Patent Publication Number: US-2022226120-A1

Title: Inflatable penile prosthesis with a structured cylinder

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of, and claims priority to, U.S. patent application Ser. No. 16/262,016, filed on Jan. 30, 2019, entitled “INFLATABLE PENILE PROSTHESIS WITH A STRUCTURED CYLINDER”, which claims priority to U.S. Patent Application No. 62/626,894, filed on Feb. 6, 2018, entitled “INFLATABLE PENILE PROSTHESIS WITH A STRUCTURED CYLINDER”, the disclosures of which are incorporated by reference herein in their entirety. 
    
    
     TECHNICAL FIELD 
     This disclosure relates generally to bodily implants and more specifically to bodily implants, such as penile prostheses that include inflatable members. 
     BACKGROUND 
     One treatment for male erectile dysfunction is the implantation of a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include inflatable cylinders or members that can be inflated or deflated using a pump mechanism. In some existing devices, the inflatable cylinder or member requires a relatively large amount of force to inflate. Additionally, in some existing devices, the pump mechanism may require many sequential squeezes or activations to inflate the cylinder or member. Furthermore, in some existing devices, the inflatable cylinder or member may assume a flat, unnatural shape when in a deflated configuration. 
     Accordingly, it would be useful to provide a bodily implant, such as a penile prosthesis, that includes an improved cylinder or member that can be more easily inflated. Additionally, it would be useful to provide a bodily implant, such as a penile prosthesis, that includes an inflatable cylinder or member that may assume a natural shape when in the deflated configuration. 
     SUMMARY 
     According to an aspect, an implant includes an inflatable member and a pump assembly configured to facilitate a transfer of a fluid from the reservoir to the inflatable member. The inflatable member has a sidewall that defines a lumen. The sidewall has an outer surface and an inner surface disposed opposite the outer surface. The inner surface has a series of undulations. 
     In some embodiments, the inflatable member defines a longitudinal axis, the series of undulations extend along the longitudinal axis. 
     In some embodiments, the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter and second portion having a second diameter, the second diameter being larger than the first diameter. In some embodiments, the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter. In some embodiments, the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter, the second portion being disposed between the first portion and the third portion along a longitudinal axis of the inflatable member. 
     In some embodiments, the outer surface of the inflatable member is substantially smooth. In some embodiments, the outer surface of the inflatable member includes a series of undulations. 
     In some embodiments, the inflatable member is unitarily formed. In some embodiments, the inflatable member is monolithic. 
     In some embodiments, the inflatable member is configured to be placed in an inflated configuration and a deflated configuration. In some embodiments, the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration. In some embodiments, the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member configured to extend along a longitudinal axis of the inflatable member when placed in the inflated configuration. 
     In some embodiments, the implant includes a first cap coupled to a first end portion of the inflatable member; and a second cap coupled to a second end portion of the inflatable member. 
     In some embodiments, the implant includes a reservoir configured to retain the fluid, wherein the pump is configured to help facilitate a transfer of the fluid from the reservoir to the inflatable member when the implant is in an inflation mode. 
     In some embodiments, the pump assembly includes a valve body and a pump bulb member. 
     According to another aspect, an apparatus includes a core member. The core member has a longitudinal axis and an outer surface. The outer surface has a series of undulations. The core member is formed of a material that is configured to dissolve. 
     In some embodiments, the core member defines a lumen, the lumen extends substantially parallel to the longitudinal axis of the core member. 
     According to another aspect, a method of making an elongate member includes forming a core member; disposing the core member within a lumen of a casing; and removing the core member from the casing. 
     In some embodiments, the core member has a longitudinal axis and an outer surface, the outer surface has a series of undulations, the core member is formed of a material that is configured to dissolve. In some embodiments, the removing the core member from the casing includes dissolving the core member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  schematically illustrates a penile prosthesis according to an embodiment. 
         FIG. 2  illustrates a penile prosthesis according to another embodiment. 
         FIG. 3  illustrates the penile prosthesis of  FIG. 2  implanted within a patient according to an embodiment. 
         FIGS. 4A, 4B, and 4C  are cross-sectional views of an inflatable member according to an embodiment. 
         FIGS. 5A, 5B, and 5C  are cross-sectional views of an inflatable member according to an embodiment. 
         FIGS. 6A, 6B, and 6C  are cross-sectional views of an inflatable member according to an embodiment. 
         FIGS. 7A, 7B, and 7C  are cross-sectional views of an inflatable member according to an embodiment. 
         FIGS. 8-9  illustrate an inflatable member according to an embodiment. 
         FIGS. 10-11  are side views of an inflatable member according to an embodiment. 
