CN100542503C - Reservoir for penile implant device and method of manufacture - Google Patents

Abstract

A kind of liquid container (118) that is used for penile implant devices comprises and the have sleeve pipe base portion (126) of (134) extends a pipe (124) from sleeve pipe.Base portion comprises the supporting structure (138) of the base portion inner surface in the hole that is arranged in adjacent vessel, and the fluid passage (136) of described pipe is led in the hole.Described supporting structure comprises that a plurality of projections (140) are arranged around described hole (127) and stretches out from the base portion (142) of base portion.The invention still further relates to a kind of manufacture method of producing the liquid container of penile implant devices, be included in and arrange a pipe in the mould and container body of injection moulding on described pipe.More specifically, described method comprises provides a mould, arranges a pipe in described mould, and injection material enters within the described mould, solidifies described material and opens described mould so that remove described container body and the pipe assembly.

Description

Reservoir for penile implant device and method of manufacture

technical field

The present invention generally relates to surgical implant devices and methods of making such devices. More particularly, the present invention relates to reservoirs for use with penile implant devices and methods of making such containers.

Background of the invention

Common treatments for erectile dysfunction include the use of penile implants. A penile implant device, commonly known as a three-piece set, comprises a pair of expandable cylindrical prostheses implanted within the corpus cavernosum, the prostheses being connected by a pump and valve assembly to a Container for liquid. Typically, the pump and valve assembly is implanted in the patient's scrotum and the container is implanted in the abdomen. A tube is used to connect each penile prosthesis to the pump, and additional tubes are used to connect the pump to the container. To activate the penile implant, the patient typically activates the pump using one of various methods that cause fluid to be transferred through the pump from the reservoir and into the prosthesis. This causes the implant to expand and create stiffness for a normal erection. Then, when the patient wishes to shrink the prosthesis, a valve assembly within the pump is activated in some way to release the fluid in the prosthesis back into the container. This contraction returns the penis to a flaccid state.

The containers used in these three-piece systems are typically in the form of flexible bags or bladders that expand and contract in volume as liquid moves to and from the container. A commonly used method for manufacturing these containers is the dip coating method. Dip coating involves inserting a mandrel of desired geometry into a self-balancing thermoplastic or thermoset material (eg, a specific solids content and viscous dispersion of silicone.) Much like old fashioned candle making, the mandrel is repeatedly dipped into the within the dispersion until the desired part wall thickness is obtained. There may be a period of time between successive dipping sessions (eg, 15 to 20 minutes) to allow the previous coating of material to fully set before the next successive dipping cycle. In the case of spherical vessels, for example, 24 to 28 dipping cycles may be required in order to obtain the proper wall thickness.

After the desired wall thickness has been achieved, the mandrel coated container can be treated with additional processing steps, such as being placed in an oven for curing. Curing is a typical step in the process of manufacturing a thermoset plastic (eg silicone) container body for a penile implant device. Sometimes, the oven curing process can be performed for a long time, such as 6 to 8 hours. After completion of the curing process, the coated mandrel was removed from the oven and cooled to room temperature. The cured container is then manually removed from the mandrel to complete the process. The total time from start to finish for dip coating can be 24 hours or more and can be costly and labor intensive. In addition, the dip coating method requires a relatively large production area, especially when many containers are produced simultaneously.

The materials used to manufacture containers by the dip-coating process are also expensive and take a long time to manufacture, further adding to the cost and time to produce dip-coated implantable containers. An example of a material that has been used in these dip coating methods is a silicone dispersion, which is a two-component platinum cured dispersion dispersed in xylene to transition from a semi-solid to a self-equilibrating liquid state. It takes 24 hours or more to prepare the dispersion before it can be used in the dip coating process, including the time required for mixing and removal of air. Batches of material are often large in order to increase production efficiency, which is often expensive. The actual cost of the dispersion increases further if a portion of the dispersion is not used and must be discarded after a predetermined expiration date.

Production of dip-coated implantable containers is also relatively complex due to the many parts and adhesives required to incorporate the container into a device for a prosthetic device. As an example, there are four parts that are often used to manufacture a typical infusion vessel assembly. These parts include a molded silicone housing adapter, a silicone standpipe, a dipping vessel housing, and bend-resistant tubing sections. In this container assembly, each individual component is bonded to adjacent components using a suitable adhesive, such as medical grade silicone glue. For each bond, an air (ambient) cure is performed, typically for at least thirty minutes or longer, followed by an oven cure, typically sixty minutes or longer, before the next bonding operation, thus resulting in The processing is relatively slow, and time-consuming. It is therefore desirable to manufacture container assemblies by lower cost manufacturing methods and materials than those produced using the above-described dip coating and bonding methods.

Contents of the invention

The present invention relates to methods and devices that overcome some of the disadvantages of previous reservoirs for penile implant devices, and to methods of producing container components (e.g., container housings) and assembling said components (e.g., support structures) A method into an implantable prosthetic device. The present invention provides reservoirs for such devices that have improved manufacturability, improved liquid flow properties, or preferably both.

The present invention comprises the use of injection molding to manufacture a liquid container body for a penile implant device. Injection molding can eliminate the multiple steps and considerable time required to manufacture containers by dip-coating methods. Injection molding methods can in particular reduce the time required to apply multiple layers of material during dip coating methods, and can also be used to manufacture container assemblies comprising fewer parts and thus requiring fewer bonding steps.

Another aspect of the invention may include a configuration for an implantable container that includes a support structure (eg, in the form of a plurality of protrusions) on the base of the container adjacent the outlet. The support structure prevents the container from collapsing during use and causing the surface of the container to cover the outlet. The support structure may preferably be included in the container body manufactured by an injection molding process.

