234 to the clip 102 after loading onto the deployment instrument 104. To. The distal end of the axial groove 160 on the inner tubular member 154 allows a suture to pass under the base portion 120. In certain embodiments, the suture 234 is secured or tied to the clip before being loaded into the deployment instrument 104. The suture line 234 extends along the outer surface of the outer tubular member 156 as shown in FIG. In other embodiments, the suture line 234 extends along the inside of the deployment instrument 104. In certain embodiments, the deployment instrument 104 includes a channel that is specialized to receive the suture 234.

The removable clip 102 is temporarily implanted using the process described above. The proximal end of the suture line 234 remains extended out of the patient's body while the clip 102 remains implanted. After a time sufficient to achieve hemostasis, the medical professional draws on the suture 234 to remove the clip, as shown in FIG. The suturing force of the clip is configured so that the fingers 122, 124 are temporarily released by the force applied to the suture line 234 so that the clip 102 reopens the arteriotomy 114 or the vessel wall 116. Ensure safe removal without damage. In certain embodiments, the clip 102 includes other or alternative release mechanisms that are triggered through the suture 234. The release mechanism facilitates removal of the clip 102 with the fingers 122, 124 open. In embodiments using shape memory clips, the clip is cooled until transformed into the martensite phase, which causes the clip to be more easily deformed and the force required to open the clip's fingers and retract it. The size of is reduced. The clip 102 is cooled through insertion of a cold probe or by application of an externally applied cold source, such as an ice pack. Additionally or alternatively, an infusion syringe is used to transfer a chilled liquid, such as chilled saline, to the clip. In certain embodiments, the clip 102 can have two shape memory effects, and cooling the clip 102 can return the clip to a second stored configuration, which can be, for example, an open structure. . The composition and processing of the clip is selected to achieve the desired phase transition temperature to facilitate these methods.

The time required to achieve hemostasis varies from patient to patient depending on a variety of factors including the patient's age, sex, medical conditions, medication, and the presence of anticoagulants used during the medical process. Under certain conditions, the clip may be about 10 minutes later, after about 15 minutes, after about 20 minutes, after about 25 minutes, after about 30 minutes, after about 35 minutes, after about 40 minutes, Removed after 45 minutes, after about 50 minutes, after about 55 minutes, or after about 60 minutes, or after a time having a tolerance of about 1/100 second at any suitable time within this range. . In some embodiments, the clip 102 is removed after about 1 hour or more. Other suitable times are also used.

In some embodiments, it may be desirable to use sutures 234 even with clips intended for permanent implantation to allow first aid removal. In such a device, a medical professional can deploy the clip using the process described above. Once it is determined that the clip has been successfully deployed, the medical professional can cut the suture 234 and fully retrieve the suture from around the clip.

Such a disclosure is a specific example of a suturing device comprising a clip and a plug. However, other types of suturing devices are also used. In certain embodiments, the suturing device is smaller with the initial structure or with the deployed structure. In certain embodiments, the suturing device can suture the tissue opening by gathering the sides of the tissue opening closer together and / or by partially or completely occluding the opening. The suturing device is made in part or in whole with one or more of polymer, rubber, silicon, metal, metal alloy, superelastic / shape memory polymer and metal alloy, combinations thereof or other suitable materials. The

In some embodiments, the suturing device comprises polyglycolic acid, polylactide, polycaprolactone, polytrimethylene carbonate, polypara-dioxanone, combinations thereof or a copolymer that is caprolactone, glycolic acid, lactide, or trimethylene carbonate, etc. Other suitable materials; (but not limited to) alginic acid, chito acid, collagen, fibrin, fibrinogen, hyaluronic acid, hyaluronic acid, combinations thereof or other suitable materials; starch Modified cellulose, collagen, fibrin, fibrinogen, fibronectin, elastin, vitronectin, laminin, thrombin, albumin and gelatin or other binding proteins, or natural materials, polymers or polyvinylpyrroline Don, polylactide [poly-L-lactide (PLLA), poly-D-lactide (PDLA)], polyglycolic acid, polydioxanone, polycaprolactone, polygluconate, polylactic acid (PLA), polylactic acid-polyethylene oxide copolymer Copolymers, poly (hydroxybutyrate), polyanhydrides, polyphosphates, poly (amino acids), poly (alpha-hydroxy acids), poly d, l-lactic acid (PLA) and copolymers of lactic acid, and glycolic acid ( PLGA), or copolymers such as related copolymers of these materials, as well as composites and combinations thereof, and other biodegradable / bioabsorbable material materials (which are not limited to these) A biodegradable / bioabsorbable material comprising one or more synthetic materials including but not limited to Minute to or overall production. In some embodiments, the suturing device is made of a biocompatible material, i.e., a biocompatible material such as expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, silicone, rubber, dacron, and / or urethane, partially or Made entirely.

In some embodiments, the suturing device can / can include one or more coatings, or one or more of the following: a swellable material, a bioadsorbable material, and a biocompatible material One or more may be formed partially or wholly.

