Patent Publication Number: US-10315015-B2

Title: Cuff-resistant anchoring balloon for medical device

Description:
RELATED APPLICATION DATA 
     The present application is a continuation of pending U.S. patent application Ser. No. 14/139,609, filed Dec. 23, 2013, the priority of which is claimed under 35 U.S.C. § 120, and the contents of which is incorporated herein by reference in its entirety, as though set forth in full. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure relates generally to medical devices and methods of manufacturing such devices. More particularly, the present disclosure relates to anchoring devices for elongated tubular members, such as catheters and probes. 
     BACKGROUND 
     The use of medical catheters and probes has become an effective method for treating many types of diseases. In general, a suitable catheter or tubular probe is inserted into a body lumen of the patient (vascular or non-vascular) and navigated through the body lumen into a desired target site. Using this method, virtually any target site in the patient&#39;s body may be accessed. In certain treatments, it is desirable to secure the catheter or probe in some manner so that proper positioning and placement is maintained during the treatment, such as in some urinary incontinence treatments. 
     Urinary incontinence is one of the most prevalent conditions of the lower urinary tract, particularly, stress urinary incontinence (hereinafter SUI) which affect a significant amount of people. SUI is the loss of small amounts of urine associated with movements, such as coughing, sneezing, laughing, and exercise that cause increased pressure on the bladder based on increased intra-abdominal pressure. Some SUI treatment includes the delivery of energy to and/or through the urethral wall by precisely placing an elongated probe having an energy delivery element within the urinary tract. These probes usually have an anchoring member, such as an inflatable balloon, at a distal portion of the probe that sits in a patient&#39;s bladder, and a locking device at the proximal portion of the probe that is placed against the patient&#39;s external urethral orifice or urinary meatus, thereby securing the probe and the energy delivery member in a desirable position within the urethra. During these treatments, minimizing movement of the probe relative to the desired treatment site in the urethra and/or paraurethral region is desirable. 
     In the past, various devices have been used for securing the positioning a catheter or probe relative to a treatment site, such as urologic bladder balloons. While known bladder balloons may hold indwelling catheters (e.g. Foley-type) from “falling out” of a bladder over a period of time by readily adapting to the bladder and body structures, and further preventing urine leakage, these balloons also allow axial displacement of the catheter relative to the balloon (i.e. cuffing) and a relative large range of axial displacement of the catheter within the urethra. Cuffing refers to the balloon tendency to fold over on itself or shift toward the bladder end of an indwelling catheter. The application of axial force to the indwelling catheter may cause cuffing and deformation of the bladder balloon and further causes axial movement of the catheter within the urethra, even when the balloon still sits within the bladder preventing expulsion from the patient. Thus, these known bladder balloons do not resist axial movement of the catheter relative to the balloon or relative to a desirable treatment site within the urthera and/or paraurethral region. Further, the known conforming urologic bladder balloons do not provide a prompt and sharp tactile feedback to the user or physician when the balloon reaches or locates the bladder neck, particularly when low force is applied to the balloon. Because these balloons are conforming and readily adaptable to body structures, the feedback is usually difficult to notice when low force is applied. 
     Accordingly, there is an ongoing need to provide for a more suitable anchoring balloon that minimizes axial translation of a catheter or probe, when the catheter or probe is positioned at a desired treatment site and axial force is applied to the catheter or probe. Further, there is an ongoing need for a more suitable anchoring balloon that resists cuffing of the balloon or axial displacement of the catheter or probe relative to the balloon. Additionally, there is an ongoing need for a more suitable anchoring balloon that provides a prompt and sharp rise in tactile feedback to the user or physician that signals the location of the balloon within a body structure or cavity when low force is applied. 