In one aspect, the invention relates to a fluid container for a penile implant device, the container comprising a base having a sleeve from which a tube can extend. The base includes a support structure disposed on an inner surface of the base adjacent a bore of the container leading to the liquid passage of the tube. In a preferred embodiment, the support structure may comprise a plurality of protrusions arranged around the aperture and projecting from the base of the base.

In another aspect, the invention relates to a method for producing a liquid container for a penile implant device, comprising the step of injection molding the body of the container. A preferred method involves arranging a tube within a mold and injection molding the container body onto the tube. More specifically, the method may include providing a mold, placing a tube within the mold, injecting material into the mold, curing the material, and opening the mold to remove the container body and tube assembly.

The present invention also relates to methods and apparatus that overcome some of the disadvantages of previous penile implant device reservoirs by providing a liquid container configuration with improved fatigue resistance for the device. The present invention also relates to methods and apparatus for providing liquid container constructions including flow control constructions.

In another aspect of the invention, a fluid container for a penile implant device includes a housing, an adapter, and preferably a tube. The housing has an annular neck defining an opening. The annular neck cooperates with the annular groove and the flange of the adapter to form a gradual transition from the adapter to the wall of the housing. This transition can help control compliance mismatch between the adapter and housing, thereby providing improved reliability, for example by providing more gradual wall thicknesses for improved fatigue resistance. The tube is preferably attached to the adapter to provide a fluid passage which can be connected to another component of the penile implant device.

In another aspect, the invention relates to a liquid container for a penile implant device, the container comprising a housing portion, an adapter portion, and preferably a tube. The housing includes a plurality of elements such as ridges formed on the inner surface of the housing. The ridge is arranged in the vicinity of the transition region between the adapter and the housing. Such ridges provide improved fatigue resistance by providing a smooth transition between the adapter and the housing.

Description of drawings

The invention will be further described with reference to the accompanying drawings, in which like numerals refer to like parts throughout the several views, in which:

Figure 1 is a top view of a three-piece implantable dildo device having a pair of dildos, a pump, and a container of the present invention;

Figure 2 is a perspective view of one embodiment of the container of the present invention;

Figure 3 is a side cross-sectional view of the container of Figure 2, illustrating a housing attached to the load-carrying structure or device of the adapter, and a tube attached to the adapter at the sleeve;

Figure 4 is a side sectional view of the adapter portion of Figure 3, also including a tube extension;

Figure 5 is a perspective view of an adapter of the type shown in Figures 3 and 4;

Figure 5a is a perspective view of another embodiment of the adapter of the present invention, including a support structure having a staggered arrangement of elongated elements and shorter elements;

Figure 5b is a perspective view of another embodiment of the adapter of the present invention, comprising a support structure with a plurality of elongate elements;

Figure 6 is a top view of another embodiment of an adapter having a c-shaped element arrangement according to the present invention;

Figure 7 is a top view of another embodiment of an adapter having another arrangement of c-shaped elements according to the present invention;

Figure 8 is a partial cross-sectional front view of another embodiment of the adapter of the present invention, illustrating a contoured support structure;

Figure 9 is a bottom view of one embodiment of a portion of a container housing, illustrating a neck with a plurality of annular spacer elements;

Figure 10 is a perspective view of a portion of one embodiment of a container of the present invention comprising a plurality of indented areas arranged annularly around the neck region of the container;

Figure 11 is a cross-sectional view of another embodiment of the container of the present invention, illustrating a base with support means within the interior space of the housing, a lid closing the opening in the housing, and a sleeve a tube attached to the housing;

Figure 12 is a perspective view of a lid of the type that may be used to close or seal an opening in the housing of the container of Figure 11;

Figure 13 is a cross-sectional view of the lid in Figure 12;

Figure 14 is a cross-sectional view of the container of Figure 11 along line 14-14; and

Figure 15 is a partial cross-sectional front view of a portion of another embodiment of an adapter of the present invention having an elongated inner tubular structure.

Detailed ways

Referring now to the drawings, in which like numerals are used to designate like parts throughout the several views, beginning with FIG. 1, there is illustrated the configuration of a preferred surgically implantable penile prosthesis device 10 having a three-piece set. As shown, the device 10 generally includes first and second inflatable penile cylinders 12 and 14, a pump 16, and a container 18 in accordance with the present invention. The first penile cylinder 12 is fluidly connected to the pump 16 by a tube 20 and the second penile cylinder 14 is fluidly connected to the pump 16 by a tube 22 . Pump 16 is fluidly connected to container 18 by tube 24 . Typically, cylinders 12 and 14 are surgically implanted in the cavernous region of the penis and pump 16 is implanted in the patient's scrotum, and container 18 is typically implanted in the patient's abdomen. In use, the patient can activate the pump 16 in certain ways (eg, squeeze the pump 16 in a specific way to open the valve) to deliver fluid from the reservoir 18 to fill the penile cylinders 12 and 14 and provide an erection. Likewise, the patient can activate the pump 16 to return fluid to the reservoir 18 and thereby deflate the penile cylinders 12 and 14 and return the cylinders to their deflated state. A wide variety of dildo device configurations can utilize the type of container 18 described herein, however, device 10 in FIG. 1 is intended to illustrate a typical system using container 18 . For example, many different types of pump configurations can be used, such as those that require minimal manual manipulation to transfer liquid between the container and cylinder, or those that require the user to repeatedly squeeze the pump body for use within a penile prosthetic device or system Transfer liquid. Additionally, devices with a greater or fewer number of components than the three-piece device may utilize the containers of the present invention.

