CLOSURE DEVICES AND RELATED SYSTEMS AND METHODS

CLOSURE DEVICES AND RELATED SYSTEMS AND METHODS

TECHNICAL FIELD

The present disclosure relates generally to devices, systems, and methods for closing openings through tissue, and more particularly for closing an opening in a blood vessel or other vessel formed during a diagnostic, therapeutic, or other such procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0002] The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:

FIG. 1 is a perspective view of an embodiment of a clip shown in an extended orientation;

FIG. 2 is an upper perspective view of the clip of FIG. 1 shown in a contracted orientation;

FIG. 3 is a lower perspective view of the clip of FIG. 1 shown in the contracted orientation;

FIG. 4 is an exploded perspective view of an embodiment of a delivery system that is configured to couple the clip of FIG. 1 with a vessel;

[0007] FIG. 5A is a perspective view of the delivery system in an early stage of delivering the clip to a vessel, wherein the delivery system is being advanced over a guide wire and through a sheath;

FIG. 5B is a perspective view of the delivery system in an alternative early stage of delivering the clip, wherein no sheath is used;

FIG. 5C is a partial cross-sectional view of another alternative early stage of delivering the clip, taken along the view line 5C-5C in FIG. 5B, in which the delivery system is at a non-orthogonal angle relative to a longitudinal axis of the vessel;

FIG. 6A is a perspective view of the delivery system in a subsequent stage of delivering the clip in which a clamp tube is advanced toward an anvil so as to clamp a portion of a vessel wall;

FIG. 6B is a partial cross-sectional view of the clip delivery stage shown in FIG. 6A taken along the view line 6B-6B in FIG. 6A; FIG. 7A is a perspective view of the delivery system in a subsequent stage of delivering the clip in which a carrier assembly is advanced distally so as to advance the clip over a portion of the vessel wall;

FIG. 7B is a partial cross-sectional view of the clip delivery stage shown in FIG. 7A taken along the view line 7B-7B in FIG. 7A;

FIG. 7C is an enlarged view of a portion of the partial cross-sectional view of FIG. 7B taken along the view line 7C-7C in FIG. 7B;

FIG. 8A is a perspective view of the delivery system in a subsequent stage of delivering the clip in which the carrier assembly is retracted proximally so as to couple the clip with a portion of the vessel wall;

FIG. 8B is a cross-sectional view of the clip delivery stage shown in FIG. 8A taken along the view line 8B-8B in FIG. 8A;

FIG. 8C is an enlarged view of a portion of the partial cross-sectional view of FIG. 8B taken along the view line 8C-8C in FIG. 8B;

FIG. 9A is a perspective view of the delivery system in a subsequent stage of delivering the clip in which the carrier assembly is further retracted proximally so as to decouple the clip from the carrier assembly;

FIG. 9B is a cross-sectional view of the clip delivery stage shown in FIG. 9A taken along the view line 9B-9B in FIG. 9A;

FIG. 9C is an enlarged view of a portion of the partial cross-sectional view of FIG. 9B taken along the view line 9C-9C in FIG. 9B;

FIG. 10A is a perspective view of the delivery system in a subsequent stage of delivering the clip in which the clamp tube is retracted away from an anvil so as to release the previously clamped portion of the vessel wall;

[0022] FIG. 10B is a cross-sectional view of the clip delivery stage shown in FIG. 10A taken along the view line 10B-10B in FIG. 10A;

FIG. 10C is an enlarged view of a portion of the partial cross-sectional view of FIG. 10B taken along the view line 10C-10C in FIG. 10B;

[0024] FIG. 1 1 A is a perspective view of a clip in an extended orientation that has been coupled with a vessel wall;

FIG. 1 1 B is a perspective view of the clip that has moved to a constricted orientation so as to substantially close an opening in the vessel wall;

[0026] FIG. 12 is a perspective view of a stage of a medical procedure in which a clip has been attached to the vessel wall and is in an extended state, and in which an access device that has been inserted through both the clip and the opening in the vessel wall;

FIG. 13 is a perspective view of another embodiment of a clip that does not include openings that are configured for use with sutures, wherein the clip is shown in an extended orientation;

FIG. 14 is a perspective view of another embodiment of a clip that includes jaws that are formed from different pieces of material and are joined by rotatable hinge members, wherein the clip is shown in a constricted orientation; and

[0029] FIG. 15 is a perspective view of another embodiment of a clip in an extended orientation, wherein the clip is bowed relative to a longitudinal direction such that the clip can conform to a contour of a vessel wall.

DETAILED DESCRIPTION

[0030] Procedures in which a vessel or vessel are accessed can result in a hole or puncture site in a vessel wall. Known methods and devices for closing such holes and puncture sites can be problematic.

For example, certain standard 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, whether concurrently with or over 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 any of various devices into the vessel, while reducing trauma to the vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and/or introducer sheath may be removed, leaving an opening or 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. For example, a physician or other caretaker may need to apply pressure for an hour or more. The sealing procedure is also uncomfortable for the patient, and can require that the patient remain immobilized in an operating room, catheter lab, or holding area. In addition, a risk of hematoma exists, as bleeding may occur before hemostasis is achieved. While some prior art devices have been developed in response to these issues, they do not adequately address the problems and may introduce additional complications. For example, in assisting with the closure of an opening in a vessel wall, some prior art devices constrict the vessel wall at the closure region.

[0033] Certain embodiments disclosed herein can address, ameliorate, resolve, and/or eliminate one or more of the shortcomings of prior art procedures, as well as one or more of the shortcomings of the prior art devices. For example, in some embodiments, separate portions of a clip can be attached to opposing sides of an opening and then approximated to each other so as to substantially close the opening. The clip can thus, for example, reduce the amount of time spent after a medical procedure to achieve hemostasis at the site of the opening. In some embodiments, the clip can substantially close the opening by moving opposing sides of the opening in opposite longitudinal directions without constricting the vessel. For example, the clip can achieve the substantial closure of the opening without reducing a circumference of the vessel. Embodiments of the clip may be arced so as to conform to a transverse perimeter of the vessel.

