Patent Document

RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 60/541,821 filed Feb. 2, 2004, which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention generally relates to the field of occluding devices, delivery systems for such devices and the method of using such devices and systems in the occlusion of body passageways. The invention is particularly useful for the occluding reproductive lumens such as a female patient&#39;s fallopian tubes or a male patient&#39;s vas deferens to affect contraception. 
     Conventional contraceptive strategies generally fall within three categories: physical barriers, drugs and surgery. While each have certain advantages, they also suffer from various drawbacks. Barriers such as condoms and diaphragms are subject to failure due to breakage, displacement and misplacement. Drug strategies, such as the pill and Norplant™, which rely on artificially controlling hormone levels, suffer from known and unknown side-effects from prolonged use. Surgical procedures, such as tubal ligation and vasectomy, are very effective, but involve the costs and attendant risks of surgery, and are frequently not reversible. 
     Recently, minimally invasive treatments have be proposed which deploy occluding stent-like devices within reproductive lumens, e.g. the fallopian tubes or vas deferens, as a contraceptive alternative to tubal ligation or vasectomy. However, placing a stent or similar occluding device may not create sufficient or permanent obstruction of the reproductive lumen depending on the nature of the obstructive device. For example, the obstructive device may be too small to provide complete obstruction of the reproductive lumen, or the device may be permeable to cell movement. An occluding device placed in a reproductive lumen, for example, may not securely seal against the luminal walls, or may initially allow egg cells or sperm cells to pass through the device until tissue growth completes the occlusion of the reproductive lumen and thus allow pregnancy to occur. Additionally, the occluding device might create an initial obstruction sufficient to prevent the passage of an egg but allow sperm cells to pass through or by the occluding device, fertilizing an egg upstream of the obstruction and resulting in an ectopic pregnancy. 
     The use of an occluding contraceptive or sterilization device, particularly with mesh or fibrous material to promote tissue ingrowth, has been proposed (See for example U.S. Pat. Nos. 6,096,052 and 6,432,116). However, with these devices there is an initial period (several weeks to several months) after deployment during which the patient is at risk for cell passage through the device that can result in pregnancy. In such situations it may be desirable to use a supplemental method of birth control until tissue ingrowth effectively occludes the fallopian tube. The same initial risks are found when occluding a male&#39;s vas deferens. 
     Even in situations in which complete obstruction has been achieved initially, the body lumen may recannalize. For example, an obstruction placed in a fallopian tube may create an initial blockage that obstructs passage of sperm or eggs. However, over time the walls of the tube may reconfigure to create a channel around the obstruction, effectively recannalizing the fallopian tube. 
     SUMMARY OF THE INVENTION 
     The present invention relates devices and methods for occluding a body lumen, particularly a reproductive body lumen such as a female patient&#39;s fallopian tube or a male patient&#39;s vas deferens, which effectively occludes the body lumen initially and over the long term. 
     Occluding devices which incorporate features of the invention generally have an expandable occluding component configured for deployment within the patient&#39;s body lumen such as a reproductive lumen. The occluding component has an impermeable barrier element secured thereto which is substantially impermeable to the passage of biological components such as cells, particularly reproductive cells such as eggs and sperm cells to provide an immediate barrier, i.e. at the time of deployment. The occluding component also has one or more permeable components that are secured to, disposed within or otherwise part of the occluding component to facilitate tissue growth that provides long term or permanent occlusion. Tissue growth can be into or onto the occluding component to at least partially occlude the reproductive lumen. Tissue growth may include epithelialization, scar formation, cell proliferation, or other cell growth or multiplication. 
     One occluding device embodying features of the invention has an occluding component in the form of a stent-like structure which has an impermeable barrier component to ensure initial occlusion of the body lumen and a permeable component to facilitate tissue ingrowth into or onto the stent-like structure of the occluding component for long term or permanent occlusion thereof. 
