CN1874737A - Fluid reservoirs for penile implant devices and methods of manufacturing - Google Patents
Fluid reservoirs for penile implant devices and methods of manufacturing Download PDFInfo
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- CN1874737A CN1874737A CNA2004800318926A CN200480031892A CN1874737A CN 1874737 A CN1874737 A CN 1874737A CN A2004800318926 A CNA2004800318926 A CN A2004800318926A CN 200480031892 A CN200480031892 A CN 200480031892A CN 1874737 A CN1874737 A CN 1874737A
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- container
- housing
- liquid container
- adapter
- base portion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/26—Penis implants
Abstract
A fluid reservoir (118) for a penile implant device that includes a body portion (126) having a sleeve (134) from which a tube (124) may extend. The body portion includes support structure (138) positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage (136) of the tube. The support structure may comprise a plurality of protrusions (140) that are arranged around the orifice (127) and that extend from a base portion (142) of the body portion. The invention also relates to a method of manufacturing a fluid reservoir for a penile implant device, which includes positioning a tube in a mold and injection molding a reservoir body onto the tube. More particularly, the method may include providing a mold, positioning a tube in the mold, injecting material into the mold, curing the material, and opening the mold to remove the reservoir body and tube assembly.
Description
Technical field
The present invention is broadly directed to the surgery implanting device and makes the method for this device.More specifically, the present invention relates to reservoir that together uses with penile implant devices and the method for making this container.
Background of invention
The method of general treatment erectile dysfunction comprises the use penile implant devices.A kind of penile implant devices common is known as a kind of three-piece device, comprises a pair of expandable cylinder prosthese that is implanted within the cavernous body of penis, and this prosthese is connected to the container of a full of liquid by pump and valve module.Typically, in the scrotum of this pump and valve module implant patient, container is implanted abdominal part.Pipe is used for each penile prosthesis is connected to pump, and additional pipe is used for pump is connected to container.In order to start penile implant devices, patient typically utilize various cause liquid by pump from container transport and enter into one of method within the prosthese and come primer pump.This causes prosthese to expand and produces hardness being used for normal erection.Then, when patient wants to dwindle prosthese, in some way the valve module in the primer pump so that false intravital liquid discharge back in the container.This contraction makes penis turn back to relaxed state.
Be used for the container of these three-piece systems common be the form of flexible pouch or capsule, volume can be travelled to and fro between the motion of container along with liquid and expand and dwindle.The normally used method that is used to make these containers is the dip coating method.Dip coating comprises that the plug with the geometry of hope inserts (for example, the silicones dispersion of particular solid composition and stickiness in balanced thermoplastic or thermosets.) the spitting image of old-fashioned wax candle manufacturing, plug repeatedly is immersed within the dispersion up to the parts walls thickness that obtains to wish.At interval (for example, 15 to 20 minutes) that can be for some time between the continuous impregnating process so that allow previous material coating can fully solidify before the cycle at next continuous impregnating.Under the situation of spherical container, for example, may need 24 to 28 dipping cycles so that obtain suitable wall thickness.
After obtaining the wall thickness of wishing, can handle with additional treatment step by the container of plug coating process manufacturing, for example be placed on and be cured processing in the baking oven.Curing is an exemplary steps in the process of thermosetting plastic (for example silicones) the container body of making penile implant devices.Sometimes, the curing oven process can be carried out for a long time, for example 6 to 8 hours.After finishing solidification process, coated plug is removed and cool to room temperature from baking oven.The container that is cured is removed so that finish processing procedure from plug in the artificially then.The dip coating process time altogether from start to finish can be 24 hours or more, and cost is very high and labor intensity is very big.Dip coating process needs big relatively Production Regional in addition, especially when making many containers simultaneously.
Be used for by the material that the dipping coating method is made container also be expensive and make chronic, this has further increased the cost and the time of the implantable container of production dip coating.An example that once was used for the material of these dipping coating methods is the silicones dispersion, and this dispersion is that the two yuan platinum of a disperse in dimethylbenzene solidify dispersion so that be transformed into from isostatic liquid state from semisolid.Preparation to dispersion before being used to flood coating method will spend 24 hours or the longer time, comprises and mixing and the removal needed time of air.In order to enhance productivity, the batch of material is very big usually, and this is normally very expensive.If a part of dispersion does not have to use and must abandon after predetermined effect duration, the actual cost of dispersion further increases.
Owing to container combination is needed many parts and binding agent to the device that is used for prosthetic appliance, so the production of the implantable container of dip coating also is relative complex.As an example, through being usually used in making four parts that have of typical steeper assembly.These parts comprise the silicones housing adapter of a mould, a silicones vertical tube, a dip-coating container casing and counter-bending pipeline section.In this container assemblies, utilize suitable adhesive, for example the medical use silicone adhesive is adhered to each individual components on the adjacent parts.Whenever carry out once bonding, carry out primary air (environment) and solidify, this curing was carried out 30 minutes or longer usually at least, carried out before carrying out next bonding operation 60 minutes usually subsequently or curing oven for more time, therefore cause processing procedure slow relatively and time-consuming.Therefore wish to produce with above-mentioned dip coating and adhesive bonding method the manufacture method more cheaply and the material manufacture container assemblies of container assemblies by Billy.
Summary of the invention
The present invention relates to overcome the method and apparatus of some shortcomings of the previous reservoir that is used for penile implant devices, with relate to produce container parts method (for example, container casing) and with described parts (for example, supporting structure) be assembled into the method within the implantable prosthesis device.The invention provides the reservoir that is used for this device, this device has improved manufacturability, has improved liquid flow character, and perhaps preferably the two has both.
The present invention includes and utilize the injection molding technique manufacturing to be used for the liquid container body of penile implant devices.Injection moulding can be omitted the dip coating method and be made needed a plurality of steps of container and plenty of time.Injection moulding method especially can reduce and applies the needed time of multilayer material and also can be used for making and comprise the still less container assemblies of part in the process of dip coating method, therefore needs adhesion step still less.
