WO1997046276A1

WO1997046276A1 - Implantable circumferential treatment delivery device

Info

Publication number: WO1997046276A1
Application number: PCT/US1997/008168
Authority: WO
Inventors: Leslie C. Butters; Lee J. Carmack
Original assignee: W.L. Gore & Associates, Inc.
Priority date: 1996-06-06
Filing date: 1997-05-14
Publication date: 1997-12-11
Also published as: AU3066897A

Abstract

An implantable medical device and method for the delivery of medical treatment to the outer circumference of an organ or tubular structure within a living body. The medical device comprises a tube which is either flexible or rigid and which contains a means for treating a medical condition on or within the structure from its outer circumference, thus obviating the need for subsequent surgeries to enter the interior of the structure and provide treatment intraluminally. This method and device provide significant adavantages over conventional medical treatments, which typically require intraluminal intervention or other surgeries to treat a condition, by providing a more effective means for treating such medical conditions.

Description

TITLE OF THE INVENTION

IMPLANTABLE CIRCUMFERENTIAL TREATMENT DELIVERY DEVICE

RELATED APPLICATIONS

The present application is a continuation-in-part of copending United States Patent Application Serial No 08/659,602 filed June 6, 1996

BACKGROUND OF THE INVENTION 1 Field of the Invention

The present invention relates to an implantable medical device and method for the delivery of medical treatment to the outer circumference of a structure within a living being

2 Description of Related Art Medical conditions which cannot be treated through the ingestion of medication or via physical therapy unfortunately often require surgery to access and treat such conditions These surgical procedures are not only invasive, often resulting in significant injury to the patient's body and extended recovery times, but also extremely expensive in this age of soaring hospital costs It is, therefore, even more unfortunate that follow-up surgeries often become necessary to address re-stenosis and re-occlusion of tubular structures, physiological responses, etc , which directly or indirectly result from the initial surgery or to address further progress of existing disease

As advancements in the field of medical treatment have progressed, the use of surgery to treat medical conditions previously regarded as untreatable has become commonplace For example, the replacement of damaged or diseased vascular sections and the removal of tumors are two examples of surgeries which have become almost routine medical treatments

Thus, the medical community is continually seeking more effective and less costly techniques for treating patients not only to minimize the extent of suffering and recovery time for the patient, but also to minimize overall costs for the medical treatment

Numerous treatment modalities have been prescribed to address the proliferation of undesirable cell growth, which encompasses a wide range of medical conditions, both malignant and benign Of these treatments, few have proven to be effective The efficiency of irradiation in minimizing pathologic proliferation of tissue has been known since the beginning of the 20th century The first successful brachytherapy treatment of keloids was in 1905 The good results of contact treatment of keloids and hypertrophied scars suggested irradiation may also be useful to prevent endovascular occlusion and re¬ occlusion. A similarity between keloids and hypertrophied scars and endovascular occlusion re-occlusion is the neoproliferative responses (e.g., excessive proliferation of normal or foreign cells within a tubular structure as a result of injury due to surgery, in response to disease, etc.). Some researchers have labeled anastomotic hyperplasia as "luminal keloids."

Brachytherapy is a method of treatment in which sealed radioactive sources (e.g., radionuclides) are used to deliver radiation at a short distance by interstitial, intracavity or surface application. With this mode of therapy, a controlled radiation dose can be delivered locally with rapid dose fall-off in the surrounding normal tissue. High dose rate (HDR) brachytherapy refers to a therapy using radiation of high energy sources, which has a high depth of radiation penetration into adjacent tissue. With increased tissue penetration, the positioning of an HDR source is less critical to the achievement of a homogeneous dose to the target tissue. However, the greater depth of radiation penetration results in less sparing of surrounding normal tissue. Low dose rate (LDR) brachytherapy delivers a more confined dose to the target, but must be placed with great precision to avoid areas of underdosage due to the limited penetration of the low energy radiation. However, the confined volume of radiation from the source minimizes the dose to the surrounding normal tissue.

Due to technological constraints (i.e., lack of slim applicators and radiation sources with high specific activity), brachytherapy could not be used for treatment of vascular stenosis and occlusion for many years. It was not until the introduction of small radiation sources and applicators in HDR brachytherapy that the idea of endovascular and luminal radiotherapy was possible.

