Abstract:
A venous closure catheter is disclosed for performing sclerotherapy which includes an elongated catheter body having opposed proximal and distal end portions, a fluid delivery lumen and a guidewire lumen. A plurality of discharge apertures are associated with the distal end portion of the catheter body and communicate with the fluid delivery lumen for delivering a sclerosing solution into the saphenous vein. A circumferential flange is positioned on an exterior surface of the catheter body proximal to the discharge apertures, which has a plurality of projections formed thereon for traumatizing the inner wall of the saphenous vein upon removal of the catheter body therefrom to promote closure of saphenous vein after sclerotherapy. A compression apparatus is disclosed for providing therapeutic pressure subsequent to sclerotherapy. The compression apparatus includes first and second wraps for providing compression of an upper leg, and the lower leg and foot, respectively.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application Ser. Nos. 61/341,921 filed on Apr. 7, 2010 and 61/342,368 filed on Apr. 13, 2010. The entire contents of these applications are incorporated herein by this reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The subject invention is directed generally to a venous catheter, and more particularly, to a venous catheter and method for performing sclerotherapy to treat varicose veins or spider veins by delivering a sclerosing solution into the saphenous vein, subsequently abrading the inner wall of the blood vessel upon removal of the catheter from the vein to promote venous closure, and using a compression apparatus to provide therapeutic pressure post-operatively. 
     2. Background of the Related Art 
     Chemical occlusion, also known as sclerotherapy, is a procedure used to treat blood vessels or vessel malformations, wherein a sclerosing solution is injected into the vessels, which makes the unwanted veins shrink and then dissolve over a period of weeks, as the body naturally absorbs the treated vein. Sclerotherapy is often used to eliminate large spider veins (telangiectasiae) and smaller varicose leg veins. 
     During a treatment procedure, sclerosing solution is injected into the abnormal veins of the involved leg. The patient&#39;s leg is then compressed with either stockings or bandages that they wear usually for two weeks after treatment. Complications, while rare, include venous thromboembolism, visual disturbances, allergic reaction, thrombophlebitis, skin necrosis, and hyperpigmentation. If the sclerosing agent is injected properly into the vein, there is no damage to the surrounding skin, but if it is injected outside the vein, tissue necrosis and scarring can result. Most complications occur due to an intense inflammatory reaction to the sclerotherapy agent in the area surrounding the injected vein. In addition, there are systemic complications that are now becoming increasingly understood. These occur when the sclerosing solution travels through the veins to the heart, lung and brain. 
     Apparatus and methods are also known for performing sclerotherapy using a catheter, as disclosed for example in U.S. Pat. No. 6,726,674, the disclosure of which is incorporated herein by reference in its entirety. When the catheter is deployed in blood vessels, an inflatable member sealingly engages the interior walls of the blood vessel, establishing an isolated vessel segment to facilitate localized introduction of a sclerosing agent. Upon collapse of the inflatable member, the sclerosing agent is also withdrawn from the blood vessel. Over time, the treated vessel segment will shrink and then dissolve, as the body naturally absorbs the treated vein. 
     It would be beneficial to provide a venous catheter for delivering a sclerosing agent into a targeted vein that is configured to prohibit the migration of the sclerosing solution during treatment of the vein and which is also adapted to enhance the closure of the vein walls following sclerotherapy treatment. 
     SUMMARY OF THE INVENTION 
     The subject invention is directed to a venous closure catheter for performing ultrasound guided sclerotherapy which includes, among other things, an elongated catheter body having opposed proximal and distal end portions and at least one interior lumen, aperture means associated with the distal end portion of the catheter body and communicating with an interior lumen of the catheter body for delivering a sclerosing solution into the saphenous vein, and abrading means operatively positioned on the exterior of the catheter body proximal to the aperture means for abrading or otherwise traumatizing the inner wall of the saphenous vein upon removal of the catheter body therefrom to promote closure of saphenous vein after sclerotherapy. 
