US20050119695A1 - Closure device and methods for making and using them - Google Patents

Abstract

A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines may include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another such that they overlap in the planar configuration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of application Ser. No. 10/435,104, filed May 9, 2003, which was a continuation-in-part of application Ser. No. 09/732,178, filed Dec. 7, 2000, now U.S. Pat. No. 6,719,777 entitled “Closure Device and Methods for Making and Using Them,” each of which are hereby expressly incorporated by reference.
FIELD OF THE INVENTION
• The present invention relates generally to apparatus and methods for engaging tissue and/or closing openings through tissue, and more particularly to devices for closing a puncture in a blood vessel or other body lumen formed during a diagnostic or therapeutic procedure, and to methods for making and using such devices.
BACKGROUND
• Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and intervening tissue into the vascular system. A guide wire may then be passed through the needle lumen into the patient's blood vessel accessed by the needle. The needle may be removed, and an introducer sheath may be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator. A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
• Upon completing the procedure, the devices and introducer sheath may be removed, leaving a puncture site in the vessel wall. External pressure may be applied to the puncture site until clotting and wound sealing occur. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient, and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
• Various apparatus have been suggested for percutaneously sealing a vascular puncture by occluding the puncture site. For example, U.S. Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the use of a biodegradable plug that may be delivered through an introducer sheath into a puncture site. When deployed, the plug may seal the vessel and provide hemostasis. Such devices, however, may be difficult to position properly with respect to the vessel, which may be particularly significant since it is generally undesirable to expose the plug material, e.g., collagen, within the bloodstream, where it may float downstream and risk causing an embolism.
• Another technique has been suggested that involves percutaneously suturing the puncture site, such as that disclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al. Percutaneous suturing devices, however, may require significant skill by the user, and may be mechanically complex and expensive to manufacture.
• U.S. Pat. No. 5,478,354, issued to Tovey et al., discloses a surgical fastener including an annular base having legs that, in a relaxed state, extend in a direction substantially perpendicular to a plane defined by the base and slightly inwards toward one another. During use, the fastener is fit around the outside of a cannula, thereby deflecting the legs outward. The cannula is placed in an incision, and the fastener is slid along the cannula until the legs pierce into skin tissue. When the cannula is withdrawn, the legs move towards one another back to the relaxed state to close the incision.
• U.S. Pat. Nos. 5,007,921 and 5,026,390, issued to Brown, disclose staples that may be used to close a wound or incision. In one embodiment, an “S” shaped staple is disclosed that includes barbs that may be engaged into tissue on either side of the wound. In another embodiment, a ring-shaped staple is disclosed that includes barbs that project from the ring. Sides of the ring may be squeezed to separate the barbs further, and the barbs may be engaged into tissue on either side of a wound. The sides may then be released, causing the barbs to return closer together, and thereby pulling the tissue closed over the wound. These staples, however, have a large cross-sectional profile and therefore may not be easy to deliver through a percutaneous site to close an opening in a vessel wall.
• Accordingly, devices for engaging tissue, e.g., to close a vascular puncture site, would be considered useful.
SUMMARY OF THE INVENTION
• The present invention is directed to devices and methods for engaging tissue, e.g., to connect tissue segments together or to close and/or seal openings through tissue, such as in a wall of a body lumen. More particularly, the present invention is directed to vascular closure devices or clips for closing a puncture in a wall of a blood vessel formed during a diagnostic or therapeutic procedure, and to methods for making and using such devices.
• In one aspect of the present invention, a device for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane. The body may be movable from a substantially planar configuration lying generally in the plane towards a transverse configuration extending out of the plane. The body may also include a plurality of looped elements including alternating first and second curved regions that define an inner and outer periphery of the body, respectively, in the planar configuration. A plurality of tines or other tissue-engaging elements may extend from the first curved regions, and may be oriented towards the central axis in the planar configuration, and substantially parallel to the central axis in the transverse configuration. The device may be biased towards the planar configuration, e.g., to bias the tines towards the central axis.
• The looped elements of the device may generally define an endless zigzag pattern, e.g., a sinusoidal pattern, extending about the central axis. The looped elements may facilitating deforming the device between the planar and transverse configurations, e.g., by distributing stresses through the device and minimizing localized stresses in the curved regions. In addition, the looped elements may be expandable between expanded and compressed states for increasing and reducing a periphery of the body in the transverse orientation, respectively. The looped elements may be biased towards one of the compressed and expanded states.
• Adjacent tines of the device may have a first curved region disposed between them. The first curved region between adjacent tines may include a substantially blunt element extending towards the central axis. The blunt element may have a length shorter than lengths of the adjacent tines.
• In addition or alternatively, the tines of the device may include first and second primary tines, having a first length and a second length, respectively, which may be the same as or different than one another. The first and second primary tines may be disposed on opposing first curved regions, and may be oriented substantially towards each other in the planar configuration. In the planar configuration, the first and second primary tines may at least partially overlap. The tines may also include one or more secondary tines having a length substantially shorter than the first and second lengths of the primary tines. The secondary tines may be disposed on either side of the first and second primary tines.
• In another aspect of the present invention, a device for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane. The body may be movable from a substantially planar configuration lying generally in the plane towards a transverse configuration extending out of the plane. A first primary tine, having a first length, may extend from the body towards the central axis in the planar configuration, and may be deflectable out of the plane when the body is moved towards the transverse configuration. A second primary tine, having a second length, may extend from the body towards the first tine when the body is in the planar configuration, and may be deflectable out of the plane when the body is moved towards the transverse configuration. The lengths of the first and second primary tines may cause the primary tines to at least partially overlap in the planar configuration. The body may be biased towards the planar configuration to bias the tines generally towards the central axis.