Numerous therapies, surgical repairs and drug treatments are often indicated in an attempt to regulate vascular stenosis and occlusion of tubular structures within the body. Tubular structures, as defined herein, include structures having a circumference about which the medical device of the present invention may be placed. Exemplary tubular structures, including but not limited to arteries, veins, intestines, bile ducts, fallopian tubes and vas deferens of the reproductive system, and the like, include those which are subject to luminal constriction and obstruction of flow. As a result, tissues and organs downstream of the obstruction are deprived of vital elements. Additionally, some complications and failures with synthetic and biologically-based grafts have been attributed in part to anastomotic stenosis. It is hypothesized that anastomotic narrowing might be due to chronic endothelial injury and turnover associated with continued cell proliferation and intimal thickening associated with extracellular matrix proliferation ("response to injury hypothesis").

Accordingly, it is a primary purpose of the present invention to provide an effective method for treating medical conditions within the body without resulting in a disorder which would complicate patency, thus requiring repeat intervention.

It is a further purpose of the present invention to provide a circumferential treatment device for delivering medical treatment to the outer circumference of a tubular structure within a living body.

It is a further primary purpose of the present invention to provide a method for preventing or minimizing/reducing anastomotic stenosis of tubular structures within a living body through implantation of a device which guides and positions radioactive sources or other modalities to the outer diameter of the tubular structure at the site of anastomosis.

It is a further purpose of the present invention to provide a device which is effective in preventing or reducing/minimizing anastomotic stenosis without resulting in a disorder which would complicate patency or cause other disorders.

These and other purposes of the present invention will become evident from review of the following specification. SUMMARY OF THE INVENTION

The present invention relates to an implantable medical device and method for the delivery of medical treatment to the outer circumference of a structure within a living being. More particularly, the present invention relates to a device which is implanted within a patient during surgery, and the device may then be utilized immediately after surgery to administer treatment to prevent, for example, in the case of a radiation treatment device, development of hyperplastic responses (i.e., excessive proliferation of normal cells in the normal tissue arrangement of an organ or tubular structure), resulting in stenosis. For convenience, the term "tubular structure" shall be used herein to refer collectively to tubular structures and organs.

The device of the present invention comprises a flexible or rigid tube of predetermined dimensions having distal and proximal portions and may be positioned circumferentially around the outer diameter or anastomosis of a structure within the body at the time of surgery or other therapies The device may be designed in any desirable configuration to incorporate a treatment means, such as a radioactive source (e g , radionuclide, etc ) For example, depending on the desired treatment method, degree of tissue attachment desired, etc , the geometry of the device may be tailored to incorporate radionuclides or other treatment modalities of varying physical geometries, bend radiuses, dimensions, rigidities, physical forms, and the like The distal portion of the device is typically sealed in a manner which contains and/or limits insertion of the radionuclide or other treatment modalities The implantable medical device of the present invention may comprise a single material or, alternatively, may be a multicompositional device, and the morphology of the device may vary from one region of the device relative to another region, depending on the desired treatment method, etc

Appropriate treatments which may be delivered through the present medical device include, but are not limited to radiation treatment, drug delivery, electrical stimulation, and other modalities for the treatment of medical conditions and diseases

DESCRIPTION OF THE DRAWINGS The operation of the present invention should become apparent from the following description when considered in conjunction with the accompanying drawings, in which

Figure 1A is a perspective view of a permanently implantable irradiation treatment device located at the end-to-side anastomosis of a synthetic graft and a host vessel,

Figure 1 B is a top perspective cut-away view of the device shown in

Figure 1A,

Figure 1C is a cross-sectional view along line A - A' of Figure 1B, Figure 2A is a perspective view of a permanently implantable irradiation treatment device of the present invention,

Figure 2B is a cross-sectional view along line B - B' of Figure 2A, and Figure 3 is a composite irradiation treatment device which includes a permanently implantable component, a removable component, a securing flange and an irradiation device

