WO2008033558A2

WO2008033558A2 - Tissue closure, delivery device and method of use

Info

Publication number: WO2008033558A2
Application number: PCT/US2007/020131
Authority: WO
Inventors: Elad Benjamin; Jonathan Thomas; Carla Pienknagura; Bauback Safa
Original assignee: Vascular Precision
Priority date: 2006-09-15
Filing date: 2007-09-17
Publication date: 2008-03-20
Also published as: WO2008033558A3

Abstract

A tissue closure assembly and a closure delivery device are provided for closing incisions in a target tissue, such as an artery, vein, fascia or hollow organ. The closure delivery device has a closure deployment mechanism within an elongated cylindrical body with an expanding dilator tip and a control handle with an actuation mechanism for sequentially actuating the expanding dilator tip and the closure deployment mechanism. A lumen locator and anchor mechanism has a guidewire and back bleed lumen, an expandable anchor and, optionally, an arteriotomy cutting blade. Various embodiments of tissue closure assemblies are provided having a first and second tissue closure component for attaching to the target tissue on either side of an intended arteriotomy site and means for approximating the first and second tissue closure component and locking them together to seal the arteriotomy after performing a transluminal procedure through the arteriotomy.

Description

TISSUE CLOSURE, DELIVERY DEVICE AND METHOD OF USE

Cross Reference to Other Applications

This application claims the benefit of U.S. provisional application 60/844,710, filed September 15, 2006. This and all patents and patent applications referred to herein are hereby incorporated by reference.

Field of the Invention

The present invention relates generally to medical devices and more particularly to devices and methods for creating and closing controlled, shaped openings in tissue, such as an arteriotomy incision.

Background of the Invention

The continued popularization of minimally invasive and endovascular procedures and the advent of devices and instrumentation for performing such procedures has seen a concurrent proliferation in the development of vessel closure devices for percutaneous procedures. These devices include clips, staples, automated suturing mechanisms, biologic plugs, fillers, glues and the like. These devices have the advantage of reducing costs and decreasing the length of hospitalizations as well as obviating the need for prolonged manual or mechanical pressure at the wound site. However, while these devices have revolutionized vascular closure in percutaneous surgery, they are designed for sealing exclusively small arteriotomy openings (6-8F).

With the introduction of a greater number and variety of intravascular techniques, including angioplasty, atherectomy, endovascular aneurysm repair, minimally invasive cardiac surgery, and the like, a need has arisen to provide relatively large diameter access to the vasculature. Thus, access sheaths having a diameter of 16F or greater are now commonly used.

While some surgeons have used existing vascular closure devices to close large arteriotomy sites, such has proven difficult, unreliable, and therefore not widely-adopted. Without the availability of closure devices for larger vascular access sites, open approaches continue to be used with larger skin and vessel incisions in order to achieve proper apposition of the vessel walls and adequate hemostasis upon vessel closure. Successful percutaneous closure of large arteriotomy sites would eliminate the need for an open procedure in the operating room, produce cost savings for the healthcare system and improve the level of patient care.

Currently, no method for arteriotomy procedures allows for controlled entry into a vessel. In all existing approaches, the initial opening in the artery is caused by inserting a needle into the artery, placing a guidewire through the needle, sliding in one or more dilators over the wire, and then placing a sheath over the dilator. The entry hole is progressively enlarged, causing it to stretch and tear. The resultant opening is not uniform and has an unpredictable shape and size. As a result, it is difficult to close and/or repair the hole created in order to gain vessel access. It would therefore be advantageous to provide a device that would create a more predictable opening in the artery in order to close the opening in the vessel wall more quickly and effectively. This concept applies to any other type of tissue closure, such as those found in orthopedic, gastro-intestinal, and laparoscopic fields. For larger arteriotomy sites (e.g. size 16F), the serial dilation causes the hole in the vessel to be so large as to require an open surgical procedure to guarantee proper apposition of the vessel walls and thereby achieve adequate hemostasis. Some surgeons have used existing vascular closure devices to close large (> 16F) arteriotomy sites, but such an approach has proven difficult, unreliable, and it has therefore not been widely adopted. Successful percutaneous closure of large arteriotomy sites would eliminate the need for an open procedure in the operating room. Instead, procedures could take place in the catheterization lab.

Commonly owned, copending patent application WO 2006128017, filed on May 24, 2006, entitled Devices and methods for the controlled formation and closure of vascular openings, describes implantable devices that are placed on the exterior of a vessel to create and maintain an opening into the vessel to provide access for performing a percutaneous or endovascular procedure. After completion of the procedure, the implantable device is used to close and seal the tissue opening for optimized hemostasis and healing of the vessel wall. U.S. provisional applications 60/840,507, filed August 28, 2006; 60/840,518, filed August 28, 2006; and 60/881,302, filed January 19, 2007; and PCT international application PCT/US07/18895, filed August 28, 2007, describe additional devices and methods for the controlled formation and closure of vascular openings. The devices and methods described are particularly useful for creating and subsequently closing large arteriotomy sites. The devices and methods of the present invention can be used in combination with many of the embodiments and components described in these other patent applications.

Summary of the Invention

The present invention provides a tissue closure assembly for closing incisions in a target tissue, such as an artery, vein, fascia or hollow organ, and a closure delivery device for delivering and deploying the tissue closure assembly. In one embodiment, the closure delivery device has an elongated cylindrical body attached to a control handle. An expanding dilator tip is positioned at the distal end of the cylindrical body for dissecting tissue away from an intended arteriotomy site. A closure deployment mechanism carrying a tissue closure assembly is positioned within the cylindrical body. A lumen locator and anchor mechanism has a guidewire and back bleed lumen for locating the artery lumen and an expandable anchor for pulling up on the artery wall to provide a positive indication of its location for attaching the tissue closure assembly. Optionally, the expandable anchor may also include an arteriotomy cutting blade. The control handle has an actuation mechanism with linkages for sequentially actuating the expanding dilator tip and the closure deployment mechanism.

Another embodiment of the closure delivery device has an elongated hollow cylindrical body that can also be used as an introducer sheath and a tissue dilator with an expandable dilator tip positioned at the distal end of the dilator for dissecting tissue away from an intended arteriotomy site. A tissue closure assembly is delivered on the distal end of the cylindrical body. An arteriotomy cutter is insertable through the hollow cylindrical body to create an arteriotomy incision in the vessel wall.

Various embodiments of tissue closure assemblies are provided having a first and second tissue closure component for attaching to the target tissue on either side of the intended arteriotomy site and means for approximating the first and second tissue closure component and locking them together to seal the arteriotomy at the end of the procedure. A two-part tissue closure assembly has a first and second tissue closure component with integral fasteners for attaching to the tissue and a first and second cable strung through cable eyes for approximating the first and second tissue closure component and locking them together at the end of the procedure. Other embodiments of the two-part tissue closure assembly are provided with alternate means for locking the first and second tissue closure component together to seal the arteriotomy. A number of unitary embodiments of the tissue closure assembly are provided having side members connecting the first and second tissue closure component together in a single unit. The first and second tissue closure components are approximated to one another and locked together by deformation of the side members to seal the arteriotomy at the end of the procedure.

A tissue closure assembly is placed on an artery wall or other target tissue and an incision is made through the tissue wall within a space or aperture defined by the tissue closure assembly. A transluminal procedure or other medical procedure is performed through the incision. After completion of the procedure, the incision is closed and sealed using the tissue closure assembly.

Brief Description of the Drawings

FIG. 1 illustrates a tissue closure delivery device.

FIG. 2 shows an enlarged view of the distal end of the delivery device being advanced over a guidewire placed into a blood vessel.

