Abstract:
A vascular closure device used in closing openings in vessel walls while permitting post-operative flow through the vessel includes a housing, at least two tissue engaging members, and at least two jaw members. The tissue engaging members engage tissue portions on opposite sides of the vessel opening and move tissue to a desired, predetermined position. The jaw members are adapted, in an open position, for positioning about the tissue portions in the predetermined position, and in a closed position, to at least partially draw the tissue together to an at least partially approximated condition. An attachment member is associated with at least one of the jaw members and arranged to contact the tissue. In one embodiment, the attachment member is adapted for connection to an energy source whereby energy is transmitted through the attachment member to thermally fuse the tissue engaged by the jaw members to substantially close the opening.

Description:
This application is a continuation application of application Ser. No. 09/883,427, filed Jun. 18, 2001, now U.S. Pat. No. 6,676,685, which is a continuation application of application Ser. No. 09/503,510, filed Feb. 14, 2000, now U.S. Pat. No. 6,248,124, which claims priority to provisional application 60/121,114, filed Feb. 22, 1999, now expired. The contents of the &#39;427 application, &#39;510 application and &#39;114 provisional application are each incorporated in their entireties by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to an arterial closure device used following a coronary catheterization procedure for closing an arterial access opening formed through the arterial wall while permitting post operative blood flow through the artery. 
     2. Background of the Related Art 
     When performing a catheterization procedure such as, for example, an angiography or angioplasty, a sharpened hollow needle is first percutaneously introduced into the vascular system. A guide wire is then inserted through the hollow needle and into the lumen of a selected blood vessel. Subsequently, the needle is removed and a dilator and/or introducer is fed into the vessel along the guide wire. The guide wire is then removed and a suitable catheter is fed through the lumen of the introducer and advanced through the vascular system until the working end thereof is positioned at the operating site. At the conclusion of the catheterization procedure, the catheter is withdrawn, followed by removal of the dilator and/or introducer. 
     At this point in the procedure, the vessel puncture must be sealed to stem the flow of blood therethrough. Generally, this procedure is extremely difficult due to the nature of the vessel tissue and to the presence of a blood thinning agent which is typically administered prior to the catheterization. A common method of closing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes about thirty minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated. When hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure application techniques, such as pressure bandages, sandbags or clamps, have been employed, but these techniques also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure the effectiveness. 
     Other devices have been disclosed that plug or otherwise provide an obstruction in the area of the puncture. See, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612, wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to create a block for the wound in the vessel wall. A potential problem of plugs introduced into the vessel is that plug particles may break off and float downstream to the point where they may lodge in a smaller vessel, causing an infarct to occur. Collagen material also acts as a nidus for platelet aggregation and, therefore, can cause intraluminal deposition of a hemostatic agent, thereby creating the possibility of a thrombosis at the puncture site. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393; 5,370,660; and 5,411,520. 
     U.S. Pat. Nos. 5,417,699 and 5,527,322 each to Klein et al. discloses a suture applying device for the percutaneous suturing of a vascular puncture site. These devices include a shaft which carries a pair of needles at its distal end. The needles are joined by a length of suture. The shaft is used to both introduce the needles within the lumen of the vessel and to draw the needle back through the vessel wall leaving a loop of suture behind to close the puncture site. 
     U.S. Pat. No. 5,810,810 to Tay et al. discloses an apparatus for closing and sealing a vascular puncture utilizing heat to thermally fuse the vascular tissue. The Tay &#39;810 device includes a vessel balloon occluder which is introduced within the lumen of the vessel to occlude the opening and a forceps which are intended to grasp the vascular tissue surrounding the opening. The forceps serve as electrodes and are energized by radiofrequency energy to thermally fuse the tissue grasped therebetween. 
     SUMMARY 
     Accordingly, the present invention is directed to an arterial closure device used following coronary catheterization procedures to close arterial access openings through the arterial wall while permitting post operative flow through the artery. In the preferred embodiments the apparatus includes a housing having proximal and distal ends, and defining a longitudinal axis, first and second arterial tissue everting members mounted adjacent the distal end of the housing and first and second jaw members mounted adjacent the first and second arterial tissue engaging members. The first and second arterial tissue everting members are dimensioned for at least partial positioning within the arterial access opening in the arterial wall and are deployable in at least a radial outward direction relative to the longitudinal axis of the housing to engage respective opposed arterial tissue portions on opposed sides of the opening and move the arterial tissue portions to an everted condition thereof. The first and second jaw members are adapted for relative movement between an open position to facilitate positioning about the arterial tissue portions in the everted condition and a closed position to at least partially draw the arterial tissue portions together to an at least partial approximated condition. An electrode is associated with at least one of the first and second jaw members and arranged to contact the respective arterial tissue portions. The electrode is adapted to be connected to a radiofrequency energy source whereby energy is transmitted through the electrode to thermally fuse the arterial tissue positions between the first and second jaw members to substantially close the opening. Preferably, an electrode is associated with each of the first and second jaw members. Each electrode may be configured as a bipolar electrode. 
