WO2000069369A1

WO2000069369A1 - A kit and method for sealing elastomeric tubing

Info

Publication number: WO2000069369A1
Application number: PCT/IE2000/000064
Authority: WO
Inventors: Murtagh Martin Murphy; Peter Vincent Wilson
Original assignee: Medisyn Technologies Limited
Priority date: 1999-05-14
Filing date: 2000-05-12
Publication date: 2000-11-23
Also published as: AU4606900A; IES990393A2

Abstract

The invention relates to a surgical method and kit for sealing elastomeric tubing. The invention describes the sealing of an elastomeric fill tube (2), the tube having being previously used to fill an implant (1) with a fluid. The invention provides a plug (14) which is adapted to seal a portion of the fill tube (2), thereby preventing the leaking of any of the fluid from the implant. A kit and method for positioning the plug within the elastomeric tube is also provided.

Description

Title

A kit and method for sealing elastomeric tubing.

Field Of The Invention

The invention relates to a kit and method for sealing elastomeric tubing and more particularly to sealing elastomeric tube connected to a mammary implant with a plug.

Background Art

It is well known in surgery to utilise a prosthesis. One commonly used prosthesis is a mammary implant which normally comprises a moulded shell or envelope which can be filled with a fluid or gel either by the manufacturer or surgeon. One such known mammary implant is described in our European patent ( EP 0872221) and comprises a silicone envelope which is placed in the desired position by the surgeon and can be filled at a later date with for example with a saline solution.

The insertion of the saline solution is a procedure which is undertaken over a number of days and as such many such mammary implants are provided with a connecting tube or fill tube which is connected at one end to the implant and at the other to a valve means or injection port.

Figure 1 shows one such known implant 1 together with a fill tube 2 and injection port 3. The injection port is in fluid communication with the implant through the fill tube and as such the saline solution can be introduced to the implant 1 via injection port 3. It is possible to vary the length of the fill tube so as to facilitate the positioning of the injection port 3 away from the implant 1. The injection port comprises a self sealing valve means such that saline solution can be introduced to the injection port over a number of days without fear of leaking. This filling is normally achieved by piercing the valve using a hypodermic syringe or other suitable means, and then introducing the saline solution into the implant via the fill tube.

The length of the fill tube 2 is chosen so as to facilitate the positioning of the injection port 3 away from the implant area. A commonly chosen area for the location of the insertion is under the arm of the patient. Once the implant been filled to a satisfactory level the injection port is redundant. The positioning of the injection port in the area close under the skin can cause some discomfort to patients as the dimensions of the injection port are such that it is noticeable under the skin.

There is therefore a need to facilitate the removal of the injection port and yet prevent the leaking of any saline solution from the implant through the fill tube. One known solution is shown in Figure 2. In this product the implant is provided with a fill tube and injection port, in a similar fashion to that shown in Figure 1, but additionally incorporates a one way valve means 4 which is located at a predetermined distance along the fill tube. The positioning of the one way valve means 4 is decided upon by the manufacturer and supplied to the surgeon in the complete packaged product. Once the required amount of fluid has been inserted via the injection port into the implant the injection port can be removed and due to the presence of the one way valve means 4 no fluid should leak from the implant. Such devices have not been completely satisfactory in that when utilising such valve means it is difficult to ensure that there is no leaking of the fluid solution through the valve means 4.

Furthermore, many surgeons would like the facility to position the sealing means at a position along the fill tube of their own choice and not utilise a pre -positioned valve means. There is therefore a need to provide a sealing means which will facilitate the removal of the injection port, but will also prevent the leaking of the saline fluid from the implant. It is preferable that such sealing means will also allow the surgeon to decide where along the fill tube the sealing tube should be positioned. Object Of The Invention

It is the object of the present invention to provide a means and apparatus suitable for sealing a fill tube. It is a further object of the present invention to provide such apparatus and means that the positioning of the point of sealing can be decided upon by the surgeon, or other suitable users or operators.

Summary Of The Invention

Accordingly the invention provides a kit and method as defined in the appended claims.

