Patent Document

REFERENCE TO PENDING PRIOR PATENT APPLICATION 
     This patent application claims benefit of prior U.S. Provisional Patent Application Ser. No. 61/189,670, filed Aug. 21, 2008 by Howard Riina et al. for METHOD AND APPARATUS FOR ACCESSING THE SIDE WALL OF A VASCULAR STRUCTURE OR OTHER BODY LUMEN, ORGAN OR TUBULAR STRUCTURE WHILE SIMULTANEOUSLY PROVIDING ZONE ISOLATION AND BYPASS CAPABILITY, which patent application is hereby incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to medical procedures and apparatus in general, and more particularly to medical procedures and apparatus for accessing the wall of a vascular structure or other body lumen. 
     BACKGROUND OF THE INVENTION 
     Medical technologies are now expanding so that curative therapies may now be applied directly to the wall of a vascular structure or other body lumen (e.g., tubular structure or organ) within the human body. In most situations it will be necessary to access the inside (or other portion) of the wall of a vascular structure or other body lumen in order to provide therapy to a patient. By way of example but not limitation, it may be necessary to treat an aneurysm formed in the wall of an artery (e.g., a lateral aneurysm such as a saccular aneurysm, a fusiform aneurysm such as a typical abdominal aortic aneurysm), or to treat a lesion formed on the wall of a vascular structure (e.g., an artery or vein) or other tubular or hollow structure. As used herein, the term “vascular structure” is intended to encompass any tubular or hollow structure of the vasculature (e.g., an artery, a vein, a blood chamber, etc.), and the term “body lumen” is intended to encompass any tubular or hollow structure, including the gastrointestinal or genitourinary tracts, the lymph system, an air passageway, the interior of a hollow organ, a passageway through a body structure, etc. As used herein, the term “wall” of a vascular structure or other body lumen is intended to encompass the inside surface of the wall and/or any other portion of the wall, including aneurysms, lesions, etc. which may be formed in or on the wall. 
     Additionally, in many situations it may be desirable to isolate a segment of the vascular structure (or other body lumen) from the remainder of the vascular structure (or other body lumen). By way of example but not limitation, a particular therapy applied to the inside of the wall of a vascular structure may create debris which should be localized and prevented from flowing downstream from the site of the therapy. 
     Furthermore, in many situations it may become necessary to apply therapy to the inside of the wall of a vascular structure (or other body lumen) without interrupting the flow of blood (or other fluids) through the vascular structure (or other body lumen). 
     Thus, there is a substantial need for a novel method and apparatus for accessing the wall of a vascular structure or other body lumen while simultaneously providing “zone isolation” and simultaneously providing fluid bypass capability. Ideally, pressure and fluid (presence or absence) should be controllable within the isolation zone, thereby facilitating the use of medical instruments (including cutting instruments, biopsy instruments, closure instruments, endoscopic visualization, etc.), vacuum, electrical energy (e.g., electrosurgery), adhesives and/or other therapies which may be difficult to apply in a zone where blood or any other biologic fluid or substance is present and/or flowing. 
     SUMMARY OF THE INVENTION 
     The present invention provides a novel method and apparatus for accessing the wall of a vascular structure or other body lumen while simultaneously providing zone isolation and simultaneously providing fluid bypass capability. 
     In one preferred form of the invention, the novel method and apparatus permits pressure and fluid (presence or absence) to be controllable within the isolation zone, thereby facilitating the use of medical instruments (including cutting instruments, biopsy instruments, closure instruments, material delivery systems, endoscopes, etc.), vacuum, electrical energy (e.g., electrosurgery), adhesives and/or other therapies (e.g., agents promoting thrombus, gene therapeutic agents, etc.) which may be difficult to apply in a zone where blood or another biologic fluid or substance is present and/or flowing. 