In some embodiments, the suturing device is an adhesive, bonding compound, or other that is intended to delay the expansion or expansion of at least one section of the suturing device once the suturing device is in contact with the fluid. It has a biocompatible contact surface such as a solution. The biocompatible contact surface is located on any surface or any surface of the suturing device. The contact surface can be applied or integrated into the suturing device in a variety of ways, for example, during the manufacturing process, immediately before deployment or after deployment of the suturing device. The joining material can be in liquid, semi-solid, or solid form. Suitable bonding materials include gels, foams and microporous mesh. Suitable adhesives include acrylates, cyanoacrylates, epoxies, fibrin series adhesives, other biological material based adhesives, UV light and / or heat activated adhesives or other special adhesives. Including. The contact surfaces may be joined at the initial contact and are joined after a longer time so that the suturing device can be repositioned. Such contact surfaces include, for example, a crystalline polymer that changes from a non-tacky crystalline state to an adhesive gel state when the temperature rises from room temperature to body temperature. Examples of these materials, as well Landec Corporation (Landec Corp.) available from tradename Inchirema adhesive ^(Intillemer TM ^adhesive), composite materials and combinations thereof, and combinations of other materials can be utilized. Biocompatible adhesive suppliers include, but are not limited to, Plasto (Dijon, France), Haemacure (Montreal, Canada), Cohesion (California Palo Alto, USA) Location), Cryolife (Kennesaw, Georgia, USA), Tissue Link (Dover, New Hampshire, USA) and other companies. In order to increase the working time of the contact surface and / or to allow repositioning of the suturing device after deployment of the suturing device, the contact surface is mixed with a material such as starch or other material, Bonding is postponed or delayed to allow repositioning of the suturing device after deployment of the device. The degradable coating is disposed on the contact surface such that the contact surface is decomposed to expose the adhesive. Other contact surfaces can include composite-based adhesives and combinations of the materials described above, and other suitable materials are known in the art.

In some embodiments, the suturing device is disassembled by hydrolysis, reabsorption, combinations thereof, or other suitable methods or processes.

The suturing device, system and method may be any suitable cardiovascular example, gastrointestinal example, nervous system example, genital example, lymphatic example, respiratory example, orthopedic example, a combination thereof, or a partial or total Temporary, removable or permanent suturing, compression, sealing, bonding, tightening, anchoring and / or strengthening, tissue transformation, stabilization, shim, tissue access, tissue modification, tissue connection (E.g., connection of tissue and medical device or connection to other tissues), used for other applications where tissue displacement and / or tissue size changes are required. In addition, the suturing device, system and method can be partially or completely, temporary, removable in connection with any lumen, tube, organ, hollow body organ or cavity, or other body structure or tissue. Or used when permanent sealing, crimping, compression, plugging, reinforcement or a combination or other purpose is required. For example, but not limited to, some examples are cerebral artery treatment, chordae tendinae shortening to handle mitral valve prolapse, regenerative for women with fistula obstruction Sterile surgery for men with obstructive or permanent sterilization and obstruction of the vas deferens or tube, sutures of diaphragm defects (or other defects) in the heart or other parts of the body, PFO (patent foramen ovale) sutures, Includes post-biopsy post-biopsy tissue closure, minimal or vascular surgery, general tissue ligation, and local therapeutic elution. Other examples are percutaneous hearts using devices and systems such as devices or systems of diagnostic or interventional processes such as minimal incision, Edwards Life Sciences (Irvine, Calif., USA). Includes suturing the access hole in the heart following a diagnostic or interventional process such as valvular reinforcement or an alternative process.

In some applications and applications of the disclosed technology, after implantation in the body or body as a plug / sealing element consisting of biocompatible material or coated material and / or material covered with biocompatible material It is advantageous to include a plug / sealing element that is not absorbed or degraded by the organism, or is absorbed, degraded and destroyed by the organism. Some examples of uses and applications using non-absorbable plug / sealing elements include, but are not limited to, cerebral artery treatment (eg, deployment of plug / sealing elements proximal to an aneurysm and intravascular Occlusion of part or all of the blood flow in the blood), chordal shortening to handle mitral valve prolapse, regenerative or permanent sterilization for women with fistula obstruction, and vas deferens or tube Infertility surgery for men with obstruction, diaphragmatic defect (or other defect) sutures in the heart or other parts of the body, PFO sutures, post-biopsy tissue sutures, tissue sutures after the open area surgical process, minimal incision, The disclosed suturing device, system and / or method configured for percutaneous surgery, transluminal procedures, general tissue ligation, and local therapeutic elution At least one of them. Other examples include suturing the access hole in the heart following the diagnostic and / or adjustment process.

For example, the system is configured to deploy an implant for local elution of a therapeutic agent or material. The implant is removable or permanent and is at least partially made of a bioabsorbable / biodegradable or non-biodegradable / water-absorbing material.

The tissue suturing system spans and / or differs from tubular medical devices including tools such as tourniquets, cutters, tweezers, probes, biopsy devices, and / or tools used during the medical process. Allows for advancement / deployment. Deployment devices and / or sealing elements can be, for example, needles, hypotubes, guide wires, electrode wires, intravenous (IV) tubes, vascular introducers, catheters, laparoscopes, endoscopes, trocars, cannulas, these Configured to advance over and / or along additional medical devices, such as combinations or other suitable medical devices. The disclosed system is packaged in or with medical devices or tools. The deployment instrument and / or sealing element is configured to work with any size medical device, including a device having an outer diameter of about 6 French or less, a device having an outer diameter of about 20 French or more, or any size device therebetween. Is done. In some embodiments, the deployment device and / or sealing element has an outer diameter of about 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 15 French, 16 French, 17 French, 19 French, 19 French, Configured to work with medical devices. Other suitable sizes are also used.