FIG. 3 shows the distal end of the delivery device with the lumen locator and anchor mechanism within the lumen of the blood vessel. FIG. 4 shows the distal end of the delivery device with the lumen locator and anchor mechanism anchored within the lumen of the blood vessel.

FIG. 5 shows the distal end of the delivery device with the expanding dilator tip expanded to dissect tissue from the exterior of the blood vessel.

FIG. 6 shows the distal end of the delivery device with the integral fasteners of the implantable tissue closure piercing the wall of the blood vessel.

FIG. 7 shows the distal end of the delivery device with the integral fasteners of the implantable tissue closure deployed to fasten the tissue closure to the wall of the blood vessel.

FIG. 8 shows the distal end of the delivery device being withdrawn after the release of the implantable tissue closure. FIG. 9 shows a tissue opening created within the aperture between the first and second components of the implantable tissue closure.

FIG. 10 shows a procedure device being inserted through the tissue opening.

FIG. 1 1 shows the procedure device in place through the tissue opening.

FIG. 12 shows the cable tightening mechanism being advanced to prepare for closing the implantable tissue closure. FIG. 13 shows the procedure device being withdrawn from the tissue opening.

FIG. 14 shows the cables being tightened to close the tissue opening with the implantable tissue closure.

FIG. 15 shows the tissue opening closed by the implantable tissue closure.

FIGS. 16A-16C illustrate successive steps of forming a tissue closure component.

FIGS. 17A-17D illustrate how the tissue closure components are held by the closure deployment mechanism of the delivery device.

FIGS. 18A-18C illustrate successive steps for actuating the integrated fasteners of a tissue closure component.

FIGS. 19A-19C illustrate successive steps of an alternate method for actuating the integrated fasteners of a tissue closure component. FIGS. 20A-20B illustrate successive steps of a method for actuating the integrated fasteners of a barbed tissue closure component.

FIGS. 21A-21B illustrate the operation of the expandable dilator tip of the tissue closure delivery device.

FIGS. 22A-22B illustrate the operation of an alternate embodiment of the expandable dilator tip. FIGS. 23A-23B show an embodiment of the tissue closure assembly where the first and second closure components are joined together in a unitary construction with side members.

FIGS. 24A-24B show another embodiment of the tissue closure assembly where the first and second closure components are joined together in a unitary construction with side members.

FIGS. 25A-25B show an oval shaped embodiment of the tissue closure assembly where the first and second closure components are joined together in a unitary construction with side members.

FIGS. 26A-26B show another approximately oval shaped embodiment of the tissue closure assembly where the first and second closure components are joined together in a unitary construction with side members.

FIGS. 27A-27B show another approximately oval shaped embodiment of the tissue closure assembly where the first and second closure components are joined together in a unitary construction with side members. FIGS. 28A-28B show an embodiment of the tissue closure assembly where the first and second closure components have interlocking features.

FIGS. 29A-29B show an embodiment of the tissue closure assembly with first and second cables for approximating the first and second closure components and a U-shaped clip member for fastening the first and second closure components together. FIGS. 30A-30B show an embodiment of the tissue closure assembly where the second closure component has side arms with locking tabs configured to lock into slots in the first closure component after they have been approximated.

FIGS. 31A-31B show an embodiment of the tissue closure assembly with first and second cables passing through cable eyes mounted on extension arms on the first and second closure components. FIGS. 32A-32B show another embodiment of the tissue closure assembly with first and second barbed cables passing through cable eyes mounted on extension arms on the first and second closure components.

FIGS. 35A-35C illustrate another embodiment of a closure deployment mechanism and a tissue closure assembly with integrated fasteners in the form of staple arms that curl outward to grasp the tissue.

FIGS. 36A-36B illustrate another embodiment of a unitary tissue closure assembly with locking members on the staple bar and/or the side members to lock the tissue closure assembly in a closed position.

FIGS. 37A-37B illustrate an embodiment of a unitary tissue closure assembly with a cylindrical configuration that can be manufactured by cutting a piece of tubing.

FIG. 38 illustrates a unitary tissue closure assembly with first and second closure components that have a curved lower edge to conform to the external curvature of the target vessel. FIG. 39 illustrates an alternate embodiment of a tissue anchor for use with a tissue closure delivery device.

FIGS. 40A-40B illustrate another embodiment of a tissue anchor for use with a tissue closure delivery device.

FIGS. 41A-41B illustrate an umbrella-shaped embodiment of a tissue anchor for use with a tissue closure delivery device.

FIGS. 42A-42B illustrate a tissue anchor with an arteriotomy blade integrated into it. FIGS. 43A-43B illustrate another embodiment of a tissue anchor combined with an arteriotomy blade.

FIGS. 44A-44E illustrate another embodiment of a tissue anchor with a sharpened cutting edge that serves as an arteriotomy blade combined with additional features.

FIG. 45 illustrates an embodiment of a tissue anchor with an arteriotomy blade. FIG. 46 illustrates another embodiment of a tissue anchor with an arteriotomy blade.

FIGS. 47A-47B illustrate a barbed fastener with a spring member configured to take up any slack between the target tissue and the tissue closure component.

FIGS. 48A-48C illustrate a barbed fastener with a one-way ratchet mechanism configured to take up any slack between the target tissue and the tissue closure component.

DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a tissue closure delivery device 200 constructed in accordance with the present invention. The delivery device 200 includes an insertion portion 202 and a control handle 204. The insertion portion 202 of the delivery device 200 includes a cylindrical body 206, which has an expandable dilator tip 208 at its distal end. The expandable dilator tip 208 is shown in a transparent or phantom view in this and some of subsequent figures to make the internal structures visible. A tissue closure assembly 100 is carried by a closure deployment mechanism 210 positioned within the cylindrical body 206. The closure deployment mechanism 210 is shown in FIGS. 17A-17D and described in greater detail below. A lunien locator and anchor mechanism 212 extends through the cylindrical body 206 and includes a guidewire lumen 214 through which a guidewire 114 can be inserted. The lumen locator and anchor mechanism 212 is configured with a flexible plastic tube 224 extending distally from the expandable dilator tip 208 at its distal end. In one preferred embodiment, the lumen locator and anchor mechanism 212 is configured with two longitudinal slits 226 in the flexible plastic tube 224 that allow it to be selectively expanded to created a vessel anchor 228, as shown in FIG. 4.

FIGS. 21A-21B illustrate the operation of the expandable dilator tip 208 on the distal end of the cylindrical body 206 of the tissue closure delivery device 200. In one preferred embodiment, the expandable dilator tip 208 has multiple triangular flaps or petals 238 that fold inward to form a tapered, conical configuration when the dilator tip 208 is in the closed position, as seen in FIG. 21 A and in FIG. 2, and fold outward to a cylindrical configuration when the tip 208 is expanded, as seen in FIG. 21B and in FIG. 5. In one preferred embodiment, the petals 238 are biased toward the closed position and are actuated by an inner cylinder that slides within the cylindrical body 206. Alternatively, the petals 238 could be biased open or closed, and the actuation could be achieved by pushing or pulling on the flaps with one or more rods, cables or wires extending through the cylindrical body 206. Preferably, the expandable dilator tip 208 is constructed integrally with the cylindrical body 206 of the tissue closure delivery device 200, however in alternate embodiments the expandable dilator tip 208 may be made separately and mounted on distal end of the cylindrical body 206. The expandable dilator tip 208 and the cylindrical body 206 can be formed and machined from a thin-walled metal tube, such as stainless steel, cobalt-chromium alloy, nickel-titanium alloy or other biocompatible metal. Alternatively, the expandable dilator tip 208 and the cylindrical body 206 can be molded of a high-strength, but flexible polymer, such as polyethylene, polypropylene, polyamide or a fluoropolymer, or constructed from a combination of materials. The tissue closure delivery device 200 is preferably configured to approach the target tissue at an oblique angle of entry. The optimum angle will vary depending on the target tissue and the procedure to be performed. For percutaneous procedures performed through a patient's femoral artery, an angle of approximately 45 degrees is generally preferred. To accommodate this oblique angle of entry, the expandable dilator tip 208 may optionally be configured to expand asymmetrically, as shown in the example of FIGS. 21 A-21B. This is accomplished by varying the length of the petals 238 and the position of the hinges or flexure points between the petals 238 and the cylindrical body 206. FIGS. 22A-22B illustrate the operation of an alternate embodiment of the expandable dilator tip 208. The expandable dilator tip 208 is constructed with stiff members 207 embedded within or attached to the wall of a flexible elastic sleeve 209. Optionally, the cylindrical body 206 may be made with the same type of construction. The expandable dilator tip 208 has a tapered, conical configuration when it is in the closed position, as shown in FIG. 22A. The flexible elastic sleeve 209 can be stretched, for example with a slidable inner cylinder, to expand the expandable dilator tip 208 to an open-ended cylindrical configuration, as shown in FlG. 22B.

