GB2151927A

GB2151927A - Inflatable implant for use in the body

Info

Publication number: GB2151927A
Application number: GB08334131A
Authority: GB
Inventors: David Sharpe
Original assignee: MEDASIL
Current assignee: MEDASIL
Priority date: 1983-12-22
Filing date: 1983-12-22
Publication date: 1985-07-31
Also published as: GB8334131D0

Abstract

There is disclosed an inflatable implant (10) having a filling pipe (11, 12) connected thereto, and a valve assembly (13, 21) attached to one end of the filling pipe (12) and having a self-sealing rupturable wall portion (25) through which an injection needle (27) can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe (11, 12) to inflate the implant (10). The valve assembly (13, 21) is made at least partly of radio-opaque material to permit under-skin locationing of the valve assembly. Also, the valve assembly is provided with at least one finger grip portion to permit a surgeon to hold the valve assembly while carrying out introduction of a charge of inflating fluid. A connector arrangement is provided to join together the filling pipe portions (11, 12) in situ during implantation. A common design of implant may be provided for right or left breast implantation. <IMAGE>

Description

SPECIFICATION Inflatable implant This invention relates to an inflatable implant or implantable expander for use in the human body.

Inflatable prostheses are well known for use in the human body, one example being an inflatable mammary implant for use following breast surgery and/or for cosmetic reasons. An inflatable implant is placed against the chest wall, following surgery, and is then progressively inflated at intervals over a period of time so as to cause progressive expansion of the adjacent skin tissue. Once the required expansion has been completed, the inflatable implant is then removed, and replaced by a permanent pre-filled implant.

The inflation of the implant is carried out using any suitable gaseous, liquid or gel material which is introduced under pressure into the implant via a valve assembly and filling pipe coupled with the implant. The implant is usually not "inflated" in the sense that the wall of the implant undergoes any appreciable expansion, but is filled with fluid so as to separate the walls of the implant and thereby increase the external volume occupied by the implant.

An implant is usually made from medical implantable grade silicone rubber material, or any other suitable material which is not deleterious to surrounding human tissue.

In operation of inflatable mammary implants, it should be borne in mind that the filling pipe and valve assembly (which are attached to the implant) remain within the body of the patient after all external skin incisions have been stitched-back into place. The periodic inflation of the implant is carried out using a hypodermic needle containing a charge of inflating fluid e.g. saline solution, which is taken through the outer skin of the patient and into the valve assembly. The valve assembly is specially constructed with a self-sealing, but rupturable wall through which the needle can be taken. The wall, following piercing by the needle, springs back into sealed engagement around the needle, rather in the manner in which injection needles are taken through rupturable caps of medical fluid containers.Operation of the hypodermic needle then introduces under pressure a charge of inflating fluid into the valve assembly, and then flows along the filling pipe to the implant.

Currently available constructions of valve assembly are somewhat hemispherical in shape, and cannot always be readily located by the surgeon. It should be appreciated that the valve assembly is attached to the end of a flexible filling pipe, and can to a certain extent migrate under the external body tissue. It can therefore be something of a problem for a surgeon to locate the valve assembly, especially with a patient with excessive "fat" in the under-arm region adjacent to the rib cage.

Obviously, to carry out injection of inflating fluid, the surgeon must be able to locate the valve assembly, and then hold it firmly with his fingers.

There is, therefore, a need to provide a valve assembly for inflating an implant which can be more readily located, and manipulated under the skin of a patient, than is possible with the existing arrangements.

It is also the case, with existing arrangements, that the filling pipe is made of two components.

The first component comprises a pipe length attached to e.g. integral with the implant, and the $econd component comprises a pipe length attached to the valve assembly. Obviously, the pipe lengths must be supplied initially in amounts sufficent for the largest envisaged size of patient - sufficient to take the filling pipe from the implant to the region between the rib cage and the outer skin, and therefore usually it is necessary to cut down the length of the filling pipe to suit each individual patient. Following cutting to size (with the implant in position) it is then necessary to complete a connection inside the patient between the two lengths of pipe.In one known arrangement, an externally ribbed connector is provided over which the pipe ends are taken and then secured by the application of sutures or other filamentary material around the pipe ends, which fit into the grooves between the external ribs and thereby draw the pipe ends onto the connector upon tightening. Clearly, this is not a very satisfactory means for a surgeon to have to employ in coupling-up two tubes inside a patient.

Therefore, there is a need also to provide an improved means for connecting together the two lengths of filling pipe which is achieved more simply than hitherto and with complete reliability.