     SUMMARY 
     In one embodiment of the disclosed inventions, a medical device, having an elongate support structure and an inflatable balloon is described. The inflatable balloon includes a first-end portion secured to the support structure at a first location, a second-end portion secured to the support structure at a second location distal to the first location, and a middle-body portion. The middle-body portion of the balloon has a first end integrally formed with or otherwise bonded to the first-end portion, and a second end integrally formed with or otherwise bonded to the second-end portion. The first-end portion has a wall thickness greater than a wall thickness of the middle-body portion; the respective first-end portion, middle-body portion and second-end portion collectively define a sealed interior of the balloon through which the support structure extends. The balloon being stretch-mounted to the support structure so as to be in tension relative to the support structure, wherein the balloon is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon, such that the balloon, when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure relative to the balloon. 
     By way of non-limiting example, the balloon middle-body portion is twisted relative to the support structure. The support structure includes a plurality of elongate members, and wherein the first-end portion of the balloon is secured to a first elongate member of the support structure, and the second-end portion of the balloon is secured to a second elongate member of the support structure. The first-end portion and second-end portion of the balloon are each secured to the support structure by one of adhesive bonding, thermal bonding, interlocking geometries, and mechanical fastening. The balloon comprises one or more polymeric materials. 
     In various embodiments of the disclosed inventions, the balloon has a shore durometer in a range of between about A90 to about A100. The balloon has a shore durometer in a range of between about D30 to about D70. The balloon, when inflated to the inflation pressure, resists cuffing relative to the support structure. The second inflation pressure is at least about 10 percent greater than the first inflation pressure. 
     In accordance with embodiments of the disclosed inventions, the balloon middle-body portion has a non-tensioned length, and wherein the balloon middle-body portion is stretched to a tensioned length that is in a range of about 8% to about 12% greater than the non-tensioned length. 
     In accordance with another embodiment of the disclosed inventions, a method of manufacturing a medical device, includes forming an inflatable balloon having a first-end portion, a second-end portion, and a middle-body portion, the middle-body portion having a first end integrally formed with or otherwise bonded to the first-end portion, and a second end integrally formed with or otherwise bonded to the second-end portion, the first-end portion having a wall thickness greater than a wall thickness of the middle-body portion; securing the first-end portion of the balloon to a first location on an elongate support structure; and securing the second-end portion of the balloon to a second location distal to the first location on the elongate support structure, the first and second locations being spaced apart such that the balloon is stretch-mounted to the support structure so as to be in tension relative to the support structure, the first-end portion, middle-body portion and second-end portion of the balloon collectively define a sealed interior of the balloon through which the support structure extends, wherein the balloon is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon. 
     By way of non-limiting example, the middle-body portion of the balloon is twisted relative to the support structure prior to securing the second-end portion of the balloon to the support structure. The support structure includes a plurality of elongate members, and wherein the first-end portion of the balloon is secured to a first elongate member of the support structure, and the second-end portion of the balloon is secured to a second elongate member of the support structure. The first-end portion and second-end portion of the balloon are each secured to the support structure by one of adhesive bonding, thermal bonding, interlocking geometries, and mechanical fastening. The balloon comprises one or more polymeric materials. 
     In various embodiments of the disclosed inventions, the balloon includes a shore durometer in a range of between about A90 to about A100. The balloon includes a shore durometer in a range of between about D30 to about D70. The balloon middle-body portion has a non-tensioned length, and wherein the balloon middle-body portion is stretched to a tensioned length that is in a range of about 8% to about 12% greater than the non-tensioned length. 
     Other and further aspects and features of embodiments of the disclosed inventions will become apparent from the ensuing detailed description in view of the accompanying figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings illustrate the design and utility of embodiments of the disclosed inventions, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. The relative scale of select elements may have been exaggerated for clarity. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the disclosed inventions and are not therefore to be considered limiting of its scope. 