As used herein, the term "substantially close" or "substantially closed" are broad terms that include situations of both complete closure, in which portions of a vessel are brought into contact so as to achieve a liquid-tight seal, and partial closure, in which portions of a vessel are brought into close proximity to each other and may contact or nearly contact each other, but may not form a liquid tight seal. For example, in some instances, portions of a blood vessel may be nearly touching, but may be slightly separated from each other so as to permit small amounts of blood to pass between them. In some embodiments, the clip may achieve only partial closure of the opening, but this partial closure may nevertheless provide a reduced period for achieving hemostasis at the opening. As further discussed below, in some embodiments, the clip may achieve complete or partial closure on its own. In other or further embodiments, sutures may be used with the clip to achieve and/or ensure complete or partial closure of an opening.

The present application discloses devices, systems, and methods for engaging tissue, such as to connect tissue segments together or to substantially close openings in the tissue, such as in a wall of a vessel. The term "vessel" is a broad term used in its ordinary sense that can include any hollow or walled organ or structure of a living organism, such as any suitable body lumen. As used herein, the term "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. The terms, a "body lumen," "vessel," and "blood vessel" may be used interchangeably, and each may refer to an elongated annular-shaped body inside a patient.

FIGS. 1 -3 depict an embodiment of a closure device or clip 10 that can be used for closing an opening through tissue, such as an incision, puncture, passage, etc. For example, the opening may be a puncture site through a wall of a blood vessel or other vessel. FIG. 1 depicts the closure device in an open, expanded, or extended state or configuration. FIGS. 2 and 3 depict the closure device in a closed, folded, doubled, or contracted state or configuration. In the illustrated embodiment, the clip 10 includes a first jaw 12a and a second jaw 12b that are substantially coplanar in the extended state and that are substantially parallel to each other in the contracted state. Other configurations are also possible. For example, in some embodiments, the jaws 12a, 12b are substantially coplanar when in the extended state and are substantially parallel to each other when in the contracted state.

[0037] In the illustrated embodiment, the first jaw 12a and the second jaw 12b each define an arc shape. The arc defined by either jaw 12a, 12b can conform to any suitable rounded profile, such as that of a circle, ellipse, parabola, or the like. In the illustrated embodiment, each jaw 12a, 12b is substantially semi-circular. The jaws 12a, 12b can define substantially the same arc shape, in some embodiments, although the arcs may be mirror images of each other. In the illustrated embodiment, the open ends of the arcs face toward each other when the clip 10 is in the extended state (FIG. 1 ) such that the clip 10 defines a generally annular shape, and the open ends of the arcs face in the same direction when the clip 10 is in the contracted state (FIGS. 2 and 3) such that the clip 10 defines a substantially open arc.

The clip comprises a base plate or base 30. A plurality of gripping members, engaging members, or teeth 16 extend from an interior edge of the base 30. The teeth 16 can extend radially inward from the base 30 toward a central axis AX that passes through a center of the clip 10. In the illustrated embodiment, the teeth 16 also extend longitudinally (e.g., upwardly) from the base in a direction parallel to the central axis AX, such that the teeth 16 are angled inwardly and away from the base 30. The teeth 16 may also be said to extend inwardly and transversely from the base 30, or generally out of a plane defined by the base 30.

[0039] The teeth 16 of each jaw 12a, 12b extend generally in the same longitudinal direction when the clip is in the extended state, and may be oriented towards one another when the clip 10 is in the contracted state. The teeth 16 of the first jaw 12a may be offset from the teeth 16 of the second jaw 12b such that the teeth 16 of the jaws 12a, 12b are interdigitated when the clip 10 is in the contracted state. The teeth 16 may otherwise be positioned asymmetrically with respect to the central axis AX.

The teeth 16 may include a variety of pointed tips 17, such as a bayonet tip, and in other or further embodiments, the tips 17 may include barbs (not shown) for penetrating or otherwise engaging tissue. For example, to increase the penetration ability of the clip 10 and/or to lower the insertion force for penetrating tissue, each tooth 16 may include a tapered edge (not shown) extending towards the tip 17 along one side of the tooth 16. In other embodiments, each tooth 16 may be provided with a tapered edge on each side of the tooth 16 extending towards the tip.

[0041] The clip 10 can include tissue stops 18 adjacent to one or more of the teeth 16. Each tissue stop 18 may be blunt, and may be generally defined by the wide or blunt edge of the base 30 from which the tooth 16 extends. During use, the tissue stops 18 may limit penetration of the respective teeth 16 into tissue by engaging with the tissue at a desired penetration distance. For example, when teeth 16 are driven into tissue, the teeth 16 may penetrate the tissue until the tissue stops 18 contact the tissue, whereupon the teeth 16 may be prevented from penetrating further into the tissue.

The clip 10 can include a pair of hinges 32 that allow the jaws 12a, 12b to transition from the extended state to the contracted state. Each jaw 12a, 12b can be connected to separate hinges 32 at opposite ends of the arc that it defines. The hinges 32 can comprise any suitable hinge structure, such as a flexible or otherwise deformable region of a unitary piece of material (as shown in FIGS 1 -3), or a rotatable hinge that connects separate pieces of material (see FIG. 14). In some embodiments, the hinges 32 provide a bias to the clip 10. For example, the hinges 32 may be biased toward the contracted (e.g., non-planar) orientation of FIGS. 2 and 3 and may be deformed to the extended (e.g., planar) orientation of FIG. 1 . The clip 10 may be constrained in the extended state for purposes of initial attachment to a vessel, as discussed further below. Accordingly, when a constraint on the clip 10 is released after the clip 10 has been attached to a vessel, the clip 10 may automatically fold towards the contracted state. Stated otherwise, the teeth 16 may be coupled with tissue around an opening in a vessel when the clip 10 is in the extended configuration, such as by gripping the tissue by penetrating or otherwise engaging it. When the clip 10 is released, the hinges 32 may cause the jaws to close or clench together to the contracted orientation, such that the teeth 16 move towards one another, thereby drawing together the engaged tissue and substantially closing the site of the opening, as discussed further below.

