Patent Publication Number: US-11027146-B2

Title: Intracavity balloon catheter

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 14/991,464, which issued on Jan. 15, 2019 as U.S. Pat. No. 10,179,249, and claims priority to U.S. Provisional Patent Application No. 62/101,187 filed on Jan. 8, 2015, the entirety of each are herein incorporated by reference 
    
    
     FIELD OF THE DISCLOSURE 
     This disclosure relates generally to the diagnostic and therapeutic treatments of disease and, more particularly, an intracavity balloon catheter and method of use thereof to protect and stabilize the prostate region during staging process and radiation therapy treatment. 
     BACKGROUND 
     Radiation therapy treatment of soft tissue tumors in the prostate using radiation therapy treatment is complicated by the proximity of the prostate to radiation-sensitive tissues. Radiation therapy treatment of the prostate is further complicated by prostate movement during treatment. 
     Typically, the planning of radiation therapy for the treatment of prostate cancer involves the patient undergoing a CT-based simulation scan of the pelvis to determine the location of the prostate gland. In the simulation procedure, the patient is placed on CT and/or MRI equipment that is similar to the radiation treatment equipment, except that it does not generate the high energy radiation beam. The simulation equipment is positioned to simulate the conditions experienced by the patient during delivery of the sequence of treatment beams prescribed by the treating oncologist. Normally, CT and/or MRI images are acquired. These CT and/or MRI images allow the oncologist to locate the position of the tumor and develop a radiation treatment plan using a tailored devoted radiation or proton therapy treatment plan. This treatment plan delineates the positions of the radiation equipment components for precise delivery of the radiation to a predetermined area. 
     During the subsequent treatment procedure, the patient is placed in the same position on the treatment equipment as in the simulation scans. Radiation-emitting devices are generally known and used for radiation therapy in the treatment of patients. During treatment, a radiation beam is delivered to the patient at the precise location as delineated by the physician during simulation. A further feature of radiation therapy involves portal images, which are commonly used to verify and record tumor location. 
     A large amount of attention has been directed to reducing the amount of pain and rectal bleeding resulting from radiation burns to, for instance, the rectal mucosa. One way physicians limit rectal bleeding is that they decrease the total radiation dose used to treat the patient&#39;s prostate cancer. However, this may lead to inadequate radiation treatment and a higher probability of local cancer recurrence. Another method physicians use to reduce rectal bleeding following radiotherapy is to immobilize the prostate with a balloon rectal catheter. The most common and oldest balloon catheter methods use a balloon that inflates in the rectum behind the prostate. This forces the posterior rectum away from the prostate. This is of very limited efficacy, however, because the posterior rectum is rarely a cause of rectal bleeding. A more common cause of rectal bleeding is damage to the anterior rectum that is directly adjacent to the posterior prostate. 
     More recent attempts at minimizing rectal bleeding using balloon catheters force the prostate into a fixed position to allow the radiation beam to be more precisely directed to the target tissue. The balloon catheter apparatuses disclosed in the prior art attempt to stabilize the prostate by using large-volume balloons (e.g. 100 cc or more) and, in some cases, have various protrusions that attempt to create a seating area to receive and immobilize the prostatic bulge. Large volume balloons and balloons with bulges distort the rectal mucosa to seat or “cup” the prostate. Large volume balloons also increase patient discomfort. 
     U.S. Pat. No. 5,476,095 and U.S. Patent Publication No. 2003/028097 both disclose a rectal balloon apparatus having an inner balloon and an outer balloon, and an overall balloon shape that is round with a saddle-shaped bulge on the anterior surface of the balloon. The inner balloon has an anterior section that is covered with an inelastic, adhesive backed cloth material. As the device is inflated, the inner balloon forces the anterior surface of the outer balloon against the prostatic region of the rectum. More specifically, as the balloon is inflated to approximately 60 cc, a saddle-shaped bulge receives the rectal prostatic bulge inferior to the ampulla of the rectum. 