         FIG. 12  is a front view of an inflatable member according to an embodiment. 
         FIG. 13  is a side view of the inflatable member of  FIG. 12 . 
         FIG. 14A  is a side view of a core member according to an embodiment. 
         FIG. 14B  is an end view of the core member of  FIG. 14A . 
         FIGS. 15-18  illustrate an inflatable member being formed according to an embodiment. 
         FIG. 19  is a flow chart of a method of making an inflatable member of a penile prosthesis according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure. 
     The terms “a” or “an,” as used herein, are defined as one or more than one. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open transition). The term “coupled” or “moveably coupled,” as used herein, is defined as connected, although not necessarily directly and mechanically. 
     In general, the embodiments are directed to medical devices such as penile prostheses or other bodily implants. The term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure. For example, in some embodiments, the patient may be a human male, a human female, or any other mammal. 
     The terms proximal and distal described in relation to various devices, apparatuses, and components as discussed in the subsequent text of the present disclosure are referred with a point of reference. The point of reference, as used in this description, is a perspective of a person who implants the inflatable penile prosthesis. The person may be a surgeon, a physician, a nurse, a doctor, a technician, and the like who may perform the implantation procedure. The term proximal refers to an area or portion that is closer or closest to the person (the surgeon, physician, nurse, doctor, technician, or the like) during the implantation procedure. The term distal refers to an area or portion that is farther or farthest from the person (the surgeon, physician, nurse, doctor, technician, or the like). 
     The embodiments discussed herein may improve the performance of an inflatable member of the device. For example, the inflatable member may have improved stiffness or rigidity, improved reliability, or improved deflation or inflation times. In some embodiments, the inflatable member may be facilitated by requiring less force or pressure to inflate the inflatable member. Additionally, in some embodiments, the inflatable member may retain or maintain a tubular shape when the inflatable member is placed in its deflated configuration. 
     The embodiments may include an inflatable penile prosthesis having a pump assembly, an inflatable member, and a reservoir. The inflatable member may be implanted into the corpus cavernosae of a patient or user, the reservoir may be implanted in the user&#39;s abdomen, and the pump assembly may be implanted in the scrotum. The pump assembly may switch between an inflation position and a deflation position such that a user can operate the device to place the inflatable penile prosthesis in either an inflation mode to transfer fluid from the reservoir to the inflatable member or a deflation mode to transfer the fluid from the inflatable member back to the reservoir. 
       FIG. 1  schematically illustrates an inflatable penile prosthesis  100  according to an aspect. The inflatable penile prosthesis  100  may include a reservoir  102 , a cylinder or inflatable member  104 , and a pump assembly  101  configured to transfer fluid between the reservoir  102  and the inflatable member  104 . In some examples, the inflatable member  104  may be implanted into the corpus cavernosae of the user, the reservoir  102  may be implanted in the abdomen or pelvic cavity of the user (e.g., the reservoir  102  may be implanted in the lower portion of the user&#39;s abdominal cavity or the upper portion of the user&#39;s pelvic cavity), and the pump assembly  101  may be implanted in the scrotum of the user. 
     The inflatable member  104  may be capable of expanding upon the injection of fluid into a cavity of the inflatable member  104 . For instance, upon injection of the fluid into the inflatable member  104 , the inflatable member  104  may increase its length and/or width, as well as increase its rigidity. In some examples, the inflatable member  104  may include a pair of cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volumetric capacity of the inflatable member  104  may depend on the size of the cylinders. In some examples, the volume of fluid in each cylinder may vary from about 10 milliliters in smaller cylinders and to about 50 milliliters in larger sizes. In some examples, the first cylinder member may be larger than the second cylinder member. In other examples, the first cylinder member may have the same size as the second cylinder member. 
     In some embodiments, the inflatable member  104  is a structured member or includes structural elements. For example, in some embodiments, the inflatable member may include a sidewall that defines a lumen. The sidewall may include structural features (such as locations of increased or decreased thickness). In some embodiments, the structural features may allow the inflatable member to be inflated at a relatively low pressure. In some embodiments, this may allow the user to inflate the inflatable member  104  with less pumps or activations of the pump or may allow the user to apply less force to the pump to inflate the inflatable member  104 . Details of the pump assembly  101  are described below. Additionally, in some embodiments, the structural features of the inflatable member  104  may allow the inflatable member  104  to retain or maintain a tubular shape (or a more anatomically correct shape) when the inflatable member  104  is in its deflated configuration. 
