Abstract:
A vascular closure device including a sheath with one or more orifices therein to detect blood flow, indicating that the sheath has entered an artery and the relative position of the sheath within the artery. Thus, the sheath can be moved and positioned relative to the artery with having to completely extract the sheath from the artery after initial penetration.

Description:
BACKGROUND  
         [0001]    The present invention relates to catheters and medical procedures involving catheters. More specifically, the present invention relates to wound closure devices, including vascular wound closure devices, and devices and methods for positioning wound closure devices, including relative to a blood vessel.  
           [0002]    Various catheterization procedures require the piercing of a blood vessel, including arteries, or a body organ. Withdrawal of the catheter leaves a puncture wound that must be closed. For pierce or puncture wounds in blood vessels, traditional closure techniques involve withdrawal of the catheter and subsequent application of pressure to the area of the puncture to facilitate natural clotting. Such a technique is time consuming, and the time required and the results vary greatly from patient to patient.  
           [0003]    The assignee of the present application owns patents and patent applications directed to vascular closure devices and their use. For example, U.S. Pat. Nos. 5,108,421, 5,192,300, 5,275,616, 5,478,352, 5,591,205, 6,601,602 and 5,716,375, all entitled “Insertion Assembly and Method of Inserting a Vessel Plug into the Body of a Patient, ” disclose closure devices and methods of using them.  
           [0004]    U.S. Pat. No. 5,306,254, which issued Apr. 26, 1994 and is incorporated herein by reference in its entirety, describes a vascular closure device and method involving introducing a mechanical seal through a sheath. Generally, the disclosed closure device enables sandwiching an arteriotomy between a bio-absorbable anchor and a collagen sponge, both of which dissolve after time. This technique consistently, reliably, and bio-mechanically seals the puncture allowing for faster recovery as well as providing for a faster completion of the procedure.  
           [0005]    During some catheterization procedures, a catheter procedure sheath is inserted into an artery and a given medical procedure, such as, for example, a cardiac catheterization, balloon angioplasty, angiographic dye injection or the like, is performed. Upon completion, a guidewire is inserted through the catheter sheath and into the artery. The procedure sheath is then removed, leaving the guidewire in place.  
           [0006]    The assignee&#39;s vascular closure devices may then be used to seal the puncture. More specifically, an inserter or arteriotomy locator is introduced into a sheath of the vascular closure device. The guidewire is then fed through the arteriotomy locator. The combined arteriotomy locator and sheath are then advanced into the artery through the existing puncture, guided by the guidewire.  
           [0007]    To determine the position of the sheath during insertion, a detection orifice is provided in the arteriotomy locator, just distal to the sheath tip. The orifice is in fluid communication with a proximal orifice (or other indicator) that is visible to the surgeon. Thus, the arteriotomy locator and sheath are advanced through the artery wall, until a “flashback” (e.g., blood flow) is detected in the proximal orifice indicating that the detection orifice is within the artery. It should be understood that the present invention need not be used exclusively on arteries; however, if it is being used on an artery, the blood flow may be pulsitile. When blood flow is detected, the sheath and arteriotomy locator are then retracted just until the flashback has ceased. This indicates that the detection orifice is aligned with the interior edge of the artery wall and the sheath has been retracted from the artery. As such, the arteriotomy locator and sheath are now in a known position relative to the artery. Both can be advanced a specific distance (e.g., 1-2 cm) and the surgeon is assured of proper placement of the arteriotomy locator and sheath relative to the artery. It is desirable to limit the advancement of the sheath so as to not pass the sheath too far into the artery. Some surgeons may repeat these steps (advancing and retracting) several time to obtain a comfort level with the position of the sheath.  
