Abstract:
An implant for closing an arteriotomy includes a head having a proximal surface and a distal surface. A tapered plug extends from the distal surface of the head. A plurality of prongs also extends from the distal surface of the head. Upon implantation, the distal surface of the head faces an outside surface of the vessel wall, the tapered plug is disposed within the passage, and the prongs are disposed in tissue of the vessel wall surrounding the passage. The prongs may include a barb to assist in embedding the prongs in the tissue surrounding the puncture. The implant may be bioabsorbable.

Description:
FIELD OF THE INVENTION 
       [0001]    The present disclosure relates to a device and method for closing an opening in a vessel wall after a medical procedure, and in particular, to a device and method for closing a puncture arteriotomy after an intra-luminal procedure such as catheterization. 
       BACKGROUND OF THE INVENTION 
       [0002]    Catheters and catheterization procedures for diagnosis or treatment of cardiovascular and/or peripheral vascular diseases are well known, and typically involve the Seldinger technique to make insertions through layers of tissue and through a wall of the femoral artery. After a diagnostic or interventional catheterization, the arteriotomy puncture formed by the catheter or introducer sheath must be closed. The puncture opening in the artery typically ranges from 5 French (0.0655 inch, 1.67 mm) such as for a diagnostic angiography procedure to as large as 30 French (0.393 inch, 10.00 mm) for an interventional procedure such as implanting an inferior vena cava (IVC) filter. Traditionally, intense pressure has been applied to the puncture site for at least 30-45 minutes after removal of the catheter. Patients who have had a femoral artery puncture are then required to remain at bed rest, essentially motionless and often with a heavy sandbag placed on their upper legs, for several hours to ensure that the bleeding has stopped. 
         [0003]    Other proposed methods or devices for sealing vascular punctures include the use of a biodegradable plugs, percutaneous suturing devices, staples and surgical clips, and skin seals. However, there is still a need for a more effective method and device for sealing punctures or other passages through tissue, e.g., an opening into a blood vessel. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    An implant for sealing a passage through a vessel wall is presented. The implant includes a head having a proximal surface and a distal surface. A tapered plug extends from the distal surface of the head. A plurality of prongs also extends from the distal surface of the head. Upon implantation, the distal surface of the head faces an outside surface of the vessel wall, the tapered plug is disposed within the passage, and the prongs are disposed in tissue of the vessel wall surrounding the passage. The prongs may include a barb to assist in embedding the prongs in the tissue surrounding the puncture. The tapered plug is larger near the distal surface of the head and smaller as the prong extends distally away from the head. The tapered plug may include a proximal end that is generally oblong in shape and a distal end that is generally circular in shape. The implant may be bioabsorbable. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0005]    The foregoing and other features and advantages of the present disclosure will be apparent from the following description of the disclosure as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the disclosure and to enable a person skilled in the pertinent art to make and use the disclosure. The drawings are not to scale. 
           [0006]      FIG. 1  is top perspective view of an implant in accordance with an embodiment of the present invention. 
           [0007]      FIG. 2  is bottom perspective view of the implant of  FIG. 1 . 
           [0008]      FIG. 3  is another bottom perspective view of the implant of  FIG. 1 . 
           [0009]      FIG. 4  is a side, partial cut-away view of delivery device in accordance with an embodiment of the present invention. 
           [0010]      FIG. 5  is cut-away view of an embodiment of a handle of the delivery device of  FIG. 4 . 
           [0011]      FIG. 6  is a perspective view of an embodiment of a retention mechanism of the delivery device of  FIG. 4  in the undeployed position. 
           [0012]      FIG. 7  is a perspective view of the retention mechanism of  FIG. 6  in the deployed position. 
           [0013]      FIG. 8  is perspective view of the retention mechanism of  FIG. 6  nested within an embodiment of a forward cam follower of the delivery device of  FIG. 4 . 
           [0014]      FIG. 9  is perspective view of an embodiment of a slide component disposed on the retention mechanism of  FIG. 8 . 
           [0015]      FIG. 10  is side, partial cut-away view of the delivery device of  FIG. 4  mated with a sheath. 
           [0016]      FIG. 11  is a perspective view of the delivery device of  FIG. 4  and the sheath of  FIG. 10  delivered to a vessel. 
           [0017]      FIG. 12  is a perspective view of an embodiment of retention feet of the delivery device of  FIG. 4  with the retention feet deployed inside a vessel. 
           [0018]      FIG. 13  is a perspective, partial cut-away view of the delivery device of  FIG. 4  with the trigger of the handle rotated. 