• The device may include a set of secondary tines having a length shorter than the first and second lengths. The secondary tines may extend from the body towards the central axis in the planar configuration, and may be deflectable out of the plane when the body is moved towards the transverse configuration. In an exemplary embodiment, a secondary tine may be disposed on either side of the first primary tine, and a secondary tine may be disposed on either side of the second primary tine.
• Optionally, adjacent tines may have a first curved region disposed between them. The first curved region between adjacent tines may include a substantially blunt element extending towards the central axis. The blunt element may have a length shorter than lengths of the adjacent tines.
• Also, the device may include a plurality of looped elements disposed around a periphery of the body. The looped elements may generally define an endless zigzag pattern extending about the central axis. The first primary tine and the second primary tine may extend from looped elements disposed opposite one another. The looped elements may be expandable between expanded and compressed states for increasing and reducing a periphery of the body in the transverse orientation, respectively. The looped elements may be biased towards one of the compressed and expanded states.
• In another aspect of the present invention, a method is provided for manufacturing a clip from an elastic material, such as a sheet of superelastic alloy, e.g., a nickel-titanium alloy (“Nitinol”). The components of the clip, e.g., a generally-annular body, optionally including looped elements, and/or tines, may be formed by removing portions from the sheet. The portions may be removed, e.g., by laser cutting, chemical etching, photo chemical etching, stamping, electrical discharge machining, and the like. The clip may be polished using one or more processes, such as electro-polishing, chemical etching, tumbling, sandblasting, sanding, and the like, and/or heat-treated to provide a desired finish and/or desired mechanical properties. Optionally, the body and tines may be coated with a therapeutic agent, e.g., a peptide coating and/or one or more clotting factors.
• In addition or alternatively, the clip may be disposed in a planar configuration, e.g., upon forming the clip from the sheet, and heat treated to form a clip biased to the planar configuration. For example, the clip may be formed from a shape memory material, e.g., Nitinol, that may substantially recover the planar configuration when heated to a first predetermined temperature corresponding to an austenitic state, e.g., a temperature close to body temperature. The clip may be cooled to a second predetermined temperature corresponding to a martensitic state, e.g., a temperature at or below ambient temperature, and malleably manipulated.
• For example, the clip formed from the sheet may be deformed to a transverse configuration, such as that described above, e.g., by loading the clip onto a mandrel or directly onto a delivery device. If the clip includes looped elements formed from the body, the looped elements may be biased upon heat treatment towards an expanded state, but may be malleably deformed to a compressed state upon cooling, e.g., to facilitate loading onto the delivery device. Alternatively, the clip may be formed from a superelastic material, e.g., Nitinol, such that the clip may be resiliently deformed to the transverse configuration and/or compressed state, yet may automatically attempt to resume its planar configuration and/or expanded state upon release from external forces.
• In still another aspect of the present invention, a method for closing an opening in a wall of a body lumen is provided. The distal end of an elongate member may be advanced through an opening in a patient's skin, along a passage through tissue, and into the body lumen. A distal portion of an obturator may be positioned distally beyond the distal end of the elongate member along the passage within the body lumen. One or more expandable elements on the distal portion of the obturator may be expanded transversely. The obturator may be withdrawn from the passage until the expandable elements contact the wall of the body lumen, thereby providing a tactile indication of a location of the wall of the body lumen between the elongate member and the plurality of expandable elements of the obturator.
• A clip may be advanced into the passage over the elongate member until tines of the clip penetrate the wall of the body lumen, the tines and the expandable elements on the obturator being angularly offset from one another such that the tines penetrate the wall at locations between the expandable elements. The obturator may be collapsed, and the elongate member and/or obturator may be withdrawn from the body lumen and passage, leaving the clip to substantially close the opening in the wall of the body lumen. When the elongate member is withdrawn, the tines may automatically at least partially move towards a planar configuration to substantially close the opening.
• The tines of the clip may include primary tines and secondary tines. Here, advancing the clip may include puncturing the wall of the body lumen with the primary tines until tips of the primary tines enter the body lumen, and puncturing the wall of the body lumen with the secondary tines. The primary tines and the secondary tines may puncture the walls without contacting the expandable elements of the obturator.
• Other objects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a top view of a first embodiment of a clip including a plurality of tines in a planar orientation, in accordance with the present invention.
• FIGS. 1B and 1C are side views of the clip ofFIG. 1A, with the tines oriented substantially transversely from the planar orientation, in compressed and expanded states, respectively.
• FIG. 2A is a top view of a second embodiment of a clip including a plurality of tines in a planar orientation, in accordance with the present invention.
• FIGS. 2B and 2C are side views of the clip ofFIG. 2A, with the tines oriented substantially transversely from the planar orientation, in compressed and expanded states, respectively.
• FIG. 3 is a top view of a third embodiment of a clip, in accordance with the present invention.
• FIG. 4 is a top view of an embodiment of a clip having radiopaque markers thereon.
• FIG. 5 is a top view of an embodiment of a clip having pockets for holding radiopaque markers therein.
• FIG. 6 is a top view of another embodiment of a clip including stop elements, in accordance with the present invention.
• FIG. 7 is a top view of yet another embodiment of a clip including stop elements, in accordance with the present invention.
• FIG. 8 is a top view of still another embodiment of a clip including stop elements, in accordance with the present invention.
• FIG. 9 is a side view of an apparatus, including an introducer sheath and an obturator, suitable for delivering a clip of the present invention.
• FIGS. 10A-10D are cross-sectional views of a blood vessel, showing a method for delivering a clip into a passage communicating with the vessel using the apparatus ofFIG. 9.