The control handle 204 is located at the proximal end of the cylindrical body 206. The control handle 204 includes a stationary pistol grip 220, a main actuation lever 218 that operates both the expandable dilator tip 208 and the closure deployment mechanism 210, and an anchor actuation lever 216 that operates the anchor function of the lumen locator and anchor mechanism 212. An anchor release mechanism 222 is mounted on the main actuation lever 218.

In one preferred embodiment shown in FIGS. 1-15, the tissue closure assembly 100 includes a first tissue closure component 104 and a second tissue closure component 106 arranged with a space between them that defines an aperture 102. The aperture 102 will demarcate the desired position for creating an opening through the vessel wall or other tissue. A first cable 122 and a second cable 124 pass through cable eyes 126 to connect the first tissue closure component 104 and the second tissue closure component 106. The first cable 122 and second cable 124 may be made of braided or monofilament suture or wire. Optionally, the first cable 122 and second cable 124 may be made of a bioabsorbable material. The first tissue closure component 104 and the second tissue closure component 106 include integrated fasteners 1 18, which, in this embodiment, are configured as needle-like staple arms 120.

FIGS. 16A-16C illustrate successive steps of forming this embodiment of the tissue closure components 104, 106 that make up the tissue closure assembly 100. As shown in FIG. 16A, a closure component blank is formed from flat metal sheet, which may be stainless steel, a cobalt-chromium alloy, a nickel-titanium alloy or other biocompatible metal, or may be partially or wholly made of a bioabsorbable material, such as polyglycolic acid (PGA), poly-L- lactide (PLLA) or a blend thereof. The closure component blank may be formed by die cutting, laser cutting, EDM, electrochemical etching or other known machining processes. The optimal thickness for the closure component blank will vary depending on the material used; for stainless steel, a thickness of approximately 0.010 inches or less is currently preferred. The closure component blank is configured with a staple bar 128 with ends connected to a pair of pointed staple arms 120. Two cable eyes 126 are attached on one side of the staple bar 128. A tab 130 is attached by way of two narrow tab arms 136 to the side of the staple bar 128 opposite the two cable eyes 126. The tab 130 is provided for gripping the tissue closure component 104, 106 with the delivery device 200 and may be provided with additional features to facilitate gripping, such as the square gripping hole 132 shown in this embodiment.

The tab 130 is intended to be detached from the tissue closure component after the tissue closure component 104, 106 has been fixated to a blood vessel or other tissue. This concept of a detachable tab 130 for holding a tissue closure component can also be adapted to other embodiments of tissue closure assemblies described herein. To facilitate detachment, a stress riser is created by bending the closure component blank at a sharp right angle 131 at the point where the staple bar 128 is attached to the tab 130 by the two narrow tab arms 136, as shown in FIG. 16B. Alternatively or in addition, other means, such as a narrowed neck, perforations, notches or a score in the metal, may be used to create a weakened spot or stress riser at the desired detachment point. Next, the staple arms 120 are bent upward at a gently radiused right angle 133 from the staple bar 128 and then bent downward again to create an inverted U-shaped curve 129 with the pointed ends of the staple arms 120 extending below the staple bar 128, as shown in FIG. 16C. If necessary, the pointed ends of the staple arms 120 can be sharpened in a secondary operation. Two completed tissue closure components 104, 106 as shown in FIG. 16C are use in the tissue closure assembly 100 with a first cable 122 and a second cable 124 threaded through the cable eyes 126, as described above.

FIGS. 17A-17D illustrate how the tissue closure components 104, 106 are held by the closure deployment mechanism 210. The closure deployment mechanism 210 is sized and configured to fit inside of the cylindrical body 206 of the delivery device 200, which is shown in FIG. 1. The closure deployment mechanism 210 has an elongated central body member 260 with a distal end 262 cut at an oblique angle to accommodate the angle of entry of the delivery device 200 to the target tissue. The optimum angle will vary depending on the target tissue and the procedure to be performed. For percutaneous procedures performed through a patient's femoral artery, an angle of approximately 45 degrees is generally preferred. The elongated central body member 260 has a through-lumen 261 to allow passage of the guidewire 114 and lumen locator and anchor mechanism 212 through the delivery device 200. The gripping hole 132 of the first closure component 104 is held by a first boss 264 that projects out on a first side of the central body member 260. Similarly, the gripping hole 132 of the second closure component 106 is held by a second boss 266 that projects out on the opposite side of the central body member 260. The first boss 264 and the second boss 266 may be formed integrally with the central body member 260 or they may be formed as separate components and assembled together. In an alternate embodiment of the closure deployment mechanism 210, the function of the first and second boss 264, 266 may be replaced with a pair of slots or ledges on opposite sides of the central body member 260 and the upper edges of the tabs 130 would be bent over at approximately a right angle to create a projection that would engage with the slots to hold the tissue closure components 104, 106 in place instead of the gripping holes 132 in the example shown. Optionally, the central body member 260 may be made of two independent halves that can move with respect to each other. This way, the angle of approach to the artery can be adjusted by sliding one central body member with respect to the other. In an extreme case, the two distal ends of the central body members may be equidistant from the proximal end, causing an approach angle of 90-degrees. Conversely, the distal ends of the members may be significantly spaced apart to accommodate a very shallow approach angle.

A first staple arm actuation member 268 is slidably positioned on the first side of the central body member 260. At its distal end, the first staple arm actuation member 268 has a first and second shoulder 270, 272 configured to contact the U-shaped curves on the staple arms 120 to apply an actuation force during fixation of the first closure component 104 to the target tissue. The first staple arm actuation member 268 has a third shoulder 274 that is slidably received in the space between the tab arms 136 of the first closure component 104 and is configured to contact the staple bar 128 to apply a separation force to release the first closure component 104 from the tab 130 after the staple arms 120 have been fully actuated. Similarly, a second staple arm actuation member 278 is slidably positioned on the opposite side of the central body member 260 with analogous first, second and third shoulders for actuating and releasing the second closure component 106.

In one preferred embodiment, the first and second staple arm actuation members 268, 278 each include a guiding slot 276 that slidably engages with the first and second boss 264, 266 of the central body member 260, and the first and second shoulders 270, 272 are extended to have a sliding fit with the lateral sides of the central body member 260. These features serve to keep the first and second staple arm actuation members 268, 278 properly aligned as they slide with respect to the central body member 260. The closure deployment mechanism 210 is preferably configured so that the first and second staple arm actuation members 268, 278 actuate the staple arms 120 of the first and second closure components 104, 106 simultaneously. Alternatively, the closure deployment mechanism 210 may be configured to actuate the first and second closure components 104, 106 sequentially or configured to actuate them individually with separate actuation levers.