     The reservoir  102  may include a container having an internal chamber configured to hold or house fluid that is used to inflate the inflatable member  104 . The volumetric capacity of the reservoir  102  may vary depending on the size of the inflatable penile prosthesis  100 . In some examples, the volumetric capacity of the reservoir  102  may be 3 to 150 cubic centimeters. In some examples, the reservoir  102  is constructed from the same material as the inflatable member  104 . In other examples, the reservoir  102  is constructed from a different material than the inflatable member  104 . 
     The inflatable penile prosthesis  100  may include a first conduit connector  103  and a second conduit connector  105 . Each of the first conduit connector  103  and the second conduit connector  105  may define a lumen configured to transfer the fluid to and from the pump assembly  101 . The first conduit connector  103  may be coupled to the pump assembly  101  and the reservoir  102  such that fluid can be transferred between the pump assembly  101  and the reservoir  102  via the first conduit connector  103 . For example, the first conduit connector  103  may define a first lumen configured to transfer fluid between the pump assembly  101  and the reservoir  102 . The first conduit connector  103  may include a single or multiple tube members for transferring the fluid between the pump assembly  101  and the reservoir  102 . 
     The second conduit connector  105  may be coupled to the pump assembly  101  and the inflatable member  104  such that fluid can be transferred between the pump assembly  101  and the inflatable member  104  via the second conduit connector  105 . For example, the second conduit connector  105  may define a second lumen configured to transfer fluid between the pump assembly  101  and the inflatable member  104 . The second conduit connector  105  may include a single or multiple tube members for transferring the fluid between the pump assembly  101  and the inflatable member  104 . In some examples, the first conduit connector  103  and the second conduit connector  105  may include a silicone rubber material. 
     The pump assembly  101  may switch between an inflation mode in which the fluid in the reservoir  102  is transferred to the inflatable member  104  through the pump assembly  101  in a first direction (e.g., inflation direction) and a deflation mode in which the fluid in the inflatable member  104  is transferred back to the reservoir  102  through the pump assembly  101  in a second direction (e.g., deflation direction). 
     The pump assembly  101  includes a pump (also referred to as a pump bulb member)  106  and a valve body  107 . The valve body  107  also includes a selection member  109 . The selection member  109  may be used to select or change the mode in which the pump assembly is in. For example, the selection member  109  may be moved from a first position to a second position to place the device in its deflation mode. The selection member  109  may then be moved back to its first position to place the device in its inflation mode. In some embodiments, the selection member  109  is movable with respect to the valve body  107 . For example, in some embodiments, the selection member  109  is slidably coupled or slideable with respect to the valve body  107 . 
     The pump  106  may be squeezed or depressed by the user in order to facilitate the transfer of fluid from the reservoir  102  to the inflatable member  104 . For example, in the inflation mode, while the user is operating the pump  106 , the pump  106  may receive the fluid from the reservoir  102 , and then output the fluid to the inflatable member  104 . When the user switches to the deflation mode, at least some of the fluid can automatically be transferred back to the reservoir  102  (due to the difference in pressure from the inflatable member  104  to the reservoir  102 ). Then, the user may squeeze the inflatable member  104  to facilitate the further transfer of fluid through the pump  106  to the reservoir  102 . 
     In some examples, the pump  106  may include a flexible member defining a cavity. In some examples, the pump  106  may define a pump shell having a flexible bulb and a valve body connector, where the valve body connector is designed to fit at least partially over the valve body  107 . In some examples, the pump  106  may include a squeeze pump. In some examples, the pump  106  may include a portion that is round or substantially round. In some examples, the pump  106  may include ribbing or dimples to aid the user in gripping the pump  106 . The pump  106  may use suction and pressure to move the fluid in and out of the cavity of the pump  106  in the inflation mode. For example, the user may depress or squeeze the pump  106  to expel the fluid out of the cavity, and, when the flexible member returns to its original shape, the resulting suction pushes the fluid into the cavity of the pump  106 . In some examples, the pump  106  may have a bulb spring rate that is designed to refill the pump  106  in a selected time frame. 
     As discussed above, the selection member  109  may be used to select or change the mode in which the pump assembly is in. For example, in one embodiment, the selection member  109  may be placed in the inflate position and the user may then operate the pump  106  to inflate the inflatable member  104  (i.e., move the fluid from the reservoir  102  to the inflatable member  104 ). For example, the user may repeatedly depress or squeeze the pump  106  until the desired rigidity is achieved. 
     In some examples, if the reservoir  102  is at least partially pressurized, the fluid may automatically flow out of the reservoir  102  and into the inflatable member  104  without the user depressing or squeezing the pump  106  until the pressure is at least partially equalized between the reservoir  102  and the inflatable member  104 . 