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to an implantable medical device for guidance and location of radionuclides for providing treatment to the outer diameter of anastomotic junctions of tubular structures, such as synthetic or biological grafts to the host vessels, intestines, bile ducts, fallopian tubes, vas deferens, ureters, and the like Appropriate treatments which may be delivered through the present medical device include, but are not limited to radiation treatment, drug delivery, electrical stimulation, and other modalities for the treatment of medical conditions and diseases For convenience, the present invention will be described with respect to radiation treatment devices, however, it should be understood that the present invention is suitable for any treatment modalities which can be incorporated into the described configurations of the present invention

The device of the present invention comprises a flexible or rigid tube of predetermined dimensions having distal and proximal portions and may be positioned circumferentially around the outer diameter of, for example, an anastomotic junction of a graft and host vessel or bowel resection at the time of surgery The device may be designed in any desirable configuration to incorporate a treatment means such as a radioactive source (e g , radionuclide, etc ) For example, the geometry of the device may be tailored to incorporate radionuclides or other treatment modalities of varying physical geometries, bend radiuses, dimensions, rigidities, physical forms, and the like The distal portion of the device is typically sealed in a manner which contains and/or limits insertion of the radionuclide or other treatment modality

The device may be designed to accept short- and/or long-term implantation of low dose rate (LDR) and/or high dose rate (HDR) radionuclides without interruption of flow through the tubular structure Depending upon the desired treatment method, the proximal portion of the device may be either open or closed For example, in applications where a radionuclide is to be temporarily inserted after implantation of the device, the proximal portion may include an opening for the radionuclide to be inserted from an external source Moreover, the proximal portion may be radiopaque (i e , impenetrable to x-ray) to assist in percutaneous location Further, the proximal portion may include means to limit contamination by biological fluids and cellular introduction into the device

In applications where the radionuclide is to be permanently located within the implantable device, distal and proximal portions may be sealed in any suitable manner which would contain the radionuclide within the device and limit biological fluid and cell introduction into the device Exemplary sealing techniques may include, but are not limited to, crimping or heat sealing one or more ends of the tube, providing a plug in the end of the tube, etc The implantable medical device of the present invention may comprise a single material or, alternatively, may be a multi-compositional device Suitable materials include any biocompatible materials and may be of any desirable microporosity, morphology, rigidity, etc , which enhances the performance of the device For example, suitable materials may include polytetrafluoroethylene, expanded polytetrafluoroethylene such as that taught in U S Patent Nos 3,953,566, 3,962,153, and 4,197,390, to Gore, silicone, urethanes, bioabsorbable, or resorbable, polymers and other biocompatible materials, modified hyaluronic acid, hydrogels, etc Bioabsorbable materials are defined as those materials of either synthetic or natural origin which when placed into a living body are degraded through either enzymatic, hydrolytic or other chemical reactions, into byproducts which are either integrated into or expelled from the body Further, the microporosity, rigidity, and other morphologies of the materials comprising the device may vary from the inner diameter to the outer diameter For example, in one embodiment it may be desirable to provide a device with an inner diameter having a non-porous surface to facilitate ease of insertion and removal of radionuclides and discourage tissue ingrowth and attachment, and an outer diameter having a microporous surface which may, for example, encourage tissue ingrowth and attachment Additionally, this device may be composed of porous biocompatible or resorbable materials with a porosity designed to allow controlled release of one or more drugs by elution from within the lumen of the device and diffusion through the pores of the device to nearby tissue adjacent the device In another embodiment, the medical device of the present invention may comprise two or more components For example, the device may comprise a permanently implantable, biocompatible outer component for attachment and securing to, for example, a vessel, prosthesis, vessel external harness, or pengraft tissue to, among other things, limit migration of the device, and a removable, biocompatible inner sleeve which facilitates ease of insertion and removal of radionuclides or other treatment modalities With this type of configuration, the inner sleeve could be removed after completion of treatment, thereby leaving only the biocompatible outer component permanently implanted within the body In a further embodiment of the present invention, the device may comprise a permanent, implantable biocompatible attachment component and a detachable/removable biocompatible segment which provides transcutaneous access to the implantable, attached component In this embodiment, the implantable, attached component may comprise a material which encourages tissue attachment to the component; whereas the detachable segment may comprise a biocompatible material which does not encourage tissue attachment. The detachable component may incorporate a flange or other means to limit contamination, infection, etc., and may also incorporate a protective cap and/or seal to protect the opening of the device at the epidermis while it is implanted within the body. The radionuclide may be inserted into the detachable component to administer treatment Moreover, the detachable component may further include means to facilitate easy detachment without aggravating the anastomosis or surrounding tissue.

