Abstract:
A breast cavity spacer device, such as for use with a percutaneous lumpectomy, is provided. The device includes a body having a projection on one end. The body has a bore extending there through. A catheter is disposed at least partially within the bore. A balloon member is fluidly coupled on one end of the catheter, the balloon member having an elliptical shape.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation application of U.S. patent application Ser. No. 13/416,459 filed on Mar. 9, 2012 entitled “Biopsy Spacer Device and Method of Operation”, which claims the benefit of U.S. Provisional Application Ser. No. 61/451,187 filed Mar. 10, 2011, the contents of both which are incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     The subject matter disclosed herein relates to a spacer device for cavities formed during a biopsy and in particular to a spacer device for maintaining a cavity formed during a percutaneous lumpectomy open for later use during radiation therapy. 
     Percutaneous lumpectomy is a method shown in  FIGS. 1-4  that is used by physicians to diagnose breast and treat cancer. One procedure uses a stereotactic system involving a procedure platform or table that supports the patient and maintains the patient&#39;s breast  20  in a fixed location. The system includes an x-ray imaging device and a three-dimensional positioning system. X-ray images of the breast  20  are take at three locations relative to the axis of the table to identify the location of a tumor or area of interest  22  by the clinician. The coordinates of the tumor  22  are utilized by the three-dimensional positioning system to guide a “wand” or needle  24  to the area of interest. 
     The physician makes an incision location  26  and inserts the needle  24 . The physician controls the progression of the needle  24  into the incision  26 . Once the needle  24  is in the proper location, a device  28  on the end of the needle  24  deploys a plurality of cauterizing filaments  30  that capture the area of interest  22  and cauterize the remaining tissue. With the area of interest  22  captured, the needle  24  is removed. The removal of the area of interest  22  leaves an elliptically shaped cavity  32  and an insertion track  34  in the breast  20 . 
     Following the biopsy procedure, there may be a period of up to four days while the specimen  22  is evaluated by a pathologist to determine if the tumor is cancerous and if it has been completely excised with clear margins. If it is determined that all of the tumor has not been removed, the physician makes a second incision to remove additional tissue. Once all of the tumor has been removed, a third incision is made for the insertion of a brachytherapy ballon that is used for radiation treatments. 
     While existing devices and methods of diagnosing and treating breast cancer are suitable for their intended purposes, the need for improvement remains in particular in reducing the number of incisions and in the placement of the brachytherapy balloon. 
     BRIEF DESCRIPTION OF THE INVENTION 
     According to one aspect of the invention, a cavity spacer device is provided. The device includes a body having a projection on one end and having a bore extending there through. A catheter is disposed at least partially within the bore. A balloon member is fluidly coupled on one end of the catheter, the balloon member having an elliptical shape. 
     According to another aspect of the invention, another cavity spacer device is provided. The device includes a body having a projection on one end, the body configured to couple with the biopsy system, the body having a bore extending there through. A first catheter is disposed at least partially within the bore. A drainage catheter is disposed at least partially within the first catheter. An inflation catheter disposed at least partially within the first catheter. A medicinal catheter is disposed at least partially within the first catheter. A balloon member is disposed on one end of the catheter and in fluid communication with the inflation catheter. 
     According to yet another aspect of the invention, a method of performing a percutaneous lumpectomy is provided. The method includes making an incision in a patient. An area of interest is excised and removed to form a cavity and an insertion tract. A catheter is provided with a balloon member disposed on one end, the balloon member being in fluid communication with the catheter. The catheter is inserted into the incision. The catheter is moved to dispose the balloon member within the cavity. The balloon member is inflated from a first size to a second size. The catheter is removed and the balloon sealed. 
