GB2305609A

GB2305609A - Intra-uterine device

Info

Publication number: GB2305609A
Application number: GB9619643A
Authority: GB
Inventors: Nicholas James Tyrrell; Jeremy Watson
Original assignee: Rocket Medical PLC
Current assignee: Rocket Medical PLC
Priority date: 1995-09-29
Filing date: 1996-09-20
Publication date: 1997-04-16
Also published as: GB9519851D0; GB9619643D0

Abstract

An intra-uterine device for manipulation of a uterus comprises an expandable member such as a balloon and a stopper slidably movable along the device such that when the balloon is inserted into the uterus and inflated, the stopper can be moved to abut the cervix thereby securely gripping the uterus.

Description

Intra-Uterine Device This invention relates to an intra-uterine device. The device of the invention is especially suited for diagnostic and operative gynaecology.

The manipulation of the uterus for surgical or diagnostic purposes is a fundamental requirement of many gynaecological procedures. For example, to permit acceptable identification, examination, dissection, and ligation of pelvic structures in laparoscopic hysterectomy it is desirable to be able to manipulate the uterus in up to 6 planes.

In most cases this is performed using rigid metal devices such as a 'Spackman Cannula' or Hegar dilator.

These instruments are inserted into the uterus with a portion exposed beyond the vulva to permit handling by an assistant. A toothed vulsellum forcep is often used to grip the cervix to prevent the device from retracting from the uterine body. It is desirable that the cervix is rigidly held to the device.

In infertility investigations it is also a common requirement to establish the patency (or characteristic of remaining open) of the fallopian tubes. This procedure is performed under laparoscopic or radiographic control following the introduction of eg methylene blue or a radio-opaque dye into the uterus.

The presence of dye at the fimbrial ends normally indicates tubal patency. It is important that any device introduced into the uterus in these patient creates as little trauma as possible otherwise infertility may be exacerbated.

According to the present invention there is provided an intra-uterine device, the device having a first end for insertion into the uterus, an expandable member (preferably radially expandable) located at or adjacent the first end, and a stopper, whereby upon insertion of the first end of the device into the uterus and expansion of the member therein, the stopper can abut against the cervix and movement of the uterus relative to the device is resisted.

The balloon and optionally also the stopper may be disposed on a support member of the device.

The expandable member is preferably a balloon.

Expansion of the member in the uterus preferably has the effect of resisting withdrawal of the device therefrom.

Preferably, the stopper can be moved along the longitudinal axis of the device (preferably the support member) and is preferably spaced from the first end.

Preferably, the stopper is shaped to complement the eternal shape of the cervix eg a general cone-shape.

Preferably the stopper is located around the device (preferably the support member) so as to be generally co-axial therewith.

In a preferred embodiment of the invention the stopper has a soft plastic end to abut the cervix to lessen any damaging effects of the stopper on the cervix.

The support member may be rigid eg a stainless-steel tube, or may be of flexible plastics material.

The balloon may be an elastic or non-elastic bag of around 5-30ml capacity (eg 7.5 or 15ml) and is preferably located around the device, preferably the support member, so as to be generally co-axial therewith. The balloon (or other expandable member) may optionally be shaped to conform with the internal shape of the uterus.

The device may also have a ratchet mechanism whereby movement of the stopper along the axis of the device (preferably the support member) is limited to discrete steps and movement in one direction (preferably away from the first end) is prevented. The ratchet mechanism can optionally be disabled with a switch so as to allow free movement of the stopper along the device (preferably the support member) (eg away from the first end).

Preferably, the stopper can be moved along the device or support member by operation of a slider located at the other (second) end of the device or support member.

This can be carried out in use of the device, ie from the second end of the device. The second end and/or the slider may incorporate hand grips etc to facilitate operation of the device outside a patient's body.

The device may have a conduit from the first end of eg the support member to the second end thereof to facilitate the injection of fluids through the device.

The device may also (or alternatively) have a second conduit to inject fluid (eg gas or liquid) into the balloon and the second conduit may extend from the second end of the support member to the balloon.

While further modifications and improvements may be made without departing from the scope of this invention, the following is a description of one or more examples of the invention, with reference to the accompanying drawings in which: Figs 1 a and b show an intra-uterine device; Figs 2 a-h show a handle assembly of the device shown in Fig 1; Figs 3 a-h show a slider of the device of Fig 1; Figs 4 a-d show a stopper of the device shown in Fig 1; Figs 5 a-d show a support member of the device shown in Fig 1; Figs 6 a and b show a sleeve forming a covering for the support member shown in Fig 5; Figs 7 a and b show a tube forming part of the support member shown in Fig 5; and Fig 8 shows a balloon of the device shown in Fig 1.

Referring now to the drawings, an intra-uterine device for manipulation of a uterus comprises a handle 1 (shown separately in Fig 2) mounted on one end of a support member 3 (shown separately in Fig 5). At the other end 3a the support member 3 is bent at an angle of approximately 250 at a distance of approximately 80mm from the tip. The support member 3 comprises a sleeve 9 (shown separately in Fig 6) preferably of plastics material such as polyurethane etc which is disposed over a steel tube 5 (shown separately in Fig 7). A conduit 7 runs axially along one side of the sleeve 9. The conduit 7 is notched at 6 through the wall of the sleeve 9 adjacent the end 3a of the support member 3, and at the other end communicates with a valve 8.On the bent portion of the end 3a, a balloon 10 (shown separately in Fig 8) is disposed over the notch 6 in the sleeve 9, so that fluid injected through valve 8 and conduit 7 enters the balloon 10 through the notch 6. The balloon 10 is sealed to the support member 3.

The tube 5 has a collar 4 at the handle end to retain the handle 1 on the support member 3 and resist relative movement of the handle 1 and the support member 3. At the handle end, the support member 3 has an inlet comprising a connector 3b for injecting dye or other material into the tube 5. At the other end 3a, the support member 3 has an outlet 3c for such fluid disposed axially of the support member 3. A second conduit connects the connector 3b and outlet 3c along the length of the support member.

The device also has a slider 15 (shown separately in Fig 3) which is disposed over the tube 5 and sleeve 7, so as to be slidable axially along the support member 3. The slider 15 has at one end a pair of projections 16a and 16b providing a hand grip 16, and at the opposite end has a stopper 20 (shown in Fig 4). The stopper 20 is preferably attached to the slider 15.

The hand grip 16 has on its upper surface one or more projections 12 functioning as ratchet teeth.

The handle 1 has co-operating ratchet teeth 13 which interact with teeth 12 to limit movement of the slider 15 and stopper 50 along the axis of the device to discrete steps, and also to restrict movement of the slider 15 and stopper 20 in a direction away from the end 3a of the support member 3. Thus axial movement of the slider 15 relative to the handle towards the bent end 3a of the support member moves the stopper 20 in discrete steps and locks it in position against backward movement.

The stopper 20 (shown separately in Fig 4) has one end 20a attached to the slider 15, an opposite end 20b which is in the general shape of a cone whose sides gradually decrease in slope to a flat circular disk 20c. The shape of the end 20b is generally moulded so as to fit snugly against the cervix.

In use, the end 3a of the support member 3 is inserted into the uterus with the balloon 10 deflated. The balloon 10 has a nominal capacity of between 5 and 30mls, and is generally inflated by the injection of fluid through the valve 8, conduit 7 and notch 6 into the balloon 10 when the device is in place. Generally around 7.5mls of fluid (ie gas or liquid) will be injected into the balloon 10. The shape of the balloon 10 can be contoured to fit the uterus internally.

Once the balloon 10 has been inflated, the slider 15 is pushed towards the end 3a by manipulation of the hand grip 16 relative to the handle 1. Movement of the slider 15 and the stopper 20 is limited to discrete steps by the ratchet 12, 13, and backward movement of the slider 15 and stopper 20 away from the end 3a is substantially prevented. The slider 15 and stopper 20 are moved forward towards the end 3a until the stopper end 20b abuts against the outer surface of the uterus.

Thus the uterus and cervix are clamped between the balloon 10 and stopper 20. The expansion of the balloon 10 prevents the device from being withdrawn from the uterus during use, and the clamp allows a surgeon to manipulate the position of the uterus in several planes during surgical procedure.

The ratchet 12, 13 ensures that the clamping force on the uterus is maintained during manipulation. The distance between the inflated balloon 10 and the stopper 20 can be adjusted to allow for variations between patients, and to adjust the force applied during use of the device. The ratchet can be disabled by a switch allowing the stopper 20 to be retracted from the cervix and the device extracted from the uterus when the balloon has been deflated. Such a switch is provided by projection 16b which can be pulled down to disengage the ratchet teeth 12, 13 during use of the device.

Fluid can also be injected into the uterus through the connector 3b. The inflation of the balloon 10 (or expansion of some other expansion member) in the uterus and the tight fitting of the stopper end 20b against the cervix provides a fluid tight seal across the cervix to prevent loss of fluid injected into the uterus through the device. The valve 8 can be self sealing so as to prevent escape of fluid from the balloon during the procedure.

The tip of the end 3a is typically formed of soft plastic material to reduce the risk of damage to the wall of the fundus of the uterus.

The opposing forces of the balloon 10 and stopper 20, clamp the uterus securely allowing enhanced control to manipulate the cervix and uterus during surgery. In addition, the invention obviates the need to use a toothed vulsellum or similar traumatic instrument to grip the cervix during manipulation. A further advantage of the invention is that in certain embodiments, the required force to grip the uterus can be applied with one hand, and the device can be adjustable to fit a wide range of patients. The device can be readily used in patients undergoing outpatient or local anaesthetic procedures without inflicting unnecessary trauma or discomfort.

Modifications and improvements may be incorporated without departing from the scope of the invention.

Claims

CLAINS

1. An intra-uterine device having a first end for insertion into the uterus, an expandable member located at or adjacent the first end, and a stopper, whereby upon insertion of the first end of the device into the uterus and expansion of the member therein, the stopper can abut against the cervix and movement of the uterus relative to the device is resisted.

2. A device as claimed in Claim 1, wherein the expandable member is a fluid-filled balloon.

3. A device as claimed in Claim 1 or Claim 2, where the expandable member is radially expandable.

4. A device according to any preceding Claim, wherein the expandable member and/or stopper are disposed on a support member.

5. A device according to any preceding Claim, wherein the stopper is movable along the longitudinal axis of the device.

6. A device according to Claim 5, wherein movement of the stopper is controllable from the other (second) end of the device.

7. A device according to any preceding Claim, wherein the stopper is spaced from the first end.

8. A device according to any preceding Claim, wherein the stopper is shaped to complement the eternal shape of the cervix.

9. A device according to any preceding Claim, wherein the stopper is located around the device so as to be generally co-axial therewith.

10. A device according to any preceding Claim, wherein the stopper comprises a soft plastic material to abut the cervix to lessen any damaging effects of the stopper on the cervix.

11. A device according to any one of Claims 4-10 wherein the support member is rigid.

12. A device according to any one of claims 4-10, wherein the support member is of flexible plastics material.

13. A device according to any preceding Claim, wherein the expandable member comprises an elastic or non elastic bag of 5-30ml capacity.

14. A device according to any preceding Claim, wherein the expandable member is located around the device so as to be generally co-axial therewith.

15. A device according to any preceding Claim, incorporating a ratchet mechanism whereby movement of the stopper along the axis of the device is limited to discrete steps and/or movement in one direction is prevented.

16. A device according to Claim 15, wherein the ratchet permits movement of the stopper towards the first end, but prevents or limits movement of the stopper away from the first end.

17. A device according to Claim 15 or Claim 16, wherein the ratchet mechanism can be disabled so as to allow free movement of the stopper along the device.

18. A device according to any preceding Claim, wherein the stopper can be moved axially by operation of a slider located at the other (second) end.

19. A device according to any preceding Claim, wherein the second end incorporates grips to facilitate operation of the device outside a patient's body.

20. A device according to any preceding Claim, wherein the device has one or more conduits from the first end to the second end to facilitate the injection of fluids through the device.

21. A device according to any preceding Claim, wherein a conduit is provided to inject fluid into the expandable member.

22. An intra-uterine device substantially as hereinbefore described with reference to, and as shown in, the accompanying drawings.

23. A method of gripping a uterus for manipulation, the method comprising inserting into the uterus an expandable member located on one end of an elongate support member, the elongate support member having thereon a stopper which is movable axially; expanding the expandable member; and moving the stopper along the support member to abut the cervix.

24. A method according to Claim 23, wherein the movement of the stopper is limited to one direction by a ratchet.

25. A method according to Claim 23 or Claim 24 wherein the movement of the stopper away from the cervix is limited by a ratchet.

26. A method of gripping a uterus substantially as hereinbefore described.