Abstract:
A method for maintaining access to a biopsy site within a patient, includes forming a passageway from an opening in an exterior site on the patient to a desired location for a biopsy specimen within the patient; removing a tissue specimen from the desired location thereby leaving a biopsy cavity; providing a temporary catheter having an elongate shaft, a flexible proximal shaft section, and a distal shaft section having a cavity filling member thereon; inserting the cavity filling member on the distal shaft section into the biopsy cavity; inflating the cavity filling member after inserting the cavity filling member within the biopsy cavity, but before closing the opening, using the flexible proximal shaft section; placing the flexible proximal shaft section at an intracorporeal location; and closing the opening so as to seal the passageway.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of application Ser. No. 11/980,307 filed Oct. 30, 2007, which is a division of application Ser. No. 11/357,274 filed Feb. 17, 2006, which is a continuation-in-part of application Ser. No. 11/105,856 filed Apr. 14, 2005, now U.S. Pat. No. 7,214,178, which is a continuation of application Ser. No. 10/849,410 filed May 19, 2004, now U.S. Pat. No. 6,955,641, which is a continuation of application Ser. No. 10/290,002 filed Nov. 6, 2002, now U.S. Pat. No. 6,923,754. All of these applications are incorporated herein in their entireties by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention generally relates to medical treatment devices and methods of using such devices. In particular, the invention is directed to devices and methods for temporarily maintaining access to a cavity in a targeted tissue region, such as a biopsy site from which cancerous, pre-cancerous or other tissue has been removed, to provide subsequent treatments to the tissue surrounding the cavity. 
       BACKGROUND OF THE INVENTION 
       [0003]    In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. A biopsy typically results in a biopsy cavity occupying the space formerly occupied by the tissue that was removed. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. Treatment of cancers identified by biopsy may include subsequent removal of tissue surrounding the biopsy site, leaving an enlarged cavity in the patient&#39;s body. Cancerous tissue is often treated by application of radiation, by chemotherapy, or by thermal treatment (e.g., local heating, cryogenic therapy, and other treatments to heat, cool, or freeze tissue). 
         [0004]    Cancer treatment may be directed to a natural cavity, or to a cavity in a patient&#39;s body from which tissue has been removed, typically following removal of cancerous tissue during a biopsy or surgical procedure. For example U.S. Pat. No. 6,923,754 to Lubock and U.S. patent application Ser. No. 10/849,410 to Lubock, describe devices for implantation into a cavity resulting from the removal of cancerous tissue which can be used to deliver cancer treatments to surrounding tissue. One form of radiation treatment used to treat cancer near a body cavity remaining following removal of tissue is “brachytherapy” in which a source of radiation is placed near to the site to be treated. 
         [0005]    The Lubock patent and patent application, above, describe implantable devices for treating tissue surrounding a cavity left by surgical removal of cancerous or other tissue that includes a cavity filling member such as an inflatable balloon constructed for placement in the cavity. The Lubock devices develop a vacuum within the biopsy cavity that is effective to draw surrounding tissue close to the surface of a treatment assembly so as to conform the tissue lining the cavity to the surface of the balloon. Such devices may be used to apply one or more of radiation therapy, chemotherapy, and thermal therapy to the tissue surrounding the cavity from which the tissue was removed. The balloon may be filled with a treatment fluid delivered via a conduit from a receptacle, syringe, or other means, or may receive a solid radiation source placed within the balloon. 
         [0006]    For example, a “MammoSite® Radiation Therapy System” (MammoSite® RTS, Proxima Therapeutics, Inc., Alpharetta, Ga. 30005 USA) includes a balloon catheter with a radiation source that can be placed within a tumor resection cavity in a breast after a lumpectomy. It can deliver a prescribed dose of radiation from inside the tumor resection cavity to the tissue surrounding the original tumor. Inflatable treatment delivery devices and systems, such as the MammoSite® RTS and similar devices and systems (e.g., GliaSite® RTS (Proxima Therapeutics, Inc.)), are useful to treat cancer in tissue adjacent a body cavity. 
         [0007]    Long term deployment of the catheter within the biopsy site may be necessary, e.g. for a few days to a few weeks to maintain access to the biopsy cavity while the biopsy sample is analyzed and it is determined whether or not irradiation of the cavity is necessary. The irradiation is not always necessary for a body cavity formed after removal of tissue. When irradiation is not needed the catheters are removed and disposed of. When in place within the patient, the proximal ends of the prior art catheters extend out of the patient providing direct access for infections to reach the biopsy site. 