     Then, when the user wants to deflate the inflatable member  104 , the user moves selection member  109  to its deflated position. The user may then operate the pump  106  to deflate the inflatable member  104  (i.e., move the fluid from the inflatable member  104  to the reservoir  102 ). The pump  106  may then return to its original form, which provides a suction force causing fluid to be drawn into the pump  106  from the inflation member  104 . The fluid from the inflation member  104  fills the pump  106  (or at least partially fills the pump  106 ). This pump cycle is repeated until the inflatable member  104  is deflated. 
     In some examples, the fluid may automatically (upon movement of the selection member  109  to its deflate position) flow out of the inflatable member  104  and into the reservoir  102  without the user depressing or squeezing the pump  106  until the pressure is at least partially equalized between the reservoir  102  and the inflatable member  104 . 
     In some examples, after the inflation member  104  has been deflated, the pump  106  may be squeezed to place the pump in a contracted position or configuration. 
       FIG. 2  illustrates a penile prosthesis  200  according to an aspect.  FIG. 3  schematically illustrates the penile prosthesis  200  placed within a body of the user or patient. 
     The penile prosthesis  200  may include a pair of cylinders  204 , and the pair of cylinders or inflatable members  204  are implanted in a penis  214 . For example, one of the cylinders  204  may be disposed on one side of the penis  214 . The other cylinder  204  (not shown in  FIG. 3 ) of the pair of cylinders may be disposed on the other side of the penis  214 . The cylinder  204  may include a distal end portion  224 , a cavity or inflation chamber  222 , and a proximal end portion  228  having a rear tip  232 . 
     The penile prosthesis  200  may include a pump assembly  201 , which may be implanted into the patient&#39;s scrotum  218 . A pair of conduit connectors  205  may attach the pump assembly  201  to the pair of inflatable members or cylinders  204  such that the pump assembly  201  is in fluid communication with the pair of inflatable members or cylinders  204 . Also, the pump assembly  201  may be in fluid communication with a reservoir  202  via a conduit connector  203 . The reservoir  202  may be implanted into the user&#39;s abdomen  219 . The inflation chamber or portion  222  of the cylinder  204  may be disposed within the penis  214 . The distal end portion  224  of the cylinder  204  may be at least partially disposed within the crown portion  226  of the penis  214 . The proximal end portion  228  may be implanted into the patient&#39;s pubic region PR with the rear tip  232  proximate the pubic bone PB. 
     In order to implant the inflatable members or cylinders  204 , the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region, e.g., where the base of the penis  214  meets with the top of the scrotum  218 . From the penoscrotal incision, the surgeon may dilate the patient&#39;s corpus cavernosae  240  to prepare the patient to receive the pair of inflatable members or cylinders  204 . The corpus cavernosum is one of two parallel columns of erectile tissue forming the dorsal part of the body of the penis  214 , e.g., two slender columns that extend substantially the length of the penis  214 . The surgeon will also dilate two regions of the pubic area (proximal corpora cavernosae) to prepare the patient to receive the proximal end portion  228 . The surgeon may measure the length of the proximal and distal corpora cavernosae from the incision and the dilated region of the pubic area to determine an appropriate size of the inflatable members or cylinders  204  to implant. 
     After the patient is prepared, the penile prosthesis  200  is implanted into the patient. The distal tip of the distal end portion  224  of each cylinder  204  may be attached to a suture. The other end of the suture may be attached to a needle member (e.g., Keith needle). The needle member is inserted into the incision and into the dilated corpus cavernosum. The needle member is then forced through the crown of the penis  214 . The surgeon tugs on the suture to pull the cylinder  204  into the corpus cavernosum. This is done for each cylinder of the pair of cylinders  204 . Once the inflation chamber  222  is in place, the surgeon may remove the suture from the distal tip. The surgeon then inserts the proximal end portion  228 . The surgeon inserts the rear end of the cylinder  204  into the incision and forces the proximal end portion  228  toward the pubic bone PB until each cylinder  204  is in place. 
     In the illustrated embodiment, each of the inflatable members or cylinders  204  is structurally and functionally similar. Accordingly, only one of the inflatable members or cylinders will be discussed in detail.  FIG. 4A  is a cross-sectional view of the inflatable member  404  taken along the longitudinal axis LA of the inflatable member  404 .  FIG. 4B  is a cross-sectional view of a portion of the inflatable member  404 .  FIG. 4C  is a cross-sectional view of the inflatable member  404  taken along line A-A of  FIG. 4A . The inflatable member  204  may be capable of expanding upon the injection of fluid into a cavity of the inflatable member  204 . For instance, upon injection of the fluid into the inflatable member  204 , the inflatable member  204  may increase its length and/or width, as well as increase its rigidity. The volumetric capacity of the inflatable member  204  may depend on the size of the cylinders. In some examples, the volume of fluid in each cylinder may vary from about 10 milliliters in smaller cylinders and to about 50 milliliters in larger sizes. 