Another aspect of the present invention can comprise the structure that is used for implantable container, and this structure comprises a supporting structure (for example, the form of a plurality of projections) on the contiguous base portion that exports in container.Supporting structure can prevent the container flat surface coverage outlet that causes container of contracting in the process of using.Supporting structure can be preferably incorporated in the container body of making by injection moulding method.
In one aspect, the present invention relates to be used for the liquid container of penile implant devices, this container comprises that has a telescopic base portion, and a pipe can extend from sleeve pipe.Base portion comprises the supporting structure on the inner surface in the adjacent vessel hole that is arranged in base portion, and the fluid passage of pipe is led in this hole.In a preferred embodiment, supporting structure can comprise a plurality of arrange around the hole and a plurality of projections that stretch out from the base portion of base portion.
In yet another aspect, the present invention relates to a kind of method that is used to produce the liquid container of penile implant devices, comprise the step of injection molding container main body.Preferable methods be included in arrange a pipe in the mould and with container body injection moulding to pipe.More specifically, described method comprises can provide a mould, arranges in mould and material is injected in the described mould pipe, solidifies described material and opens described mould so that remove described container body and the pipe assembly.
The invention still further relates to by providing liquid container to construct the method and apparatus of some shortcoming of the reservoir that overcomes previous penile implant devices with the device that improves fatigue resistance.The invention still further relates to the method and apparatus that the liquid container structure that comprises the flow-control structure is provided.
Another aspect of the present invention, a kind of liquid container that is used for penile implant devices comprises a housing, adapter and pipe preferably.Described housing has an annular neck portion that limits opening.Described annular cervical region cooperates so that form gradual transition between the wall from the adapter to the housing with the flange of cannelure and adapter.This transition can help to be controlled at the flexible mismate (compliance mismatch) between adapter and the housing, thereby provides the reliability of improvement for example to be used to improve fatigue resistance by the wall thickness that more gradual change is provided.Pipe preferably is attached on the adapter so that fluid passage is provided, and this fluid passage can be connected to another parts of penile implant devices.
In yet another aspect, the present invention relates to a liquid container that is used for penile implant devices, this container comprises a housing parts, adapter part and pipe preferably.Described housing comprises that a plurality of elements for example are formed on the ridge on the inner surface of described housing.Described ridge be arranged in transition region between adapter and the housing near.Thereby this ridge is by providing one to seamlessly transit the fatigue resistance that improvement can be provided between adapter and housing.
Description of drawings
Will the present invention is further described with reference to the accompanying drawings, in whole views of accompanying drawing with the same member of same numeral, wherein:
Fig. 1 is the top view of an implantable penile prosthesis devices of three-piece, and this device has a pair of penile prosthesis, a pump and a container of the present invention;
Fig. 2 is the perspective view of an embodiment of container of the present invention;
Fig. 3 is the side sectional view of the container among Fig. 2, has illustrated one to be attached to the bearing structure of adapter or housing and pipe that is attached to this adapter at the sleeve pipe place of device;
Fig. 4 is the side sectional view of the adapter part among Fig. 3, also comprises a pipe extension;
Fig. 5 is the perspective view of the adapter of Fig. 3 and 4 shown types;
Fig. 5 a is the perspective view of another embodiment of adapter of the present invention, comprises that has a supporting structure that prolongs element and the arrangement staggered than short element;
Fig. 5 b is the perspective view of another embodiment of adapter of the present invention, comprises a supporting structure with a plurality of prolongation elements;
Fig. 6 is the top view of another embodiment of adapter, and described adapter has a kind of according to c-shape element arrangements of the present invention;
Fig. 7 is the top view of another embodiment of adapter, and described adapter has another kind of according to c-shape element arrangements of the present invention;
Fig. 8 is the part cross sectional front elevation of another embodiment of adapter of the present invention, has illustrated a supporting structure that profile is arranged;
Fig. 9 is the bottom view of an embodiment of the part of container casing, has illustrated a cervical region with a plurality of annular spacer element;
Figure l0 is the perspective view of a part of an embodiment of container of the present invention, comprises that a plurality of indentures zone arranges around the neck regions of described container circlewise;
Figure 11 is the viewgraph of cross-section of another embodiment of container of the present invention, has illustrated a base portion, and this base portion has the bracing or strutting arrangement in the inner space of housing, and a cap seal closes the intravital opening of described shell and a pipe that is attached to described housing at the sleeve pipe place;
Figure 12 is the perspective view of the lid of described type, and it can be used for closing or sealing the intravital opening of shell of the container among Figure 11;
Figure 13 is the viewgraph of cross-section of Figure 12 middle cover;
Figure 14 is the viewgraph of cross-section of the container 14-14 along the line among Figure 11; With
Figure 15 is the part cross sectional front elevation of the part of another embodiment of adapter of the present invention, and this adapter has the internal tubular of a prolongation.
The specific embodiment
Referring now to accompanying drawing, wherein in whole accompanying drawings with the identical parts of same figure notation, from Fig. 1, illustrated an implantable structure of preferred surgery with penile prosthesis devices 10 of three-piece device.As shown in the figure, this device 10 generally includes according to the of the present invention first and second expandable penile cylinder 12 and 14, one pumps 16 and a container 18.First penile cylinder 12 by being connected to pump 16, the second penile cylinder 14 by being connected to pump 16 with managing 20 fluids with managing 22 fluids.Pump 16 by being connected to container 18 with managing 24 fluids.Typically, in the scrotum of the spongy body of cylinder 12 and 14 surgery ground implantable peniles zone and pump 16 implant patients, in the abdominal part of container 18 common implant patients.In use, patient can be with some mode primer pump 16 (for example, extrusion pump 16 is opened valve in a particular manner) thereby so that is transmitted the full penile cylinder 12 of liquid and 14 and erection is provided from container 18.Same, thus patient can primer pump 16 makes liquid turn back to container 18 and therefore dwindles penile cylinder 12 and 14 and make cylinder recover to contract flat state.The structure of a variety of penile prosthesis devices can utilize container 18 types described herein, still, and the canonical system of the use container 18 of device 10 intention signals among Fig. 1.For example, can use many dissimilar pumps structure, for example those need few artificial manipulation to transmit liquid between container and cylinder, and perhaps those require the user to repeat the extrusion pump body to be used for fluid transfer within penile prosthesis devices or system.In addition, more many than the number of components in the three-piece device or device still less also can utilize container of the present invention.