• FIG. 11A is a top view of the blood vessel ofFIGS. 10A-10D, showing the orientation of the expandable elements of the obturator and openings produced by primary tines of the clip relative to an arteriotomy in the vessel.
• FIG. 11B is a top view of the blood vessel ofFIG. 11A, showing the arteriotomy being closed by the clip.
• FIG. 12 is a top view of an embodiment of a clip having arcuate tines, in accordance with the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBOIDMENTS
• Turning now to the drawings,FIGS. 1A-1C show a first preferred embodiment of a closure device orclip10 for closing an incision, puncture, or other passage through tissue, e.g., communicating with a blood vessel or other body lumen (not shown). Theclip10 includes abody12, which may be generally annular in shape and surrounds acentral axis24, and a plurality oftines16 extending from thebody12. As used herein, an “annular-shaped body” includes any hollow body, e.g., including one or more structures surrounding an opening, whether the body is substantially flat or has a significant thickness or depth. Thus, although an annular-shaped body may be circular, it may include other noncircular shapes as well, such as elliptical or other shapes that are asymmetrical about a central axis.
• Thebody12 may include a plurality of looped orcurved elements30 that are connected to one another to form thebody12. Each loopedelement30 may include an inner or firstcurved region32 and an outer or secondcurved region34. In a preferred embodiment, the first and secondcurved regions32,34 are out of phase with one another and are connected alternately to one another, thereby defining an endless sinusoidal pattern. Alternatively, other generally zigzag patterns may be provided that repeat periodically, e.g., saw tooth or square tooth patterns (not shown), instead of a sinusoidal pattern, thereby defining inner and outer regions that alternate about thebody12. When theclip10 is in a substantially planar configuration, as shown inFIG. 1A, the firstcurved regions32 may define aninner periphery36 of thebody12 and theclip10, and the secondcurved regions34 may define anouter periphery38.
• The plurality oftines16 may be biased to extend generally inwardly, e.g., towards one another and/or towards thecentral axis24. Thetines16 may be disposed on the firstcurved regions32, and oriented toward thecentral axis24 when theclip10 is in the planar configuration. In a preferred embodiment, thetines16 may be provided in pairs opposite from one another or provided otherwise symmetrically with respect to thecentral axis24.
• Thetines16 may include a variety of pointed tips, such as a bayonet tip, and/or may include barbs (not shown) for penetrating or otherwise engaging tissue. For example, to increase the penetration ability of theclip10 and/or to lower the insertion force required to penetrate tissue, eachtine16 may include a tapered edge (not shown) extending towards the tip along one side of thetine16. Alternatively, eachtine16 may be provided with a tapered edge on each side of thetine16 extending towards the tip.
• Additionally, as shown inFIGS. 1A-1C, thetines16 may be disposed on alternating firstcurved regions32. Thus, at least one period of a zigzag pattern may be disposed betweenadjacent tines16, which may enhance flexibility of theclip10, as explained further below.
• As shown inFIGS. 1B and 1C (where opposite ends33a,33bare connected to one another), thebody12 and/or thetines16 may be deflected such that thetines16 extend transversely with respect to the plane defined in the planar configuration, thereby defining a transverse configuration for theclip10. Preferably, thetines16 are oriented substantially parallel to thecentral axis24 in the transverse configuration, as shown inFIG. 1B. In the transverse configuration, thebody12 may have a generally annular shape defining a length, L.sub.1, that extends generally parallel to thecentral axis24, and corresponds generally to an amplitude of the zigzag pattern. Preferably, thebody12 is sufficiently flexible such that theclip10 may assume a generally circular or elliptical shape (not shown), e.g., conforming to an exterior surface of a delivery device (not shown) used to deliver theclip10.
• In a preferred embodiment, thetines16 and/orbody12 are biased to move from the transverse configuration towards the planar configuration ofFIG. 1A. Thus, with thetines16 in the transverse configuration, thetines16 may penetrate and/or be engaged with tissue at a puncture site. When theclip10 is released, thetines16 may attempt to return towards one another as theclip10 moves towards the planar configuration, thereby drawing the engaged tissue together and substantially closing and/or sealing the puncture site, as explained further below.
• The loopedelements30 may distribute stresses in theclip10 as it is deformed between the planar and transverse configurations, thereby minimizing localized stresses that may otherwise plastically deform, break, or otherwise damage theclip10 during delivery. In addition, when theclip10 is in the transverse configuration, the loopedelements30 may be movable between a compressed state, such as that shown inFIG. 1B, and an expanded state, such as that shown inFIG. 1C. Preferably, the loopedelements30 are biased towards the expanded state, but may be compressed to the compressed state, e.g., by constraining theclip10. Alternatively, only a portion of the loopedelements30 may be biased towards the expanded state, e.g., the firstcurved regions32, and/or the loopedelements30 may be biased towards the compressed state. Furthermore, the loopedelements30 reduce the force required to be exerted on theclip10 to transition theclip10 from the planar configuration to the transverse configuration before loading onto a delivery device (not shown).
• With theclip10 in the transverse configuration, the loopedelements30 may be circumferentially and/or radially compressed to the compressed state until theclip10 defines a first diameter or circumference26a, such as that shown inFIG. 1B. Theclip10 may be constrained in the compressed state, e.g., by loading theclip10 onto a carrier assembly of a delivery device (not shown), as described further below. When released from the constraint, e.g., when deployed from the carrier assembly, theclip10 may automatically expand towards the expanded state, such as that shown inFIG. 1C, thereby defining a second diameter orcircumference26b. Thus, the loopedelements30 may facilitate reducing the profile of theclip10 during delivery, e.g., to facilitate introducing theclip10 through a smaller puncture or passage. Once theclip10 is deployed entirely from the delivery device, the loopedelements30 may resiliently expand as theclip10 returns towards the planar configuration, as explained further below.
• To manufacture the clip10 (or, similarly, any of the other clips described herein), thebody12 and thetines16 may be integrally formed from a single sheet of material, e.g., a superelastic alloy, such as a nickel-titanium alloy (“Nitinol”). Portions of the sheet may be removed using conventional methods, such as laser cutting, chemical etching, photo chemical etching, stamping, using an electrical discharge machine (EDM), and the like, to form the clip. Thetines16 may be sharpened to a point, i.e., tips may be formed on thetines16 using conventional methods, such as chemical etching, mechanical grinding, and the like.