     More particularly, the present invention comprises the provision and use of an access system comprising an erectable proximal isolation barrier (e.g., a balloon, a superelastic shape memory alloy ring, etc.), an erectable distal isolation barrier (e.g., a balloon, a superelastic shape memory alloy ring, etc.), and a bypass channel extending between the proximal isolation barrier and the distal isolation barrier, such that when the access system is erected in a body lumen, the access system can isolate a segment of the body lumen from the remainder of the body lumen, while still permitting a fluid to flow independently through the isolated segment of the body lumen. Additionally, the access system preferably comprises a working catheter extending through the proximal isolation barrier and providing access (e.g., for instruments, etc.) to the wall of the isolated segment of the body lumen. Furthermore, the access system can be configured so as to be mountable on a guidewire, so that the access system can be delivered over a guidewire to a desired position within a body lumen. 
     In one preferred form of the present invention, there is provided apparatus for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the apparatus comprising: 
     an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen; 
     an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen; 
     a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; and 
     a working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier. 
     In another preferred form of the present invention, there is provided a method for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the method comprising: 
     providing an access system comprising:
         an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen;   an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen;   a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; and   a working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier;       

     deploying the access system within the body lumen; 
     erecting the distal isolation barrier and the proximal isolation barrier; and 
     accessing the wall of the body lumen through the working catheter. 
     As noted above, the present invention provides a novel method and apparatus for accessing the wall of a vascular structure or other body lumen while simultaneously providing zone isolation and fluid bypass capability. In the following description, the present invention may sometimes hereinafter be discussed in the context of application to a vascular structure, however, it should be appreciated that this is done solely for the sake of clarity of illustration and should not be considered as limiting the scope of the present invention. Thus, the present invention may also be used in conjunction with body lumens other than vascular structures, e.g., the gastrointestinal or genitourinary tracts, the lymph system, an air passageway, the interior of a hollow organ, a passageway through a body structure, etc. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein: 
         FIG. 1  is a schematic perspective view showing the access system of the present invention deployed within a vascular structure; 
         FIG. 2  is a schematic side view showing the access system of  FIG. 1  deployed within a vascular structure, wherein the vascular structure includes an aneurysm; 
         FIG. 3  is a schematic end view, as seen from the distal end, showing the access system of  FIG. 1  deployed within the vascular structure shown in  FIG. 2 ; 
         FIG. 4  is a schematic perspective view showing an alternative form of an access system deployed within a vascular structure; 
         FIG. 5  is a schematic side view showing the access system of  FIG. 4  deployed within a vascular structure, wherein the vascular structure includes an aneurysm; 
         FIG. 6  is a schematic perspective view showing an alternative form of an access system; 
         FIG. 7  is a schematic end view of the access system shown in  FIG. 6 ; 
         FIG. 8  is a schematic sectional view taken along line A-A of  FIG. 7 ; 
         FIG. 9  is a schematic enlarged view of the segment labeled B in  FIG. 8 ; 
         FIG. 10  is a schematic perspective view showing an alternative form of an access system; 
         FIG. 11  is a schematic end view of the access system shown in  FIG. 10 ; 
         FIG. 12  is a schematic sectional view taken along line C-C of  FIG. 11 ; and 
         FIGS. 13, 14, 14A and 15-20  illustrate a delivery catheter which may used to deploy the access system of the present invention at a procedure site within a vascular structure. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Looking first at  FIGS. 1-3 , there is shown an access system  5  formed in accordance with the present invention. Access system  5  generally comprises an erectable proximal isolation barrier  10  and an erectable distal isolation barrier  15  for disposition within the lumen of a vascular structure or other body lumen. Erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  are formed so that they can (i) initially assume a diametrically-reduced configuration so as to facilitate insertion of access system  5  to a site where a procedure (e.g., therapy, diagnosis, exploration, etc.) is to be conducted, and (ii) thereafter assume a diametrically-expanded configuration once at the procedure site so as to form a fluid-tight (occlusive) seal against the wall of the vascular structure, whereby to isolate a segment of the vascular structure from the remainder of the vascular structure, e.g., while a procedure is performed. In one preferred form of the invention, proximal isolation barrier  10  and distal isolation barrier  15  have a peripheral surface texture to help ensure that the barriers will maintain their position in the vascular structure once deployed. By way of example but not limitation, such peripheral surface texturing may comprise dimpling, circumferential ribbing, etc. In this respect it will be appreciated that the proximal and distal isolation barriers should remain in place when systolic pressure is present on the outer surfaces of each of the isolation barriers and atmospheric pressure is present within the isolated segment of the vascular structure. Furthermore, erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  are formed so that they may be collapsed when desired so as to facilitate removal of access system  5  from the vascular structure, e.g., at the conclusion of the procedure. By way of example but not limitation, erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  may be formed by inflatable/deflatable balloons, compressible/expandable superelastic shape memory alloy (e.g., Nitinol) rings, etc. As a result of this construction, when access system  5  has been deployed at a desired point in a vascular structure or other body lumen, and erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  have been expanded to their sealing condition, access system  5  can isolate a segment of the vascular structure (i.e., the portion located between erected proximal isolation barrier  10  and erected distal isolation barrier  15 ) from the remainder of the vascular structure, e.g., while a procedure is performed. This can be important in a variety of situations, e.g., where the procedure may dislodge debris which could harm downstream tissue. 
