GB2391852A

GB2391852A - Enclosures for embryo transfer catheters

Info

Publication number: GB2391852A
Application number: GB0316851A
Authority: GB
Inventors: Giles Andrew Bishop
Original assignee: Smiths Group PLC
Current assignee: Smiths Group PLC
Priority date: 2002-08-13
Filing date: 2003-07-18
Publication date: 2004-02-18
Also published as: GB0316851D0; GB0218755D0

Abstract

An enclosure for an embryo transfer catheter has an elongate carton 2 hinged in two halves 21 and 22. The carton 2 is of a thermally-insulating foamed plastics and is preferably warmed before use so that the temperature of the catheter 40 can be maintained. The carton 2 is enclosed before use within an outer pouch (1) of a gas-permeable material that allows gas sterilization.

Description

2391 852

EN CL O SURF, S

This invention relates to enclosures and methods.

The invention is more particularly concerned with enclosures for embryo transfer catheters and methods for using embryo transfer catheters and enclosures.

An embryo transfer catheter is used to transport an embryo from a location where the embryo was fertilised to the woman in whom the embryo is to be transferred. One end of the catheter is inserted in the uterus and the embryo is expelled from the catheter to the uterus.

Prior to implantation, the embryo is fertilised and grown under carefully controlled conditions in a culture medium, in particular, care is taken to keep the embryo at the correct temperature to encourage its growth. Although the embryo in the catheter is transported as quickly as possible, there can often be delays in transferring the embryo to the patient. In particular, if the position of the uterus is found to be difficult, the surgeon may need to manipulate it for insertion of the catheter. This can delay insertion of the embryo and may lead to a drop in the temperature of the embryo while the catheter is exposed to room temperature. It is an object of the present invention to provide an enclosure for an embryo transfer catheter and a method that will help maintain the desired temperature of the catheter.

According to one aspect of the present invention there is provided an enclosure for an embryo transfer catheter, the enclosure having an outer pouch containing a carton adapted to

contain an embryo transfer catheter, the carton being themally-insulating and being closable about the catheter such as to maintain the temperature of the catheter, and the pouch being adapted to maintain the sterility of the carton before use.

According to another aspect of the present invention there is provided an enclosure comprising an outer pouch, a carton within the pouch and an embryo transfer catheter within the carton, the carton being thermallyinsulating and being resuable to contain and maintain the temperature of the catheter after removal of the carton from the pouch and after transfer of an embryo to the catheter.

The carton is preferably of elongate shape and may have two halves hinged with one another. The carton may be of an expanded plastics material, such as polystyrene. The pouch preferably includes a gas-permeable material that allows gas sterilization of its contents.

According to a further aspect of the invention there is provided a method of handling an embryo comprising the steps of providing an embryo transfer catheter in a therrnally-

insulating carton, warming the carton, transferring an embryo to the catheter and placing the catheter containing the embryo in the warmed carton.

The carton may be warmed without the catheter or with the catheter.

An enclosure according to the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of the enclosure comprising an outer pouch and inner carton; Figure 2 is a perspective view of the carton removed from the pouch with its lid open; Figure 3 illustrates the carton being warmed; and Figure 4 is a cross-sectional view of the carton with the catheter.

With reference to Figure 1, the enclosure comprises an outer pouch 1 containing an inner carton 2.

The pouch 1 is of a flexible material that maintains sterility within the pouch and typically is of a conventional gas-permeable material used in the packaging of medical devices that allows sterilizing gas to penetrate the pouch but prevents the entry of bacteria and the like.

With reference to Figure 2, the carton 2 has an elongate, rectangular shape and is moulded from a thermally-insulating material, such as expanded polystyrene. The carton 2 is Conned of two halves 21 and 22 integrally connected with one another by a living hinge 23 extending along a longer side of each half. When opened, as shown in Figure 2, the upwardly-facing surface 24 and 25 of the two halves each have a recess 26 and 27 extending in a straight line along the length of the carton to within a short distance of the opposite ends.

The recesses 26 and 27 are shaped to retain an embryo transfer catheter 40. As shown, the catheter 40 lies in the recess 26 in the lower half 21 of the carton, when open. The dimensions of the recesses 26 and 27 are such that when the two halves 21 and 22 of the carton 2 are closed they grip the catheter 40 with a very light pressure just sufficient to prevent movement of the catheter within the carton. Various arrangements of recess are possible. The recess could be provided only in the lower half, the facing surface of the upper half being flat or having a projection that extends slightly into the recess in the lower half.

The carton 2 has engaging catches 28 and 29 on the two halves 21 and 22 so that they are retained closed together until the catches are released.

The enclosure is provided with the catheter 40 enclosed within the closed carton 2 and with the carton within the sealed pouch 1. The inside of the pouch 1, the carton 2 and the catheter 40 are all sterile.

To use the catheter 40, the pouch 1 is first torn open and disposed of. The carton 2 is then opened as shown in Figure 2 to expose the catheter 40. The catheter 40 is then removed and the (now empty) carton 2 is placed in an incubator 50 (as shown in Figure 3) to raise the temperature of the carton to an optimum for embryo storage, around 37 C. While the carton 2 is warming, the surgeon loads an embryo into the catheter 40, in the usual way. The carton 2 is then removed from the incubator, it is opened, the catheter with its embryo is placed in the carton and it is then closed, as shown in Figure 4.

The carton 2 could alternatively be warmed in the incubator 50 with the catheter 40 in the carton, or before the outer pouch is removed.

The catheter 40 and embryo are transported in the warmed carton 2 to the location at which the embryo is transferred to the mother. In difficult cases, it may be necessary to remove the catheter 40 from the patient before transfer of the embryo in order to reposition the uterus. Where this is necessary, the catheter 40 can be placed back in the carton 2, which is closed to maintain the warmth of the embryo as close as possible to the optimum and to protect the catheter from contamination.

The present invention provides a simple way of reducing temperature fall of an embryo during handling and also provides protection against contamination. The enclosure can be of low cost, enabling it to be disposed of after a single-use. The carton could be large enough so that it can also contain the syringe used with the catheter, so that the syringe does not have to be detached when the catheter is placed in the carton.

Claims

1. An enclosure for an embryo transfer catheter, wherein the enclosure has an outer pouch containing a carton adapted to contain an embryo transfer catheter, wherein the carton is thermally-insulating and is closable about the catheter such as to maintain the temperature of the catheter, and wherein the pouch is adapted to maintain the sterility of the carton before use.

2. An enclosure comprising an outer pouch, a carton within the pouch and an embryo transfer catheter within the carton, wherein the carton is thermally-insulating and is reusable to contain and maintain the temperature of the catheter after removal of the carton from the pouch and after transfer of an embryo to the catheter.

3. An enclosure according to Claim 1 or 2, wherein the carton is of elongate shape.

4. An enclosure according to any one of the preceding claims, wherein the carton has two halves hinged with one another.

5. An enclosure according to any one of the preceding claims, wherein the carton is of an expanded plastics material.

6. An enclosure according to Claim 5, wherein the plastics material is polystyrene.

7. An enclosure according to any one of the preceding claims, wherein the pouch includes a gas-permeable material that allows gas sterilization of its contents.

8. An enclosure substantially as hereinbefore described with reference to the accompanying drawing.

9. A method of handling an embryo comprising the steps of providing an embryo transfer catheter in a thermally-insulating carton, warming the carton, transferring an embryo to the catheter and placing the catheter containing the embryo in the warmed carton.

10. A method according to Claim 9, wherein the carton is warmed without the catheter.

11. A method according to Claim 9, wherein the carton is warmed with the catheter in the carton.

12. A method substantially as hereinbefore described with reference to the accompanying drawing.

13. Any novel and inventive feature or combination of features as hereinbefore described.