• Theclip10 may be polished to a desired finish using conventional methods, such as electro-polishing, chemical etching, tumbling, sandblasting, sanding, and the like. Polishing may perform various functions depending on the method used to form theclip10. For a clip formed by laser cutting or using an EDM, polishing may remove heat affected zones (HAZ) and/or burrs from the clip. For a clip formed by photo chemical etching, polishing may create a smoother surface finish. For a clip formed by stamping, polishing may remove or reduce burrs from the bottom side of the clip, and/or may smooth the “roll” that may result on the topside of the clip from the stamping process.
• In addition or alternatively, theclip10 may be formed from a shape memory alloy, e.g., Nitinol, with the loopedelements30 formed initially in the compressed state and/or theclip10 in the planar configuration. With theclip10 deformed to the transverse configuration, theclip10 may be expanded, e.g., by applying a force radially outwards against an inner surface of theclip10, thereby expanding the loopedelements30 to the expanded state. The loopedelements30 may then be heat treated, e.g., by heating theclip10 to an austenitic state, to cause the loopedelements30 to “remember” the expanded state, as is known to those skilled in the art. It may also be necessary to further heat treat theclip10 further, e.g., with the tines in the planar configuration to cause thebody12 and/ortines16 to “remember” and be biased towards the planar configuration, as is known to those skilled in the art. Theclip10 may then be cooled, e.g., to a martensitic state, which may be at or close to ambient temperature, and manipulated, e.g., malleably deformed to the transverse configuration, for example, by loading theclip10 onto a delivery device (not shown), as described below. Thus, if theclip10 is subsequently heated to a predetermined temperature, e.g., at or below body temperature, the material may remember the planar configuration and/or expanded state and become biased towards them.
• FIGS. 2A-2C show another preferred embodiment of a closure device or clip110 that includes a generally annular-shapedbody112 defining a plane and disposed about acentral axis124 extending through the plane. Thebody112 preferably includes a plurality of loopedelements130 that are connected to one another to form thebody112, similar to the previous embodiment. Each loopedelement130 includes an inner or firstcurved region132 and an outer or secondcurved region134. Similar to the previous embodiment, the first and secondcurved regions132,134 may form an endless sinusoidal pattern or other generally zigzag pattern. When theclip110 is in a substantially planar configuration, as shown inFIG. 2A, the firstcurved regions132 may define aninner periphery136, and the secondcurved regions134 may define an outer periphery.
• Unlike the previous embodiment, theclip110 includes a plurality ofprimary tines114 and a plurality ofsecondary tines116. Each of the primary andsecondary tines114,116 may include a variety of known pointed tips, similar to the previous embodiment.
• Each of theprimary tines114 may have a length l.sub.1, although alternatively each of theprimary tines114 may have a different length than one another. Theprimary tines114 may be disposed in one or more opposing pairs, e.g., on opposing firstcurved regions132, and may be oriented towards and/or across thecentral axis124 in the planar configuration. In the planar configuration, the lengths l.sub.1 may be sufficiently long such that theprimary tines114 at least partially overlap one another, i.e., extend across thecentral axis124 towards an opposingtine114. Therefore, the tips of theprimary tines114 may extend past thecentral axis124 and/or theprimary tines114 in each pair may lie substantially parallel to each other when theclip110 is in the planar configuration.
• Each of thesecondary tines116 may be disposed on a first or innercurved region132, e.g., such that one or moresecondary tines116 may be provided between opposing pairs ofprimary tines114. Each of thesecondary tines116 may have a length l.sub.2 that is substantially less than the length l.sub.1 of theprimary tines114.
• Preferably, asecondary tine116 is disposed on either side of eachprimary tine114. For example, theclip110 shown inFIGS. 2A-2C has first and secondprimary tines114, and each of the first and secondprimary tines114 has asecondary tine116 on either side of it. Thus, theclip110 may have a total of twoprimary tines114 and foursecondary tines116. Optionally, thesecondary tines116 may be disposed substantially symmetrically about thecentral axis124. Thetines114,116 may be provided on every other firstcurved regions132. For example, a firstcurved region132 having neither aprimary tine114 nor asecondary tine116 may separate each adjacent tine, e.g., between two adjacentsecondary tines116, or between asecondary tine116 and aprimary tine114.
• As shown inFIGS. 2B and 2C, thebody112 and/or thetines114,116 may be deflected such that they extend transversely with respect to the plane defined inFIG. 2A. Preferably, theprimary tines114 andsecondary tines116 are oriented substantially parallel to thecentral axis124 to define a transverse configuration, as shown inFIG. 1B. In the transverse configuration, thebody112 has a generally annular shape defining a length, LE.sub.1, that extends generally parallel to thecentral axis24, and corresponds generally to an amplitude of the sinusoidal pattern. Preferably, thebody112 is sufficiently flexible such that theclip110 may assume a generally circular or elliptical shape (not shown), e.g., conforming to an exterior surface of a delivery device (not shown).
• Thetines114,116 may be biased towards one another and/or towards thecentral axis124, i.e., due to the bias of theclip110 towards the planar configuration ofFIG. 2A, similar to the previous embodiment. With theclip110 in the transverse configuration, theclip110 may be delivered such that theprimary tines114 entirely penetrate the wall of a blood vessel or other body lumen, while thesecondary tines116 only partially penetrate the wall due to their relative lengths, as explained further below.
• The loopedelements130 may be expandable between a compressed state, as shown inFIG. 2B, and an expanded state, as shown inFIG. 2C, similar to the previous embodiment. Preferably, the loopedelements130 are biased to the expanded state, but may be resiliently compressed to the compressed state, e.g., by constraining theclip110.
• Turning toFIG. 3, an alternative embodiment of aclip210 is shown that includes abody112 including loopedelements130, andprimary tines114, similar to the previous embodiment, but has no supplemental orsecondary tines116. The reference numbers for elements of theclip210 are consistent with like elements used for theclip110.
• Any of the clips of the present invention may include one or more radiopaque markers or other markers visible using external imaging, such as fluoroscopy. For example, using theclip110 ofFIGS. 2A-2C as an example, theentire clip110 may be coated with radiopaque material, which may be a high density material such as gold, platinum, platinum/iridium, and the like.
• Alternatively, theclip110 may be partially coated with radiopaque material by using masking techniques. For example, theentire clip110 may first be coated with radiopaque material. Theclip110 may then be masked at locations where the radiopaque coating is desired. For example, the loopedelements130 of theclip110 may be left unmasked during this process if it is desired to leave the loopedelements130 uncoated by radiopaque material. This may be desirable, e.g., to prevent radiopaque material from adversely affecting the flexibility of the loopedelements130. Theclip110 may then be treated to remove the radiopaque material from the unmasked areas, in this example, the loopedelements130. The masking may then be removed using conventional processes, leaving the rest of theclip110 coated with radiopaque material.
