FR2612394A1 - FILLING ORIFICE FOR PROSTHESIS - Google Patents

Abstract

THE FILLING PORT INTENDED TO INJECT INTO A PROSTHESIS OR TO TAKE FLUID FROM A PROSTHESIS INCLUDES A FLUID FLOW MEDIA INCLUDING A FLUID PASSAGE AND A PAIR OF END PARTS. ONE OF THE END PARTS 18 INCLUDES A CLOSING MEANS 20 SHOWING A CLOSED AND AN OPEN STATE AND IS NORMALLY CLOSED SUCH AS FLUID FLOW IS ALLOWED BETWEEN THE PROSTHESIS AND THE CLOSING MEANS 20 THROUGH THIS PASSAGE 14 WHEN THE SAID PROSTHESIS IS CONNECTED TO THE MEDIUM FLUID FLOW AUDIT 10. APPLICATION TO FILLING PROSTHESES REQUIRING PERIODIC FLUID INTRODUCTIONS.

Description

2 6 1 2 3 9L

261239L

  The present invention relates to devices for the injection or sampling of fluid at predetermined locations of the body, and more particularly to a new introduction and sampling device located at the

outer surface of the skin.

  Prostheses implanted in the body to restore

  shapes and outlines that have been modified by the surgeon

  or accidentally deformed usually require the periodic introduction of fluid to maintain a suitable pressure in a pocket and to modify the

  shape or contour of the prosthesis.

  Generally, a periodic introduction program is based on factors such as the size and type of the prosthesis, the location of the prosthesis in the body and the

  time during which the prosthesis remained in place. cer-

  some prostheses require relatively frequent fluid introductions for a prescribed time, just after the initial placement. After this period of time, introductions can be made with longer time intervals. Thus, if a prosthesis normally requires fluid introductions on a quarterly or semi-annual monthly basis, it may be necessary to make weekly fluid introductions.

  for a prescribed period of time.

  Devices that facilitate the administration of

  fluid in a prosthesis, such as septa, are generally

  implanted under the skin near the prosthesis. A known septum has a small filling chamber into which the fluid is either injected or taken with a syringe. The syringe needle is directed through the skin to access the septum. The needle enters a

  septum organ likely to be penetrated by the

  guille, said member sealing the fluid chamber and preventing leakage after the needle has been

  removed from the filling chamber with a partition.

  Because the septum is subcutaneous, it is necessary to penetrate the skin in the area of the organ that can be penetrated by the needle, whenever fluid introduction into the prosthesis is desired. The penetration of the needle into the skin to access the septum is usually an operation without consequence. However, when there is a need for frequent fluid introductions, especially during the period following implantation

  of a prosthesis, a patient may experience discomfort

  penetration due to the fact that the skin is not

  completely healed where the needles enter.

  Thus, it is desirable to provide a device to facilitate fluid introductions and / or specimens

  fluid in and out of a prosthesis, which

  sitive is accessible outside the skin, to eliminate any discomfort due to frequent penetrations of needles in

a particular area of the skin.

  Among the various objects of the invention, it may be considered

  to provide a new prosthesis filling port, a new prosthesis

  is accessible without penetration into the skin, a new

  low-profile prosthesis fill, a new fill port that does not normally allow the fluid to flow unless under the influence of fluid pressure, or manual manipulation, a new

  filling port which does not allow the fluid to flow

  until communication is established with a

  guille or a cannula, and a new method of introducing fluid and sampling fluid into a prosthesis and

out of this last.

  Other objects and features of the invention will appear in part and will be partly underlined in

what follows.

261239L

  The fill port according to the present invention comprises a fluid flow member and a flow control means such as a valve member which

  is normally in the closed position, connected to one of its

  mited to the fluid flow member. The opposite end

  of the fluid flow member communicates with a

  thesis. In one embodiment of the invention, the valve member is in the open position when it comes into contact with a syringe having a needle that sinks into the valve. According to this arrangement, a communication line is established between the prosthesis and the syringe. The valve which can be a check valve, also creates leak tightness around the syringe needle when

  the communication is established between the prosthesis and the syringe.

  This embodiment of the invention can be used either for introducing fluid or for sampling

  fluid in and out of a prosthesis.

  In another embodiment, a syringe without

  needle comes into contact with the check valve of the

  fluid flow, but does not extend inside the check valve. The pressurized fluid is transferred from the syringe into the holding valve by actuating the plunger of the syringe. In this way, the fluid under

  pressure opens the check valve to create the flow line.

  from the syringe to the prosthesis for the purpose of

the introduction of fluid.