The invention also provides a kit suitable for sealing an elastomeric tube so as to prevent the flow of a fluid through the elastomeric tube, the elastomeric tube having a first end through which the fluid can enter the tube and a second end connected to a reservoir for storing said fluid, the kit comprising: a sealing plug, expanding means adapted to expand the first end of the elastomeric tube so as to facilitate the entry of the sealing plug into the elastomeric tube, and insertion means adapted to position the plug at a desired position in the elastomeric tube and whereby on insertion of the sealing plug to a desired position in the elastomeric tube the insertion means can be partially or completely removed from the elastomeric tube.

The kit may be used to seal the tube during surgery or post operatively

The elastomeric tube may be a fill tube used in conjunction with a mammary implant and the reservoir for storing said fluid is the mammary implant.

The insertion means is preferably a rod, and more preferably a rod with a handle and tapered end. The expansion means is preferably a barrel

The insertion means is preferably inserted in and protrudes from the end of the barrel such that the tapered end extends from the end of the barrel and is used to facilitate the introduction of the expansion means into said first end of the elastomeric tube.

The invention also provides a surgical method for sealing an elastomeric tube with a sealing plug the method comprising the manually operated steps of: expanding an entry port in the elastomeric tube so as to broaden the tube and facilitate the entry of a sealing plug into said tube, utilising an insertion means to position the sealing plug substantially within the tube at a desired position, removing at least partially the insertion means.

On insertion of the expansion means into said elastomeric tubing the insertion means is preferably withdrawn, leaving said barrel in situ. The insertion means is then utilised to project the sealing plug along the barrel and substantially into the elastomeric tube.

Brief Description Of The Drawings

Figure 1 shows a mammary implant according to the prior art, Figure 2 shows the implant of Figure 1, incorporating a one way valve according to the prior art,

Figure 3 shows a device according to the invention,

Figure 4 shows in detail one portion of the device shown in Figure 3, and

Figures 5 to 9 show the method of sealing according to the present invention.

Detailed Description Of The Drawings Figures 1 and 2 have been hereinbefore described with reference to the prior art, in the section "Background to the Invention".

Figure 3 shows one embodiment of a surgical kit suitable for sealing a fill tube so as to prevent the flow of fluid through a tube in accordance with the invention. The kit is comprised of two parts; insertion means or push rod 5 which is used in conjunction with a carrier tube 6 to form expanding means. The insertion means and expansion means are used in conjunction with a sealing plug (not shown) to form a sealing arrangement suitable for sealing elastomeric tubing (not shown). The push rod 5 comprises a handle 7 which is suitable to be held within one hand of the user. The handle 7 is connected to a preferably cylindrically shaped rod 8 which has a tapered end 9 shown in detail in Figure 4.

The carrier tube 6 is preferably a barrel type arrangement 10, the internal diameter of which is sufficient so as to allow the insertion of the rod 8 of the insertion means 5 into the barrel 10. The carrier tube 6 may additionally have a disk 11 which is adapted to facilitate the easy holding of the carrier tube 6 by the user. The inclusion of the disk 11 provides a larger area around the opening of the barrel 10 which assists the user in guiding plugs into the barrel during loading, it reduces the possibility of the plug being sheared at the opening to the barrel when being loaded and enables the user to get a better grip on the barrel when removing the barrel from the fill tube. The length of the carrier tube 6, is such that when the push rod 5 is inserted within the carrier tube 6 the tapered end 9 will protrude out one end of the barrel 10. The barrel 10 additionally has an etch mark 12.

Figures 5 through 9 show the method of operation of the sealing method according to the present invention. The surgeon takes the implant of Figure 1 and cuts the fill tube at a predetermined distance along the fill tube so as to separate the valve means from the implant. The fill tube is pinched (or sealed in some other temporary manner) so as to prevent the leaking of saline fluid out through the cut end of the elastomeric tube. The push rod 5 is inserted into the carrier tube 6 until the handle 7 abuts the disk 11, thus forming the expansion means. The tapered end 9 of the rod 8 will protrude beyond the barrel 10. The assembled push rod 5 and carrier tube 6 are then introduced to the fill tube, preferably manufactured from elastomeric materials such as silicone. The benefit of using a tapered end at the end of the rod 8 is to facilitate the expansion of the entry port 13 of the elastomeric tube 2 and allow the entry of both the rod and barrel in a predetermined distance, as signified by the positioning of the etch mark 12 on the barrel 10, to the elastomeric tube 2.