FIGS. 18A-18C illustrate successive steps for actuating the integrated fasteners 118 of a tissue closure component 104, 106 of the type shown in FIG. 16C. This fixation method can be modified for use with any of the tissue closure assemblies 100 described herein. This method of fixation does not require an anvil or forming tool beneath the target tissue. The closure deployment mechanism 210 applies a force, indicated by the downward arrows 135, to the inverted U-shaped curves 129 of the staple arms 120 which initially causes the pointed ends of the staple arms 120 to pierce through the tissue wall, as shown in FIG. 18A. Next, the closure deployment mechanism 210 continues to push downward on the inverted U-shaped curves 129 of the staple arms 120 while applying an upward restraining force on the staple bar 128 (by way of the tab 130) This causes the staple arms 120 to rotate about the gently radiused right angles 133, which provide a natural pivot point, as shown in FIG. 18B. The staple arms 120 continue to rotate until they have closed around the tissue wall, as shown in FIG. 18C. This is desirable, because the rotating staple arms 120 can grab significant amounts of tissue as they trace their trajectory. Further, the end position of the pointed ends of the staple arms 120 can be above the pivot point, allowing the resulting fixation to be robust.

Alternatively, the staple arms 120 can be constructed to have a shape memory that causes the staple arms to curl to grasp the tissue. This can be accomplished with a tissue closure assembly 100 made of a superelastic nickel-titanium alloy.

Referring again to FIG. 1 , the anchor actuation lever 216 on the control handle 204 is connected to the proximal end of an inner tubular member 225 that extends through the flexible plastic tube 224 and attaches to it distal to the two longitudinal slits 226. The guidewire lumen 214 passes through the inner tubular member 225. When the anchor actuation lever 216 is rotated downward tension on the inner tubular member 225 causes the vessel anchor 228 to expand outward, as shown in FIG. 4.

A first actuator link 232 extends from a connection point on the upper part of the main actuation lever 218 above the pivot point 219 to a first collar 234, which is attached to the proximal end of the elongated central body member 260 of the closure deployment mechanism 210 (shown in FIG. 17A). The first collar 234 is in turn connected by a connector link 244 to a third collar 246, which is attached to the proximal end of an inner cylinder 236, which has a sliding fit with the interior lumen of the cylindrical body 206. The connector link 244 maintains the desired spacing between the inner cylinder 236 and the elongated central body member 260 of the closure deployment mechanism

210 so that the two will move forward in unison. In alternate embodiments, another linkage or other mechanism may be added so that these two components will move sequentially or so that they can be moved independently. A second actuator link 240 is connected from the upper end of the main actuation lever 218, above the pivot point 219 and the first actuator link 232, to a second collar 242, which is attached to the proximal end of the first and second staple arm actuation members 268, 278 of the closure deployment mechanism 210. The longer, second actuator link 240 is curved so that it will not interfere with movement of the first actuator link 232. When the main actuation lever 218 is squeezed a first increment, the first actuator link 232 and the second actuator link 240 both move forward toward the distal end of the delivery device 200. The first actuator link 232 and the connector link 244 move the inner cylinder 236 distally within the cylindrical body 206, which forces the petals 238 of the expandable dilator tip 208 to expand outward. The first actuator link 232 also moves the elongated central body member 260 of the closure deployment mechanism 210 distally as the expandable dilator tip 208 opens. At the same time, the second actuator link 240 also moves the first and second staple arm actuation members 268, 278 distally with the elongated central body member 260 of the closure deployment mechanism 210. Since the entire closure deployment mechanism 210 moves distally approximately simultaneously, there is no actuation of the integrated fasteners 118 of the tissue closure assembly 100 at this time.

When the main actuation lever 218 is squeezed a second increment, the first actuator link 232 goes over center, halting the forward movement of the inner cylinder 236 and the elongated central body member 260 of the closure deployment mechanism 210. The second actuator link 240 continues to move the first and second staple arm actuation members 268, 278 distally so that the first and second shoulders 270, 272 deform the staple arms 120 of the integrated fasteners 1 18 and the first tissue closure component 104 and the second tissue closure component 106 become affixed to the vessel wall, as shown in FIG. 7.

When the main actuation lever 218 is squeezed a third increment, the first actuator link 232 is past center, therefore it pulls the elongated central body member 260 in the proximal direction, pulling back on the tabs 130 of the first tissue closure component 104 and the second tissue closure component 106. The second actuator link 240 continues to move the first and second staple arm actuation members 268, 278 distally so that the third shoulder 274 contacts the staple bar 128 and pushes it in the distal direction. The tension created breaks the connection between the staple bar 128 and the tab arms 136. This causes the closure deployment mechanism 210 to release the first tissue closure component 104 and the second tissue closure component 106, leaving them fixated to the vessel wall, as shown in FIG. 8. Approximately simultaneously with this, the anchor release mechanism 222 mounted on the main actuation lever 218 contacts the anchor actuation lever 216 and releases the tension on the wire or suture, thus allowing the lumen locator and anchor mechanism 212 to contract from its expanded state.

Optionally, the main actuation lever 218 may be configured with a return spring in order to reverse the motion of the mechanism when the handle is released. Alternatively or in addition, the mechanism may be configured with a detent system to bias the lever in one or more positions when actuated by the user.

FIGS. 2-15 illustrate the distal end of the tissue closure delivery device 200 delivering a tissue closure assembly 100 for creating and closing an arteriotomy. The apparatus and the method steps illustrated can be adapted or modified for use with other target tissues, such veins, fascia and hollow internal organs. The method begins by gaining access to the lumen of a blood vessel with a guidewire 114. This can be done with an arterial cutdown or, more preferably, by percutaneous access by introducing the guidewire 114 through an access needle (not shown) inserted percutaneously into the vessel lumen. The access needle is then withdrawn, leaving the guidewire 1 14 in place. The proximal end of the guidewire 1 14 is inserted into the guidewire lumen 214 of the lumen locator and anchor mechanism 212.

Typically, the skin is nicked with a scalpel to avoid tearing, then the delivery device 200 is advanced along the guidewire 114. The tapered conical configuration of the expandable dilator tip 208 in the closed position dilates a tissue tract from the skin to the outer surface of the blood vessel. Optionally, the tissue tract can be predilated with one or more tapered dilators inserted over the guidewire 114 before insertion of the delivery device 200. When the two longitudinal slits 226 in the flexible plastic tube 224 enter the lumen of the vessel, as shown in FIG. 3, blood pressure forces blood through the guidewire lumen 214 to the proximal end of the flexible plastic tube 224 to indicate that the lumen of the vessel has been accessed. Optionally, the lumen locator and anchor mechanism 212 may be configured with a flashback chamber (not shown) to provide a visual indication of the blood entering the guidewire lumen 214 and to prevent excessive backbleeding.

Next, the anchor actuation lever 216 on the control handle 204 is rotated to expand the vessel anchor 228, as shown in FIG. 4. The expanded vessel anchor 228 is pulled back until it contacts the interior surface of the vessel wall. This provides a reliable datum for the location of the vessel wall so that the tissue closure assembly 100 can be accurately fixated to the vessel wall.