In some embodiments, a resilient force provided by the hinges 32 is sufficiently strong to move the jaws 12a, 12b into a sufficiently close proximity to each other that the clip 10 can automatically close an opening in a vessel once any constraint that is maintaining the clip 10 in the extended configuration is removed. In other or further embodiments, sutures may be used to assist in moving the jaws 12a, 12b together and/or in tightening a grip of the jaws 12a, 12b so as to seal closed the site of the opening. Accordingly, in some embodiments, the clip 10 includes suture openings 36 through which sutures can be received. In the illustrated embodiment, the suture openings are at least partially formed by protrusions 35 that extend radially outwardly from the base 30.

As previously discussed, each jaw 12a, 12b can be arc shaped, and each can have an apex 37a, 37b that is a point that is spaced furthest from the hinges 32. In the illustrated embodiment, when the clip 10 is in the extended orientation, the apexes 37a, 37b are diametrically opposite one another. The apexes 37a, 37b and the base 30 are positioned on a plane that extends through and is perpendicular to the central axis AX. When the clip 10 is in the contracted state, the apexes 37a, 37b and the base 30 are no longer coplanar. The apexes 37a, 37b are close to each other. In the illustrated embodiment, the apexes 37a, 37b are at the ends of outward protrusions 35. The hinges 32 can define an axis of rotation (not shown) about which the jaws 12a, 12b rotate when transitioning from the extended state to the contracted state. In the illustrated embodiment, the axis of rotation is perpendicular to the central axis AX.

In the illustrated embodiment, the clip 10 is integrally formed from a single sheet of material. Any suitable material is contemplated, such as for example a superelastic alloy (e.g., nickel-titanium alloy or "Nitinol"), titanium, or corrosion resistant steel. Portions of the sheet may be removed using any suitable method, such as laser cutting, chemical etching, photo chemical etching, stamping, using an electrical discharge machine (EDM), and the like, to form the clip 10. The teeth 16 may be sharpened to a point, i.e., tips may be formed on the teeth 16 using conventional methods, such as chemical etching, mechanical grinding, and the like. The teeth may be plastically deformed transversely from the first jaw 12a and second jaw 12b via any suitable method, such as by using mandrels. In some embodiments, the jaw 12a and jaw 12b may be made from a material that may elastically stretch due to forces induced on the clip when attached to a vessel, and that may allow the vessel wall to expand and contract under normally occurring pressure changes.

[0046] The clip 10 may be polished to a desired finish using any suitable method, such as electro-polishing, chemical etching, tumbling, sandblasting, sanding, and the like. Such polishing may perform various desirable functions, depending on the method used to form the clip 10. For example, 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.

As previously noted, the clip 10 can be formed from the sheet may be constrained the extended configuration, such as that described above, e.g., by loading the clip onto a mandrel or directly onto a delivery device. In other instances, the clip may be formed from a superelastic material, e.g., Nitinol, such that the clip may be resiliently deformed to the planar configuration and/or expanded state, yet may automatically attempt to resume its non-planar configuration and/or contracted state upon release from external forces. Any suitable process may be used to provide the desired shape memory properties to the clip 10. For example, in some instances, it can be desirable for the clip 10 to be biased toward the contracted state. For example, in some instances, the clip 10 may be configured to be in the expanded state at relatively low temperatures, and can be configured to be biased toward the contracted state when heated to a predetermined temperature (e.g., a temperature at or below body temperature). Accordingly, the clip 10 may be positioned in the expanded state when at room temperature and prior to placement in a patient, and may be biased toward the contracted state when implanted in a patient.

The clip 10 may be disposed in a planar configuration upon initial formation of the clip from a sheet of material. The material can be heat treated to bias the clip 10 to the contracted configuration. For example, the clip 10 may be formed from a shape memory material that may substantially recover the contracted 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.

[0049] By way of non-limiting example, in some embodiments, the hinges 32 are formed initially in the folded state, or stated otherwise, the clip 10 is placed initially in the folded configuration. With the clip 10 in the folded configuration, the clip 10 may be expanded, e.g., by applying forces to the hinges 32 and the jaws 12a, 12b to achieve a planar configuration, thereby expanding the hinges 32 to the expanded state. The clip 10 may then be heat treated, e.g., by heating the clip 10 to an austenitic state, to cause the hinges to "remember" the expanded state. It may also be desirable to further heat treat the clip 10 while it is in the expanded state so as to cause the clip 10 to "remember" and be biased towards the folded configuration. The clip 10 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 planar configuration. For example, in some instances, it may be desirable to load the cooled or cooling clip into a delivery system 100 (see FIG. 5A) in the expanded configuration. When the clip 10 is subsequently heated to a predetermined temperature (e.g., at or below body temperature), the material of which the clip 10 is formed may "remember" the folded configuration and be biased towards it or, if unrestrained, naturally move towards it.

The clip 10 may include one or more radiopaque markers or other markers visible using external imaging, such as fluoroscopy. For example, in some embodiments, the entire clip 10 may be coated with radiopaque material, which may be a high density material such as gold, platinum, platinum/iridium, and the like.

[0051] In other embodiments, the clip 10 may be partially coated with radiopaque material by using masking techniques. For example, the entire clip 10 may first be coated with radiopaque material. The clip 10 may then be masked at locations where the radiopaque coating is desired. For example, the hinges 32 of the clip 10 may be left unmasked during this process if it is desired to leave these elements uncoated by radiopaque material. This may be desirable, e.g., to prevent radiopaque material from adversely affecting their flexibility. The clip 10 may then be treated to remove the radiopaque material from the unmasked areas, in this example, the hinges 32. The masking may then be removed using conventional processes, leaving the rest of the clip 10 coated with radiopaque material.

