Patent Abstract:
Devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Full Description:
RELATED APPLICATIONS  
       [0001]     This patent application claims priority to U.S. Provisional Patent Application No. 60/483,587 filed on Jun. 27, 2003, the entirety of which is expressly incorporated herein by reference. Additionally, this application is a continuation-in-part of co-pending U.S. patent application Ser. No. 08/770,123 (Callister et al.) filed on Dec. 18, 1996 and published on Jan. 31, 2002 as U.S. patent application 2002/0013589A1, the entirety of which is expressly incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates generally to medical devices, methods and systems and more particularly to medical devices and more particularly to devices that are implanted within body lumens (e.g., fallopian tubes, vas deferens, bronchi, blood vessels, etc.) to occlude that body lumen and/or to deliver therapeutic substance(s) for local or systemic therapeutic effect.  
       BACKGROUND OF THE INVENTION  
       [0003]     There exist various situations in which it is desirable to implant embolic or occlusive devices within lumens or anatomical passageways within the bodies of human or animal subjects. In at least some of those situations, it is additionally desirable to deliver a substance (e.g., a drug, a protein, cells, a biological material, a chemical substance, a gene therapy preparations, etc.) for at least an initial period of time following implantation of the embolic or occlusive device.  
         [0004]     For example, it has been known to implant occlusive devices into the fallopian tubes of females or the vas deferens of males for contraceptive purposes. Examples of implantable occlusive devices useable for such purposes are described in U.S. Pat. No. 6,096,052 (Callister et al.) entitled Occluding Device and Method of Use and U.S. Pat. No. 6,432,116 (Callister et al.) entitled Occluding Device and Method of Use, the entireties of both such United States Patents being expressly incorporated herein by reference. Some of these devices have been constructed and/or implanted in a manner to facilitate tissue ingrowth subsequent to implantation of the device such that, after such tissue ingrowth has occurred, the ingrown tissue alone or in combination with the implanted device will provide complete occlusion of the lumen of the fallopian tube or vas deferens. Thus, during the period between implantation of the device and completion of the lumen-occluding tissue ingrowth, the lumen of the fallopian tube or vas deferens may remain at least partially open. Thus, it may be desirable to provide alternative contraceptive means to prevent unwanted pregnancy during the period between implantation of the device and completion of the lumen-occluding tissue ingrowth.  
         [0005]     The above incorporated U.S. patent application Ser. No. 08/770,123 (Callister et al.) described various embodiments of lumen occluding devices that may be used to occlude the lumen of a fallopian tube or vas deferens, some of which may deliver a drug, such as a contraceptive agent.  
         [0006]     There remains a need in the art for the development of new implantable lumen occluding devices that are capable of delivering a substance (e.g., a drug, a protein, cells, a biological material, a chemical substance, a gene therapy preparations, etc.).  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention provides devices that may be implanted into a body lumens (e.g., fallopian tube, vas deferens, bronchus, blood vessel or other anatomical passageway or lumen) of a human or veterinary subject to occlude that body lumen and/or to deliver a substance (e.g., a drug, a protein, cells, a biological material, a chemical substance, a gene therapy preparations, etc.) for at least a period of time following implantation of the device.  
         [0008]     In accordance with the invention there is provided an implantable occlusion and/or substance delivery device of the foregoing character that comprises; a) an expandable intraluminal member which is i) disposable in a first configuration wherein it is sufficiently compact to be advanced into the body lumen and ii) subsequently expandable to a second configuration wherein the intraluminal member becomes implanted within the body lumen; and., b) a quantity of a substance disposed on or in the device such that the substance will be delivered from the intraluminal member into some target tissue for at least some period of time following implantation of the intraluminal member within the body lumen. In some embodiments, the intraluminal member may include a mesh material or other matrix designed to facilitate cellular or tissue ingrowth such that cells or tissue that ingrow into the device will effect occlusion of the body lumen in which the device is implanted. The present invention additionally includes systems wherein the implantable occlusion and/or substance delivery device is used in combination with a delivery catheter and/or guidewire and/or endoscopic device.  
         [0009]     Further in accordance with the invention, there are provided methods for sterilization or contraception wherein a lumen occluding and/or substance delivering device of the foregoing character is implanted in a fallopian tube of a female subject or the vas deferens of a male subject. In such applications, the substance disposed on or in the device may comprise a contraceptive or spermicidal agent that will be delivered by the device in a concentration and form that is effective to cause a contraceptive effect in the subject, at least during a period of required for the implanted device to effect complete occlusion of the fallopian tube or vas deferens. Still further in accordance with the invention, there are provided methods for treating disorders or injuries of the lung by implantation of a lumen occluding and/or substance delivering device of the foregoing character within a bronchus, bronchiole or other anatomical passageway within the lung. In such applications, the device may occlude a bronchus to stop the flow of inspired air to a portion of the lung (e.g., a lobe or portion of a lobe) that is diseased or injured. In such applications, the substance disposed on or in the device may comprise an agent that causes a therapeutic effect in the lung such as an antimicrobial agent, mucolytic agent, bronchodilator, antiinflamatory, expectorant, antineoplastic agent, chemotherapeutic agent, immunomodulator, etc.  
         [0010]     Still further in accordance with the invention, there are provided varied and universal methods for treating disorders or injuries of human or animal subjects by implanting a device of the foregoing character in a body lumen (e.g., a man-made lumen or a natural passageway within the body such as a blood vessel, lymphatic duct, duct of the biliary tree, etc.) so as to cause occlusion of that body lumen and to release a therapeutically or diagnostically effective amount of a substance for at least some period of time following implantation of the device.  
         [0011]     Further aspects, elements and embodiments of the invention will become apparent to those of skill in the art upon reading and consideration of the detailed description set forth herebelow and the accompanying drawings to which it refers.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]      FIG. 1A  is a side view of one embodiment of a lumen occluding and/or substance delivery device according to the present invention, disposed in a collapsed configuration.  
         [0013]      FIG. 1B  is a side view of the device of  FIG. 1A , disposed in an expanded configuration.  
         [0014]      FIG. 1C  is a side view of the device of  FIGS. 1A and 1B , disposed in an expanded configuration and having an optional substance delivery and/or ingrowth supporting matrix thereon.  
         [0015]      FIG. 2A  is an exploded perspective view of one embodiment of system of the present invention comprising a lumen occluding/substance delivery device as shown in  FIGS. 1A and 1B , in combination with a delivery cannula and a pusher device.  
         [0016]      FIG. 2B  is a perspective view of the system of  FIG. 2A  wherein the pusher has been used to expel the lumen occluding/substance delivery device out of the distal end of the delivery catheter.  
         [0017]      FIG. 3A  is a partial longitudinal sectional view of another embodiment of system of the present invention designed for over-the-wire delivery of the implantable device.  