In a further embodiment of the present invention, it may be desirable to provide a vessel harness or other similar component as a means to stabilize the location of the device and provide attachment in the event that the attachment of the device to the vessel is complicated by disease, vessel configuration (e.g., vein wall cross-sectional thickness, etc.) or the like The harness structure may comprise, for example, a biocompatible material and may be positioned circumferentially around, for example, an anastomotic junction for attachment of the device.

Depending on the desired function of the present invention, one or more combinations of the above features may be incorporated into the device in order to achieve a desired result.

In the embodiment of the present invention wherein the medical device comprise a radiation treatment device, a variety of radiation sources may be used in conjunction with either permanent or temporary implant therapies (e.g , LDR, HDR, or the like) Such sources may comprise singular species or, alternatively, plural species, wherein the species may have differing half-lives to provide varying levels of radiation treatment Preferred radionuclides may include, but are not limited to, 226Ra, 222Rn, 137Cs, 192lr, 198Au, 1251, 55Co, 56Co, 57Co, 58Co, 60Co, 52Mn, 95Tc, 96Tc, 99Mo, 57Nι, 55Fe, 65Zn, 51Cr, 181Re, 182Re, 144Sm, 145Sm, 103Pd, 48V, 181W, 90Y, 169Yb and

32P Moreover, depending on the desired treatment, any combination of singular or multiple radiation species, whether administered by temporary or permanent means, may be utilized in connection with the present invention

A preferred embodiment of the present invention is shown in Figure 1A, wherein the device 10 comprises a permanently implantable irradiation treatment device implanted around an end-to-side anastomotic junction 12 of a host vessel 9 and a synthetic graft 8. Shown in Figure 1B is a top perspective cut-away view of device 10, wherein the device includes a sleeve 13 and radionuclides 14 spaced within the device by a spacing member 15 End seals 16 are provided to seal the radionuclides within the sleeve 13 Figure 1C is a cross-sectional view along line A - A' of Figure 1 B, showing the radionuclide seed 14 attached to the spacing member 15, all within the sleeve 13 The spacing member of the present invention may comprise any material which is compatible with the device and is capable of spacing the treatment components (e g , radionuclides, drugs, etc ) within the device The treatment components may be attached to the spacing member, may be held within the spacing member, or held in any other manner which provides the desired spacing or separation of the treatment components In a particularly preferred embodiment of the present invention, the spacing member may comprise a woven suture material which is capable of holding the treatment device within the interior of the suture material, such as a synthetic absorbable suture sold under the name VICRYL® polyglactic 910 suture by Amersham Healthcare, located in Arlington Heights, IL

Figure 2A shows a further preferred embodiment of the present invention wherein the permanently implantable composite medical device 23 includes an outer sleeve 22, an inner sleeve 20, and radionuclides 14 spaced within the device by a spacing member 15 Figure 2B is a cross-sectional view along line B - B', showing the radionuclide seed 14 attached to the spacing member 15, all within the inner sleeve 20 and surrounded by the outer sleeve 22 End seal 16 is provided to seal the radionuclides within the inner sleeve 20

Figure 3 shows a further embodiment of the present invention comprising a composite irradiation treatment device 30 which includes a permanently implantable outer sleeve 31, a removable inner sleeve 20 which may be removably placed within the outer sleeve 31 , an outer flange 33 for securing the device to the epidermis and/or limiting contamination, infection, etc , and aradionuclide 14 which may be guided into the inner sleeve Without intending to limit the scope of the present invention, it is envisioned that this device could be implanted within a patient at the time of undergoing surgery to repair or replace a defective or diseased structure within the body It is also envisioned that the device could be implanted at the time of the above-mentioned surgery with the insertion of the radionuclide being performed at a later time (i e , minutes to days after surgery)