To prepare the exterior surface of the blood vessel for fixation of the tissue closure assembly 100, the main actuation lever 218 of the control handle 204 is squeezed a first increment to expand the expandable dilator tip 208, as shown in FIG. 5. As it expands, the expandable dilator tip 208 pushes tissue away from the area of the vessel surface surrounding the guidewire 114. Optionally, the petals 238 may have a roughened or ridged outer surface to grip the tissue in order to push it away from the arteriotomy site. Approximately simultaneously, the closure deployment mechanism 210 with the tissue closure assembly 100 mounted on it advances distally to contact the exterior surface of the vessel, and the staple arms 120 of the integrated fasteners 118 pierce through the vessel wall, as shown in FIG. 6.

Squeezing the main actuation lever 218 of the control handle 204 a second increment causes the closure deployment mechanism 210 to deform the staple arms 120 of the integrated fasteners 1 18 so that the first tissue closure component 104 and the second tissue closure component 106 are fixated to the vessel wall, as shown in FIG. 7.

Squeezing the main actuation lever 218 of the control handle 204 a third increment causes the closure deployment mechanism 210 to release the first tissue closure component 104 and the second tissue closure component 106, leaving them fixated to the vessel wall, as shown in FIG. 8.

The vessel anchor 228 is allowed to contract from its expanded condition and the delivery device 200 is withdrawn, leaving the first tissue closure component 104 and the second tissue closure component 106 fixated to the vessel wall and with the proximal ends of the first cable 122 and the second cable 124 extending out through the open tissue tract, as shown in FIG. 9. At this point, an arteriotomy opening 134 through the vessel wall can be created in the aperture 102 between the first tissue closure component 104 and the second tissue closure component 106. This can be done by cutting an opening through the vessel wall with a sharp instrument or electrosurgery device and/or by dilating the vessel puncture site with one or more tapered dilators introduced over the guidewire 114.

One or more transluminal diagnostic or therapeutic procedures can be performed through the arteriotomy opening 134. FIG. 10 shows a procedure device 148 being inserted through the tissue opening 134. FIG. 1 1 shows the procedure device 148 in place through the tissue opening 134. Once the diagnostic or therapeutic procedures have been performed, the implantable tissue closure 100 is prepared for closing the tissue opening 134 by advancing the cable tightening mechanism 250 into the tissue tract as shown in FIG. 12. The cable tightening mechanism 250 is configured with a tube 252 having two lumens 254, 256 arranged side-by-side to be inserted over the first cable 122 and the second cable 124. The lumens 154, 156 may extend the full length of the tube 252 or they may be configured as short rapid-exchange lumens. The cable tightening mechanism 250 is preferably made from a flexible or semi-flexible polymer, such as polyethylene, polypropylene, polyamide or a fluoropolymer. The cable tightening mechanism 250 should be strong in compression to avoid buckling during advancement, but should be somewhat flexible to self-guide along the cables 122, 124. Optionally, a cutting mechanism may be incorporated into the cable tightening mechanism 250 for cutting the cables 122, 124 at the end of the procedure.

FIG. 13 shows the procedure device 148 being withdrawn from the tissue opening 134. Immediately, the implantable tissue closure 100 is closed by pulling on the first cable 122 and the second cable 124 while pushing distally on the cable tightening mechanism 250. This moves the first tissue closure component 104 and the second tissue closure component 106 toward one another to close the tissue opening 134 as shown in FIG. 14. Optionally, the first tissue closure component 104 and the second tissue closure component 106 may be configured to rotate as the arteriotomy opening 134 is closed so that the vessel wall will be approximated with intima-to-intima contact.

The cable tightening mechanism 250 is withdrawn, leaving the implantable tissue closure 100 in place on the vessel wall, as shown in FIG. 15. Optionally, one or more knots or suture locking devices may be applied to secure the first cable 122 and the second cable 124. The knots may be pre-tied (e.g. fisherman's knots) onto the cables 122, 124 or the knots may be tied in the cables 122, 124 (separately or together) at this point in the procedure. The proximal ends of the first cable 122 and the second cable 124 are detached by cutting or by breaking them off close to the implantable tissue closure 100.

FIGS. 19A-19C illustrate successive steps of an alternate method for actuating the integrated fasteners 118 of a tissue closure component 105. As with the method illustrated in FIGS. 18A-18C, this fixation method does not require an anvil or forming tool beneath the target tissue. This fixation method can be modified for use with any of the tissue closure assemblies 100 described herein. As shown in FIG. 19A, the tissue closure component 105 is held in a closure deployment mechanism 210 that has guiding members 21 1 at the distal end where the tissue closure component 105 will exit. A downward force on the tissue closure component 105 causes the staple arms 120 to encounter the guiding members 21 1 and deform inwards, as shown in FIG. 19B. Each section of the staple arms 120 that passes the guiding members 21 1 is curled into a given radius. The localized curving of the staple arms 120 only occurs while that portion of the staple arms 120 is forced through the guiding members 21 1. After each portion of the staple arms 120 passes the guiding members, the localized curving in that portion of the staple arms 120 remains constant. This localized curling propagates down the length of the staple arms 120 as the tissue closure component 105 is advanced. Eventually, the entire length of the staple arms 120 are curled back towards the tissue membrane being penetrated by the time the staple bar 128 reaches the tissue surface, as shown in FIG. 19C. The curling staple arms 120 can be integral with the staple bar 128 and other components of the tissue closure component 105, or the staple arms 120 could be separate components. For example, the main body of the tissue closure component 105 may be made of a bioabsorbable material, and the curling staple arms 120 may be made of a metal.

FIGS. 20A-20B illustrate successive steps of another alternate method for actuating the integrated fasteners 1 18 of a barbed tissue closure component 107. This fixation method can be modified for use with any of the tissue closure assemblies 100 described herein. Furthermore, any of the staple-like fasteners described herein may be enhanced through the addition of barb features on the tissue-grabbing staple arms. With the addition of these barb-like features, any tissue that is captured within the staple upon fixation will be less likely to become detached before or during closure. The tissue closure component 107 has staple arms 120 with barbs 108 at the distal tips and/or along the length of the staple arms 120, as shown in FIG. 2OA. A downward force on the tissue closure component 107 causes the staple arms 120 to pierce the tissue, and the barbs 108 anchor into the tissue, as shown in FIG. 2OB. The barbed tissue closure component 107 may benefit from rapid insertion into the tissue, which allows the barbs 108 to penetrate cleanly without the tissue moving away. Passive barbs 108 of this type can potentially simplify the closure deployment mechanism of the closure delivery device.

It may be advantageous to incorporate fixation that actively gives the closure device positive purchase on the tissue so that the fasteners used naturally take up any slack between the vessel and the tissue closure component. To do this, there may be springy barbs that can pull upwards on tissue once they are embedded in the muscular layer of the vessel. For example, FIGS. 47A-47B show a barb 108 on the end of a spring member 109. FIG. 47A shows the barb 108 and the spring member 109 in a retracted position and FIG. 47B shows the barb 108 and the spring member 109 in an extended position for piercing the tissue. Once the barb 108 is embedded in the tissue, the spring member 109 attempts to return to the retracted position, taking up any slack between the vessel and the tissue closure component. In a similar way, preformed structures, such as superelastic nickel-titanium alloy hooks, can be inserted into the vessel wall in one configuration (such as inside an introducing needle) and then allowed to change shape to provide adequate fixation.

FIGS. 48A-48C show a one-way ratchet mechanism 110 that does not allow reverse travel (similar to that found on plastic cable ties) that can be employed to take up any slack between the vessel and the tissue closure component during the barb fixation process. FIG. 48A shows the barb 108 positioned to penetrate the tissue of a blood vessel wall with the ratchet mechanism 110 in an extended position. FIG. 48B shows the barb 108 after penetrating the blood vessel wall with the ratchet mechanism 1 10 still in the extended position. After the barb 108 penetrates the muscle layer, the barb 108 is pulled upwards by retracting the one-way ratchet mechanism 1 10 as shown in FIG.