There is a further problem with the existing arrangement, in that the pipe length attached to the implant has to be guided from the breast/implant laterally through muscle and other tissue, and this is not particularly easy in that the pipe end will have to be guided through previously formed passages in the body tissue.

According to one aspect of the invention there is provided an inflatable implant having a filling pipe connected thereto, and a valve assembly attached to one end of the filling pipe and having a selfsealing rupturable wall portion through which an injection needle can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe to inflate the implant, in which the valve assembly is made at least partly of radio opaque material to permit under-skin locationing of the valve assembly.

Alternatively, or in addition, the valve assembly may be provided with at least one finger grip portion to permit a surgeon to hold the valve assembly while carrying out introduction of a charge of inflating fluid.

According to a further aspect of the invention there is provided an inflatable implant having a filling pipe connected thereto, and a valve assembly attached to one end of the filling pipe and having a self-sealing rupturable wall portion through which an injection needle can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe to inflate the implant, in which: the filling pipe comprises a first pipe portion attached to the implant, a second pipe portion attached to the valve assembly, and a connector arrangement to which the first and second portions are detachably connected, and in which:: the connector arrangement comprises a connector sleeve which is shaped externally so as to receive pushed-over ends of the first and second portions, a pair of external grooves on the outer periphery of the connector sleeve corresponding one each to a respective one of the filling pipe portions, and a pair of locking sleeves corresponding one each to a respective one of the filling pipe portions, each locking sleeve having an inwardly projecting rib and being slidable over its respective pipe portion, and pipe end on the connector sleeve, until its projecting rib snaps into engagement with a respective groove on the connector sleeve thereby to clamp the pipe end in position on the connector sleeve.

In order to facilitate lateral movement of the first filling pipe portion through body tissue towards the side of the patient, following implanting of the implant, it is preferred that the pipe portion be provided initially in its leading end with a removable stylet. This may be straight, or curved, to suit the requirements of the surgeon, and will be fitted into the leading end so as to present a substantially uninterrupted external profile whereby forcing of the stylet through body tissue can readily be followed by the accompanying pipe portion. This greatly assists the surgeon, and also keeps the interior of the pipe portion free from blockage or inclusions.Once the leading end has reached a position suitable for a connection to be made with the second pipe portion (which is attached to the valve assembly), the stylet is removed and then any necessary cuttingdown to length of either or both of the pipe portions takes place. Thereafter, coupling-up is achieved using the connector arrangement referred to above.

The invention is particularly applicable to mammary implants, but it should be understood that the invention has general application to implant surgery in which various shapes of inflatable implant can be provided for different regions throughout the body to fill out body contours or to fill regions from which something has be excised.

One embodiment of inflatable implant according to the invention will now be described in detail, by way of example, only with reference to the accompanying drawings in which: Figure 1 is a schematic front view of an inflatable implant and a portion of a filling pipe attached thereto; Figure 2 is a schematic illustration of a valve assembly and a further portion of filling pipe attached thereto; Figure 3 is a schematic illustration of a connector arrangement for connecting together the two portions of filling pipe; Figure 3a is a schematic illustration of means whereby a pipe end can be clamped in a pushed over position on one end of a connector sleeve of the connector arrangement; Figure 4 is a diagrammatic vertical sectional view of the valve assembly which is shown schematically in Figure 2; Figure 5 is a plan view of the valve assembly shown in Figure 4;; Figure 6 is a side view of a tear-drop shaped inflatable mammary implant; and Figure 7 is a front view of the mammary implant shown in Figure 6.

Referring now to the drawings, description will be made of an inflatable mammary implant, though it should be understood that the invention is not restricted to mammary implants, and has general application to implant surgery in which various shapes of inflatable implant can be provided for different purposes throughout the body to fill out body contours or to fill regions from which something has been excised, or to expand tissue.

In Figure 1, there is shown schematically an inflatable mammary implant 10 which is made of any convenient material which is not deleterious to surrounding human tissue, being preferably made of implantable grade silicone rubber. Inflatable mammary implants are well known, and detailed illustration and description of the implant 10 is therefore not necessary. To the lower side of the implant 10 there is attached a portion 11 of a filling pipe through which a charge of pressurised inflating fluid can pass (to or from the implant 10) in order to adjust the external volume occupied by the implant. Following breast surgery, the implant 10 will be implanted adjacent to the chest wall, and will then be periodically inflated so as to cause progressive expansion of the adjacent body tissue.

Once the required profile has been achieved, the inflatable implant 10 (which is a temporary implant only) can be removed and be replaced by a permanent pre-filled implant.