     In the illustrated embodiment, the inflatable member  204  includes a sidewall  280  that defines a lumen or cavity  282 . In the illustrated embodiment, the inflatable member  204  includes structural features. In some embodiments, the structural features may allow the inflatable member to be inflated at a relatively low pressure. In some embodiments, this may allow the user to inflate the inflatable member  204  with less pumps or activations of the pump or may allow the user to apply less force to the pump to inflate the inflatable member  204 . Additionally, in some embodiments, the structural features of the inflatable member  204  may allow the inflatable member  204  to retain or maintain a tubular shape (or a more anatomically correct shape) when the inflatable member  204  is in its deflated configuration. 
     In the illustrated embodiment, the structural features of the inflatable member  204  include a sidewall  280  that includes structural features. The sidewall  280  has an inner surface  284  and an outer surface  286 . The outer surface  286  is disposed opposite the inner surface  284 . The inner surface  284  defines the cavity or lumen  282  (and is disposed adjacent the lumen  282 ). The inner surface  284  of the sidewall  280  has a series of undulations. In other words, the inner surface  284  of the sidewall  280  is not smooth. The series of undulations extend along the longitudinal axis LA of the inflatable member  204 . In the illustrated embodiment, the outer surface  286  is smooth (or devoid of undulations). In other embodiments, the outer surface includes a series of undulations and is not smooth. 
     In the illustrated embodiment, the sidewall  280  includes portions of increased thickness and portions of decreased thickness. For example, at location  280 A the sidewall  280  has a smaller or decreased thickness. At location  280 B, the sidewall  280  has a larger or increased thickness. The thickness of the sidewall  280  at location  280 A is smaller than at location  280 B. The sidewall  280  has a smaller or decreased thickness at location  280 C. The sidewall  280  has a larger or increased thickness at location  280 D. Locations  280 A,  280 B,  280 C, and  280 D are disposed along the longitudinal axis LA of the inflatable member  204  with location  280 B being disposed between  280 A and  280 C and location  280 C being disposed between  280 B and  280 D. 
     In the illustrated embodiment, the size or diameter of the lumen  282  defined by the sidewall  280  varies along the longitudinal axis LA of the inflatable member. Specifically, as illustrated, the portion of the lumen disposed adjacent location  280 A of the sidewall  280  is larger than the portion of the lumen disposed adjacent location  280 B of the sidewall  280 . Similarly, the portion of the lumen disposed adjacent location  280 C of the sidewall  280  is larger than the portion of the lumen disposed adjacent location  280 D of the sidewall  280 . 
     As best illustrated  FIGS. 10 and 11 , the inflatable member  204  is configured to expand along the longitudinal axis (increase in length) and expand radially when the inflatable member  204  is place in its inflated configuration.  FIG. 10  is a side view of the inflatable member  204  in its deflated configuration.  FIG. 11  is a side view of the inflatable member  204  in its inflated configuration. As illustrated, inflatable member  204  is longer in length and is larger in radial size in its inflated configuration. 
       FIG. 12  is a front view of the inflatable member  204  in its deflated or relaxed configuration.  FIG. 13  is a side view of the inflatable member in its relaxed configuration. As best illustrated in  FIGS. 12 and 13 , the inflatable member  204  is configured to retain or maintain a tubular shape when the inflatable member  204  is disposed in its deflated or relaxed configuration. In some embodiments, by retaining a tubular or substantially tubular shape, the inflatable member  204  does not flatten or fold when the inflatable member  204  is disposed in its deflated or relaxed configuration. In some embodiments, this allows the inflatable member to more correctly assume a natural bodily shape (such as a flaccid penis). 
       FIGS. 8 and 9  illustrate a cross-sectional side view and a cross-sectional perspective view, respectively. In some embodiments, the inflatable member  204  extends in length and/or the size of the outside diameter of the inflatable member  204  increases when an amount of pressure is placed or applied to the lumen of the inflatable member  204 . In some embodiments, when a pressure is placed or applied to the lumen of the inflatable member, the pressure is evenly applied to all portions of the lumen of the inflatable member. In other embodiments, when a pressure is placed or applied to the lumen of the inflatable member, the pressure is applied to different portions of the lumen in different amounts. 
     In one embodiment, when pressure was applied to the lumen of the inflatable member at 20 pounds per square inch, the overall length of the inflatable member increased by about 0.01 inch and the outside diameter of the inflatable member increased by about 0.026 inches. In another embodiment, when pressure was applied to the lumen of the inflatable member at 20 pounds per square inch, the overall length of the inflatable member increased by about 0.014 inches and the outside diameter of the inflatable member increased by about 0.016 inches. In other embodiments, the length and diameters changed at different amounts. 