     In one embodiment, the impermeable barrier component is an inflatable and detachable balloon formed of impermeable material. The stent-like structure is mounted onto an impermeable, inflatable and detachable balloon of a delivery device such as a catheter. and the distal end of the delivery device is introduced into the body lumen and advanced therein until the detachable balloon is disposed in the location where the user desires to place the occluding device. The balloon is then inflated to the desired size, preferably to the diameter or a slightly larger dimension than the diameter of the body lumen. The expansion of the balloon expands the stent-like structure mounted on the balloon and against the wall of body lumen. After inflation, the shaft of the delivery catheter is disengaged from the detachable balloon portion of the delivery catheter and then withdrawn, leaving the stent-like structure in place against the walls of the body structure with the inflated, detached balloon disposed within the inner lumen of the stent-like occluding component. One or more permeable components such as fibrous mesh, a fiber bundle or a porous polymeric mass or plug are provided within the occluding component to facilitate tissue ingrowth and over time to create an effective and permanent occlusion of the body lumen. 
     A modification of the embodiment described above is to provide an impermeable diaphragm or membrane within the inner lumen of the stent-like occluding component or over one or more ends of the stent-like occluding component that seals the lumen of the stent when the stent-like structure is expanded against the walls of the body structure. The stent-like occluding component may be balloon expandable or self-expandable. A fibrous or otherwise porous mass or body, for example strands or bundles of biocompatible fibers or open cell biocompatible foam, may be provided within the stent-like structure as described above to facilitate tissue ingrowth. 
     A self-expanding occluding component may be formed of a superelastic metal such as NiTi which has been treated to have a stable austenite phase at body temperature and stress induced or stress maintained martensite phase. The occluding component may be in one, small diameter configuration for delivery in a suitable delivery catheter and expand upon discharge from the delivery catheter to a larger dimensioned second configuration within the body lumen. Alternatively, the occluding component may be formed of shape memory metallic material such as NiTi alloy which has a stable martensite phase at body temperature but which expands to a remembered larger diameter configuration when heated to transform the martensite to the austenite phase. 
     An expandable mass such as a plug on the interior of the occluding component may also to provide the expansion or augment natural or other expansion of the occluding component. The expandable mass may be the impermeable barrier component or the permeable component which facilitates tissue ingrowth. 
     Another occluding device embodying features of the invention is an occluding component comprising an expandable plug having a plurality of segments, at least one of which is an impermeable barrier component for initial occlusion of the body lumen and at least one of which is a permeable component configured to facilitate tissue ingrowth that provides a long term or permanent occlusion. The plug is configured to be compressible for delivery within a delivery sheath and to be expandable within the body lumen when discharged from the delivery sheath. The impermeable barrier segment may be an impermeable membrane or a closed cell mass or both. The permeable segment may be a fibrous or porous mass or both. The occluding component of this embodiment may have a stent-like attachment ring at one or both ends of the occluding device to secure the occluding component at least partially within the body lumen. The occluding component or attachment rings may be provided with anchoring elements such as hooks or barbs to secure the occluding component within the body lumen. The expanded occluding device provides an immediately effective occlusion of the body lumen, while tissue ingrowth over time provides a permanent and effective occlusion of the body lumen. 
     The occluding component may have the structure described in copending application Ser. No. 10/746,131, filed on Dec. 24, 2004, assigned to the present assignee which discloses an occluding component having one or more expanding spider-like elements. The impermeable barrier component is an impermeable membrane secured to the expanding legs of the spider-like element to provide initial occlusion of the body lumen. Fibrous or porous material may be secured to the expanding legs of the spider-like elements or to a central support shaft or spine connecting spider-like elements of the occluding component. 
     Other occluding components embodying features of the invention may comprise a plurality of expandable disks on a shaft in which at least one of the disks is an impermeable barrier component and at least one is a permeable component as described above. 
     Another occluding device has a stent-like occluding component with an enlarged bullet shaped impermeable barrier component on the leading end of the occluding component. One or more permeable components may be disposed in the interior of the occluding component. 
     The occluding component will generally be about 1 to about 5 mm, preferably about 2 to about 4 mm in transverse dimension in the expanded configuration and will generally be about 0.5 to about 8 cm, preferably about 1.5 to about 4 cm in length. While the description herein is focused on the use of only one occluding device, two or more occluding devices may be employed in a reproductive lumen. 