In certain embodiments, the tissue suturing system is configured to be operable as an independent surgical system. For example, in certain embodiments, the tissue suturing system is configured to advance over or along a long medical device or otherwise operate without being guided by a long medical device.

The deployable element may be used as a temporary or permanent spacer, shim, or used for movement and / or support, stabilization, reinforcement or occlusion of any tissue, including bone. The deployable element can be partly or wholly a plurality of various types of materials, such as polymers, sponges, metals, metal alloys, superelastic / shape memory materials (including polymers and metal alloys), or any other Made of any suitable material. The deployable element is deployed through a pusher element, eg, a tube with a probe, plunger, inner tubular member or rod, and allowed to expand before, during and / or after deployment. The deployment element is biased in the expanded configuration. The unfoldable element is maintained in a compressed structure during element positioning and is allowed to expand with the expanded structure when no more constrained. Generally, the suturing device is constrained with a smaller cross-sectional profile and is allowed to expand itself once the restraining force is removed. Furthermore, the suturing device is constrained in the open position and allowed to close itself once the opening force is removed.

The general components and / or the disclosed system, modified as required, may be used / used for temporary or permanent suturing or of the heart, through the heart or inside the heart. Location; processes including electrophysiology, congestive heart failure, valvular related treatments (eg, including dilation, valvular reinforcement, replacement, papillary muscle treatment, chordae and other related structures, combinations thereof and / or other purposes) Tissue access enhancement for medical procedures such as minimal incision biopsy, other tissue removal, or diagnosis or treatment process, including location for; and / or any other location on tissues or organs including skin Used for.

The system of the present invention facilitates minimal incision with thoracoscopic access to the target location and visualization. In some embodiments, the system of the present invention is adjacent to a median sternotomy, lateral thoracotomy, intercostal port access, minimal sternotomy, or saccular cartilage access, buttocks approach or diaphragm Suitable for use across other minimal incisions with chest approach. In other embodiments, the system of the present invention is configured for catheter-based applications by elongating the shaft and changing the diameter and other feature dimensions for intravascular access. The

The system of the present invention can be achieved through thoracotomy, thoracotomy, median sternotomy, minimal sternotomy, minimal thoracic duct insertion, saccular cartilage access, thoracic lower access, arthroscopy, or laparoscopic Deployed, thereby potentially eliminating the need for long incisions to access soft tissue and corresponding anatomy.

Suture devices, systems and methods are used for occasional or permanent tissue reshaping, reforming and / or resizing. Tissues that can be reshaped and / or resized include organs such as the stomach, lungs, other structures such as the esophagus, and heart and / or valvular structures. For example, in certain embodiments, one or more clips may be reshaped by one or more of tissue access, gathering, pursing, bunching, cinching, or holding alone. Sufficient to be remodeled and / or resized. In other embodiments, a plurality of clips are coupled together from the outer or inner surface of a tissue structure or organ by a suitable tether, such as a static or elastic tether. In certain embodiments, the tether will become tensioned following implantation of the clip to achieve further resizing, reforming and / or reshaping of the tissue. In certain embodiments, one or more clips and / or appropriate tethers are provided for resizing and / or reinforcing LES (Lower Esophageal Spincter) for gastrointestinal applications or for resizing tissue around the pericardium. used.

The disclosed clip and / or delivery system can also be configured to anchor the implanted stent-graft by immobilizing the stent-graft to the tissue wall without allowing the stent graft to move. For example, stent graft [W. L. Devices such as Gore, Cook, Medtronic (WL Gore, Cook, Medtronic) and systems] are used to treat abdominal aortic aneurysms by reinforcing the aortic wall to prevent rupture. One or more clips can be deployed inside the stent-graft and / or outside the abdominal aorta to contact / can contact the stent-graft or act to limit potential graft movement. The devices, systems and methods disclosed in connection with anchoring or attachment of stent grafts, prostheses or other structures or devices are further used at any other location on or within the body.

Common suturing systems include surgical systems available from Intuitive Surgical, Inc. (Sunnyvale, Calif., USA), and Stereotaxis (St. Louis, MO) and Hansen, Inc. Configured for use with robotic or computer controlled medical processes, including catheter-based technology available from Hansen Medical (Mountain View, Calif.).

The suturing system is a heart that can be performed by Core Valve (Irvine, California), Edward Life Sciences (Irvine, California), Sandra Medical Inc. (Campbell, Calif.), Etc. Used to suture vascular access in large catheter-based percutaneous angioplasty processes, including valvular reinforcement / alternative processes.

As shown in more detail in FIGS. 90A-90E in connection with deployment of the plug device from the capsule 630 having a hemostatic structure, the plug may be disposed between the introducer device and the guide seal assembly as illustrated above. Located in capsule 630 positioned at In FIG. 90B, looking down the barrel of capsule 630 from distal end 80, the wall of capsule 630 can be seen with the positioned plug down in the opening. The plug skirt region covers the bore and the hemostatic pressure applies a force to the skirt surface to seal the housing, thereby preventing fluid leakage through the capsule 630 as shown in FIGS. 90C-90E. Form. In operation, the introducer is advanced into place at the site where the plug is deployed. The plunger is advanced distally through the plunger stem, the capsule body 634 and the introducer, thereby pushing the plug through the introducer to the position as shown in FIG. 91A.