     Access system  5  is preferably constructed so that erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  may be diametrically-expanded and diametrically-reduced independently of one another. In other words, access system  5  is preferably constructed so that proximal isolation barrier  10  may be diametrically-expanded or diametrically-reduced regardless of the condition of distal isolation barrier  15 , and vice-versa. 
     Where erectable proximal isolation barrier  10  and erectable distal isolation barrier  15  are formed out of an inflatable/deflatable balloon, access system  5  also comprises channels for delivering fluid (a liquid or a gas) for inflating/deflating the balloons. By way of example but not limitation, a channel  16  may be provided for inflating the balloon of erectable proximal isolation barrier  10  and a channel  17  may be provided for inflating the balloon of erectable distal isolation barrier  15 . 
     Access system  5  further comprises a bypass channel  20  secured to, and extending between and through, proximal isolation barrier  10  and distal isolation barrier  15 . Bypass channel  20  comprises a central lumen  25  ( FIG. 3 ) which opens proximal to proximal isolation barrier  10  and distal to distal isolation barrier  15 , whereby to permit flow from one side of access system  5  to the other side of access system  5 . As a result of this construction, when access system  5  is deployed in a vascular structure so as to isolate a segment of the vascular structure from the remainder of the vascular structure, access system  5  can still permit blood to flow uninterrupted through the bypass channel  20  which traverses the isolated segment of the vascular structure. This can be important in a variety of physiologic situations, e.g., such as where continued blood flow is important for the oxygenation of downstream tissues. 
     In one embodiment, the upstream isolation barrier may be configured so as to channel blood flow into bypass channel  20 . Thus, for example, in  FIG. 1 , proximal isolation barrier  10  may be configured so as to channel blood flow into bypass channel  20 . By way of example but not limitation, the upstream side of proximal isolation barrier  10  may be formed with a concave (e.g., funnel-shaped) surface surrounding the entrance to bypass channel  20 . 
     Thus it will be seen that access system  5  provides both zone isolation (via proximal isolation barrier  10  and distal isolation barrier  15 ) and distal perfusion (via bypass channel  20 ). These features can be important in a variety of situations where zone isolation and distal perfusion are both desirable and/or necessary, e.g., where vascular trauma needs to be temporarily stabilized while the patient is transported to another site for further treatment, where an aneurysm (e.g., abdominal or thoracic, iliac or femoral, etc.) is bleeding and/or threatening to rupture, or actually has ruptured, etc. Furthermore, it should be appreciated that access system  5  may be used on both the arterial and venous sides of the circulation system. 
     Access system  5  further comprises a working catheter  30  which passes through proximal isolation barrier  10  and provides access (e.g., for medical instruments including but not limited to cutting instruments, biopsy instruments, closure instruments, material delivery systems, endoscopes, etc., including for the delivery of adhesives and/or agents for promoting thrombus, gene therapeutic agents, etc.) to the wall of the isolated length of the vascular structure. Preferably, working catheter  30  can slide forward and backward through proximal isolation barrier  10  such that working catheter  30  can be positioned anywhere between proximal isolation barrier  10  and distal isolation barrier  15 . Additionally, access system  5  is preferably configured so that working catheter  30  can be rotated in order that the distal tip  33  of working catheter  30  can access substantially the entire circumference of the isolated vessel. 