         [0008]    The prior catheters are expensive and a catheter used only to hold the shape of the biopsy cavity is disposed of afterwards. Thus there is need in the art for less expensive devices which are temporary and capable of maintaining access to the biopsy device with reduced risk of infection. 
       SUMMARY OF THE INVENTION 
       [0009]    The invention is directed to methods and devices for temporary subcutaneous deployment while at least partially filling a body cavity in a targeted tissue region within a patient&#39;s body, such as a cavity formed by the removal of tissue from a patient. The catheter device embodying features of the invention has distal shaft section with a cavity filling member such as an inflatable member (e.g. balloon) and the proximal shaft portion of the device is configured to be deployed subcutaneously so that no direct access is provided to the intracorporeal cavity for pathogens. 
         [0010]    The invention, in one form thereof, is directed to a method for maintaining access to a biopsy site within a patient. The method includes forming a passageway from an opening in an exterior site on the patient to a desired location for a biopsy specimen within the patient; removing a tissue specimen from the desired location thereby leaving a biopsy cavity; providing a temporary catheter having an elongate shaft, a flexible proximal shaft section, and a distal shaft section having a cavity filling member thereon; inserting the cavity filling member on the distal shaft section into the biopsy cavity; inflating the cavity filling member after inserting the cavity filling member within the biopsy cavity, but before closing the opening, using the flexible proximal shaft section; placing the flexible proximal shaft section at an intracorporeal location; and closing the opening so as to seal the passageway. 
         [0011]    The invention, in another form thereof, is directed to a method of temporarily filling an intracorporeal site within a breast of a patient. The method includes forming an opening in the breast; forming a passageway in the breast from the opening in the breast to a desired intracorporeal location; forming a cavity in the breast at the desired intracorporeal location; providing a catheter device having an elongated shaft with a flexible proximal shaft section, a distal shaft section and a cavity filling member on the distal shaft section; inserting the catheter device through the opening and advancing the catheter device within the passageway until the cavity filling member on the distal shaft section is disposed within the cavity formed in the breast; inflating the cavity filling member after disposing the cavity filling member within the cavity in the breast, but before closing the opening, using the flexible proximal shaft section; placing the flexible proximal shaft section used to inflate the cavity filling member within the breast; and closing the opening after placing the flexible proximal shaft section within the breast. 
         [0012]    The invention, in another form thereof, is directed to a method for maintaining access to a body cavity at an intracorporeal location of a patient. The method includes providing a catheter having an elongate shaft, a flexible proximal shaft section, a distal shaft section, and an inflatable cavity filling member on the distal shaft section configured to at least partially fill the body cavity; inserting the catheter through an opening in the patient&#39;s skin and advancing the catheter within the patient until the inflatable cavity filling member on the distal shaft section of the catheter is disposed in the body cavity at the intracorporeal location; inflating the inflatable cavity filling member after disposing the inflatable cavity filling member within the body cavity, but before closing the opening, using the flexible proximal shaft section; deploying the flexible proximal shaft section in a folded or coiled configuration within a subcutaneous region of the patient; and closing the opening in the patient&#39;s skin so as to prevent pathogen access therethrough. 
         [0013]    One embodiment of a catheter device having features of the invention has a proximal shaft section that is flexible enough to be folded, e.g. folded over upon itself, or coiled and placed within a subcutaneous region through an opening in the patient&#39;s skin. After deployment of the proximal shaft section of the catheter device, the opening in the patient&#39;s skin is closed or sealed, e.g. by sutures, staples or clips adhesives and the like. 
         [0014]    In another embodiment of a catheter device having features of the invention has a detachable proximal shaft section or sections to allow the distal shaft section of the catheter device to remain within the patient and sealed therein by closing the access opening in the patient&#39;s skin, 
         [0015]    Additionally, the catheter device and method of using the device may include application of a vacuum within the body cavity that is effective to draw tissue surrounding the body cavity towards the surface of the cavity filling member of the catheter device, which is placed within the body cavity. 
         [0016]    A catheter device embodying features of the invention may also include an anti-bacterial agent on or incorporated within a surface of the device to further prevent infection. The catheter device is preferably configured to be deployed within the patient for a period of time from a few days to a few weeks. 