• Turning toFIG. 4, in another alternative, one or morediscrete markers102 may be provided at predetermined locations on theclip110. For example, high density orradiopaque material102 may be crimped or otherwise secured onto opposing double looped orcircular regions130. In another embodiment, shown inFIG. 5, a plurality ofpockets104 may be provided on the loopedelements130 into which high density plugs (not shown) may be bonded or otherwise secured. These various radiopaque markers may also be incorporated in any of the embodiments described herein.
• Turning toFIG. 6, another embodiment of aclip310 is shown that, similar toclip110, may include a plurality of loopedelements330 that interconnect to form abody312. Each loopedelement330 may have a first or innercurved region332 and a second or outercurved region334.Primary tines314 may be disposed on opposing firstcurved regions332, which, optionally, may include abarb302 thereon to enhance engagement with tissue.Secondary tines316 may be provided on firstcurved regions332 on either side of eachprimary tine314. In addition, a firstcurved region332 without atine314,316 may separate adjacent tines, as described above with regard to the previous embodiments.
• Theclip310 also includes stopmembers306 on one or more of thetines314,316, e.g., adjacent the respective firstcurved region332. Eachstop member306 may be blunt-shaped, e.g., generally triangularly with an apex307 of thestop member306 extending from the firstcurved region332, and thetine314,316 extending from a wide orblunt base307 of thestop member306. During use, theblunt bases307 may limit penetration of therespective tines314,316 into tissue by reducing an effective length of therespective tine314,316. For example, when thetines314,316 are driven into tissue, thetines314,316 may penetrate the tissue until theblunt bases307 contact the tissue, whereupon thetines314,316 may be prevented from penetrating further into the tissue. Turning toFIG. 7, another embodiment of a clip410(i) is shown that includes abody412, a plurality oftines414, and a plurality of spring elements440(i) that interconnect betweenadjacent tines414. Thebody412 includes outercurved regions434 that extend betweenadjacent tines414, thereby defining an outer periphery for the clip410(i). The clip410(i) may be moveable between a substantially planar configuration such as that shown inFIG. 7, and a transverse configuration (not shown), and preferably is biased towards the planar configuration, similar to the previous embodiments.
• In the embodiment shown, the spring elements440(i) generally are hollow diamond shaped elements, including curved inner regions432(i) oriented towards thecentral axis424 of thebody412 when the clip410(i) is in the planar configuration. The spring elements440(i) may serve multiple purposes. First, the spring elements440(i) may bias the clip410(i), e.g., allowing the clip410(i) to at least partially expand resiliently. For example, when the clip410(i) is deflected into the transverse configuration (not shown), the spring elements440(i) may allow thetines414 to be moved away from thecentral axis424 and/or one another. Thus, during deployment, thetines414 may be deflected radially outwardly or otherwise expanded to engage a larger area of tissue.
• As thetines414 are expanded, the spring elements414(i) may deform to become wider (along a dimension extending generally between the adjacent tines414) and shorter (along a dimension extending generally parallel to the tines414). Once a force causing thetines414 to expand is removed, the spring elements414(i) may resiliently try to return towards their original shape, thereby pulling thetines414 closer towards one another.
• In addition, the curved inner regions432(i) of the spring elements414(i) may provide stops limiting penetration of thetines414 into tissue, similar to the stop members described above. For example, when the clip410(i) is in the transverse configuration and the spring elements414(i) are expanded, the curved inner regions432(i) may be become more oblique, possibly becoming generally linear. Thus, when thetines414 are driven into tissue, the curved inner regions432(i) may limit penetration of thetines414.
• Finally, after the clip410(i) is deployed, e.g., thetines414 are penetrated into tissue, the curved inner regions432(i) may return towards their original shape, and may pinch or otherwise engage tissue between the inner curved regions432(i) and theadjacent tines414. Thus, contracting the spring elements440(i) may enhance the ability of the clip410(i) to seal a puncture site, e.g., by pulling engaged tissue inwardly towards thecentral axis424 of the clip410(i).
• Turning toFIG. 8, an alternative embodiment of a clip410(ii) is shown that is substantially similar to the clip410(i) shown inFIG. 7, with the exception of the shape of the spring elements440(ii). Rather than diamond shaped elements, the spring elements440(ii) are looped elements generally defining a circular shape.
• Turning now toFIG. 12, another preferred embodiment of aclip710 of the present invention is illustrated. Similar to the previous embodiments, theclip710 includes a generally annular-shapedbody712 that defines a plane. Thebody712 is disposed about acentral axis724 that extends through the plane. Thebody712 preferably includes a plurality of outercurved elements730 that extend betweenadjacent tines716 and are connected to each other to form thebody712. When theclip710 is in a substantially planar configuration, as shown inFIG. 12, thecurved elements730 define anouter periphery738 of theclip710.
• Thetines716 are curved or arcuately shaped and includedistal tips715 that extend toward thecentral axis724 when theclip710 is in the substantially planar configuration. Optionally, one or more of thetines716 may includebarbs717, similar to the previous embodiments. Preferably, the curve of thetines716 are all in phase with one another such that thetines716 spiral about thecentral axis724. This may allow a length of thetines716 to be maximized for a given diameter of thebody712.
• For example, thetines716 may have a length that is greater than a radius of thebody712 without thedistal tips715 of thetines716 touching one another. Thus, due to the arcuate shape of eachtine716, thetines716 ofclip710 may be generally longer than the straight tines of the previous clips having comparable diameters. Thetines716 may, therefore, penetrate deeper into tissue than the tines of the other clips.
• As with the previous embodiments, thebody712 and/or thetines716 ofclip710 may be deflected until thetines716 extend transversely with respect to the plane defined in the planar configuration, thereby defining a transverse configuration. In the transverse configuration, thetines716 may be oriented substantially parallel to thecentral axis724. Additionally, as with the previous embodiments, thetines716 and/orbody712 may be biased to move from the transverse configuration towards the planar configuration. Theclip710 may be delivered in substantially the same manner as will be described with respect to other clips of the present invention.