     Access system  5  is preferably configured so as to be mountable on a guidewire  35 , so that access system  5  may be delivered to a desired position within the vascular structure. By way of example but not limitation, access system  5  may comprise a guidewire channel  40  mounted to proximal isolation barrier  10  and/or working catheter  30  (e.g., proximal to proximal isolation barrier  10 , as shown in  FIG. 1 ), such that guidewire  35  may be received within bypass channel  20  and guidewire channel  40 , whereby to permit controlled delivery of access system  5  to a desired location within a vascular structure. 
     In one preferred form of use, and looking now at  FIGS. 1-3 , access system  5  may be used to isolate, bypass and access the wall of a vascular structure. By way of example but not limitation, access system  5  may be used to isolate, bypass and access a lateral aneurysm  45  formed in the wall of a vascular structure  50 . In this case, guidewire  35  is first deployed down vascular structure  50 . Then access system  5 , with proximal isolation barrier  10  and distal isolation barrier  15  set in their diametrically-reduced condition, is advanced over the guidewire to a point adjacent to lateral aneurysm  45 . Next, proximal isolation barrier  10  and distal isolation barrier  15  are set in their diametrically-expanded condition, so as to conform to, and seal against, the wall of the vascular structure and thereby create an isolation zone  55  which encompasses lateral aneurysm  45 . However, it will be appreciated that blood is still able to flow past the isolation zone (e.g., from flow zone  60  to flow zone  65 ) via bypass channel  20 . To the extent that the proximal end of working catheter  30  is open to the atmosphere, blood in the isolation zone may flow out of the isolation zone via the working catheter and be replaced with air. Alternatively, the working catheter may be used to introduce another fluid (e.g., saline) into the isolation zone. At this point, instruments may be advanced through working catheter  30  so as to access, and provide therapy to, lateral aneurysm  45 . Such instruments may include, but are not limited to, cutting instruments, biopsy instruments, closure instruments, material delivery systems, endoscopes, etc. At the conclusion of the procedure, proximal isolation barrier  10  and distal isolation barrier  15  are set in their diametrically-reduced condition, and then access system  5  is withdrawn along guidewire  35 . Finally, guidewire  35  is removed from vascular structure  50 . 
     Any debris created in isolation zone  55  during the procedure may be removed by withdrawing blood/debris from isolation zone  55 . In one form of the invention, blood/debris evacuation may be effected by applying suction via working catheter  30  while both proximal isolation barrier  10  and distal isolation barrier  15  remain erected. In another form of the invention, blood/debris evacuation may be effected by first returning proximal isolation barrier  10  to its diametrically-reduced configuration while retaining distal isolation barrier  15  in its diametrically-expanded configuration, then removing blood/debris via suction, and then returning distal isolation barrier  15  to its diametrically-reduced configuration so that access system  5  may be removed from the vascular structure. This latter approach may be particularly applicable to angioplasty in the coronary and/or carotid arteries. 
       FIGS. 4 and 5  show an alternative form of access system  5 . The access system shown in  FIGS. 4 and 5  is substantially the same as the access system shown in  FIGS. 1-3 , except that guidewire channel  40  extends parallel to, but spaced from, bypass channel  20  and bypass channel  20  is positioned diametrically outboard so as to sit proximate to the wall of the vascular structure. 
     If desired, working catheter  30  may be made detachable from the remainder of access system  5 . This feature can be advantageous where longer term isolation of a vascular region is desired, e.g., for aneurysm embolization, since it allows the relatively large-bore working catheter to be removed, leaving only the zone isolation apparatus and fluid bypass apparatus present in the body lumen. 
     As noted above, proximal isolation barrier  10  and distal isolation barrier  15  are designed so as to be able to assume a diametrically-expanded configuration or a diametrically-reduced configuration. As also noted above, proximal isolation barrier  10  and distal isolation barrier  15  may comprise an inflatable/deflatable balloon or a compressible/expandable ring, etc. In this respect it should be appreciated that where proximal isolation barrier  10  and distal isolation barrier  15  comprise an inflatable/deflatable balloon, the balloon may extend across substantially the entire diameter of the vascular structure. Alternatively, the balloon may extend only about the periphery of the diameter of the vascular structure, and a membrane  67  may extend across the interior of the balloon, such as is shown in  FIG. 3 . A similar construction may be used where proximal isolation barrier  10  and distal isolation barrier  15  comprise a compressible/expandable ring, e.g., such as one formed from a superelastic shape memory alloy. Again, a membrane may extend across the interior of the ring. 