         [0018]      FIG. 3B  is a showing of the system of  FIG. 3A  with the guidewire protruding from the distal end of the delivery catheter.  
         [0019]      FIG. 4  is a sectional showing of the uterus and left fallopian tube of a human patient having the over-the-wire system of  FIGS. 3A and 3B  inserted into the left fallopian tube.  
         [0020]      FIGS. 4A-4C  show three steps in a procedure wherein the system shown in  FIG. 4  is used to implant a lumen occluding/substance delivery device in the patient&#39;s left fallopian tube.  
         [0021]      FIG. 5  is an enlarged perspective view of a lumen occluding/substance delivery device of the present invention having an optional substance delivery and/or ingrowth supporting matrix thereon.  
         [0022]      FIG. 5A  is an enlarged, cut away view of a portion of the substance delivery and/or ingrowth supporting matrix of the device of  FIG. 5  illustrating one way in which the substance delivery and/or ingrowth supporting matrix may be constructed to deliver a substance following its implantation within the body of a patient.  
         [0023]      FIG. 5B  is an enlarged, cut away view of a portion of the substance delivery and/or ingrowth supporting matrix of the device of  FIG. 5  illustrating another way in which the substance delivery and/or ingrowth supporting matrix may be constructed to deliver a substance following its implantation within the body of a patient.  
         [0024]      FIG. 6  is an enlarged perspective view of a lumen occluding/substance delivery device of the present invention having an optional substance delivery and/or ingrowth supporting matrix thereon and wherein portions of the device are constructed to carry out controlled delivery of a substance following its implantation within the body of a patient.  
         [0025]      FIG. 6A  is an enlarged view of a portion of the device of  FIG. 6  illustrating one way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.  
         [0026]      FIG. 6B  is an enlarged view of a portion of the device of  FIG. 6  illustrating another way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.  
         [0027]      FIG. 6C  is an enlarged view of a portion of the device of  FIG. 6  illustrating yet another way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.  
         [0028]      FIG. 7  is a side view of a lumen occluding/substance delivery device according to the present invention, disposed in a collapsed configuration and having a substance delivery reservoir thereon.  
         [0029]      FIG. 7A  is a side view of the device of  FIG. 7  disposed in an expanded configuration.  
         [0030]      FIG. 7B  is an enlarged perspective view of the substance delivery reservoir of the device of  FIGS. 7 and 7 A.  
         [0031]      FIG. 8  is a perspective view of another embodiment of a lumen occluding/substance delivery device according to the present invention having an optional visualization member thereon.  
         [0032]      FIG. 8A  is an enlarged view of a portion of the device of  FIG. 8 .  
         [0033]      FIG. 9  is a sectional showing of the uterus and left fallopian tube of a human patient having a hysteroscope and a delivery system according to the present invention inserted into the left fallopian tube.  
         [0034]      FIG. 9A  is an enlarged view of the distal end of the hysteroscope and adjacent portion of segment  9 A of  FIG. 9 , showing advancement of the delivery catheter out of a working channel of the hysteroscope.  
         [0035]      FIG. 10  is a schematic showing of the trachea and lungs of a human patient wherein a lumen occluding/substance delivery device of the present invention implanted in a bronchus of the patient&#39;s left lung.  
         [0036]      FIG. 10A  is an enlarged sectional view of a bronchus of the left lung shown in  FIG. 10  having a lumen occluding/substance delivery device of the present invention implanted therein.  
         [0037]      FIG. 10B  is a sectional view of a lung showing the manner in which implantation of a lumen occluding/substance delivery device of the present invention may block the flow of inspiratory air to a diseased or injured portion of the lung parenchyma.  
         [0038]      FIG. 11  is a view of the lungs of a patient into which an occlusive delivery device of the invention has been inserted.  
         [0039]      FIG. 11A  is an expanded, partially cut-away view of the portion of  FIG. 11  indicated by the dashed circle.  
         [0040]      FIG. 11B  is a cut-away view of a portion of a patient&#39;s lung showing the delivery catheter and the occlusive device in place. 
     
    
     DETAILED DESCRIPTION  
       [0041]     In particular, the present invention relates to devices, methods and systems for the occlusion of various passageways of the body including the delivery of therapeutic substances by placement of drugs or drug secreting material on or within such devices. In the various aspects of occluding body passageways, one object of this invention that is particularly useful is for the occlusion of the fallopian tubes to effect permanent contraception. Although the occlusion of the fallopian tubes will be discussed in detail, it can be appreciated that the devices, methods and systems described herein can easily be adapted to occlude the vas in the male patient, arteries or veins in the nidus of an arterial-venous malformation, patent ductus arteriosis in infants, as well as feeding arteries to cancerous tumors, among other passageways. The invention also provides means for delivering vessel supporting devices such as coronary stents or venous or arterial embolic filters, to the desired location through a steerable system. Although any of these procedures may benefit from the inventions described herein, one particularly useful and immediate benefit for these devices, methods and systems is in the delivery of occlusion devices to the fallopian tubes for contraceptive purposes. At least some of these objectives will be met by the novel inventions, devices, methods and systems described hereinbelow. This invention in some embodiment also provides for delivery of therapeutic substances to desired locations and in advantageous manners  
         [0042]     Those skilled in the art will recognize that various combinations, modifications, and equivalents of the inventions described herein can be used without departing from the scope of these inventions.  
         [0043]     The present invention provides devices, methods and systems for the occlusion of various body passageways. It also includes catheter systems for the delivery of embolic devices as well as vascular stents, especially small diameter stents as may be desirable in the coronary or cerebral vasculature. Typically these devices are delivered either by direct placement or by using “over-the-wire” (OTW) designs or techniques. Although OTW designs allow for steerability of the guide wires and delivery catheters, the devices typically must have in inner diameter larger than the removable guide wire with which it is used. The diameter of the guide wire, however, may be too large, even it its smallest functional diameter, to allow for a small enough collapsed profile to transverse through the target passageway. The alternative means of using a pushing device proximal to the collapsed device allows for the device to have a very small collapsed profile since no guide wire needs to pass through it, however such systems may have reduced steerability of the system through the body lumens, particularly distal to the collapsed device. For these reasons and others it would be desirable to have a small diameter system that still allows for steerability of the guide wire while advancing through the body passageways.  