         FIG. 1  is a plan view of a SUI assembly constructed according to one embodiment of the disclosed inventions; 
         FIG. 2  is a cross-sectional view of an exemplary method of use of the SUI assembly of  FIG. 1 ; 
         FIGS. 3A-E  are perspective views of an anchoring balloon constructed according to various embodiments of the disclosed inventions; and 
         FIG. 4  is a cross-sectional view of an anchoring balloon coupled to the SUI assembly of  FIG. 1 , constructed according to one embodiment of the disclosed inventions; 
         FIGS. 5A-B  are flow charts showing methods of manufacturing an anchoring balloon according to one embodiment of the disclosed inventions; 
         FIGS. 6A-B  are cross-sectional view of the anchoring balloon of  FIG. 3A , and experimental data table according to embodiments of the invention; and 
         FIG. 7  is an experimental data table according to embodiments of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     Various embodiments of the disclosed inventions are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the inventions or as a limitation on the scope of the inventions, which are defined only by the appended claims and their equivalents. In addition, an illustrated embodiment of the disclosed inventions needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated. 
       FIG. 1  illustrates a SUI assembly  100  according to the disclosed inventions. The SUI assembly  100  includes an elongate member  110  having a proximal portion  112 , a distal portion  114 , and defining one or more inner lumens extending therebetween (shown in  FIG. 4 ). The proximal portion  112  of the elongate member  110  is coupled to a handle  116 . The distal portion  114  of the elongate member  110  includes an anchoring balloon  120 , a cooling balloon  122  and an energy delivery member  118  (e.g. transducer) disposed within the cooling balloon  122 . The one or more lumens of the elongate member  110  are in fluid communication with respective anchoring  120  and cooling  122  balloons for inflation and/or deflation of the balloons with fluid and/or gas. The SUI assembly may be made of polymeric materials and/or alloy materials, such as polyethylene, stainless steel or other suitable biocompatible materials or combinations thereof. As used in this specification, the term “elongate member” may refer to any member having a variety of elongated shapes, including a catheter, a tubular probe, a shaft, a needle, a wire, a sleeve, or any other configuration. 
     The SUI assembly  100  further includes an adjustable locking device  10  disposed around the elongate member  110 . The adjustable locking device  10  includes a housing  19  and an axial elongate passageway  18  for allowing passage of the elongate member  110  ( FIGS. 1-2 ). For example, the passageway  18  may have a diameter larger than the outer diameter of the elongate member  110 , when the locking device  10  is disengaged, so that, the locking device  10  slides over and/or rotates around the elongate member  110  with minimal friction or non-friction to the elongate member  110 . As used in this specification, the term “engaged” may refer to the adjustable locking device  10  being activated, actuated or in a locked position along the length of the elongate member  110 , and the term “disengaged” may refer to the locking device  10  being deactivated, in an unlocked position, freely movable along the length of the elongate member  110 . 
       FIG. 2  illustrates an exemplary method of use of the assembly  100  of  FIG. 1  for treatment of SUI in a female patient. After gaining access to a patient&#39;s urethra  200 , the elongate member  110  is introduced until the anchoring balloon  120  is disposed within a bladder  220 . Then, the anchoring balloon  120  is inflated and positioned at the neck  222  of the bladder  220 , where the anchoring balloon  120  sits against the orifice of the interior of the bladder so that the energy delivery member  118 , disposed within the cooling balloon  122 , in positioned in the urethra  200  at a desired treatment site. An advantage of the disclosed inventions is that the target force for the SUI assembly  100  having the anchoring balloon  120  (further disclosed in  FIGS. 3A-4, 6A ) is approximately 0.5 pound force (lbf) when the user or physician pulls back (i.e. withdraw motion) on the handle  116  and/or the elongate member  110  coupled to the anchoring balloon  12 , so that the user or physician detects contact and/or seating of the balloon  120  with the bladder neck  222  via tactile feedback ( FIG. 7 ). When using the anchoring balloon  120 , the force to detect contact and/or seating with a body cavity is relatively low (e.g. approximately 0.5 lbf). Another advantage of the low applied force when positioning the anchoring balloon  120  within the bladder  220  and pulling to detect its seating against the neck  222  is to minimize or avoid deformation of the urethra  200 , so that the energy delivery element  118  is disposed in the desired position, and the anatomy and length of the urethra  200  is maintained. For example, if a higher force (approximately 2 lbf) is required to detect contact/seating of a balloon at the bladder neck  222 , the higher force will compress or deform the anatomy and/or length of the urethra  220 , which may result in misplacement of an energy delivery element. 