Once the barrel and rod have been inserted to a sufficient distance within the tube 2 it is possible to withdraw the push rod 5. At all stages during this operation the silicone tube should be pinched by the operator (not shown) so as to prevent any leaking of the saline fluid from the implant. Once the push rod 5 has been removed from the carrier tube 6 it is possible to introduce a fill plug 14 into the barrel 10.

The push rod 5 is inserted into the carrier tube 6 and used to inject or push the fill plug into the silicone tube 2. The plug is preferably of a diameter greater than the inner diameter of the fill tube 2. On complete insertion of the fill plug 14 into the fill tube 2 the push rod 5/carrier tube 6 combination can be withdrawn from the fill tube 2. The addition of the disk 11 facilitates this withdrawal process.

Once the rod/tube combination have been withdrawn the sealing plug remains within the fill tube 2, sealing the tube as shown in Figure 9.

Although described with reference to silicone elastomeric materials the method and apparatus of the described invention can be applied to any surgical sealing process requiring the sealing of an elastic type membrane with a sealing plug. The invention has the advantage that as the fill tube can be cut at any position between the valve and the prosthesis membrane the surgeon can dictate where the plugging of the tube is located. Furthermore the method of the invention can be repeated by cutting the fill tube further towards the implant and repeating the procedure.

The words "comprises/comprising" and the words "having/including" when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

Claims

1. A kit for sealing an elastomeric tube (2) used for filling an implant (1), so as to prevent the flow of a fluid through the elastomeric tube (2), the elastomeric tube (2) having a first end through which the fluid can enter the tube and a second end connected to an implant reservoir for storing said fluid, the kit comprising: a) a sealing plug (14), b) expansion means (6) adapted to expand the first end of the elastomeric tube so as to facilitate the entry of the sealing plug into the elastomeric tube, and c) insertion means (5) adapted to position the plug (14) at a desired position in the elastomeric tube and whereby on insertion of the sealing plug to a desired position in the elastomeric tube the insertion means can be partially or completely removed from the elastomeric tube.

2. The kit as claimed in claim 1 wherein the insertion means is a rod (5).

3. The kit as claimed in any preceding claim wherein the insertion means is a rod with a handle (7) and tapered end (9).

4. The kit as claimed in any preceding claim wherein the expansion means is a barrel (6).

5. The kit as claimed in claim 3 or 4 wherein the insertion means is adapted to protrude when inserted from the end of the barrel such that the tapered end extends from the end of the barrel and, the insertion means may be adapted to effect the introduction of the expansion means into said first end of the elastomeric tube.

6. The kit as claimed in any preceding claim wherein the elastomeric tube is a fill tube used in conjunction with an implant, and the reservoir for storing said fluid is the implant.

7. The kit as claimed in claim 6 wherein the implant is a mammary prosthesis implant.

8. Use of the kit as claimed in any preceding claim for sealing an implant in situ within a mammalian body.

9. A method for sealing an elastomeric tube (2) with a sealing plug (14) the method comprising the steps of: a) expanding an entry port in the elastomeric tube (2) so as to broaden the tube (2) and facilitate the entry of a sealing plug (14) into said tube, b) utilising an insertion means (5) to position the sealing plug (14) substantially within the tube (2) at a desired position, c) removing at least partially the insertion means.

10. The method as claimed in claim 9 wherein the insertion means is a rod (5) with a handle (7) and a tapered end (9) and the expansion means is a barrel (6), the rod

(5) being insertable into the barrel (6), and wherein on insertion of the rod/ barrel combination into the elastomeric tube (2), the rod (5) is withdrawn, leaving said barrel (6) in situ, and wherein the rod (5) is then utilised to project the sealing plug (14) along the barrel and substantially into the elastomeric tube.

11. The method as claimed in claim 9 or 10 wherein the elastomeric tube is in fluid communication with an implanted prosthesis, the prosthesis adapted to maintain a reservoir of fluid, and wherein the sealing of the elastomeric tube effects a sealing the prosthesis and prevents any leaking of fluid from the prosthesis.

2. The method as claimed in claim 10 wherein the prosthesis is a mammary implant, and the method of sealing takes place when the implant is in situ.