         [0044]     Referring now to the examples of the invention shown in the drawings, in accordance with one aspect of this invention, there is provided an expandable lumen occluding and/or substance delivery device  10  that is delivered through a suitable delivery cannula  20  (e.g., a rigid or flexible tube or catheter such as a microcatheter or hypotube). As shown in  FIGS. 2A and 2B , the device  10  may be placed in its collapsed configuration and inserted into the lumen of a delivery cannula  20 . The delivery cannula  20  comprises a wall  24  that devices a lumen that extends through the cannula  20 . A hub  26  may be formed on the proximal end of the delivery cannula  20 . After the device  10  has been advanced into the lumen of the cannula, the cannula wall  24  will constrain the device  10  in a relatively collapsed configuration while the device  10  remains inside lumen. In this example, a pusher device  22  comprising an elongate rod  28  and pusher head  30 , is useable to facilitate expulsion or release of the device  10  from the delivery cannula  20 . Upon exiting the delivery cannula  20 , the device  10  resumes its expanded or remembered configuration by the release of a radially expansive force. Alternatively, the device  10  may expand or assume a larger diameter as a result of shape memory (e.g., becoming larger in diameter as a result of temperature change) or other shape altering properties or instrumentalities.  
         [0045]     Although the pusher  28  with bulbous pusher head  30  may, in some embodiments, comprise a “pusher wire”, it will be understood that the device  10  may be end-loaded into the cannula  20  in the compressed configuration with the pusher  28  in place immediately proximal to the device. When the delivery catheter  20  is placed in the desired location in the body, for example in the fallopian tube, then the cannula  20  may then be withdrawn in the proximal direction while the pusher  28  is held stationary in the longitudinal direction. This has the effect of laying down the expanding occlusive device without actually pushing it forward in the potentially fragile body lumen such as a fallopian tube or tubule in the lung. In this way any injury to the body structure that would otherwise occur by pushing the expanded device forward through the body lumen is avoided. Also, by back-loading the device into the distal end of the delivery catheter, it need not be pushed through the entire length of the catheter. Thus the distal end portion of the delivery cannula  20  may be reinforced, perhaps with slippery substance that makes movement of the device smooth and convenient, and may be reinforced, perhaps with stainless steel wire or the like which would be undesirable for flexibility if the entire length of the catheter had to be so reinforced. In those cases, the “pusher” does not expel the device forward and push it longitudinally thorough the body lumen, but rather stabilizes it as the catheter is withdrawn from over it. Nonetheless, with that understanding, the term “pusher wire” will be used in this patent to describe that device.  
         [0046]     In the particular embodiment of the device  10  shown in the drawings, a plurality of first leg segments  15  emanate from a central apex  16 . Each first leg segment  15  is joined at an angle with a second leg segment  12 , thereby forming a plurality of secondary apices  14 , as shown. When the device  10  is expanded or allowed to expand within a body lumen, the second leg segments  12  will contact and exert a constant outward force on the wall of the body lumen in which the device  10  is positioned thereby maintaining in a substantially stationary position within that body lumen. Sometimes at least one of the second leg segments  12  may be formed of thin, relatively rigid material and/or may comprise a projection (e.g., a hook, barb, etc.) that will lodge in the lumen wall to secure the device  10  in place.  
         [0047]     It will be appreciated that, although the device  10  may comprise a single unit as shown in the figures, the invention includes systems or embodiments wherein a plurality of these single unit devices  10  are aligned or positioned adjacent to each other to form a multi-unit occluding system or structure within a body lumen. In such embodiments, the aligned or adjacently positioned single unit devices  10  may optionally be joined or connected to one another to form a unitary structure. In this regard, it will be appreciated that two or more of the devices  10  (separate or conjoined) may be loaded into the lumen of the delivery cannula  20  an expelled from the distal end  25  of the delivery cannula  20  by the pusher  22 . Alternatively, a plurality of the devices  10  may be loaded into and expelled from the delivery cannula  20 , one at a time, thereby implanting a plurality of the devices  10  in series within a body lumen.  
         [0048]     In some embodiments, the configuration of the device may be modified from that shown in the figures to a generally tubular shape that is expandable and collapsible, as with a stent. Devices of this general nature are described in U.S. Pat. No. 6,096,052 (Callister et al.) and U.S. Pat. No. 6,432,116 (Callister et al.), the complete disclosures of which are incorporated herein as if set forth in full.  
         [0049]     The device  10  may be configured, constructed or contain materials that support or facilitate tissue ingrowth. As used herein, the term tissue ingrowth includes but is not limited to cell mulitiplication and/or or growth resulting in tissue formation into, onto, or surrounding a particular region and/or into, onto or surrounding an obstructive device. This may be epithelization, scar formation, or other cell growth or multiplication. For example, the leg portions  12 ,  15  and/or matrix  18  may incorporate materials that promote epithelialization, endothelialization, granulation or other proliferative or tissue growth response within the body to create a more effective occlusion of the passageway or to result in a more secure attachment of the occlusion device to the walls of the body lumen. For instance, polyester fibers may be attached to the device  10  such that tissue ingrowth into and around the device will form a plug and thereby occlude the lumen in which the device is implanted. In some embodiments, a volitionally deployable wall abrading projection (e.g., a flare or projection) may be provided on the distal portion of the cannula  20  and/or on the device  10  to abrade or denude the epithelial layer of the fallopian tube FT or other body lumen in which the device  10  is implanted, thereby enhancing the tissue ingrowth response. Such volitionally deployable wall abrading projection could both be deployed when entering the body lumen and/or when deploying the device  10 .  
         [0050]     Additionally, as described in detail herebelow, substances such as therapeutic agents, drugs, (e.g., contraceptive hormones, spermicidal agents, spermatogenesis inhibitors, antimicrobials, antibiotics, antifungals, chemotherapeutic agents, biologics, etc.) or biological factors (VEGf, FGF, etc.) may be incorporated on or within the device in order to bring about some desired effect (e.g., to accelerate tissue ingrowth, prevent/treat infection, cause drug-induced contraception for at least a sufficient period of time to allow the implanted lumen occluding device to become fully functional, treat a disease or disorder in the adjacent tissue, etc). When the implantable device of this invention is used to block the lumen of a fallopian tube, vas deferens or other body lumen for the purpose of deterring pregnancy, the lumen blocking efficacy of the device (and thus its reliability as a contraceptive measure) may not become maximized for several weeks or months after the initial implantation of the device  10  as such amount of time may be required for the implanted device  10  to become fully epithelialized or for other tissue ingrowth to become complete. In such instances, a quantity of a contraceptive agent and/or spermicidal agent may be incorporated on or in the device so as to provide for drug-induced contraception for a period of time that is at least sufficient to allow the lumen blocking efficacy of the device to become maximized. Examples of specific substances (e.g., drugs, therapeutic agents, biological factors, etc.) that may be incorporated into or onto the device  10  of this invention or any other lumen occluding device are described herebelow.  