     Further advantage of the disclosed inventions is that the anchoring balloon  120  resists axial movement of the elongate member  110  relative to the anchoring balloon  120 , which will be discussed in greater detail below. When the elongate member  110  is axially moved, the anchoring balloon  120  moves axially as well, so that cuffing is not produced or at least minimized at the anchoring balloon  120  when the elongated member  110  moves. The adjustable locking device  10  is then advanced or distally moved along the elongate member  110  to press against the external urethral orifice, urinary meatus  210  and/or adjacent tissue  211 , and engages the elongate member  110  to thereby secure the elongate member  110  at the desired position. It will be appreciated that placement of the anchoring balloon  120  within the bladder  220  (e.g. seating at the neck  222 ) and engagement of the locking device  10  to the elongate member  110 , provides a controlled securement and positioning of the elongate member  110  at the desired treatment site and/or position in the urethra  200 . 
     The anchoring balloon  120  and adjustable locking device  10  further secure the energy delivery member  118  in the desired position or treatment site within the urethra  200  during the treatment of SUI, avoiding or minimizing displacement of the elongate member  110  relative to the treatment site. When the locking device  10  is engaged (i.e. locked) along a portion of the elongate member  100  and the inflated anchoring balloon  120  is disposed within the bladder  200  (as shown in  FIG. 2 ), the anchoring balloon  120  resists, minimizes and/or avoid axial movement of the elongate member  110  and cuffing of the balloon, securing the desired position or treatment site of the SUI assembly  100 . After the treatment of SUI is completed (i.e. desirable amount of energy delivered to the urethra  200  and/or to the parauretral region beyond the urethral wall), the anchoring balloon  120  is deflated, the cooling  122  balloon may or may not be deflated, and the locking device  10  may be disengaged and moved proximally along the elongate member  110 , and the SUI assembly  100  is withdrawn from the treatment site. 
     Although, the use of the anchoring balloon  120  is described in connection with the assembly  100  for treatment of male and female SUI, it will be appreciated that the anchoring balloon  120  may be used in connection with any other type of assembly, device, catheter, tubular probe, shaft or any other configuration of an elongate member. 
       FIGS. 3A-5B  show various features of the anchoring balloon  120  according to embodiments of the inventions. The anchoring balloon  120  is shown in a preformed molded configuration ( FIG. 3A ), a pre-stretched or stretched-mounted (also deflated) configuration ( FIG. 3B ), and in an inflated or deployed configuration ( FIGS. 3C-D ). According to one embodiment of the invention, when supporting the anchoring balloon  120  to the SUI assembly  100 , as shown in  FIGS. 1 and 4 , at least a portion of the elongate member  110  or other type of support structure (e.g.  150  of  FIG. 4 ) is disposed within the balloon  120 . Further, the support structure  150  engages and secures the anchoring balloon  120  in place, which will be discussed in greater detail below. The anchoring balloon  120  includes a first-end portion  142  (e.g. proximal), a middle-body portion  141  (e.g. expandable) and a second-end portion  144  (e.g. distal), collectively defining a sealed interior of the balloon through which the support structure  150 , elongate member  110  or other type of elongate structure extends. As used in this specification, the term “support structure” may refer to any device or component to which one or more components may be directly or indirectly coupled, attached or secured. For example, the support structure  150  may include a plurality of elongate members (e.g.  132 ), where the first-end portion  142  of the balloon  120  is secured to a first elongate member of the support structure  150 , and the second-end portion  144  of the balloon is secured to a second elongate member of the support structure  150 . The first-end portion  142  and second-end portion  144  of the balloon  120  may include respective tubular or other suitable configurations to be coupled to the support structure  150  by adhesive, thermal bonding or the like, interlocking geometries, mechanical fastening, sutures or combinations thereof. The anchoring balloon  120  may be made of, or otherwise include polymeric materials, such as silicone, urethane polymer, thermoplastic elastomers rubber, such as santoprene, nylon, and polyethylene terephthalate (PET) and other suitable materials or combinations thereof. In one embodiment, the anchoring balloon  120  is composed of polyurethane which provides a balloon having superior performance and manufacturing attributes. Further, the anchoring balloon  120  material may have a shore durometer range between A90 to A100, and/or a shore durometer range between D30 to D70. For example, the anchoring balloon  120  may be manufactured with standard processing equipment to obtain a molded balloon having a wall thickness of approximately between 0.001 inches to 0.003 inches. Further, the wall thickness of the anchoring balloon  120  may vary from thicker, in and around the first-end portion  142  and in and around the second-end portion  144  to thinner in and around the a middle-body portion  141  at least. For example, the first-end portion  142  may have a wall thickness greater than a wall thickness of the middle-body portion  141 . 