           [0019]      FIGS. 14 and 15  are perspective views of the implant of  FIG. 1  being implanted in an arteriotomy. 
           [0020]      FIG. 16  is a perspective, partial cut-away view of the delivery device of  FIG. 4  with the trigger rotated more than in  FIG. 13 . 
           [0021]      FIG. 17  is a perspective view of the retention feet being undeployed. 
           [0022]      FIG. 18  is a perspective view of the retention feet completely undeployed. 
           [0023]      FIG. 19  is a perspective view of the implant of  FIG. 1  implanted into an arteriotomy after the delivery device has been withdrawn. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    Specific embodiments of the present disclosure are now described with reference to the figures, where like reference numbers indicate identical or functionally similar elements. The present disclosure is directed to a vascular closure implant and a method for closing an arteriotomy using such a vascular closure implant after a medical procedure in which a blood vessel wall was punctured to gain access to the vessel lumen. 
         [0025]      FIGS. 1-3  show perspective views of a vascular closure implant  100  in accordance with an embodiment of the present invention. Implant  100  includes a head  102  and a tapered plug  104 . Head  102  is generally shaped like a disc or button and includes a proximally facing surface  106  and an opposite, distally facing surface  112 . Tapered plug  104  extends from distally facing surface  112 . Tapered plug  104  can be unitary with head  102 , or may be a separate piece attached to head  102  by techniques such as insert molding, adhesive bonding, solvent bonding, or melt bonding, e.g. ultrasonic welding, vibration welding or spin welding. Tapered plug  104  includes a proximal end  118  adjoining distally facing surface  112  of head  102 , a distal end  116 , and a generally conical surface  120  disposed there between. In the embodiment shown in  FIGS. 1-3 , proximal end  118  is generally oblong or elliptically shaped and distal end  116  is generally circular in shape, with surface  120  being tapered there between. In an alternative embodiment (not shown), plug proximal end  118  is generally circular. 
         [0026]    Implant  100  further includes a plurality of prongs  108  extending generally in the distal direction from head  102 . In the embodiment shown in  FIGS. 1-3 , implant  100  includes four prongs  108  spaced equally around head  102 . Prongs  108  may be oriented generally orthogonally from head distal surface  112  or splayed to pierce the vessel wall somewhat farther from the arteriotomy and to thereby encompass more arterial tissue. Each prong  108  includes a pointed tip  122  and a barb  114 . Barbs  114  aid in grasping tissue of a vessel wall when implanted in a vessel. As will be understood by those of skill in the art, prongs  108  may number two, three, four, or more. Prongs  108  can be unitary with head  102 , or may be separate pieces attached to head  102 . Prongs  108  can be of the same or different lengths, and may be shorter, longer, or the same length as tapered plug  104 . In one embodiment, prongs  108  are short enough to pierce the vessel wall without entering the lumen of the blood vessel where prong tips  122  could be potential sites for thrombus formation. 
         [0027]    Head  102  of implant  100  may also include slots  110  on opposite sides thereof. Slots  110  are essentially cut-outs or notches where the continuous circular shape of head  102  is interrupted, but it is understood that slots  110  need not be cut-out of head  102 , but instead may be formed in head  102  when head  102  is formed. Slots  102  may be semi-circular in shape and are sized and shaped to allow retention wires (described in more detail below) to pass there through. As best seen in  FIG. 3 , the long axis of the oblong shaped proximal end  118  of plug  104  extends in a direction generally orthogonal to an axis extending between slots  110 . In an alternative embodiment, slots  110  may be aligned with the long axis of the oblong shaped proximal end  118  of plug  104  (not shown). 
         [0028]    Implant  100  may be made of biocompatible metallic or polymeric materials. Prongs  108  are made of a rigid material so that they can pierce the tissue surrounding an arteriotomy. Head  102  and plug  104  may be made of either rigid or semi-rigid materials. In embodiments where head  102 , tapered plug  104  and/or prongs  108  are made as separate pieces, as described above, the components may be made of the same or dissimilar materials. In one example, implant  100  may comprise unitary head and prongs  102 ,  108  made of biocompatible metal by techniques such as stamping, casting or metal-injection-molding (MIM) and plug  104  may be made of a biocompatible polymer and attached to head  102  by suitable techniques that may be selected from the methods described above. 