     The occluding devices and methods of using such occluding devices embodying features of the invention are effective both initially and over the long term in occluding the body lumen sufficiently to prevent the passage therethrough of undesirable biological elements, e.g. cells. The methods and devices are particularly beneficial for occluding reproductive lumens for contraceptive purposes. Although the occlusion of a patient&#39;s reproductive lumens are discussed herein in detail, it can be appreciated that the devices, methods and systems described herein can easily be adapted to occlude a patient&#39;s arteries or veins in a variety of situations, the nidus of an arterial-venous malformation, patent ductus arteriosis in infants, as well as arteries feeding blood to cancerous tumors. 
     These and other features of this invention will become more apparent in light of the detailed description of the invention and the exemplary drawings contained herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is an elevational view of an occluding device embodying features of the invention with a detachable, unexpanded balloon disposed within the inner lumen of the stent-like occluding component. 
         FIG. 1B  is an elevational view of the invention depicted in  FIG. 1A  with the balloon inflated. 
         FIG. 1C  is an elevational view of the inflated balloon in a detached configuration. 
         FIG. 2A  is a longitudinal cross sectional view of an alternative occluding device embodying features of the invention wherein an impermeable sack is disposed within the interior of the occluding component which is shown in an unexpanded configuration. 
         FIG. 2B  is a longitudinal cross sectional view of the occluding device shown in  FIG. 2A  with the device in an expanded configuration and with tissue ingrowth about the occluding component, taken along the lines  2 B- 2 B in  FIG. 2A . 
         FIG. 3A  is a longitudinal center-line cross sectional view of an alternative occluding device embodying features of the invention with a detachable occluding component with inflatable segments. 
         FIG. 3B  is a transverse cross-sectional view of the occluding device shown in  FIG. 3A . 
         FIG. 4  is a perspective view of an alternative occluding device embodying features of the invention having impermeable and permeable components forming part of the occluding component. 
         FIG. 5  is a perspective view of another alternative occluding device embodying features of the invention wherein the occluding component has a plurality of permeable and impermeable components and stent-like attachment rings at each end. 
         FIG. 6A  is an elevational view of another alternative occluding device embodying features of the invention with porous plugs disposed within the occluding component in an unexpanded configuration. 
         FIG. 6B  is an elevational view of the occluding device shown in  FIG. 6A  in an expanded configuration. 
         FIG. 7A  is an elevational view of another alternative occluding device disposed within a delivery tube with impermeable barrier components and permeable components in the form of unexpanded disks. 
         FIG. 7B  is an elevational view, partially in section, with the occluding device extending out of the delivery tube and the impermeable barrier component and the permeable components in expanded configuration. 
         FIG. 8  is an elevational view of an occluding device embodying features of the invention where the occluding component is in the form of a stent-like structure, impermeable components are on both ends of the stent-like occluding component and permeable components in the form of fibrous masses are within the inner lumen of the stent-like occluding component. 
         FIG. 9A  is an elevational view, partially in section, of another alternative occluding device embodying features of the invention with the occluding device contained within the lumen of a delivery tube. 
         FIG. 9B  is an elevational view, partially in section, of the occluding device shown in  FIG. 9A  deployed within a body lumen in an expanded configuration. 
         FIG. 10  is an elevational view, partially in section, of an alternative occluding device having features of the invention with an enlarged impermeable barrier component on the distal end of the occluding component. 
         FIG. 11  is a schematic view of the occluding device shown in  FIG. 10  disposed within a fallopian tube of a human female. 
         FIG. 12  illustrates detail of a stent-like occluding component that is suitable for use in the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 1A-1C  depict an occluding device  10  embodying features of the invention which includes an expandable, stent-like occluding component  11  and an inflatable detachable balloon-like barrier component  12  contained within the inner lumen  13  of the stent-like occluding component. The detachable balloon-like barrier element  12  is releasably secured to the distal shaft portion  14  of delivery catheter  15 . The inflatable balloon-like barrier  12  is located distal to a one-way valve  16  (e.g. a duck-billed valve as shown) which allows inflation fluid to be injected into the interior or the balloon like barrier, but prevents inflation fluid from flowing out of the balloon interior. A threaded connection  17  is provided between the balloon assembly and the distal shaft portion  14  of the delivery catheter  15  to detach the balloon-like barrier component  12  at the desired location. A second optional one-way valve  18  may be located proximal of the threaded connection  17  to act as a back flow valve within the inflation lumen  19  of the delivery catheter  15  to prevent body fluid from entering the inflation lumen after the balloon-like barrier element  12  has been detached. 