     In one embodiment of the invention and with the use of such standard molding procedures, a double conical or diamond molded configuration is manufactured ( FIG. 3A ).  FIG. 3E  illustrate an embodiment of the molded double conical or diamond configuration of the anchoring balloon  120 , which may have an approximately angle of 30° (A1-4) from an axis  140  (e.g. aggregated 60°), a corresponding inside diameter D 1  of approximately 13 millimeters (0.51 inches) at the center of the balloon  120 , and a length L 1  of approximately 18 millimeters (0.7 inches) at middle-body portion  141  of the balloon  120 . By way of example, the anchoring balloon  120  can have a variety of shapes in the molded, mounted or inflated configurations, including but not limited to: a double conical, diamond, circular, oval, multi-sided, or irregular shapes, and/or angles that are adapted to resists or avoid cuffing of the balloon  120  when placed in-situ in a body cavity. Further, the balloon middle-body portion  141  has a non-tensioned length L 1  ( FIG. 3A, 3E ), and the balloon middle-body portion  141  may be stretched to a tensioned length that is in a range of about 8% to about 12% greater than the non-tensioned length L 1  ( FIG. 3B ). When inflated ( FIG. 3D ), the anchoring balloon  120  may have a diameter D 2  of approximately of 22 millimeters (0.86 inches). 
     The molded preformed configuration of the anchoring balloon  120 , as shown in  FIG. 3A , is stretched, for example, in a longitudinal direction along the axis  140  to form the pre-stretched or stretched-mounted configuration of the balloon  120 , as shown in  FIG. 3B . Further, the balloon  120  is stretch-mounted to the support structure  150  so as to be in tension relative to the support structure  150 . Additionally, the balloon middle-body portion  141  may be twisted relative to the support structure  150 . 
     In one embodiment, the balloon  120  is formed in a diamond-like configuration ( FIG. 3A ) that transitions to a substantially spherical configuration ( FIG. 3D ) when the balloon  120  is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon  120 , such that the balloon, when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure  150  relative to the balloon  120 . 
     As shown in  FIGS. 3B and 4 , the first and second end portions  142  and  144  of the balloon  120  may be secured to the elongate member  110  or suitable support structure using bonding, brazing, adhesive, thermal bonding or the like, interlocking geometries, mechanical fastening, sutures or combinations thereof. The molded configuration of the anchoring balloon  120  is stretched and the stretching of the balloon  120  is preferably in a longitudinal direction along the axis  140  of the molded configuration. In addition to the longitudinal stretch, the molded configuration of the anchoring balloon  120  may be rotated and/or twisted around the axis  140 ; rotation and/or twisting may occur simultaneously or consecutively with the longitudinal stretch of the anchoring balloon  120 . As shown in  FIG. 3C , an inflated configuration of the mounted anchoring balloon of  FIG. 3B  has a double conical or diamond configuration when the interior of the balloon is inflated to a pressure equal or similar to the atmospheric pressure. When the pressure of the interior of the balloon is higher than the atmospheric pressure (e.g. at least about ten percent greater than atmospheric pressure external to the balloon), the anchoring balloon  120  has a substantially spherical configuration when inflated, as shown in  FIG. 3D . The inflated configurations of the anchoring balloon  120  ( FIGS. 3C-D ) resist or avoid cuffing of the balloon  120  when placed in-situ in a body cavity, further resisting movement of the elongate member  110  relative to the balloon. Alternatively, the inflated balloon  120  may have an elliptical or other suitable inflated configuration when the molded anchoring balloon has other shapes including but not limited to: a circular, oval, multi-sided, or irregular shapes. 