• Any of the clips of the present invention may be coated with a substance that enhances hemostasis and/or healing of a blood vessel, e.g., by increasing a rate of regeneration of endothelium on the interior surface of the vessel, or by decreasing inflammatory response at the treatment site. In one embodiment, a suitable synthetic peptide coating may be applied to a clip to attract endothelial cells to the surface. An exemplary synthetic peptide coating may, for example, attach to the same cell binding sites as collagen. In another embodiment, a clip may be coated with a combination of clotting factors in order to promote hemostasis. For example, one side of the clip may be coated with Factor III and an endopeptidase, such as PTA, to accelerate the intrinsic clotting pathway. On the opposite side of the clip, a combination of a protein cofactor proaccelerin (Factor V) and an activated endopeptidase, such as serum prothrombin conversion accelerator (SPCA), cothromboplastin, and the like, may be applied to accelerate the extrinsic clotting pathway. The clips of the present invention may also be coated with any suitable hydrophilic polymer that swells in the presence of bodily fluids in order to reduce, minimize, or stop blood flow, thereby aiding the hemostasis process.
• The clips of the present invention may be delivered using various apparatus and methods. Anexemplary apparatus500 suitable for delivering a clip of the present invention is shown inFIG. 9. Other suitable apparatus that may be used to deliver a clip of the present invention are disclosed in co-pending U.S. application Ser. No. 10/081,723, filed on the same day as the present application and entitled “Apparatus and Methods for Delivering a Closure Device” (attorney docket no. 262/280), which is assigned to the assignee of the present application. The disclosures of this application and any references cited therein are expressly incorporated by reference.
• Generally, theapparatus500 includes anintroducer sheath552, and a housing orcarrier assembly554 slidably disposed on thesheath552. Thesheath552 includes a substantially flexible or semi-rigidtubular body558 including alumen560 extending between its proximal anddistal ends562,564. Thedistal end564 has a size and shape configured to facilitate insertion into a blood vessel, e.g., having a tapered tip for facilitating substantially atraumatic introduction through the passage and at least partially into the vessel. Thelumen560 has a size for inserting one or more devices therethrough, such as a catheter, guidewire, and the like (not shown). Thesheath552 also preferably includes one or more seals (not shown), such as a hemostatic valve, within thelumen560 at or near theproximal end562 that provides a fluid-tight seal, yet accommodates inserting one or more devices into thelumen560 without fluid passing proximally from thesheath552.
• Optionally, thesheath552 may include aside port566 that communicates with thelumen560, for example, to deliver fluids into thelumen560. Alternatively, or in addition, theside port566 may be used to provide a “bleed back” indicator. An exemplary “bleed back” indicator and related methods of use are disclosed in co-pending application Ser. No. 09/680,837, filed Oct. 6, 2000, entitled “Apparatus and Methods for Positioning a Vascular Sheath,” which is assigned to the assignee of the present application. The disclosure of this application and any other references cited therein are fully incorporated by reference herein.
• Theapparatus500 may also include a mechanical locator orobturator600, such as that disclosed in U.S. application Ser No. 10/081,723 (attorney docket no. 262/280), incorporated by referenced above, that may be part of an actuator assembly (not shown) that is attachable to the proximal end of thesheath552. Alternatively, the mechanical locator orobturator600 may be a separate device that is insertable into thelumen560, e.g., through the actuator assembly. Generally, theobturator600 is an elongate member including adistal tip614 and adistal portion616. Thedistal tip614 may be substantially soft and/or flexible such that thedistal tip614 may substantially atraumatically enter the vessel590 (not shown, seeFIGS. 10A-10D). Thedistal portion616 generally includes one or more wings or otherexpandable elements618 for providing tactile feedback, as described further below.
• Thecarrier assembly554 is slidably disposed on an exterior of thesheath552, and is configured for releasably carrying a clip110 (shown in phantom), which may any of the clips described herein. Thecarrier assembly554 may be substantially permanently attached to thesheath552 and/or may be actuated from theproximal end562 of thesheath552, for example, by the actuator assembly (not shown), to advance theclip110 distally during deployment. Alternatively, theclip110 may be carried by an actuator assembly, as disclosed in co-pending U.S. application Ser. No. 10/081,725, filed on the same day as the present application and entitled “Sheath Apparatus and Methods for Delivering a Closure Device,” which is assigned to the assignee of the present application (attorney docket no. 267/117). The disclosures of this application and any references cited therein are expressly incorporated herein by reference.
• Turning to FIGS.10A-D, theapparatus500 may be used to deliver theclip110 to close and/or seal an incision, puncture, orother passage592 that extends from a patient'sskin594, through interveningtissue596, and into awall598 of avessel590 or other body lumen. Alternatively, theapparatus500 may be used to deliver theclip110 to engage tissue in other procedures, e.g., to connect tissue segments together or otherwise to secure tissue structures with respect to one another. For example, theapparatus500 andclip110 may be used to attach an anastomosis during a bypass procedure. It will be appreciated by those skilled in the art that theclip110 and/orapparatus500 may be useful in a variety of procedures.
• As shown inFIG. 10A, thesheath552 may be inserted or otherwise positioned within thevessel590, i.e., through thepassage592. Thesheath552 may be advanced over a guidewire or other rail (not shown) previously positioned through thepassage592 into thevessel590 or advanced in conjunction with a pointed stylet directly through tissue using conventional procedures. Preferably, thevessel590 is a peripheral vessel, such as a femoral, radial, or carotid artery, although other body lumens may be accessed using thesheath552, as will be appreciated by those skilled in the art.
• Thepassage592, and consequently thesheath552, may be oriented at an angle “alpha” with respect to thevessel590, thereby facilitating introducing devices through thelumen560 of thesheath552 into thevessel590 with minimal risk of damage to thevessel590. One or more devices, such as a guide wire, a catheter, and the like (not shown), may be inserted through thesheath552 and advanced to a desired location within the patient's body. For example, the devices may be used to perform a therapeutic or diagnostic procedure, such as angioplasty, atherectomy, stent implantation, and the like, within the patient's vasculature.
• After the procedure is complete, any devices used during the procedure may be removed from thesheath552, and theobturator600 may be inserted into thelumen560. For example, theobturator600 may be part of an actuator assembly (not shown), and may be advanced through the lumen when the actuator assembly is attached to the proximal end of thesheath552. Alternatively, the actuator assembly andobturator600 may be coupled separately to thesheath552.
• When theobturator600 is fully inserted within thesheath552, thedistal portion616 of theobturator600 may extend beyond thedistal end564 of thesheath552. In an alternative embodiment, theobturator600 may be attached to an exterior surface (not shown) of thesheath552, for example, along a track, e.g., including cooperating slots, grooves, and the like (not shown) in thesheath552 andobturator600.
