GB2293975A

GB2293975A - Self sealing pillow valve system

Info

Publication number: GB2293975A
Application number: GB9420826A
Authority: GB
Inventors: Joseph Gallagher
Original assignee: Individual
Current assignee: Individual
Priority date: 1994-10-15
Filing date: 1994-10-15
Publication date: 1996-04-17
Also published as: GB9420826D0

Abstract

A self-sealing valve for use in fluid inflatable and implantable devices e.g. mammary prothesis in conjunction with a removable "sleeved" filling introducer. The main section of the valve has a passage 27 for inserting the filling introducer 10. The valve includes two gel filled pillows 11 and 12 that seal the slit 28 by compression thus self-sealing the valve passage 27 between the two gel filled pillows once the filling introducer 10 is withdrawn. The valve includes a 'sleeved' fitting 32 around the filling introducer that prevents any fluid flowing into or back through the valve passage 27. The valve includes a folded deflector tab 26 which ensures that the valve passage exit 31 remains closed once the filling introducer has been removed, as well as a circular disc 22 that guides the filling introducer through the slit 28. <IMAGE>

Description

SELF SEALING "PILLOW" VALVE SYSTEM FOR IMPLANTABLE DEVICES This invention relates to self sealing valves, and in particular, it relates to a "Pillow" type pressure sealing valve.

Inflatable type mammary prostheses of single and multiple lumen designs currently have a closed valve system built into the shell of the implant. The valve is operational when the rigid end of the ( metalfplastic ) fill tube introducer is inserted into the inlet to open the valve, to allow isotonic sterile saline or other sterile solutions to enter through a valve system into the interior of the implant.

This procedure is normally performed at the time of surgery, with a reasonable possibility of mechanical stress and subsequent damage to the valve structure, which can impede permanent full closure of the valve, after withdrawal of the filling introducer.

Extant valve designs are made up of a number of silicone elastomer layers which are bonded together along the edges to form a passage way. The filling introducer is inserted through this passage way and may remain in place for a period of up to 5 years during storage of this device. The passage way may be permanently deformed by the filling introducer during this period possibly preventing a complete seal on removal of the filling introducer.

The present invention includes two gel filled pillows within the main portion of the valve.

The filling introducer passes through the slit in the valve passage and between the two gel filled pillows. These pillows mould themselves to the shape of the filling introducer passing between them, allowing fluid to pass through the filling introducer unrestricted.

The gel filled pillows are constructed in such a way that the filling introducer does not come in contact with either of the gel filled pillows, thus the silicone gel itself is completely sealed off in closed cavities. When the filling procedure is satisfactorily performed, the filling introducer is withdrawn outward through the valve system. As this is done the two silicone gel filled pillows will compress themselves upon the slit, thus self-sealing the passage of the valve.

The stresses that are placed in the valve material which surrounds the filling introducer will be distributed through the silicone gel filled pillows avoiding the risk of permanent deformation of these surfaces, that could affect the integrity of the valve system.

The present invention overcomes the problems and disadvantages of valve failure after the filling procedure of inflatable type mammary implants have been performed. This invention eliminates the requirement of the user to mechanically interfere with the valve situated in the shell of the implant, therefore ensuring viability of the valve after the implant has been filled with a solution.

This invention comprises a new design valve system for use in a "liquid" filled inflatable mammary implants. A sleeved filling introducer of specifically determined dimensions and physical characteristics with a filling medium attached to its distal end is inserted through a passage within the main portion of the valve. This filling introducer will pass between the closed gel filled " pillow " section of the valve and extending out through the end portion of the valve. After exiting the valve passage the filling introducer is deflected from the shell wall by a folded deflector tab.

The present invention includes a folded deflector tab that ensures the passage exit remains closed. The exit of the passage is achieved by the elastomeric nature of the silicone elastomer layers within the valve of the present invention.

The present invention also includes a sleeved fitting at a specific position around the fill introducer. This device when in position within the valve passage acts as a " cork preventing any fluid flowing into or back through the valve passage whilst the inflation procedure is being performed.

A specific embodiment of the invention will now be described by way of example with reference to the accompanying drawings in which: Figure 1 is a cross sectional view of the valve of the present invention in a prosthesis shell with the filling introducer in place.

Figure 2 is an exploded perspective view showing all parts that make up the valve of the present invention.

Figure 3 is a cross sectional and perspective view of the valve with the fill introducer in position.

Figure 4 is a cross sectional and perspective view of the valve with the fill introducer partially withdrawn.

Figure 5 is a cross sectional and perspective view of the valve with the fill introducer completely withdrawn.

With reference to Figure 1, a mammary prosthesis is shown including the valve of the present invention. The prosthesis comprises of an outer barrier shell 8 outlining an inflatable cavity 9. The filling introducer 10 enters the valve passage opening 15 and exits the valve passage exit 31. The filing introducer thus protrudes out from the valve into the inflatable cavity 9, enabling fluid to be passed through the filling introducer 10 with ease into the cavity 9.

Fluid is injected into the inflatable cavity 9 via an additional device (not shown) which is attached to the distal end of the filling introducer 10. Although a single cavity prosthesis is shown in Figure 1, the valve of the present invention can be utilised for multi-cavity inflatable mammary prostheses. For example, in a bi-lumen mammary prosthesis which comprise of two barrier shells.