48C, effectively taking up any slack between the vessel and the tissue closure component. In this way, compressive fixation is achieved between the tissue and the closure component. Optionally, the ratchet mechanism may be releasable in order to revise or remove the fixation.

In the embodiment of the tissue closure assembly 100 shown in FIGS. 1-15, the first and second cables 122, 124 serve the two purposes of approximating the first and second closure components 104, 106, and fastening the first and second closure components 104, 106 together. Other structures may be provided to fulfill these functions. FIGS. 23A-23B show an alternate embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 are joined together in a unitary construction with side members 138, 140. FIG. 23 A shows the tissue closure assembly 100 in an open position with the side members 138, 140 in a straight configuration. FIG.

23B shows the tissue closure assembly 100 in a closed position with the side members 138, 140 crimped or buckled upward to approximate the first and second closure components 104, 106, and hold them together. FIGS. 24A-24B show another embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 are joined together in a unitary construction with side members 138, 140. FIG. 24A shows the tissue closure assembly 100 in an open position with the side members 138, 140 in a straight configuration. FIG. 24B shows the tissue closure assembly 100 in a closed position with the side members 138, 140 crimped or buckled inward to approximate the first and second closure components 104, 106, and hold them together. FIGS. 25A-25B show an oval shaped embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 are joined together in a unitary construction with side members 138, 140. FIG. 25A shows the tissue closure assembly 100 in an open position with the side members 138, 140 in an extended configuration. FIG. 25B shows the tissue closure assembly 100 in a closed position with the side members 138, 140 crimped or buckled outward to approximate the first and second closure components 104, 106, and hold them together. FIGS. 26A-26B show another approximately oval shaped embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 are joined together in a unitary construction with side members 138, 140. FIG. 26A shows the tissue closure assembly 100 in an open position with the side members 138, 140 in an extended configuration with pleats to facilitate crimping. FIG. 26B shows the tissue closure assembly 100 in a closed position with the pleated side members 138, 140 crimped or buckled inward to approximate the first and second closure components 104, 106, and hold them together. FIGS. 27A-27B show another approximately oval shaped embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 are joined together in a unitary construction with side members 138, 140. FIG. 27A shows the tissue closure assembly 100 in an open position. FIG. 27B shows the tissue closure assembly 100 in a closed position with the first and second closure components 104, 106 crimped inward with respect to the side members 138, 140.

FIGS. 28A-28B show an alternate embodiment of the tissue closure assembly 100 where the first and second closure components 104, 106 have interlocking features 142, 144. FIG. 28A shows the tissue closure assembly 100 in an open position. FIG. 28B shows the tissue closure assembly 100 in a closed position with the interlocking features 142, 144 locked together after the first and second closure components 104, 106 have been approximated.

Optionally, the interlocking features 142, 144 may be configured to lock together with the first and second closure components 104, 106 rotated to provide intima-to-intima approximation of the arteriotomy incision.

FIGS. 29A-29B show an alternate embodiment of the tissue closure assembly 100 with first and second cables 122, 124 for approximating the first and second closure components 104, 106, and a U-shaped clip member 146 for fastening the first and second closure components 104, 106 together. FIG. 29A shows the tissue closure assembly 100 in an open position. FIG. 29B shows the tissue closure assembly 100 in a closed position with the U-shaped clip member 146 clipped over top of the first and second closure components 104, 106 to lock them together.

FIGS. 30A-30B show an alternate embodiment of the tissue closure assembly 100 where the second closure component 106 has side arms 150, 152 with locking tabs 154, 156 configured to lock into slots 158, 160 in the first closure component 104 after they have been approximated. Preferably, the locking tabs 154, 156 are configured to provide a tapered entry for the first closure component 104. FIG. 30A shows the tissue closure assembly 100 in an open position. FIG. 30B shows the tissue closure assembly 100 in a closed position with the locking tabs 154, 156 on the side arms 150, 152 locking the first closure component 104 onto the second closure component 106.

FIGS. 31A-31 B show an embodiment of the tissue closure assembly 100 similar to the one previously described with first and second cables 122, 124 passing through cable eyes 126 on the first and second closure components. In this embodiment, the cable eyes 126 are mounted on extension arms 127 that extend from the ends of the staple bars 128. FIG. 31A shows the tissue closure assembly 100 in an open position. Pretied slip knots 123 are positioned on a proximal part of the first and second cables 122, 124. FIG. 31B shows the tissue closure assembly 100 in a closed position. The extension arms 127 provide additional leverage for rotating the first and second closure components 104, 106 to provide intima-to-intima approximation of the arteriotomy incision. The pretied slip knots 123 are slid down the first and second cables 122, 124 to fasten the first and second closure components 104, 106 together.

FIGS. 32A-32B show another embodiment of the tissue closure assembly 100 with first and second cables 122, 124 passing through cable eyes 126 mounted on extension arms 127 that extend from the ends of the staple bars 128 of the first and second closure components. FIG. 32A shows the tissue closure assembly 100 in an open position. The first and second cables 122, 124 have barbs 125 on them that allow the first and second cables 122, 124 to be tightened to approximate the first and second closure components 104, 106 and automatically locks the tissue closure assembly 100 in the closed position. FIG. 32B shows the tissue closure assembly 100 in a closed position with the first and second closure components 104, 106 rotated to provide intima-to-intima approximation of the arteriotomy incision. Alternatively, a one-way locking device may be used with, built into or attached to the first and/or second closure components 104, 106 to perform the same locking function as the barbs 125. The first and second cables 122, 124 may have a smooth surface or may be configured with ratchet teeth, bumps, ribs, or other features designed to cooperate with the one-way locking device

FIGS. 33A-33E and 34A-34F illustrate the operation of another embodiment of the tissue closure delivery device 200 and tissue closure assembly 100.

FIGS. 33A-33E and 34A-34F illustrate the operation of another embodiment of the tissue closure delivery device 200 and tissue closure assembly 100. FIG. 33A shows the tissue closure assembly 100 in an open position mounted on the distal end of a delivery device 200. The cylindrical body 206 of the delivery device 200 is inserted coaxially over a tissue dilator 300 that has a cylindrical body 306 with an expandable dilator tip 308. FIGS. 33D and 33E show enlarged views of the expandable dilator tip 308 in the closed position and expanded position, respectively. In the example shown, the expandable dilator tip 308 is configured with two approximately rectangular petals 310, 312 on the lateral sides and two approximately triangular petals 314, 316 on the top and bottom respectively. This petal configuration creates a wedge-shaped taper on the expandable dilator tip 308 in the closed position, which opens up to an open-ended cylindrical shape in the expanded position. The expandable dilator tip 308 can be expanded from the closed position to the expanded position by a procedure device inserted through it or, alternatively, an inner cylinder (not shown) can be used to expand the expandable dilator tip 308, similar to the embodiment of FIG. 1.

FIG. 33B shows the tissue dilator 300 and the delivery device 200 with the tissue closure assembly 100 mounted on it being introduced over a guidewire 114 that has previously been inserted into the vessel lumen. The expandable dilator tip 308 in the closed position dilates a tract through the tissue from the skin to the exterior of the vessel wall. At the vessel wall, the expandable dilator tip 308 is expanded to the open position, as shown in FIG. 33C, to dissect tissue away from the intended arteriotomy site to create space for affixing the tissue closure assembly 100.