     Preferably, the aperture means is a plurality of fluid delivery ports formed in the distal end portion of the catheter body, although alternative features may be employed. Preferably, the abrading means is a circumferential flange having a plurality of projections adapted and configured to abrade the inner wall of the saphenous vein. It is envisioned that the flange has a generally frusto-conical configuration with a base oriented toward the proximal end portion of the catheter body and each projection has a barb-shaped configuration with a point that is oriented toward the proximal end portion of the catheter body. It is also envisioned that the flange may be adapted and configured for selective positioning along the length of the catheter body. 
     The subject invention is also directed to a method for performing sclerotherapy that includes the steps of introducing an elongated venous catheter into the saphenous vein, delivering a sclerosing solution into the saphenous vein through a distal end portion of the venous catheter, and abrading or otherwise traumatizing the inner wall of the saphenous vein upon removal of the venous catheter from the saphenous vein. 
     Preferably, the method further includes the steps of dividing the saphenous vein a short distance below the sapheno-femoral junction, percutaneously introducing a guidewire into the saphenous vein at a location proximate the ankle and advancing the guidewire toward the divided end of the saphenous vein. In such a case, the step of introducing the venous catheter into the saphenous vein includes the step of guiding the introduction of the venous catheter along the guidewire from the divided end of the saphenous vein. 
     The subject invention is also directed toward a method of providing post operative pressure to the leg using a compression apparatus. In conjunction with performing the methods of sclerotherapy described herein, the method includes the step of providing post operative pressure to the leg containing the abraded saphenous vein. The method may further comprise the step of encircling the leg with a compression apparatus. In one embodiment, the step of encircling the leg with the compression apparatus further comprises the step of encircling at least an upper portion of the leg with a first wrap member. In another embodiment, the step of encircling the leg with the compression apparatus further comprises the step of encircling a lower portion of the leg and foot with a second wrap member. In yet another embodiment, the method of the subject invention further comprises the step of inflating a continuous chamber within a material of the compression apparatus. The method may further comprise the step of measuring pressure supplied to the leg by the inflated compression apparatus. The method may further comprise the step of securing the first wrap member about the upper portion of the leg using an adjustable strap around a patient&#39;s waist. 
     These and other aspects of the venous closure catheter of the subject invention will become more readily apparent from the following description taken in conjunction with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the female connector of the subject invention, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein: 
         FIG. 1A  is a schematic representation of the ligation of the saphenous vein below the sapheno-femoral junction to facilitate a sclerotherapy treatment within the long saphenous vein, 
         FIG. 1B  shows the positioning of a guidewire in the divided saphenous vein, which is introduced percutaneously from the ankle; 
         FIG. 2  is a plan view of a preferred embodiment of the venous closure catheter of the subject invention; 
         FIG. 3  is a cross-sectional view of the venous closure catheter taken along line  3 - 3  of  FIG. 2 , showing the interior lumens thereof; 
         FIG. 4  shows the guided introduction of the venous closure catheter of the subject invention into the divided saphenous vein; 
         FIG. 5  shows the transvenous placement of the venous closure catheter of the subject invention through the saphenous vein; 
         FIG. 6  shows introduction of sclerosing solution into the saphenous vein from the distal end portion of the venous catheter of the subject invention; 
         FIG. 7  shows the removal of the venous closure catheter from the saphenous vein after sclerotherapy, wherein the interior walls of the saphenous vein are abraded by the catheter during removal to promote vessel closure; 
         FIGS. 8 and 9  show alternate embodiments of the abrading feature of the venous closure catheter of the subject invention; 
         FIG. 10A  is a perspective view of the exterior surface of an exemplary upper leg wrap according to the subject invention illustrated in an unwrapped state; 
         FIG. 10B  is a perspective view of the interior surface of the upper leg wrap illustrated in an unwrapped state; 
         FIG. 11A  is a perspective view of an upper leg wrap encircled around the upper leg and further secured to the upper leg using an optional adjustable belt around the patient&#39;s waist, the upper leg wrap being inflated using a detachable manual pump; 
         FIG. 11B  is a side view of the upper leg wrap of  FIG. 11A , the manual pump having been detached; 
         FIG. 12  is a perspective view of the interior surface of an exemplary lower leg wrap according to the subject invention illustrated in an unwrapped state; 
         FIG. 13A  is a perspective view of the exemplary lower leg wrap of  FIG. 12  as it is being encircled around the lower leg of a patient; and 
         FIG. 13B  is a perspective view of the exemplary lower leg wrap of  FIG. 13A  as the stirrup of the lower portion is being secured to the upper portion. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     1. Venous Closure Catheter Apparatus and Method 
     Referring now to the drawings wherein like reference numerals identify similar structural elements of the venous catheter of the subject invention, there is illustrated in  FIG. 1A  a schematic representation of the greater saphenous vein  10  of the leg, divided and freed a short distance below the sapheno-femoral junction  12 , to facilitate sclerotherapy treatment utilizing the venous closure catheter of the subject invention, described in detail below. At such a time, the divided end of the sapheno-femoral junction, above the ligation is tied-off with one or more sutures  13 . 