     In one embodiment, when pressure was applied to the lumen of the inflatable member at 10 pounds per square inch, the overall length of the inflatable member increased by about 0.005 inches and the outside diameter of the inflatable member increased by about 0.012 inches. In another embodiment, when pressure was applied to the lumen of the inflatable member at 10 pounds per square inch, the overall length of the inflatable member increased by about 0.007 inches and the outside diameter of the inflatable member increased by about 0.008 inches. In other embodiments, the length and diameters changed at different amounts. 
     In one embodiment, when pressure was applied to the lumen of the inflatable member at 5 pounds per square inch, the overall length of the inflatable member increased by about 0.002 inches and the outside diameter of the inflatable member increased by about 0.003 inches. In another embodiment, when pressure was applied to the lumen of the inflatable member at 5 pounds per square inch, the overall length of the inflatable member increased by about 0.004 inches and the outside diameter of the inflatable member increased by about 0.005 inches. In other embodiments, the length and diameters changed at different amounts. 
     The pump assembly  201  may switch between an inflation mode in which the fluid in the reservoir  202  is transferred to the inflatable member  204  (or inflatable members) through the pump assembly  201  in a first direction (e.g., inflation direction) and a deflation mode in which the fluid in the inflatable member  204  (or inflatable members) is transferred back to the reservoir  202  through the pump assembly  201  in a second direction (e.g., deflation direction). 
     An end cap  290  may be coupled to the end portions of the sidewall  280 . In some embodiments, an end cap  290  is coupled to each of the end portions of the sidewall  280 . In some embodiments, the end caps  290  help facilitate the fluidic sealing of the lumen  282 . The end caps  290  may be coupled to the end portions of the sidewall via an adhesive or any other know coupling method. In some embodiments, the end cap may be shaped as the ends, tips or caps  224  or  232 . 
     The pump assembly  201  includes a pump bulb member or pump  231 , a valve body  233 , and a selection member  239 . The selection member may be used to select or change the mode in which the pump assembly  201  is in. For example, the selection member  239  may be moved from a first position to a second position to place the device in its deflation mode. The selection member  239  may then be moved back to its first position to place the device in its inflation mode. In some embodiments, the selection member  239  is movable with respect to the valve body  233 . For example, the selection member  239  may be slidably coupled or slideable with respect to the valve body  233 . In some embodiments, the selection member  239  includes stop members, such as shoulders or detents that engage members of the valve body  233  to lock or help retain the selection member  239  in one of its first and second positions. In other embodiments, the selection member  239  may be disposed or coupled to another portion of the device. 
     The pump  231  may be squeezed or depressed by the user in order to facilitate the transfer of fluid from the reservoir  202  to the inflatable member  204 . For example, in the inflation mode, while the user is operating the pump  231 , the pump  231  may receive the fluid from the reservoir  202 , and then output the fluid to the inflatable member  204 . When the user switches to the deflation mode, at least some of the fluid can automatically be transferred back to the reservoir  202  (due to the difference in pressure from the inflatable member  204  to the reservoir  202 ). Then, the user may squeeze the inflatable member  204  to facilitate the further transfer of fluid through the pump  231  to the reservoir  202 . 
     Then, when the user wants to deflate the inflatable members  204 , the user moves selection member  239  to its deflate position. The user may then operate the pump  231  to deflate the inflatable members  204  (i.e., move the fluid from the inflatable members  204  to the reservoir  202 ). For example, the user may repeatedly depress or squeeze the pump  231  until the deflation is completed. The pump  231  may then return to its original form, which provides a suction force causing fluid to be drawn into the pump  231  from the inflation members  204 . The fluid from the inflation members  204  fills the pump  231  (or at least partially fills the pump  231 ). This pump cycle is repeated until the inflatable members  204  are deflated. 
     In some examples, the fluid may automatically (upon movement of the selection member  239  to its deflate position) flow out of the inflatable member  204  and into the reservoir  202  without the user depressing or squeezing the pump  231  until the pressure is at least partially equalized between the reservoir  202  and the inflatable member  204 . 
     In some examples, after the inflation member  204  has been deflated, the pump  231  may be squeezed to place the pump in a contracted position or configuration. 
       FIGS. 14A, 14B, and 15-18  illustrate a process for manufacturing an inflatable member according to an embodiment.  FIGS. 14A and 14B  illustrate a core member  310 . The core member  310  is formed to have an outer surface  314  having a shape of the desired inner surface of the inflatable member. The core member  310  is formed of a material that may be melted or dissolved. For example, in some embodiments, the core member  310  is formed of a wax material. In the illustrated embodiment, the core member  310  defines a lumen  312 . The lumen  312  of the core member  310  may help facilitate the dissolving or melting of the core member  310 , as will be discussed in more detail below. 