         [0051]      FIGS. 3A-3B  show a system for OTW delivery of the lumen occluding and/or substance delivery device  10 . This system generally comprises the lumen occluding and/or substance delivery device  10 , a delivery cannula  20  as described above and a modified pusher device  28   a  that has a guidewire lumen extending longitudinally therethrough such that a guidewire  32  may pass through the lumen of the pusher device  28   a , through the lumen occluding and/or substance delivery device  10  and through the lumen of the delivery cannula  20 , as shown in  FIG. 3A . Alternatively, and not shown in the figures, the pusher head  30   a  may have a groove therein through which the guidewire  32  may slide so that it will be located longitudinally side-by side with the pusher  29   a . Optionally, the guidewire  32  may have a distal portion  34  that is more flexible than the proximal portion of the guidewire and/or is otherwise deflectable, flexible or steerable. In operation, the guidewire  32  may be advanced into a desired body lumen (e.g., a fallopian tube) into which it is desired to implant the lumen occluding and/or substance delivery device  10 . Thereafter, the delivery cannula  20  having the device  10  and pusher  28   a  within its lumen may be advanced over the previously inserted guidwire to a location where the distal end of the delivery cannula  20  is adjacent to the location where it is desired to implant the device  10 . Thereafter, the pusher  28   a  may be advanced over the guidewire  32  such that the enlarged distal end  30   a  of the pusher  28   a  will expel the lumen occluding and/or substance delivery device  10  out of the distal end of the delivery cannula  20 . The device  10  will then self expand within the body lumen such that the second leg segments  12  of the device engage the wall of the body lumen. Thereafter, the delivery cannula  20 , pusher  28   a  and guidewire  32  may be removed, leaving the device  10  implanted within the body lumen.  
         [0052]      FIGS. 4-4C  show a specific procedure in which the OTW system shown in  FIGS. 3A-3C  is used to implant a lumen occluding and/or substance delivery device  10  within a fallopian tube. Initially, the guidewire  32  is advanced through the uterus UT and into the fallopian tube FT. The delivery catheter  20  (with the collapsed device  10  and pusher  28   a  positioned therein) is advanced over the guidewire  32 , as seen in  FIG. 4A . Thereafter, as shown in  FIG. 4B , the pusher  28   a  is advanced over the guidewire  32  such that the enlarged distal end  30   a  of the pusher  28   a  pushes the device  10  out of the distal end  25  of the delivery cannula  20 . Upon exiting the distal end  25  of the delivery cannula  20 , the device  10  self expands to its expanded configuration whereby the second leg segments  12  of the device  10  are urged against the wall of the fallopian tube FT, thereby holding the device  10  in a fixed position, as shown in  FIG. 4C . The delivery cannula  20 , pusher  28   a  and guidewire  32  are then withdrawn through the uterus UT and removed, leaving the device  10  implanted within the fallopian tube FT. Following implantation, tissue will ingrow into the device  10  to cause complete occlusion of the fallopian tube FT. At least during the period of time during which such tissue ingrowth is occurring, the device  10  may elute a substance (e.g., a contraceptive or spermicidal substance) in an amount that causes a desired therapeutic effect (e.g., contraception or spermicide) in the patient. Optionally, the device  10  may include a matrix  18 , as described above, to facilitate the desired tissue ingrowth and/or to deliver the desired substance.  
         [0053]     If more than one device  10  is to be implanted within the subject&#39;s body, there is no need to remove the delivery cannula  20  to deliver the additional devices. For instance, if devices  10  are to be implanted in both fallopian tubes FT, the delivery catheter  20  may initially contain two devices  10 , one for each fallopian tube FT. In such an instance, the physician may insert the delivery catheter  20  through the uterus of the patient, and deliver one device to the first of two fallopian tubes FT, and, after delivery of the first device  10 , the physician may then insert the delivery catheter  20  into the other fallopian tube  20  and deploy the second device  10  into the other fallopian tube FT without having to withdraw the delivery cannula  20  from the uterus UT. This has the advantage of speeding the overall procedure time since there is no need to remove and replace a delivery cannula  20  for each fallopian tube FT. Additionally, overall costs for the procedure are reduced since only one delivery cannula  20  and one pusher  28   a  are used to place two devices  10 . Alternatively, the present invention also allows for the lumen occluding and/or substance delivery device  10  to be advanced through the entire length of the delivery cannula  20 . In such an instance, the delivery cannula  20  is advanced to the location where the device  10  is to be placed. The guide wire  32  may aid in positioning the delivery cannula  20 . Following acceptable placement of the delivery cannula  20 , the guide wire  32  may be removed from the delivery cannula  20  and the first occlusion device  10  may then be placed in a collapsed configuration and loaded into the lumen of the cannlua  20  through its proximal end. After the device  10  has been located within lumen of the delivery cannula  20 , a standard pusher  38  (see  FIGS. 2A and 2B ) may be used to advance the device  10  through the length of the delivery cannula  20  and out of its distal end  25 . The device  10  will then expand and become implanted within the lumen of the fallopian tube FT in the manner described hereabove.  
         [0054]     In accordance with yet another aspect of this invention, it will be appreciated that the enlarged pusher head  30  or  30   a  could actually be mounted on the guidewire  32  at a location proximal to the device  10  such that, as the guidewire  32  is advanced in the distal direction (or as the cannula  20  is withdrawn in the proximal direction) the pusher head  30  or  30   a  will push the device  10  along with it.  
         [0055]     One major advantage to the type of system shown in  FIGS. 4A-4B  is that the entire system may be steerable, since the distal portion  34  of the guide wire  32  may be constructed to be torqued or steered through the body passageways to its desired location. A small hole may be formed in the central apex  16  of the device  10  and the guidewire  32  may pass through that hole. Thus, such torquing the guide wire  32  may have no significant effect on the device  10  since even in its collapsed state within the delivery cannula  20  there is still a small hole through the device  10  through which the guide wire  32  passes.  
         [0056]     The distal portion  34  of the guide wire  32  may be flexible and may incorporate a conventional spring tip or, alternatively, it may be made of or incorporate a plastic or Teflon coating to prevent any snagging of any attached fibers on the occlusion device. Additionally, the device  10  may be positioned on a reduced diameter segment of the guidewire  32  and such reduced diameter segment may be longer than the device  10 . This will permit a limited amount of axial movement of the guide wire  32 , either proximally or distally, to further aid in the bendability and/or steerability of the system. Delivery cannula  20  may thus be able to provide either more or less support for the guide wire support, depending on the circumstances and the tortuosity of the vasculature or passageway being navigated. In such embodiments wherein the guide wire  32  is axially moveable over a limited range but not completely removeable may allow the use of a steerable guide wire  32  having a relatively large diameter distal portion in combination with a low profile delivery cannula  20  (e.g., a delivery cannula  20  that has a diameter that is the same as or even smaller than the diameter of the distal portion of the guide wire  32 ). It will be appreciated by those of skill in the art that the device  10  may be self-expanding, or it may be pressure expanded (e.g., plastically deformable) through the use of a balloon catheter or the like. In some self-expanding embodiments, the device  10  may assume its expanded configuration as a result of temperature shape memory or release of compression, or any other appropriate means. As the device  10  assumes its expanded configuration as shown in  FIG. 4C , it may expand across the body lumen in which it is positioned and assume a configuration wherein any guidewire passage hole or opening formed in the device  10  will be large enough to allow the guidewire  32  to be retracted through the expanded device  10  and back into the lumen of the delivery cannula  20  for withdrawal, leaving the device  10  in place.  