     U.S. Patent Publication No. 2009/0221899 discloses a rectal balloon apparatus wherein the balloon element has two inflated conditions. The first inflated condition, occurring when approximately 100 cc of fluid are introduced into the balloon, creates a flat surface with a seating area for the prostate to rest. In the second inflated position, a bulbous portion protrudes from the balloon at a position adjacent to the tip of the balloon. This protrusion occurs when at least 140 cc of fluid are introduced into the balloon. The purpose of the bulbous portion is to better isolate the prostate. 
     Moreover, previously disclosed embodiments of an intra cavity balloon catheter are disclosed in U.S. Pat. No. 8,840,542, the entire contents of which are herein incorporated by reference. 
     The methods and balloon catheter apparatuses in the prior art have not adequately addressed the causes of rectal bleeding. Indeed, between 20-30% of men still experience rectal bleeding during radiation therapy treatments. Moreover, the use of large volume balloons and balloons with bulges that protrude into the anterior rectum to receive the prostatic bulge increase patient discomfort and may, in some cases, aggravate rectal bleeding. 
     BRIEF SUMMARY OF THE DISCLOSURE 
     In one embodiment of the disclosure, an intracavity balloon catheter may include a flexible catheter having a proximal catheter portion, a distal catheter portion having a distal tip, and a fluid passageway between the distal tip and the proximal catheter portion. The intracavity balloon catheter may further include a balloon disposed at the distal end of the catheter, the tip of the flexible catheter extending into the balloon, the balloon having an exterior balloon surface comprising a posterior surface and an anterior surface opposed to the posterior surface, the balloon composed of a center section and at least two side sections. The balloon may be inflatable between a deflated condition and an inflated condition by introduction of a fluid into the balloon from the distal tip of the flexible catheter, the exterior balloon surface having a deflated posterior position and a deflated anterior position in the deflated condition, and the exterior balloon surface having an inflated posterior position and an inflated anterior position in the inflated condition. 
     In a further embodiment of the disclosure, an intracavity balloon catheter may include a flexible catheter having a proximal catheter portion, a distal catheter portion having a distal tip, and a fluid passageway between the distal tip and the proximal catheter portion. The intracavity balloon catheter may further include a balloon disposed at the distal end of the catheter, the tip of the flexible catheter extending into the balloon, the balloon inflatable between a deflated condition and an inflated condition by introduction of a fluid into the balloon from the distal tip of the flexible catheter. The intracavity balloon catheter may also include a positioning ring comprising a first component matable with a second component at a connection point, and a passage along a longitudinal axis of the positioning ring, the passage having a first opening at a first end of the first component and a second opening at a second end of the second component. The flexible catheter may be positionable through the passage, and the positioning ring may be securable to the flexible catheter between the proximal catheter portion and the distal catheter portion. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  illustrates a side elevation view of an embodiment of an intracavity balloon catheter in a partially deflated position; 
         FIG. 2  illustrates a side elevation view of the intracavity balloon catheter of  FIG. 1  illustrating the change from a deflated position to an inflated position; 
         FIG. 3  illustrates a side elevation view of the intracavity balloon catheter of  FIG. 1  in an inflated position; 
         FIG. 4  illustrates a top view of an embodiment of the balloon used with the intracavity balloon catheter of  FIG. 1 ; 
         FIG. 5  illustrates a side perspective view of an embodiment of a balloon as may be used with embodiments of an intracavity balloon catheter; 
         FIG. 6  illustrates a side perspective view of an embodiment of a balloon as may be used with embodiments of an intracavity balloon catheter; 
         FIG. 7  illustrates a side perspective view of embodiments of a securing device as may be used with embodiments of an intracavity balloon catheter, the embodiments of the securing device illustrated with a catheter tube as may be used with embodiments of an intracavity balloon catheter; 
         FIG. 8  illustrates a side perspective of cross sectional views of the embodiments of the securing devices and catheter tube of  FIG. 7 ; 
         FIG. 9  illustrates a side cross sectional view of an embodiment of a securing device for use with embodiments of an intracavity balloon catheter; 
         FIG. 9A  illustrates an enhanced perspective side view of the latching mechanism of the securing device of  FIG. 9 ; 
         FIG. 10  illustrates an exploded view of the two components of the securing device of  FIG. 9 ; 
         FIG. 11  illustrates a side cross sectional view of an embodiment of a securing device for use with embodiments of an intracavity balloon catheter; 
         FIG. 11A  illustrates an enhanced view of the latching mechanism of the securing device of  FIG. 11 ; 
         FIG. 12  illustrates an exploded view of the two components of the securing device of  FIG. 11 ; and 
         FIG. 13  illustrates a method of using an embodiment of an intracavaity balloon catheter, shown in a deflated condition, for immobilizing the prostate during staging process and radiation therapy treatment. 