A further portion of the filling pipe for the implant 10 is shown in Figure 2, comprising a pipe portion 12 which is attached to a valve assembly 13. Following implanting of the implant 10 in a patient, the filling pipe portions 11 and 12 can be connected together, by a connector arrangement shown in more detail in Figures 3 and 3a, and a charge of inflating fluid can then flow along the filling pipe, to or from the implant 10, following insertion of an injection needle through the outer skin of the patient and into a pressure chamber of the valve assembly 13. The construction of the valve assembly 13 is shown in more detail in Figures 4 and 5.

Referring now to Figures 3 and 3a, there is shown the connector arrangement for coupling-together the pipe portions 11 and 12, which will be coated with medical implantable grade silicone rubber. The connector arrangement comprising a connector sleeve 14 which is shaped externally so as to receive pushed-over ends of the first and sec ond pipe portions, and a pair of locking sleeves corresponding one each to a respective one of the filling pipe portions. In Figure 3, there is shown a locking sleeve 15 associated with filling pipe portion 12, and over which it is slidable towards the connector sleeve 14.

The connector sleeve 14 is shown only schematically in Figure 3, but as shown in more detail in Figure 3a it has at least one external groove on its outer periphery at its end which will receive the pushed-over end of one of the pipe portions. As shown in Figure 3a, each end of the connector sleeve 14 has a pair of external ramp-shaped teeth 16 which define external grooves 17, for a purpose which will be described in more detail below.

To assemble the filling pipe, the pipe end of each of the portions 11 and 12 is pushed-over an adjacent end of the connector sleeve 14, which is shaped somewhat in the manner of an "acorn" type coupling, so as to overlie at least one of the external grooves 17 provided therefor. Thereafter, the respective locking sleeve (15) is slid over its respective pipe portion, and the pipe end on the connector sleeve, until an inwardly projecting rib 18 of the locking sleeve 15 snaps into engagement with a respective groove 17 on the connector sleeve, thereby to clamp the pipe end on the connector sleeve. Once the coupling has been completed, the locking sleeves 15 will be butting against each other, and preferably so also will the adjacent ends of the pipe portions.

Referring again to Figure 1, there is shown schematically a stylet 19 which is removably mounted in the leading end 20 of the filling pipe portion 11 which is attached to the implant 10. The purpose of the stylet 19 is to facilitate lateral movement of the first filling pipe portion 11 through body tissue towards the side of the patient, following implanting of the implant. The stylet 19 may be curved, as shown, or straight, to suit the requirements of the surgeon. The stylet enables the surgeon to guide the leading end 20 of the filling pipe portion 11 through fat and body tissue to any convenient location at which coupling-up can take place between the pipe portions 11 and 12 using the connector arrangement just described.The stylet 19 is shown only schematically, but will be capable of having suitable press-fit engagement with the leading end 20, and also will be such as to present a substantially uninterrupted external profile, whereby forcing of the stylet through body tissue can readily be followed by the accompanying pipe portion 11. Once the leading end 20 has reached a position suitable for the connection to be made with the second pipe portion 12 (attached to the valve assembly 13), the stylet is removed and then any necessary cutting down to length of either or both of the pipe portions 11, 12 takes place. Thereafter, coupling-up is achieved using the connector arrangement.

Referring now to Figures 4 and 5, the construction of the valve assembly 13 is shown in more detail. The valve assembly is designated generally by reference numeral 21 and comprises a base 22 which will normally be located adjacent to the rib cage of a patient, and a dome shaped cover 23 which, together with the base 22, defines a pressure chamber 24. At least a portion of the cover 23 comprises a wall which is made of a material which is self-sealing, but rupturable by an injection needle. As shown in Figure 4, this portion comprises a substantially central portion 25 of the cover 23. This wall portion 25 may be made of similar material to that employed in the self-sealing, but rupturable closures of medical containers of injectable fluid. As is well known, containers of this type are ruptured by injection needles, which are then operated to withdraw a charge of the injecting fluid.

There is shown in Figure 4 a hypodermic needle 26 having an injection needle 27 which can be taken through the outer skin of the patient, and through the wall portion 25, and into the pressure chamber 24. Depression of the plunger 28 can then cause introduction of a charge of pressurised inflating fluid into the pressure chamber 24, which can then flow along the pipe portions 2 and 11, and thence into the implant 10. Evidently, withdrawal of the plunger 28 can cause corresponding withdrawal of inflating fluid from the implant 10.

To prevent undue insertion of the needle 27, a reaction plate 29 is provided within the pressure chamber 24 and adjacent to the base 22. This reaction plate 29 will prevent the needle passing straight throught the valve assembly.