     Referring to  FIG. 1B , there is shown a guidewire  14  for guiding the transvenous introduction of the venous catheter of the subject invention into the divided saphenous vein  10 . In accordance with a preferred embodiment of the subject invention, the guidewire  14  is percutaneously introduced into the saphenous vein  10  from a location proximate the ankle and subsequently advanced toward the divided end of the saphenous vein where it is grasped and retained by the practitioner. 
     Referring now to  FIG. 2 , there is illustrated the venous closure catheter of the subject invention, which is designated generally by reference numeral  20 . Venous catheter  20  includes an elongated catheter body  22  formed from a soft or otherwise flexible medical grade polymer, such as, for example, Polyurethane, Tecothane, Pebax, C-Flex or Silicone. The flexible catheter body  22  is preferably provided in various lengths to accommodate different anatomy (e.g., 30 to 60 centimeters in length) and has an outer diameter of about between 4 F and 5 F. 
     Referring to  FIG. 3 , catheter body  22  includes one or more interior lumens  23   a ,  23   b  to facilitate the delivery of sclerosing solution or other media into a targeted vein section. In addition, at least one interior lumen  25  is provided to accommodate the passage of guidewire  14  during the transvenous introduction and removal of catheter  20 . The interior lumens communicate with conventional fittings  27  operatively associated with the proximal end portion  29  of the catheter body  22 . 
     Referring back to  FIG. 2 , the distal end portion  24  of catheter body  22  includes a plurality of apertures or ports  26  that are in fluid communication with one or both of the interior fluid delivery lumens  23   a ,  23   b  provided within catheter body  22 . The apertures  26  are adapted and configured to introduce or otherwise deliver a sclerosing solution into the saphenous vein  10  during a sclerotherapy procedure. Alternatively, the distal end portion  24  of catheter body  22  can be open-ended to serve as a fluid delivery port. In such an instance, one or both of the fluid delivery lumens  23   a ,  23   b  would communicate directly with the open distal end of the catheter body  22 . 
     With continuing reference to  FIG. 2 , venous closure catheter  20  also includes a circumferential flange  28  spaced from the distal end of the catheter body  22 , proximal to the fluid discharge apertures  26 . The circumferential flange  28  preferably has a frusto-conical shape to ease transvenous introduction of the catheter body  22 . However, those skilled in the art should readily appreciate that the flange  28  can have a different shape than frusto-conical without departing from the spirit or scope of the subject disclosure. For example, as shown in  FIG. 8  it is envisioned that the circumferential flange  28   a  could be circular or ovoid in shape, or as shown in  FIG. 9 , the flange  28   b  could be cylindrical or annular in shape. 