     As illustrated in  FIG. 15 , the core member  310  is disposed or placed within a lumen of a tubular member  320 . In some embodiments, the tubular member  320  is an extruded tubular member  320 . In some embodiments, the tubular member  320  is made of silicone. In other embodiments, it may be formed of anther material such as a material that may help limit the expansion of the inflation member once formed. 
     As illustrated in  FIGS. 16 and 17 , material is then injected between the core member  310  and the tubular member  320 . The injected material flows around the core member  310  and adheres to the tubular member  320 . In some embodiments, the material that is injected is a silicone material. For example, the material that is injected may be platinum cure silicone. In other embodiments, it is a different type of material is injected. 
     As illustrated in  FIG. 18 , the core member  310  is then removed. In some embodiments, the core member  310  is melted or dissolved to remove the material of the core member  310 . In some embodiments, the core member  310  is heated. In some embodiments, a fluid is passed through the lumen  312  of the core member  310  to facilitate the melting or dissolving of the material of the core member  310 . 
       FIG. 19  is a flow chart for a method  400  of forming an inflatable member. At  410 , the core member is formed. At  420 , the core member is disposed within a lumen of a casing or tubular member. At  430 , the core member is removed from the tubular member or casing. In some embodiments, the material of the core member is melted or dissolved and removed from the tubular member or the casing. 
       FIGS. 5A, 5B, and 5C  illustrate an inflatable member  504  according to another embodiment.  FIG. 5A  is a cross-sectional view of the inflatable member  504  taken along the longitudinal axis of the inflatable member  504 .  FIG. 5B  is a cross-sectional view of a portion of the inflatable member  504 .  FIG. 5C  is a cross-sectional view of the inflatable member  504  taken along line B-B of  FIG. 5A . The inflatable member  504  may be capable of expanding upon the injection of fluid into a cavity of the inflatable member  504 . For instance, upon injection of the fluid into the inflatable member  504 , the inflatable member  504  may increase its length and/or width, as well as increase its rigidity. 
     In the illustrated embodiment, the inflatable member  504  includes a sidewall  580  that defines a lumen or cavity  582 . In the illustrated embodiment, the inflatable member  504  includes structural features. In some embodiments, the structural features may allow the inflatable member to be inflated at a relatively low pressure. In some embodiments, this may allow the user to inflate the inflatable member  504  with less pumps or activations of the pump or may allow the user to apply less force to the pump to inflate the inflatable member  504 . Additionally, in some embodiments, the structural features of the inflatable member  504  may allow the inflatable member  504  to retain or maintain a tubular shape (or a more anatomically correct shape) when the inflatable member  504  is in its deflated configuration. 
     In the illustrated embodiment, the structural features of the inflatable member  504  include a sidewall  580  that includes structural features. The sidewall  580  has an inner surface  584  and an outer surface  586 . The outer surface  586  is disposed opposite the inner surface  584 . The inner surface  584  defines the cavity or lumen  582  (and is disposed adjacent the lumen  582 ). The inner surface  584  of the sidewall  580  has a series of undulations. In other words, the inner surface  584  of the sidewall  580  is not smooth. The series of undulations extend along the longitudinal axis of the inflatable member  504 . 
     In the illustrated embodiment, the sidewall  580  includes portions of increased thickness and portions of decreased thickness. For example, at location  580 A the sidewall  580  has a smaller or decreased thickness. At location  580 B, the sidewall  580  has a larger or increased thickness. The thickness of the sidewall  580  at location  580 A is smaller than at location  580 B. The sidewall  580  has a smaller or decreased thickness at location  580 C. The sidewall  580  has a larger or increased thickness at location  580 D. Locations  580 A,  580 B,  580 C, and  580 D are disposed along the longitudinal axis of the inflatable member  504  with location  580 B being disposed between  580 A and  580 C and location  580 C being disposed between  580 B and  580 D. 
     In the illustrated embodiment, the size or diameter of the lumen  582  defined by the sidewall  580  varies along the longitudinal axis of the inflatable member. Specifically, as illustrated, the portion of the lumen disposed adjacent location  580 A of the sidewall  580  is larger than the portion of the lumen disposed adjacent location  580 B of the sidewall  580 . Similarly, the portion of the lumen disposed adjacent location  580 C of the sidewall  580  is larger than the portion of the lumen disposed adjacent location  580 D of the sidewall  580 . 