Advantages of the present invention over conventional treatment methods include, without limitation, the capability to administer long term LDR and/or HDR irradiation treatment without intravascular obstruction, accurate and precise radionuclide positioning without the need for angiography, CT or fluoroscopy, ease of multiple fractionations (i.e., dose schedules) using HDR or LDR irradiation without the potential for luminal balloon injury. Additionally, the use of this invention in conjunction with LDR irradiation eliminates the need for a shielded vault. Moreover, the use of this invention in conjunction with HDR reduces shielded vault times due to the elimination of angiography, CT, fluoroscopy, etc., for radionuclide positioning, catheter introduction, etc. Without intending to limit the scope of the present invention, the following example illustrates how the present invention may be made and used:

EXAMPLE 1

A two-piece stainless steel mold is manufactured from 2 inch ( 50.80 mm) diameter bar stock. First, a circular groove about 0.078 inch wide and 0.078 inch deep (2 mm by 2 mm) , with an inner diameter of about 5 mm, is machined on the center line of one of the 2 inch ( 50.80 mm) diameter pieces.

A straight, full radius bottom groove measuring 0.078 inch by 0.078 inch ( 2 mm by 2 mm) intersecting the circular groove is machined into the face of one of the mold pieces at approximately the 9:00 position. Two bolt holes are machined into the mold to permit the two pieces to be bolted together using two 10-32 inch bolts. The two pieces are then joined together perpendicular to the center line groove so that the piece with the straight, full radius bottom groove is flush with the ungrooved piece. It should be understood that the present invention is not limited to the specific configuration specified herein, and that many different geometries may be manufactured in this manner. To form the inner sleeve of the device, a 3 inch (76 mm) length of full density polytetrafluoroethylene (PTFE) tubing having an outer diameter of 0.070 inch ( 1.8 mm) and an inner diameter of 0.044 inch ( 1.1 mm) having a 0.002 inch ( 0.05 mm) thick coating of FEP on the outer diameter (commercially available from W. L. Gore and Associates, Inc., Flagstaff, AZ as Part No. IMF1036-3), is inserted into the center line groove within the mold, with the two parts of the mold bolted together. Any excess tubing is trimmed so that the end of the tubing is flush with the outer diameter of the mold.

The mold containing the ePTFE tubing is inserted into an air oven set at about 370°C for about 15 minutes. The mold is positioned so that the exposed end of the tubing is in contact with a flat surface inside the oven, thus insuring that the tubing will not flow out of the mold during heating. The mold is then removed from the oven and placed on a flat cooling plate with the tubing in contact with the surface of the plate. The mold containing the ePTFE tubing is then air cooled, and the mold is disassembled to provide the ePTFE inner sleeve of the medical device

To form the distal seal of the ePTFE inner sleeve, a 0 0625 (1 59 mm) length of FEP beading having an outer diameter of 0 044 inch (1 12 mm), (W L Gore and Associates, Inc , Flagstaff, AZ) is inserted into the internal diameter of the distal segment

The external or outer sleeve, comprising a 2 mm inner diameter piece of ePTFE tubing ( W L Gore and Associates, Inc , Flagstaff, AZ) is slid over the inner sleeve containing the FEP beading in the distal segment, and the composite device is placed into a mold similar to that used to form the inner sleeve, except that the center line groove of the mold measures about 0 125 inch wide by 0 125 inch deep ( 3 18 mm by 3 18 mm)

The mold containing the device is placed into a 370°C air oven for 5 minutes, the mold being positioned so that the exposed end of the tubing is in contact with a flat surface within the oven The mold is removed from the oven and cooled in the same manner as described above, then the mold is disassembled to reveal the device The FEP layer on the outer diameter of the inner sleeve melts during the second heating cycle and adheres the inner sleeve to the outer sleeve Additionally, the FEP beading located in the distal end of the inner sleeve melts to create a seal

EXAMPLE 2

A two-piece stainless steel mold is manufactured in the same manner as described in Example 1 To form the inner sleeve of the device, a 3 inch (76 mm) length of full density polytetrafluoroethylene (PTFE) tubing, without an FEP layer, having an outer diameter of 0 070 inch (1 8 mm) and an inner diameter of 0 04 inch (1 0 mm) ( W L Gore and Associates, Inc , Flagstaff, AZ ), is inserted into the center line groove within the mold, with the two parts of the mold bolted together Any excess tubing is trimmed so that the end of the tubing is flush