     Each arterial tissue everting member includes a distal memory portion comprising a shape memory material, the distal memory portion being adapted to assume a normal unstressed condition upon deployment to engage and move the arterial tissue portions to the everted condition. The normal unstressed condition of each arterial tissue everting member may be a general hook-shaped configuration. Preferably, the distal memory portions of the tissue everting members define general hook-shaped configurations in diametrical opposed relation and extending in radial opposite directions. 
     A manually operable deployment member may be operatively connected to the arterial tissue everting members, and movable to deploy the tissue everting members. An actuator is operatively connected to the first and second jaw members with the actuator movable to cause corresponding movement of the first and second jaw members between the open and closed positions. 
     The apparatus may include an elongated shaft at least partially disposed within the housing. The elongated shaft has camming structure which cooperates with corresponding camming structure of the first and second jaw members to move the jaw members between the open and closed positions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred embodiments of the disclosure are described herein with reference to the drawings wherein: 
         FIG. 1  is a perspective view of the surgical apparatus for facilitating closure of an arterial access opening in the arterial wall in accordance with the principles of the present disclosure; 
         FIG. 2  is a perspective view with parts separated of the apparatus of  FIG. 1 ; 
         FIGS. 3-4  are side cross-sectional views of the apparatus in an unactuated position; 
         FIGS. 5-6  are side cross-sectional views of the apparatus in an actuated position; and 
         FIGS. 7A-7D  are perspective views depicting the sequence of movement of the arterial tissue everters members and the jaw members during movement of the apparatus to the actuated position. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In general, the object of the apparatus is to close an arterial access opening in an arterial wall following a coronary catheterization procedure, to stem the flow of blood through the opening while permitting post operative blood flow through the artery. In the drawings and in the description which follows, the term “proximal”, as is traditional, will refer to that end of the apparatus, or component thereof, which is closer to the operator, while the term “distal” will refer to that end of the apparatus, or component thereof, which is more remote from the operator. 
     Referring now in detail wherein like reference numerals identify similar components throughout the several views,  FIG. 1  illustrates in perspective the apparatus in accordance with the principles of the present disclosure. Arterial closure apparatus  10  is configured to close an arterial access opening in an arterial wall. In achieving this objective, arterial apparatus  10  has incorporated therein several mechanisms; namely, 1) an arterial tissue everting mechanism which everts the tissue portions on each side of the arterial opening such that the arterial portions are exposed and arranged at a desired orientation; and 2) an arterial tissue approximating mechanism which draws the everted arterial portions to a general closed approximated position and maintains a predetermined degree of pressure on the arterial portions. A thermal treatment mechanism supplies thermal energy across the approximated everted arterial tissue portions for a desired predetermined time and intensity to effectuate complete thermal fusion of the everted arterial portions. 
     Referring now to  FIGS. 2-4 , in conjunction with  FIG. 1 , the components of apparatus  10  will be discussed in detail. Apparatus  10  includes main housing  12  which accommodates the mechanisms discussed above. Main housing  12  includes outer sleeve  14  and circular flange  16  which is fixedly mounted to the proximal end of outer sleeve  14 . Outer sleeve  14  defines longitudinal axis “a” and has a longitudinal opening  14   a  extending completely therethrough. Circular flange  16  also defines longitudinal opening  16   a  ( FIG. 3 ) in general alignment with the opening of the outer sleeve  14 . Circular flange  16  may be fixedly mounted to outer sleeve  14  by any conventional means including adhesives, snap-groove fit, bayonet coupling etc. . . . Outer sleeve  14  and circular flange  16  may be fabricated from any suitable rigid material including stainless steel titanium, or a rigid polymeric material. Housing  12  further includes central elongated shaft  18  disposed within outer sleeve  14  and mounted for relative longitudinal movement therewithin. Central shaft  18  defines a central lumen  20  dimensioned to receive a guide wire. The remaining features and components of housing  12  will be discussed in greater detail below. 