     
    
    
     DETAILED DESCRIPTION OF THE DISCLOSURE 
     The following detailed description and the appended drawings describe and illustrate some embodiments of the disclosure for the purpose of enabling one of ordinary skill in the relevant art to make and use the embodiments. As such, the detailed description and illustration of these embodiments are purely illustrative in nature and are in no way intended to limit the scope of the disclosure in any manner. It should also be understood that the drawings are not to scale and in certain instances details have been omitted, which are not necessary for an understanding of the disclosure, such as details of fabrication and assembly. In the accompanying drawings, like numerals represent like components. 
     In one embodiment of the disclosure, an intracavity balloon catheter may include a flexible catheter having a proximal catheter portion, a distal catheter portion having a distal tip, and a fluid passageway between the distal tip and the proximal catheter portion. The intracavity balloon catheter may further include a balloon disposed at the distal end of the catheter, the tip of the flexible catheter extending into the balloon, the balloon having an exterior balloon surface comprising a posterior surface and an anterior surface opposed to the posterior surface, the balloon composed of a center section and at least two side sections. The balloon may be inflatable between a deflated condition and an inflated condition by introduction of a fluid into the balloon from the distal tip of the flexible catheter, the exterior balloon surface having a deflated posterior position and a deflated anterior position in the deflated condition, and the exterior balloon surface having an inflated posterior position and an inflated anterior position in the inflated condition. 
     In further embodiments of an intracavity balloon catheter, the inflated posterior position and the inflated anterior portion of the center section may be substantially equidistant to the distal catheter portion such that the center section is at least substantially radially symmetric about a longitudinal axis. Each of the side sections may have substantially similar dimensions, and the balloon has a substantially cylindrical shape in the inflated position. The distance between the inflated positions may be greater at the center section than at the side sections. The intracavity balloon catheter may further include a plurality of protrusion provided along at least a portion of the exterior balloon surface, each protrusion having a semi-hemispherical dimension. 
     In a further embodiment of the disclosure, an intracavity balloon catheter may include a flexible catheter having a proximal catheter portion, a distal catheter portion having a distal tip, and a fluid passageway between the distal tip and the proximal catheter portion. The intracavity balloon catheter may further include a balloon disposed at the distal end of the catheter, the tip of the flexible catheter extending into the balloon, the balloon inflatable between a deflated condition and an inflated condition by introduction of a fluid into the balloon from the distal tip of the flexible catheter. The intracavity balloon catheter may also include a positioning ring comprising a first component matable with a second component at a connection point, and a passage along a longitudinal axis of the positioning ring, the passage having a first opening at a first end of the first component and a second opening at a second end of the second component. The flexible catheter may be positionable through the passage, and the positioning ring may be securable to the flexible catheter between the proximal catheter portion and the distal catheter portion. 
     In further embodiments of an intracavity balloon catheter may include a plurality of tabs provided proximate to the first end and extending into the passage thereby preventing sliding of an inserted flexible catheter. The plurality of tabs may be resilient and angled towards the passage and the second component. The intracavity balloon catheter may include a plurality of ribs provided proximate to the second end, each rib running parallel to the longitudinal axis of the positioning ring. The intracavity balloon catheter may include a latching mechanism at the connection point, the latching mechanism comprising a first latch on the first component securable with a second latch on the second component. The intracavity balloon catheter may further include a locking mechanism provided about the passage between the first end and the second end, the locking mechanism including a plurality of tabs projecting towards the passage. 