           [0008]    Once properly positioned, the arteriotomy locator and guidewire are withdrawn through the sheath. An anchor device is inserted through the sheath and into the artery. The anchor is deployed so as to engage the tip of the sheath. That is, the tip of the sheath is specifically shaped and contoured to engage the anchor and cause it to move to a locking or engaging position wherein retraction through the sheath is precluded. The sheath is withdrawn exposing a coupling to the anchor that includes a suture, an advancer, and a collagen sponge. In short, the collagen sponge in pressed against the outer artery wall by repeated strokes of the advancer. This serves to compress the collagen sponge against the outer wall while cinching the anchor to the inner wall. The suture remains and holds these components in this configuration. The exposed portion of the suture is trimmed and the anchor, suture and collagen sponge dissolve within the body after a period of time (e.g., 60-90 days). In this manner, the arteriotomy is hemostatically sealed.  
           [0009]    The vascular closure device described above is effective at rapidly sealing an arteriotomy. However, during the initial insertion of the arteriotomy locator and sheath, the retraction of the arteriotomy locator and the sheath requires the withdrawal of the sheath from the artery. That is, the position of the detection orifice is distal to the tip of the sheath; thus, when the detection orifice is aligned with the edge of the artery wall the sheath tip is necessarily withdrawn from said wall. Upon subsequent advancement, the sheath must re-penetrate the artery wall. Such advancement occurs at least once to properly position the sheath tip within the artery and may occur several times if the surgeon elects to reposition the device. While in most instances the advancement and retraction does not cause any difficulty, repeated penetrations could potentially adversely affect the vessel wall.  
           [0010]    Thus, there exists a need to position a vascular wound closure device relative to a blood vessel without the sheath penetrating the vessel multiple times.  
         SUMMARY  
         [0011]    In one embodiment, the present invention comprises a device for positioning a vascular wound closure device comprising a sheath having a distal end and a proximal end, a first detection orifice located near the distal end, and a first locator orifice near the proximal end, wherein the first detection orifice is in fluid communication with the first locator orifice such that when the first detection orifice is disposed within a blood vessel and exposed to blood flow, such blood flow is indicated at the first locator orifice. The invention encompasses a method of positioning a vascular wound closure device in a vascular closure procedure, wherein, in one embodiment, the method comprises inserting a distal end of a sheath into a blood vessel, advancing the sheath until blood flow is detected at an orifice disposed on the sheath, retracting the sheath until the blood flow ceases without completely withdrawing the sheath from the blood vessel, and determining that the orifice is positioned adjacent an edge of the vessel wall. The method further comprises advancing the sheath forward from the determined edge a predetermined distance.  
           [0012]    The present invention, in one embodiment, is a vascular closure device comprising a sheath having a distal end and a proximal end and a first detection orifice located in the sheath near the distal end. The device also includes a first locator orifice disposed in the sheath near the proximal end, wherein the first detection orifice is in fluid communication with the first locator orifice such that when the first detection orifice is disposed within a blood vessel and exposed to blood flow, such blood flow is indicated at the first locator orifice.  
           [0013]    The present invention also includes a method of using a catheter device in a vascular closure procedure, wherein, in one embodiment, the method comprises inserting a distal end of a sheath into blood vessel wall. The method also includes advancing the sheath through the blood vessel until blood flow is detected at an orifice disposed on the sheath and retracting the sheath until the blood flow ceases without completely withdrawing the sheath from the blood vessel and determining that the orifice is positioned adjacent an edge of the vessel wall. The method further includes advancing the sheath forward from the determined edge a predetermined distance.  
           [0014]    The present invention also includes another method of using a catheter device in a vascular closure procedure. The method includes inserting a distal end of a sheath into the wall of a blood vessel, for example an artery, until blood flow is detected at a first orifice disposed on the sheath near the distal end indicating that the first orifice has entered the artery and advancing the sheath a predetermined distance into the artery. The method also includes stopping advancement if blood flow is detected at a second orifice disposed on the sheath at a further distance from the distal end than the first orifice is disposed.  