       FIG. 4  illustrates the anchoring balloon  120  in an unexpanded, pre-stretched or stretched-mounted configuration disposed on the distal portion  114  of the SUI assembly  100  according to one embodiment of the disclosed inventions. The elongate member  110  includes at least a lumen  130  that accommodates a hypotube  132  within the cooling balloon  122  and energy delivery member  118 , and provides a fluid path for inflation and deflation of the anchoring balloon  120 . The structure of the assembly  100  and elongate member  110  allows fluid communication between a fluid port  134  ( FIG. 1 ), the lumen  130  ( FIG. 4 ) and the anchoring balloon  120 . A seal  136  ( FIG. 1 ) is included at the fluid port  134  to provide a fluid seal and maintain inflation or deflation of the anchoring balloon  120 . Alternatively, the fluid seal may be positioned at any suitable location between the fluid port  134  and the anchoring balloon  120 . An inflation source (not shown) is fluidly connected to the lumen  130  to deliver and/or withdraw fluid from the anchoring balloon  120 . From the proximal opening of the lumen  130  at the fluid port  134 , the introduced fluid travels in the lumen  130  into the interior of the balloon  120  to inflate the balloon thereof. 
     Further, the distal portion  114  of the assembly  100  may include a support structure  150  where the stretched configuration of the anchoring balloon  120  is mounted. The support structure  150  may be composed of rigid, semi-rigid and/or compliant materials and/or alloys, such as, acrylonitrile butadiene styrene (ABS), or combination thereof. The support structure  150  includes a first location  152  (e.g. proximal portion) and a second location  154  (e.g. distal portion). The first location  152  of the support structure  150  secures the first-end portion  142  of the anchoring balloon  120 , while the second location  154  of the support structure secures the second-end portion  144  of the anchoring balloon  120 , using bonding, brazing, adhesive, thermal bonding or the like, interlocking geometries, mechanical fastening, sutures or combinations thereof. For example, the first-end portion  142  of the balloon is secured to the support structure  150  at the first location  152 , and the second-end portion  144  is secured to the support structure  150  at the second location  154  distal to the first location  152 , and to the middle-body portion  141 . The first location  152  of the support structure  150  may accommodate a portion of the hypotube  132  to provide fluid communication of the lumen  130  to the anchoring balloon  120 . The second location  154  of the support structure  150  may include a non-traumatic, semi-spherical or rounded tip end  156 . Further, the anchoring balloon  120  is stretch-mounted to the support structure  150  so as to be in tension relative to the support structure  150 . In one embodiment, the balloon  120  is formed in a diamond-like configuration ( FIG. 3A ) that transitions to a substantially spherical configuration ( FIG. 3A ) when the balloon  120  is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon  120 , such that the balloon, when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure  150  relative to the balloon  120 . 
     As shown in  FIG. 5A , the anchoring balloon  120  may be manufactured by forming an inflatable balloon  120  having a first-end portion  142 , a second-end portion  144 , and a middle-body portion  141 , the middle-body portion  141  having a first end integrally formed with or otherwise bonded to the first-end portion, and a second end integrally formed with or otherwise bonded to the second-end portion, the first-end portion having a wall thickness greater than a wall thickness of the middle-body portion  141 . Then, securing the first-end portion  142  to the first location  152  on an elongate support structure  150  (step  300 ). Securing the second-end portion  144  of the balloon  120  to a second location  154  (step  306 ) distal to the first location  152  on the elongate support structure  150 , the first and second locations being spaced apart such that the balloon  120  is stretch-mounted (step  302 ) to the support structure  150  so as to be in tension relative to the support structure  150 , where the first-end portion  142 , middle-body portion  141  and second-end portion  144  of the balloon  120  collectively define a sealed interior of the balloon  120  through which the support structure  150  extends. The balloon  120  is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon  120  is inflated to an inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon  120 . 