       FIGS. 1-3  illustrate an embodiment of an intracavity balloon catheter  10  having an inflatable balloon portion  100 , a locking device  200 , and an inflation device  300 . Inflatable balloon portion  100  may include an inflatable balloon  110  and a flexible catheter tube  102  projecting or extending into inflatable balloon  110 . Air or another fluid may be injected into balloon  110  through an opening, which in one embodiment is positioned at or proximate to the distal tip  104  of balloon catheter  102 . Balloon  110  may have a posterior surface  112  and an anterior surface  114 , and may be constructed from a plurality of sections  116 . Balloon  110  may be attached to flexible catheter  102  at a joint  118 , thereby sealing the interior of balloon  110  from the environment and permitting inflation and deflation upon insertion or removal of fluid through catheter  102 . 
     Balloon  110  may be made from a thin, elastic material such as PVC, polyurethane or a similar material. In some embodiments, anterior surface  114  is reinforced with silicone or another semi-flexible material. The reinforced nature of the anterior surface  114  will result in less elasticity than posterior surface  112 . When balloon  110  inflates, posterior surface  112  may expand from a deflated posterior position  112 A to an inflated posterior position  112 B, and anterior surface  114  may expand from a deflated anterior position  114 A to an inflated anterior position  114 B. Where anterior portion  114  is constructed from a reinforced material, it will expand a shorter distance than posterior portion  112 . Described another way, the distance between the deflated and inflated posterior positions  112 A,  112 B will be greater than the distance between the deflated and inflated anterior positions  114 A,  114 B. In embodiments where anterior surface  114  is reinforced, it may be appreciated that balloon  110  will have greater expansion in the direction towards the posterior surface  112 , and the restrained expansion of anterior surface  114  may prevent anterior surface  114  forcibly expanding into the anterior tissue of the cavity which balloon  110  is inserted into, thereby reducing pressure or compression of the anterior tissue of the cavity. 
     In order to provide fluid to inflatable balloon portion  100 , an inflation device  300  may be connected to flexible catheter  102  at the end opposite of its distal tip  104 . One embodiment of inflation device  300  includes a syringe  302 , a port  304 , and a valve  306  which may be operated by a switch  308 . In one embodiment, valve  306  is a stopcock and switch  308  is an arm handle. Catheter  102  may be joined with syringe  302  at port  304 , for instance by a threaded connection. Once joined, syringe  302  may pressurize or depressurize balloon  110  through catheter  102 . Valve  306  may operate to prevent unintended inflation or deflation of balloon  110 , as well as to maintain a constant pressurization of balloon  110  in order to, for instance, maintaining the inflated state of balloon  110 . Switch  308  may be manually operated by a user of intracavity balloon catheter  10  thereby allowing fluids to selectively through catheter  102  into balloon  110 . With valve  306  closed or sealed, syringe  302  may be released from catheter  102  as desired by the operator. In one embodiment, balloon  110  may receive between 40 cc and 70 cc of fluid from inflation device  300 . It should be understood and appreciated that while most embodiments of syringe  302  are manually operated, other pressurization devices for adding or removing fluid from balloon  110 , including automated pumps, are contemplated in alternative embodiments. 
       FIGS. 3-5  illustrate embodiments of balloon  110  in an inflated state. As may be appreciated in the illustration, balloon  110  may be manufactured from a plurality of sections  116 , including a center section  116 A and a plurality of side sections  116 B. When inflated, at least center section  116 A may inflate to a cylindrical shape having radial symmetry about a longitudinal axis from a cross sectional perspective. Side sections  116 B may further inflate, giving inflated balloon  100  an overall substantially cylindrical, quasi-cylindrical, semi-cylindrical or pillow shape, with or without tapered proximal and distal portions. Such a shape may occur by constructing the ends of center section  116 A to be approximately parallel from one another. In one embodiment, the diameter of balloon  110  at center section  116 A may be about 0.35 inches. Side section  116 B may be of varying sizes and dimensions, and in some embodiments side sections  116 B on either side of center section  116 A may be substantially the same. Protrusions  120  may also be provided on the surface of balloon  110 , and in one embodiment protrusions  120  are provided along the anterior surface  114 . Protrusions  120  may have a small elevation height, at least compared to the diameter of center section  116 A, so as to assist in stabilization of the inserted and inflated balloon  110  while not contributing to excessive compression on an anterior surface. Protrusions  120  may be hemispherically-shaped and may be uniformly distributed across at least a portion of the surface. 