           [0015]    In another embodiment, the present invention is a vascular wound closure device that includes a sheath for penetrating an artery, the sheath having a distal end and a proximal end. The device includes a first detection orifice disposed on the sheath, a second detection orifice disposed on the sheath further from the distal end that then first detection orifice and a first indicator in fluid communication with the first detection orifice via a first fluid passageway, the first indicator disposed on the sheath proximate the proximal end, wherein the first indicator indicates when the first detection orifice is exposed to blood flow. The device includes a second indicator in fluid communication with the second detection orifice via a second fluid passageway, the second indicator disposed on the sheath proximate the proximal end, wherein the second indicator indicates when the second detection orifice is exposed to blood flow.  
           [0016]    While multiple embodiments are disclosed, other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    [0017]FIG. 1A is a side schematic view of a catheter device having a detection orifice disposed on a sheath.  
         [0018]    [0018]FIG. 1B is a side schematic view illustrating two detection orifices disposed on the sheath.  
         [0019]    [0019]FIG. 1C is a side schematic view illustrating two, linearly offset orifices disposed on the sheath.  
         [0020]    [0020]FIGS. 2A-2E schematically illustrate the sheath of FIG. 1 puncturing and entering an artery.  
         [0021]    [0021]FIG. 3 is a side schematic view of a sheath having two detection orifices.  
         [0022]    [0022]FIG. 4 is a schematic view of a dial display.  
         [0023]    [0023]FIG. 5 is a schematic view of an indicator.  
         [0024]    [0024]FIG. 6 is a side, partially sectional view of a catheter having an orifice in a sheath and an orifice in a arteriotomy locator.  
         [0025]    [0025]FIG. 7 is a flowchart illustrating the steps of scaling a puncture.  
         [0026]    [0026]FIG. 8 is a side, sectional view of an insertion sheath and arteriotomy locator in an artery.  
         [0027]    [0027]FIG. 9 is an illustration of an anchor device being inserted through an insertion sheath.  
         [0028]    [0028]FIG. 10 is a side, sectional partially enlarged view of a set anchor.  
         [0029]    [0029]FIG. 11 is a flowchart illustrating the steps of inserting and setting the anchor. 
     
    
     DETAILED DESCRIPTION  
       [0030]    In the present invention, specific reference is made to exemplary embodiments of a catheter sheath and a vascular closure device and method. However, vascular closure devices and methods can take many forms and may be used in various catheterization, laproscopic, and minimally invasive procedures, and the position detecting features and steps of the present invention are intended to be applicable as suitable to any form of vascular closure device and method.  
         [0031]    [0031]FIG. 1A is a side view of a vascular closure device  10  that includes a sheath  12  and a arteriotomy locator  14  that is receivable within the sheath  12 . The arteriotomy locator  14  is positionable over and guidable by a guide wire  16 . It should be appreciated that the various components (e.g., the arteriotomy locator  14 , guide wire  16 ) may be inserted into and removed from the sheath  12  before or after the sheath  12  has been passed through a wall of blood vessel. In other words, the sheath  12  provides a known access point once so inserted. The various components are made from any suitable material such as metal or medical grade plastic.  
         [0032]    In one embodiment, the sheath  12  includes a detection orifice  18  located near a distal end of the sheath  12 . The detection orifice  18  is in fluid communication with a locator orifice  20  that is located near a proximal end of the sheath  10  (or any suitable portion of the device  10 ), so that the locator orifice  20  is visible to a surgeon even when the sheath  12  is inserted through the wall of a blood vessel. The locator orifice  20  is an indicator that may take any configuration suitable to provide a visual, audible, and/or tactile indication of blood flow.  
         [0033]    Fluid communication between the detection orifice  18  and the locator orifice  20  may be achieved in a number of ways. In one embodiment, the arteriotomy locator  14  includes a hollow passageway and a arteriotomy locator orifice  19 . When properly positioned within the sheath  12 , the arteriotomy locator orifice  19  aligns with the detection orifice  18 . Similarly, the arteriotomy locator  14  includes an exit orifice  21  that aligns with locator orifice  20 . Alternatively, the proximal end of arteriotomy locator  14  could be exposed and exit orifice  21  could function as the indicator (e.g., functionally replacing locator orifice  20 ). In another embodiment, a separate, dedicated lumen is provided within the sheath  12  between the two orifices  18 ,  20 . In another embodiment, no such lumen is provided. Rather, the presence of the arteriotomy locator  14  within the hollow sheath  12  forms a fluid passageway between the detection orifice  18  and the locator orifice  20 . In some embodiments, a gap between the interior cavity of the sheath  12  and the arteriotomy locator  14  forms the fluid passageway. It may be formed in other suitable ways, too. For example, the outer surface of the arteriotomy locator  14  or the inside surface of the sheath  12  may be provided with grooves or channels.  
         [0034]    [0034]FIGS. 1B and 1C illustrate variations of the device  10 , wherein two detection orifices  18 A and  18 B are provided and both are in fluid communication with the locator orifice  20 . As will be explained more fully below, blood flow is observed through the locator orifice  20  to indicate proper positioning. Thus, by providing two (or more) detection orifices  18 A,  118 B, a larger volume of blood flow may be achieved to provide a greater indication. In FIG. 1B, the two orifices  18 A,  18 B are provided adjacent to one another. In FIG. 1C, the two orifices  18 A,  18 B are axially offset from one another. As the sheath  12  is generally inserted into the artery (or other blood vessel) at a non-perpendicular angle, this offset (indicated generally by the hatched line) will generally be positioned parallel to a main axis of the artery wall. Thus, both detection orifices  18 A,  18 B will be exposed to the same flow rates at the same time as the sheath  12  is moved and positioned through and within the artery.  
         [0035]    [0035]FIGS. 2A-2E schematically illustrate the deployment of the device  10  into an artery  30  through an artery wall  32 , while using the present invention to properly position the device. In FIG. 2A, the sheath  12  partially pierces the artery wall  32 . The arteriotomy locator  14  and the guidewire  16  are passed through the sheath and into the artery  30 . As the device  10  is advanced in FIG. 2B, the distal end of the sheath  12  passes through the artery wall  32  and enters the artery  30 . At this point, the detection orifice  18  is still occluded by the artery wall  32 , thus no blood flow is detected at the locator orifice  20 . The operator knows to further advance the device  10 , as illustrated in FIG. 2C. As indicated, the detection orifice  18  is within the artery  30  and exposed to blood flow. Blood is delivered from the detection orifice  18  to the locator orifice  20  (or otherwise indicated). Thus, the operator now knows that the distal end  15  of the sheath and at least a portion of the detection orifice  18  is within the artery.  
         [0036]    Once blood flow is detected, the operator knows that the sheath is properly positioned. That is, the tip or distal end  15  is just inside the artery  32  and the device is ready for anchor deployment. This is advantageous in that the device  10  is properly positioned with only one advancing and one retracting stroke, without removing the sheath  12  completely from the artery wall  32 . That is, because the detection orifice  18  is positioned on the sheath  12 , the retraction of the device  10  to find the edge of the artery wall  32  does not require the sheath  12  to be withdrawn from the wall  32 . The space between the detection orifice  18  and the distal end  15  is such that locating the edge of the artery wall in the above manner, positions the distal end  15 . Of course, a given operator may advance or retract the sheath  12  multiple times based upon a familiarity with previous devices (that required such actions) or to simply gain a comfort level with the positioning. The present invention is advantageous in this regard because such repetitive strokes still do not withdraw the sheath  12  from the artery wall  32 . Thus, even though they are ultimately unnecessary, they are generally harmless.  
         [0037]    [0037]FIGS. 2D-2E , generally illustrate the deployment of an anchor  40 . The anchor  40  is passed through the sheath  12  and into the artery. The sheath  12  is subsequently extracted and the anchor  40  is used as one half of a sealing device (within the artery) to seal the puncture.  