To help control the direction of travel of the plunger grip, a locking split bushing is included in the configuration described above, as shown in FIGS. 91B-91I. The configuration of the conical split bushing comprises a conical taper on the stem and a conical split bushing coupled to the conical taper when attempting to move backward (proximally directed) While locking itself, it is released while moving forward (directed distally). In other configurations, tilted disks that lock and release are used as shown in FIGS. 91D and 91E. As the disc is tilted back and forth, the disc either allows the stem to move forward or locks the stem to prevent backward movement. Yet another configuration is a ratchet configuration as shown in FIGS. 91F and 91G, where the stem forms a notch and is locking in the forward direction but not in the backward direction. Combined with fingers. Yet another configuration uses a silent ratchet as shown in FIGS. 91H and 91I, where the fingers are provided to penetrate into the stem.

As shown in FIGS. 92A-92T, the introducer device is placed within the blood vessel such that the distal end of the introducer device is positioned across the vessel wall and the distal end 80 of the introducer device is positioned within the lumen of the vessel. Advance. As shown in FIGS. 92A and 92B, the hemostatic valve is closed to hold the sealing device in place within the capsule 630. Once the introducer is positioned, for example, in a predetermined position across the vessel wall, the plunger is inserted from the introducer cap into the proximal opening of the capsule 630, as shown in FIGS. 92C and 92D. As the plunger is advanced through the capsule 630, the plunger tube contacts the tether, collet insert, and collet, but the collet allows some forward movement, but does not allow backward movement. Apply frictional force. The collet is composed of a spirally wound blade or a biaxial blade, which causes relaxation when the plunger is pushed through the blade, but the plunger may be When recovered by reducing the radial distance to and from the collar around the plunger, it is tensioned to prevent backward movement, so that, as shown here, if the plunger is tensioned through the tapered outer collar, The plunger applies a strong clamping force. The plunger and cartridge are inserted into the proximal end 70 of the introducer, as shown in FIGS. 92E and 92F. Such a combination is advanced into the introduction device and placed in the introduction device, as shown in FIGS. 92G and 92H, and the hemostasis valve exists as an open structure. As the plunger becomes advanced in the advancing collet, the plug is directed forward [still in the capsule 630] as shown in FIGS. 92I and 92J. The plunger is further advanced into the introducer to push the plug into the inner lumen of the introducer as shown in FIGS. 92K and 92L. At this point, the side wings of the plug are folded backwards so as to have a small cross-sectional profile structure with an outer diameter smaller than the inner diameter of the introducer while the plug is advanced through the introducer. As shown in FIGS. 92M and 92N, the plug is advanced 80% through the introducer toward the distal end 80 of the introducer (located within the lumen of the vessel). The plug is advanced beyond the distal end 80 of the introducer, at which point the plug restores its original profile without further restraint, but the diameter of the plug distal end 80 is It is larger than the diameter of the introducer, as shown in 92O and FIG. 92P. The introducer then retracts. As the introducer retracts, the plug stem is pulled across the opening in the vessel wall and the plug is pulled in a position where the plug surface is joined to the inside of the vessel wall. Once the introducer exits the vessel, the proximal end 70 of the plug stem can be observed from the outside of the vessel, and in some configurations, as shown in FIGS. 92Q and 92R, the inner surface of the vessel wall can be seen. Extend beyond. A further enlarged detail view of the plug positioned within the vessel is shown in FIGS. 92S and 92T. If a tether is used, the tether can extend from the plug to assure the user that the stem of the plug has been properly advanced through the opening in the vessel wall. The tether is removed as necessary. Alternatively, the tether may remain in the body as needed. For example, the tether may be made of a biodegradable / bioabsorbable material and remain in the body, with the proximal end of the tether cut to the same height as the skin. The plug is fixedly held in place by the inner fluid pressure and exerts a force on the corresponding distal surface of the plug against the inner vessel wall. Such a force increases in proportion to the fluid pressure, improving plug fixation. No other features are required to achieve plug hemostasis. The stem has essentially three functions. First, the stem contacts the inner vascular contact element with the inner wall of the vessel and then achieves temporary hemostasis that activates itself. Second, the stem acts as a centering element for centering blood vessels that contact in the vicinity of the hole location (eg, the stem is positioned at the center point and not positioned out of the center). Finally, the stem prevents the plug from flowing away from the hole location due to the force applied by the blood flow through the blood vessel. A simple stem configuration is as shown in FIGS. 85A and 85B.

FIG. 96 shows a vascular access suture part. In some embodiments, the vascular access suture 960 is provided without a tether. In other embodiments, the vascular access suture 960 is provided with a tether 962, although the tether may or may not be a removable tether. The suturing device 960 can include a skirt 964, which acts as a sealing surface. The suturing device also includes a stem 966. In some embodiments, the suturing device 960 includes one or more ribs 968 or protrusions. A suturing device represents a clip, plug, or any configuration of suturing device as described elsewhere herein.

The suturing device can penetrate the artery 970. In some embodiments, the suturing device is used to suture the hole location 972 with the artery. The artery can represent fluid pressure at the interior 974, which holds the suturing device 960 in place. In some embodiments, skin surface 976 is provided near or adjacent to artery 970 and has an existing hole location 972. The suturing device 960 is provided such that the skirt 964 is within the artery 970 and the stem 966 extends into the existing hole location 972. In some embodiments, a tether 962 is provided that extends through an existing hole location 972.

97A-97E illustrate the steps used to transfer a removable vascular access suture with the additional ability to re-access an existing hole location. FIG. 97A shows the first stage in which the suturing device 980 is used to suture the hole location 985. The suturing device 980 includes a stem 982. Suture device 980 is coupled to tether 983. In some embodiments, at least a portion of the tether 983 is within, adjacent to or near the re-dilator in the tether-guided re-expander 984. In some embodiments, the re-dilator 984 surrounds at least a portion of the tether 983. Re-dilator 984 can slide along tether 983 and reach stem 982 of suturing device 980. In some embodiments, the re-dilator 984 can enter the hole 985 before reaching the stem 982 of the suturing device 980. In some embodiments, as shown at A1, the re-dilator 984 narrows at its distal tip. In other embodiments, the re-dilator 984 is widened at its distal tip, as shown at A2.

The re-dilator 984 stops at the stem 982 of the suturing device 980 as illustrated in option A. In other embodiments, as shown in option B, the re-dilator 984 extends across the stem 982 of the suturing device 980. The dilator tip 984 extends completely across the stem 982.

FIG. 97B illustrates a second stage in which a re-dilator 984 is pushed into a blood vessel 986, such as an artery, to disengage the suturing device 980 from its original location. Re-dilator 984 pushes suturing device 980 into vessel 986. Tether 983 is still attached to stem 982 of suturing device 980. The tether 983 is within the re-dilator 984, adjacent to or adjacent to the re-dilator.

FIG. 97C illustrates the third stage, showing a detached suturing device 980, such as a plug, within the blood vessel 986, while showing a re-dilator 984 that extends through the vessel wall into the blood vessel. A tether 983 coupled to the detached suturing device 980 extends through the dilator 984. An introducer sheath 988 of introducer 987 can slide across dilator 984. The introducer sheath 988 surrounds at least a portion of the tether 983, is adjacent to, or is in close proximity to, at least a portion of the tether.

FIG. 97D shows a fourth stage in which the introducer sheath 988 is fully pushed into a blood vessel 986 such as an artery. The introducer sheath 988 is pushed out until the dilator 984 protrudes from the introducer sheath 988. The dilator 984 is pulled until the suturing device 980 is completely collapsed into the introducer tip 988. The dilator 984 continues to be pulled until the suturing device 980, the tether 983, and the dilator 984 are fully withdrawn from the introducer 987.

FIG. 97E shows various alternative structures. For example, as shown in A, a particularly long tether 983 is provided with a preinstalled dilator 984 and introducer 987. The tether 983 is fed through the entire length of a particularly long dilator 984. The pre-installed dilator 984 is longer than the introducer 987. The dilator 984 is drawn through the introducer 987. In some embodiments, the dilator 984 is pulled together with the tether 983 and the suturing device 980.

As shown in B, the dilator 984 is provided with a snap end 990. The dilator 984 is within the introducer 987 and protrudes from the introducer sheath 988. In some embodiments, the dilator 984 has a snap end 990 at the proximal end, and the dilator grip 989 extends generally through the introducer 987 so that the grip 989 is introduced into the introducer 987. Projecting from the proximal end of the gripper 989 has a snap end 991 at the distal end of the gripper. The introducer sheath 988 and dilator grip 989 slide over the tether 983 and slide toward the dilator 984. The distal end of the grip 989 with the snap end 991 is snapped in place to the proximal snap end 990 of the dilator 984. The introducer sheath 988 slides over the dilator / gripping interface and over at least a portion of the dilator 984. In some embodiments, the dilator grip 989 is pulled through the introducer 987. In some embodiments, the grip 989 is pulled together with the dilator 984, the tether 983 and the suturing device 980.

III. Production method The deployment device 104 comprises the following materials: nylon, polyamide, polycarbonate (e.g., Makrolon (R)), acrylonitrile butadiene styrene (ABS), polyester, polyethylene terephthalate (PET), polyether ether. Ketone (PEEK ^™ ), polyimide, polymers including superelastic / shape memory polymers, and spring steel, stainless steel, nickel titanium alloy (Nitinol), 17-7PH, cobalt-chromium-nickel alloy (Elgiloy®), And one or more metals including nickel-base alloys (Inconel®) with chromium and iron. Other suitable materials are also used. The deployment tool 104 may be wholly or partially used using one or more of the following methods: casting, injection, laminating, machining, molding (injection or other methods), sintering, or stereolithography. Are produced. Other suitable methods are used.

As shown, in certain embodiments, deployment device 104 is configured with a relatively small number of components, such as an inner tubular member, an outer tubular member, and a pressurizing element. Each component is manufactured by injection molding at low cost. In certain embodiments, deployment device 104 is configured to be disposable. As an alternative, the deployment device 104 is configured for repeated sterilization and repeated use.