       FIGS. 6-9  show an alternative form of access system  5 . The access system shown in  FIGS. 6-9  is substantially the same as the access system shown in  FIGS. 1-3  except that proximal isolation barrier  10  and distal isolation barrier  15  comprise multi-segmented balloons  70 , and working catheter  30  includes an opening  75  connected to the lumen of working catheter  30 . The use of these multi-segmented balloons  70  to form proximal isolation barrier  10  and distal isolation barrier  15  provide a wider, more stable barrier without restricting blood flow through bypass channel  20 . As seen in  FIG. 9 , channels  80  may be provided between adjacent balloons so that the interior of the balloons are in communication with one another. 
       FIGS. 10-12  show an alternative form of access system  5 . The access system shown in  FIGS. 10-12  is substantially the same as the access system shown in  FIGS. 6-9  except that channels  80  may be replaced with holes  85  so that the interior of the balloons are in communication with one another. 
     Deployment 
     Access system  5  may be deployed in a vascular structure or other body lumen using a delivery catheter. More particularly, and looking next at  FIGS. 13, 14, 14A and 15-20 , a delivery catheter  100  comprising a delivery sheath  103  may be provided for advancing access system  5  to a procedure site within a vascular structure (or other body lumen), and for erecting access system  5  in the manner previously discussed. Furthermore, delivery catheter  100  may be used for advancing instruments down to the procedure site and/or removing debris from the procedure site (e.g., a fusiform aortic aneurysm  104  of the type shown in  FIG. 14A ), again in the manner previously discussed. Finally, delivery catheter  100  may be used to collapse access system  5  and remove it from the vascular structure (or other body lumen). In the case where access system  5  comprises inflatable/deflatable balloons in its proximal isolation barrier and/or distal isolation barrier  15 , delivery catheter  100  may contain one or more fluid supply tubes  105  for inflating/deflating the balloons. It should be appreciated that delivery sheath  103  of delivery catheter  100  may also perform the function of an introducer sheath, in the sense that it can be secured to the exterior tissue of the patient once the delivery catheter is properly positioned. A hemostatic valve  110 , with a side port  115 , is preferably located on the proximal end of the delivery catheter to prevent the loss of blood through the catheter while still allowing the insertion of access system  5 . 
     Anatomical Applications 
     It should be appreciated that access system  5  can be used to provide a wide range of therapies to vascular structures, e.g., aneurysm therapy, lesion therapy, infusion therapy, gene therapy, photodynamic therapy, etc. Access system  5  may also be used to repair tears, flaps and leaks in a vascular structure. 
     Furthermore, it should be also be appreciated that the present invention can be used to access structures other than vascular structures, e.g., the esophagus, stomach, small or large bowel, ureter, bladder, urethra, bronchus, bile duct, ear, nose, fallopian tube, other tubular or hollow structures within the human body, etc. In essence, the present invention can be advantageously used in substantially any body lumen where isolation, access and/or fluid bypass are desired. Additionally, it should be appreciated that the zone which is isolated between the proximal and distal isolation barriers could be of varying lengths, and of various diameters as well. Furthermore, many different catheter shapes and sizes may be utilized. 
     Without limiting the breadth and scope of the present invention, it is anticipated that the present invention is particularly well suited for treating fusiform aneurysms in the aorta and the larger peripheral blood vessels. 
     Furthermore, without limiting the breadth and scope of the present invention, it is anticipated that the present invention is particularly well suited for treating vascular trauma in a variety of situations where zone isolation and distal perfusion are both desirable and/or necessary, e.g., where vascular trauma needs to be temporarily stabilized while the patient is transported to another site for further treatment. 
     Modifications 
     While the present invention has been described in terms of certain exemplary preferred embodiments, it will be readily understood and appreciated by one of ordinary skill in the art that it is not so limited, and that many additions, deletions and modifications may be made to the preferred embodiments discussed above while remaining within the scope of the present invention.

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