As indicated above, the valve assembly 21 will normally be located between the rib cage and the external skin of the patient. In order to facilitate locationing of the valve assembly 21, it is preferred that at least part of the valve assembly should be made of radio opaque material. In addition, to facilitate necessary manual manipulation of the valve assembly 21 by the surgeon, when carrying out introduction or removal of inflating fluid from the implant, the housing of the valve assembly 21 is provided with at least one finger-grip portion. As shown in Figure 5, the housing includes four curved lobes 30 which define therebetween curved finger-grip portions 31 (not shown in Figure 4).

Finally, referring to Figures 6 and 7, there is shown a typical shape of tear-drop shaped mammary implant 32. The implant 32 is shown in side view in Figure 6, having a back face or posterior aspect 33, an anterior aspect 34, a superior aspect 35 and an inferior aspect 36. It will be noted that the connection of the filling pipe portion 11 to the implant 32 is made along the inferior aspect 36 at a small spacing from the posterior aspect 33.

The construction of implant 32 illustrated in Figures 6 and 7 is advantageous, in that it provides a common design suitable for right or left breast implantation. In addition, positioning of the filling pipe portion on the inferior aspect provides an immediate indication to the surgeon as to which way up to insert the implant. Furthermore, unlike some known constructions in which a valve assembly enters the implant via the posterior aspect, there is the advantage in the illustrated arrangement that there is no protruberance to engage the chest wall, which could cause damage to adjacent tissue.

The invention is not limited to inflatable mammary implants, nor to the tear drop shapes as illustrated. Inflatable implants may be made in a range of sizes, and a variety of wall thicknesses to suit requirements. The inflating fluid may be sterilized saline or other liquid/air fluids, or gel.

Among other examples of expandable implant use, there should be mentioned tattoo removal, cosmetic surgery on the neck region, and accident surgery.

While there has been described above a valve assembly for use in passing inflating fluid to and from an implant, the invention also contemplates the use of the valve assembly disclosed herein for the direct injection of fluids, from a remote location, into a vein or other body parts requiring medication. Such medication can be injected from a remote location e.g. externally of the body, through the outer skin of the patient and into the valve assembly and then passing along a charging tube which has previously (e.g. during surgery) been introduced into the vein or other body part requiring medication.

The invention also contemplates the construction of an inflatable implant having such a wall thickness as to be capable, at least at a fluid charging or removal location, of being rupturable but selfsealing following direct injection therethrough by an injection needle. In such event, the filling pipe and valve asesembly, already described herein, can be dispensed with.

Claims

1. An inflatable implant having a filling pipe connected thereto, and a valve assembly attached to one end of the filling pipe and having a selfsealing rupturable wall portion through which an injection needle can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe to inflate the implant, in which the valve assembly is made at least partly of radio-opaque material to permit under-skin locationing of the valve assembly.

2. An inflatable implant according to claim 1, in which the valve assembly is provided with at least one finger-grip portion.

3. An inflatable implant having a filling pipe connected thereto, and a valve assembly attached to one end of the filling pipe and having a selfsealing rupturable wall portion through which an injection needle can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe to inflate the implant, in which the valve assembly is provided with at least one finger-grip portion.

4. An inflatable implant according to claim 2 or 3, in which the valve assembly has a four-lobed housing to define four finger-grip portions.

5. An inflatable implant having a filling pipe connected thereto, and a valve assembly attached to one end of the filling pipe and having a selfsealing rupturable wall portion through which an injection needle can be taken in order to introduce a pressurised charge of inflating fluid to the valve assembly which can then flow along the filling pipe to inflate the implant, in which: the filling pipe comprises a first pipe portion attached to the implant, a second pipe portion attached to the valve assembly, and a connector arrangement to which the first and second portions are detachably connected, and in which:: the connector arrangement comprises a connector sleeve which is shaped externally so as to receive pushed-over ends of the first and second portions, a pair of external grooves on the outer periphery of the connector sleeve corresponding one each to a respective one of the filling pipe portions, and a pair of locking sleeves corresponding one each to a respective one of the filling pipe portions, each locking sleeve having an inwardly projecting rib and being slidable over its respective pipe portion, and pipe end on the connector sleeve, until its projecting rib snaps into engagement with a respective groove on the connector sleeve thereby to clamp the pipe end in position on the connector sleeve.

6. An inflatable implant according to claim 5, in which the first pipe portion is provided in its free end with a removable stylet.

7. An inflatable implant according to any one of the preceding claims, in which the implant is a mammary implant which is a common design suitable for right or left breast implantation.

8. An inflatable implant according to any one of claims 1,3 or 5, and substantially as hereinbefore described with reference to, and as shown in any one of the embodiments illustrated in the accompanying drawings.