     These and other advantages and features will become more apparent from the following description taken in conjunction with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       The subject matter, which is regarded as the invention, is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which: 
         FIGS. 1-5  are illustrations of a prior art biopsy procedure; 
         FIG. 6  is a perspective view illustration of a spacer device in accordance with an embodiment of the invention; 
         FIG. 7  is an exploded view illustration of the spacer device of  FIG. 6 ; 
         FIG. 8  is a side view of a catheter balloon assembly for use with the spacer device of  FIG. 6 ; 
         FIG. 9  is a schematic illustration of the balloon end portion of the breast cancer spacer device of  FIG. 6 ; and, 
         FIG. 10  is a sectional schematic illustration of the catheter portion of the spacer device of  FIG. 6 ; 
         FIG. 11  is a side view of another embodiment of a spacer device 
         FIG. 12  is an end view of the spacer device of  FIG. 11 ; 
         FIG. 13  is a side view of another embodiment of a spacer device; 
         FIG. 14  is a side view of another embodiment of a spacer device; and, 
         FIG. 15-16  are side views of another embodiment of a spacer device having a mechanical expansion arrangement. 
     
    
    
     The detailed description explains embodiments of the invention, together with advantages and features, by way of example with reference to the drawings. 
     DETAILED DESCRIPTION OF THE INVENTION 
     A percutaneous lumpectomy is a biopsy procedure that removes cancerous tissue and leaves behind an open tract. Embodiments of the present invention provide a breast cavity spacer device that is utilized after the lumpectomy procedure to keep the tract open for the three to four days while the removed tissue is analyzed. The breast cavity spacer device may provide advantages in eliminating or reducing the number of incisions needed to treat the patient. The breast cavity spacer device may provide advantages in allowing radiation treatment to be initiated quickly if the tumor is found to be cancerous. The breast cavity spacer device may provide further advantages allowing a brachytherapy balloon to be placed in substantially the same position as the removed tumor. The breast cavity spacer device may provide yet further advantages in the delivery of medication to the cavity to decrease patient pain or discomfort. 
     Referring to  FIGS. 6-10  an exemplary embodiment of a breast cancer spacer device  36  is shown. The device  36  includes a wand member  38  having a body  44  with a projection  46  extending from one end. The wand member  38  further includes a threaded flange  40  and a holder member  42  disposed adjacent the projection  46 . The wand member  38  is configured to interface with the handle of a stereotactic lesion excision system (not shown) that is used for the lumpectomy procedure. In one embodiment, the stereotactic lesion excision system is a MammoTest® Intact® Medical Breast Lesion Excision System manufactured by Siemens AG. The stereotactic system is used to guide the device  36  to the location of the removed tissue. 
     A bore  48  extends longitudinally through the body  44  and projection  46 . The bore  48  is sized to allow a catheter  50  to extend through the wand member  38 . The wand member  38  is made from a suitable material such as high molecular weight polyethylene for example. The thread flange  40  is configured to allow the wand member  38  to be secured into the stereotactic system handle while it is being inserted into the breast  20 . The holder member  42  keeps the threads in the proper location on the wand member  38  while procedure is being performed. 
     Extending through the bore  48  is a catheter  50 . The catheter  50  is a generally thin walled member of sufficient length to allow the physician to extend the catheter through the bore  48  to place a balloon member  52  in substantially the same location where the tumor  22  was excised. In one embodiment, the catheter  50  includes three conduits or catheters for the delivery or extraction of materials from the patient. As shown in  FIG. 10 , these conduits may include a drainage catheter  54 , a medication catheter  56  and a balloon inflation catheter  58 . It should be appreciated that this provides advantages in providing a means for inflating the balloon, in the draining of any seroma that may form and in the delivery of medication to ease pain or discomfort. In one embodiment, the catheter  50  may have a manifold  60  ( FIG. 8 ) that bifurcates the catheter to allow multiple internal conduits  54 ,  56 ,  58  to be segregated for their intended functions. 