The clip 10 may be coated with one or more substances that enhance healing of a blood vessel and/or hemostasis, e.g., by decreasing inflammatory response at the treatment site and/or increasing a rate of regeneration of endothelium on the interior surface of the vessel. In various embodiments, the clip 10 can include one or more materials or agents that provide antiseptic, antimicrobial, antibiotic, antiviral, antifungal, anti-infection, or other desirable properties, such as the ability to inhibit, decrease, or eliminate the growth of microorganisms at or near a surface of clip 10. For example, in various embodiments, the clip 10 can comprise one or more of silver, platinum, gold, zinc, iodine, phosphorus, bismuth, alexidine, 5- flurouracil, chlorhexidine, sulfadiazine, benzalkonium chloride, heparin, complexed heparin, benzalkonoium chloride, 2,3 dimercaptopropanol, ciprofloxacin, cosmocil, cyclodextrin, dicloxacillin, EDTA, EGTA, myeloperoxidase, eosinophil peroxidase, fusidic acid, hexyl bromide, triclosan, polymyxin B, isopropanol, minocycline rifampin, minocycline EDTA, octenidine, orthophenyl phenol, triclocarban, triclosan, cephazolin, clindamycin, dicloxacillin, fusidic acid, oxacillin, rifampin, antibodies, peptides, polypeptides, free fatty acids, and oxidative enzymes. 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, which could aid the hemostasis process in some instances.

Embodiments of the clip 10 can be attached to a vessel wall in any suitable manner. FIG. 4 illustrates one embodiment of a delivery assembly 100 that is suitable for use with some embodiments of the clip 10, and FIGS. 5A-1 1 B depict various stages of illustrative methods for implanting the clip 10.

[0054] With reference to FIG. 4, the delivery assembly 100 is suitable for deploying a clip 10 to substantially close an incision, puncture, other passage, or opening 52 that extends through a wall 51 of a vessel 50 (see FIG. 6B). The clip 10 and/or the delivery assembly 100 can be useful in a variety of medical procedures. For purposes of illustration, the following disclosure relates to the delivery of the clip 10 to a blood vessel.

The delivery assembly 100 includes an anvil assembly 120, a clamping assembly 138, and a carrier assembly 150 that are configured to translate relative to each other relative to a common longitudinal axis, but are constrained from rotating relative to each other about the longitudinal axis.

The anvil assembly 120 includes an anvil 1 10 that is fixedly attached to a pass-thru member, such as a pass-thru rod or pass-thru tube 129, which is fixedly mounted to a proximal handle 122 by adhesives or in any other suitable manner. The anvil 1 10 can include a pointed region or distal end 1 12 that is sized and shaped to facilitate insertion of the anvil 1 10 into a blood vessel. For example, in the illustrated embodiment, the distal end 1 12 is substantially conically shaped or tapered so as to facilitate substantially atraumatic introduction of the anvil 1 10 through a vessel wall. The anvil 1 10 can further include a clamping surface 1 1 1 that projects radially outwardly from a narrower proximal region of the anvil 1 10. A radially expanded portion of the anvil 1 10 that extends distally from the clamping surface 1 1 1 can define a series of recesses 1 14, which can be configured to receive the teeth 16 of the clip 10, as further discussed below.

The handle 122 can include a rod 124 that defines a hole or passage 126 that is sized to receive an alignment pin 123. An upper end of the rod 124 includes threading 125. The alignment pin 123 can define a passage 123 that is sized to receive the pass-thru tube 129. When the handle 122 is assembled, alignment pin 123 extends through the rod 124 and the pass-thru tube 129 extends through the alignment pin 123 such that the alignment pin 123 is maintained in fixed relation to the handle 122. Any other suitable arrangement of the anvil assembly 120 is contemplated.

The clamping assembly 128 is positioned over the anvil assembly 120. The clamping assembly 128 comprises a clamp member or clamp tube 130 that is slidably disposed around a proximal portion of the anvil 1 10 and a distal portion of the rod 124 of the handle 122. The clamp tube 130 defines one or more longitudinally extending alignment slots 137 that are configured to receive the alignment pin 123 and are configured to permit the clamp tube 130 to translate longitudinally relative to the anvil assembly 120 by a fixed amount. Only one alignment slot 137 is shown, but in the illustrated configuration, a second alignment slot 137 can be positioned diametrically opposite the illustrated alignment slot 137. Rotational alignment of the clamp tube 130 and the anvil 1 10 is maintained by the alignment pin 123 riding in the one or more alignment slots 137.

[0059] The clamping assembly 128 further includes a knob 134 that defines an inner cavity 136. A collar 132 is sized to capture a shoulder 133 that extends outwardly at a proximal end of the clamp tube 130. Both the collar 132 and the shoulder 133 are received into the cavity 136 of the knob 134. The collar 132 is fixed relative to the knob 134, but the clamp tube 130 is not fixedly attached to either the knob 134 or the collar 132 such that the knob 134 and the collar 132 can rotate freely relative to the clamp tube 130.

The knob 134 defines threads 135 that cooperate with the threads 125 of the handle 122 finely adjust a size of a gap between a distal end or clamping surface 131 of the clamping tube 130 and the clamping surface 1 1 1 of the anvil 1 10. Rotation of the knob 134 in one direction can advance the clamp tube 130 distally, and rotation of the knob 134 in the opposite can retract the clamp tube 130 proximally. The knob 134 can include any suitable gripping features to facilitate its rotation. For example, in the illustrated embodiment, the knob 134 includes longitudinally oriented striations.

The carrier assembly 150 is positioned over the clamp tube 130. The carrier assembly 150 includes a carrier tube 151 and a distal handle 161 that are fixedly attached to each other. The carrier tube 151 may also be referred to as a carrier member, and may have configurations other than tubular in some embodiments. Indeed, any of the tubular members discussed herein can have arrangements other than tubular. In the illustrated embodiment, the carrier tube 151 comprises a substantially cylindrical member that defines a series of resilient fingers or arms 152 at a distal end thereof. Each set of adjacent arms 152 defines a gap, opening, or channel 154. Interior surfaces of the arms 152 define a retention groove 153.