FIG. 34A shows the delivery device 200 with the tissue closure assembly 100 mounted on its distal end positioned around the guidewire 1 14 in the dilated tissue tract. The tissue dilator 300 can be removed at this point or after fixation of the tissue closure assembly 100. In the example shown, the tissue closure assembly 100 has the first and second closure components 104, 106 joined together in a unitary construction with side members 138, 140. In one preferred embodiment, the tissue closure assembly 100 has integrated fasteners 118 in the form of tissue-holding barbs, which simplifies the design of the delivery device 200 allowing it to also serve as an introducer sheath for the intraluminal procedure to be performed. The side members 138, 140 of the tissue closure assembly 100 are prebent in an upward arch 137. The arch 137 may be symmetrical or asymmetrical to accommodate an oblique angle of insertion, as in the example shown.

FIG. 34B shows the tissue closure assembly 100 affixed to the vessel wall with the barb-shaped integrated fasteners 1 18. An arteriotomy cutter 201 is inserted delivery device 200 to cut an arch-shaped arteriotomy flap in the vessel wall, as shown in FIG. 34C. FIG. 34D shows a procedure device 148 being inserted through the delivery device 200 and the tissue closure assembly 100 for performing an intraluminal procedure. FIG. 34E shows the procedure device 148 and the delivery device 200 withdrawn, leaving the tissue closure assembly 100 affixed to the vessel wall. The arteriotomy is closed and sealed by bending the side members 138, 140 to approximate the first and second closure components 104, 106, thereby compressing the tissue on the sides of the incision to achieve hemostasis, as shown in FIG. 34F. The side members 138, 140 may be bent by a deployment device or by pulling cables through optional cable eyes 126 on the first and second closure components 104, 106, or, alternatively, the side members 138, 140 may be constructed to have an elastic memory that urges the tissue closure assembly 100 toward the closed position.

FIGS. 35A-35C illustrate another embodiment of a closure deployment mechanism 210 and a tissue closure assembly 100 with integrated fasteners 1 18 in the form of staple arms 120 that curl outward to grasp the tissue. The tissue closure assembly 100 has first and second closure components 104, 106 that are joined together in a unitary construction with arch-shaped side members 138, 140. The staple arms 120, which extend downward from the staple bars 128, are initially straight. Guiding members 211 at the end of the closure deployment mechanism 210 encounter the staple arms 120 and force them to bend as they exit the tool. The bend propagates along the staple arms 120 and causes the staple arms 120 to curl back on themselves. FIG. 35A shows the tissue closure assembly 100 in the closure deployment mechanism 210 with the staple arms 120 in a state of partial deployment. FIG. 35B shows the tissue closure assembly 100 with the staple arms 120 just starting to curl outward. FIG. 35C shows the tissue closure assembly 100 with the staple arms 120 fully deployed and curled back upon themselves. The guiding members 21 1 of the closure deployment mechanism 210 may be configured to curl the staple arms 120 outwards (as shown here), inwards, or in virtually any direction with respect to the tissue closure assembly 100 and the incision in the vessel wall. Alternatively, the staple arms 120 can be constructed to have a shape memory that causes the staple arms to curl to grasp the tissue. This can be accomplished with a tissue closure assembly made of a superelastic nickel- titanium alloy.

Once fixated to the tissue, the structure of the tissue closure assembly 100 can be compressed to achieve closure of an incision or wound, such as an arteriotomy, made within its borders. This compression can happen in multiple directions within the structure. The opposing fixation points can be pulled together, and the entire structure can be collapsed to minimize the profile and to provide sound closure. In addition to compressing the tissue on opposing sides of the incision, it may also be advantageous to rotate the edges of the incision upwards so as to provide direct contact between the intima layers on either side of the incision.

FIGS. 36A-36B illustrate another embodiment of a unitary tissue closure assembly 100 similar to the ones just described. Rather than relying on deformation of the side members to hold the tissue closure assembly 100 in a closed position, locking members 162 are included on the staple bar 128 and/or the side members to lock the tissue closure assembly 100 in a closed position, as shown in FIG. 36B. The locking members 162 may be in the form of barbs, hooks, latches, etc. FIGS. 37A-37B illustrate an embodiment of a unitary tissue closure assembly 100 with a cylindrical configuration that can be manufactured by cutting a piece of tubing, for example by laser cutting or photochemical etching.

FIG. 38 illustrates a unitary tissue closure assembly 100 with first and second closure components 104, 106 that have a curved lower edge to conform to the external curvature of the target vessel, an optional feature that can be used in any embodiment of the closure assembly 100.

FIG. 39 illustrates an alternate embodiment of a tissue anchor 320 for use with a tissue closure delivery device. The tissue anchor 320 is mounted on a tubular shaft 319 with a guidewire lumen 321 for following a guidewire and for observing back bleeding to locate the vessel lumen. The tissue anchor 320 is configured with a smoothly tapered distal end 322 for entering a needle puncture in the vessel wall and a blunt proximal end 323 for pulling back to positively locate the inner surface of the vessel wall. The passive operation of the tissue anchor 320 simplifies the method of use by eliminating the steps of expanding and retracting an active tissue anchor. The tissue anchor 320 is easily withdrawn from the vessel lumen after an arteriotomy incision has been made.

FIGS. 40A-40B illustrate another embodiment of a tissue anchor 324 for use with a tissue closure delivery device. The tissue anchor 324 is configured as a bar or toggle pivotally mounted on a tubular shaft 325, which encloses a guidewire and back bleed lumen. The toggle-shaped tissue anchor 324 can be pivoted to be in line with the shaft 325 for entry through a needle puncture, as shown in FIG. 40A. Once it is inside the vessel lumen, the tissue anchor 324 is rotated to a position perpendicular to the shaft 325, as shown in FIG. 4OB, to pull back on the interior of the vessel wall. The toggle-shaped tissue anchor 324 can be pivoted by means of a cable, wire or pushrod in the shaft 325.

FIGS. 41A-41B illustrate an umbrella-shaped embodiment of a tissue anchor 326 for use with a tissue closure delivery device. FIG. 41 A shows the tissue anchor 326 collapsed around the tubular shaft 327 for entry through a needle puncture in a vessel wall. Once it is inside the vessel lumen, the tissue anchor 326 is expanded like an umbrella, as shown in FIG. 41B, to pull back on the interior of the vessel wall. The umbrella-shaped tissue anchor 326 can be expanded by means of a cable, wire or pushrod in the shaft 327.

The function of an arteriotomy cutter can also be combined with a lumen locator and anchor mechanism. FIGS. 42A-42B illustrate a tissue anchor 328 with an arteriotomy blade 329 integrated into it. The tissue anchor 328 is configured with a smoothly tapered distal end for entering a needle puncture in the vessel wall and a blunt proximal end for pulling back to positively locate the inner surface of the vessel wall. FIG. 42A shows the tissue anchor 328 with the arteriotomy blade 329 in a concealed position. FIG. 42A shows the tissue anchor 328 with the arteriotomy blade 329 exposed for cutting an arteriotomy opening from the inside of the blood vessel.

FIGS. 43A-43B illustrate another embodiment of a tissue anchor 330 combined with an arteriotomy blade. The tissue anchor 330 is configured as a double toggle pivotally mounted on a tubular shaft 331. The toggle bars of the tissue anchor 330 have a blunt edge 332 for pulling back on the vessel wall, but can be rotated to face a sharpened cutting edge 333 in the proximal direction for cutting an arteriotomy opening from the inside of the blood vessel. This feature of a sharpened cutting edge 333 can also be combined with the single toggle embodiment described in FIGS. 40A-40B. FIGS. 44A-44E illustrate another embodiment of a tissue anchor 330 with a sharpened cutting edge 333 that serves as an arteriotomy blade combined with additional features. In a closed position, as shown in FIG. 44A, the double toggle tissue anchor 330 is withdrawn into a tubular member 334 with a pair of slits 335 extending proximally from the distal end. The slit tubular member 334 has a sliding fit with an outer tube 336. When the outer tube 336 is withdrawn, the slit ends 337 of the tubular member 334, which have been heat treated to give them an elastic memory, expand outward and the double toggle tissue anchor 330 expands to a deployed position with the sharpened cutting edge 333 facing in the proximal direction, as shown in FIG. 44B.The slit ends 337 of the tubular member 334 function as a bumper for the sharpened cutting edge 333 allowing the tissue anchor 330 to pull back without cutting the tissue. At the appropriate point in the procedure, the slit ends 337 of the tubular member 334 are withdrawn into the outer tube 336 to expose the sharpened cutting edge 333, as shown in FIG. 44C, for cutting an arteriotomy opening from the inside of the blood vessel.