     With continuing reference to  FIG. 2  in conjunction with  FIG. 4 , the circumferential flange  28  is provided with a plurality of spaced protuberances or projections  30 . The projections  30  are preferably barb-shaped and are oriented in rows with the pointed edges facing toward the proximal end of the catheter body  22 , and away from the distal end portion  24 . By orienting the projections  30  in this manner, during transvenous introduction of the venous catheter  20  into the saphenous vein  10 , the projections  30  do not affect or other traumatize the vessel wall  16 , as illustrated in  FIG. 5 . 
     When the distal end portion  24  of catheter body  22  has reached the treatment site within the saphenous vein  10 , as shown in  FIG. 6 , the sclerosing solution is delivered into the blood vessel through the plurality apertures  26 . Thereupon, the sclerosing solution works to close and shrink the saphenous vein. During treatment, the circumferential flange  28  functions to limit or otherwise prohibit the migration of the sclerosing solution from the treatment site. 
     Referring to  FIG. 7 , when the venous closure catheter  10  is withdrawn or otherwise removed from the saphenous vein  10  after sclerotherapy treatment, the barb-like projections  30  on circumferential flange  28  abrade or otherwise traumatize the interior wall  16  of the saphenous vein  10 . By abrading the vein wall  16  vessel closure is further promoted, enhancing the effect of the sclerosing solution. After the venous catheter  20  has been removed from the saphenous vein  10 , the dissected free end of the vein is tied off and the entrance wound adjacent the sapheno-femoral junction is closed. 
     It is envisioned that the circumferential flange  28  can be fixedly attached to the catheter body  20  at a desired location relative to the apertures  26  in the distal end portion  24 , or it could be adapted and configured for selective placement at a desired location along the length of the catheter body  22  prior to vascular introduction. 
     2. Method for Providing Post-Operative Pressure Using Compression Apparatus 
     The subject invention is also directed to methods for supplying pressure post-operatively using a compression apparatus. Following sclerotherapy treatment of the saphenous vein, for example, the compression apparatus of the subject invention may be used to provide therapeutic pressure to the upper leg and lower leg and foot in order to promote circulation and healing. The features of the upper leg wrap and the lower leg and foot wrap and methods associated therewith will be discussed in turn. 
     Referring now to  FIG. 10A , an exemplary embodiment of an upper leg wrap  110  according to the subject invention is shown. The upper leg wrap  110  is shown in an unwrapped state having an exterior surface  112   a . A user applies the upper leg wrap  110  by encircling the thigh in order to supply compression thereto. The exterior surface  112   a  and interior surface  112   b  of the upper leg wrap  110  are joined along common peripheral edges of the upper leg wrap  110  to form a chamber. The exterior surface  112   a  and interior surface  112   b  are both made of non-elastic materials, which do not stretch when inflated, in order to facilitate localized compression of the treatment site. As shown in  FIG. 10A , the upper leg wrap  110  is also manufactured with a number of stitched darts  122  and gathers  124  which are strategically placed to contour the upper leg wrap  110  around the thigh. The upper leg wrap  110  may also include a permanent or detachable pressure gauge  121 , such as a manometer, which may be capable of being detached using a connector at the inlet port  119 . A pump  120 , for example, a manual or electric pump, may also provided for pumping air into the inflatable chamber through an optional tube  117 . 
     Referring now to  FIG. 10B , upper leg wrap  110  of  FIG. 10A  is illustrated in an unwrapped state having interior surface  112   b . The upper leg wrap  110  may be attached to a patient&#39;s upper leg  111 , by encircling the upper leg  111  and attaching the upper leg wrap  110  to itself along the vertical peripheral edges  116   a  and  116   b  using a number of connecting structures. For example, three hook and loop fastening tabs, such as connecting tabs  114   a ,  114   b , and  114   c , may be provided to connect the opposing vertical peripheral edges  116   a  and  116   b  of the upper leg wrap  110  securely about the upper leg  111 . Buckles, straps, snaps or other known structures may also be used to secure the upper leg wrap  110  around the patient&#39;s upper leg  111 . The number and position of the connecting tabs  114   a ,  114   b ,  114   c , may be selected based on the anatomical dimensions of the patient&#39;s upper leg  111  in order to reduce bunching, sagging and patient discomfort. 