Fig. 2 and 3 has illustrated an embodiment of container 18 of the present invention, this container to generally include one to have the housing 26 of inner space 28 and the adapter 34 that extends from housing 26.Pipe 24 among the figure extends from adapter 34, is not to extend from container 18 to be used for unique equipment that fluid is communicated with between adjacent device of container 18 and other or parts though manage 24.For example, can be directly connected to the additional or different adapters or the equipment of 34 1 ends of adapter.In this case, any pipe of use selectively is connected to this device at other away from housing 26 and adapter 34 parts.Under the situation of using this pipe 24, pipe 24 preferably includes an interior fluid passage 36, and this fluid passage extends along its length, and liquid can be travelled to and fro between housing 26 by this passage and transmit.Preferably, pipe 24 is separate parts that are sealed to adapter 34 in mould processing procedure as described below.But pipe 24 can be used as a part of mould of adapter 34 or with other suitable technological incorporation or be adhered on the sleeve pipe 25 of adapter 34.
Further, adapter 34 can comprise annular lip 40 and and the housing 26 isolated sleeve pipes 25 of a contiguous housing 26, and pipe 24 can be attached to adapter 34 at sleeve pipe 25 places.Adapter 34 preferably includes an opening 27 in abutting connection with fluid passage 36, and this opening 27 is configured to provide fluid connection between the interior zone of pipe 24 and annular lip 40.Therefore, preferably, the shape of opening 27 and size are identical with fluid passage 36 to transmit and do not have fluid seepage and further allow liquid to flow out from the inner space 28 of housing 26 by fluid passage 36 and flow to be attached with to manage other parts of 24 between parts in the inner space 28 that allows liquid to travel to and fro between housing 26 by fluid passage 36.For example, with reference to exemplary device 10 shown in Figure 1, container 18 can by manage 24 to pump 16 provide liquid and pump can be subsequently to penile cylinder 12 and 14 toward the ground return fluid transfers.
In addition with reference to Figure 4 and 5, shown adapter 34 does not have the housing 26 that links to each other so that illustrate the feature of adapter better.As shown in the figure, adapter 34 comprises base portion 38 and annular lip 40.Preferably, the diameter of annular lip 40 increases to the end of flange 40 from the open region 27 in the adapter 34.Base portion 38 also comprises an annular groove 42, and this annular groove to small part is limited by flange 40 and base portion 38, as shown in the figure.That is, base portion 38 provides the inner surface of groove 42 usually, and the inner surface 46 of flange 40 provides the outer surface of groove 42, and the outer surface of groove and base portion 38 keep at a certain distance away, and this distance is the width of the annular groove 42 of expectation.The width of groove 42 is preferably designed so that the free margins of energy receiving vessel assembly housing.Referring again to Fig. 3, housing 26 preferably includes an annular neck portion 44 that is coupled within the annular groove 42.When housing 26 is positioned so that its cervical region 44 when being positioned within the groove 42, the inner surface 46 of flange 40 preferably contacts with the outer surface of housing 26.Therefore, flange 40 preferably enough pliable and tough can be roughly expand with the flat state that contracts under all the profile with housing 26 is consistent.Further, in the time of within cervical region 44 is located at groove 42, the inner surface 46 of flange 40 can adhere at cervical region 44 places or other modes are adhered to the outer surface of housing 26.In addition or selectively, the outer surface of base portion 38 can be adhered to the inner surface of annular cervical region 44 so that housing 26 is fixed on the adapter 34.In addition, the inner surface 46 of flange 40 also can adhere to the part that surpasses cervical region 44 of housing 26, and for example the diameter of housing 26 increases there, and surpasses cervical region 44 and be positioned at zone within the annular flange 40.The thickness that can be contemplated that cervical region can change and/or the width of annular opening can change along its length direction.Can use any medical use adhesive or analog to be applied to any part of container parts bonded to each other.
Referring again to Fig. 3 and 4, when flange 40 outwards extends away from base portion 38, the thickness of flange 40 diminishes gradually so that be the thickest at the regional inward flange 40 of the most close base portion 38, is less thickness when the thickness of flange 40 when extending away from base portion 38 diminishes gradually then.Preferably, flange 40 diminishes gradually in distance base portion 38 position farthest and is tip or small size (that is the end of flange 40).By utilizing such tapered flanges 40, as shown in the figure, can provide one to seamlessly transit to the transition position of housing 26 at the base portion 38 of adapter 34.Perhaps, annular flange 40 can be than shown in Figure 3 further expanding outwardly or launching.Therefore in this case, the cervical region of housing preferably is designed to closely cooperate with the annular lip of adapter and annular opening and need not to apply more pressure on flange and/or container casing.
When the penile prosthesis devices that uses container 18 of the present invention was implanted user, housing 26 can repeatedly contract flat and expand.In the process of shrinking, housing 26 self inwardly contracts flat and cervical region 44 places bending (also other position of the housing 26).This repeated flex can cause fatigue at cervical region 44 places, and it can cause wall attenuation and final fracture (for example, seepage) gradually between flange 40 and housing 26.Therefore, expectation is set to provide at cervical region 44 places additional support that seamlessly transitting from the base portion 38 of adapter 34 to housing 26 also is provided simultaneously flange 40, and makes the area of stress concentration minimum.In other words, in base portion 38 vicinity of adapter 34, cervical region 44 preferably sealeds or be attached on the flange 40.Therefore the whole wall thickness near base portion 38 regional is the wall thickness that the thickness of flange 40 adds cervical region 44.But because the minimizing of thickness of flange, the combination thickness of the wall of flange 40 and cervical region 44 is in base portion 38 places minimizing further away from each other.Therefore, when flange 40 when its end or edge diminish gradually, combination thickness reduces or carries out the transition to the wall thickness of housing 26 gradually.The reliability that this has reduced the submissive mismate between adapter 34 and the housing 26 and can improve container 18.Usually, submissive mismate is meant in the flexibility of transition or the change aspect the compliance, for example suddenlys change to thin part from thickness portion.At such sharp transition place, the pressure concentrated area can produce too early fatigue and might rupture.Therefore the present invention provides a level and smooth and gradual transition a part or the approaching of major part and housing or container of adapter between the part.
