WO2007071381A2 - Anal pressure measuring adapter - Google Patents
Anal pressure measuring adapter Download PDFInfo
- Publication number
- WO2007071381A2 WO2007071381A2 PCT/EP2006/012264 EP2006012264W WO2007071381A2 WO 2007071381 A2 WO2007071381 A2 WO 2007071381A2 EP 2006012264 W EP2006012264 W EP 2006012264W WO 2007071381 A2 WO2007071381 A2 WO 2007071381A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pressure measuring
- basic body
- measuring adapter
- adapter according
- pressure
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
- A61B5/224—Measuring muscular strength
- A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/31—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
Abstract
An anal pressure measuring adapter has a closure plug (1), which can be inserted into the anus, has a peripheral seal (10) and is provided with an opening (6) , which is designed for the attachment of a pressure measuring device. A measuring device for the retrograde measurement of the urethral opening pressure is preferably connected to the opening (6).
Description
Anal pressure measuring adapter
The invention relates to an anal pressure measuring adapter, which can be used for measuring the function and the opening pressure of the anal sphincter.
When giving birth, mothers often suffer injury to the anal sphincter. The use of forceps represents a particular risk factor here. Such injuries may lead to malfunctions or incontinence. Before treatment can be administered, there must be a clear diagnosis. However, it is not easy to appraise the integrity of the anal sphincter mechanism.
US Patent 5,533,515 discloses a device with which the pressure exerted by the anal sphincter can be measured. In this case, a cylindrical measuring probe which is provided with pressure sensors on its lateral surface is inserted into the anus of a patient. However, this device is complex and relatively awkward to handle.
In the article by M. Slack et al . "Urethral Retro- Resistance Pressure: a New Clinical Measure of Urethral
Function", Neurology and Urodynamics 23, 1-6 (2004), a method of measuring the function of the urethral sphincter in women is described. In order to measure the opening pressure in a retrograde way, a conical probe approximately 5 mm wide is inserted into the external opening of the urethra. A seal thereby forms around the probe . The probe is provided with a bore and is connected to a measuring device, which pumps a
sterile liquid through the bore to the patient's bladder and measures the pressure thereby occurring. When the pressure has built up, it rises until the sphincter opens. After that, the pressure curve exhibits a plateau region, the pressure of which reproduces the opening pressure of the sphincter. Although the measurement takes place in a retrograde way, which is very comfortable for patients, it is also characteristic of the opening pressure of the urethral sphincter under physiological conditions.
It is an object of the invention to provide a possible way of checking the function of a patient's anal sphincter in a manner that is easy, reliable, less costly and comfortable for the patient.
This object is achieved by an anal pressure measuring adapter with the features of Claim 1. Advantageous refinements of the invention are provided by the subclaims . Claim 19 relates to a method in which the pressure measuring adapter according to the invention is used.
The anal pressure measuring adapter according to the invention has a closure plug which can be inserted into the anus, has a peripheral seal and is provided with an opening which is designed for the attachment of a pressure measuring device. The opening is preferably designed for the connection of a pressure measuring device for the retrograde measurement of the urethral opening pressure. An example of a device that can be used as such a measuring device is the one described in the aforementioned publication by M. Slack et al . , which is sold by Gynecare (Ethicon, Inc.) under the name "MoniTorr" . The opening in the closure plug is in this case preferably chosen to be of such a size that the probe of the "MoniTorr" device can be pushed in at this point and thereby forms a seal with respect to the closure plug.
For carrying out a measurement of the anal opening pressure of a patient, firstly the pressure measuring adapter according to the invention is inserted into the patient's anus, to be precise in such a way that the peripheral seal of the closure plug lies against the tissue of the patient with a pressure-tight effect. Subsequently, a measuring device for the retrograde measurement of the urethral opening pressure is connected at the opening of the pressure measuring adapter, for example by inserting the described probe of a "MoniTorr" device. The subsequent measurement is carried out with the aid of this device. When the "MoniTorr" device is used, this takes place in a way analogous to a measuring procedure for determining the urethral opening pressure. For this purpose, a sterile liquid, for example a physiological saline solution, is forced from the basic unit, to which the probe is connected, for example by means of a tube, in the direction of the patient and the pressure profile is simultaneously recorded. The pressure increases until the anal sphincter opens, which is evident in the pressure profile by a plateau region, since the pressure does not rise any further (at least initially) if liquid continues to be pumped in the direction of the patient. The pressure in the plateau region is the opening pressure sought .