The resilient arms 152 are configured to retain the clip 10 in a releasable, temporary, or non-permanent manner. In the illustrated embodiment, the base 30 of the clip 10 is positioned in the retention groove 153, and the protrusions 35 of the clip 10 are positioned in the channels 154 that extend longitudinally between adjacent sets of arms 152 (see also FIG. 7C). The clip 10 can be loaded into the carrier tube 151 in the extended state. As previously discussed, and as discussed further below, in some embodiments the clip 10 is biased to the contracted state. Accordingly, the retention groove 153 can maintain the clip 10 in the extended state against the internal bias of the clip 10. Moreover, the clip 10 can be configured to move naturally toward the contracted state upon being released from the carrier tube 151 .

The carrier tube 151 can define one or more longitudinally extending alignment slots 157. The alignment slots 157 can be longer than the alignment slots 137 of the clamp tube 130 such that the carrier tube 151 can be configured to move relative to the anvil 1 10 by a greater amount than the clamp tube 130. The alignment slots 157 can receive the alignment pin 123 therein such that longitudinal movement between the carrier tube 151 and the clamp tube 130 and/or the anvil 1 10 is permitted but rotational movement between these components is prevented.

[0064] The distal handle 161 can receive the carrier tube 151 therein and can be fixedly attached thereto. In other embodiments, the carrier tube 151 and the distal handle 161 can be integrally formed of a single piece of material. The handle 161 can define one or more longitudinally extending alignment slots 167 that are the same size and shape as the alignment slots 157. In some embodiments, the alignment slots 167 can receive the alignment pin 123 therein.

[0065] The distal handle 161 can include any suitable gripping features that can assist in selectively moving the distal handle 161 away from and toward the proximal handle 122. In the illustrated embodiment, the distal handle 161 comprises gripping recesses 163, which can be sized and shaped to receive one or more portions of a thumb and an opposing finger (e.g., can be sized and shaped to receive finger pads). The carrier assembly 150 thus may be actuated from the proximal end of the assembly 100 by the handles 122, 161 so as to deploy the clip 10, as discussed further below.

The proximal handle 122 may be shaped to visually orient the deployment assembly 100 with the longitudinal direction of the vessel to control the orientation and deployment of the clip 10 relative to the vessel. In the illustrated embodiment, the proximal handle 122 is elongated in a direction that is parallel to a longitudinal axis of the subject vessel. For example, a first jaw 12a of the clip 10 may extend in a direction of one elongated portion of the handle 122, and second jaw 12b of the clip 10 may extend in a direction of the other elongated portion of the handle 122. Other arrangements of the handle 122 and other orientation features are also possible.

[0067] With reference to FIGS. 5A-5C, one or more medical access devices, such as a guide wire 60, a catheter (not shown), and the like, may be inserted through skin of a patient and through a wall 51 of a vessel 50 into an interior lumen of the vessel 50, and may be advanced to a desired location within the patient's body. The guide wire 60 and/or additional insertion devices can form an opening 52 in the wall of the vessel 50, which may desirably be closed upon completion of the medical procedure. The medical procedure may be of any suitable variety, such as a therapeutic or diagnostic procedure (e.g., angioplasty, atherectomy, stent implantation, mechanical heart assist device deployment, artificial heart valve replacement, and the like) within the patient's vasculature. The opening 52 desirably will attain adequate hemostasis before the patient is safely released from medical supervision. Use of the clip 10 can greatly reduce the amount of time in which adequate hemostasis of the opening 52 is achieved, as compared with the natural healing response (thrombus and clotting) to an unassisted opening.

[0068] In some embodiments, a medical procedure is performed before the delivery assembly 100 is used to deploy the clip 10. For example, the vasculature of the patient can be accessed and one or more medical devices inserted into the vessel 50, and thereafter the delivery assembly 100 is used. In other embodiments, the clip 10 is installed on the vessel 50 prior to insertion of other medical devices into the vessel, such that the other medical devices are inserted into the vessel through the clip 10.

FIG. 5A illustrates that in some embodiments, a guide wire 60 may be used in manners known in the art. In further embodiments, one or more dilators (not shown) and introducer sheaths may be used to create an access passage or pathway of a desired size to the vessel 50. In the illustrated embodiment, a sheath 170 may be used to advance the delivery assembly 100 to the vessel 50. The sheath 170 or accompanying devices (not shown) may include any suitable "bleed back" indicator that can permit a small amount of blood to flow from the vessel so as to indicate when the delivery assembly 100 is properly placed for deployment of the clip 10 (e.g., when the clamping surface of the anvil 1 10 is within the vessel). The sheath 170 may also include one or more seals (not shown), such as a hemostatic valve, at or near the proximal end that provides a fluid-tight seal with the delivery assembly 100, yet accommodates insertion of the delivery assembly 100 and/or one or more other devices into the vessel 50 without fluid passing proximally from the sheath 170.

As shown in FIG. 5B, in other embodiments, the sheath 170 may be removed, or may not be used at all. In FIGS. 5A and 5B (as well as FIGS. 6A-10B) the delivery assembly 100 is shown positioned normally to a longitudinal axis of the vessel. However, in many instances, a longitudinal axis of the delivery assembly 100 will in fact be at a non-orthogonal angle relative to the longitudinal axis of the vessel. Such an angled orientation can facilitate insertion of the anvil 1 10 into the vessel. It is noted that the vessel can be flexible so as to conform locally to the delivery assembly 100. Accordingly, the orthogonal orientations shown in the drawings are generally for illustrative purposes.