         [0038]    [0038]FIG. 3 illustrates another embodiment of the device  10  that includes a first detection orifice  50  and a second detection orifice  52 . The first and second detection orifices  50 ,  52  are in fluid communication with a first locator indicator  54  and a second locator indicator  56  respectively. Once again, blood flow is detected at the appropriate indicator  54 ,  56  and blood is allowed to enter the appropriate orifice  50 ,  52 .  
         [0039]    In order to differentiate between the first orifice  50  and the second orifice  52 , there are separate paths of fluid communication between the respective orifice  50 ,  52  and the indicator  54 ,  56 . This can be accomplished with a separate lumen provided within the sheath  12  for each flow path. Alternatively, one such flow path could be the open interior or the sheath  12  as limited by the presence of the arteriotomy locator  14 . One flow path could be the hollow interior of the arteriotomy locator  14 , as described above. Thus, as blood flow is achieved through first detection orifice  50 , such flow is indicated at the first locator indicator  54 . Similarly, as blood flow is achieved through second detection orifice  52 , such flow is indicated at second locator indicator  56 . Thus, the first and second detection orifices  50 ,  52  act as position identifiers.  
         [0040]    The orifices  50 ,  52  are selectively positioned on the sheath  12  to indicate a selected position within the artery  30 . That is, the first detection orifice  50  is located near the distal end  15  of the sheath  12 . Thus, as described above the first detection orifice indicates successful entry into the artery  30 , beyond the artery wall  32 . Continued advancement of the device  10  beyond this initial indication places the sheath  12  further into the artery. Blood flow through second detection orifice  52  and indicated by second locator indicator  56  indicates that the sheath  12  has advanced into the artery sufficiently far to allow second detection orifice  52  to be in fluid communication with the blood flow of the artery  30 .  
         [0041]    In one embodiment, the second orifice  52  is positioned so that if blood flow is detected, this indicates the sheath has been advanced “too far ” and should be slightly retracted or at least not advanced farther. Alternatively, the second orifice  52  could be positioned so that once blood flow is detected, the operator knows the sheath is properly positioned. In either case, the recurrent advancing and retracting with previous embodiments may be avoided. That is, the sheath  12  can normally be inserted in a single advancing action, with at most, a slight retraction if a “too far ” condition is reached. Alternatively, such an embodiment could be used as previously described with advancing and retracting strokes. The second indicator would simply provide an additional safety function of alerting the surgeon that the device  10  has been inserted too far.  
         [0042]    [0042]FIGS. 4 and 5 illustrate various indicators  60 ,  62  that can be provided as locator indicators  54 ,  56 . In its simplest form, locator indicator  54 ,  56  is simply an opening through which blood flow occurs and is viewed or otherwise sensed. The locator indicator  54 ,  56  could be open to the environment or shielded by a viewing port. FIG. 4 illustrates dial-type display device  60  that indicates the absence of blood flow; blood flow at the first orifice  50  (I); or blood flow at the second orifice  52  (II). FIG. 5 illustrates a simple fluid communication path  62  interconnecting the two orifices  50 ,  52 . The direction of the blood flow will move the indicator ball  64  to an appropriate point to indicate which orifice  50 ,  52  is within the artery  30 .  
         [0043]    [0043]FIG. 6 illustrates another embodiment wherein a arteriotomy locator orifice  70  is provided in the arteriotomy locator  14 . The arteriotomy locator orifice  70  is in fluid communication with a arteriotomy locator indicator  76  disposed at a proximal end of the device  10 . Similarly, a sheath orifice  18  is provided in the sheath  12  and functions in the same manner as previously described in conjunction with a sheath indicator  20 . In this embodiment, blood flow initially indicated by the arteriotomy locator orifice  70  indicates that the distal end  15  of the sheath  12  is proximate the artery wall  32 . Blood flow indicated at the sheath orifice  18  will indicate the location of the sheath orifice  18  relative to the artery wall  32 . That is, depending on where the sheath orifice is positioned relative to the distal end  15 , the detected blood flow could indicate different parameters. For example, when placed near the distal end  15 , such blood flow could indicate the proper positioning of the sheath. If the sheath orifice  18  is positioned further away from the distal end  15 , blood flow could indicate a “too far ” positioning of the sheath  12 . In either case, it is unnecessary to withdraw the sheath  12  from the artery wall during initial positioning and, thus, repetitive entry of the sheath  12  through the artery wall  32  is avoided.  