  In another embodiment of the invention, the retaining valve and the fluid flow member are made of flexible materials that can be manually deformed. The check valve can thus be manipulated to an open position and a closed position

  by crushing the fluid flow member in the area of the.

  valve. The alternative opening and closing of the valve

  restrained by such manual manipulation creates a listening

  in the opposite direction of the prosthesis

  fluid flow to a receiving pocket.

  In another embodiment of the invention, an elongated, flexible retaining valve member and a fluid flow member cooperate with a filling cannula to create a flow of fluid from a source of fluid. , to the prosthesis. The flow is established only when the filling cannula is placed in the channel portion of the check valve. In all

  embodiments of the invention, the flow organ

  fluid and / or the retaining valve member is disposed on the surface of the skin and held by sutures,

  tape or other suitable bandage means.

  The communication of a fluid source such as a syringe with the liquid flow member is accomplished outside the surface of the skin by causing the normally closed valve to open. Thus, it is not necessary to penetrate the skin or palpate the skin for an implanted septum. Since it is not necessary to penetrate the skin whenever fluid introduction or fluid sampling is required, patient discomfort

is decreased.

  Accordingly, the invention includes the constructs and methods described hereinafter, the scope of the invention being

indicated in the claims.

  In the accompanying drawings in which several embodiments of the invention are shown: FIG. 1 is a simplified perspective view of one of the embodiments of the filling orifice as used for the invention. introduction of fluid into a prosthesis; - Figure 2 is a perspective view of the latter before connection to a prosthesis; Figure 3 is an exploded view thereof; - Figure 4 is a perspective view thereof in the assembled state and including a protective sleeve; - Figure 5 is a sectional view thereof, mounted on a prosthesis; FIG. 6 is a sectional view of the latter

  that it is used to make an intro-

  fluid duction in the prosthesis; FIG. 7 is a sectional view of another embodiment thereof as used for withdrawing fluid from a prosthesis; - Figure 8 is a perspective view of a double socket mounting of the latter; FIG. 9 is an exploded view of another embodiment of the latter; - Figure 10 is a perspective view of the latter, in the assembled state, shown partially in section; - Figure 11 is a longitudinal sectional view of the latter; - Figure 12 is a schematic perspective view showing the manual manipulation of the latter; FIG. 13 is a simplified perspective view of the embodiment of FIGS. 1 to 7, connected to a prosthesis; FIG. 14 is an exploded perspective view of another embodiment of the invention; - Figure 15 is a schematic view of the latter, connected to a prosthesis; - Figure 16 is a sectional view of the latter, the protective sleeve being removed; - Figure 17 is a sectional view of the latter with a filling cannula; FIG. 18 is a sectional view of the latter with

a protective sleeve mounted.

  Corresponding reference numbers indicate the

  corresponding parts in the various views of the drawings.

  A fill port incorporating one of the embodiments of the invention is generally indicated by the

  reference numeral 10 in Figures 1 and 13.

  Referring to Figures 2, 3 and 5, the filling port 10 comprises a generally tubular fluid flow accommodating member 12 having an oblong passage 14 therein. The fluid flow accommodating member 12 is preferably flexible and may be made of a material such as a silicone elastomer. Overbeening 16 is formed at one of the end portions 18 of the fluid flow accommodating member 12. It should be noted that the

  housing 12 may also consist of a thermally

  rigid plastic in some applications of the orifice of

filling 10.

  A protective sleeve 19 (FIG. 4) which can be

  made of Dacron, is mounted around the organ 12 of

  to limit the growth of the skin along the

  housing 12 and to improve bacterial sealing.

  at the fabric / housing interface. The sleeve 19 can extend

  over the entire length of housing member 12 or on

  part of this length as shown in Figure 4.

  The thickness or gauge of the sleeve and the type of fabric or knitting is a matter of choice that depends on the size and

  the location of the fill port, and the

  filling the filling port.

  Flow control means for the filling port 10 comprises a retainer member 20 having a duckbill shaped portion 20. The retainer member 20 further includes a stem 24 and a neck 26 disposed at the end portion 18 of the fluid flow accommodating member 12 such that the collar 26

  is received in the over-bore 26. The valve member 20 rete-

  is made of a silicone elastomer, ethylene-

  polypropylene or other suitable material and it's from

  preferably molded in one piece.

  A female socket member 28 which is in contact with the retaining valve member 20 comprises an end portion 30 provided with a retaining profile which is urged inside the shank 24 of the member 20 forming a valve to form a leak tight seal. The female socket member 28 which can be molded from a suitable thermoplastic material also comprises a cylindrical portion 32 having spaced flanges 34, 36. An opening

  38 (FIG. 5) exists in part 32 of cylindrical shape.

  drique. A connector 40 which can be made of steel

  stainless steel, titanium or a suitable thermoplastic material

  nable is connected to the fluid flow housing member 12. The connector 40 is provided with end portions 42 and

  44 having a latching profile, the end portion

  Miter 42 being inserted into an opposite end portion 46 of the fluid flow accommodating member 12 in the passage 14. The snap-fitting profile 14 thus provides a leak tight connection between the connector 40 and the member 12 for accommodating fluid flow and also prevents the connector 40 from separating from the flow housing member 12

of fluid.

  By using the filling port 10 to introduce a fluid into a prosthesis 47, a conduit 48 of the prosthesis is disposed to pass through an opening 50 of the prosthesis 47.

  52, an end portion 54 of the duct 48 being

  outside the skin 52. The filling port 10

  is connected to the prosthesis 47 by inserting the end portion 44

  mité having a snap profile of the connector 40 in the end portion 54 of the conduit 48 of prosthesis. If desired, the connection between the filling port 10 and the prosthesis tube 58 can be done subcutaneously, as

shown in Figure 13.

  A fluid source, such as a syringe 56 (FIG.

  1 and 6) is connected to the filling port 10 in

  housing a male socket portion 58 of the syringe into

  the opening 38 of the female socket member 28. The cylinder

  6 of the syringe is filled in any suitable manner with the desired fluid to be introduced. Lowering the plunger 62 of the syringe forces the plunger head 64 to

  push the liquid to be introduced in the direction of the arrow.

  66. The fluid to be introduced passes from the cylinder 60 of the male socket syringe 58 into the female socket 28 to the

stem 24 of the retaining valve 20.

  The establishment of pressure in the fluid, caused by the

  movement of the plunger 62, forces the fluid to open the

  tie 22 duckbill of the check valve 20, this

  which allows the fluid to flow into the passage 14 of the

  fluid flow housing 12, in the connection 40 -

  and in the conduit 48 of the prosthesis 46.

  Because the duckbill-shaped portion 22 of the holding valve 20 is in the normally closed position, there should be no leakage of fluid from the prosthesis 46 into

  passing through the filling orifice 10.

  The check valve 20 thus plays the role of an organ

  when the filling port is not used.

  The sealing function is operational as soon as

  62 of the syringe is released to decrease the pressure

  exerted on the check valve 20.

  When the syringe 56 is not in use, it can be removed from the filling port 10 in a relatively simple manner, which only requires separation of the

  58 part forming the male sleeve of the syringe with the oouver-

  38 conical portion of the female socket 28. The duckbill-shaped portion 22 of the check valve 20 closes

  automatically and the valve end of the refill port

  pleating 10 can be provided with any cover or

  detachable lid known to be suitable until a new

  the introduction of fluid is necessary.

  If desired, a piece of tape 68 may be used to secure the fill port 10 to the skin surface 52. Alternatively, sutures or other suitable known fastening means may be used to secure the port filling 10 to the skin. Although not shown, a suitable pad may be placed between the fill port 10 and the skin surface 52 if a cushioning effect is desired. The tampon and / or cushion may be placed around the entire port of

filling 10.

  When the use of the filling orifice 10 is no longer desired, it is easily removed by detaching the connector 40 from the conduit 48. If desired, the conduit 48 may be

  subcutaneously connected to a known subcutaneous septum.

  However, during a chosen period when it is necessary

  It is also possible to introduce a fluid into the prosthesis 46 relatively frequently, causing the source of fluid to communicate with the prosthesis 46 via the filling orifice 10 without having to enter the chamber.

  52 skin, is a considerable benefit to the patient.

  Another embodiment of the filling orifice

  This is generally indicated by numeral 70 in FIG. 7. Filling port 70 includes all components of filler port 10, together with a double socket assembly 80, as shown in FIGS.

Figures 7 and 8.

  The double bushing assembly 80 comprises a male bushing piece 82 and a female bushing piece 84. The male bushing piece 82 includes a protruding needle 86 having a non-pointed end 88. The female bushing piece 84 cylindrical portion 90 having spaced flanges 92 and 94. The cylindrical portion 90

  has inside a conical opening 96 (Figure 8).