With reference to FIG. 5C, the delivery assembly 100 may be oriented at an angle a with respect to the vessel 50, which may reduce a risk of damaging the vessel 50 when a portion of the anvil 1 10 is introduced through the vessel wall 51 . Various anvil shapes and anvil materials and also mechanisms are contemplated to allow a portion of anvil assembly 1 10 to enter the vessel through opening 52. The distal tip 1 12 of the anvil 1 10 may be substantially soft and/or flexible such that the distal tip 1 12 may substantially atraumatically enter the vessel 50. The delivery assembly 100 may be guided over the guide wire 60 using any suitable technique so as to position a portion of anvil 1 10 inside of vessel 50. The vessel 50 may be a peripheral blood vessel, such as a femoral, radial, or carotid artery, although other blood vessels may be accessed.

FIGS. 6A and 6B show a portion of anvil 1 10 positioned inside the vessel 50 and the clamp tube 120 and carrier tube 150 advanced forward by rotation of the knob 134 so as to clamp the vessel wall 51 . In particular, as is best shown in FIG. 6B, the delivery assembly 100 is advanced over the guide wire 60 to insert a portion of the anvil 1 10 into the vessel 50, up until the clamping surface 1 1 1 is positioned inside of the vessel 50 and the clamping surface 131 of the clamp tube 120 remains outside of the vessel 50. Then the clamp tube 130 is driven forward to clamp or restrain a portion of the vessel wall 51 that is at the periphery of the opening 52. In particular, the vessel wall 51 is clamped between the clamping surface 131 of the clamp tube 130 and the clamping surface 1 1 1 of the anvil 1 10. Clamping the wall 51 of the vessel 50 can control or steady the wall 51 during initial phases of deploying the clip in which the teeth 16 are engaged with the wall 51 , as further discussed hereafter.

In the illustrated embodiment, as can be seen in FIG. 6B, the teeth 16 of the clip 10 may be in contact with an outer surface of the clamping tube 130 at the depicted stage of deployment (e.g., when the clip 10 is in a pre-delivery position). The teeth 16 may be resiliently deflected from their natural orientation such that they are flexed radially outward about the clamp tube 130. The teeth 16 thus may be under tension when they are positioned about the clamp tube 130.

[0074] FIGS. 7A-7C show the carrier tube 151 (and hence, the clip 10) being advanced distally relative to the handle 122 by manipulation of the handles 122, 161 . In particular, distally directed forces are applied to the recesses 163 of the handle 161 , as depicted by the bold arrow in FIG. 7A. The carrier tube 151 may be constrained to an end-of-stroke position by the alignment pin 123 in the alignment slots 157, 167, which can prevent the clip 10 from advancing too far over the anvil 1 10, and also can control an amount of tissue margin of the vessel wall 51 that extends between a perimeter of the opening 52 and the tips 17 of the teeth 16.

[0075] As shown in FIGS. 7B and 7C, the clip 10 is advanced distally beyond the distal end 131 of the of clamp tube 130. The teeth 16 of clip 10 may contract radially inward upon passing the end 131 of the clamp tube 130, as they are no longer maintained in their deflected state by the outer surface of the clamp tube 130. The clip 10 may be advanced further in the distal direction such that the teeth 16 are spaced from the distal end 131 of the clamp tube 130. The teeth 16 can extend about or encompass the anvil 1 10 and can contact an outer surface of the vessel wall 51 . The inwardly directed, resilient forces acting on the teeth 16 can cause them to initially engage the vessel wall 51 . In some embodiments, the recesses 1 14 in the anvil 1 10 are rotationally aligned with teeth 16, which can permit the teeth 16 to flex radially inward to a greater extent. Such an arrangement can facilitate control or relative fixation of the margin of the vessel wall 51 that extends from the perimeter of the opening 52 to the tips 17 of the teeth 16.

FIGS. 8A-8C show the carrier tube 151 being retracted in the proximal direction by proximally directed forces that are exerted on the recesses 163 of the handle 161 , as depicted by the bold arrow. As seen in FIGS. 8B and 8C, this retraction of the carrier tube 151 causes the tips 17 of the teeth 16 to be urged into the vessel wall 51 . In various embodiments, the teeth 16 may partially or totally penetrate vessel wall 51 . In the illustrated embodiment, the teeth 16 fully penetrate the vessel wall 51 , but they do not extend through an interior surface of the vessel wall 51 , although they may in other embodiments. Retraction of the carrier tube 151 causes the tips 17 to approximate or contact the clamping surface 131 of the clamp tube 130, thereby embedding the teeth 16 within the vessel wall 51 and fixing the clip 10 to the vessel wall 51 around the opening 52. As previously discussed, in some embodiments, serrations or barbs in the profile of the teeth 16 may assist in keeping the clip 10 engaged with the tissue that surrounds the opening 52. In some instances, the teeth 16 may puncture the vessel wall 51 or otherwise be introduced through an exterior surface of the vessel wall 51 without contacting the anvil 1 10 and/or the clamp tube 130.

The recesses 1 14 in the anvil 1 10 may assist with the penetration of the teeth 16 into the portion of the vessel wall 51 that is draped over the anvil 1 10. For example, the radially inward directed forces of the teeth 16 can urge the vessel wall 51 into the recesses 1 14, and can permit the tips 17 of the teeth 16 to move inwardly by a sufficient amount to be able to contact the distal surface 131 of the clamp tube 130.

FIGS. 9A-9C show the carrier tube 151 being further retracted (as depicted by the bold arrow in FIG. 9A) to cause the clip 10 to release from the arms 152 of carrier tube 151 . As previously discussed, the clip 10 is initially constrained in the extended state by the arms 152. However, as the carrier tube 151 is retracted, interference between the teeth 16 and the clamping surface 131 of the clamp tube 130 can cause the tips of the teeth to at least partially penetrate the vessel wall 51 , as previously discussed, and further, can resist proximal movement of the clip 10 as the carrier tube 151 is retracted further. Accordingly, the clip 10 can remain substantially fixed relative to the clamp tube 130 as the carrier tube 151 is withdrawn, thereby causing tapered surfaces 155 at the base of the retention groove 153 defined by the arms 152 (see FIG. 8C) to slide past the clip 10 and deflect the arms 152 outwardly. Outward deflection (e.g., radial spreading) of the arms 152 allows them to move proximally over the clip 10 and fully release or disengage from the clip 10.