     The balloon-like barrier component  12  is formed of impermeable, biocompatible polymeric material. Suitable polymeric materials include polyethylene terephthalate (PET), nylon and polyesters such as Hytrel®. Other moderately-compliant to essentially non-compliant biocompatible polymeric materials are suitable. Biocompatible and bioresorbable materials such as polylactic acid, polyglycolic acid, polycaprolactone and blends and copolymers thereof are also suitable in some instances. 
     A plurality of fibrous permeable components  20  and  21  are provided within the stent-like occluding component  11  at each end thereof to facilitate tissue ingrowth therein. The permeable components may be a mass of fibrous material as shown, or a plug or mass of porous polymeric material. 
     The occluding member  10  is advanced to the desired location within the body lumen  22 , such as a female patient&#39;s fallopian tube, with the stent-like occluding component  11  mounted on the balloon-like barrier element  12  in a non-inflated condition. Inflation fluid (indicated by the arrows  23  in  FIG. 1B ) is introduced through the catheter&#39;s inflation lumen  19  into the interior of the balloon-like barrier component  11  to inflate the barrier component within the stent-like occluding component  11  to expand the occluding component until it is in contact with the wall  24  of the body lumen  22 . The inflation fluid may be saline, a biocompatible gas, or some other similar fluid or fluid like substance. The inflation fluid may be a liquid or foam that solidifies after inflation, so that the balloon is a relatively solid structure after inflation. 
     The balloon of the occluding component  11  will be inflated with sufficient pressure to press the stent like component  11  against the wall of the body lumen  22  and form a secure seal between the balloon and the body lumen wall, but not with sufficient force to rupture or otherwise damage the lumen or the balloon. The detachable distal shaft section  14  of the delivery catheter  15  is detached from the balloon assembly by rotating the shaft to unscrew the shaft section from the balloon section. After detaching the shaft  15  from the balloon, the back-flow valve  18  prevents fluid in the body lumen from traveling back up the inner lumen  19  of the delivery catheter  15 . The one-way valve  16  adjacent the balloon prevents loss of inflation fluid and ensures that the balloon remains in the inflated condition. 
     The balloon of the impermeable barrier component  12  is made of a material which is impermeable to preselected biological elements in order to seal the body lumen and prevent the passage of such biological elements. As used herein, “impermeable” means impermeable to the extent and appropriate for the purpose. For example, a barrier for contraceptive purposes in a reproductive lumen such as a fallopian tube or vas deferens is impermeable if, when placed across the reproductive lumen, it will block the passage of sperm cells or an egg through the reproductive lumen. The barrier need not be air tight, fluid tight (indeed the ability to pass some fluid might be desirable) and may even allow the passage and ingrowth of smaller cells. It need only be sufficiently impermeable in this use to seal the reproductive lumen sufficiently to effect contraception. 
     The stent-like occluding component  11  will usually have an open walled structure and will be permeable enough to allow tissue growth into the interior thereof. The stent-like occluding component  11  has at least one end portion that extends beyond the ends of the balloon-like barrier component  12 . The proximal end portion  25  or the distal end portion  26  or both of the stent-like occluding component  11  which extend beyond the barrier component  12  have fibrous members  20  and  21  within them to facilitate and support tissue ingrowth for long term or permanent occlusion of the body lumen. Hooks or barbs  27  are provided on the stent-like occluding component  11  to secure the occluding device within the body lumen  22  when in the expanded configuration as shown in  FIG. 1B . 