• Turning toFIG. 10B, theexpandable elements618 on the distal portion of theobturator600 may then be directed to their expanded configuration, for example, by activating a switch on the proximal end (not shown) of theobturator600. With thesheath552 andobturator600 coupled to one another, thesheath552 andobturator600 may be moved in conjunction with one another.
• As shown inFIG. 10C, thesheath552 may be partially withdrawn from thevessel590, until theexpandable elements618 contact thewall598 of thevessel590. Thus, theexpandable elements618 may provide a tactile indication of the position of thesheath552 with respect to thewall598 of thevessel590. In addition, theexpandable elements618 may assist in “presenting” thewall598 of thevessel590, e.g., for receiving theclip110.
• Generally, theclip110 is carried by thecarrier assembly554 before the procedure. Theclip110 may be constrained in its transverse configuration on thecarrier assembly554, and thecarrier assembly554 may be provided on or adjacent the proximal end of thesheath552. Because the tines, which may include primary andsecondary tines114,116 may be biased towards one another, thetines114,116 may slidably contact an inner surface (not shown) of thecarrier assembly554 or an outer surface of thesheath552, thereby constraining theclip110 in its transverse configuration.
• Turning toFIG. 10D, with thesheath552 properly positioned, thecarrier assembly554 may then be actuated, for example, to advance thecarrier assembly554 distally over thesheath552 to deliver theclip110. Preferably, thecarrier assembly554 may only be advanced a predetermined fixed distance relative to the distal end of thesheath552, and consequently, theexpandable elements618 of theobturator600, such that theclip110 substantially engages thewall598 of theblood vessel590. This predetermined distance may facilitate properly deploying theclip110 with respect to thewall598 of thevessel590, e.g., to prevent advancing theclip110 too far, i.e., into thevessel590.
• As theclip110 is deployed from thecarrier assembly554, theclip110 may be expanded to an enlarged diameter. For example, a distal end of thecarrier assembly554 may include a ramped region (not shown) that may deflect thetines114,116, and/or the body of theclip110 radially outwardly. As theclip110 is advanced over the ramped region, thetines114,116 may be deflected radially outwardly as they are being driven into the surrounding tissue, thereby engaging a larger region of tissue than if thetines114,116 had been maintained substantially axially.
• Alternatively, theclip110 may include expandable looped elements and/or spring elements (not shown), such as those described above, that may facilitate expanding theclip110 as it is deployed from thecarrier assembly554 and/or thesheath552. For example, the looped elements of theclip110 may be compressed when theclip110 is loaded into thecarrier assembly554, e.g., thereby allowing a relatively smallerprofile carrier assembly554 to be used. Theclip110 may automatically expand upon deployment from thecarrier assembly554 to engage a larger region of tissue surrounding the opening, such as anarteriotomy591 in thewall598 of the vessel590 (seeFIG. 11A).
• Once theclip110 is deployed entirely or otherwise released from thesheath552, theclip110 may resiliently move towards its substantially planar configuration, such as that shown inFIG. 1B.
• During delivery of theclip110, radiopaque markers (not shown) on theclip110, thecarrier assembly554, and/or theexpandable members618 may be monitored, e.g., using fluoroscopy, to facilitate observing and/or positioning theapparatus500. Thus, a relative position of theclip110 with respect to theexpandable elements618, and consequently to thewall598 of thevessel590, may be ascertained before theclip110 is deployed from thecarrier assembly554.
• Turning toFIGS. 11A and 11B, in a preferred embodiment, theexpandable elements618 of theobturator600 may be rotationally offset from the one ormore tines114 on theclip110. For example, if theclip110 includes primary tines (such as those shown inFIGS. 2A and 3), theobturator600 andclip110 may have a predetermined relative angular orientation about thecentral axis124. Preferably, theclip110 is loaded onto thecarrier assembly554 in a predetermined angular orientation and theobturator600 is receivable in thesheath552 only in a predetermined angular orientation that is offset such that thetines114,116 are out of axial alignment with theexpandable elements618, as shown inFIG. 11A.
• This predetermined rotational orientation may substantially minimize the possibility of theprimary tines114 contacting and/or damaging theexpandable elements618. For example, with particular reference toFIG. 11A, a preferred relative angular orientation of the clip100 andobturator600 is shown relative to anarteriotomy591 in thewall598 of thevessel590. Here, theexpandable elements618 are oriented to crisscross diagonally thearteriotomy591 within the interior of thevessel590. Generally, because of the natural structure of the tissue in the wall of a vessel, an arteriotomy generally tends to adopt an elongate shape that extends transversely to the direction of flow (i.e., across the circumference of the vessel wall).
• Theprimary tines114 are oriented such that theprimary tines114 pierce thewall598 of thevessel590 on either side of thearteriotomy591, as shown. With theexpandable elements618 crisscrossing diagonally, risk of contact with theprimary tines114 is substantially reduced. Thus, theprimary tines114 may be sufficiently long to extend entirely through thewall598 of thevessel590 while avoiding theexpandable elements618.
• Theexpandable elements618 may then be collapsed and/or withdrawn into thedistal end564 of thesheath552. As theclip110 is released entirely from thesheath552, theprimary tines114 may partially overlap, as shown inFIG. 11B, thereby pulling thearteriotomy591 closed, similar to a single-thread suture. For example, theexpandable elements618 may be automatically collapsed immediately before or after theclip110 is deployed from thecarrier assembly554 or when thecarrier assembly554 reaches its extreme distal position. Preferably, thedistal portion616 of theobturator600 is collapsed and retracted into thesheath554 after theprimary tines114 have pierced thewall598 of thevessel590, but before theclip110 is entirely released from thesheath552.
• In addition, if theclip110 includes secondary tines116 (such as those shown inFIG. 2A), thesecondary tines116 may partially penetrate thewall598 of thevessel590 during deployment of theclip110. Preferably, the lengths of thesecondary tines116 are relatively short or stop members (not shown) may be provided that prevent thesecondary tines116 from piercing entirely through thewall598. When theclip110 is released, thesecondary tines116 may pull the tissue inwardly, behaving somewhat similarly to a purse-string suture, to enhance closing thearteriotomy591.
• Once theclip110 is successfully deployed into thewall598 of thevessel590, e.g., on either side of anarteriotomy591, theapparatus500 may be withdrawn from thepassage592. Theentire apparatus500 may be removed in one step, or alternatively, theobturator600 may first be withdrawn from thesheath552 before withdrawing thesheath552, thereby leaving theclip110 in place to close thearteriotomy591 and/or seal thepassage592. In addition, if desired, a sealant or other material may be introduced into thepassage592 in conjunction with or separate from delivery of theclip110 to further seal thepassage592, as is known to those skilled in the art.
• While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims.