     In addition to the stretch-mounting step, the middle-body portion  141  of the balloon  120  is twisted (step  304 ) relative to the support structure  150  prior to securing the second-end portion  144  of the balloon  120  to the support structure  150 . The support structure  150  may include a plurality of elongate members, where the first-end portion  142  of the balloon  120  is secured to a first elongate member of the support structure  150 , and the second-end portion  144  of the balloon is secured to a second elongate member of the support structure  150 . Further, the first-end portion  142  and second-end portion  144  of the balloon  120  are each secured to the support structure  150  by one of adhesive bonding, thermal bonding, interlocking geometries, and mechanical fastening. 
     In one embodiment, the mounted balloon  120  is manufactured by securing one end portion of the balloon  120  (either the first-end portion  142  or the second-end portion  144  portion) to the support structure  150  (step  300 ), then balloon  120  is stretched (step  302 ), and then, the unsecured end portion of the balloon  120  is also secured to support structure  150  (step  306 ). In addition to the stretching, the anchoring balloon  120  may be rotated and/or twisted around the axis  140  (step  304 ) simultaneously or consecutively with the longitudinal stretching of the balloon  120 . After stretching, rotation and/or twisting of anchoring balloon  120 , the unsecured second end portion of the balloon  120  is mounted and secured to the support structure  150  (step  306 ). Subsequent to the securement of the first-end portion  142  and second-end portion  144  end portions after stretching, rotation and/or twisting of the balloon  120 , the pre-stretched or stretched-mounted configuration of the balloon  120  is formed, as shown in  FIG. 3B . Then, the balloon  120  may be deflated, as shown in  FIG. 3B , and/or inflated, as shown in  FIGS. 3C-D  (step  308 ). 
     Alternatively, as shown in  FIG. 5B , the anchoring balloon  120  may be manufactured by first stretching the molded configuration of the anchoring balloon  120  (step  302 ) along the axis  140 , before mounting the anchoring balloon  120  to the support structure  150 . In addition to the stretching, the anchoring balloon  120  may be rotated and/or twisted around the axis  140  (step  304 ) simultaneously or consecutively with the longitudinal stretching of the balloon  120 . Next, one end portion of the balloon  120  (i.e. either the first-end portion  142  or the second-end portion  144  portion) is mounted and secure to the support structure  150  (step  300 ). Then, the second end portion of the balloon  120  is also mounted and secured to the elongate member  110  or support structure  150  (step  306 ). 
     Experimental Data 
     In accordance with the disclosed inventions, experiments were conducted on a pre-stretched or stretched-mounted anchoring balloon  120  of a molded configuration having a diameter D 1  and a length L 1 , as shown in  FIG. 6A . The results from the pressure tests and dimensional analysis (diameter and length variations) on the anchoring balloon  120  ( FIGS. 3A-4 and 6A ) when inflated by fluid and/or gas at ambient room conditions are shown in  FIG. 6B  in comparison with a Silicon Foley Catheter 12 French (Universa® by Cook Medical). 
     In accordance with the disclosed inventions,  FIG. 7  illustrates experimental data conducted on the anchoring balloon  120  ( FIGS. 3A-4 and 6A ) when being placed through the urethra  200  into the bladder  220  (as shown in  FIG. 2 ). The results are shown in comparison with a Silicon Foley Catheter 12 French (Universa® by Cook Medical). The anchoring balloon  120  constructed according to the embodiments of the disclosed invention is configured to provide a substantially immediate and sharp rise in tactile feedback to the end user or physician, particularly under low force or load conditions (e.g. represented as the slope of force over displacement in  FIG. 7 ) to detect location of the anchoring balloon  120  within the bladder  220 . The slope column of  FIG. 7  represents the amount of force (e.g. applied by physician/user to the balloon when pulling or withdrawing the medical assembly in-situ), over the displacement (e.g. distance to balloon moves over that force range). 
     Although particular embodiments of the disclosed inventions have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the present inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made (e.g., the dimensions of various parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments of the disclosed inventions shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.