2 and 3 illustrate one embodiment of the container 18 of the present invention, which generally includes a housing 26 having an interior volume 28 and an adapter 34 extending from the housing 26 . Tube 24 is shown extending from adapter 34, although tube 24 is not the only means extending from container 18 for fluid communication between container 18 and other adjacent devices or components. For example, additional or different adapters or devices may be connected directly to one end of adapter 34 . In this case, any tubing used may alternatively be connected to the device elsewhere remote from the housing 26 and adapter 34 . Where such a tube 24 is used, the tube 24 preferably includes an internal fluid passage 36 extending along its length through which fluid may be communicated to and from the housing 26 . Preferably, tube 24 is a separate component that is sealed to adapter 34 during the molding process described below. However, tube 24 may be molded as part of adapter 34 or fused or bonded to sleeve 25 of adapter 34 using other suitable techniques.

Further, adapter 34 may include an annular flange 40 adjacent housing 26 and a sleeve 25 spaced from housing 26 at which tube 24 may be attached to adapter 34 . Adapter 34 preferably includes an opening 27 adjacent to fluid passage 36 configured to provide fluid communication between tube 24 and the interior region of annular flange 40 . Accordingly, opening 27 is preferably the same shape and size as fluid passage 36 to allow fluid to pass through fluid passage 36 to and from interior space 28 of housing 26 without leakage of fluid between components and further to allow fluid to pass through fluid passage 36 Flows out from the interior space 28 of the housing 26 and flows to other components to which the tube 24 is attached. For example, referring to the exemplary device 10 shown in FIG. 1 , the reservoir 18 can provide fluid to the pump 16 through the tube 24 , and the pump can then transfer the fluid to and from the penile cylinders 12 and 14 .

Referring additionally to Figures 4 and 5, the adapter 34 is shown without the associated housing 26 in order to better illustrate the characteristics of the adapter. As shown, the adapter 34 includes a base 38 and an annular flange 40 . Preferably, the diameter of the annular flange 40 increases from the open area 27 in the adapter 34 towards the end of the flange 40 . The base 38 also includes an annular groove 42 at least partially defined by the flange 40 and the base 38, as shown. That is, the base 38 generally provides the inner surface of the groove 42, the inner surface 46 of the flange 40 provides the outer surface of the groove 42, and the outer surface of the groove is spaced from the base 38 by a distance of the desired annular groove 42. width. The width of the groove 42 is preferably designed to receive the free edge of the container assembly housing. Referring again to FIG. 3 , the housing 26 preferably includes an annular neck 44 that fits within the annular groove 42 . The inner surface 46 of the flange 40 preferably contacts the outer surface of the housing 26 when the housing 26 is positioned such that its neck 44 is within the groove 42 . Accordingly, flange 40 is preferably sufficiently flexible to generally conform to the shape of housing 26 in both the expanded and deflated states. Further, the inner surface 46 of the flange 40 may be adhered or otherwise bonded to the outer surface of the housing 26 at the neck 44 when the neck 44 is located within the groove 42 . Additionally or alternatively, the outer surface of base 38 may be bonded to the inner surface of annular neck 44 to secure housing 26 to adapter 34 . In addition, the inner surface 46 of the flange 40 may also be adhered to the portion of the housing 26 beyond the neck 44, for example where the diameter of the housing 26 increases, and beyond the region where the neck 44 is located within the annular flange 40. . It is contemplated that the thickness of the neck may vary and/or the width of the annular opening may vary along its length. Any medical adhesive or the like may be applied to any portion of the container parts that are bonded to each other.

Referring again to FIGS. 3 and 4, as the flange 40 extends outwardly away from the base 38, the thickness of the flange 40 tapers so that the flange 40 is thickest in the area closest to the base 38, and then as it extends away from the base 38. The thickness of the flange 40 tapers to a smaller thickness when extended. Preferably, the flange 40 tapers to a point or a small dimension (ie, the end of the flange 40 ) at a location furthest from the base 38 . By utilizing such a tapered flange 40, a smooth transition may be provided at the transition from the base 38 of the adapter 34 to the housing 26, as shown. Alternatively, the annular flange 40 may flare or spread further outward than shown in FIG. 3 . In this case, the neck of the housing is therefore preferably designed to fit snugly with the annular flange and the annular opening of the adapter without exerting further pressure on the flange and/or the container housing.

When a dildo device using the container 18 of the present invention is implanted in a user, the housing 26 can be repeatedly deflated and expanded. During contraction, the housing 26 collapses inwardly on itself and bends at the neck 44 (and elsewhere on the housing 26 as well). This repeated bending can cause fatigue at the neck 44, which can lead to progressive thinning and eventual failure of the wall between the flange 40 and the housing 26 (eg, leaks). Accordingly, it is desirable to locate the flange 40 to provide additional support at the neck 44 while also providing a smooth transition from the base 38 of the adapter 34 to the housing 26 and minimizing areas of stress concentration. In other words, the neck 44 is preferably sealed or attached to the flange 40 near the base 38 of the adapter 34 . The overall wall thickness in the region near the base 38 is thus the thickness of the flange 40 plus the wall thickness of the neck 44 . However, the combined thickness of the flange 40 and the wall of the neck 44 decreases further away from the base 38 due to the reduction in flange thickness. Thus, as the flange 40 tapers toward its ends or edges, the combined thickness tapers or transitions to the wall thickness of the housing 26 . This reduces the compliant fit between the adapter 34 and the housing 26 and may improve the reliability of the container 18 . Generally, a misfit refers to a change in the flexibility or compliance of a transition, such as a sudden change from a thick section to a thin section. At such an abrupt transition, areas of concentrated stress can experience premature fatigue and possible fracture. The present invention thus provides a smooth and gradual transition between a part or main part of the adapter and the thinner part of the housing or container.