         [0044]    Referring to FIG. 7, in one embodiment an insertion procedure utilizing the device  10  comprises three steps: locate the blood vessel, in this instance an artery ( 180 ), set the anchor ( 185 ), and seal the puncture ( 190 ). Before beginning the procedure, the surgeon may conduct a fluoroscopic assessment of the arteriotomy region, to confirm the correct placement of the procedure sheath that is already in place, for example, in the common femoral artery.  
         [0045]    The procedure will be described in reference to the flowchart of FIG. 11 as well as the illustrations presented in FIGS. 8-10. To begin the surgeon inserts and snaps ( 200 ) the arteriotomy locator  14  into the insertion sheath  12 . The locking interaction between the sheath  12  and the arteriotomy locator  14  at a locking head  100  assures that the appropriate detection orifices are aligned. Next, the guide wire  16  is inserted ( 210 ) into the existing procedure sheath. The procedure sheath is removed over the guide wire  16 . The locator insertion sheath  12  and arteriotomy locator  14  are inserted ( 230 ) over the guide wire  16 .  
         [0046]    The assembly is advanced through the puncture track and into the artery  30 . When the tip  15  of the insertion sheath  12  enters the artery  30 , blood will begin to flow from the proximal locator orifice  20  ( 240 ). The assembly is then backed out slowly until the blood flow stops ( 250 ), indicating that the detection orifice  18  has been occluded by the artery wall  32 . The device  10  is now properly positioned. Earlier devices required subsequent advancement from this position. Thus, at least at first, subsequent advancement may be performed as a matter of habit for some surgeons. This will simply further advance the sheath  12  further into the artery. While unnecessary, this action is generally not harmful.  
         [0047]    Once positioned, the proximal end of the arteriotomy locator  14  is bent down slightly, to unlock it from the insertion sheath. The arteriotomy locator  14  and guide wire  16  are removed ( 240 ) from the sheath  12 . The anchor materials ( 110 ) are then advanced ( 270 ) into the sheath  12  as shown in FIG. 9. A secure cap  120  will only allow the device sleeve and sheath cap to fit together in the correct position. While holding the sheath hub steady within the artery, the secure cap is grasped and slowly pulled back until resistance is felt, indicating the anchor is now positioned against ( 280 ) the distal end  15  of the insertion sheath  12 .  
         [0048]    The device-sheath assembly is slowly withdrawn along the angle of the puncture track to position the anchor  40  against the artery wall  32 . As the sheath  12  clears the skin, a tamper tube and suture will appear. The tamper tube is advanced to move ( 290 ) a collagen sponge  130  down the tissue track. The suture is retained within the cap  120  and appears as the sheath  12  is withdrawn. Tension is maintained on suture and the tamper tube is advanced along the puncture track to help form the collagen anchor seal at the arteriotomy. The seal is complete when resistance is felt and the tamping marker is revealed on the suture, above the tamping tube. This confirms that the self-tightening suture has secured the collagen sponge at the arteriotomy as illustrated in FIG. 10.  
         [0049]    The procedure is completed by cutting the suture and removing the tamper tube. The remaining suture is pulled upwards and cut below skin level. The anchor, collagen sponge, and suture will be naturally absorbed by the body within sixty to ninety days.  
         [0050]    The present invention is useful for any type of catheter that is placed within an artery or similar structure. In one context, the present invention is used with an artery puncture sealing apparatus, however, such use is merely meant to be exemplary and not limiting.  
         [0051]    Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.