       FIGS. 2A and 2B  illustrate an alternative occluding device  30  which has a self-expanding stent-like occluding component  31 , an impermeable barrier component  32  and one or more fibrous permeable components  33  and  34  disposed within the inner lumen  35  of the occluding component. The impermeable barrier component  32  is an impermeable membrane sack  36  loosely contained within the inner lumen  35  of the stent-like occluding component  31 . The occluding device  30  is delivered to a desired location within a patient&#39;s body lumen  37  and released as previously described. The stent-like occluding component  31  self expands as depicted in  FIG. 2B , for example if it is formed of a heat memory metal that expands to the larger diameter configuration when it reaches body temperature or it self expands due to a phase change from stress induced or stress maintained martensite to austenite upon release of the stress resulting in expansion. The occluding component expands so that it is in contact with the luminal walls of the body lumen  37  and simultaneously expands the membrane sack  36  within it which forms the barrier component  32 . The membrane sack  36  may be secured to the wall of the occluding component  31  and expand when the occluding component expands. Alternatively, the membrane sack  36  may be biased to expand, for example, by the presence of compressed gas within the interior  40  of the membrane sack, so that when the stent like structure expands when released from the delivery catheter, the barrier component expands to its larger diameter configuration to provide an impermeable barrier across the inner lumen  35  of the occluding component  31 . One or more fibrous bodies  33  and  34  are provided in the ends of the occluding component  31  to facilitate and enhance tissue ingrowth therein. Tissue ingrowth  38  and  39  occurs over time around and through the perimeter of the occluding component  31  including the ends, forming a permanent barrier to the passage of biological components. If the membrane sack is formed of a material that causes irritation or otherwise stimulates a tissue ingrowth response, e.g. PET, the tissue ingrowth may be enhanced or accelerated. 
       FIGS. 3A and 3B  illustrate an alternative occluding member  50  embodying features of the invention which has an occluding component  51  comprising inflatable impermeable segments  52  and  53  and one intermediate permeable component  54  disposed between the impermeable segments. The inflatable impermeable end segments  52  and  53  of the occluding component may be formed of impermeable material such as polyethylene terephthalate (PET), silicone rubber and other impermeable biocompatible polymeric materials. The permeable intermediate section  54  may be made of compressible open celled foam. The balloon segments  52  and  53  may be separated from the foamed intermediate section  54  by impermeable sectioning walls  55  and  56 . An inflation tube  57  passes through the intermediate section  54  and connects the two inflatable segments  52  and  53  so that when an inflation fluid, such as saline, contrast fluid or a biocompatible gas, is introduced down the catheter lumen  58 , it will inflate both segments  52  and  53 . Forming the inflatable segments  52  and  53  of a relatively non-compliant polymeric material such as PET allows the size and form of the inflatable portions  52  and  53  to be predetermined, for example as a dumb bell shape with the intermediate foam segment  54  between the two large segments. Bio-absorbable material materials may be used for the inflatable segments, but the rate of bio-absorption should be sufficiently slow so that the these segments which form an impermeable barrier component will not be absorbed prior to effective sealing of the body lumen by tissue ingrowth. 
     The occluding device  50  is releasably attached to the distal shaft section of delivery catheter (not shown) in a similar manner to that shown in  FIGS. 1A-1B . A one-way duck-billed inflation valve  55  is provided, as in the previous example, to maintain the inflated segments of the occluding component  51  inflated when the component  51  is detached from the delivery catheter. The permeable intermediate foam segment  54  may be formed of suitable biocompatible polymeric material that will form a support matrix for and enhance tissue ingrowth. For example, the intermediate foam segment  54  may be formed of open celled foam into and through which tissue ingrowth can occur. 
     In use, the compressible occluding device  50  will be compressed to fit within the inner lumen of a delivery sheath (not shown). The occluding device  50  may be constrained within a stent-like tubular structure (not illustrated) or may be a free-standing device. When the occluding device  50  has been advanced to the desired place in the patient&#39;s body lumen, e.g. a fallopian tube and discharged the intermediate foam segment  54  usually expands because there is no further constraints and the segment is biased to expand. Inflation fluid is injected into the interior of the inflatable segments  52  and  53  of the occluding component  51  through the inner lumen of tubular member  57 . Likewise, the inflatable end segments  53  and  54  of the occluding component  51  will generally be inflated to essentially the same diameter or a slightly larger diameter of the body lumen so that the exterior surface of the occluding component segments  52  and  53  are snugly pressed against the lumen wall defining the body lumen. The expansion of the intermediate, foam segment  54  may be assisted by the inflation of the end segments  52  and  53 , if these inflatable end segments are attached to the ends of the intermediate foam segment  54 . 