Referring again to FIGS. 4 and 5 , the adapter 34 preferably includes a support structure 47 that includes a plurality of elements 48 . Element 48 is located within interior space 50 of base 38 . In a preferred embodiment, elements 48 are arranged circumferentially around opening 27 of fluid flow channel 36 . The element 48 preferably has a generally cylindrical shape as it extends away from the direction of the opening 27; however, the element 48 may be of any number of regular or irregular shaped configurations. In a particular adapter 34 , each of the plurality of elements 48 may be identical in shape and size to one another, or may be replaced with elements of a different size, shape, and/or height than other adjacent elements 48 .

The container shell of the present invention is generally illustrated as having a spherical, oval, or elliptical shape. However, the shell may be changed to a more irregular or asymmetric shape or may include a shell having another configuration, such as more cylindrical, kidney-shaped, disk-shaped, or otherwise shaped (with appropriate size and material) so that the shell can expand or "fill" to receive the desired amount of liquid. The housing shape can also collapse or "collapse" as liquid is drained from the container. With any shape of housing chosen, the associated adapter should be designed to accommodate the portion of the housing attached to the adapter or mold the housing adapter as a unitary structure. For example, the flange portion needs to be more or less tapered to provide a smooth transition between the housing and the adapter. The adapter may or may not include an annular opening in which to place and attach a portion of the housing, other parts of the housing and adapter may be designed to enable an expandable and deflated housing and adapter according to the present invention.

Since the device of the present invention using the container preferably shuts off the liquid system when the liquid is transferred from the container, the housing will deflate itself as the penile cylinder fills. The manner in which a housing, such as housing 26, collapses or folds is generally unpredictable, so any portion of housing 26 may collapse toward opening or aperture 27 and thereby restrict or block fluid flow through passage 36 without additional configuration. or components. In use, the element 48 may thus serve to prevent the opening 27 from being blocked by parts of the housing 26 when liquid flows from the reservoir 18 to the penile cylinder, eg by a pump, causing the housing 26 to deflate. Elements 48 can prevent such flow problems and clogging because when housing 26 collapses, one or more elements 48 will keep housing 26 spaced from opening 27, thus preventing flow clogging. Therefore, there is preferably at least a small spacing between elements 48 in order to allow sufficient fluid flow. Likewise, even if a portion of the housing is arranged on the elements 48, liquid can flow between the elements 48 spaced apart by a certain distance. Further, the elements may be entirely separate elements which project separately from the main body region, or there may be at least some appendages molded or formed between adjacent elements along the height of the elements. Flow control means or support means or members other than those specifically illustrated in the drawings of the present application may be used.

Figure 5a illustrates another embodiment of an adapter 34a for use with a housing attachable thereto to form a container assembly, the adapter 34a comprising a base 38a, an annular flange 40a, and a substantially extending from the base 38a. Support structure 47a. The support structure 47a includes a plurality of elements 48a located within the interior space of the base 38a. In a preferred embodiment, elements 48a are arranged circumferentially around the opening of tube 24a, which extends from base 38a. As shown, this embodiment includes a total of eight elements 48a, four of which are of the same height, which is higher than the height of the remaining four elements 48a, which are also of the same height. In this embodiment, the four elements 48a having a higher height actually extend beyond the end of the annular flange 40a, while the remaining four elements 48a do not extend beyond the end of the flange 40a. As shown, elements 48a having a higher height are shaped differently than those having a lower height; however, any number of combinations of shapes and heights are considered to be within the scope of the present invention. For example, in the embodiment shown in Figure 5a, all elements 48a may also have the same cross-section, or each element 48a may have a different cross-section than every other element 48a. Furthermore, a given adapter may have elements of more than two heights, if desired. In addition, as described herein with respect to other embodiments of the invention, the number, configuration, height, and other features of the adapter elements are preferably selected to prevent or minimize obstruction of fluid flow to and from the attached housing. At a minimum, and especially prevent the attached housing from collapsing and clogging the fluid opening.

Figure 5b illustrates another embodiment of the adapter 34b of the present invention. The adapter 34b includes a plurality of elements 48b extending from the body portion 38b, all of the elements 48b extending beyond the end of the flange 40b. In this case, alternating elements 48b of different cross-section surround the periphery of the base 38b, so that half of the elements 48b are of circular cross-section and the other half of the elements 48b are of oval or elliptical cross-section. However, it is possible that all elements 48b are of the same cross-sectional shape or that the set of elements 48b comprises more than two differently shaped elements.

FIG. 6 illustrates a top view of another embodiment of an adapter 60 of the present invention. The adapter 60 includes c-shaped elements 62 that can replace elements 48 in FIGS. 4 and 5 . The elements 62 are arranged with each c-shaped opening portion facing the opening portion of another adjacent element 62 to advantageously provide a path for liquid to flow between the two elements as well as within the c-shaped portion of the element itself. . Another embodiment of adapter 64 is illustrated in FIG. 7 . The adapter 64 includes a plurality of c-shaped elements 66 arranged all facing the center of the adapter 64 . Likewise, the elements 66 are preferably arranged in a manner to provide passages for fluid to flow between and within the individual elements 66 .