         [0029]    Biocompatible metals suitable for use in implant  110  include stainless steel 316L, stainless steel 316 LVM, titanium or bioabsorbable magnesium, which is absorbed by a patient&#39;s body as the arteriotomy into which implant  100  is inserted heals. Biocompatible non-resorbable polymeric materials suitable for use in implant  110  may include polymethylmethacrylate (PMMA), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). Implant  100  is preferably made as a unitary construction of a rigid implant grade bioabsorbable polymer material such that implant  100  is absorbed by a patient&#39;s body as the arteriotomy into which implant  100  is inserted heals. For example, and not by way of limitation, implant  100  may be made from polyglycolic acid (PGA), polylactic acid (PLA), alloys or blends of PGA and PLA, alloys or blends of PGA and tri-methyl carbonate, and alloys or blends of PLA and tri-methyl carbonate. 
         [0030]      FIGS. 4-9  illustrate an embodiment of a device for delivering and implanting an implant such as implant  100  to an arteriotomy in a vessel following an intra-luminal procedure. In particular,  FIG. 4  illustrates a cut-away view of a delivery device  400 . Delivery device  400  includes a handle  402 , a push rod  404 , and retention feet  416 . Implant  100  is disposed at a distal end of push rod  404 . 
         [0031]    Handle  402  is shown in greater detail in  FIG. 5 . Handle  402  includes a trigger  412 , a cam gear  406 , a rear cam follower  410 , and a front cam follower  408 . Trigger  412  includes a handle  418 , pivot point  420 , and a rack  422 . Rack  422  includes teeth that engage teeth of cam gear  406 . Trigger  412  further includes a rear arm projection  414 . Cam gear  406  is disposed between rear cam follower  410  and front cam follower  408  such that rotation of cam gear  406  translates into linear motion of rear cam follower  410  and/or front cam follower  408 . 
         [0032]      FIGS. 6 and 7  illustrate a retention mechanism  600 . Retention mechanism  600  includes a tube holder component  602 , a wire holder component  604 , and retention feet  416 . Retention feet  416  each include a tube  606  and a wire  608  disposed within tube  606 . Wire  608  is slidable within tube  606 , although a distal portion of wire  608  is coupled to a distal portion of tube  606  to deploy retention feet  416 , as described in more detail below. Wire  608  is looped through a slot  610  in wire holder component  604 . Wire holder component  604  is moveable within a slot  612  through tube holder component  602 . A distal portion  614  of tube holder  608  holds tubes  606 . Tube holder component  602  further includes an extension  614  extending downward from a proximal end of tube holder component  602 .  FIG. 6  illustrates wire holder component  604  in a distal position corresponding to the retention feet  416  in an undeployed position in which retention feet  416  are generally straight, as shown in  FIGS. 11 and 18 .  FIG. 7  illustrates wire holder component  604  in a proximal position corresponding to retention feet  416  in a deployed position in which retention feet  416  include a portion that is disposed generally transverse to the longitudinal axis of retention feet  416 , as shown in  FIGS. 12 ,  14 , and  15 . 
         [0033]      FIG. 8  illustrates retention mechanism  600  nested within front cam follower  408  such that there may be relative linear movement between front cam follower  408  and retention mechanism  600 , particularly wire holder component  604 . Front cam follower  408  includes a surface  802  facing retention mechanism  600 . A slide component  900  is coupled to wire holder component  604  of retention mechanism  600 , as shown in  FIG. 9 , to allow for manual movement of wire holder component  604 . Slide component  900  includes a lever  902  extending vertically substantially orthogonal from a distal end  906  of slide component  900 . Slide component  900  further includes a rear extension  904  extending horizontally substantially orthogonal from a proximal end  908  of slide component  900 . Front cam follower  408 , with retention mechanism  600  nested therein and slide component  900  coupled to retention mechanism  600 , is disposed within handle  402 , as shown in  FIG. 4 . Lever  902  extends through an opening in the handle housing for access by the clinician, as shown in  FIGS. 4 and 10 . 
         [0034]      FIGS. 10-19  illustrate an embodiment of a method for delivering and implanting an implant such as implant  100  to an arteriotomy in a vessel following an intra-luminal procedure, using the delivery device  400  described with above. Delivery device  400 , with implant  100  disposed at a distal end of push rod  404 , is inserted into an introducer sheath  1004 , as shown in  FIG. 10 . A coupling device  1002  disposed a proximal end of introducer sheath  1004  snap-fits with a distal end of handle  402 . Introducer sheath  1004  may be a procedural sheath used for the intra-luminal procedure such as catheterization, or the procedural sheath may be exchanged for introducer sheath  1004  following the intra-luminal procedure. In either situation, sheath  1004  provides access through a tissue track (not shown) to an arteriotomy  1108  through a wall  1106  in a vessel  1102 , as shown in  FIG. 11 . Sheath  1004  is already disposed in arteriotomy  1108 , and push rod  404  and retention feet  416  of delivery device  400  are inserted through sheath  1004  to access lumen  1104  of vessel  1102 . Sheath  1004  may be, for example, an 8 French sheath. 