Although the measurement that has been explained takes place in a retrograde way, the opening pressure thereby determined is characteristic of the opening pressure of physiological interest in the direction from the inside to the outside and allows a clear diagnosis to be made.
The anal pressure measuring adapter according to the invention is of a simple construction and can be produced at low cost. In principle, many types of pressure measuring devices can be attached to the opening of the closure plug, but the special advantages
- A - of the invention are obtained if, as explained, an already known measuring device for the retrograde measurement of the urethral opening pressure is used. The invention therefore makes it possible to use a measuring device known from another medical application, dispensing with the need for high development costs and allowing the user to be offered a system that is versatile in the way it can be used. If, for example, the "MoniTorr" device is to be used, all that is necessary, at most, is to set up the software or firmware of the device for determining the known anal opening pressure, for example by adapting the time profile of the rising pressure.
The configuration of the closure plug with the peripheral seal is not a trivial problem, since the required integrity of the pressure-tight effect between the peripheral seal and the body tissue of the patient is not readily obtained.
In the case of preferred embodiments of the invention, the closure plug has a basic body, which may be formed in the manner of the frustum of a cone, with a base, a lateral surface and a side opposite from the base. The base of the basic body is preferably surrounded by an inwardly projecting flange, the flange also being able to extend from the basic body offset in relation to the base (i.e. towards the side opposite from the base) . The base may act as a retaining means for the peripheral seal and, if it is large enough, prevents the closure plug from being inserted too far into the patient .
The basic body preferably comprises an elastic material, for example a silicone.
A frustoconical basic body is preferably hollow and open at the base. The opening for the attachment of the pressure measuring device is preferably arranged on
the side of the basic body that is opposite from the base.
The peripheral seal of the closure plug is preferably arranged on the lateral surface of the basic body and may be formed for example by the material of the basic body itself.
The peripheral seal may, however, also have components in addition to the basic body, for example an outer membrane, preferably made of silicone, which encloses an intermediate space. In this case, the outer membrane may delimit the intermediate space together with the basic body. The intermediate space may be filled with a gas, for example air, but also with a gel and/or a liquid, for example a silicone oil. Given a suitable material of the basic body, the filling substance for the intermediate space can be filled into the intermediate space through the basic body, for example with a syringe, the point of perforation closing again once the cannula is withdrawn. In the case of such embodiments, the configuration of the membrane, including its shape, and the selection of the filling material for the intermediate space and the setting of the pressure in the intermediate space can be used to adapt the peripheral seal of the closure plug in a wide range, in order to achieve a reliable sealing effect.
It is also conceivable for the peripheral seal to comprise a gel, which preferably lies against the basic body. Such a gel may also be used without an outer membrane .
In the case of other preferred embodiments, the peripheral seal comprises a foam, preferably a polyurethane foam, the peripheral seal preferably lying against the basic body. It is also conceivable for the basic body itself to be formed from a foam, preferably
a polyurethane foam, and for the peripheral surface of the basic body to be formed as a peripheral seal . In this case, the basic body may be provided with a frustoconical cavity, at the tip of which the opening is formed.
Apart from the described frustoconical shape, other shapes also come into consideration for the basic body, for example frustoconical configurations with surfaces curved in the direction of the longitudinal cone axis, spherical shapes, hump-like shapes, etc.
The invention is described below on the basis of exemplary embodiments . In the drawings :
Figure 1 shows a longitudinal section through a first embodiment of a pressure measuring adapter according to the invention,
Figure 2 shows a longitudinal section through a second embodiment of a pressure measuring adapter according to the invention and
Figure 3 shows a longitudinal section through a third embodiment of a pressure measuring adapter according to the invention.
In Figure 1, an embodiment of an anal pressure measuring adapter 1 is represented in longitudinal section, the longitudinal axis being denoted by L. The pressure measuring adapter 1 is configured as a closure plug that can be inserted into the anus and has a basic body 2, which in Figure 1 is depicted simply by shading. The basic body 2 is formed in the manner of the frustum of a cone and hollow and has a lateral surface 4. At the base 5, the basic body 2 is open, so that there is free access to the interior space of the basic body 2, while on the side opposite from the base 5 there is an opening 6. In the exemplary embodiment,
the opening 6 is produced by cutting off the tip of a cone. The opening 6 has a diameter which is adapted to the connection of a separate pressure measuring device, preferably to the probe described above of a "MoniTorr" device .
At the height of the base 5, the basic body 2 is surrounded by an outwardly projecting flange 8.