         [0057]      FIGS. 9 and 9 A show an example of a procedure wherein a hysteroscope  64  is used to view and/or facilitate implantation of a lumen occluding and/or substance delivery device  10 . The hysteroscope  64  comprises an elongate, flexible device having a lumen or working channel  70 , a light emission lens or port  68  and an image receiving lens or port  66 . Initially, the hysteroscope  64  is advanced through the uterus UT and into the proximal fallopian tube FT, as shown. The delivery cannula  20  is then advanced through the working channel  70  of the hysteroscope  64 . The physician may view, through the hysteroscope  64 , the advancement of the delivery cannula  20  out of the distal end of the hysteroscope  64 . Length indicating colored zone(s) and/or markings  72  may be provided at specific locations on the delivery cannula  20  to indicate the length delivery cannula  20  that has been advanced from the distal end of the hysteroscope  64 . Thus, the physician may advance the cannula  20  until he or she sees a specific colored zone or other length marking  72  which indicates that the cannula  20  has been advanced to the desired depth or location within the fallopian tube FT. length marking(s)  72  may be formed at locations on the delivery cannula  20  to indicate to the physician through the hysteroscope  64  that the distal end of the delivery cannula  20  has reached a desired implantation site distal to the fallopian tube ostium OS, typically within the intramural portion IMP of the fallopian tube FT or within the utero-tubal UTJ. In some cases the device  10  may be implanted elsewhere in the fallopian tube FT, such as in the isthmic region of the fallopian tube FT, distal to the isthmic region, or even in or near the ampulla region of the fallopian tube. In some embodiments, three separate markings  72  (e.g., 3 different colored zones or visible markings such as ruler type hash marks) the physician to selectively advance the delivery cannula  20  to one of several identified implantation sites (e.g., in the isthmus, between or spanning the transition between the isthmus and ampulla and in the ampulla. An alternative to visual means of determining the position or depth of insertion of the delivery cannula  20  is the use of ultrasound, electronic or image based guidance. In embodiments where ultrasound is used to determine the position of the delivery cannula  20 , one or more echogenic marker(s) may be placed on the tip of or elsewhere on the delivery cannula  20  and/or on the implantable device  10  within the delivery cannula  20  to facilitate ultrasonic imaging and proper placement of the device  10  under ultrasonic guidance. Optionally, a physical barrier may be located on the delivery cannula  20  to prevent over-insertion.  
         [0058]     Another means of placement for the device is under fluoroscopic guidance. In this case, one or more radiopaque marker(s) may be located on the tip of or elsewhere on the delivery cannula  20  and/or on the implantable device  10  within the delivery cannula  20  to facilitate positioning of the delivery cannula  20  and/or device  10  under fluoroscopy.  
         [0059]     The lumen occluding and/or substance delivery device  10  may deliver (e.g., elute) substance(s) (e.g., drugs, therapeutic agents, biologics, proteins, spermicides, biological factors, cell preparations, friendly microbes, etc.) for some period of time following implantation into the body. In this regard, the device  10  may be of the configuration and structure shown in the figures and described hereabove, may be configured as a drug eluting substance such as fibers contained in a tubular structure, or may be of any other suitable configuration or structure. The rate and/or amount of substance delivered from the implanted device may be designed or controlled, in accordance with known drug delivery technology, to both control dosage (e.g. concentration in the uterus, fallopian tube, lung, tumor or other tissue, organ or anatomical structure), the location of delivery (e.g. systemic, local, topical, directed downstream in a feeding artery, etc.) and the time period over which the drug or other substance would be eluded or otherwise delivered by the implanted device. Also, in some aspects, the delivery of a substance from the device  10  may be responsive to a physical condition or presence/flow of a body fluid in the patient, such as a substance that is eluted by the device  10  and/or carried from the device  10  to another location as a result of the presence of certain conditions, such as different times in the menstrual cycle, or different blood chemistry conditions during the diurnal cycle, or different conditions as a result of physical or medical conditions such as the presence of certain biological factors, the blood pressure presented, the blood flow encountered, or the like.  
         [0060]     The substance that is to be eluted or delivered from the implanted intraluminal device may be placed on or in the device  10  in various ways, examples of which are shown in  FIGS. 5A-7B . For example, the device  10  or some portion thereof may be consist of or comprise a hollow member (e.g., a tube or hollow fiber) having a lumen or inner cavity wherein the substance is contained and the substance may then elute from that hollow member by diffusion through a wall or portion of the hollow member, by seepage or transport out of an aperture or opening formed in the hollow member, or by any other suitable means.  FIG. 5  shows an example of the device  10  wherein a substance delivering matrix  18  is disposed on the device  10 . This matrix  18  acts not only acts as a matrix (e.g., scaffold, form or support structure) for tissue ingrowth but also is coated with, impregnated with or contains a substance, such that the substance will elute from or otherwise be delivered from the matrix  18  following implantation of the device  10 .  FIG. 5A  shows an example wherein the matrix  18  or a portion thereof is formed of a hollow member  18   a  (e.g., a hollow fiber) that has a lumen  38  wherein the substance is initially contained and a wall  36  through which the substance will diffuse or otherwise pass, thereby resulting in a release or elution of the substance from the hollow member  18   a .  FIG. 5B  shows another example wherein the matrix  18  or a portion thereof is formed of a hollow member  18 B that has a wall  40  and a lumen of inner cavity that opens through an opening  42  formed in one end or elsewhere in the wall  40  of the hollow member  18   b  such that substance contained in the lumen or inner cavity of the hollow member  18   b  will pass out of the opening  42 , thereby resulting in a release or elution of the substance from the hollow member  18   a . Each hollow member  18   a ,  18   b  may be extruded or otherwise formed such that its inner diameter, wall thickness and/or outlet opening size controls the rate at which the drug or other substance will be eluted from or delivered by the device  10 . The amount of or depth to which the drug or other substance is loaded into each hollow member  18   a ,  18   b could control the dispersal of the drug over time (i.e. more drug in the hollow fiber will provide for a longer period of time over which the drug will be delivered). It will be appreciated that, additionally or alternatively, the hollow members  18   a ,  18   b  shown in  FIGS. 5A and 5B  could be used to form all or portions of the leg members  12  and/or  15  such that substance will elute from or be delivered by the leg members  12  and/or  15  in addition to or as an alternative to elution or delivery of substance from the matrix  18 .  
         [0061]      FIGS. 6-6C  show other examples wherein all or portion(s) of the leg member(s)  12  and/or  15  are constructed to contain and deliver a drug or other substance. In some embodiments, all or portion(s) of the leg members  12  and/or  15  may be hollow, cellular, permeable or cavernous such that they may contain a drug or other substance (see  FIGS. 6B and 6C ) or one or more reservoir members may be attached to the device  10  to contain the drug or other substance (see  FIG. 6A ). The drug or other substance may then diffuse, leak, transport or otherwise pass out of the reservoir through semipermiable membrane(s) or openings.  
         [0062]     For example, as shown in  FIG. 6A , a semipermiable reservoir member  47  which contains the drug or other substance may be attached to the end of one or more leg(s)  12  such that the drug or substance will diffuse through the wall of the reservoir member  47  thereby delivering a therapeutically effective dose of the drug or substance to the subject over a desired period of time. The reservoir member  47  may or may not be removable from the implanted device  10  and, in some embodiments, the reservoir member  47  may be replaceable by another full reservoir member  47  in situ while the device  10  remains in place. For example, in applications where the device  10  is implanted within a fallopian tube FT for the purpose of contraception, the reservoir member  47  may be removed and/or replaced at a later date via a hysteroscope  64  and a suitable removal device such as a gripping device or forceps that may be passable through a working channel  70  of the scope  64 . Alternatively, the reservoir member  47  may be refillable, for example by a syringe.  
         [0063]      FIG. 6B  shows an example wherein a portion  48  of a leg member  12  is hollow and contains the drug or substance and wherein a semipermiable window  50  is formed of material through which the drug or other substance will diffuse such that therapeutically effective dose of the drug or substance will be delivered to the subject over a desired period of time.  
         [0064]      FIG. 6C  shows an example wherein a portion  44  of a leg member  12  is hollow and contains the drug or substance and wherein a plurality of small holes  46  are formed in that portion of the leg  12  such that the drug or other substance will seep or otherwise flow out of the holes and a therapeutically effective dose of the drug or substance will be delivered to the subject over a desired period of time.  
         [0065]     Additionally or alternatively, the substance may comprise or may be contained in particles (e.g., granules, beads, vesicles, blisters, bubbles, capsules, lyposomes, microcapsules, etc.) that are disposed on (e.g., adhered or affixed to) some portion of the device  10  such that the substance will be released is from the particles after the device  10  has been implanted.  
         [0066]      FIGS. 7-7B  show another example, wherein a substance delivering implant  52 , such as a pellet or capsule, is separate from or may be attached to and/or associated with the lumen occluding and/or substance delivery device  10 .  
         [0067]     For example, in embodiments where the device  10  is implanted in a fallopian tube FT for contraceptive purposes, a contraceptive drug delivering implant  52  may be implanted proximally to, within, or distally to the device  10 . The matrix of the pellet, in some embodiments, may be biodegradable (e.g., formed of polylactic acid, polyglycolic acid, etc.) such that after a desired or predetermined period of time, the pellet would dissolve and be gone. Methods for making substance delivering pellets or implants are previously known in the art including those described in U.S. Pat. Nos. 3,625,214; 3,991,750; 5,855,915 and 6,306,914, the entireties of which are expressly incorporated herein by reference.  
         [0068]     It is to be appreciated that the drug or other substance may be incorporated into any portion or element of the device  10  in any suitable way. For example, the drug or substance may be mixed in to a material (e.g., a plastic) that flows, dissolves, melts, oozes or otherwise passes out of the device  10  following implantation. In such embodiments, the molecules of the drug or substance may be sized so as to migrate or pass between polymer chains of the plastic such that the drug or substance will leach or pass out of the plastic over a desired time period. In certain embodiments, the drug or substance may make up or be incorporated into a coating that is extruded or applied over all or a portion of the material located in or on the device, such that the drug or substance will elute or pass out of the coating at a desired rate or over a desired time period. In certain embodiments the drug or substance may make up or may be incorporated in a coating that is applied to all or a portion of the device  10  (e.g., the leg members  12  and/or  15  may be formed of a material such as self expanding nickel-titanium alloy or other metal and may be coated with a coating that consists of or contains the drug or substance) such that the drug or substance will elute or pass out of that coating at a desired rate or over a desired time period. In certain embodiments, one or more holes, indentations or other texture may be drilled or otherwise formed in the leg members  12  and/or  15  or the optional matrix  18  or other portion(s) of the device  10  and the desired drug or substance may be placed in the hole(s), indentation(s) or other texture such that the drug or substance will elute or pass out of the hole(s), indentation(s) or other texture over a desired time period. The diameter(s) and/or depth(s) of the hole(s), indentation(s) or other texture may be selected to control the rate and time over which the drug or substance will elute or otherwise pass from the device. In certain embodiments the substance may be responsive to the physiological conditions and thereby control the delivery of the substance in response to those conditions. For example, where the substance is released for contraceptive purposes within the fallopian tubes, the release of the substance may be controlled to some extent by the menstrual cycle of the patient. Certain well known biochemical conditions prevail within the uterus and fallopian tubes at the time and shortly after the release of the egg from the ovaries (referred to here as ovulation). A pellet of spermicidal substance or other similar contraceptive substance may be coated with a substance that is soluble in response to the biochemical conditions that prevail at the time of ovulation, but relatively insoluble in the biochemical conditions that prevail in the uterus and fallopian tubes at other times. This would result in the release of the substance primarily at the time of ovulation, and thus result in a long lasting contraceptive pellet that enhances contraception at precisely the time when it will be effective. Another example of the release of the substance in response to physiological conditions would be where a greater amount of substance is released in response to increased blood flow, as in a chemotherapeutic agent located in a feeding artery to a tumor. As the blood flow decreases, smaller amounts of the chemotherapeutic substance is released, resulting in decreased systemic effects as the blood flow to the tumor is cut off. Responses to blood pressure, diurnal cycles, and the like can also be engineered in accordance with this invention.  
         [0069]     As shown in  FIGS. 8 and 8 A, the invention also provides an implantable lumen occluding and/or substance delivering device  54  that further comprises a flag or marker  60  that unravels or extends out of the fallopian tube and into the uterus for visual confirmation to indicate which fallopian tube has a device  54  in it. In this particular non-limiting example, the device  54  comprises a mesh body  56  that is designed to facilitate tissue ingrowth and occlude of a fallopian tube or other body lumen in which it is implanted. An arm  58  extends from the body  56  and the marker  60  is attached to the arm  58 , as shown. Optionally, this flag or marker  60  and/or the body  56  of the device  54  can contain a substance (e.g., contraceptive drug, antifungal, antibiotic, agent for treatment of STD such as pelvic inflammatory disease, spermicidal agent, etc.) as described above. Also, optionally, this flag or marker  60  may be dissolvable or biodegradable and/or retrievable and removable at a later date, such through an endoscope or hysteroscope as described above. In embodiments, where the flag or marker  60  or any other component of the device is removable from the body, that component may contain substance(s), such as copper, that are desirable for only for short term implantation.  