In other embodiments, a slide tube (not shown) can be positioned at an exterior of the arms 152 of the carrier tube 151 . The arms 152 may be biased so as to naturally spring radially outwardly. The slide tube can constrain the arms 152 inwardly to an orientation such as that depicted in FIG. 8A, which can constrain the clip 10 to the extended orientation in a manner such as described above. Once the clip 10 has been attached to the vessel wall 51 as desired, the slide tube can be retracted proximally so as to release the arms 152. The arms 152 can spring outwardly, thereby releasing the edges of clip 10, and the carrier assembly 150 can then be fully retracted from the clip 10 to a position such as that depicted in FIG. 9A.

[0080] FIGS. 10A-10C illustrate the unclamping of the vessel wall 51 . In particular, the knob 134 can be rotated in an opposite direction so as to retract the clamp tube 130 from the anvil 1 10 and thereby release the vessel wall 51 . The full delivery assembly 100 can then be retracted from the vessel 50. The angled profiles of the teeth 16 and the recesses 1 14 of the anvil 1 10 can aid in centering the anvil 1 10 as it is removed from the vessel 50 through the clip 10.

As previously discussed, in some embodiments, the clip 10 may be biased to the contracted state. Accordingly, once the clamp tube 130 and/or the anvil 1 10 no longer restrain the clip 10 in the extended state, the clip 10 can automatically move to the contracted state so as to automatically substantially close the opening 52 in a manner such as discussed below. In other embodiments, the clip 10 may not be biased toward the contracted state and/or may only be able of partially moving toward the contracted state on its own. Accordingly, the clip 10 may be urged to the contracted state so as to substantially close the opening 52, such as by suturing (as discussed below) or other suitable methods.

FIG. 1 1A shows the clip 10 after it has been deployed about the opening 52 of vessel 50. In some embodiments, sutures 80 may extend through the suture openings 36 of the clip 10. In some embodiments, the sutures 80 may be present throughout the full deployment sequence described above, whereas in other embodiments, the sutures 80 may be introduced through suture openings 36 at any suitable stage during or after the deployment sequence.

With reference to FIG. 1 1 B, the sutures 80 can assist in closing the site of the opening 52 (e.g., in transitioning the clip 10 to the contracted state) and/or in maintaining the site of the opening 52 closed. For example, in some embodiments, the clip 10 may not be biased to the contracted state such that the sutures 80 cause the clip 10 to transition to the contracted state. In other embodiments, the clip 10 may automatically transition to the contracted state. However, in certain of such embodiments, the clip 10 may not completely seal the opening 52 on its own and the sutures 80 may be used to provide additional aid in closing the opening 52. The sutures 80 may be tied off and excess suture material can be removed in any suitable manner. Knots 81 may be used to tie off the sutures 80. The sutures 80 may be tied remotely outside the skin of the patient and the knots 81 can then be advanced down to the proximity of the clip 10 device by suturing techniques known to those skilled in the art. In the illustrated embodiment when the sutures 80 are tied off, no portion of them extends into or through the vessel wall 51 .

[0084] Each suturing site, which can include a pair of suture openings from the respective jaws 12a, 12b, can be referred to as a pinch point of the clip 10. Any suitable number of pinch points may be used. In the illustrated embodiment, the clip 10 includes three pinch points. Various embodiments may include one or more, two or more, three or more, four or more, or five or more pinch points. The pinch points can be distributed about a periphery of the vessel wall 51 .

With reference again to FIG. 1 1A, the first and second jaws 12a, 12b of the clip 10 can encompass the opening 52 when the clip 10 is originally attached to the vessel 50. The clip 10 can be in the extended state such that the first jaw 12a projects in one longitudinal direction and the second jaw 12b projects in another longitudinal direction. With reference to FIG. 1 1 B, as the clip 10 transitions to the contracted state, portions of the vessel wall 51 are moved in opposite longitudinal directions, as depicted by the bold arrows. Accordingly, a portion of the vessel wall 51 that defines one side of the opening 52 and that is attached to the first jaw 12a is brought into proximity with an opposing portion of the vessel wall 51 that defines an opposite side of the opening 52 and is that is attached to the second jaw 12b. The opposing sides of the vessel wall 51 (or stated otherwise, the opposing sides of the opening 52) are pinched between the jaws 12a, 12b. The amount of pinching or closing force provided by the jaws 12a, 12b and/or the sutures 80 can determine an extent to which the opening 52 is sealed. In some embodiments, the amount of closing force can be sufficient to achieve an liquid-tight seal between the opposing sides of the vessel wall 51 prior to initial healing stages of the vessel wall.

[0086] Stated another way, comparison of FIGS 1 1 A and 1 1 B shows that the first and second jaws 12a, 12b can extend parallel to a longitudinal axis defined by the vessel 50 when the jaws 12a, 12b are in the extended state. A first point on the first jaw 12a, such as the apex 37a, is opposite from a second point on the second jaw 12b, such as the apex 37b, along a line that is parallel to the longitudinal axis of the vessel 50. When the clip 10 transitions to the contracted state, the first point 37a is brought closer to the second point 37b so as to the move the opposing sides of the opening 52 toward each other in a longitudinal direction.

As the clip 10 transitions to the contracted state, the jaws 12a, 12b can rotate relative to each other. The clip 10 can be attached to the vessel 50 such that the hinges 32 are transverse to a longitudinal direction defined by the vessel. An axis of rotation defined by each hinge 32 can be transverse to a longitudinal axis (e.g., orthogonal to, if it intersects the longitudinal axis) that is defined by the vessel 50.

As can be understood from FIG. 10C, in the illustrated embodiment, the teeth 16 do not extend to an interior surface of the vessel wall 51 . Accordingly, when the clip 10 is transitioned to the contracted state shown in FIG. 1 1 B, the teeth 16 may not extend into an interior lumen of the vessel and/or the tips of the teeth 16 may be fully embedded within the vessel wall 51 . However, in other embodiments, the portions of the teeth 16 may penetrate through an interior surface of the vessel wall 51 and/or may extend into an interior lumen of the vessel when the opening 52 has been closed. In either case, the base 30 of the clip 10 may remain at an exterior of the vessel 50 when the opening 52 has been closed.