The mold containing the PTFE tubing is inserted into an air oven set at about 370°C for about 15 minutes The mold is positioned so that the exposed end of the tubing is in contact with a flat surface inside the oven, thus insuring that the tubing will not flow out of the mold during heating The mold is then removed from the oven and placed on a flat cooling plate with the tubing in contact with the surface of the plate The mold containing the PTFE tubing is then air cooled, and the mold is disassembled to provide the PTFE inner sleeve of the medical device.

To form the distal seal of the ePTFE inner sleeve, a 0.0625 (1.59 mm) length of FEP beading having an outer diameter of 0.044 inch (1.12 mm), W. L. Gore and Associates, Inc., Flagstaff, AZ) is inserted into the internal diameter of the distal segment.

The external or outer sleeve, comprising a 2 mm inner diameter piece of ePTFE tubing (W. L. Gore and Associates, Inc., Flagstaff, AZ) is slid over the inner sleeve containing the FEP beading in the distal segment. The mold containing the device is placed into a 370°C air oven for 5 minutes, the mold being positioned so that the exposed end of the tubing is in contact with a flat surface within the oven. The mold is removed from the oven and cooled in the same manner as described above, then the mold is disassembled to reveal the device. It should be noted that the absence of an FEP layer on the outer diameter of the inner sleeve (an FEP layer was present in Example 1 ) permits the removal of the inner sleeve from the outer sleeve after treatment, thereby leaving the outer sleeve permanently implanted. While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.

Claims

The invention claimed is 1 A method of delivering therapeutic treatment to the circumference of a tubular structure within a living body, comprising attaching around the outer perimeter of an internal body part a circumferential treatment delivery device, said device being capable of providing therapeutic treatment at the point of attachment, and administering said therapeutic treatment 2 The method of claim 1 , wherein said internal body part comprises a structure selected from the group consisting of an artery, an intestine, a bile duct, a fallopian tube, a vas deferens and a vein 3 The method of claim 1 , wherein said therapeutic treatment comprises at least one treatment selected from the group consisting of irradiation and drug therapy 4 The method of claim 1 , wherein said therapeutic treatment is administered through a single treatment 5 The method of claim 1 , wherein said therapeutic treatment is administered through multiple treatments over a period of time 6 The method of claim 1 , wherein said circumferential treatment delivery device is attached by a harness which stabilizes the location of the device 7 A method of preventing at least one of vascular occlusion, stenosis and hyperplastic responses at the anastomotic junction of a graft and host vessel following surgical implantation of a vascular prosthesis, said method comprising attaching around the outer perimeter of an anastomotic junction a device for guiding and positioning at least one irradiation source, said irradiation source being capable of providing therapeutic treatment at said anastomotic junction, administering said therapeutic treatment, said treatment being sufficient to reduce the occurrence of vascular disease at the anastomotic junction, proximally and distally of the anastomosis relative to an anastomotic junction which is not treated in such a manner

8 The method of claim 7, wherein said therapeutic treatment is administered through a single treatment

9 The method of claim 7, wherein said therapeutic treatment is administered through multiple treatments over a period of time 10 The method of claim 7, wherein said at least one irradiation source comprises at least one radionuclide selected from the group consisting of 226Ra, 222Rn, 137Cs, 192lr, 198Au, 1251, 55Co, 56Co, 57Co, 58Co, 60 Co, 52Mn, 95Tc, 96Tc, 99Mo, 57Nι, 55Fe, 65Zn, 51Cr, 181Re, 182Re, 144Sm, 145Sm, 103Pd, 48V, 181W, 90Y, 169Yb and 32P 11 The method of claim 7, wherein said at least one irradiation source compπses at least two radionuclides having different half-lives and activity levels 12 The method of claim 7, wherein the host vessel is selected from the group consisting of an artery, an intestine, a bile duct, a fallopian tube, a vas deferens and a vein 13 The method of claim 7, wherein said circumferential treatment delivery device is attached by a harness which stabilizes the location of the device 14 A circumferential treatment delivery device for delivering therapeutic treatment to an outer circumference of a body part within a living body, comprising a tube having proximal and distal parts, a therapeutic treatment means within said tube which is capable of being delivered through said tube, wherein said tube substantially conforms to the outer circumference of said body part