In the exemplary embodiment, the basic body 2 including the flange 8 is produced from a silicone of medical quality, for example from the material sold by Wacker Chemie AG under the name "Elastosil E 43". This silicone is deformable and elastic, so that the edge of the opening 6 serves at the same time as a sealing surface .
Arranged on the lateral surface 4 of the basic body 2 is a peripheral seal in the form of a membrane 10, an intermediate space 12 (double shading) being formed between the lateral surface 4 and the membrane 10. In the exemplary embodiment, the intermediate space 12 is delimited on the base side of the basic body 2 by the flange 8. However, it is also conceivable for the flange 8 to project further outwards than in the exemplary embodiment according to Figure 1. In the vicinity of the opening 6, the membrane 10 is connected to the lateral surface 4. In the exemplary embodiment, the membrane 10 likewise consists of silicone, preferably of the same material as the basic body 2.
The connection between the basic body 2 and the membrane 10 may take place for example by adhesive bonding with silicone material.
In the exemplary embodiment, the intermediate space 12 is filled with a silicone oil. Air or a gel also come into consideration, for example, as filling materials. To introduce the filling material into the intermediate space 12, a syringe may be used for example. In this
case, the flange 8, for example, is perforated. After withdrawing the syringe, the point of perforation closes again on account of the material properties, or it may be closed with additional material (for example silicone adhesive) .
The membrane 10 forms together with the filling material in the intermediate space 12 a soft and adaptable peripheral seal and ensures that, after insertion into the anus, the pressure measuring adapter
1 lies against the body tissue of the patient with a sealing effect. The only access to the patient's rectum that then remains is the opening 6, into which the probe of a "MoniTorr" device can be inserted in a sealed way in order to measure the opening pressure of the anal sphincter in a retrograde way, as explained above .
In the exemplary embodiment, the overall length of the pressure measuring adapter 1 is approximately 25 mm, the outside diameter of the flange 8 is likewise approximately 25 mm, the diameter of the opening at the base 5 is approximately 11 mm, the diameter of the opening 6 is approximately 3 mm, the wall thickness of the shell (lateral surface 4) of the basic body 2 is approximately 1 mm and the thickness of the flange 8 is approximately 2 mm.
In Figure 2, a further embodiment of a pressure measuring adapter is shown, denoted here by 20. The pressure measuring adapter 20 comprises the basic body
22 and is produced in one piece from a compliant foam, preferably a closed-pore polyurethane foam. The peripheral surface 24, that is the outer surface of the basic body 22 thereby forms a peripheral seal. In the interior of the basic body 22 there is a frustoconical cavity 25 with an opening 26 at the tip, which is designed for the attachment of an external pressure
- S - measuring device (for example a "MoniTorr" device) , and an open base side 28.
In the exemplary embodiment, the basic body 22 is spherical. Other shapes, for example hump-like configurations or configurations which taper more in the direction of the opening 26 (or are pointed with a flat end) are likewise conceivable.
In use, the basic body 22 is placed in the anus of a patient. The opening 26 for connecting a pressure measuring device is in this case easily accessible via the cavity 25.
Figure 3 shows as a further embodiment a pressure measuring adapter 30 with a basic body, which is configured in a way similar to the basic body 2 from Figure 1, for which reason the same reference numerals as in Figure 1 are used for the basic body and partial regions thereof. A gel body 31 (double shading) is used as the peripheral seal, which here lies directly against the lateral surface 4 of the basic body 2. An additional outer membrane, surrounding the gel body 31, is not provided. In the exemplary embodiment, the gel body 31 consists of a silicone gel of medical quality. The use of other plastics that are comparable to a gel in their elastic behaviour is likewise conceivable.
The pressure measuring adapter 30 is used in the way described in conjunction with the pressure measuring adapter 1.
Claims
1. Anal pressure measuring adapter, with a closure plug (1; 20; 30) , which can be inserted into the anus, has a peripheral seal (10; 24; 31) and is provided with an opening (6; 26), which is designed for the attachment of a pressure measuring device.
2. Pressure measuring adapter according to Claim 1, characterized in that the closure plug (1; 20; 30) has a basic body (2; 22) .
3. Pressure measuring adapter according to Claim 2, characterized in that the basic body (2) is formed in the manner of the frustum of a cone, with a base (5), a lateral surface (4) and a side opposite from the base (5) .
4. Pressure measuring adapter according to Claim 3, characterized in that the base (5) of the basic body (2) is surrounded by an outwardly projecting flange (8) .
5. Pressure measuring adapter according to Claim 3 or 4, characterized in that the basic body (2) is hollow and is open at the base (5) .