In certain embodiments, the advance / deploy tool includes one or more clips, but can now deploy one or more clips at a time, and only one (or more) clips at a time. Indexing means or other means for controllably deploying. Embodiments comprising multiple clips comprise at least two or more clips that are tethered with a suitable tether. Is the tether elastic / is it subject to tensile forces such that the deployed clips are pulled together (or pulled) so that the tissue between two or more deployed clips is contracted? Or in other ways. The tether is permanently or temporarily tensioned, for example, secured at one or more ends of the tether to maintain tension.

A method for loading the clip 102 onto the deployment tool 104 will be described with reference to FIGS. A loading mechanism 240 is used to easily load the clip 102 onto the distal end 165 of the inner tubular member 154. The loading mechanism 240 includes a proximal section 244 that mates with the inner lumen of the inner tubular member, as shown in FIG. The clip 102 is advanced over the tapered distal section 242 of the loading mechanism 240. The distal section 242 progressively applies force to move the clip fingers 122, 124 away, as shown in FIG. The loading mechanism 240 further comprises an intermediate section 245 having a substantially constant circumference, the circumference being substantially the same as the circumference of the inner tubular member 154. A pusher mechanism 249 is used to advance the clip over the deployment instrument 104 and over the loading mechanism 240. Pusher mechanism 249 includes an end geometry configured to pair with the distal end of clip 102, as shown in FIG. Once clip 102 is fully loaded onto deployment device 104, pusher mechanism 249 and loading mechanism 240 are removed. In embodiments using a super elastic or shape memory clip, the clip 102 is cooled until the martensite phase is transformed to facilitate the deformation of the clip. While the clip is held in the martensite phase, the clip 102 is more easily deformed so that the fingers 122, 124 are more easily spread away for loading of the clip 102 onto the deployment instrument 104. These methods are used as an alternative to or in addition to the loading process described above.

Coating methods after device fabrication include, but are not limited to, spin coating, RF plasma polymerization, dipping, spraying, brushing, device in a beaker containing treatment solution while penetrating device material in a vacuum chamber. Can be included, combinations thereof, or other suitable methods.

As an alternative or in combination with the above therapeutic substances, for example, platinum, gold, tantalum, tin, tin-indium, zirconium, zirconium alloys, zirconium oxide, zirconium nitrate, phosphatidylcholine, pyrolytic carbon, these One or more materials, such as combinations or other materials, are deposited on the suture device surface using electroplating, sputtering vacuum vaporization, ion assisted beam evaporation, vapor deposition, silver doping, boronization techniques or other coating processes Is done.

Radiopaque materials such as barium sulfate, bismuth oxide, tantalum, platinum / iridium or other suitable materials are visualized under fluoroscopic or other visualization means commonly used in catheterization laboratories or operating rooms Is added to any of the suturing devices. In addition, these materials are added to the suturing device by sputtering coating, ion deposition, vapor deposition, combinations thereof, or other suitable processes.

In certain embodiments, the clip is configured to be in its conformable martensite phase at room temperature. The clip is loaded onto the deployment device in an open configuration. The clip is configured to transition to the austenite phase upon application of heat during or after deployment. Application of heat causes the clip to return to its stored configuration, i.e., the closed configuration. In certain embodiments, the clip is configured to return to its closed structure when heated to a temperature close to a person's body temperature. In these embodiments, the clip is transferred to the arteriotomy and partially deployed in place on the outside of the vessel wall 16 for a time sufficient to heat the clip to its austenite transition temperature, Or maintained. In other embodiments, heat is applied remotely through insertion of a heated probe or through the application of intensive electromagnetic energy.

The clip comprises at least one (single element) hinge feature to aid in deployment, tissue bonding, compression and / or removal from tissue. The clip is one of the following materials: metal, including superelastic / shape memory polymers, spring steel and stainless steel, Nitinol, 17-7PH, Elgiloy®, and Inconel®. Manufactured in part or in whole from one or more. Other suitable materials are also used. In desirable embodiments, the clip is partially or wholly made of superelastic and / or shape memory material such as Nitinol. A discussion of specific physical properties of superelastic and / or shape memory materials can be found in US Pat. No. 7,182,771, the entire contents of which are hereby incorporated by reference and are incorporated herein by reference. Form. In certain embodiments using nitinol or other superelastic and / or shape memory materials, it is desirable for the clip to have a curved portion that is relatively tight with the memorized structure. In some situations, it is advantageous to use a bend that is tight enough to exceed the elastic limit of the material and thereby be permanently deformed. In order to prevent permanent deformation, a bending portion is formed in the device by a subsequent annealing process in order to eliminate bending portion stress in the device. After such a first bend, the device is further folded to form a sharper bend and then re-annealed to relieve stress due to such further bends. Such a process is repeated to achieve the desired substantial curvature or radius reduction or angle reduction, but this is not the case if the curvature is formed in a single folding run. To permanently deform the device. In certain embodiments, any surface of the clip that comes into contact with blood and / or tissue is electropolished, and in particular can be a metal or metal alloy surface, such as a superelastic / shape memory alloy. Electropolishing is used to form a soft surface. Electropolishing also advantageously removes or reduces flash and other workpieces from device manufacture.