Referring again to Figure 4 and 5, adapter 34 preferably includes supporting structure 47, and it comprises a plurality of elements 48.Element 48 is positioned at the inner space 50 of base portion 38.In a preferred embodiment, element 48 around the opening 27 of fluid course 36 along circumferential array.Preferably when extending away from the direction of opening 27, element 48 has the roughly shape of cylinder; But element 48 can be the rule or the erose structure of any amount.In specific adapter 34, the shape of each in a plurality of elements 48 is consistent each other with size, perhaps can use with other the different size, shape of adjacent elements 48 and/or the element of height to replace.
Container casing of the present invention is illustrated as usually to have globular, avette or oval in shape.But, housing can change more irregular or asymmetrical shape into or can comprise the housing with another structure, for example more cylindrical, kidney shape, disc or be shaped (having suitable size and material) so that housing can expand or " filling " accepts the liquid of desired amt with additive method.Hull shape also can be along with liquid is discharged from the container and shrinkage or " it is flat to contract ".With the housing of selected Any shape, relevant adapter should be designed to part or the as a whole structure of mold housing adapter that the energy housing case is attached to adapter.For example, flange portion needs either large or small taper to seamlessly transit so that provide one between housing and adapter.Adapter can or cannot comprise annular opening, the part of in this annular opening, arranging and adhering to housing, and the miscellaneous part of housing and adapter can be designed to make an energy according to the present invention to expand and contract flat housing and adapter.
Because when liquid during from container transport, the device of use container of the present invention is the closing liquid system preferably, therefore housing self will contract flat when penile cylinder fills.Housing is housing 26 for example, and the flat or folding mode that contracts is normally unpredictable, so any part of housing 26 can contract flat towards opening or hole 27 and therefore restriction or block liquid flow through passage 36 and do not need other structure or member.In use, when liquid is flowing to penile cylinder and housing 26 is contracted when flat from container 18 under the effect of for example pump, therefore element 48 can be used to prevent that opening 27 is by some partial blockage of housing 26.Element 48 can prevent this flow field problem and obstruction, because contract when flat when housing 26, one or more elements 48 will keep housing 26 and opening 27 spaced apart, therefore stop mobile obstruction.Therefore, between element 48, preferably has at least one little spacing so that allow enough liquid stream.Similarly, even the part of housing is arranged on the element 48, liquid also can flow between at interval the element 48 at a certain distance.Further, element can be complete isolating element, and it stretches out from body region respectively, perhaps can at least some appurtenances between adjacent elements along the short transverse mold or the shaping of element.Can use with the present patent application accompanying drawing in different volume control device or the bracing or strutting arrangement or the members of device of concrete signal.
Fig. 5 a has illustrated another embodiment of adapter 34a, this adapter together uses so that form a container assemblies with the housing that can be attached on it, adapter 34a comprises base portion 38a, annular lip 40a and the supporting structure 47a that roughly extends from base portion 38a.Supporting structure 47a comprises a plurality of element 48a that are positioned at the inner space of base portion 38a.In a preferred embodiment, the opening of element 48a surrounding tube 24a is along circumferential array, and pipe 24a extends from base portion 38a.As shown in the figure, this embodiment comprises eight element 48a of total, and wherein four element 48a have same height, and the height of all the other four element 48a of this aspect ratio is higher, and these all the other four element 48a also have same height.In this embodiment, in fact four element 48a with high height extend beyond the end of annular lip 40a, and all the other four element 48a do not extend beyond the end of flange 40a.As shown in the figure, the element 48a with high height is different with the shape of element that those have lower height; But the combination of the shape of any amount and height is contemplated within the scope of the present invention.For example, in the embodiment shown in Fig. 5 a, all element 48a also can have identical cross section, and perhaps each element 48a can have the different cross section with each other element 48a.In addition, if necessary, given adapter can have the element more than two kinds of height.In addition, as described here with respect to other embodiments of the invention, select the quantity, structure of adapter element, highly, and during other feature, the mobile obstruction of housing of preferably selecting to stop or to make liquid to be travelled to and fro between and adhering to minimizes and especially prevents that the housing that adheres to from contracting flat and the block liquid opening.
Fig. 5 b has illustrated another embodiment of adapter 34b of the present invention.This adapter 34b comprises a plurality of element 48b that extend from main part 38b, and all element 48b extend beyond the end of flange 40b.In this case, have the staggered element 48b of different cross sections to be centered around the periphery of base portion 38b, thereby the element 48b of half is a circular cross section, second half element 48b is avette or oval cross section.But element 48b that might be all is that same shape of cross section or element 48b group comprises more than two kinds of difform elements.
Fig. 6 has illustrated the top view of another embodiment of adapter 60 of the present invention.This adapter 60 comprises a plurality of c-shape elements 62 of the element 48 that can replace in the Figure 4 and 5.Element 62 is arranged advantageously being that liquid is provided between the two elements and mobile passage within the c-of element self shape part in the face of the mode of the opening portion of another adjacent elements 62 with the opening portion of each c-shape.Fig. 7 has illustrated another embodiment of adapter 64.This adapter 64 comprises a plurality of c-shape elements 66, and this element 66 is arranged in the mode at all centers of facing adapter 64.Equally, these elements 66 preferably think liquid between the independent element 66 and within flow and to provide the mode of passage to arrange.
In addition, Fig. 8 has illustrated the cutaway view of another embodiment of adapter 68 of the present invention.This adapter 68 comprises that one has around the net grain surface of fluid passage 74 or the supporting structure 70 of molded surface 72.Surface 72 molded surfaces that can only comprise as shown in the figure, perhaps can comprise other the profile of type or for example fan-shaped, the ridge of structure, button, projection, flange, groove and/or other can keep or support the supporting structure away from fluid passage 74 openings of the part of housing wall at least.In this way, flat even the part of housing contracts near the hole of the internal tank fluid passage 74 that adheres to, surface 72 also can allow liquid to pass through passage 74 to flow.