         [0017]    The flexible proximal shaft section may be formed of suitable compliant polymers such as polyolefins (e.g. polyethylene and polypropylene), polyurethanes, polyesters, polyvinylchloride, polystyrene, thermoplastic polymers such as C-Flex® (Consolidated Polymer Technologies, Inc., Clearwater Fla. 33762), block polymers such as Kraton™ (Kraton Polymers, Houston Tex. 77208), an ionomer such as Surlyn® (Dupont, Wilmington Del. 19880), nylon, latex rubber, and silicon rubber (e.g., SILASTIC™, Dow Corning, Midland, Mich.). 
         [0018]    Body cavities, particularly cavities from which tissue has been removed (e.g. for biopsy) are typically not uniform in size or regular in shape. The catheter devices and systems and methods of using such devices or systems having features of the invention utilize suction to draw tissue surrounding the body cavity against the surface of the cavity filling member on the distal shaft section of the catheter device within a body cavity to ensure good contact therebetween. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  is a partial elevational view of a catheter device embodying features of the invention which has a balloon configured to temporarily maintain the shape of a cavity in a patient&#39;s body tissue. 
           [0020]      FIG. 2  is a transverse cross-sectional view of the catheter device shown in  FIG. 1  taken along line  2 - 2 . 
           [0021]      FIG. 3  is an enlarged longitudinal cross section of the distal shaft section of the catheter device shown in  FIG. 1  taken along the line  3 - 3 . 
           [0022]      FIG. 4  is an elevational view, partially in section, of a patient&#39;s breast after removal of a tissue specimen therefrom. 
           [0023]      FIG. 5  is a partial elevational view, partially in section, of a patient&#39;s breast device with the catheter shown in  FIG. 1  deployed within the patient and the cavity filling balloon inflated within the cavity. 
           [0024]      FIG. 6  is a partial elevational view, partially in section, of a patient&#39;s breast with the catheter device shown in  FIG. 1  deployed within the patient with the cavity filling balloon inflated within the cavity and after the application of a vacuum within the cavity to pull the cavity lining into contact with the inflated cavity filling balloon. 
           [0025]      FIG. 7  is an elevational view of a patient&#39;s breast with the catheter shown in  FIG. 1  completely deployed within the patient and the surgical opening closed. 
           [0026]      FIG. 8  is an elevational view of a temporary catheter having features of the invention having a detachable proximal portion or portions which can be removed after the distal shaft section has been deployed within the patient. 
           [0027]      FIG. 9  is a transverse cross-sectional view of the catheter device shown in  FIG. 8 , taken along the lines  9 - 9 . 
           [0028]      FIG. 10  is a transverse cross-sectional view of the catheter device shown in  FIG. 8 , taken along the lines  10 - 10 . 
           [0029]      FIG. 11  is a transverse cross-sectional view of the catheter device shown in  FIG. 8 , taken along the lines  11 - 11 . 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0030]    The present invention is directed to catheter devices and methods of using such devices for temporarily maintaining access to an intracorporeal cavity in a targeted tissue region within in a patient&#39;s body, such as a biopsy site or a cavity left after removal of a tissue specimen. The catheter device embodying features of the invention has an elongated shaft with a proximal shaft portion that is either detachable or foldable or coilable to facilitate deployment of the proximal end of the catheter within the tissue surrounding the biopsy site. After tissue has been removed from the targeted tissue region, the cavity filling member on the distal end of the catheter is inserted through an opening in the patient&#39;s skin and advanced through a passageway in the patient to the body cavity where the cavity filling member is deployed. The proximal shaft section of the catheter is folded or coiled and placed in a subcutaneous location and the opening in the patient&#39;s skin is closed or otherwise sealed, e.g. by sutures, staples, clips, adhesive or the like. A vacuum may be applied to cavity to enhance contact between the cavity filling member and the tissue defining the cavity before the opening in the patient&#39;s skin in closed or sealed. 
         [0031]      FIGS. 1-3  illustrate a catheter device  10  embodying features of the invention which has an elongated shaft  11 , a flexible proximal shaft section  12 , a distal shaft section  13  and a cavity filling inflatable balloon  14  on the distal shaft section. As shown in  FIGS. 2 and 3 , the elongated shaft  11  has an inflation lumen  15  extending from the proximal end of the shaft  11  to a discharge port  16  to discharge inflation fluid within the interior of the balloon  14 . The elongated shaft  11  also has a vacuum lumen  17  which extends from the proximal end of shaft  11  to a vacuum port  18  located distal to the balloon  14  and a vacuum port  19  proximal to the balloon  14 . Alternatively, individual vacuum lumens may be provided for each vacuum port. Passage of inflation fluid through inflation lumen  15  and discharge port  16  is effective to inflate the balloon  14 . Inflation fluid may be a gas or a liquid, and is typically inert. Suitable gases may be air, nitrogen or carbon dioxide. Suitable fluids include water, saline, mineral oil and contrast media with radiopaque material. The balloon in an inflated configuration is shown in phantom in  FIG. 1 . 
