GB2560963A

GB2560963A - A balloon tamponade device

Info

Publication number: GB2560963A
Application number: GB1705116.0A
Authority: GB
Inventors: Varma Rajiv; Varma Natasha
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-03-30
Filing date: 2017-03-30
Publication date: 2018-10-03
Also published as: GB201705116D0

Abstract

A balloon tamponade device 8 is described for controlling post-partum haemorrhage. In one embodiment the tamponade 8 comprises surface features 13 configured to increase friction between the device 8 and the uterus into which it is inserted. The features 13 preferably take the form of projections, domes or nubs, or may be formed by providing the balloon with a knurled surface. In another embodiment the tamponade 8 comprises both first 11 and second 10 regions configured such that, when the uterus in which the device 8 is inserted is not contracted, the first region 11 limits expansion in the first region 11, thereby resulting in increased expansion of the second region 10. When the uterus in which the device 8 is inserted however contracts, a compressive force is applied by the uterus to the second region 10 and the first region 11 distends further than the limit. In another embodiment the tamponade 8 comprises a reinforced insertion end 12 against which an insertion tube 15 is located, and wherein the reinforced end 12 projects beyond the tube in an insertion direction.

Description

(71) Applicant(s):

Rajiv Varma

Hillwood Grove, Hutton Mount, Essex, CM13 2PF, United Kingdom (56) Documents Cited:

WO 2018/033401 A1 WO 2002/024085 A1 US 3049125 A US 20060212064 A1 US 20020082634 A1

WO 2005/013834 A1 CN 201341907 Y US 20140243845 A1 US 20030236546 A1

Natasha Varma

Hillwood Grove, Hutton Mount, Essex, CM13 2PF, United Kingdom (58) Field of Search:

INT CLA61B, A61M

Other: WPI, EPODOC, Patent fulltext (72) Inventor(s):

Rajiv Varma Natasha Varma (74) Agent and/or Address for Service:

Reddie & Grose LLP The White Chapel Building,

Whitechapel High Street, London, E1 8QS, United Kingdom (54) Title of the Invention: A balloon tamponade device Abstract Title: A uterine balloon tamponade device (57) A balloon tamponade device 8 is described for controlling post-partum haemorrhage. In one embodiment the tamponade 8 comprises surface features 13 configured to increase friction between the device 8 and the uterus into which it is inserted. The features 13 preferably take the form of projections, domes or nubs, or may be formed by providing the balloon with a knurled surface. In another embodiment the tamponade 8 comprises both first 11 and second 10 regions configured such that, when the uterus in which the device 8 is inserted is not contracted, the first region 11 limits expansion in the first region 11, thereby resulting in increased expansion of the second region 10. When the uterus in which the device 8 is inserted however contracts, a compressive force is applied by the uterus to the second region 10 and the first region 11 distends further than the limit. In another embodiment the tamponade 8 comprises a reinforced insertion end 12 against which an insertion tube 15 is located, and wherein the reinforced end 12 projects beyond the tube in an insertion direction.

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A BALLOON TAMPONADE DEVICE

FIELD OF THE INVENTION

The present invention relates to a balloon tamponade device for controlling post-partum haemorrhage.

BACKGROUND OF THE INVENTION

Post partum haemorrhage (PPH) occurs in around 10% of all births, the most common cause of PPH is uterine atony (inability of uterine muscle to contract after the delivery of placenta). Use of uterotonic drugs is the first-line treatment for such bleeding. When these drugs fail to control the bleeding, balloon devices are inserted into the uterine cavity.

BRIEF SUMMARY OF THE INVENTION

The invention in its various aspects is defined in the independent claims below to which reference should now be made. Advantageous features are set forth in the dependent claims.

The example arrangements disclosed comprise a surgical instrument for controlling PPH due to uterine atony after normal delivery or after a caesarean section.

Arrangements are described in more detail below and take the form of a balloon tamponade device for controlling post-partum haemorrhage. The balloon tamponade device comprises surface features configured to provide or increase friction between the device and a uterus or cavity. The described balloon tamponade device comprises a first region and a second region. The device is configured such that: when a uterus or cavity in which the device is inserted is not contracted, the first region limits the expansion of the device in the first region to a limit so as to increase expansion of the second region; and when the uterus or cavity in which the device is inserted contracts, a compressive force is applied by the uterus or cavity to the second region and the first region distends further than the limit. The described balloon tamponade device comprises a reinforced insertion end against which a tube is located to insert the device into a uterus or cavity; wherein the reinforced insertion end projects beyond the tube in an insertion direction.

Arrangements are described in more detail below and take the form of a device for controlling haemorrhage from the uterine cavity, comprising of an expandable balloon, a tube for insertion and drainage and another tube for supplying a fluid such as or a gas to inflate the balloon. When the balloon is inserted into the uterine cavity or cavity, it is inflated with a fluid or gas such as a gas, so that the balloon expands and conforms to the uterine cavity and exerts compressive force against the walls to control haemorrhage. The balloon has a thickened portion at the distal end that forms a cuff around the insertion and drainage tube for a safer insertion. The balloon also has a middle thin portion that forms the main expansion part and a lower thicker portion (first region) that only expands in the lower uterine segment if the upper part of uterus has contracted. The surface of the balloon has small projections that increase the resistance between the balloon surface and the internal surface of the uterine cavity.

The device is as a balloon device to control haemorrhage after childbirth and may be used to control or stop post partum haemorrhage PPH (bleeding after childbirth) due to atonic uterine muscle.

The advantage of the instrument is the safety of insertion, ease of use, reduced risk of expulsion and ability to control haemorrhage from the lower uterine segment. It can also be used temporarily to control bleeding occurring from the cervix and vaginal walls.

The balloon tamponade device for controlling post partum haemorrhage described may comprise an expandable balloon comprising of thick distal part forming a cuff around the insertion/drainage tubing, a thin middle part and a thicker lower part. The balloon surface may have projections to increase the friction between the balloon and the inner surface of the uterus. Insertion and drainage tubing and a smaller tube within or outside this tube for inflation and deflation may be provided. The balloon of the balloon tamponade device may comprise a thicker upper part that forms a cuff around the distal end of the insertion/drainage tubing. The balloon may comprise a thicker upper part of the balloon that forms the dome of the balloon and extends beyond the distal end of insertion/drainage tubing. The balloon may comprise a thinner middle part of the balloon that distends when inflated to exert pressure on the inner surface of the middle and upper part of the uterus. The balloon may comprise a thicker lower part of the balloon that distends partially when inflated to form a plug that helps to reduce the risk of balloon expulsion from the cervix.

The balloon may comprise a thicker lower part of the balloon that distends further when upper part of uterus is contacted that helps to reduce the bleeding from the lower part of the uterus. The balloon may have projections on the surface that increase the frictional forces between the balloon and the inner uterine surface. The projections on the surface may be of varying length and numbers. The balloon may have projections on the surface that can be directed downwards to further reduce the risk of expulsion. The projections may be spaced apart over the surface of the wall, for example, spaced apart evenly over the surface of the wall. The outer surface of the wall may comprise a knurled surface. The projections may be domes or nubs.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in more detail, by way of example, with reference to the accompanying drawings, in which:

FIG. 1 is a view of a balloon tamponade device embodying an aspect of the present invention in the form of a complete device with the balloon in the neutral position;

FIG. 2 is a cross section of part of the balloon tamponade device of FIG. 1 in the form of a longitudinal section of the balloon showing details of the surface with projections, details of balloon wall and the details of tubing;

FIG. 3 is a cross section of part of the balloon tamponade device of FIG. 1 in use in the form of a longitudinal section of the balloon inflated inside the upper part of a uterus; and

FIG. 4 is a cross section of part of the balloon tamponade device of FIG. 1 in use in the form of a longitudinal section when the upper part of uterus has contracted thereby squeezing the fluid from the upper thinner part of balloon to the lower thicker part and inflating it against the walls of the lower part of the uterus.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

The present invention is not limited to the particular shape disclosed. It is expressly understood that a large number of different sizes, shapes and dimensions of the inflatable portion can be made. The following description is meant to be illustrative only and not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art, in view of this description.

An example balloon tamponade device 8 will now be described with reference to Figures 1 to 4. In use, the device is inserted in an insertion direction into a uterus.

The balloon of the balloon tamponade device can be in different shapes. In this example, neutral volume of the balloon is around 200cc but can be smaller or larger. In this example, the inflated balloon can hold up to 1500cc of fluid or gas. The material of the balloon may be a thin distensible biocompatible material.

The distal end of the balloon is thicker or reinforced to form a cuff 12 forming a reinforced insertion end around the insertion/drainage tube 15 that acts as a safety mechanism during insertion and reduces the risk of perforation of the uterine wall during insertion. The reinforced insertion end projects beyond the tube in the insertion direction. This also forms a funnel or funnel shape to allow better attachment to the uterine walls when suction is applied to the proximal end of the drainage tubing 15. It funnels towards the tube. It also allows the physician to have a better feel of resistance when the distal end of balloon reaches the uterine fundus 20. This obviates the need for use of ultrasound scanning to check the position of the balloon as required by several other devices. The middle part of balloon 10 is a thinner part (second region) that distends the most when inflated, and is located in the middle and upper part of the uterine cavity 20. The lower or proximal part of the balloon wall 11 (first region) is made of thicker material that is less distensible than the upper thinner part. It can be the lower 1/3 or % or % of the balloon depending upon the design or materials. This part distends partially in the lower part or lower segment of the uterine cavity 21. The distension of the lower part 11 of the balloon is greater 21a if the upper part of the uterine wall contracts 20a. The lower part of the balloon when partially inflated forms a plug at the cervix 23 and also prevents the balloon from expulsion into the vagina 22.

The surface of the balloon includes surface features in the form of multiple projections 13 that can be of varying length or thickness, and these are attached to the balloon surface, at an outer surface of the wall, at different intervals. In this example, the projections are nubs. These projections increase the resistance of balloon surface with the inner uterine surface and serve to reduce the risk of balloon expulsion that which is a common problem with the balloons presently available balloons. These projections can be made from the same material as the balloon or a different material and can be in a direction that would further to improve the grip of the balloon in the cavity of the uterus, for example, angled in a direction opposite to an insertion direction of the balloon tamponade device. The balloon surface can also be coated with one or more substances that promotes blood coagulation.

The attached tubing 15 has smaller tubing 16 within or outside the larger tube’s lumen that is connected to the balloon for inflation, forming an inflation tube with an inflation end, and has a two-way tap 19 or other mechanism to attach it to a syringe (or other inflation means) or any other method to inflate the balloon from the inflation end using fluid, such as air, this is also used to empty the balloon or reduce the fluid as required for deflation purposes.

The larger tube is open at the distal end of the balloon 14 and acts as the drainage tube to drain any blood that is collected in the uterine cavity, it can be connected at its proximal end 17 to a bag for collecting the blood.

Tubing 15 due to its firm material serves dual purpose of being a drainage tube as well as a handle to insert the balloon into the uterine cavity.

Embodiments of the present invention have been described. It will be appreciated that variations and modifications may be made to the described embodiments within the scope of the present invention.

Claims

I. A balloon tamponade device for controlling post-partum haemorrhage, the balloon tamponade device comprising surface features configured to provide friction between the balloon tamponade device and a uterus.

5
2. A balloon tamponade device according to any preceding claim, wherein the device comprises a balloon, the balloon comprising a wall which distends when inflated.
3. A balloon tamponade device according to claim 2, wherein the surface features are located on an outer surface of the wall.
4. A balloon tamponade device according to claim 3, wherein the surface features comprise

10 a plurality of projections projecting outwardly from the outer surface of the wall.
5. A balloon tamponade device according to claim 4, wherein the plurality of projections are spaced apart over the surface of the wall.
6. A balloon tamponade device according to claim 5, wherein the plurality of projections are spaced apart evenly over the surface of the wall.

15
7. A balloon tamponade device according to any preceding claim, wherein the outer surface of the wall comprises a knurled surface.
8. A balloon tamponade device according to any preceding claim, wherein the surface features are domes.
9. A balloon tamponade device according to any preceding claim, wherein at least some of 20 the surface features are nubs.
10. A balloon tamponade device according to any preceding claim, wherein at least some of the surface features are angled towards an end of the balloon tamponade device.

II. A balloon tamponade device according to any preceding claim, wherein at least some of the surface features are angled at an angle with a component in a direction opposite to

25 an insertion direction of the device.
12. A balloon tamponade device according to any preceding claim, further comprising an insertion tube for insertion.
13. A balloon tamponade device according to claim 12, wherein the insertion tube is also a drainage tube.
14. A balloon tamponade device according to claim 13, the device further comprising an inflation tube.

5 15. A balloon tamponade device according to claim 14, wherein the inflation tube is located within the insertion tube.

16. A balloon tamponade device according to any of claims 12 to 15 when dependent on any of claims 2 to 11, the device comprising a balloon which distends when inflated, and the tube further comprising an insertion end, wherein the insertion end of the tube is

10 attached to the balloon.

17. A balloon tamponade device according to any of claims 12 to 16, wherein the tube comprises an inflation end.

18. A balloon tamponade device according to claim 17, the device further comprising an inflation means, such as a syringe, for inflating the balloon, the inflation means attached to
15 the inflation end of the tube.
19. A balloon tamponade device according to claim 18, wherein the inflation means is attached to the inflation end of a tube through a tap configured to inflate and deflate the balloon.
20. A balloon tamponade device for controlling post-partum haemorrhage, the balloon

20 tamponade device comprising a first region and a second region, and the device being configured such that:

when a uterus in which the device is inserted is not contracted, the first region limits the expansion of the device in the first region to a limit so as to increase expansion of the second region; and

25 when the uterus in which the device is inserted contracts, a compressive force is applied by the uterus to the second region and the first region distends further than the limit.
21. A balloon tamponade device according to claim 20, the device comprising a balloon which distends when inflated, and the tube further comprising an insertion end, wherein the insertion end of the tube is attached to the balloon.
22. A balloon tamponade device according to claim 21, wherein the first region is thicker than at least some of the rest of the balloon.
23. A balloon tamponade device according to any of claims 20 to 22, wherein the tube comprises an inflation end.
24. A balloon tamponade device according to claim 23, the device further comprising an inflation means for inflating the balloon, the inflation means attached to the inflation end of the tube.
25. A balloon tamponade device according to claim 24, wherein the inflation means is attached to the inflation end of a tube through a tap configured to inflate and deflate the balloon
26. A balloon tamponade device according to any of claims 20 to 25, wherein the first region is configured to form a plug at a cervix to prevent expulsion from the uterus.
27. A balloon tamponade device according to any of claims 20 to 26, wherein the first region is configured to form a plug at a cervix when the balloon is at least partially inflated.
28. A balloon tamponade device according to any of claims 20 to 27, further comprising an insertion tube for insertion.
29. A balloon tamponade device according to claim 28 wherein the insertion tube is also a drainage tube.
30. A balloon tamponade device according to claim 29, further comprising an inflation tube.
31. A balloon tamponade device according to claim 30, wherein the inflation tube is located within the insertion tube.
32. A balloon tamponade device for controlling post-partum haemorrhage, the balloon tamponade device comprising:

a reinforced insertion end against which a tube is located to insert the device into the uterus; wherein the reinforced insertion end projects beyond the tube in an insertion direction.
33. A balloon tamponade device according to claim 32, wherein the reinforced insertion end forms a funnel that funnels towards the tube.

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34. A balloon tamponade device according to claim 32 or claim 33, wherein the tube is an insertion tube and also a drainage tube.
35. A balloon tamponade device according to claim 34, further comprising an inflation tube.
36. A balloon tamponade device according to claim 35, wherein the inflation tube is located within the insertion tube.

10
37. A balloon tamponade device according to any of claims 32 to 36, the device comprising a balloon which distends when inflated, and the tube further comprising an insertion end, wherein the insertion end of the tube is attached to the balloon.
38. A balloon tamponade device according to claim 37, wherein the reinforced insertion end is thicker than at least some of the rest of the balloon.

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39. A balloon tamponade device according to any of claims 32 to 38, wherein the tube comprises an inflation end.
40. A balloon tamponade device according to claim 39, the device further comprising an inflation means for inflating the balloon, the inflation means attached to the inflation end of the tube.

20
41. A balloon tamponade device according to claim 40, wherein the inflation means is attached to the inflation end of a tube through a tap configured to inflate and deflate the balloon
42. A balloon tamponade device according to any preceding claim, wherein at least some of the device is coated with a substance that promotes blood coagulation.

Intellectual

Property

Office

GB1705116.0

1-19 & 42 (in part)