     With continued reference to  FIGS. 2-4 , the components of the arterial tissue approximating mechanism will be discussed. The tissue approximating mechanism includes manually operable actuator  22  which is mounted to outer sleeve  14  in a manner to permit relative longitudinal movement of the actuator  22  and the sleeve  14 . Actuator  22  includes main portion  24  defining a central lumen  26  and tubular portion  28  extending from the main portion  24 . Main portion  24  defines a pair of manually engageable finger grips  30  extending radially outward from the main portion  24 . Finger grips  30  are positioned to be engaged by the user&#39;s fingers during use while the user&#39;s palm engages circular flange  16 . Tubular portion  28  of actuator  22  possesses a pair of resilient legs  32  ( FIG. 2 ) extending in a general longitudinal direction. Resilient legs  32  have radially outwardly extending resilient tabs  34  adjacent their distal ends which are received within corresponding slots  36  of elongated shaft  18  in a snap fit manner to connect the two components. With this arrangement, actuator  22  is longitudinally fixed with respect to elongated shaft  18 . Tabs  34  of actuator legs  32  are also accommodated within longitudinal slots  38  of outer sleeve  14  to operatively connect these components. Tabs  34  of actuator legs  32  are capable of sliding within slots  38  to thereby provide relative movement between outer sleeve  14  and actuator  22 . 
     With reference still to  FIGS. 2-4 , the arterial tissue approximating mechanism further includes a pair of jaw members  40 . Jaw members  40  are connected to outer sleeve  14  at location “P” ( FIG. 4 ) through a pivot pin arrangement (not shown) and thus are longitudinally fixed with respect to the sleeve  14 . Jaw members  40  are adapted to move or pivot from the closed or approximated position depicted in  FIG. 3  to the open position depicted in  FIG. 5 . Jaw members  40  each define an arterial tissue contacting portion  42  adjacent their respective distal ends. Arterial tissue contacting portion  42  each depend radially inwardly and define a planar tissue contacting surface  44 . In the closed position of jaw members  40  depicted in  FIG. 3 , tissue contacting portions  42  are received within corresponding recesses  46  of elongated shaft  18  to define the reduced profile shown. Jaw members  40  further define first and second interior camming surfaces  48 . Camming surfaces  48  engage corresponding camming surfaces  50  of elongated shaft  18  to cause the jaw members  40  to assume the open position depicted in  FIG. 5  as will be discussed. 
     The tissue approximating mechanism is normally biased to the closed position of  FIG. 3  by coil spring  52 . More particularly, coil spring  52  is in engagement with flange  16  of housing  12  and actuator  22  and serves to normally bias the flange  16  and the actuator  22  in opposite directions, thus biasing outer sleeve  14  and jaw members  40  in the opposite (proximal) direction relative to elongated shaft  18 . 
     With continued reference to  FIGS. 2-4 , the arterial tissue everter mechanism will be discussed. The arterial tissue everter mechanism includes a manually operative lever  54  pivotally mounted to actuator  22  about pivot pin  56  and drive tube  58  which is operatively connected to operative lever  54  through pin  60 . With this arrangement, pivotal movement of lever  54  causes drive tube  58  to longitudinally translate. Drive tube  58  includes central opening  62  which receives guide wire “w” and outer longitudinal slots  64  ( FIG. 2 ) defined in the outer wall of the drive tube  58 . With reference to  FIG. 2 , the tissue everter mechanism further includes a pair of arterial tissue everting members  66 . In FIGS.  1  and  3 - 6 , everting members  66  are not shown/visible. Tissue everting members  66  are accommodated within longitudinal slots  64  of drive tube  58  and extend distally with elongated shaft  16  through a pair of longitudinal slots  67  ( FIG. 2 ) defined within the outer wall of the elongated shaft  16 . Each tissue everting member  66  is fixed to drive tube  58  by conventional means to thereby longitudinally move with the drive tube  58 , but, is capable of sliding within slots  67  of elongated shaft  16 . Each everting member  66  defines a generally straight proximal portion  68  and a curved distal portion  70 . Tissue everting members  66  are fabricated from a shape memory material such as Tinel™. In the normal unstressed condition of tissue everting members, the distal portions  70  assume the opposed hook or J-shaped configuration shown. In this configuration, the distal portions  70  engage the interior arterial portions to surrounding the vessel opening to evert the tissue portions to a desired orientation. The extreme distal end of each tissue everting member is relatively sharp to facilitate engagement with the vessel portion. In the non-deployed position, tissue everting members  66  are received within longitudinal slots  67  of elongated shaft  18  whereby the curved distal portion is straightened by the biasing affects of the elongated shaft  18 . 