       FIG. 6  illustrates an additional embodiment of balloon  110 . Here, the side sections  116 B immediately adjacent to either side of center section  116 A are substantially the same, thereby resulting in a substantially, cylindrically shaped inflated balloon  110 . Additionally, this embodiment illustrates where protrusions  120  are distributed across both anterior and posterior surfaces  112 ,  114 . 
       FIGS. 7 and 8  illustrate various embodiments of a locking device  200 , each embodiment of which having a through passage  202  which catheter tube  102  is dimensioned to pass through. It should be understood that while three embodiments of locking device  200  ( 200 A,  200 B,  200 C) are illustrated in these figures, only one locking device  200  is necessary in any given embodiment while three possible embodiments are simultaneously illustrated in these figures for comparison purposes. In use, such as when balloon  110  is properly positioned within a patient, locking device  200  may be axially adjusted along catheter tube  102  and secured against the external sphincter to prevent migration of inserted balloon  110 . One locking device embodiment is positioning ring  200 A, previously disclosed in U.S. Pat. No. 8,840,542, the contents of which are herein incorporated by reference in its entirety. Positioning ring  200 A may include a latch  210  and a receiving slot adjacent latch  210 , whereby latch  210  may be snap fittable into the receiving slot, having the effect of squeezing positioning ring  200 A about catheter  102 . This squeezing prevents positioning ring  200 A from sliding along catheter  102 . As latch  210  is released, then positioning ring  200 A may slide along catheter  102 . 
     With reference now to  FIGS. 9 and 10 , an embodiment of securing device  200  may be a positioning ring  200 B including a first component  220  configured to snap fit or otherwise mate with a second component  222  at a connection point  240 . A first end  202 A of through passage  202  may be associated with first component  220 , while a second end  202 B of through passage  202  may be associated with second component  222 . A locking mechanism  230  may be provided in order to secure the position of positioning ring  200 B. In one embodiment, locking mechanism  230  includes a plurality of tabs  232 , which may be resilient or flexible, that project through passage  202  and are angled away from first end  202 A. Tabs  232  permit positioning ring  200 B to be slid along an inserted catheter tube  102  in the direction towards second end  202 B, but simultaneously limit or prevent sliding of positioning ring  200 B in the opposite direction towards first end  202 A. In order to maintain alignment of catheter tube  102  with through passage  202 , a plurality of ribs  234  may be provided on second component  222 . These ribs  234  may run parallel to, and along a portion of, through passage  202 . 
     First component  220  may be detachably secured with second component  222  by a latching mechanism  240 . In one embodiment, latching mechanism includes a first latch  242  on first component  220  and a second latch  244  on second component  222 . Positioning of each latch  242 ,  244  adjacent to one another may then secure first and second components  220 ,  222  together. Similarly, first and second components  220 ,  222  may be detached by rotating one component with respect to another thereby separating latches  242 ,  244 . One embodiment may provide a pair of latching mechanisms  240  provided opposite sides of joined first and second components  220 ,  222 .  FIG. 9A  further illustrates an embodiment of latching mechanism  240 , with the outer shell of components  220 ,  222  shown transparently. 
       FIGS. 11 and 12  illustrate an embodiment of securing device  200 , which may be a positioning ring  200 C. In this embodiment, second component  222  is substantially the same as the second component  222  shown and described in positioning ring  200 B, however locking mechanism  230  may be a separate component from first component  220 , and may be insertable between first and second components  220 ,  222 . Therefore, positioning ring  200 C may be composed of three separable components: first component  220 , second component  222 , and locking mechanism  230 . In one embodiment, locking mechanism  230  includes a plurality of flexible tabs  232 , of which may project towards through passage  202  and angled in the direction away from first end  202 A. Tabs  232  may permit positioning ring  200 C to be slid along an inserted catheter tube  102  in the direction towards second end  202 B, but simultaneously prevent sliding of positioning ring  200 B in the opposite direction towards first end  202 A. Ribs  234  may be provided parallel to passage  202  on first component  220 , on second component  222 , or on both components. 