     Once the inflatable end segments are inflated within a body lumen (not shown), the distal shaft section  55  of the delivery catheter  56  is detached from the occluding device  50  by rotating the distal shaft section  55  counter clockwise to undo the threaded connection  59  therebetween and then withdrawn the delivery catheter  56 . The one way valve  55  prevents inflation fluid within the end segments  52  and  53  from escaping and helps maintain the inflated end segments in their inflated configuration. Because the impermeable end segments  52  and  53  are pressed snugly against the body lumen wall, an effective occlusion of the body lumen occurs that is immediately effective and continues to be an effective barrier until tissue growth into and onto the occluding component  51  effectively occludes and seals the body lumen. By the time the tissue of the body lumen is capable of regrowing and reorganizing to form a bypass around the obstruction (i.e. recannalize), tissue ingrowth into the foam section has formed a permanent occlusion and the body lumen has been effectively and permanently sealed. 
     For example, if this device were placed in a fallopian tube, the balloon segments would form an immediate occlusion to prevent the passage of egg cells down the fallopian tube or sperm cells up the fallopian tube, effectively providing immediate contraception by the impermeable balloon in the fallopian tube. By the time the fallopian tube could form a new channel around the balloon structures, a process that might take several weeks to several months, tissue ingrowth into the open celled foam of the permeable component  54  between the impermeable segments  52  and  53  would permanently seal the fallopian tube, thus providing permanent contraception. 
       FIG. 4  illustrates in another occluding device  70  embodying features of the invention in which the occluding component  71  is in the form of an elongated plug  72 . The occluding component  71  has a plurality of segments  72  and  73 , at least one of which is permeable and one of which is impermeable. Permeable segment  72  is formed of permeable open celled polymeric foam which facilitates tissue ingrowth. Impermeable segment  73  is formed of impermeable closed cell polymeric foam. Preferably, an impermeable membrane  74  is provided between the permeable and impermeable segments  72  and  73 . 
     Essentially the entire occluding component  71  is compressible to facilitate delivery within a delivery sheath (not shown, but see  FIGS. 7A and 9A ) and is biased to expand when released for deployment within desired location of the body lumen. The expanded deployed configuration is preferably of sufficient size to press against the wall of the lumen to secure the plug  72  in the body lumen. 
     The segments  72  and  73  may be separated by an impermeable membrane  74 , or may be merely formed in alternating sections. At least one segment will generally be permeable to support cell ingrowth, and at least one segment will generally be impermeable to form an immediately effective barrier to cellular migration through the body lumen, although only the membrane may be impermeable and may form the impermeable barrier. 
       FIG. 5  illustrates another alternative embodiment of an occluding device  80  having features of the invention which include an occluding component  81 , a plurality of impermeable barrier components  82 ,  83  and  84  and a plurality of permeable components  85  and  86  for facilitating tissue ingrowth. Preferably, impermeable membranes  87 ,  88 ,  89  and  90  are provided between adjacent permeable and impermeable components. Impermeable membranes  91  and  92  are preferably provided on the ends of the occluding component. Short stent like attachment rings  93  and  94  may be provided at the ends of the occluding component to help anchor the component within the body lumen it is deployed and resist expulsion, e.g. by the sweeping of the cilia of a fallopian tube. The attachment rings  93  and  94  may have hooks or barbs (not shown) to more firmly secure the device  80  within a body lumen. The attachment rings  93  and  94  may also support tissue ingrowth to further seal the occluding device  80  within the body lumen. The occluding device  80  may be deployed in a manner similar to that described above for the embodiment shown in  FIG. 4 . 
     A further alternative embodiment is depicted in  FIGS. 6A and 6B . In this embodiment the occluding device  100  comprises a stent-like occluding component  101  with foam plugs  102  and  103  disposed within the inner lumen  104  of the occluding component  101  at each end. The foam plugs  102  and  103  are formed of suitable foamed polymeric material that is sufficiently porous to facilitate tissue ingrowth but is of sufficient length to act as an impermeable barrier to preclude passage of undesirable biological components when deployed within the patient&#39;s body lumen. Alternatively, one foam plug may be formed of permeable open cell foam and one foam plug may be formed of impermeable closed cell foam. The individual plugs  102  and  103  may also have one section formed of permeable open cell foam and one section formed of impermeable closed cell foam as shown in  FIG. 4   FIG. 6A  illustrates the occluding device  100  in the unexpanded configuration and  FIG. 6B  illustrates the device in the expanded configuration. The foam plugs  102  and  103  are sufficiently flexible so as to expand with the stent like occluding component  101  or be biased to expand with the occluding component. The stent-like occluding component  101  may have barbs  105  to secure the occluding component within the body lumen. 