     With reference to  FIG. 1 , in conjunction with  FIG. 3 , the thermal treatment energy source  100  is shown in block diagram. The thermal treatment energy source does not form part of the invention as a variety of different generators can be utilized to apply thermal energy to the tissue. Preferably, the energy source includes an RF energy source which is capable of supplying RF energy at a frequency ranging between 10 Khz to 300 GHz. One suitable RF energy source is the WeO Fich LT made by Mentor U&amp;O, Inc. Another suitable power source is the Valley Lab Force FX an Force EZ generator. Other RF generators suitable for this use are envisioned as well such as those enumerated in U.S. Pat. No. 5,810,810. The generator selected may depend on the intended use requirements of the surgeons. Also, energy can be supplied at other frequency ranges other than radiofrequency, as well. The energy source needs to be in electrical contact with jaw member  40 . In the illustrated embodiment, this is achieved through conventional leads with electrodes associated with jaw members  40 . In one embodiment, the contacting surface  44  of each jaw member  40  functions as the RF electrode and is electrically connected through lead lines (not shown) to the RF power source. Preferably, the RF electrodes are each configured as bipolar electrodes to transmit RF energy therebetween. A monopolar arrangement is envisioned as well. It is also envisioned the jaw members  40  may be conductive with the extreme tissue contacting portion  42  left uninsulated to transmit the thermal energy. 
     Operation of the Apparatus 
     The operation of surgical apparatus  10  will now be discussed. Apparatus  10  is used to close an arterial access opening in an arterial wall subsequent to a coronary catheterization procedure while permitting blood flow through the artery. The initial position of apparatus  10  is best depicted in  FIGS. 3-4 . 
     Surgical apparatus  10  is then advanced along a guide wire which had been previously introduced in connection with the angioplasty procedure to access the surgical site. The guide wire is received within the central lumen  20  of elongated shaft  18  and extends proximally within opening  62  of drive tube  58  where it passes through the opening  16   a  of flange  16 . Apparatus  10  is advanced along the guide wire until the distal hub portion is received within the opening of the arterial wall and at least partially disposed within the vessel lumen. Thereafter, lever  54  is pivoted from its initial position of  FIG. 3  to its position of  FIG. 5  to cause corresponding movement of drive tube  58  and tissue everting members  66  to advance within slots of elongated shaft  18 . Upon deployment from elongated shaft  18 , distal portions  70  of tissue everting members  66  assume their normal unstressed condition, i.e., the J-shaped configuration shown in  FIG. 7A . In this position, the extreme distal ends of the distal hook portion  70  engage the interior arterial wall portions “a” on each side of the opening “o” to essentially draw the wall portions “a” upwardly to an everted position shown in the Figure. It is noted that at this point the surgeon may slightly “pull-back” the apparatus to exaggerate the everted condition of the arterial portions “a” if desired. 
     With the arterial portions “a” properly everted, the surgeon thereafter pushes on flange  16  to cause drive sleeve  14  and jaw members  40  to distally move. During such movement, camming surfaces  50  of elongated shaft  18  engage camming surfaces  48  of jaw members  40  to cause the jaw members  40  to pivot outwardly to the open position depicted in  FIGS. 5 and 7B . In the open position, the jaw members  40  are positioned about the everted wall portions “a” as depicted in  FIG. 7C . Thereafter, jaw members  40  are closed by either releasing actuator  22  or flange  16 , or a combination of each movement, to cause the jaw members  40  to close or clamp tightly down on the everted wall portions as shown in  FIG. 7D . 
     With the everted wall portions “a” in their proper everted positions clamped by jaw members  40 , the RF energy source is energized to cause current to be emitted through the arterial tissue captured by the jaw members  40 . Preferably, the energy is for a sufficient period of time and at an appropriate level to thermally treat and fuse the tissue portions to each other. Once fused, the access opening is closed while blood flow through the artery continues. If desirable, the RF energy source may incorporate various means to detect when treatment has been successfully accomplished or when undesired treatment of neighboring tissue areas occurs. Such means may include temperature sensor means, impedance measurement means, etc. appreciated by one skilled in the art. Other types of feedback mechanism or circuits can optimally be provided as part of the energy source if monitoring of specific parameters is desired by the surgeon. It is noted that the clamping pressure provided by jaw members  40  ensures that the tissue portions are approximated thereby facilitating the fusion process. Upon completion, the apparatus may then be removed from the surgical site along the guide wire. 
     Although certain embodiments and examples have been used to illustrate and describe the apparatus of the present invention, it is intended that the scope of the invention not be limited to the specific embodiments of the apparatus set forth herein. The scope of the invention is to be defined by the claims which follow.