Adapter 68 further comprises an annular lip 80 and an annular ridge 82, the two all with fluid passage 74 spaced apart and along circumferential hoop around fluid passage 74.Particularly, spine 82 is with fluid passage 74 and molded surface 72 is all spaced apart and preferably extend beyond surface 72 at least a little, and contracting at least in part with convenient housing, further to stop when flat the container casing that adheres to contract flat to fluid passage 74 and block liquid passage 74.Spine 82 is also preferably spaced apart so that a ring-shaped groove 84 is provided with annular lip 80, the part of housing case in this ring-shaped groove 84, for example top description with reference to Fig. 3 to 5.This housing arrange can also comprise bonding or other the adhesion mode of type so that housing is fixed to adapter 68.
Figure 15 illustrates another embodiment of adapter 168, comprises a main fluid path 174, and it roughly extends through the center of adapter 168.Adapter 168 further comprises an annular lip 180, this flange 180 and path 174 spaced apart and along circumferential hoop around path 174 and a ring pipe extension 190, it is closely around path 174.Additional annular ridge 182 can also selectablely be included among this member and between pipe extension 190 and flange 180.Pipe extension 190 preferably enough height so that extend across the end of annular lip 180, as shown in the figure, if, can contact deferent extension 190 so that the housing that adheres to contracts when flat.In order to promote liquid flow, pipe extension 190 also preferably includes a series of perforation or opening 196, can flow between fluid passage 174 and the housing that adheres to by this perforation or opening 196 liquid.Perforation or opening 196 preferably directly are communicated with main fluid path 174 and the regional fluid that centers on extension 190 with being right after, as shown in the figure.Perforation 196 structures that can wish arbitrarily are provided with size and interval around the periphery of pipe extension 190, thereby the liquid stream that does not have the pipe stretching force (that is, pipe extension 190 will can not be contracted flat or distortion significantly) of hope is provided.
Can utilize the whole bag of tricks manufacturing and assemble pipe of the present invention extension.An example is that the pipe extension is molded as the part of relative adapter, so that pipe extension and adapter comprise an assembly that is molded as.Also can with the pipe extension be molded as or strike out a separate part, with some mode with this adhering components to adapter.Also can the pipe extension is Overmolded to the pipe that adheres to, so that can utilize arbitrarily suitable binding or adhesive bonding method that this two-tube assembly is bonding or be attached on the adapter.When the pipe extension comprises when perforation, these perforation in the process of mold treatment, form or the secondary operations after pipe manufacturer is come out in form.
Embodiment among Figure 15 has described the use of the perforation of the pipe extension with adapter in detail, and other embodiments of the invention can utilize perforation that extra liquid flow is provided between housing and fluid course equally.For example, the element 48 among Fig. 5 can comprise at least one perforation or an opening and a relevant fluid path, and this relevant fluid path is communicated with fluid path 36 fluids to provide additional path to be used for transmitting liquid between housing and fluid path.
Another aspect of the present invention, as shown in Figure 9, the housing 90 of container can comprise multiple structure or element 92, for example rib or projection are used for the submissive mismate of control between the adapter of multi-assembly container and housing 90.It is molded or be configured as the submissive mismate of the container of one that this structure or element 92 also can be used to control adapter and housing.Preferably, a plurality of elements 92 periphery around housing 90 in the zone of the cervical region 94 that roughly is close to housing 90 is spaced apart from each other.But element 92 can change in opening part (that is, the edge of housing 90 or end) that is positioned at cervical region 94 or the inner surface that further enters into housing 90 so that can not see element 92 when observing housing 90 from the edge of cervical region.This element 92 can seamlessly transit to providing between the housing at adapter or analog.That is, can provide a mild tapered wall thickness to housing from adapter or analog.
Even element 92 is preferably outstanding and have at least one little spacing between the adjacent elements so that also can promote liquid flow when housing contracts when flat towards the inner space 96 of housing 90 from the inwall of housing 90.Element 92 can be various structures so that desirable control to submissive mismate is provided between housing and adapter, and this structure for example is cylinder or the rib that same or different sizes are arranged along the length direction of element 92.In other words, element 92 also can have width or the thickness that reduces gradually at length direction.Element 92 can be to construct arbitrarily or the surface, thereby this structure or surface by between at least a portion of adapter or analog and housing 90, provide seamlessly transit help from least a portion of adapter or analog carry out the transition to housing 90 and preferably should construct or shaping surface for providing gradual transition from adapter or analog.For example, element 92 can form outward extending parts of projection or ridge or other or analog.Preferably, element 92 form sphere or oval or roughly the smoothed curve structure so that allow liquid free-flow to make the frictional resistance minimum simultaneously.
When a plurality of element 92 each intervals around the time, as mentioned above, element 92 can be with the distance of any hope at interval, the interval of usually considering this element in design simultaneously and quantity are to obtain specific flow behavior.For example, in preferred a layout, the spacing of element can be equal to or less than the width of each element.In addition, element 92 is preferably along cervical region 94 longitudinal extensions of housing 90 with can extend beyond within the base portion that cervical region 92 enters into housing 90.
Figure 10 has illustrated another embodiment of container to comprise can to help the parts of control (for example by dwindling) submissive mismate.Container 86 comprises the indenture zone 87 of a plurality of each intervals among this figure, and this indenture zone 87 forms projection on the inner surface of the cervical region of container.Indenture zone 87 is near the transition region between the main body of cervical region and housing.As shown in figure 10, indenture zone 87 is roughly square; But, the zone 87 can change different shape and size into, for example roughly rectangular shape, curve shape or other can have the shape that desirable submissive mismate control is provided between different flexible materials and/or the material thickness when applied load arbitrarily.Preferably select to promote open these parts by the fluid passage.Indenture zone 87 also can be longer so that they further extend on the housing and/or neck regions of container than what illustrated, perhaps can be shorter so that they do not extend on the housing and/or neck regions of container.Indenture zone 87 is the cervical region of recessed container more or less, and this depends on the desirable character in this zone.Further, these indenture zones can be used separately or be used jointly with any other design part of the present invention described here.