As shown in FIG. 1 1 B, when the clip 10 is in the contracted state, the clip 10 define an arc that conforms to a transverse perimeter of the vessel 50. The transverse perimeter can be defined as the annular shape defined by a transverse cross-section through the vessel 50. Accordingly, the contracted clip 10 may not constrict the vessel 50, or stated otherwise, may not reduce a diameter of the vessel 50, due to the in shape between the clip 10 and the vessel wall 51 . The contracted clip 10 can extend about a portion of the transverse perimeter of the vessel 50. In various embodiments, the contracted clip 10 extends about no less than about 25, 30, 35, 40, 45, or 50 percent of a transverse perimeter of the vessel 50.

[0090] During delivery of the clip 10, radiopaque markers (not shown) on the clip 10, the carrier tube 150, and/or other members of delivery assembly 100 may be monitored, e.g., using fluoroscopy, to facilitate observing and/or positioning the clip 10. Thus, a relative position of the clip 1 10 with respect to the wall 51 of the vessel 50, may be ascertained before the clip 10 is deployed from the carrier assembly 150.

[0091] As previously mentioned, in some embodiments, a medical procedure is performed before the delivery assembly 100 is used to deploy the clip 10. For example, the vasculature of the patient can be accessed and one or more medical devices inserted into the vessel 50, and thereafter the delivery assembly 100 is used. In other embodiments, the clip 10 is installed on the vessel 50 prior to insertion of other medical devices into the vessel, such that the other medical devices are inserted into the vessel through the clip 10.

FIG. 12 depicts a situation in which an access device 190 is present when the clip 10 has been installed on the vessel 50. The access device 190 extends through the opening 52 and the clip 10. One or more medical devices (e.g., a catheter or a stent) may be inserted through the access device 190 and advanced to a desired location within the patient's body. For example, the medical devices may be used to perform a therapeutic or diagnostic procedure, such as angioplasty, atherectomy, stent implantation, mechanical heart assist device deployment, artificial heart valve replacement, and the like, within the patient's vasculature. After the access procedure is completed, the access device 190 may be removed and the clip 10 can transform to the closed configuration. Sutures 80 may also be left in-place during the access procedures for assistance in closing the clip 10 or maintaining a closed clip configuration.

FIG. 13 illustrates another embodiment of a clip 210, which can resemble the clip 10 described above in certain respects. Accordingly, like features are designated with like reference numerals, with the addition of a leading digit "2." Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the clip 10 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the clip 210. Any suitable combination of the features and variations of the same described with respect to the clip 10 can be employed with the clip 210, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

The clip 210 is shown in an extended state. The clip 210 includes a base 230 from which teeth 216 extend. The base 230 is substantially planar when in the extended state. Opposing jaws 212a, 212b are configured to rotate relative to each other about hinges 232. The clip 210 is strongly biased toward the contracted or closed orientation (such as that shown in FIGS. 2 and 3). The clip 210 is configured to substantially close an opening 52 in a vessel 50 without assistance from sutures. The clip 210 is devoid of suture openings, such as the suture openings 36 discussed above.

FIG. 14 illustrates another embodiment of a clip 310. The clip 310 includes a first jaw 312a and a second jaw 312b that are formed from separate pieces of material. The first and second jaws 312a, 312b are connected to each other by rotatable hinges 332. Each hinge 332 is formed from a cooperating pin 333 and socket 334. The pins 333 and sockets 334 are defined at opposing ends of the base 330 of each jaw 312a, 312b. In the illustrated embodiment, the clip 310 is not biased toward either the extended state or the contracted state. In other embodiments, the hinges 332 may provide a bias to the contracted state (e.g., the clip 10 may additionally include one or more biasing members, such as one or more springs). The illustrated embodiment includes suture openings, whereas other embodiments may not include suture openings.

FIG. 15 illustrates another embodiment of a clip 410 that is formed from a superelastic material. The clip 410 is shown in the extended state. The clip 410 includes a first jaw 412a and a second jaw 412b that are configured to rotate about hinges 432. The clip 410 defines a central axis AX that extends between the first and second jaws 412a, 412b, and further defines a longitudinal axis LONG that extends perpendicularly to the central axis AX. The first and second jaws 412a, 412b are bowed relative to the longitudinal axis. The radius of curvature of the bowed jaws 412a, 412 b can be configured to match a radius of curvature of a vessel wall 51 to which the clip 410 is to be attached. Accordingly, the clip 410 can define a non-planar configuration when in the extended state. The clip 410 can be "programmed" to be biased toward a contracted state, which can resemble the configurations shown in FIGS. 2 and 3. In other embodiments, the clip 410 includes suture openings, such as those described above with respect to FIGS. 1 -3. In the illustrated embodiment, the hinges 432 comprise flexible portions of a unitary piece of material. In other embodiments, the hinges 432 may resemble the hinges 332 of the clip 310.

It is again noted that while many of the examples provided herein relate to the use of clips with blood vessels, this method of disclosure is employed for the sake of convenience and efficiency, but should not be construed as limiting of the types of procedures with which embodiments may be used. Indeed, embodiments of the apparatus, methods, and systems disclosed herein can be used with vessels other than blood vessels, such as, for example, vessels within the gastrointestinal tract. Accordingly, the term "vessel" is a broad term that can include any hollow or walled organ or structure of a living organism.

It will be understood by those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles presented herein. For example, any suitable combination of various embodiments, or the features thereof, is contemplated.

[0099] Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification, such as by use of the terms "about" or "approximately." For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as "about," "substantially," and "generally" are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term "substantially planar" is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely planar orientation.

[00101] Reference throughout this specification to "one embodiment," "an embodiment," or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

[00103] The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. Recitation in the claims of the term "first" with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.