  The double socket mount 80 is connected to the female socket 28 by engaging the male socket piece 82 in

  the conical opening 38 of the cylindrical portion 32 in fact

  thus providing a tight seal against leaks. The length of the needle 86 is determined in advance so that the non-pointed end portion 88 projects into and beyond the duckbill portion 22 of the needle valve.

retained 20.

  With this arrangement, the filling orifice 70 can be used to take samples. For example, the syringe 56 is connected to the double socket mount 80 by engaging the male socket portion 58 of the syringe to form a leak tight junction. A communication

  is thus established between the filling orifice 70 and the

  ringue 56. If desired, syringe 56 and assembly 80 of double socket can be assembled beforehand and then

  connected to this female socket 28.

  The cylinder 60 of the syringe 56 is initially empty

  and the plunger 62 is fully retracted into the cylinder

  60. When the plunger 62 is pulled from the cylinder 60 of the

  syringe in the other direction, the fluid coming from the

  The thesis 46 is drawn into the conduit 48, the connector 40 and into the passage 14 of the filling orifice as indicated by the arrows 98 (FIG. 7). The withdrawn fluid is then directed into the unspotted end 88 of the needle 86 to pass

  in the cylinder 60 of the syringe 56.

  If the amount of fluid to be withdrawn from the prosthesis 46 exceeds the capacity of the cylinder 60, the syringe 56 can be

  detached from the filling orifice 70 when it is full.

  The fluid that has just been removed is then emptied from the cylinder.

  the syringe 56 is again connected to the filling port

  70. One can then continue to remove fluid from the

  prosthesis 46 as previously described.

  It is evident that putting the syringe 56 in place and removing it from the filling port 70 is a virtually painless operation in that one does not

  penetrate needles into the patient's skin.

  Another embodiment of the filling orifice

  is generally indicated by the numerical reference

  100 of FIG. 9. The filling orifice 100 comprises a fluid flow accommodating member 102 identical to the fluid flow accommodating member 12 of the filling orifice 10. A super-bearing 104 is provided. at a party 106

  end of the fluid flow housing member 102.

  An opposite fitting (not shown), similar to connector 40, connects flow chamber member 102 to

  fluid to a prosthesis (not shown) in a similar manner.

  to that described for the filling orifice 10.

  A retaining valve 108 having a duckbill flexible portion 110 and a neck portion 112 engages the end portion 106 of the dummy organ.

fluid flow housing.

  A fluid flow receiving member 114, comprising a tube 116 having a neck portion 118 having a narrowing, is connected to the member 102 of the present invention.

  fluid flow housing at its end portion 106.

  The neck-forming portion 118 having a constriction has a dimension such that it surrounds the neck 112 of the retaining valve 108 by lodging in the over-bore 104 to create a leak-tight junction between the housing member 102

  fluid flow, the restraining valve 108 and the or-

  gane 114 for receiving the fluid flow.

  Using the fill port 100, the fluid flow accommodating member 102 is manually squeezed into the vicinity of the edges 120 and 122 of the duckbill of the retainer valve 108. The portion 110 in the form of a duckbill of the holding valve 108, which is normally in the closed position, is thus placed in the open position thanks to the

  manual deformation of the housing member 102 of the

  fluid. Squeezing the fluid flow housing member 102 creates a reverse flow from the prosthesis and is easily performed using the

  thumb 124 and index 126, as shown in Figure 12.

  The fluid sucked out of the prosthesis as a result of the opening of the portion 110 of the valve 108 retaining passes

  through the filling aperture 110 into the body

  No. 114 for receiving the flow of liquid. The DISCHARGE

  The fluid flow past the member 114 may be directed to a collection device (not shown) such as a cup, bowl, or syringe. If desired, a socket

  female (not shown) can be incorporated into the

  114. When filling port 100 is not used,

  the member 114 for receiving the flow of fluid may be provided with a plug or otherwise closed

well known.

  Another embodiment of the filling orifice

  is generally indicated by the numerical reference

  130 in FIG. 14. The filling orifice 130 comprises a fluid flow member 132 connected to a

flat member 133 forming a valve.