         [0032]    Vacuum applied through the one or more vacuum ports  18  and  19  to the body cavity is effective to urge tissue surrounding the cavity into contact with at least a portion of the surface of the outer balloon  14 . 
         [0033]    The catheter device  10  has a two-arm adapter  20  on the proximal end of the elongated shaft  11 . One arm  21  has an inner lumen (not shown) that is in fluid communication with the inflation lumen  15  and the other arm  22  has an inner lumen (not shown) that is in fluid communication with the vacuum lumen  17 . 
         [0034]      FIG. 4  illustrates a patient&#39;s breast  40  which has had a tissue specimen removed, leaving a biopsy cavity  41 . An accessing passageway  42  extends from an opening  43  made in the patient&#39;s skin to the cavity  41 . A cannula  44  remains disposed in the passageway  42  after the biopsy device has been removed. 
         [0035]      FIG. 5  illustrates the catheter device shown in  FIG. 1  disposed within the patient with the cavity filling balloon  13  inflated within the cavity  41  in the patient&#39;s breast  FIG. 6  illustrates the body cavity  41  after a vacuum is applied to the cavity so as to conform the tissue of the body cavity  41  to the exterior of the balloon  14 . 
         [0036]    After the balloon  14  is inflated within the body cavity  41 , the flexible proximal shaft section  12  with attached adapter  20  is folded over (or coiled) within the patient&#39;s breast  40  and the opening  43  sutured closed with sutures  45 . Alternatively, the opening can be closed with a suitable adhesive. A suitable adhesive may also be employed to seal the opening after closure with sutures. 
         [0037]    The flexible proximal shaft section  12  can be made flexible enough to be deployed folded or coiled within the patient&#39;s breast by thinning the wall of the section or making the wall of a compliant or semi-compliant polymeric material which provides the desired flexibility. Suitable polymeric materials include polyurethane, silicone, C-Flex and Kraton. The proximal shaft section  12  should not have a spring back which would cause discomfort or pain to the patient. The adapter  20  is also preferably formed of flexible materials to facilitate deployment and to minimize pain and discomfort. 
         [0038]    The exterior surfaces of the shaft  11  and the balloon  14  are preferably provided with an anti-microbial agent or biocide which retards or prevents pathogen growth within the cavity  41  or the passageway  42 . Suitable anti-microbial agents or biocides include silver ions in a hydrophilic carrier, silver ions implanted into the surface of the shaft by ion beam deposition, an antiseptic or disinfectant such as chlorhesqdiene, benzyl chloride. Suitable anti-microbial coatings are provided by Spire, AST, Algon, Surfacine, Ion Fusion and Bacterin International. Other treatment agents such as chemotherapeutic agents may be coated onto or incorporated within the surface of the catheter shaft  11  or balloon  14 . 
         [0039]    The catheter device  10  which embodies features of the invention is designed to remain within the patient for a few days to several weeks. For example, the catheter device  10  is deployed within the patient&#39;s breast after a biopsy specimen has been removed leaving a cavity  41 . The catheter device  10  prevents tissue growth within the cavity  41  and the passageway  42 . Evaluation of the tissue specimen after removal will determine whether cancer or pre-cancer cells are present or not. If no cancer or pre-cancer cells are found in the specimen, the catheter device may be removed from the patient, the opening re-closed and the catheter device discarded. If cancer cells are found, a radiation balloon catheter such as described in U.S. Pat. No. 6,923,754 to Lubock and U.S. patent application Ser. No. 10/849,410 to Lubock may be utilized to provide radiation treatment to the tissue surrounding the cavity after the temporary catheter device is removed from the patient. The radiation balloon catheter may be advanced through the passageway  42  until the balloon on the catheter is deployed within the cavity  41 . The radiation balloon is inflated in a conventional manner so that a uniform dose of radiation is provided to the tissue lining the cavity. 
         [0040]    Although a cavity  41  is typically an artificial cavity remaining after removal of tissue at biopsy, surgery, or other medical procedure, a body cavity may be a natural body cavity. For example, devices  10  may be inserted into a bladder for the treatment of bladder cancer. Application of suction is effective to enhance contact with a device  12  in such an example as well. Such enhanced contact may be effective to improve the delivery of radiation or other treatment, and may be effective to avoid “hot spots” (tissue regions receiving more radiation than is received by neighboring tissue regions) and is one of the important advantages provided by the present invention. 