Furthermore, FIG. 8 illustrates a cross-sectional view of another embodiment of the adapter 68 of the present invention. The adapter 68 includes a support structure 70 having a textured or contoured surface 72 surrounding a fluid passage 74 . Surface 72 may comprise only a contoured surface as shown, or may comprise other types of contours or configurations such as scallops, ridges, buttons, protrusions, flanges, grooves, and/or other features capable of retaining or supporting at least A support structure for a portion of the housing wall remote from the opening of the liquid channel 74 . In this way, the surface 72 allows liquid to flow through the passage 74 even if a portion of the housing collapses adjacent to the bore of the attached container interior liquid passage 74 .

Adapter 68 further includes an annular flange 80 and an annular ridge 82 both spaced from and circumferentially surrounding fluid passage 74 . In particular, the ridge 82 is spaced from both the liquid passage 74 and the contoured surface 72 and preferably extends at least slightly beyond the surface 72 to further prevent the attached container shell from collapsing to the liquid passage 74 when the shell is at least partially collapsed. Up and block fluid channel 74. The ridge 82 is also preferably spaced from the annular flange 80 to provide an annular groove 84 in which a portion of the housing is received, such as described above with reference to FIGS. 3 to 5 . This housing arrangement may also include adhesives or other types of adhesion to secure the housing to the adapter 68 .

FIG. 15 shows another embodiment of adapter 168 that includes a main fluid passage 174 extending approximately through the center of adapter 168 . Adapter 168 further includes an annular flange 180 spaced from and circumferentially surrounding passage 174 , and an annular tube extension 190 that closely surrounds passage 174 . An additional annular ridge 182 may optionally be included in the member and located between the tube extension 190 and the flange 180 . The tube extension 190 is preferably high enough to extend beyond the end of the annular flange 180, as shown, so as to contact the tube extension 190 if the attached housing collapses. To facilitate fluid flow, tube extension 190 also preferably includes a series of perforations or openings 196 through which fluid can flow between fluid channel 174 and the attached housing. Perforations or openings 196 are preferably in direct fluid communication with main fluid passage 174 and the region immediately surrounding extension 190 , as shown. Perforations 196 may be sized and spaced about the circumference of tube extension 190 in any desired configuration to provide the desired fluid flow without tube extension forces (ie, tube extension 190 will not collapse or deform significantly).

The tube extension 190 either has an open end to allow liquid to flow directly to and from the fluid passage 174 when the collapsed housing is not resting on the end of the extension 190, or the tube extension 190 has a closed end for fluid connection with the fluid passage 174. The only way of communication is through perforation 196 . Further, when the perforation or opening is arranged along the length direction of the extension tube 190, the perforation can be of any shape and size, such as the annular perforation 196 in FIG. 15 . Depending on the configuration of the adapter, the number of perforations in a particular tube extension 190 may also vary, and the shape, location, and spacing of the perforations may vary. Tube extension 190 optionally includes a shaped member (eg, spherical, elliptical, etc.) at its end that expands into the interior region of the attached vessel shell. The shaped member can help maintain patency and minimize wear or damage to the collapsed shell resting on its surface. Whether or not such components are used, preferably the surface of the tube extension 190 is relatively smooth and free of sharp edges that would mar the surface of the housing.

Various methods can be utilized to manufacture and assemble the tube extensions of the present invention. One example is to mold the tube extension as part of its associated adapter, so that the tube extension and adapter comprise one molded component. It is also possible to mold or stamp the tube extension as a single part which is glued to the adapter in some way. The tube extension can also be overmolded onto the attached tube so that the dual tube assembly can be bonded or attached to the adapter using any suitable adhesive or bonding method. When the tube extension includes perforations, these perforations are formed during the molding process or in a secondary process after the tube has been manufactured.

While the embodiment in Figure 15 details the use of perforations in the tube extension with adapter, other embodiments of the invention may also utilize perforations to provide additional fluid flow between the housing and the flow channel. For example, element 48 in FIG. 5 may include at least one perforation or opening and an associated fluid passage in fluid communication with fluid passage 36 to provide an additional path for transferring fluid between the housing and the fluid passage.

In another aspect of the invention, as shown in FIG. 9, the shell 90 of the container may include various formations or elements 92, such as ribs or protrusions, for controlling a compliant fit between the adapter and the shell 90 in a multi-component container. improper. This configuration or element 92 may also be used to control the compliant fit of containers where the adapter is molded or formed as one piece with the housing. Preferably, the plurality of elements 92 are spaced from one another around the periphery of the housing 90 in a region generally adjacent the neck 94 of the housing 90 . However, the element 92 may instead be located at the opening of the neck 94 (i.e., the edge or end of the housing 90) or further into the inner surface of the housing 90 so that the housing 90 cannot be seen when viewed from the edge of the neck. Element 92. Such an element 92 may provide a smooth transition from the adapter or the like to the housing. That is, a gently tapered wall thickness can be provided from the adapter or the like to the housing.

Elements 92 preferably protrude from the inner walls of housing 90 toward interior space 96 of housing 90 and have at least a small spacing between adjacent elements to facilitate fluid flow even when the housing is deflated. Element 92 may be of various configurations such as cylinders or ribs of the same or different dimensions along the length of element 92 to provide the desired control over compliant fit between the housing and the adapter. In other words, element 92 may also have a tapering width or thickness along its length. Element 92 may be any configuration or surface that facilitates the transition from at least a portion of the adapter or the like to the housing 90 by providing a smooth transition between at least a portion of the adapter or the like and the housing 90, And preferably the formation or surface is shaped to provide a gradual transition from the adapter or the like. For example, elements 92 may be formed as protrusions or ridges or other outwardly extending features or the like. Preferably, element 92 is formed in a spherical or elliptical or generally smooth curved configuration to allow free flow of liquid while minimizing frictional resistance.