FIG. 44D shows an optional feature of the tissue anchor 330, wherein the sharpened cutting edge 333 is in the configuration of an arc or crescent when viewed from the distal end. This allows the sharpened cutting edge 333 to cut an actuate arteriotomy opening with a tissue flap. FIG. 44D shows an optional feature wherein, when viewed from the side, the tissue anchor 330 has a sickle shape with upturned ends that facilitate cutting through the vessel wall.

FIG. 45 illustrates an embodiment of a tissue anchor 338 with an arteriotomy blade 339. The tissue anchor 338 is configured as an expandable cage, which may be made of a polymer or metal, mounted on the distal end of a tubular shaft 340. The expandable cage tissue anchor 338 is preferably self-expanding, but alternatively may be expanded by the action of a pull wire or the like. The arteriotomy blade 339, in an undeployed position, is surrounded by the expandable cage tissue anchor 338. When the arteriotomy blade 339 is needed, it pivots out from the center of the expandable cage tissue anchor 338 for cutting an arteriotomy opening from the inside of the blood vessel.

FIG. 46 illustrates another embodiment of a tissue anchor 342 with an arteriotomy blade 343. The tissue anchor 342 is configured as an expandable hoop, which may be made of a polymer or metal, deployable from inside of a tubular shaft 344. The expandable hoop tissue anchor 342 is preferably self-expanding, but alternatively may be expanded by the action of a pull wire or the like. The arteriotomy blade 343 is also configured as an expandable hoop with a sharpened proximal edge 345, preferably self-expanding, independently deployable from inside of the tubular shaft 344. When the arteriotomy blade 343 is needed, the expandable hoop tissue anchor 342 is at least partially withdrawn into the tubular shaft 344 to collapse it, and the arteriotomy blade 343 is advanced out of the tubular shaft 344, allowing it to expand and exposing the sharpened proximal edge 345 for cutting an arteriotomy opening from the inside of the blood vessel.

While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.

Claims

We claim:

1. A tissue closure delivery device, comprising: an elongated hollow cylindrical body having a proximal end and a distal end; an expandable dilator tip located at the distal end of the hollow cylindrical body, the expandable dilator tip having a closed position with an approximately conical tapered configuration and an open position with an approximately cylindrical configuration that is open on its distal end; a closure deployment mechanism positioned within the hollow cylindrical body, the closure deployment mechanism initially holding a tissue closure assembly in an undeployed position, the tissue closure assembly having fasteners configured for fastening to a target tissue within a patient; and a control handle connected to the proximal end of the hollow cylindrical body, the control handle having at least one actuator for selectively expanding the expandable dilator tip from the closed position to the open position, advancing the closure deployment mechanism distally within the hollow cylindrical body, actuating the fasteners of the tissue closure assembly to fasten to the target tissue and releasing the tissue closure assembly from the closure deployment mechanism.

2. The tissue closure delivery device of claim 1, further comprising: a selectively expandable tissue anchor extending distally from the expandable dilator tip of the hollow cylindrical body.

3. The tissue closure delivery device of claim 2, wherein: the selectively expandable tissue anchor comprises a flexible plastic tube having a plurality of longitudinal slits through a wall of the plastic tube, and an inner tubular member passing through the flexible plastic tube and attached to the flexible plastic tube at a point distal to the longitudinal slits, whereby, when tension is placed on the inner tubular member, the flexible plastic tube expands outward at the area of the longitudinal slits to create an expanded tissue anchor.

4. The tissue closure delivery device of claim 2, further comprising: an anchor release mechanism that automatically allows the tissue anchor to contract from its expanded position after the fasteners of the tissue closure assembly are fastened to the target tissue.

5. The tissue closure delivery device of claim 1, wherein: the expandable dilator tip comprises a plurality of approximately triangular shaped petals configured to bend inward into an approximately conical tapered configuration when the expandable dilator tip is in the closed position and to bend outward into an approximately cylindrical configuration when the expandable dilator tip is in the open position.

6. The tissue closure delivery device of claim 5, further comprising: an inner cylinder slidable within the hollow cylindrical body, the inner cylinder having a proximal position that allows the approximately triangular shaped petals of the expandable dilator tip to bend inward toward the closed position and a distal position in which the inner cylinder forces the approximately triangular shaped petals of the expandable dilator tip outward toward the open position.

7. The tissue closure delivery device of claim 5, wherein: the approximately triangular shaped petals of the expandable dilator tip are configured to open asymmetrically such that the open distal end of the expandable dilator tip is at an oblique angle to the hollow cylindrical body when the expandable dilator tip is in the open position.

8. The tissue closure delivery device of claim 1, wherein the tissue closure assembly comprises: a first tissue closure component having at least one integrated fastener for fastening to tissue on a first side of a tissue opening in a patient; a second tissue closure component having at least one integrated fastener for fastening to tissue on a second side of the tissue opening in the patient; a first cable attached to the first tissue closure component and passing through the second tissue closure component; a second cable attached to the first tissue closure component and passing through the second tissue closure component; a cable tightening mechanism configured for tightening the first cable and the second cable to draw the first tissue closure component into proximity with the second tissue closure component; and means for locking the first cable and the second cable in a tightened position.

9. The tissue closure delivery device of claim 8, further comprising: a first tab attached to the first tissue closure component configured to facilitate gripping and holding the first tissue closure component, the first tab being detachable from the first tissue closure component; and a second tab attached to the second tissue closure component configured to facilitate gripping and holding the second tissue closure component, the second tab being detachable from the second tissue closure component.

10. The tissue closure delivery device of claim 9, further comprising: a first stress riser at the attachment between the first tab and the first tissue closure component configured to facilitate detachment of the first tab from the first tissue closure component; and a second stress riser at the attachment between the second tab and the second tissue closure component configured to facilitate detachment of the second tab from the second tissue closure component.

1 1. A tissue closure device comprising: a first tissue closure component having at least one integrated fastener for fastening to tissue on a first side of a tissue opening in a patient; a second tissue closure component having at least one integrated fastener for fastening to tissue on a second side of the tissue opening in the patient; a first cable attached to the first tissue closure component and passing through the second tissue closure component; a second cable attached to the first tissue closure component and passing through the second tissue closure component; a cable tightening mechanism configured for tightening the first cable and the second cable to draw the first tissue closure component into proximity with the second tissue closure component; and means for locking the first cable and the second cable in a tightened position.

12. The tissue closure device of claim 11, further comprising: a first tab attached to the first tissue closure component configured to facilitate gripping and holding the first tissue closure component, the first tab being detachable from the first tissue closure component; and a second tab attached to the second tissue closure component configured to facilitate gripping and holding the second tissue closure component, the second tab being detachable from the second tissue closure component.

13. The tissue closure device of claim 12, further comprising: a first stress riser at the attachment between the first tab and the first tissue closure component configured to facilitate detachment of the first tab from the first tissue closure component; and a second stress riser at the attachment between the second tab and the second tissue closure component configured to facilitate detachment of the second tab from the second tissue closure component.