         [0070]     The substance eluting implantable devices  10 ,  54  of the present invention may be useable in various applications. For example, as described above, in applications where the device  10 ,  54  is implanted in a fallopian tube FT or elsewhere in the female genitourinary tract for the purpose of blocking egg migration or implantation, the device  10 ,  54  may additionally elute or deliver a female contraceptive agent or spermicidal agent to deter pregnancy, at least for some initial period of time following implantation of the intraluminal device. Any effective contraceptive or spermicidal agent may be used, in amounts that result in the desired therapeutic effect of avoiding pregnancy.  
         [0071]     Specific examples of contraceptive agents that may be used include; the contraceptive hormone contained in the Norplant system (e.g., a synthetic progestin, namely, levonorgestrel having the molecular formula (d (−)- 13 -beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one) and a molecular weight of 312.45 and/or various other contraceptive hormone preparations including but not limited to medroxyprogesterone acetate, norethisterone enanthate, progestogen, levonorgestrel, levonorgestrel (as progestogen), ethinyl estradiol (as estrogen), norgestrel (as progestogen), levonorgestrel in combination with ethinyl estradiol, Norethisterone enanthate, norgestrel in combination with ethinyl estradiol, quinacrine, etc. Quinacrine is not a hormone. Rather, quinacrine is an agent which may be used to cause chemical, non-surgical female sterilization. When a quinacrine hydrocholoride pellet is inserted directly into the uterus, the guinacrine liquefies and flows into the fallopian tubes, causing permanent scarring. Although recorded failure rates and persistent side effects related to quinacrine sterilization have been low, controversy has developed around quinacrine&#39;s long-term safety, efficacy, and link to upper genital tract infections. However, direct placement of quinacrine into the fallopian tube in combination with or as part of a lumen blocking implantable device of this invention may permit the use or relatively low levels of quinacrine which would facilitate a local effect within the fallopian tube without untoward systemic toxicity.  
         [0072]     In applications where the device  10  is implanted within a fallopian tube FT to cause contraception, the device  10  may deliver a contraceptive agent in an amount that a) causes an effect on the uterine tissue (e.g., endometrium) such that eggs will not become implanted within the uterus UT and/or b) causes cessation of ovulation. Typically, the dose of contraceptive substance delivered to cause cessation of ovulation is higher than the dose delivered to cause non-implantation of eggs in the endometrium. For example, the device  10  may deliver from about 10 micrograms to about 70 micrograms of levonorgestrel (d (−)-13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one). Dosages of levonorgestrel within the lower portion of this dosage range (e.g., from about 10 micrograms per day to about 30 micrograms per day) may be used to cause non-implantation of eggs in the endometrium while dosages within the higher portion of that dosage range (e.g., from about 30 micrograms per day to about 70 micrograms per day) may be used to cause cessation of ovulation. The dosages may vary however and this invention is not limited to any specific dosage or any specific agent. Indeed, the optimal dosage of a particular contraceptive agent to be delivered from the device  10  may depend on various factors, such as the age of the patient, the specific location at which the device  10  is implanted in the fallopian tube FT, whether devices  10  are implanted on only one or both fallopian tubes FT, etc.  
         [0073]     Specific examples of specific spermicidal agents that may be used include but are not limited to nonoxynol-9, octoxynol-9, menfegol, benzalkonium chloride and N-docasanol.  
         [0074]     Also, in any application where infection or microbial infestation is a concern, the device may elute or deliver antimicrobial agent(s) (e.g., microbicidal agents, antibiotics, antiviral agent(s), anti paracyte agent(s), etc.) Specific examples of antimicrobial agents that may be eluted or delivered from the implanted device include but are not limited to: Acyclovir; Amantadine; Aminoglycosides (e.g., Amikacin, Gentamicin and Tobramycin); Amoxicillin; Amoxicillin/Clavulanate; Amphotericin B; Ampicillin; Ampicillin/sulbactam; Atovaquone; Azithromycin; Cefazolin; Cefepime; Cefotaxime; Cefotetan; Cefpodoxime; Ceftazidime; Ceftizoxime; Ceftriaxone; Cefuroxime; Cephalexin; Chloramphenicol; Clotrimazole; Ciprofloxacin; Clarithromycin; Clindamycin; Dapsone; Dicloxacillin; Doxycycline; Erythromycin; Fluconazole; Foscarnet; Ganciclovir; Gatifloxacin; Imipenem/Cilastatin; Isoniazid, Itraconazole+(Sporanox®); Ketoconazole; Metronidazole; Nafcillin; Nafcillin; Nystatin; Penicillin; Penicillin G; Pentamidine; Piperacillin/Tazobactam; Rifampin; Quinupristin-Dalfopristin; Ticarcillin/clavulanate; Trimethoprim/Sulfamethoxazole; Valacyclovir; Vancomycin; Mafenide; Silver Sulfadiazine; Mupirocin; Nystatin; Triamcinolone/Nystatin; Clotrimazole/Betamethasone; Clotrimazole; Ketoconazole; Butoconazole; Miconazole; Tioconazole, detergent-like chemicals that disrupt or disable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride, menfegol, and N-docasanol); chemicals that block microbial attachment to target cells and/or inhibits entry of infectious pathogens (e.g., sulphated and sulponated polymers such as PC-515 (carrageenan), Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPA gel) that prevent HIV or other retroviruses from replicating in the cells; genetically engineered or naturally occurring antibodies that combat pathogens such as anti-viral antibodies genetically engineered from plants known as “Plantibodies,” agents which change the condition of the tissue to make it hostile to the pathogen (such as substances which alter vaginal pH (e.g., Buffer Gel and Acidform) or bacteria which cause the production of hydrogen peroxide within the vagina (e.g.,  lactobacillus ).  