The clip may have a completely adjacent cross section, or may have a partially incompletely adjacent cross section. Non-adjacent cross-sections allow loading from the side of the vascular introducer and / or deployment device in certain embodiments of the clip. In certain embodiments, the deployment instrument comprises a slot or opening that secures the deployment instrument to the tubular medical device from the side. Tissue binding elements (eg, antlers, fingers, protrusions, etc.) are parallel, overlapping, intersecting, spiraling, or combinations or other types thereof. The clips may include the length of tissue-binding element that may be the same, different, or a combination thereof. The clip can compress tissue in a horizontal plane, a vertical plane, or a combination of both. The tissue binding element can be linear, curved, or a combination of both. The tissue attachment movement / direction may be linear, twisted, rotational, combinations thereof or other suitable and desirable movements.

A number of different types of transfer features are included during the manufacturing process for any of the devices and systems disclosed herein, for example, coatings on vascular suturing devices may include, for example, Vinca alkaloids (ie, vinblastine, vincristine, and vinorelbine), paclitaxel, epipodophyllotoxin (ie, etoposide, teniposide), antibiotics [dactinomycin (actinomycin D) daunorubicin, doxorubicin, and idarubicin], anthracycline Mitoxantrone, bleomycin, primycin (mitromycin) and mitomycin, enzymes (L-asparaginase obtained from cells that do not have the ability to systematically metabolize L-asparagine and synthesize asparagine by itself), etc. Antiproliferative / cell division inhibitors including natural products; G (GP) I1. sub. b / III. sub. a anti-platelet agents such as inhibitors and vitronectin receptor antagonists; nitrogen mustard (mechloretamine, cyclophosphamide and analogues, melphalan, chlorambucil), ethyleneimine and methylmelamine (hexamethylmelamine and thiotepa), alkyl sulfonate- Anti-proliferative / cytostatic alkylating agents such as busulfan, nitrosourea compounds [carmustine (BCNU) and analogs, streptozocin], trazen-dacarbazine (DTIC); folic acid analogs (methotrexate), pyrimidine analogs [fluorouracil, Antiproliferative / mitotic inhibition such as floxuridine and cytarabine], purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin, and 2-chlorodeoxyadenosine {Cladribine}) Antimetabolites; platinum-oriented compounds (cisplatin, carboplatin), procarbazine, urea hydroxide, mitotane, aminoglutethimide; hormones (ie estrogens); anticoagulants, synthetic heparin salts, and other inhibitors of thrombin) Fibrinolytics (fibrinolytic agents such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratri; secretion inhibitor [breveldin]; corticosteroid (Cortisol, cortisone, fludrocortisone, redonizone, prednisolone, 6. alpha.-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agent (salicyl) Derivatives, i.e., aspirin; paraaminophenol derivatives, i.e., acetominophen), and other anti-inflammatory agents; (Ibuprofen and derivatives), anthranilic acid (mefenamic acid and meclofenamic acid), enolic acid (piroxicam, tenoxicam, phenylbutazone, and oxyfentatrazone), nabumetone, gold compound (auranofin, aurothioglucose, gold thioapple) Acid suppressor [cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil]; growth Blocking agent: VEGF (Vascular Endothelial Growth Factor), FGF (Fibroblast Growth Factor); Angiotensin receptor blocking agent; Nitric oxide donor; Antisense oligonucleotide and its preparation; Cell cycle inhibitor, mTOR inhibitor, and / or growth factor Used to deliver a therapeutic agent, including but not limited to one or more of the signal transduction kinase inhibitors. As an alternative, coagulation promoters such as protamine sulfate or calcium hydroxide are used. Endothelial cells are further added to the vascular suturing device.

One or more therapeutic agents may be used in a variety of ways, such as a method of mixing a therapeutic agent with a device base material during fabrication, a method of applying a therapeutic agent immediately before deployment, or a method of applying a therapeutic agent after deployment of the device. Included in the device. One or more therapeutic agents are used in a single device. The transfer feature is configured to provide advantages over time or quickly. The transfer feature may be stable or eluting. Coatings, materials, compounds, substances, therapeutic agents, etc., are eluted from the coated (or implanted) device (or component) over time and flow into the surrounding tissue. In certain embodiments, the transfer feature is valid for at least about 3 days in some examples, from about 7 to 30 days in other examples, and / or up to 6 months in some examples. Any desired embodiments, such as materials, specific dimensions, are not intended to be limiting.

IV. Kits Vascular suturing systems such as those described above are sold to end users in the form of kits. The kit includes a plurality of articles including, but not limited to, one or more deployment devices and one or more clips. The kit further includes a tissue cutter and a tissue dilator as described above. In some embodiments, the kit includes an inflatable plug instead of or in addition to the clip. The deployment tool is preloaded with clips or plugs, or the kit requires assembly by the end user. In some embodiments, the kit comprises a long medical device. In some embodiments, the kit is selected from the group consisting of a needle, hypotube, guide wire, electrode wire, intravenous wire, vascular introducer, catheter, laparoscope, endoscope, trocar and cannula. One or more articles. In some embodiments, the kit includes a compound for transfer to tissue. The compound is at least one of a curing agent, an antibiotic, and an anti-inflammatory agent. In some embodiments, the kit comprises any one or more of a pair of scissors, a scalpel, a bag, a syringe, a tourniquet, a lubricant, a needle, a snare, a preservative, or a drunk agent. The kit components are constructed and intended for single use or multiple use.