         [0041]    Vacuum applied to intermediate space  45  effects good contact between tissue surrounding body cavity  41  and the wall of the balloon  14 . 
         [0042]      FIGS. 8-11  illustrate a catheter device  50  embodying features of the invention which has an elongated shaft  51 , detachable proximal shaft sections  52  and  53 , a distal shaft section  54  and a cavity filling inflatable balloon  55  on the distal shaft section. The elongated shaft  51  has an inflation lumen  56  extending from the proximal end of the detachable proximal shaft section  52  to a discharge port  57  in fluid communication with the interior of balloon  55  to discharge inflation fluid therein to inflate the balloon  55 . A one-way valve element  60  is disposed within the inflation lumen  56  to allow passage of inflation fluid to the interior of the balloon  55  but prevent discharge of the inflation fluid in the reverse direction. Alternatively or additionally, a one-way valve  61  may also be employed at the discharge port  57  for the same purpose. 
         [0043]    The elongated shaft  51  may also has a vacuum lumen  62  which extends from the proximal end of detachable proximal shaft section  53  to a vacuum port  63  located distal to the balloon  55  and a vacuum port  64  proximal to the balloon. A one-way valve  65  may be provided within the vacuum lumen  62  to maintain the vacuum which is developed within the body cavity. While only one vacuum lumen  62  is shown in communication with the vacuum ports  63  and  64 , separate vacuum lumens may be provided for each of the vacuum ports. 
         [0044]    The one way valve elements  60  and  65  provided within the inflation and vacuum lumens  56  and  62  respectively may be reed or duckbilled valve elements. The one way valve  61  may be a flapper valve. 
         [0045]    The detachable proximal shaft sections  52  and  53  may be connected to the distal shaft section  54  of the catheter device  50  by threaded connections, friction fit connections or other suitable releasable connections. Moreover, while separate detachable proximal shaft sections are shown, they may be combined into a single detachable proximal shaft section. 
         [0046]    After a biopsy specimen is removed from the patient, leaving a cavity therein, the catheter device  50  is advanced within the patient until the cavity filling balloon  55  is disposed within the cavity. Inflation fluid is introduced into the interior of the balloon  55  through the inflation lumen  56 . The inflation fluid passes through the one-way valve  60  on its way to the balloon interior. Pressure within the lumen distal to the valve  60  and/or the valve structure prevents inflation fluid from passing proximally through the valve. The balloon  55  is inflated to at least partially fill the body cavity within the patient and preferably not to stretch the tissue surrounding the cavity. Vacuum is then pulled through the vacuum ports  64  and  65  to draw the tissue surrounding the cavity towards the balloon  55  to conform the tissue lining to the exterior of the inflated balloon. 
         [0047]    Once the balloon  55  is inflated and the vacuum developed to conform the tissue lining to the exterior of the balloon  55 , the proximal shaft sections  52  and  53  can be detached from the catheter shaft and the opening in the patient&#39;s skin can be closed by suturing, adhesives or other suitable means. The one way valves  60  and/or  61  and  65  minimize or prevent loss of inflation fluid and vacuum. 
         [0048]    The portion of the catheter device  50  which remains in the patient can be removed by accessing the proximal portion of the catheter device which remains in the patient by opening the original opening that had been closed or forming a new opening in the patient&#39;s skin. The catheter shaft can be severed proximal to the balloon to release the inflation fluid and deflate the balloon to facilitate its withdrawal. If needed, a radiation balloon catheter can be inserted into the patient as previously described to irradiate the tissue lining of the body cavity. If radiation or other treatment is not needed, the opening in the patient&#39;s skin may be closed. 
         [0049]    While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications of the invention can be made to the invention. For example, while the various embodiments of the invention have been described herein in terms of a catheter device for treating a biopsy site, it should be apparent that the catheter device and the method of use may be employed elsewhere in the patient&#39;s body. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. 
         [0050]    Terms such as “element”, “member”, “device”, “section′, “component”, “portion”, “means”, “step” and words of similar import, when used in the following claims, shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the claims expressly use the term “means” followed by a particular function without specific structure or the terms “step” or “steps” followed by a particular function without specific action. All patents and patent applications referred to herein are incorporated by reference in their entirety.