6. Pressure measuring adapter according to Claim 5, characterized in that the opening (6) is arranged on the side of the basic body (2) that is opposite from the base (5) .
7. Pressure measuring adapter according to one of Claims 3 to 6, characterized in that the peripheral seal is arranged on the lateral surface (4) of the basic body (2) .
8. Pressure measuring adapter according to one of Claims 2 to 7, characterized in that the peripheral seal has an outer membrane (10) , preferably of silicone, which encloses an intermediate space (12) .
9. Pressure measuring adapter according to Claim 8, characterized in that the outer membrane (10) delimits the intermediate space (12) together with the basic body (2) .
10. Pressure measuring adapter according to Claim 8 or 9, characterized in that the intermediate space (12) is filled with a gas, preferably air.
11. Pressure measuring adapter according to Claim 8 or 9, characterized in that the intermediate space
(12) is filled with a gel and/or with a liquid, preferably a silicone oil.
12. Pressure measuring adapter according to Claim 10 or 11, characterized in that the intermediate space
(12) can be filled through the basic body (2) .
13. Pressure measuring adapter according to one of Claims 2 to 7 , characterized in that the peripheral seal comprises a gel (31) , which preferably lies against the basic body (2) .
14. Pressure measuring adapter according to one of Claims 2 to 7 , characterized in that the peripheral seal comprises a foam, preferably a polyurethane foam, the peripheral seal preferably lying against the basic body.
15. Pressure measuring adapter according to one of Claims 2 to 14, characterized in that the basic body (2) comprises an elastic material, preferably a silicone.
16. Pressure measuring adapter according to Claim 2, characterized in that the basic body (22) is formed from a foam, preferably a polyurethane foam, and in that the peripheral surface (24) of the basic body (22) is formed as a peripheral seal.
17. Pressure measuring adapter according to Claim 16, characterized in that the basic body (22) is provided with a frustoconical cavity (25) , at the tip of which the opening (26) is formed.
18. Pressure measuring adapter according to one of Claims 1 to 17, characterized in that the opening (6; 26) is designed for the connection of a measuring device for the retrograde measurement of the urethral opening pressure .
19. Method of measuring the anal opening pressure of a patient, with the steps of: - inserting a pressure measuring adapter (1; 20; 30) according to one of Claims 1 to 18 into the anus of a patient with a sealing effect,
- connecting a measuring device for the retrograde measurement of the urethral opening pressure to the opening (6; 26) of the pressure measuring adapter (1; 20; 30) ,
- retrograde measuring of the anal opening pressure by means of the measuring device.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE200510061593 DE102005061593B3 (en) | 2005-12-22 | 2005-12-22 | Anal pressure measuring adapter |
| DE102005061593.7 | 2005-12-22 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2007071381A2 true WO2007071381A2 (en) | 2007-06-28 |
| WO2007071381A3 WO2007071381A3 (en) | 2007-08-30 |
Family
ID=38162134
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2006/012264 WO2007071381A2 (en) | 2005-12-22 | 2006-12-19 | Anal pressure measuring adapter |
Country Status (2)
| Country | Link |
|---|---|
| DE (1) | DE102005061593B3 (en) |
| WO (1) | WO2007071381A2 (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5533515A (en) | 1994-08-11 | 1996-07-09 | Foster-Miller | Solid state sphincter myometers |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3721229A (en) * | 1972-04-06 | 1973-03-20 | N Panzer | Obturator device for hysterosalpingography and the like |
| JP2000325301A (en) * | 1999-05-18 | 2000-11-28 | Asahi Optical Co Ltd | Auxiliary tool for inserting endoscope in large intestine |
| EP1424045A3 (en) * | 2000-10-23 | 2004-11-10 | Ethicon, Inc. | Apparatus and method for the measurement and assessment of sling-tension for treatment of female urinary incontinence |
| JP2004531340A (en) * | 2001-06-29 | 2004-10-14 | エシコン・インコーポレイテッド | Systems and methods for assessing urinary function |
| EP1455857B1 (en) * | 2001-11-21 | 2011-08-03 | Bracco Diagnostics Inc. | Device or system for collecting effluent from an individual |
-
2005
- 2005-12-22 DE DE200510061593 patent/DE102005061593B3/en active Active
-
2006
- 2006-12-19 WO PCT/EP2006/012264 patent/WO2007071381A2/en active Application Filing
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5533515A (en) | 1994-08-11 | 1996-07-09 | Foster-Miller | Solid state sphincter myometers |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2007071381A3 (en) | 2007-08-30 |
| DE102005061593B3 (en) | 2007-08-23 |
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