The kit can be deployed to quickly stop bleeding from blood vessels (arteries or veins), organs and / or other tissues that are bleeding as a result of impact trauma such as stab or gun injury, or significantly Configured to reduce. Thus, the device is configured such that its size is determined for various applications.

While preferred embodiments of the present invention are illustrated and described herein, it will be apparent to those skilled in the art that these embodiments are presented by way of example only. Multiple variations, modifications and alternatives are possible to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be employed in the practice of the invention. The following claims limit the scope of the invention and include methods and structures belonging to these claims and their corresponding scope.

Claims (29)

A suturing device,
(A) a flexible distal skirt having a self-intersecting geometric structure;
(B) a stem having one end in contact with the proximal surface of the flexible distal skirt;
A suturing device comprising: The suturing device of claim 1, wherein the flexible distal skirt comprises one or more foldable features. The suturing device of claim 2, wherein the bendable feature is a thin section that forms a natural position for bending when an external force is applied. The self-intersecting geometry is configured to contact between two regions of the skirt surface when a force is applied in a selected direction, thereby deflecting the self-intersecting geometry The suturing device according to claim 1, wherein the magnitude of the force required to be increased is increased by further increments. 2. The one or more radial extension elements positioned proximally, wherein the stem is positioned between the flexible distal skirt and the one or more radial extension elements. The suturing device as described. The suturing device according to claim 1, wherein a proximal surface of the flexible distal skirt has at least one of an anchor ring protrusion, a nib, and a rib. The suturing device of claim 1, wherein the flexible distal skirt has a shape selected from a circle, a triangle, an egg, an oval, an oval, a square, a dish, or a rounded edge. . The suturing device according to claim 1, wherein the stem is positioned on a proximal surface of the flexible distal skirt in at least one of a central and non-central region. The suturing device according to claim 1, wherein the stem has a cross-sectional profile selected from the group comprising a square, a triangle, an arrowhead, a trapezoid, a rectangle, a J-shape, a Y-shape, a hook shape, and a bulb shape. The suturing device according to claim 1, wherein the stem further comprises an opening positioned proximally through the stem. The suturing device according to claim 1, wherein the stem further comprises one or more external features suitably configured to achieve stem anchoring in the body. The suturing device of claim 1, wherein the stem further comprises one or more slots along at least a portion of its length parallel to a stem longitudinal axis starting from a proximal end thereof. The suturing device according to claim 1, wherein the stem has a proximal end configured to form a clasp, socket, breakable stem or tearable stem. The suturing device according to claim 1, wherein at least one of the stem and the flexible distal skirt is in releasable communication with a tether. The suturing device according to claim 14, wherein the tether is one or more of a wire, a spring, a screw, a ribbon, a suture line, and a tube. A tissue suture transfer system;
A tubular medical device;
A tissue suture transfer cartridge;
A suturing device according to claim 1;
A guide and seal assembly;
A plunger,
A tissue suture transfer system comprising:
The tubular medical device is configured to be releasably coupled with a tissue suture transfer cartridge at a proximal end, the tissue suture transfer cartridge being releasably coupled with a guide and seal assembly at a proximal end. And wherein the plunger is configured to be advanced through the lumen in a guide and seal assembly, a tissue suture transfer cartridge, and a tubular medical device, respectively. The tubular medical device is one of a needle, tube, guide wire, electrode wire, intravenous wire, introduction device, sheath, dilator, catheter, laparoscope, endoscope, trocar, deployment tool, or cannula. The tissue suture transfer system according to claim 16, which is as described above. The cartridge body; taper distal tip; compressible section; transparent section; further comprising a transfer capsule comprising a lumen extending therethrough, wherein the transparent section is configured to house a suturing device. Tissue suture transfer system. 19. The tissue suture transfer system according to claim 18, wherein the at least one tubular medical device or transfer capsule further comprises a valve. The transfer capsule has one or more pawl features positioned proximally on the outer surface of the cartridge body; one or more undercuts positioned distally; an outer groove in the cartridge body; 19. The tissue suture delivery system of claim 18, further comprising one or more of a snap feature; an undercut central bore; or one or more collets. The tissue suture transfer system according to claim 18, wherein the transfer capsule is configured to receive a plunger through a central opening. The tissue suture transfer system according to claim 21, wherein the transfer capsule is configured to be resistant to movement of the plunger in a first axial direction and movement in a second axial direction different from the first axial direction. A tissue suturing method,
Inserting the distal end of the tubular medical device into the blood vessel through an opening in the vascular tissue;
Receiving the suturing device of claim 1 at or near the proximal end of the tubular medical device;
Advancing the suturing device through the tubular medical device, thereby allowing the suturing device to partially or completely exit the distal end of the tubular medical device within the blood vessel;
A tissue suturing method comprising: Removing the tubular medical device from the blood vessel through an opening in the vascular tissue;
The tissue suturing method according to claim 23, further comprising: Allowing the stem of the suturing device to enter an opening in the vascular tissue while the flexible distal skirt remains in the vessel;
The tissue suturing method according to claim 24, further comprising: The tissue suturing method according to claim 23, wherein the suturing device is coupled to a tether. Removing the tether from the suturing device;
The tissue suturing method according to claim 26, further comprising: Allowing the tether to remain connected to the suturing device;
The tissue suturing method according to claim 26, further comprising: 29. The tissue suturing method according to claim 28, wherein the tether is made of a bioabsorbable material.