     Referring to  FIG. 13 , a method of using the intracavity balloon catheter  100  is shown.  FIG. 12  shows the intracavity balloon catheter  100  in the anal cavity with the balloon  110  in the inflated position. The desired depth may be attained through use of numerical markings on the catheter  102 . The external securing device  200  is placed against the external sphincter and secured to prevent inadvertent movement of the device  100  during use. The planar anterior surface  114  rests against the anterior rectal mucosa and the balloon  110  is expanded upon introduction of fluid. Valve  306 , as controlled by switch  308 , may operate to maintain a constant pressurization of balloon  110 . In addition to the rectal application shown, a method of using intracavity balloon catheter  100  may include insertion of the device  100  in alternative cavity, such as the vagina, esophagus, abdominal cavity, or other parts of the body reachable by an insertable probe. 
     The balloon can be coated with radioprotective materials to provide further protection to the rectal mucosa against the negative effects of radiation therapy. Exemplary radioprotective elements include Vitamin A, Vitamin E, misoprostal, amifostine, formalin solution and sulfasalazine. The radioprotective material can be chemically bonded to the balloon during the manufacturing process or it can be applied to the balloon prior to insertion. 
     Alternatively, the balloon can have both a reinforced anterior surface and reinforced posterior surface with less elasticity than the lateral surfaces of the balloon. During inflation, expansion would occur in the lateral directions and both the reinforced anterior surface and the reinforced posterior surface would remain substantially planar, thereby reducing compression of the rectal mucosa in both the anterior and posterior directions. The distal portion of the catheter can be connected to the anterior surface of the lumen of the balloon to restrict rotation between the catheter and the balloon. Exemplary mechanisms of connecting the distal portion of the catheter to the interior anterior surface of the balloon include through mechanical connection, chemical bonding or welding process. 
     Embodiments of the disclosure may generally relate to intracavity probes, and more specifically intrarectal probes and methods of using the probes for immobilizing the prostate during staging purposes and radiation therapy treatment. Although the probes are described herein as principally to image and immobilize the prostate, it should be understood that the disclosure is equally application to other application necessitating an imaged and immobilized area and for other anatomical regions of interest, such as parts of the body reachable by an insertable probe. Embodiments disclosed herein may aim to improve the reproducibility day to day in the patient by having a substantially cylindrical balloon shape that minimizes the impact of positioning changes. Such a cylindrical shape may thereby remove variations caused by depth being symmetrical along a longitudinal axis. Balloon embodiments may incorporate surface modification of the balloon that create small (essentially not visible through convention imaging) changes in the depth of the rectal mucosa having a radioprotective effect on the rectal mucosa while not affecting the gross relative position of the prostate day to day. The various embodiments of the device disclosed herein may have an application for providing delivery of radioprotective materials to a treatment area in a manner such that surrounding tissue is actively protected from over-exposure to radiation delivery. 
     The descriptions set forth above are meant to be illustrative and not limiting. Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the concepts described herein. The disclosures of each patent, patent application and publication cited or described in this document are hereby incorporated herein by reference, in their entireties. 
     The foregoing description of possible implementations consistent with the present disclosure does not represent a comprehensive list of all such implementations or all variations of the implementations described. The description of some implementation should not be construed as an intent to exclude other implementations. For example, artisans will understand how to implement the invention in many other ways, using equivalents and alternatives that do not depart from the scope of the invention. Moreover, unless indicated to the contrary in the preceding description, none of the components described in the implementations are essential to the invention. It is thus intended that the embodiments disclosed in the specification be considered as illustrative, with a true scope and spirit of the invention being indicated by the following claims.