Claims (24)

1. A tissue engaging device, comprising:

a plurality of curved elements defining a first curved region and a second curved region, said curved elements connected to one another thereby defining an offset pattern; and

at least one tine extending from one of the curved elements defining the first curved region.

2. The device ofclaim 1, further comprising a second tine, wherein said second tine has a length greater than said first tine.

3. The device ofclaim 1, wherein said plurality of curved elements are formed as a unitary member from a single sheet of material.

4. The device ofclaim 3, wherein said closure device is made by chemical etching said material.

5. The device ofclaim 3, wherein said closure device is made by stamping said material.

6. The device ofclaim 1, wherein at least one tine has a first thickness, a second thickness, wherein a transition section defines the two thicknesses.

7. The device ofclaim 1, further comprising a plurality of tines, said tines extending from said first curved region.

8. The device ofclaim 7, wherein said plurality of tines extend from said first curved region in an alternating pattern.

9. The device ofclaim 8, wherein at least two tines have a length greater than the others.

10. The device ofclaim 1, further comprises a radiopaque coating disposed on at least one side of the plurality of curved elements.

11. The device ofclaim 1, further comprising at least one radiopaque marker associated with at least one of the curved elements.

12. The device ofclaim 1, wherein the plurality of curved elements define a generally planar surface, wherein said generally planer surface is movable towards a transverse configuration extending out of the plane.

13. The device ofclaim 12, wherein the plurality of curved elements are biased towards the planar configuration.

14. The device ofclaim 8, wherein adjacent tines have at least one first curved region disposed between them.

15. The device ofclaim 10, wherein the radiopaque coating is chosen from the group consisting of gold, tantalum, platinum, platinum/iridium.

16. A tissue engaging device, the tissue engaging device comprising:

a plurality of curved elements having a first surface and a second surface defining a plane, wherein the plurality of curved elements define a first curved region and a second curved region, said curved elements coupled to one another and defining an offset pattern; and

at least one tine extending from one of curved elements defining the first curved region.

17. The device ofclaim 16, further comprising a beneficial agent disposed upon at least one surface.

18. The device ofclaim 17, wherein the beneficial agent enhances hemostasis.

19. The device ofclaim 17, wherein the beneficial agent is a synthetic peptide.

20. The device ofclaim 16, wherein a second beneficial agent is disposed upon said second surface.

21. The device ofclaim 20, wherein said first and second beneficial agents are similar.

22. The device ofclaim 20, wherein said first and second beneficial agents are dissimilar.

23. The device ofclaim 16, wherein said plurality of curved elements are biased towards said planar configuration.

24. The device ofclaim 23, wherein said plurality of curved elements is movable between said generally planar configuration and a generally cylindrical configuration.

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