         [0035]    Lever  902  is then actuated proximally, as shown in  FIG. 11 . Actuating lever  902  proximally slides wire holder component  604  proximally, resulting in the position shown in  FIG. 7 . With wire holder component  604  in the proximal position, retention feet  416  are deployed. Retention feet  416  may be deployed, for example, by including slits in tube  606  and fixing wire  604  to tube  606  distally of the slits. When wire  604  is drawn proximally, tube  606  compresses and buckles at the slits, as described, for example, in U.S. Pat. No. 6,767,356 to Kanner et al., the entirety of which is incorporated by reference herein. Other methods and devices to deploy retention feet may be utilized, as would be apparent to one of ordinary skill in the art. 
         [0036]    Upon deployment of retention feet  416 , the clinician manually retracts the entire assembly (i.e., handle  402 , push rod  404 , retention feet  416 , implant  100 , and sheath  1004 ) until tactile feedback is felt, signifying retraction of introducer  1004  from vessel  1102 , as well as contact of deployed retention feet  416  with an inside surface of vessel wall  1106 . 
         [0037]    Trigger  412  of handle  402  is then actuated to deliver implant  100  and to advance and undeploy retention feet  416  for removal. In particular, trigger  412  is pulled proximally, resulting in counter-clockwise rotation of cam gear  406 . At a prescribed stage of trigger  412  rotation, for example, 25 degrees, as shown in  FIG. 13 , cam gear  406  rotates such that a surface thereof contacts front cam follower  408 . Forward (i.e. distal) translation of front cam follower  408  causes implant  100  to be moved distally. Further, front cam follower  408  moves relative to retention mechanism  600  until surface  802  of front cam follower  408  contacts retention mechanism  600 , thereby initiating distal advancement of retention mechanism  600 . 
         [0038]    Continued rotation of trigger  412  causes continued translation of implant  100  so that tapered plug  104  is fully pushed into the arteriotomy  1108  and arteriotomy  1108  conforms to the oblong shaped proximal end  118  of tapered plug  104 . Further, prongs  108  pierce the tissue of the vessel wall  1106  and barbs  114  are submerged in the tissue such that implant  100  is securely anchored in place. At this point, distally facing surface  112  of head  102  is in intimate contact with vessel wall  1106 , as shown in  FIGS. 14 and 15 . 
         [0039]    Referring to  FIG. 16 , after implant  100  is anchored in place, at another prescribed stage of rotation of trigger  412  (e.g. approximately 30 degrees), extension  614  of tube holder component  602  abuts an internal surface in handle  402 . Such contact stops tube holder component from moving distally. Further, cam gear  406  begins to clear forward cam follower  408  and rear arm projection  414  of trigger  412  abuts rear extension  904  of slide component  900 . As trigger  412  continues to be rotated, tube holder component  602  stops translating distally while rear arm projection  414  continues to translate wire holder component  604  distally. Such motion causes retention mechanism  600  to move from the position shown in  FIG. 7  with wire holder  604  in the proximal position corresponding to retention feet  416  in the deployed position, to the position shown in  FIG. 6  with wire holder component  604  in the distal position corresponding to the retention feet  416  in the undeployed position.  FIG. 17  illustrates retention feet  416  as they start to undeploy and  FIG. 18  shows retention feet  416  in the undeployed, straightened position. 
         [0040]    After implant  100  is secured in place and retention feet  416  are in the undeployed, straightened position, delivery device  400  is withdrawn proximally such that retention feet  416  exit vessel  1102  through slots  110  in implant  100 , leaving implant  100  in place in vessel  1103 , as shown in  FIG. 19 . 
         [0041]    While various embodiments of the present disclosure have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the disclosure. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. For example, and not by way of limitation, the implant described in FIGS.  1 - 3  can be implanted using a delivery device and method other than the delivery device and method described with respect to  FIGS. 4-19 . Similarly, the delivery device and method described with respect to  FIGS. 5-19  can be used to deliver an implant different than the one described with respect to  FIGS. 1-3 . All patents and publications discussed herein are incorporated by reference herein in their entirety.