     An additional alternative occluding device  110  having features of the invention is depicted in  FIGS. 7A and 7B , wherein the device  110  has an occluding component  111 , an impermeable barrier component  112  for an immediate occluding of the body lumen and permeable components  113  and  114  to facilitate tissue ingrowth as described above for a permanent occlusion. The impermeable barrier component  112  is in the form of a disk and is secured to a central shaft  115 . They may be formed of impermeable closed cell polymeric material. The permeable components  113  and  114  are secured to the shaft  115  and are in the form of a disk formed of an open celled polymeric material. The occluding device  110  may be inserted into the body lumen  116  with the disks in a compressed configuration ( FIG. 7A ) within the lumen of a delivery sheath  117 . When the disks are located at the desired place in the body lumen, the shaft  115  is held in place and the delivery sheath  117  is withdrawn. Upon discharge, the disks  112 - 114  expand into secure contact with the wall defining the body lumen  116  as shown in  FIG. 7B . 
     While not shown in  FIGS. 7A and 7B , the proximal portion of the support shaft  115  may have a threaded releasable attachment such as the threaded connection shown in  FIGS. 1A-1B  to allow for release of the occluding device  110  by rotating the proximal portion of the support shaft  115 . This configuration has the added advantage of allowing the shaft  115  to be used initially to load the occluding device by pulling it into the lumen of a delivery sheath, e.g. through a funnel, and subsequently deploying the occluding device by holding the device in place while the delivery sheath  117  is withdrawn. 
     Impermeable disk  112  effects an immediate barrier to the passage of undesirable biological components such as eggs and sperm cells and permeable disks  113  and  114  facilitate tissue ingrowth for permanent occlusion. The disks forming the occluding device  110  should have sufficient length to diameter aspect ratios to create a slightly cylindrical shape to enhance the placement and ensure that the disks do not rotate into a flat position that would not effectively seal the body lumen. 
       FIG. 8  illustrates yet another embodiment which has features of the invention. Specifically, the occluding device  120  has a stent-like occluding component  121  similar to that shown in  FIGS. 1A-1C , impermeable barrier components  122  and  123  in the form of impermeable membranes on each end of the occluding component. Permeable components  124 ,  125  and  126  in the form of fibrous masses are disposed within the inner lumen  127  of the occluding component  121 . The permeable components encourage tissue ingrowth as in the previous embodiments. The impermeable barrier component  122  and  123  may be stretched over the ends the expandable stent-like structure  121  to provide for an immediate effective seal of a body lumen when the occluding component  121  is expanded within the body lumen. The permeable components  124 - 126  are preferably secured within the inner lumen  127  and configured to expand with the wall of the occluding component  121  when it is expanded during deployment at the desired site. 
       FIGS. 11A and 11B  illustrate an alternative occluding device  130  which is similar to the occluding device described in co-pending application Ser. No. 10/746,131, filed on Dec. 24, 2004. The device  130  comprises an occluding component  131  which has spider-like expandable elements  132  and  133  secured to a central shaft  134 . The spider-like elements  132  and  133  each have a plurality of legs which extend out from the shaft  134  and which have first leg sections  135  and second leg sections  136 . An impermeable membrane  137  is secured to one side of the spider-like element  132  which is secured to the legs of spider-like element  132  in the nature of the fabric of an umbrella secured to the ribs thereof. Spider-like expandable element  133  is provided with a fibrous mass  138  similar to the fibrous masses shown in  FIG. 8 . The occluding device  130  is shown in a retracted configuration in  FIG. 9A  within a delivery sheath  140  to facilitate advancement and deployment within the patient&#39;s body lumen  141 . At the deployment site within the body lumen  141 , the plunger  142  is held in place while the delivery sheath  140  is withdrawn to discharge the occluding device  130  from the sheath  140 . When deployed within the patient&#39;s body lumen  141 , as shown in  FIG. 9B , the spider-like elements  132  and  133  of the occluding component  131  expand to engage the inner surface of the body lumen  141 . Upon expansion of the spider-like element  132 , the expanded legs thereof stretch the impermeable membrane  137  across the body lumen  141  to provide immediate effective sealing of the body lumen. The fibrous mass  138  within the spider-like element  133  acts to enhance tissue growth within the occluding component  131  and the permanent occlusion of the body lumen  141 . Instead of the permeable fibrous mass  138  within the spider-like element  133 , a porous permeable membrane may be secured to the legs of the spider-like element  133  to enhance tissue growth within the occluding component  131 . There may be an impermeable membrane on one side of the legs of a spider-like element and a permeable membrane on the other side of the legs. 