         [0075]     Also, in some applications, a substance eluting implantable device may be placed in a body lumen (e.g., blood vessel, bronchus, hepatic duct, common bile duct, pancreatic duct, etc.) near a tumor and the device may deliver one or more anti-tumor agents to treat the tumor. Specific examples of anti-tumor agents that may be used in this invention include but are not limited to: alkylating agents or other agents which directly kill cancer cells by attacking their DNA (e.g., cyclophosphamide, isophosphamide), nitrosoureas or other agents which kill cancer cells by inhibiting changes necessary for cellular DNA repair (e.g., carmustine (BCNU) and lomustine (CCNU)), antimetabolites and other agents that block cancer cell growth by interfering with certain cell functions, usually DNA synthesis (e.g., 6 mercaptopurine and 5-fluorouracil (5FU), Antitumor antibiotics and other compounds that act by binding or intercalating DNA and preventing RNA synthesis (e.g., doxorubicin, daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin)Plant (vinca) alkaloids and other anti-tumor agents derived from plants (e.g., vincristine and vinblastine), Steroid hormones, hormone inhibitors, hormone receptor antagonists and other agents which affect the growth of hormone-responsive cancers (e.g., tamoxifen, herceptin, aromatase ingibitors such as aminoglutethamide and formestane, trriazole inhibitors such as letrozole and anastrazole, steroidal inhibitors such as exemestane), antiangiogenic proteins, small molecules, gene therapies and/or other agents that inhibit angiogenesis or vascularization of tumors (e.g., meth-1, meth-2, thalidomide (Thalomid), bevacizumab (Avastin), squalamine, endostatin, angiostatin, Angiozyme, AE-941 (Neovastat), CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P), SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, IM862, TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha, interleukin-12 (IL-12) or any of the compounds identified in  Science  Vol. 289, Pages 1197-1201 (Aug. 17, 2000)), biological response modifiers (e.g., interferon, bacillus calmette-guerin (BCG), monoclonal antibodies, interluken 2, granulocyte colony stimulating factor (GCSF), etc.), PGDF receptor antagonists, herceptin, asparaginase, busulphan, carboplatin, cisplatin, carmustine, cchlorambucil, cytarabine, dacarbazine, etoposide, flucarbazine, flurouracil, gemcitabine, hydroxyurea, ifosphamide, irinotecan, lomustine, melphalan, mercaptopurine, methotrexate, thioguanine, thiotepa, tomudex, topotecan, treosulfan, vinblastine, vincristine, mitoazitrone, oxaliplatin, procarbazine, streptocin, taxol, taxotere, analogs/congeners and derivatives of such compounds as well as other antitumor agents not listed here.  
         [0076]     In some embodiments the lumen occluding and/or substance delivering device  10 ,  54  may be used for antitumor applications. In the example shown in  FIGS. 10 and 10 A, a tumor T has a peduncle P through which and artery A and vein V run. A lumen occluding and/or substance delivering device  10  of the present invention is implanted in the artery A to occlude the artery A thereby cutting of blood flow to the tumor and/or to deliver an antineoplastic or antitumor substance to the tumor T. In some of these applications, the implanted device  10  may continue to allow some flow of blood or other body fluid through the body lumen in which it is positioned and into the tumor for at least an initial period of time following implantation of the device (e.g., until tissue ingrowth into the device  10  closes off the lumen of the blood vessel or other body lumen). In this way, the antitumor substance eluted or delivered by the device  10  will be carried into the tumor T for some desired period of time following implantation. Thereafter, cellular ingrowth into the device  10  causes a progressive and complete occlusion of the artery A after the desired dose of antitumor substance has been delivered to the tumor T. This blockage of blood flow to the tumor T may further serve to inhibit or kill some or all of any remaining tumor cells that have not been killed by the antitumor drug. The release of the drug may be controlled based on the rate of blood flow through the feeding vessel. As the artery A occludes over time, less total amount of the drug will be released into the bloodstream and thus there will be less systemic effects of the chemotherapeutic agent which will generally result in less dramatic side effects. On the other hand, the concentration of the antitumor substance will generally be slightly more concentrated in the blood based on the reduced flow, resulting in a more concentrated but more localized therapeutic effect on the tumor T.  
         [0077]     In yet another example of an application of this invention shown in  FIGS. 11-11B , the implantable intraluminal device  10  is implanted into a lung L to block air flow to a portion of the lung L. As seen in  FIG. 11 , the trachea T is bifurcated into right and left mainstem bronchi MB. Each mainstem bronchus MB then branches into a number of secondary bronchi SB. In the particular non-limiting example shown, the device  10  is implanted into a secondary bronchus SB that leads into the lower lobe of the left lung L. Following implantation, the device  10  may cause instant or progressive full occlusion of the secondary bronchus SB, so as to prevent air from entering the diseased lobe or region of lung parenchyma that receives air through that secondary bronchus SB. Such leakage or disease may result from, for example, a ruptured emphysematous bleb, traumatic lung puncture or iatrogenic lung rupture. In other cases the device  10  may be constructed so as not to substantially block airflow through the bronchus and possibly even to perform a scaffolding or stenting function which holds the lumen of the bronchus open. In either type of device, a drug or substance may be eluted or delivered by the device into the adjacent pulmonary tissue. For example, in cases where the device has been implanted to close off flow to a punctured area of the lung, the device may elute an antibiotic or other agent (e.g., a bronchodilator, mucolytic agent, expectorant, etc.) to locally deter or treat any infection or other condition present or developing in the lung tissue. In cases where the device  10  is implanted in a bronchus to treat emphysema or chronic obstructive pulmonary disease, the device may elute a therapeutic agent that is effective to treat that underlying condition or its symptoms.  
         [0078]     Some examples of drugs that may be eluted from the device for the purpose of treating such lung diseases include but are not limited to: antimicrobial substances (examples of which are listed hereabove); corticosteroids such as beclomethasone (Vanceril, Beclovent), triamcinolone (Azmacort), flunisolide (Aerobid), fluticasone (Flovent), budesonide (Pulmicort), dexamethasone, prednisone, prednisolone, methylprednisolone (Medrol, SoluMedrol, DepoMedrol), methylprednisolone (Depo-Medrol), hydrocortisone (SoluCortef), methylprednisolone (SoluMedrol); Mediator-release inhibitors or cromones such as, cromolyn sodium (Intal), nedocromil sodium (Tilade); anti-leukotriene drugs such as leukotriene-receptor antagonists (e.g., zafirlukast (Accolate)), leukotriene-synthesis inhibitors (e.g., zileuton (Zyflo)) and other anti-leukotrienes (e.g., montelukast (Singulair)), mucolytic agents and expectorants (e.g., guifenisn); bronchodilator drugs such as beta-adrenergic agonists (e.g., epinephrine (Primatene), isoproterenol (Isuprel), isoetharine (Bronkosol), metaproterenol (Alupent, Metaprel), albuterol (Proventil, Ventolin), terbutaline (Bricanyl, Brethine), bitolterol (Tornalate), pirbuterol (Maxair), salmeterol (Serevent), Methyl xanthines (e.g., caffeine, theophylline, aminophylline and oxtriphylline (Choledyl)) and anticholinergics (e.g., atropine, ipratropium bromide (Atrovent).  
         [0079]     It will be appreciated by those skilled in the art that various modifications, additions, deletions, combinations and changes may be made to the examples described hereabove and shown in the drawings, without departing from the intended spirit and scope of this invention. All such reasonable modifications, additions, deletions, combinations and changes are included in this disclosure.

Technology Classification (CPC): 0