  The fluid flow member 132 is made of a flexible material such as a silicone elastomer and includes a duckbill shaped portion 134 extending from a receiving portion 136. The receiving portion 136 comprises a bore or fluid transfer passage 137. An end portion of the fluid transfer passage 137 receives an end portion 138 having a retention profile of a connector 140 (FIGS. 16-18) which is similar to the fitting 40

  of the filling orifice 10. An opposite end comprising

  both a retaining profile (not shown) of the connector 140 is connected to an end portion 54 of a prosthesis duct 48

  which extends from the prosthesis 47.

  The valve member 133 which is made of a soft silicone elastomer, ethylene / propylene copolymer or other suitable material, includes facing sections 143 and 144 which are normally in surface-to-surface contact. An end portion 146 of the sections 142 and 144 is sandwiched between the duckbill portion 134 of the fluid flow member 132. The end portion 146 adheres inseparably or is connected

  in a leak-tight manner at the beak-shaped portion 134.

duck.

  A channel 148 (FIG. 14) delimited between the sections 142 and 144 extends from the end of the end portion 146 to an end portion 150 slightly beyond an inlet slot 152. section 142. The end portion 150 is located near an opposite end portion 154 of the

sections 142 and 144.

  Channel 148 is filled with a suitable lubricating gel.

  nable (not shown) and the portions of sections 142 and 144 surrounding the channel 148 are welded together. A protective sleeve 156, similar to the Dacron sleeve 19, is mounted around the valve member 133, as shown in Figures 15 and 18, between the beak-shaped portion 134

duck and the entrance slot 152.

  When using the filling orifice 130,

  the fluid flow member 132 and a part of the

  The fluid valve member 132 extends below the skin as shown in FIG. 15. The fluid flow member 132 is connected to the end portion 54 of the prosthesis conduit 48 through the connector 140 (FIG. 16). Part of the organ 133 forming

  predetermined valve, which extends from the end portion

  154 at a point beyond the inlet slit 152, is above the skin 162 such that the inlet slit 152 is accessible to a filling cannula (Fig. 17) which can be manufactured in a metal te than steel

  stainless steel or a thermoplastic material. The filling cannula

  pleating 158 passes into the inlet slot 152 and the channel 148 until a tip 160 of the filling cannula passes

  in or access to the fluid transfer passage 137 of the or-

132 of fluid flow.

  The movement of the filling cannula 158 to the end portion 146 or beyond thereof, of the valve member 133, has the effect of removing the duck bill portion 134 from the fluid flow member 132, as shown in FIG. 17. The filling cannula 158 is then connected to a source of fluid such as a syringe 164 in any suitable manner, allowing the prosthesis 47

to fill or empty.

  When the prosthesis 47 has been filled or emptied adequately, the filling cannula 158 is removed from the inlet slot 152, allowing the valve member 133 to move to its normal sealing position. Draining the prosthesis 47 either by opening the visible end of the filling cannula in a cup or bowl (not shown), or using the syringe 164, for example,

  to remove the desired amount of fluid.

  When the valve member 133 is in the closed position, the facing sections 142 and 144 are substantially in contact with one another. The surface-to-surface contact is further provided by the duckbill portion 134 which pushes the sandwiched portions of sections 142 and 144 facing each other against each other. The valve member 133 is thus likely to be sold in a leak-tight manner at the time the cannula is removed.

  This sealing is reinforced by the pre-

  gel within the channel 148 by the force of sections 142 and 144 facing each other and

  by the flexible nature of the valve member 133.

26 12394

  Some advantages of the present invention, obvious

  according to the foregoing description, comprise an orifice of

  filling that allows the introduction of fluid or the removal of fluid from a prosthesis without the need to feel to find an implanted septum or to penetrate a needle into the skin. A major advantage is the minimal discomfort of the patient resulting from the fact that there is no need to penetrate a hypodermic needle into the skin and

  that there is no need to create an extra subcutaneous

  to house an implanted septum. Another advantage is that any leakage from the inlet valve is evident from the moment it occurs and can be remedied.

or repair it immediately.

  In view of the foregoing, it will be appreciated that the many objects of the invention are achieved and that other advantageous results are achieved. Since various modifications can be made in the above constructions and process, without departing from the scope of the invention,

  It is understood that any subject contained in the description below

  above or that is shown in the accompanying drawings

  will be interpreted as having a sense of non-limitative

tif.