     Another embodiment of an effective occluding device  150  having features of the present invention is shown in  FIGS. 10 and 11 . The occluding device  150 . has an occluding component  151  which includes a stent-like structure  152 , a bulbous, bullet-shaped impermeable component  153  secured to the distal end  154  of the stent like structure  152  which is generally slightly larger than the body lumen to be occluded. Permeable components  155   a  and  155   b  in the form of porous polymeric masses or bundles are provided within the distal end  154  and the proximal end  156  of the stent-like structure  152 . As shown in  FIG. 10 , the occluding device  150  is partially disposed within a delivery sheath  157  with the enlarged impermeable component  153  extending out of the catheter. A plunger  158  is slidably disposed within the inner lumen  159  of the delivery sheath, proximal to the occluding device  150  and is configured to hold the occluding device  150  while the delivery sheath  157  is withdrawn to deploy the occluding device into the body lumen. 
       FIG. 11  illustrates the occluding device  150  shown in  FIG. 10  disposed within a female patient&#39;s fallopian tube  160  after discharge of the occluding device from the delivery sheath  157 . The bulbous structure of the enlarged impermeable barrier component  153  stretches the diameter of the body lumen  160  and immediately seals off the lumen to prevent passage of eggs or sperm cells. Other elements such as barbs or hooks (not shown) may be provided on the occluding component to further secure the occluding device  150  within the fallopian tube  161 . The stent-like structure of the occluding component  151  may be self-expanding, and the permeable components  152  and  153  which may be secured within the ends of the occluding component  151  and may expand with the occluding component to extend across the luminal passageway and act to enhance and support tissue ingrowth and thereby provide a permanent occlusion of the lumen  160 . The permeable components are shown as porous polymeric masses but they may be fibrous mesh or bundled fibers. While the occluding device  150  is shown deployed within a female patient&#39;s fallopian tube, it should be apparent that the occluding device may be employed to occlude the reproductive lumen such as a vas deferens of a male patient. 
       FIG. 12  illustrates a portion of the wall  170  of a stent-like occluding component  171  which is suitable for use with the present invention. The occluding component  171  has a plurality of interconnected ring sections  172 . The ring sections  172  are interconnected by one or more connecting members  173  extending between the peak  174  of an undulation in one ring section to the valley  175  of an adjacent ring section. The adjacent ring sections are off-set or out of phase so that the peaks of one ring section are aligned with the valleys of an adjacent ring section. 
     The stent-like members described herein can be formed of conventional stent materials including stainless steel, NiTi alloy (shape memory and superelastic), MP35n, Elgiloly and the like. The impermeable materials may be formed of somewhat compliant to essentially non-compliant biocompatible polymeric materials such as PET, nylon Hytrel® and the like. The permeable materials can be fibrous materials such as polyester, nylon, and the like or porous polymeric foam materials impermeable closed cell foam and permeable open cell foam may be formed of expanded polytetraflouroethyene (ePTFE). 
     Various modifications and improvements may be made to the present invention without departing from the scope thereof. For example, while the invention has been discussed primarily in terms of occluding a reproductive body lumen, the occluding device may be used to occlude a variety of body lumens or passageways. Moreover, although individual features of the invention may be described with respect to one or more of the embodiments but not in other embodiments, those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of one or more of other embodiments. 
     Terms such as “element”, “member”, “device”, “section”, “portion”, “component”, “means”, “step” and words of similar import, when used in the following claims, shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the claims expressly use the term “means” followed by a particular function without specific structure or the term “step” or “steps” followed by a particular function without specific action. The full disclosures of all patents and patent applications referred to are incorporated herein by reference.

Technology Category: 1