In another aspect of the present invention, slick reinforcement coating for example parylene coating or analog can be applied at least a portion of inner surface of container, the for example description of relevant penile prosthesis parts, at United States Patent (USP) U.S.6,558,315 (Kuyava) and the U.S. openly apply for U.S.No.2003/0220540 (Kuyava), 2003/0220540 (Kuyava), and the two is all owned together by assignee of the present invention.Further described another example that uses the parylene coating, wherein phenylene dimethyl coating is used for artificial sphincter, for example, at U.S. Patent Application Publication No.2003/0028076 (people such as Kuyava) 2003/0028076 (Kuyava et al.), it is also owned together by assignee of the present invention.Can utilize traditional known technology for example vapour deposition or similarly method apply the parylene coating.This smooth reinforcement coating can be improved the frictional behavior of inner surface of container and the ruggedness of container.Can improve the reliability of container by the friction effect on the control inner surface of container, this friction is to produce in the expansion of container and contraction process.
In another aspect of the present invention, at least some parts of penile implant devices can be coated in their outer surface with the antimicrobial antimicrobial, comprise cylinder, pump and/or container.Describe the example that is coated in the anti-microbial agent coating on the implantable medical device is existing, for example, at United States Patent (USP) U.S.No.6,534,112 (people such as Bouchier) 6,534,112 (people such as Bouchier) and U.S. Patent Application Publication No.2004/0040500 (people such as Bouchier), 2004/0040500 (people such as Bouchier), the two is all owned together by assignee of the present invention.
Figure 11 has illustrated according to the present invention another embodiment of container 118, and it can be used for the implantable device with aforesaid device same-type, a three-piece penile prosthesis devices for example shown in Figure 1.As shown in the figure, container 118 comprises base portion or the housing 126 with inner space 128, at the opening 132 and the lid 130 of housing 126 1 ends, arranges that cover 130 is used to close or opening 132 that seal casinghousing 126 is interior.Container 118 further comprises the sleeve portion or the adapter 134 that extend from housing 126.Manage 124 in this embodiment from sleeve portion 134 extensions; But might sleeve portion 134 changing unfavorable usefulness into for example manages 124 pipe fluid and is connected to other parts or device.Under the situation of using pipe 124, pipe 124 preferably includes an internal fluid channels 136 that extends along its length direction, by this channel liquid can be in the inner space 128 of housing 126 back and forth movement.Container 118 further comprises a supporting structure 138 within the inner space 128 of housing 126.As shown in figure 11, sleeve portion 134 124 is connected so that limit fluid passage 136 with pipe, and this passage is used for liquid, and to travel to and fro between the inner space 128 of base portion 126 mobile.Liquid can move to pipe 124 other parts that adhere in space 128 internally by fluid passage 136.For example, with reference to typical devices among Fig. 1, container can provide liquid to pump 16 by managing 24, and pump 16 fluid transfer is subsequently travelled to and fro between the cylinder 12 and 14 of penis.Preferably, the pipe 124 among Figure 11 is separate parts, and this pipe 124 is sealed to sleeve portion 134 in molding process as described below.But it is molded or with suitable technological incorporation or be adhered to sleeve portion 134 that pipe 124 can be used as the part of housing 126.
Figure 12 has illustrated to cover the perspective view of an embodiment of 130 and Figure 13 and has illustrated the cutaway view of this lid 130.As described below, because the container 118 of molded this embodiment has produced the opening 132 of housing 126, this technology utilizes opening 132 to remove mould after being included in and having formed container 118.For sealed open 132 with make housing 126 become closing volume, available lid 130 covers opening 132 fully, for example uses suitable adhesive or analog, so that liquid seal is provided.For example, can use medical use silicone adhesive or analog.As shown in the figure, lid 130 preferably includes an extra curvature surface 150 and roughly matches with the curve of housing 126 so that surface 150 makes housing 126 become successive, level and smooth member basically.In addition, lid 130 also preferably has an insertable part 152, and the diameter of this part 152 is littler than the diameter of curved surface 150, and the diameter of the insertable part 152 roughly diameter with the opening 132 of housing 126 is identical.
In a preferred embodiment of the invention, container 118 (with the inner space 128 of housing 126 particularly) comprises that one is arranged in the outlet area of housing 126 or near the supporting structure the hole 127.Particularly, supporting structure 138 preferably is arranged into roughly the opposite at the opening 132 and the lid 130 of housing 126.In use, the liquid in container 118 can be from its inner space 128 transmission so that fill with the expandable cylinder of prosthese.When liquid withdraws from housing 126, along with the flat container 118 of contracting of the flexible wall of the housing that holds transfer liquid becomes empty.Because the preferred flexible materials that adopt of housing 126 and be applied to housing 126 outsides at the fluid pressure of container 118 generation negative pressure trend to have caused this contract when liquid space 128 transmission internally from various pressure such as user's body organ, liquid in system flat.When the housing 126 of container 118 oneself contracts when flat, the inner surface of housing 126 is cover outlet 127 and do not hinder liquid flow by exporting 127 not partly or completely preferably.Therefore a supporting structure according to the present invention be used for preventing the obstruction in hole 127 and preferably this supporting structure be a member in the inner surface cover outlet 127 of the process prevention housing 126 that uses.The concrete form of supporting structure and shape can comprise various structures, and for example many element or projections with same or different shapes and size are arranged around outlet 137.Element can be circular relatively or oval or be shaped in cross-sectional direction to have same or different size, perhaps irregular shape.