Claims (26)

  1.- Filling port for injecting into a prosthesis or withdrawing fluid from a prosthesis comprising a fluid flow means having a fluid passage and a pair of end portions, one of said end portions having means for connection to a prosthesis, the other of said end portions having a closure means having a closed state and a state   open and normally closed in such a way that the listening   fluid is permitted between said prosthesis and said closure means by said passageway when said prosthesis is connected to said fluid flow means and when said means   closure is put in the open position.   2.- Filling orifice according to claim 1,   wherein said closing means comprises a valve.   3. Filling orifice according to claim 2, wherein said valve comprises a closing part.   elasticity, the elasticity of said closure part now   Normally, said valve is in the closed state.   4.- Filling port according to any one of   1 to 3, wherein the other said end portion   said fluid flow means is flexible and deformable.   mable and in which the other said part of said listening means   fluid fluid surrounds said valve closure portion such that said fluid flow means   said valve closing portion in said closed state.   5. Filling orifice according to claim 4, wherein said valve is a flexible retaining valve in duckbill shape.   6.- Filling port according to any one of   1 to 5, comprising needle means capable of   able to be engaged with said closing means, said   means of closure being shaped in such a way that the penetration   said needle to a predetermined distance from   the interior of said closure means provides said means for closing   in the open state to allow the flow of   fluid between said prosthesis and said needle means. 2641239A4   7. A filling port according to claim 6, wherein said closure means comprises a duckbill-shaped flexible retention valve and wherein said needle has a size determined in advance to extend beyond beyond said valve in said passage for   fluid to establish communication with said prosthesis.   The fill port of claim 7, wherein said needle has a non-pointed end portion. 9.- Filling port according to any one of   Claims 1 to 8, wherein said flow means of   fluid comprises a tubular member comprising said pair   end portions and wherein a means for   tubular cord is placed at one of the end   view of the connection to said prosthesis.   10.- Filling port according to any one of   Claims 1 to 8, wherein said flow means of   fluid comprises a tubular member comprising said parts   end portions and wherein said closure means   comprises a check valve at the other said end portion   moth. 11.- Filling port according to any one of   Claims 1 to 10, further comprising means for   passing fluid through said closure means into said passage and connecting means for separably joining the fluid supply medium said closing means.   The fill port of claim 10, wherein said fluid supply means comprises means for forcing the fluid to pass into said closure means such that pressure of said fluid in said closure means sets said means closing opening position.   The fill port of claim 12, wherein said fluid supply means comprises a syringe. 14.- Filling orifice according to claim 1, comprising means producing a suction to suck the   fluid of said prosthesis through said closure means.   The fill port of claim 14, wherein said suction producing means comprises a syringe. 16.- Filling orifice according to claim 2,   wherein said valve is an elongate flexible member having   a normally closed flow channel and a means of   in said flow channel.   17. Filling port according to claim 16, comprising means for putting said flow channel   normally closed in the open state.   18.- Filling orifice according to claim 17,   wherein said means for setting said flow channel   in the open state comprises a filling cannula capable of being inserted into said inlet means and having a predetermined length to extend at least   from said input means to said passage.   19.- Filling orifice according to claim 16,   wherein said valve is substantially flat.   20.- Filling port installed on the outside of the skin for injecting and withdrawing fluid from a prosthesis   implanted under the skin, said filling opening comprises   a fluid flow means having a pair of   end portions, one of said end portions comprises   providing means for engaging said prosthesis in a leak-tight arrangement, the other said end portion comprising valve means having an open state and a closed state, said valve means being normally closed such that fluid flow is permitted between the prosthesis and said valve means   when said valve means is put in the open state.   21.- Method for injection into a prosthesis and sampling   out of a prosthesis comprising: a) placing a conduit of said prosthesis to a fluid transfer member; b) combining a normally closed valve member   with the fluid transfer member to avoid hearing   fluidly in said fluid transfer member, except when said valve member is placed in an open state; c) allowing access to the valve member from a position external to the skin; and d) causing the valve member to open from the position outside the skin to allow fluid to flow through the fluid transfer tube into the prosthesis or out of the prosthesis. 22. The method of claim 21, wherein the valve member is set in the open position by imposing a predetermined fluid pressure in advance to the valve member. 23. The process as claimed in claim 21, in which the valve member is placed in an open state by virtue of a manual manipulation.   24. The process according to claim 21, wherein   the valve member is brought into the open state by inserting needle.   25. The process according to claim 21, wherein   the valve member is brought into the open state by inserting cannulation.   The method of claim 21 including attaching the conduit to the fluid transfer tube to allow removal of the fluid transfer tube when the desire.