15 The circumferential treatment delivery device of claim 14, wherein both said proximal and said distal portions of said tube are sealed 16 The circumferential treatment delivery device of claim 14, wherein said proximal portion is open and accessible through the epidermis, and said distal portion is sealed, said therapeutic treatment means being insertable into and removable from said tube through said proximal portion 17 The circumferential treatment delivery device of claim 16, wherein said therapeutic treatment means is replenishable through said proximal portion 18 The circumferential treatment delivery device of claim 16, further comprising a flange at the epidermis which performs at least one function selected from the group consisting of anchoring the device to the epidermis and limiting the entry of contamination 19. The circumferential treatment delivery device of claim 18, further comprising a protective cap to limit entry of contamination. 20. The circumferential treatment delivery device of claim 16, further comprising a protective cap to limit entry of contamination. 21. The circumferential treatment delivery device of claim 14, further comprising a harness to stabilize the location of the device. 22. The circumferential treatment delivery device of claim 14, wherein said therapeutic treatment means is selected from the group consisting of irradiation and drug therapy. 23. The circumferential treatment delivery device of claim 14, wherein said tube comprises a flexible material. 24. The circumferential treatment delivery device of claim 14, wherein said tube comprises a rigid material. 25. The circumferential treatment delivery device of claim 14, wherein said tube comprises at least one material selected from the group consisting of PTFE, expanded PTFE, silicone, urethane, resorbable polymers, biocompatible materials, modified hyaluronic acids and hydrogels. 26. The circumferential treatment delivery device of claim 14, wherein tube further comprises an inner tube and an outer tube, said inner tube being insertable into and removable from said outer tube. 27. A circumferential irradiation device for delivering radiation to the outer circumference of an organ or tubular structure within a living body, comprising: a tube having proximal and distal portions, said proximal portion being open and said distal portion being sealed; a radioactive source which is insertable into and removable from said tube through said proximal portion; wherein said tube substantially conforms to the outer circumference of said tubular structure. 28. The circumferential irradiation device of claim 27, wherein said organ or tubular structure around which said tube substantially conforms comprises an anastomotic junction. 29. The circumferential irradiation device of claim 27, wherein said tube comprises a flexible material. 30. The circumferential irradiation device of claim 27, wherein said tube comprises a rigid material. 31. The circumferential irradiation device of claim 27, wherein said tube comprises at least one material selected from the group consisting of PTFE, expanded PTFE, silicone, urethane, resorbable polymers, biocompatible materials, modified hyaluronic acids and hydrogels 32 The circumferential irradiation device of claim 27, wherein tube further comprises an inner tube and an outer tube, said inner tube being insertable into and removable from said outer tube 33 The circumferential irradiation device of claim 27, further comprising a flange which performs at least one function selected from the group consisting of anchoring the device to the epidermis and limiting the entry of contamination 34 The circumferential irradiation device of claim 33, further comprising a protective cap to limit entry of contamination 35 The circumferential irradiation device of claim 27, further comprising a protective cap to limit entry of contamination 36 The circumferential irradiation device of claim 27, further comprising a harness to stabilize the location of the device

37 The circumferential treatment delivery device of claim 14, wherein said tube includes at least some porosity

38 The circumferential treatment delivery device of claim 37, wherein said at least some porosity is provided to promote tissue ingrowth on the exterior of the tube

39 The circumferential treatment delivery device of claim 37, wherein said at least some porosity is provided to facilitate delivery of drugs through the tube

40 The circumferential irradiation device of claim 27, wherein said tube includes at least some porosity

41 The circumferential irradiation device of claim 40, wherein said at least some porosity is provided to promote tissue ingrowth on the exterior of the tube

42 The circumferential irradiation device of claim 40, wherein said at least some porosity is provided to facilitate delivery of drugs through the tube