       FIGS. 6A, 6B, and 6C  illustrate an inflatable member  604  according to another embodiment.  FIG. 6A  is a cross-sectional view of the inflatable member  604  taken along the longitudinal axis of the inflatable member  604 .  FIG. 6B  is a cross-sectional view of a portion of the inflatable member  604 .  FIG. 6C  is a cross-sectional view of the inflatable member  604  taken along line C-C of  FIG. 6A . The inflatable member  604  may be capable of expanding upon the injection of fluid into a cavity of the inflatable member  604 . For instance, upon injection of the fluid into the inflatable member  604 , the inflatable member  604  may increase its length and/or width, as well as increase its rigidity. 
     In the illustrated embodiment, the inflatable member  604  includes a sidewall  680  that defines a lumen or cavity  682 . The lumen  682  includes a first portion  692  and a second portion  694 . The first portion  692  of the lumen  682  extends from one end of the inflatable member  604  to another end of the inflatable member  604  and is substantially linear (extends along or parallel to the longitudinal axis of the inflatable member  604 ). The second portion  694  of the lumen  682  forms a spiral or helix that extends along the length of the inflatable member  604 . 
     In the illustrated embodiment, the structural features that form the portions of the lumen may allow the inflatable member to be inflated at a relatively low pressure. In some embodiments, this may allow the user to inflate the inflatable member  604  with less pumps or activations of the pump or may allow the user to apply less force to the pump to inflate the inflatable member  604 . Additionally, in some embodiments, the structural features of the inflatable member  604  may allow the inflatable member  604  to retain or maintain a tubular shape (or a more anatomically correct shape) when the inflatable member  704  is in its deflated configuration. 
       FIGS. 7A, 7B, and 7C  illustrate an inflatable member  704  according to another embodiment.  FIG. 7A  is a cross-sectional view of the inflatable member  704  taken along the longitudinal axis of the inflatable member  704 .  FIG. 7B  is a cross-sectional view of a portion of the inflatable member  704 .  FIG. 7C  is a cross-sectional view of the inflatable member  704  taken along line D-D of  FIG. 7A . The inflatable member  704  may be capable of expanding upon the injection of fluid into a cavity of the inflatable member  704 . For instance, upon injection of the fluid into the inflatable member  704 , the inflatable member  704  may increase its length and/or width, as well as increase its rigidity. 
     In the illustrated embodiment, the inflatable member  704  includes a sidewall  780  that defines a lumen or cavity  782 . In the illustrated embodiment, the inflatable member  704  includes structural features. In some embodiments, the structural features may allow the inflatable member to be inflated at a relatively low pressure. In some embodiments, this may allow the user to inflate the inflatable member  704  with less pumps or activations of the pump or may allow the user to apply less force to the pump to inflate the inflatable member  704 . Additionally, in some embodiments, the structural features of the inflatable member  704  may allow the inflatable member  704  to retain or maintain a tubular shape (or a more anatomically correct shape) when the inflatable member  704  is in its deflated configuration. 
     In the illustrated embodiment, the structural features of the inflatable member  704  include a sidewall  780  that includes structural features. The sidewall  780  has an inner surface  784  and an outer surface  786 . The outer surface  786  is disposed opposite the inner surface  784 . The inner surface  784  defines the cavity or lumen  782  (and is disposed adjacent the lumen  782 ). The inner surface  784  of the sidewall  780  has a series of undulations. In other words, the inner surface  784  of the sidewall  780  is not smooth. The series of undulations extend along the longitudinal axis of the inflatable member  704 . 
     In the illustrated embodiment, the sidewall  780  includes portions of increased thickness and portions of decreased thickness. For example, at location  780 A the sidewall  780  has a smaller or decreased thickness. At location  780 B, the sidewall  780  has a larger or increased thickness. The thickness of the sidewall  780  at location  780 A is smaller than at location  780 B. The sidewall  780  has a smaller or decreased thickness at location  780 C. The sidewall  780  has a larger or increased thickness at location  780 D. Locations  780 A,  780 B,  780 C, and  780 D are disposed along the longitudinal axis of the inflatable member  704  with location  780 B being disposed between  780 A and  780 C and location  780 C being disposed between  780 B and  780 D. 
     In the illustrated embodiment, the size or diameter of the lumen  782  defined by the sidewall  780  varies along the longitudinal axis of the inflatable member. Specifically, as illustrated, the portion of the lumen disposed adjacent location  780 A of the sidewall  780  is larger than the portion of the lumen disposed adjacent location  780 B of the sidewall  780 . Similarly, the portion of the lumen disposed adjacent location  780 C of the sidewall  780  is larger than the portion of the lumen disposed adjacent location  780 D of the sidewall  780 . 
     While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments.