GB2391815A

GB2391815A - A vaginal speculum for use with an embryo transfer catheter

Info

Publication number: GB2391815A
Application number: GB0317878A
Authority: GB
Inventors: Giles Andrew Bishop
Original assignee: Smiths Group PLC
Current assignee: Smiths Group PLC
Priority date: 2002-08-13
Filing date: 2003-07-31
Publication date: 2004-02-18
Anticipated expiration: 2023-07-31
Also published as: GB0317878D0; GB0218752D0; GB2391815B

Abstract

A vaginal speculum has two arms 1 and 2 hinged with one another at a point along their length to form a pair of handles 11 and 21 at one end and a pair of jaws 10 and 20 at the other end. A warming pod 49 is secured by an adhesive 45 to one of the arms 1 and contains a heated gel. The pod 49 has a channel 49 in which an embryo transfer catheter 61, 62 can be inserted. The other arm 2 has a hinged beam 30 close to its patient end, the guide having an aperture 33 through which the catheter 61, 62 can be extended to form a guide for insertion of the catheter.

Description

l VAGINAL SPEC1JLA

This invention relates to vaginal specula.

Vaginal specula are used to enlarge the passage through the vagina for gynaecological examination, sampling or treatment. The specula usually comprise two angled arms pivoted with one another to fonn jaws at one end and handles at the other end. The jaws can be separated by squeezing together the handles. The speculum often has some means by which the two jaws can be held in their separated state, so that the handles can be released once the passage has been enlarged sufficiently. One way of achieving this is by means of a ratchet arrangement, as in the speculum sold by Portex Limited of Hythe, Kent, England under the Red trade mark Cytospec. Other arrangements are described in EP 407357 and GB 2334449.

Where a speculum is used for inserting an embryo transfer catheter this is usually contained within an outer sheath, such as of the kind described in US 4863423, in order to provide an increased stiffness for insertion through the cervix. Even with this outer sheath, however, it can be quite difficult to direct the catheter correctly because it is held at some distance away from the tip. There is a further problem during embryo transfer generally of maintaining the embryo in the catheter at the best temperature to ensure its viability. This is a particular problem where the anatomy of the patient makes insertion difficult since this may cause delays of several minutes while the surgeon manipulates the uterus.

It is an object of the present invention to provide an alternative vaginal speculum.

According to one aspect of the present invention there is provided a vaginal speculum for use with an embryo transfer catheter, the speculum comprising two arms hinged with one another at a point along their length and forming a pairs of jaws on one side of the hinge point and a pair of handles on the opposite side of the hinge point arranged such that the jaws can be separated by squeezing together the handles, the speculum including means for receiving the catheter.

The means for receiving the catheter may be warming means, which may be attached with an arm of the speculum and have a channel in which a part at least of the catheter is received. The warming means may be attached with the ann by an adhesive and may contain a heat-retaining material such as a gel. Alternatively, the means for receiving the catheter may be a guide located towards the patient end of at least one of the arms. The guide preferably has an aperture through which the catheter is extended. The guide is preferably foldable from a first position in which it extends substantially lengthwise of the arm to a second position in which the guide is operable to guide the catheter. The speculum may have warming means attached with one of the arms and a guide attached with the other of the arms. According to another aspect of the present invention there is provided an assembly of a speculum according to the above one aspect of the invention and an embryo transfer catheter.

A vaginal speculum for use with an embryo transfer catheter, 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 side elevation view of the speculum; Figure 2 is a view of the guide means along the axis of the arms of the speculum; Figure 3 is a perspective view of a warming pod for use in the speculum, and Figure 4 is a sectional side elevation view of Me pod of Figure 3.

The speculum has two moulded arms 1 and 2 of a transparent rigid plastics material, such as SAN, polystyrene or ABS, and a rigid, elongate locking member or bar 3 of a slightly soRer plastic material, such as polypropylene or PVC.

The upper arm 1 is angled approximately midway along its length at an angle of about 120 degrees to divide the arm into a forward portion forming a jaw I O and a rear portion forming a handle 11. The jaw is about lOOmm long with a shape of a semicylindrical shell and having a rounded forward end or nose 12. The handle 11 has a generally convex external profile and a concave internal profile. A large oval aperture 13 extends through the handle 11 at its forward end, where the arm is angled, through which observations or procedures can be

performed. Approximately midway along its length, the handle I 1 has a second, smaller elongate locking aperture 14, aligned axially of the handle.

The second, lower arm 2 is similarly divided into a forward jaw 20 and a rear handle 21, which are angled relative to one another at a sharper angle of about 90 degrees, so that when the two jaws 10 and 20 are brought together, the handles 11 and 21 diverge at an angle of about 30 degrees. The lower arm 2 has a generally convex external profile, a concave internal profile and a rounded forward or patient end 22. In the corner between the jaw 20 and handle 21, the arm 2 has two pivot pins 23, which project inwardly, towards one another, from opposite sides of the arm and engage in holes 18 in the upper ann 1. The locking bar 3 is mounted on the handle 21 and projects through the aperture 14 in the upper arm 1, in the manner described in GB 2334449.

The lower arm 2 has guide means in the form of a short beam 30 hinged at one end 31 with the inside of the arm close to its patient end 22. The opposite end 32 of the guide 30 is enlarged and has a central guide aperture 33 formed through it. The guide 30 is hinged between a stored position where it lies substantially flat within the arm 2, as shown by the broken outline, and the raised position where it extends substantially at right angles to the arm and where the aperture 33 is aligned axially.

The speculum is completed by warming means in the fonn of a pod 40 having an outer jacket 41 containing a gel 42. The pod 40 is generally elongate and oval in shape, its rear end 43 being canted by about 20 relative to the forward end 44 and being dimensioned to fit within the interior surface of the upper jaw 10. The warming pod 40 is secured with the

s jaw 10 by means of an adhesive 45 on the side 46 facing the jaw. On the opposite side 47, the pod 40 has an opening 48 in the heel region between the rear and forward ends 43 and 44.

The opening 48 opens into one end of a channel 49 extending forwardly along the interior of the pod. The channel 49 is closed towards its forward end 50.

Prior to use, the speculum with the warming pod 40 in position is placed in an incubator (not shown) to warm the pod to about 37 C. The handles 11 and 21 are initially fully separated so that the jaws 10 and 20 are closed together, presenting a generally rounded nose, for insertion in the vagina. The jaws 10 and 20 of the speculum are then inserted in the usual way to the desired position. The handles 11 and 21 are then squeezed together until the desired enlargement of the vagina is produced. The jaws 10 and 20 can now be locked in this position using the locking bar 3. The user folds the guide 30 to its raised position and pushes the patient end 60 of an embryo transfer catheter 61 within an outer sheath 62 through the aperture 13 and into the aperture 33 of the guide 30. Because the guide 30 is located close to the forward end of the speculum it can be used to help direct the patient end 60 of the catheter 61 by appropriately angling the speculum.

If difficulties are experienced in inserting the catheter 61 through the cervix, it is withdrawn and its patient end 60 is inserted in the channel 49 in the warming pod 40 via the opening 48. The width of the channel 49 is such that the catheter 61 and its sheath 62 are a close, sliding fit and there is an effective thermal contact of the catheter with the pod 40. The pod 40 can keep the temperature of the catheter elevated sufficiently to ensure the optimum temperature of the embryo is maintained for up to about 30 minutes. Because the warming pod 40 is in intimate contact with the speculum, the body heat of the patient helps maintain

the temperature of the pod. The speculum could have a stopper post formed on it shaped for insertion into the machine end of the catheter. In this way, the machine end of the catheter can be closed while the catheter is stored in the warming pod.

The catheter 61 could be stored in the channel 49 of the warming pod 40 in the speculum prior to use if desired. Altematively, the catheter could be stored in the warming pod separately of the speculum, the pod being secured in the speculum just before use, or after insertion of the speculum in the patient.

The present invention in its various aspects facilitates insertion of a catheter and helps prevent temperature loss that might affect the viability of embryos for transfer.

It will be appreciated that the warming means could take various different forms. For example, the pod could be heated electrically or by flow of a heated fluid supplied externally.

Alternatively, the pod could contain chemicals that liberate heat when combined together.

The warning means need not be a separate component but could be an integral part of the speculum. The guide in the speculum could be used with other catheters and instruments.

Claims

1. A vaginal speculum for use with an embryo transfer catheter, the speculum comprising two arms hinged with one another at a point along their length and forming a pairs of jaws on one side of the hinge point and a pair of handles on the opposite side of the hinge point arranged such that the jaws can be separated by squeezing together the handles, wherein the speculum includes means for receiving the catheter.

2. A speculum according to Claim 1, wherein the means for receiving the catheter is

warning means.

3. A speculum according to Claim 2, wherein the warming means is attached with an arm of the speculum and has a channel in which a part at least of the catheter is received.

4. A speculum according to Claim 3, wherein the warming means is attached with the arm by an adhesive.

5. A speculum according to any one of Claims 2 or 4, wherein the warming means contains a heat-retaining material.

6. A speculum according to Claim 5, wherein the heat-retaining material is a gel.

7. A speculum according to Claim 1, wherein the means for receiving the catheter is a guide located towards the patient end of at least one of the arms.

8. A speculum according to Claim 7, wherein the guide has an aperture through which the catheter is extended.

9. A speculum according to Claim 7 or 8, wherein the guide is foldable from a first position in which it extends substantially lengthwise of the arm to a second position in which the guide is operable to guide the catheter.

10. A speculum according to any one of the preceding claims including warming means attached with one of said arms and a guide attached with the other of said arms.

11. A speculum substantially as hereinbefore described with reference to the accompanying drawings.

12. An assembly of a speculum according to any one of the preceding claims and an embryo transfer catheter.

13. An assembly substantially as hereinbefore described with reference to the . accompanying drawings.

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