With reference to Figure 11 and 14, a specific embodiment of supporting structure 138 comprises that a plurality of elements 140 stretch out from the base portion 142 of the housing 126 of container 118.Element 140 is arranged within the inner space 128 of housing 126.With reference to Figure 14, a plurality of element 140 wound holes 127 are arranged, and preferably have between adjacent elements 140 to when young interval or breach particularly.In this embodiment, supporting structure 138 comprises four cylindrical projections 146 particularly, and this cylindrical projections has the cross section of circular when extending away from base portion 142.The supporting structure 138 of present embodiment also comprises four elements 148, and the shape of cross section of this element 148 is different from element 146.As shown in the figure, the width of element 148 approximates the diameter of element 146 and the length radius greater than element 146. Element 146 and 148 centers on hole 127 each other and alternately arranges so that a breach is arranged between each adjacent elements 146 and 148.Thereby the staggered adjacent elements of different shape of cross sections preferably selects and is designed to prevent or to make element 146 and 148 to be extruded into together or squeeze mutually and flatly block or forbid liquid and minimize by the mobile of hole 127.
In use, a supporting structure, the supporting structure of for example being illustrated 138 can be used for self contracting and preventing that hole 127 is by some partial blockage of housing 126 or close in flat when liquid moves to penile prosthesis and housing 126 from container 118.The type that does not have supporting structure of Miao Shuing here, housing (for example housing 126) can contract flat to hole 127 and therefore restriction or the block liquid of flat or folding mode any part normally unpredictable so housing 126 that contract flows through path 136.A supporting structure according to the present invention can prevent this flow field problem, because contract when flat when housing 126, housing 126 can support or remain on the place away from hole 127 by supporting structure (for example projection 146 and 148).Therefore liquid can flow through the hole 137 between element 146 and 148.
When housing 126, when sleeve pipe 134 and supporting structure 138 were made of single-piece, this structure can form by injection mold.Injection molding method can comprise utilizes mobile material (for example, thermoplastic or thermosetting plastic), for example polymeric material and a mould.This mobile material is placed under the temperature of requirement (for example, by heating) and is injected within the cavity so that make a molded assembly (referring to a liquid container here).Open this mould then, after selectively cooling off, molded assembly can be removed from mould and selectively be cured.In particularly preferred embodiment, can make container with injection moulding method, wherein container comprises a housing, a sleeve pipe, and supporting structure.Container can be molded as in the exit of this container casing and be attached on the pipe.That is by preferred injection molding technique, one prolongs pipe, for example manages 124, can invest on the container in the process of injection molding container.For achieving this end, pipe can be arranged on the plug of mould.Also comprise spheric relatively, a block mold core bar, it is a formwork that is used for internal tank.The exterior portion that limits the mould of container outer surface is placed so that therefore produce an identical cavity of size and dimension with liquid container (comprising sleeve pipe and bracing or strutting arrangement) around core bar.Then whole mould is sent under the temperature of processing, be predetermined the requiring material to be injected within the mould to surpass pipe and spherical cast core bar of quantity then and fill with cavity.After preset time, open mould and from this mould, remove container with tube-carrier, sleeve pipe is therefore around the external diameter of this pipe and molded when the sleeve base portion of container forms.
By the container that flexible material is made, can be after cooling off as required or solidifying this flexible material from removing around core bar.The mode of the container material that can center on core bar by stretching is removed container from core bar.Selectable, water, soap, air or these combination can be used for the inner surface of container is separated with core bar.One especially convenient and effectively import water, soap and the air mode to the space between core bar and the internal tank, is to inject their any or multiple by the pipe that is connected to container.
For example, container can be by the liquid silica gel manufacturing.Molded temperature at 250 (121 ℃) within the scope of 275 (135 ℃).In addition, molding time is approximately 2.5 minutes.Perhaps, container can be by any other available material, biology inert and with the unresponsive flexible medical science of tympanites liquid or the industrial materials manufacturing that are included in the container.Material can be thermosetting plastic or thermoplastic.The object lesson of spendable material comprises thermosetting plastic silicone rubber (for example, polydimethylsiloxane), thermosetting plastic or thermoplastic urethane, and C-flex, the santoprene thermoplastic, or the like.
Invention has been described with reference to some embodiment.Any as mentioned herein patent or the whole of patent application openly are incorporated herein by reference.Above detailed explanation and example only are used for clear understanding of the present invention.Therefrom can not be interpreted as any restriction.The many changes of carrying out according to described embodiment that do not break away from the scope of the invention are conspicuous to the one skilled in the art.Therefore, scope of the present invention will be not limited to structure described here, and it is only constructed by the structure of the term description of claim and equal those and limits.
Claims (30)
1. liquid container that is used for penile prosthesis devices, this container comprises:
A housing that comprises internal liquid storage areas and neck opening;
An adapter that extends from the neck opening of described housing, described adapter comprises a base portion and a hole;
Base portion from described adapter extends to the supporting structure within the described internal liquid storage areas, it is characterized in that described supporting structure is suitable for preventing that described housing block liquid from flowing through described hole.
2. liquid container as claimed in claim 1 is characterized in that, described adapter and described housing are integrally molded as single parts.
3. liquid container as claimed in claim 2 is characterized in that, described adapter and described housing are that injection moulding forms.
4. liquid container as claimed in claim 1 is characterized in that described adapter is adhered to described housing.
5. liquid container as claimed in claim 1, it is characterized in that, described housing comprises that a flexible wall section who extends from described neck opening and described flexible wall section comprise one with the moulded openings of described neck opening maintenance certain distance with arrange that a lid is used to cover described moulded openings.
6. liquid container as claimed in claim 5 is characterized in that described lid is adhered to described moulded openings.
7. liquid container as claimed in claim 1 is characterized in that, described housing is to inject mold to form.
8. liquid container as claimed in claim 1 is characterized in that, described supporting structure comprises and a plurality ofly extends to element within the described internal liquid storage areas from described base portion.
9. liquid container as claimed in claim 8 is characterized in that, each in described a plurality of elements is all identical from the structure of other element of described base portion extension with each.
10. liquid container as claimed in claim 8 is characterized in that, the structure of at least one in described a plurality of elements is different with at least one other element that extends from described base portion.
11. liquid container as claimed in claim 10 is characterized in that, aspect at least one in height and shape of cross section of at least one in described a plurality of elements with different from least one other element of described base portion extension.