The general arrangement of the valve of the present invention is best illustrated by reference to Figures 1 and 2. The valve consists of two gel filled 'pillows' 11 and 12 of the present invention, one either side of the filling introducer 10. The gel filled chamber 13 is constructed by bonding an outer vulcanised silicone elastomer patch 20 with the valve passage opening 15 joined to a circular patch 16 of vulcanised silicone elastomer using an unvulcanised silicone elastomer patch 17.

The gel filled chamber 14 is constructed by bonding an outer vulcanised silicone elastomer patch 21 joined to a circular patch 18 of vulcanised silicone elastomer using an unvulcanised silicone elastomer patch 19. The gel filled pillows 11 and 12 provide the self sealing mechanism. The gel used is a cross-linked silicone gel that is widely used in the construction of mammary prostheses.

Referring to Figure 2 the valve passage of the present invention indicated by an arrow line 27, into which the filling introducer 10 will be inserted, is formed by bonding vulcanised silicone elastomer patches 16, 18, 20 and 23 using unvulcanised silicone elastomer patches 17 and 19.

An unvulcanised silicone elastomer disc 22 of the present invention is placed concentrically over the vulcanised silicone elastomer patch 16 and bonded to the vulcanised silicone elastomer patch 23. This adds additional strength to this portion of the valve passage 27. Also when the filling introducer 10 is inserted through the passage 27 it minimises any possibility of the filling introducer 10 from deviating from the line of the passage 27.

The unvulcanised silicone elastomer disc 22 acts as a guide for the filling introducer 10 to pass through the slit 28 of the present invention with ease and without deforming the valve passage 27. In Figure 4 the filling introducer 10 is being removed as shown by arrow 33 from the valve passage 27, the slit 28 will be sealed by the presence of the two gel filled pillows of the present invention compressing themselves upon the slit 28.

This compressing action is shown by the arrows as indicated in Figure 4.

Prior to the bonding together of items 16, 17, 18 ,19, 20, 21, 22 and 23 a removable mylar strip is placed between the layers as indicated by an arrow line 27 as indicated in Figure 1. The mylar strip is removed when bonding is complete, forming the valve passage 27 into which the filling introducer 10 is inserted.

In addition, a further sealing mechanism is adopted by means of a folded deflector tab 26 of the present invention as in Figure 4. The folded deflector tab 26 comprises of a vulcanised silicone elastomer patch 24 bonded to an unvulcanised silicone elastomer patch 25, which in turn are joined to the outer surfaces of the vulcanised silicone elastomer patches 20 and 21 as shown in Figure 1 and 2. The valve exit 31 remains sealed by the elastomeric nature of the silicone elastomer layers of the valve. In addition the folded deflector tab 26 assists in maintaining the closure of this exit 31, when the filling introducer 10 is withdrawn in the direction shown by 33 from the valve passage 27 as indicated in Figure 4.

The sleeve 32 of the present invention that is attached to the filling introducer 10 as in Figure 1, is an additional safety measure that prevents any fluid flowing into or back through the valve passage 27 of the present invention whilst the inflation procedure is being performed.

Figure 3 indicates the filling introducer 10 of the present invention fully in position within the valve of the present invention. The filling introducer 10 passes through slit 28 guided by the circular disc 22 as indicated in Figure 2. The construction of the two gel filled chambers 13 and 14, is such that the filling introducer 10 can pass through slit 28 of the present invention with ease and without making contact with either of the two gel filled chambers 13 and 14 of the present invention.

Figure 5 shows the filling introducer 10 completely withdrawn from the valve passage 27 of the present invention. The two gel filled pillows 11 and 12 of the present invention are relaxed and have returned to their original rest positions, thus compressing upon the slit 28 of the present invention. The compression action of the two gel filled pillows 11 and 12 of the present invention are shown by the arrows.

Claims

1. A valve for use in a variety of 'fluid inflatable and implantable devices in conjunction with a 'sleeved' filling introducer, the valve including:a slit which is closed off by the two gel filled pillows that provide the self sealing mechanism by compressing themselves upon the slit when the filling introducer is withdrawn from the valve passage.

a circular disc that guides the filling introducer through the slit in the valve passage.

2. The valve in claim 1 and including:the two gel filled pillows, which relax and seal the slit when the filling introducer is removed.

the two gel filled pillows that are completely sealed in their own individual cavities.

3. An implantable device including the valve in claim 1.

4. The device of claim 3, including a "sleeved' fitting on the filling introducer that prevents any fluid flowing into or back through the valve passage.

5. The valve in claim 1 and further including the folded deflector tab which ensures the valve passage exit remains closed when the filling introducer is withdrawn from the valve passage.

6. The valve for the use in a variety of 'fluid' inflatable and implantable devices in conjunction with a removable "sleeved' filling introducer, the valve comprising of:two gel filled pillows therein; and a slit that is closed off by the compression of the two gel filled pillows when the filling introducer is removed from the valve passage therein; and a 'sleeved' fitting around the filling introducer that prevents any fluid flowing into or back through the valve passage whilst the inflation procedure is being performed therein; and a folded deflector tab that ensures the valve passage exit remains closed when the filling introducer is withdrawn from the valve passage therein; and a circular disc that guides the filling introducer through the slit in the valve passage therein; and the two gel filled pillows that are completely sealed off in their own cavities. This allows the gel filled pillows to compress upon the slit and seal the passage on withdrawal of the filling introducer.

7. The implantable device including the valve of claim 6.

8. An implantable device of claim 6 substantially as described herein with reference to Figures 1 to 5 of the accompanying drawing.