     The balloon member  52  is arranged on one end of the catheter  50  in fluid communication with the inflation catheter  56 . Once the balloon  52  is in the desired location (e.g. the location where the tissue  22  was removed), the balloon  52  is configured to be inflated with saline solution that will keep the cavity  32  open (e.g. will not close due to healing). The balloon  52  is made from a suitable material to withstand the pressures internal to the patient&#39;s body. Once the balloon  52  is inflated, the catheter  50  and the wand member  38  are removed. In the exemplary embodiment, the balloon  52  is a self-sealing balloon that allows the catheter  50  to be removed with substantially no loss of pressure. In one embodiment, the balloon  50  includes a tube portion  53  that extends from one side. The tube portion  53  may be pinched by the physician when the catheter  50  is removed. The tube portion  53  may be positioned within the insertion tract  34  to keep the tract  34  open between the time the tissue  22  is removed and subsequent procedures are performed (e.g. 2-4 days). In one embodiment, the balloon member is elliptically shaped and available in three sizes corresponding to the three sizes of brachytherapy balloons. In another embodiment, the balloon member  52  has a water vapor transmission rate of less than 0.01 g/m 2 /hr. 
     After the tissue sample  22  is analyzed, the physician will then drain the saline from the balloon member  52  and the balloon member  52  is removed from the cavity  32  and track  34 . In one embodiment, the balloon  50  is deflated by draining the saline solution and applying a negative pressure within the interior of the balloon  50 . With the balloon and catheter removed, the physician may then use the same incision  26  to excise additional tissue if the tumor was not completely removed, or insert a brachytherapy balloon to initiate radiation treatment. It should be appreciated that the use of the same incision reduces the pain and discomfort for the patient and allows the physician to place the brachytherapy balloon in substantially the same location as where the tumor  22  was removed. 
     Another embodiment of the spacer device  36  is shown in  FIGS. 11-12 . In this embodiment, the catheter extends through the balloon  52 . The catheter includes a first conduit  62  that includes an opening on the end of the catheter  50  to allow for drainage of seroma. The catheter further includes a second conduit  64  that is in fluid communication with a cylindrical projection  66 . The cylindrical projection  66  is positioned within the interior of the balloon  52 . During operation, once the balloon  52  is in the desired position, a fluid such as saline for example flows through the second conduit  64  and into the interior of the balloon  52 . The fluid inflates the balloon  52  to fill the cavity. In one embodiment, the balloon  52  is made from a self-sealing type material that allows the catheter  52  to be removed after the procedure is complete while leaving the inflated balloon  52  in place. 
     Another embodiment for a balloon  52  is illustrated in  FIG. 13 . In this embodiment, the balloon  52  includes one or more ridges  49  disposed longitudinally about the periphery of the balloon  52 . The ridges  49  provide additional resistance and provide advantages in preventing the balloon  52  from falling out of the cavity. Yet another embodiment for a balloon  52  and catheter  50  is shown in  FIG. 14 . In this embodiment, the catheter  50  has a plurality of branch conduits  51  with openings  55  on the end. The openings  55  allow seroma from areas disposed about the cavity. In one embodiment, medication may also be delivered through the openings  55 . 
     Yet another embodiment of the spacer device  36  is shown in  FIGS. 15-16 . In this embodiment, the spacer device  36  includes a mechanical expansion assembly  68 . The assembly  68  includes a button  70  that slides within a slot  72  in the body  44 . The button  70  is coupled to a shaft  74  having a spring  76 . On one end of the shaft  74  are a plurality of slats  78  that are movable from a first position inside the catheter  50  to a second position inside the balloon  52 . As the button  70  is slid within the slot the slats  78  move from the first position to the second position bend to the desired shape of the cavity as they exit the catheter  50 . 
     It should be appreciated that while embodiments herein describe the use of the spacer device in conjunction with a percutaneous lumpectomy, this is for exemplary purposes and the claimed invention should not be so limited. The invention may also be used with internal radiotherapy, sealed source radiotherapy, curietherapy or endocurietherapy in the treatment of cervical, breast, prostate or skin cancer for example. 
     While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which are commensurate with the spirit and scope of the invention. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the invention may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims.