WO2021045710A1

WO2021045710A1 - Anal biofeedback device

Info

Publication number: WO2021045710A1
Application number: PCT/TR2020/050794
Authority: WO
Inventors: Vafi ATALAY
Original assignee: T.C. Marmara Üni̇versi̇tesi̇
Priority date: 2019-09-03
Filing date: 2020-09-02
Publication date: 2021-03-11

Abstract

Invention relates to an anal biofeedback device (10) to be used for treatment of anal diseases causing leakage of gas and stool and comprising a balloon (6) entering anal canal of patient and providing measurement of pressure of flexing anal canal muscle, an inlet end (7) formed in front part of said balloon (6) and put into anal canal firstly for entering embodiment into anal canal, air pump (1) providing manual inflation of said balloon (6), manometer (2) displaying visual display of pressure applied to balloon (6) by anus after placement of inflated balloon (6) in anal canal, resetting ring (21) mounted on said manometer (2) and rotatable and providing reset of value read on manometer (2), pressure indicators (212) located side by side in 3 different colours, indicating 0 point on said resetting ring (21) and indicating pressure intervals, a catheter (4) connected to said manometer (2) and air pump (1) and providing transmission of air to balloon (6).

Description

ANAL BIOFEEDBACK DEVICE

Technical Field

The invention relates to a biofeedback method providing muscle exercise, one of methods used in anal incontinence (uncontrolled leakage of gas on stool from anus) treatment.

The invention particularly relates to anal muscle exercise device not requiring hospital for anal biofeedback treatment, not requiring a practicing physician or a nurse but patient himself/herself conduct treatment easily,

Present State of the Art

Although stool/anal incontinence is a common problem today, it is not pronounced so much because of embarrassing. The problem is an important one in such that it can impact social activities of patient as well as cause changes in life style. It can be seen in every man and woman. Frequency of it in society is reported as 2 %. Although it is seen more common, it is not discussed so much because of embarrassment. The rate of it in the elder in pensions is 30 %.

There are several methods applied for treatment of anal incontinence. They are change in life style, diet and intestinal habit changes, medicines aiding hardening intestinal content, pelvic base exercises, anal biofeedback, sacral nerve simulation and surgical treatments.

Success in anal biofeedback treatment is reported as 70 % of biofeedback treatment of patients suffering from faecal incontinence. Beside high rate of success in anal biofeedback treatment, high cost of it creates disadvantage in terms of applicability.

Anal biofeedback devices are used in treatment of anal incontinence (uncontrolled leakage of gas and stool from anus). Working of muscles in anal area where disease occurs is provided. Computerized devices with electronic hardware are used for this. Some of those devices have balloon structure and exercises made after placement of balloon in anus provide improvements.

In the previous art, anal biofeedback treatment was conducted at hospital under supervision of physician. The success rate of the treatment is high but its cost is also high, which creates disadvantage in terms of applicability.

In the related art, cost per session of biofeedback applications is estimated as 125$ -600$ This is a price not convenient for users and also does not allow treatment for every body.

Because of requirement for hospital for applied anal biofeedback, need for a physician or nurse health staff to manage application and high cost, it is difficult to apply in practice and it is not available in all hospitals in terms of availability. In the related art, work force works of biofeedback applications are too much.

During patent research made in previous related art, US patent numbered US5924984A is seen. In the invention a balloon located on sharp end of apparatus is placed in anorectal canal and treatment is made by means of measurement of the pressure applied onto the balloon by anorectal canal by means of pressure electronic sensor. As hospital conditions are required for the treatment, the application can be given as example for disadvantages mentioned above.

In conclusion, developments have been made in anal biofeedback device in parallel to technology and, therefore, new embodiments eliminating the above disadvantages and offering solutions to existing systems are needed.

Purpose of the Invention

Differently from the embodiments used in the present related art the invention relates to anal biofeedback device developed to solve said disadvantages and provide some additional advantages.

Main purpose of the invention is to apply anal biofeedback treatment by means of eliminating use of materials such as computer, electronic device and sensor probes. Balloon on end of a catheter specifically designed for this is connected to manometer and visual biofeedback is given to patient according to pressure values read on manometer. Thus patient may continue treatment at home on his/her own as long as wanted and without need for a physician or nurse health staff.

Another purpose of the invention is to facilitate practical application of the device as no hospital environment is needed for applied anal biofeedback, no practicing physician or nurse health staff is needed and cost is low.

A further purpose of the invention is to provide easy treatment at home for those not desiring to have treatment because of embarrassment as the patient can apply device on his/her own.

Another purpose of the invention is to provide better hygienic use by replacing catheter as part of application a time patient desires. In addition, as the device is special for person, replaceable part, catheter is not to be replaced after each use. Therefore, catheter is not based on use-discard model but clean and use. Thus patient is not exposed to extra cost.

The structural and characteristic features and all advantages of the invention will be understood better in the figures given below and the detailed description by reference to the figures. Therefore, the assessment should be made based on the figures and taking into account the detailed descriptions.

Brief Description of Figures

Figure - 1 shows perspective view of biofeedback treatment device of the invention. Figure - 2 shows perspective view of distal end of biofeedback treatment device of the invention. Figure - 3 shows exploded view of resetting ring of biofeedback treatment device of the invention.

Reference Numbers

10. Anal biofeedback device

1. Air pump

2. Manometer

21. Resetting ring

211. Dial indicator

212. Pressure indicator

3. Manometer hose

4. Catheter

5. Limiting end

6. Balloon

7. Inlet end

Detailed Description of an illustrative embodiment of the Invention

Structure principle

Anal biofeedback device (10) comprises air pump (1) and connected manometer hose (3) catheter (4) limiting end (5), balloon (6) and Teflon end (7) Also manometer (2) is provided in upper part of air pump (1). Figure 1 shows two-dimension view of anal biofeedback device (10).

Air pump (1) is used to inflate balloon (6) by hand pressing.

Manometer (2) displays pressure change in balloon (6) and provides feedback to patient. Front part has resetting ring (21). Resetting ring (21) is the component resetting value read after inflation of the balloon (6). After balloon (6) is inflated, reset point on ring is brought to dial (211) position by turning ring. Thus measured value is reset. Figure 3 shows resetting ring (21) embodiment.

Manometer hose (3) provides connection between manometer (2) and catheter (4).

Catheter (4) is connected to manometer hose (3) and air given by air pump (1) is transmitted to balloon (6) on distal end.

Inlet end (7) of said catheter (4) is inserted to balloon (6) and limiting end (5).

Limiting end (5) prevents further escape of balloon (6) further in anus. The balloon (6) is the part that is inflated by air pump (1) and placed in anus as described above. Pressure increase in balloon (6) after compression of anus is reflected to manometer (2).

Inlet end (7) can enter anus without creating trauma in anus thanks to robust and fusiform shape.

Mounting Principle

Manometer (2) is connected onto air pump (1). Resetting ring (21) is mounted on manometer (2) device. Then manometer hose (3) is placed in centre of these two components. Catheter (4) is inserted to manometer hose (3).

Inlet end (7) of said catheter (4) is inserted to balloon (6) and limiting end (5). Inlet end (7) is placed at the very distal end of structure. Balloon (6) is located between inlet end (7) and limiting end (5).

Said manometer hose (3) is fixed to manometer (2) and is not changed. Catheter (4) installed to manometer hose can be replaced whenever required.

Use principle

Air pump (1) is manually tightened and air occurring therein is sent to balloon (6) from manometer hose (3) and catheter (4) and provides inflation of balloon (6). Lubricant (Vaseline) is put onto inlet end (7) and entrance into anal canal from anus is provided. Entrance is made with no hurting thanks to structure of inlet end (7). Limiting end (5) is proceeded by means of catheter (4) until it reaches anus opening in order to keep balloon (6) at anus muscle (sphincter) level. Figure 2 shows detailed view of inlet end (7), balloon (6) and limiting end (5) embodiment.

After placement, patient flexes anus and causes increase in pressure of balloon (6) and pressure occurring in balloon (6) is seen in manometer (2). The more patient flexes the more pressure increases and results in value increase in manometer (2). Zero point on resetting ring (21) is brought to the position when indicator (211) was at before compression by patient. The degree of flexing anus by patient is easily learnt as visual feedback from colours on manometer (2) thanks to thick lines in 3 different colours on the ring.

Patient repeats flexing for half an hour to 1 hour on average a day for several times during day and tries to increase manometer (2) value. Doing exercise for development of tightening power of anal sphincter muscle is provided by monitoring progress in manometer (2) every day by use of the device.

Patient can do this operation easily at home on his/her own. Thus patients not having treatment because of embarrassment can get the treatment of diseases on their own.

As the variable material here is catheter (4). As the device belongs to the patient himself/herself, s/he can use catheter (4) after washing it as well as use new catheter (4) by disconnecting it from manometer hose (3) whenever desires so. Thus hygiene is provided. Alternatively, material to be put onto catheter (4) can be used as a protective bag ad thus hygiene can be provided.

Claims

1. An anal biofeedback device (10) comprising a balloon (6) entering anal canal of patient and providing measurement of pressure of flexing anal canal, inlet end (7) formed in front part of said balloon (6) and put into anal canal firstly for entering embodiment into anal canal for use in treatment of anal diseases causing leakage of gas and stool and characterized in comprising

• an air pump (1 ) providing manual inflation of said balloon (6),

• a manometer (2) displaying visual display of pressure applied to balloon (6) by anus after placement of inflated balloon (6) in anal canal,

• a resetting ring (21) mounted on the manometer (2) and providing reset of value read on manometer (2) after turning,

• a catheter (4) connected to the manometer (2) and air pump (1) and providing transmission of air to balloon (6) keeping the inlet end (7) and balloon (6) in same direction and thus facilitating easy insertion of embodiment into anal canal.

2. An anal biofeedback device (10) according to claim 1 characterized in comprising a manometer hose (3) inserted onto air pump (1) and manometer (2) from one end and to catheter (4) from other end and transmitting air exiting from air pump (1) to balloon (6) through catheter (4).

3. An anal biofeedback device (10) according to claim 1 characterized in comprising a limiting end (5) placed on back of said balloon (6) and limiting progress of balloon (6) in anal canal after entering anal canal.

4. An anal biofeedback device (10) according to claim 1 characterized in the inlet end (7) is blunt and fusiform for enable easily entrance into anal canal.

5. An anal biofeedback device (10) according to claim 1 characterized in comprising a dial indicator (211) moving at rate of pressure quantity reflected into the manometer (2) and displaying measured value thereof.

6. An anal biofeedback device (10) according to claim 1 or claim 5 characterized in comprising pressure indicators (212) formed on the resetting ring (21) and displaying pressure intervals to be indicated by the dial (211 ).