12. liquid container as claimed in claim 8 is characterized in that, at least one described element comprises an interior fluid passage and at least one perforation that fluid is communicated with between the interior fluid passage of described internal liquid storage areas and described element.
13. liquid container as claimed in claim 1 is characterized in that, described adapter further comprise one from described base portion extend and with described aperture to the spaced-apart ring-shaped flange.
14. liquid container as claimed in claim 13 is characterized in that, described adapter comprises that further an annular opening between described annular lip and described supporting structure is used to receive at least a portion of described housing.
15. liquid container as claimed in claim 14 is characterized in that, described housing is to be bonded within the annular opening of described adapter.
16. liquid container as claimed in claim 13, it is characterized in that described supporting structure comprises that further a plurality of element and described a plurality of element at least one within described base portion extends to described internal liquid storage areas extend bigger distance from described base portion and surpass described annular lip.
17. liquid container as claimed in claim 1, it is characterized in that, described supporting structure comprises a tubular extension of extending from described base portion, described tubular extension has an inside master's fluid path to described hole, and described tubular extension comprises that at least one perforation is used for that fluid is communicated with between described internal liquid storage areas and described main fluid path.
18. liquid container as claimed in claim 17 is characterized in that, described tubular extension comprises a blind end away from described base portion.
19. liquid container as claimed in claim 17 is characterized in that, described tubular extension comprises an opening away from described base portion, and described opening is communicated with described main fluid path and described internal liquid storage areas fluid.
20. liquid container as claimed in claim 1 is characterized in that, described housing flows to according to fluid and flows out described internal liquid storage areas and can expand into a swelling state respectively and be collapsible into the flat state that contracts.
21. liquid container as claimed in claim 8 is characterized in that, each in described a plurality of elements is around hole and other element annular space of described adapter.
22. a liquid container that is used for penile prosthesis devices, described container comprises:
A housing that comprises internal liquid storage areas and neck opening;
An adapter that extends from the neck opening of described housing comprises a base portion, a pipe and a hole of passing described base portion of extending from described base portion, and described hole is used for fluid connection between described internal liquid storage areas and described pipe;
One from the base portion of described adapter extending to supporting structure within the described internal liquid storage areas from the opposite direction of described base portion bearing of trend with described pipe, it is characterized in that described supporting structure comprises at least one extending element.
23. liquid container as claimed in claim 22 is characterized in that, described housing, described adapter and described pipe are that whole mold is single parts.
24. liquid container as claimed in claim 22 is characterized in that, described at least one extending element comprises a plurality of elements of arranging around the orifice ring shape of described adapter.
25. a manufacture method that is used for the liquid container of penile prosthesis devices, described method comprises step:
Provide a mould, described therein cavity defining surface with cavity:
A container casing with internal liquid storage areas;
A sleeve pipe from described housing extension; With
Extend to small part from described sleeve pipe and enter into a supporting structure within the described internal liquid storage areas;
Flowable materials is injected within the cavity of described mould;
Described material in predetermined a period of time in the cavity of the described mould of curing; With remove solidified liquid container from described mould.
26. method as claimed in claim 25 further is included in flowable materials is injected into the step of arranging a prolongation pipe before the described cavity within described die cavity.
27. method as claimed in claim 25, further comprise step: before the described fluent material of injection enters into described cavity, arranging within the described die cavity that a mold plug is so that produce the space between described mold plug and described die cavity, described space boundary the surface of described liquid container, the step of wherein said injection fluent material comprises that injecting described fluent material enters into space between described mold plug and the described die cavity.
28. method as claimed in claim 27 further comprises the step of removing the liquid container of described mold by stretching around the described container of described core bar from described mold plug.
29. method as claimed in claim 28, wherein the step of removing the liquid container of described mold from described mold plug further comprises a kind of material is imported the container of described mold and the step within the space between the described core bar, is convenient to separate described container from described core bar.
30. method as claimed in claim 29, being used for of wherein said input comprises water to described container from the isolating material of described core bar, soap and airborne at least a.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US50797403P | 2003-10-02 | 2003-10-02 | |
| US60/507,972 | 2003-10-02 | ||
| US60/507,974 | 2003-10-02 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1874737A true CN1874737A (en) | 2006-12-06 |
| CN100542503C CN100542503C (en) | 2009-09-23 |
Family
ID=37484864
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004800318926A Expired - Fee Related CN100542503C (en) | 2003-10-02 | 2004-10-01 | The reservoir and the manufacture method that are used for penile implant devices |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100542503C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105056336A (en) * | 2008-10-10 | 2015-11-18 | 米卢克斯控股股份有限公司 | Infusion of drugs |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4009711A (en) * | 1976-03-17 | 1977-03-01 | Uson Aurelio C | Penile prosthesis for the management of erectile impotence |
| US4267829A (en) * | 1979-04-11 | 1981-05-19 | American Medical Systems, Inc. | Penile prosthesis |
| US4602625A (en) * | 1983-03-04 | 1986-07-29 | Medical Engineering Corporation | Penile erectile system |
| US4566446A (en) * | 1983-04-08 | 1986-01-28 | Mentor Corporation | Penile prosthesis device |
| US5062416A (en) * | 1988-12-01 | 1991-11-05 | Stucks Albert A | Penile erection system |
| US5048511A (en) * | 1989-10-06 | 1991-09-17 | Advanced Surgical Intervention, Inc. | Method and apparatus for treating impotence |
| US5895424A (en) * | 1996-11-12 | 1999-04-20 | Mentor Corporation | Prosthesis having an alignment indicator and method of using same |
| US6558315B1 (en) * | 2000-03-15 | 2003-05-06 | Ams Research Corporation | Parylene-coated components for inflatable penile prosthesis |
-
2004
- 2004-10-01 CN CNB2004800318926A patent/CN100542503C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105056336A (en) * | 2008-10-10 | 2015-11-18 | 米卢克斯控股股份有限公司 | Infusion of drugs |
| CN105056336B (en) * | 2008-10-10 | 2019-09-13 | 医树专利有限公司 | Infusion of drug |
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| Publication number | Publication date |
|---|---|
| CN100542503C (en) | 2009-09-23 |
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