When a plurality of elements 92 are spaced around one another, as described above, the elements 92 may be spaced at any desired distance, and often the spacing and number of elements are considered in the design to achieve particular flow characteristics. For example, in a preferred arrangement the pitch of the elements may be equal to or less than the width of each element. Additionally, member 92 preferably extends longitudinally along neck 94 of housing 90 and may extend beyond neck 92 into the base of housing 90 .

Figure 10 illustrates another embodiment of a container that includes features that can help control (eg, by shrinking) a compliant fit. The container 86 in this figure includes a plurality of spaced apart indented areas 87 forming protrusions on the inner surface of the neck of the container. The indented area 87 is located near the transition between the neck and the body of the housing. As shown in FIG. 10, the indented area 87 is generally square; however, the area 87 can be changed into various shapes and sizes, such as a generally rectangular shape, a curved shape, or any other material that can flex differently under an applied load. and/or material thickness to provide the desired compliant fit without proper control over the shape. These components are preferably selected to facilitate opening of passage fluid passages. The indentation areas 87 can also be longer than shown so that they extend further above the shell and/or neck area of the container, or can be shorter so that they do not extend beyond the shell and/or neck area of the container superior. The indented area 87 may be more or less recessed into the neck of the container, depending on the desired properties of the area. Further, these indented areas may be used alone or in conjunction with any other design features of the invention described herein.

In another aspect of the invention, a lubricious reinforcing coating such as a parylene coating or the like may be applied to at least a portion of the inner surface of the container, such as described for dildo components in U.S. Pat. U.S. 6,558,315 (Kuyava) and U.S. Published Applications U.S. No. 2003/0220540 (Kuyava), 2003/0220540 (Kuyava), both of which are commonly owned by the assignee of the present invention. Another example of the use of parylene coatings for artificial sphincters is further described, for example, in U.S. Patent Application Publication No. 2003/0028076 (Kuyava et al.) 2003/0028076 (Kuyava et al.), which is also commonly owned by the assignee of the present invention. The parylene coating can be applied using conventional known techniques such as vapor deposition or the like. This slip enhancement coating can improve the friction characteristics of the inner surface of the container and the durability of the container. The reliability of the container can be improved by controlling the effects of friction on the inner surface of the container, which occurs during expansion and contraction of the container.

In another aspect of the invention, at least some components of the penile implant device may be coated with an antimicrobial agent on their outer surfaces, including the cylinder, pump and/or container. Examples of antimicrobial coatings applied to implantable medical devices have been described, for example, in U.S. Patent No. 6,534,112 (Bouchier et al.) 6,534,112 (Bouchier et al.) and U.S. Patent Application Publication No. /0040500 (Bouchier et al.), 2004/0040500 (Bouchier et al.), both of which are commonly owned by the assignee of the present invention.

FIG. 11 illustrates another embodiment of a container 118 according to the present invention, which may be used with the same type of implantable device as described above, such as a three-piece dildo device shown in FIG. 1 . As shown, container 118 includes a base or housing 126 having an interior space 128 , an opening 132 at one end of housing 126 , and a lid 130 arranged to close or seal opening 132 within housing 126 . Container 118 further includes a sleeve portion or adapter 134 extending from housing 126 . Tube 124 extends from sleeve portion 134 in this embodiment; however, it is possible that sleeve portion 134 is instead fluidly connected to other components or devices without utilizing a tube such as tube 124 . Where tube 124 is used, tube 124 preferably includes an internal fluid passageway 136 extending along its length through which liquid may reciprocate within interior volume 128 of housing 126 . Container 118 further includes a support structure 138 within interior space 128 of housing 126 . As shown in FIG. 11 , sleeve portion 134 is connected to tube 124 to define a fluid passage 136 for fluid to flow to and from interior space 128 of base 126 . Liquid may move from interior space 128 to other components to which tube 124 is attached through liquid channel 136 . For example, referring to the typical device in FIG. 1 , the container may provide fluid through tube 24 to pump 16 which may then transfer the fluid to and from the cylinders 12 and 14 of the penis. Preferably, tube 124 in FIG. 11 is a separate component that is sealed to sleeve portion 134 during the molding process described below. However, tube 124 may be molded as part of housing 126 or fused or bonded to sleeve portion 134 using suitable techniques.

FIG. 12 illustrates a perspective view of one embodiment of a cover 130 , and FIG. 13 illustrates a cross-sectional view of the cover 130 . As described below, since molding the container 118 of this embodiment creates the opening 132 of the housing 126, the process includes removing the mold using the opening 132 after the container 118 has been formed. To seal the opening 132 and make the housing 126 a closed volume, the opening 132 may be completely covered with a cover 130, for example with a suitable adhesive or the like, so as to provide a liquid tight seal. For example, medical silicone glue or the like can be used. As shown, the cover 130 preferably includes a curved outer surface 150 that generally matches the curve of the housing 126 so that the surface 150 substantially renders the housing 126 a continuous, smooth member. In addition, the cover 130 also preferably has an insertable portion 152 having a diameter smaller than the diameter of the curved surface 150 , the insertable portion 152 having a diameter approximately the same as the diameter of the opening 132 of the housing 126 .

In a preferred embodiment of the invention, the container 118 (and in particular the interior space 128 of the housing 126 ) includes a support structure disposed adjacent the exit region or aperture 127 of the housing 126 . In particular, the support structure 138 is preferably disposed generally opposite the opening 132 of the housing 126 and the cover 130 . During use, liquid within container 118 may be transferred from its interior space 128 to fill the inflatable cylinder of the prosthesis. As the liquid exits the housing 126, the container 118 empties as the flexible wall of the housing containing the transferred liquid collapses.

Due to the flexible material of the shell 126 and the various pressures applied to the outside of the shell 126 from the user's body organs, liquid, etc., together with the liquid pressure in the system that produces a negative pressure tendency in the container 118 when the liquid is transferred from the internal space 128 It's time to shrink. When the shell 126 of the container 118 collapses on itself, the inner surface of the shell 126 preferably partially or completely uncovers the outlet 127 and does not impede the flow of liquid through the outlet 127 . A support structure according to the invention is therefore used to prevent clogging of the hole 127 and preferably the support structure is a member which prevents the inner surface of the housing 126 from covering the outlet 127 during use. The specific form and shape of the support structure may include various configurations such as a number of elements or protrusions of the same or different shapes and sizes arranged around the outlet 137 . The elements may be relatively circular or oval or shaped in cross-section, of equal or different size, or of irregular shape.

Referring to FIGS. 11 and 14 , a specific embodiment of the support structure 138 includes a plurality of elements 140 extending from a base 142 of the housing 126 of the container 118 . Element 140 is arranged within interior space 128 of housing 126 . Referring specifically to FIG. 14 , a plurality of elements 140 are arranged around aperture 127 , preferably with at least a small spacing or gap between adjacent elements 140 . In this embodiment, the support structure 138 specifically includes four cylindrical protrusions 146 having a generally circular cross-section when extending away from the base 142 . The support structure 138 of this embodiment also includes four elements 148 that have a different cross-sectional shape than the elements 146 . As shown, element 148 has a width approximately equal to the diameter of element 146 and a length greater than the radius of element 146 . Elements 146 and 148 alternate with each other around aperture 127 so that there is a gap between each adjacent element 146 and 148 . The staggered adjacent elements of different cross-sectional shape are preferably selected and designed to prevent or minimize elements 146 and 148 from squeezing together or from each other to block or inhibit the flow of liquid through aperture 127 .

In use, a support structure, such as the illustrated support structure 138, may be used to prevent the aperture 127 from being blocked by portions of the housing 126 as liquid moves from the container 118 to the dildo and the housing 126 itself collapses. or off. Of the type described here without a support structure, the manner in which the housing (such as housing 126) collapses or folds is generally unpredictable so that any portion of housing 126 can collapse onto aperture 127 and thereby restrict or block fluid flow. via passage 136 . A support structure according to the present invention can prevent this flow problem because the housing 126 can be supported or held away from the aperture 127 by the support structure (eg, protrusions 146 and 148 ) when the housing 126 collapses. Liquid is thus able to flow through aperture 137 between elements 146 and 148 .

The typical container 118 shown in Figures 11 and 14, housing 126, sleeve 134, and support structure 138 are preferably formed as a unitary structure (i.e., a one-piece structure); The manner in which the attached individual parts are arranged. In any case, the tube 124 of the present embodiment is preferably formed as a separate component attached to the sleeve 134 as described below. As noted above, cover 130 is also formed as a separate member attached to housing 126 when desired.

When housing 126, sleeve 134, and support structure 138 are formed from a single piece, the construction may be formed by injection molding. Methods of injection molding may include the use of a flowable material (eg, thermoplastic or thermoset), such as a polymeric material, and a mold. The flowing material is placed at the desired temperature (for example, by heating) and injected into the cavity to make a molded component (here, a liquid container). The mold is then opened and, optionally after cooling, the molded assembly can be removed from the mold and optionally cured. In particularly preferred embodiments, the container may be manufactured by injection molding, wherein the container includes a housing, a sleeve, and support structure. The container may be molded to attach to a tube at the outlet of the container housing. That is, by the preferred injection molding process, an extension tube, such as tube 124, can be attached to the container during injection molding of the container. To achieve this, the tube can be arranged on the mandrel of the mould. Also included is a relatively spherical, integral molding mandrel that is a formwork for the interior of the container. The outer portion of the mold defining the outer surface of the container is placed around the mandrel so as to thereby create a cavity of the same size and shape as the liquid container (including sleeve and support means). The entire mold is then brought to processing temperature and a predetermined amount of the desired material is injected into the mold over the tube and spherical casting core to fill the cavity. After a preset time, the mold is opened and the container with the attached tube is removed from the mold, the sleeve thus being molded around the outer diameter of the tube when the sleeve base of the container is formed.

A container made of flexible material can be removed from the surrounding mandrel after the flexible material has cooled or solidified as required. The container can be removed from the mandrel by stretching the container material surrounding the mandrel. Alternatively, water, soap, air, or a combination of these, can be used to separate the inner surface of the container from the mandrel. A particularly convenient and effective way of introducing water, soap, and air into the space between the mandrel and the interior of the vessel is to inject any one or more of them through a tube connected to the vessel.

For example, the container can be fabricated from liquid silicone. The molding temperature ranged from 250°F (121°C) to 275°F (135°C). In addition, the molding time is about 2.5 minutes. Alternatively, the container may be fabricated from any other available material, flexible medical or industrial material that is biologically non-hazardous and non-reactive to swelling fluid contained in the container. The material can be thermoset or thermoplastic. Specific examples of materials that may be used include thermoset silicone rubber (eg, polydimethylsiloxane), thermoset or thermoplastic urethane, C-flex, santoprene thermoplastic, and the like.

The invention has been described with reference to several embodiments. The entire disclosure of any patent or patent application mentioned herein is hereby incorporated by reference. The above detailed description and examples are only for a clear understanding of the present invention. No limitation of any kind is to be understood therefrom. Many modifications will be apparent to those skilled in the art from the described embodiments which can be made without departing from the scope of the invention. Accordingly, the scope of the present invention shall not be limited to the constructions described herein, but only by the constructions described by the terms of the claims and those constructions equivalent thereto.

Claims (29)

1. A liquid container for a penile prosthetic device, the container comprising: a housing comprising an inner surface surrounding an internal fluid storage region and a neck opening; an adapter extending from said neck opening of said housing, said adapter comprising a base, a bore and an annular flange extending from said base and radially spaced from said bore; a support structure extending from said base of said adapter to said internal fluid storage region, wherein said support structure is in contact with said inner portion of said housing when said housing is in an at least partially inflated state The surfaces are spaced apart, and the support structure is adapted to prevent the housing from blocking liquid flow through the aperture. 2. The liquid container of claim 1, wherein said adapter is integrally molded with said housing as a single part. 3. The liquid container of claim 2, wherein the adapter and the housing are injection molded. 4. The liquid container of claim 1, wherein the adapter is bonded to the housing. 5. A liquid container for a dildo device, said liquid container comprising A housing comprising an inner surface surrounding an internal liquid storage area and a neck opening, wherein the housing includes a flexible wall portion extending from the neck opening, and includes a mold spaced apart from the neck opening. molding opening, and a cover positioned to cover said molding opening; an adapter extending from said neck opening of said housing, said adapter comprising a base and an aperture; a support structure extending from said base of said adapter to said internal fluid storage region, wherein said support structure is spaced from said inner surface of said housing when said housing is in an at least partially expanded state and the support structure is adapted to prevent the housing from blocking liquid flow through the aperture. 6. The liquid container of claim 5, wherein the lid is bonded to the molded opening. 7. The liquid container of claim 1, wherein the housing is injection molded. 8. The liquid container of claim 1, wherein said support structure includes a plurality of elements extending from said base to said internal liquid storage area. 9. The liquid container of claim 8, wherein each of the plurality of elements has the same structure as each of the other elements extending from the base. 10. The liquid container of claim 8, wherein at least one of the plurality of elements comprises a different configuration than at least one of the other elements extending from the base. 11. The liquid container of claim 10, wherein at least one of said plurality of elements differs in at least one of height and cross-sectional shape from at least one of the other elements extending from said base of. 12. The liquid container of claim 8, wherein at least one of said elements includes an internal liquid passage and at least one perforation in fluid communication between said internal liquid storage area and the internal liquid passage of said element . 13. The liquid container of claim 1, wherein said adapter further includes an annular gap between said annular flange and said support structure for receiving at least a portion of said housing. 14. The liquid container of claim 1, wherein said shell is bonded within said annular gap of said adapter. 15. The liquid container of claim 1, wherein said support structure further comprises a plurality of elements extending from said base into said interior liquid storage region, at least one of said plurality of elements extending from The base extends a greater distance than the annular flange. 16. The liquid container of claim 1, wherein said support structure comprises a tubular extension extending from said base, said tubular extension having an internal main liquid passageway to said bore , the tubular extension includes at least one perforation for fluid communication between the internal fluid storage region and the main fluid passage. 17. The liquid container of claim 16, wherein said tubular extension includes a closed end remote from said base. 18. The liquid container of claim 16, wherein said tubular extension includes an open end away from said base, said open end being fluidly connected to said main liquid passageway and said internal liquid storage area. connected. 19. The liquid container of claim 1, wherein said housing expands to an expanded state and contracts to a deflated state in response to liquid flow into and out of said internal liquid storage region, respectively. 20. The liquid container of claim 8, wherein each of said plurality of elements is spaced circumferentially about said aperture of said adapter from each of the other said elements. 21. A liquid container for a dildo device, said container comprising: a housing including an internal fluid storage area and a neck opening; an adapter extending from said neck opening of said housing, said adapter comprising a base, a tube extending from said base and an aperture through said base for said internal fluid communication between the liquid storage area and the tube; a support structure extending from said base of said adapter to said internal fluid storage area in the opposite direction of the tube extension from said base, wherein said support structure comprises at least one extension element when said The extension element is spaced apart from the housing when the housing is in an at least partially expanded state. 22. The liquid container of claim 21, wherein said housing, said adapter and said tube are integrally molded as a single part. 23. The liquid container of claim 21, wherein said at least one extension member comprises a plurality of members positioned circumferentially about said aperture of said adapter. 24. A method of manufacturing a liquid container for a dildo device, said method comprising the steps of: A mold is provided having a cavity, wherein the cavity defines surfaces of: a container shell having an internal liquid storage area; a sleeve extending from the housing; and a support structure extending at least partially from the sleeve into the internal fluid storage region; injecting a flowable material into the cavity of the mold; curing the material within the cavity of the mold for a predetermined period of time; and removing the cured liquid container from the mold. 25. The method of claim 24, further comprising the step of disposing an elongated tube within said cavity prior to injecting said flowable material into said cavity. 26. The method of claim 24, further comprising the step of arranging a mold mandrel within said cavity prior to injecting said flowable material into said cavity so that said mold mandrel and said mold mandrel A space is created between the cavities, the space defining a surface of the liquid container, wherein the step of injecting a flowable material includes injecting the flowable material into the space between the mold plug and the cavity middle. 27. The method of claim 26, further comprising the step of removing said molded liquid container from said mold mandrel by stretching said container around said mandrel. 28. The method of claim 27, wherein the step of removing the molded liquid container from the mold mandrel further comprises introducing a material between the molded container and the mandrel step within the space to facilitate separation of the container from the mandrel. 29. The method of claim 28, wherein said material introduced to separate said container from said mandrel comprises at least one of water, soap, and air.

Images