     Referring now to  FIGS. 11A and 11B , at a horizontal proximal end  118   a , opposite the distal end  118   b  located towards the knee, an optional garter or adjustable belt  126  may be provided to further secure the upper leg wrap  110  in place. The adjustable belt  126  may be worn around the waist and connected to the upper leg wrap  110  using expandable connecting straps  128   a  and  128   b . The number and placement of the expandable connecting straps  128   a ,  128   b  may also be altered to accommodate the patient&#39;s anatomical dimensions. 
     Referring now to  FIG. 12A , an exemplary embodiment of a lower leg and foot wrap  130  according to the subject invention is illustrated in an unwrapped state. The lower leg and foot wrap  130  includes two portions, an upper portion  132  and a lower portion  134 . The upper portion  132  is adapted and configured to supply compression of a patient&#39;s lower leg  142 , whereas the lower portion  134  is adapted and configured to supply compression of a patient&#39;s foot  148 . In one embodiment, the upper portion  132  and lower portion  134  are provided as one continuous piece of inflatable material, as shown in  FIG. 112A . However, the upper portion  132  and the lower portion  134  may also be provided separately. 
     Like the upper leg wrap  110 , the lower leg and foot wrap  130  is formed of an interior surface  150   a  and exterior surface  152   b  joined along common peripheral edges to faun an inflatable chamber  140 . In addition, the exterior surface  152   b  and interior surface  152   a  of the lower leg wrap  130  are made of non-elastic materials, which do not stretch when inflated, in order to facilitate localized compression of the lower leg  142  and foot  148 . The lower leg wrap  130  may also be manufactured with a number of stitched darts  122  and gathers  124  (not shown) which are strategically placed to contour the lower leg and foot wrap  130  around the lower leg  142  and foot  148 . The lower leg and foot wrap  130  may also include a permanent or detachable pressure gauge  121 , (e.g. a manometer) and a pump  120  for inflating the compression apparatus  130 . In one exemplary embodiment, the lower leg and foot wrap  130  is configured such that the inflatable chamber  140  is confined to only a portion of the lower leg and foot wrap  130 . For example, the inflatable chamber  140  is illustrated in  FIG. 12  by the area within the dotted lines. The exemplary inflatable chamber  140  is typically inflated with air, but may be filled with a number of different fluids including liquids and gels. 
     Referring now to  FIG. 13A , the lower leg and foot wrap  130  may be attached to by the patient to his or her lower leg  142  using one hand to hold vertical peripheral edge  136   a  in place, and encircling the upper portion  132  of the lower leg wrap  130  around the lower leg  142 . The upper portion  132  of the lower leg and foot wrap  130  is then attached to itself along opposing vertical peripheral edges  136   a  and  136   b  using a number of connecting structures provided along vertical peripheral edge  136   b , such as hook and loop fastening tabs  144   a ,  144   b , and  144   c . The structure and configuration of the connecting structures  144   a - 144   c  may also be varied, as described above with respect to fastening tabs  114   a ,  114   b , and  114   c  of the upper leg wrap  110 . 
     The lower portion  134  of the lower leg wrap  130  may have a number of configurations depending on the therapeutic needs of the patient. The lower portion  134  may be open-toed to expose the toes of the patient&#39;s foot  148  as shown in  FIGS. 12A-12C . Alternatively, the lower portion  134  may be configured as a close-toed boot (not shown). In addition, the lower portion  134  may have an open heel as shown in  FIGS. 13A-B  or have a closed heel, similar to a boot (not shown). 
     Referring now to  FIG. 13B , a stirrup  146  may also be provided to help to secure the lower portion  134  in place. As shown in  FIG. 12 , the stirrup  146  is located between the upper portion  132  and the lower portion  134 , and is typically one continuous piece of elastic material connected to and integrated with the lower portion  134 . The stirrup  146  may have a hook and loop connecting tab  150 , or other suitable connecting structure, to help secure the stirrup  146  to the upper portion  132 . 
     While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein.