WO2010083836A1

WO2010083836A1 - A device for anatomical mesurements relating to pelvic organ prolapse and use of the device

Info

Publication number: WO2010083836A1
Application number: PCT/DK2010/000014
Authority: WO
Inventors: Thomas Heitmann
Original assignee: Thomas Heitmann
Priority date: 2009-01-26
Filing date: 2010-01-26
Publication date: 2010-07-29

Abstract

A device for measurement of pelvic organ prolapse consists of a single-bladed speculum, to which is fitted a measurement base carrying a reference point slider that in itself carries a ruler. The measurement base is lockable when a zero setting for measurement and classification is obtained, and the measurement may be read off the ruler.

Description

A device for anatomical mesurements relating to pelvic organ prolapse and use of the device

5 The invention relates to a device for anatomical measurements taken in relation to female pelvic organ prolapse comprising extensible measuring rods and a single- bladed speculum. One type of single-bladed speculum is known as Sims' speculum or vaginal retractor, and it is the preferred speculum for the present invention. 0 Female pelvic organ prolapse is a complex of conditions related to dysfunction of the pelvic floor, and it may be diagnosed by evaluating the relative positions of various characteristic anatomical elements. The development in disease or treatment may be monitored by comparing changes in these relative positions. In order that this may be done in a systematic and unambiguous manner, terminology has been standardised5 and points in the anatomy have been identified that are practical "landmarks". This is described in great detail in Bump et al., "The standardization of terminology of female pelvic prolapse and pelvic floor dysfunction", American Journal of Obstetrics and Gynecology, Vol. 175, pp. 10-17 (1996). The present device is useful in pelvic organ prolapse quantification (POPQ). 0

One type of measurement is a set of measurements of distances inside the vagina with a reference to the outside part of the body or a part close to the outside part. Traditionally, the medical examiner's index or middle finger has been used for probing, for instance the tip of the finger is placed against the anatomical part whose5 location is to be measured, and the other end of the finger (the base) is placed against a pre-determined reference point (such as the pubis). A finger on the other hand is placed against the inserted finger at the point of contact with the pubis to mark this point in order that when the fingers are withdrawn the desired measurement is represented by the distance between the finger tip and the other finger. This may in0 turn be quantified by an assistant by means of a ruler or indexed callipers. This is a complex procedure, and e.g. US 3,643,651 proposes to fix an unextendible calibrated tape to the finger, so that the measurement may be directly read off the probing finger. This patent was considered an improvement over the use of a rubber glove fmger with a scale printed on the rubber. In combination with the use of expandable specula for maintaining the vagina open (vaginal dilator) other solutions have been proposed, such as in US 6,379,299. Here, a blade of such an expandable speculum is provided with a scale for reading the measurements, and the whole speculum as such is single-use.

None of the above mentioned solutions provides a fast determination of a quantified measurement in a form that is useful for entering on a chart in order to classify it in combination with other measurements and to monitor the progress of the condition diagnosed.

According to the invention this is obtained in that that said speculum is provided with a measurement base carrying said rod in the form of an indexed ruler and a reference point slider.

According to an advantageous embodiment of the invention the measurement base is releasable by means of a dove-tail joint to the edge of the speculum and that said measurement base is slid onto the end of said speculum. In this manner the parts of the now measuring speculum may be disassembled for sterilisation.

According to a further advantageous embodiment of the invention the measurement base is fixed to the inside of the hollow of said speculum by means of interactive elements placed on the measurement base and in the hollow of the speculum respectively. In this manner, the whole measuring device takes up much less space.

A further advantageous embodiment is particular in that said reference point slider is disposed longitudinally slideable inside said measurement base and that a detent mechanism is able to maintain a desired longitudinal position of said reference point slider with respect to said measurement base as a zero setting. This means that the reference point is not inclined to be shifted when the measurement ruler is moved.

A still further advantageous embodiment is particular in that said ruler is disposed slideably inside the reference point slider and that at the obtaining of the zero setting said ruler locks the detent mechanism to fix the desired longitudinal position of said reference point slider. Hereby it is completely certain that the reference point slider may be moved as required before measurement commences and held securely in its reference position when the ruler is moved into its measurement position.

According to a further advantageous embodiment of the invention the longitudinal axis of the ruler is angled towards the handle of the speculum with respect to the longitudinal axis of the speculum, at least near said handle. This construction offers a clearer view of the figure on the ruler to be read off. The angle of exit of the ruler at the front of the speculum should not deviate too much from being parallel to the longitudinal axis of the speculum, in order to ensure that correct measurements are taken, however a slightly flexible ruler may bend to provide the desired angle at the point opposite the reference point.

An advantageous embodiment of the invention is particular in that the reference point slider and the ruler form part of an electronic linear encoder, and that distances encoded are taken to a data logger for storing and monitoring. In this manner it is possible to dispense with reading of the ruler and to concentrate on zero-setting and the organ parts it is desired to measure.

According to a further advantageous embodiment of the invention said measurement base, said ruler, and said reference point slider are made in a disposable material. This will make the measuring part adaptable to single-use. This also means that the measuring part may be taken sterile out of a pack, fitted to the single-blade speculum and discarded after use.

In use, the measurement device is used by performing an insertion of the speculum fitted with the measurement base and its reference point slider and its ruler into the vagina and by letting the reference point slider be placed at the hymenal ring that is used as a reference point for a series of the pelvic organ prolapse quantification measurements necessary for characterisation and classification. Once this point has been determined, the ruler is pushed forward, locking the reference point and permitting reading the necessary dimensions from the ruler. The invention will be described in greater detail in the following with reference to the drawing, in which

Fig. 1 shows a simple one-bladed speculum suitable for use in the invention,

Fig. 2 shows a measurement base fitted to the speculum,

Fig. 3 shows an inverted image of the fitted measurement base,

Fig. 4 shows the reference point slider locked in its position by the ruler,

Fig. 5 shows an alternative embodiment of fitting the measurement base,

Fig. 6 shows a cross section of the embodiment of Fig. 5, and

Fig. 7 shows a block diagram of the electrical connection from a linear encoder integral with the device according to the invention, to a data logger.

Fig. 1 shows a speculum of the Sims type, having one blade 1 and a handle 2. The blade is outwards hollow and bounded by a plane defining an edge Ia. It is inserted into the vagina by the skilled physician and manipulated by means of the handle in order to afford the views desired for the examination.

Fig. 2 shows a speculum with blade 1 and a measurement base 3 fitted to the edge 1 a of the speculum. Inside the measurement base there is provided a reference point slider 4 and inside this there is provided a ruler 5. The same elements are seen in Fig. 3 that shows the speculum with fitted measurement device turned around with respect to Fig. 2. It is seen that the reference point slider 4 is longitudinally and freely slideable in the measurement base 3. There is provided a serrated edge 6 in the measurement base for enabling locking of the reference point slider by click of a tooth 7 to the measurement base.

This locking is obtained as shown in Fig. 4, by pushing the ruler 5 into the channel that holds it inside the reference point slider 4 until it engages the spring-loaded tooth 7, which now protrudes and locks the reference point slider to the measurement base

3 and thereby to the speculum blade 1. As shown, the tooth 7 moves in the plane of the ruler 5 and reference slider 4. However an arrangement where the tooth 7 moves at right angles to the plane of the ruler 5 is equally feasible, and the serrations 6 are now in and out of the plane of the measurement base 3. Such an arrangement is indicated in Fig. 6. With reference to the zero point thus defined, all longitudinal measurements may be made with respect to the zero point by pushing the ruler 5, which slides inside the reference point slider (now fixed). As will be seen by comparing Figs. 2 and 4, in the embodiment shown the ruler may be read from both sides.

In Fig. 5 is seen how the measurement base 3 looks very small from above and almost obscured by the reference slider 4 when fitted inside the hollow of the speculum 1 , and in Fig. 6 such an arrangement is shown in cross section. Furthermore, Fig. 5 shows how the ruler 5 protrudes from the tip of the speculum 1 to the organ part T, the distance of which from the zero point is to be measured.

In Fig. 6 is shown how fastening means al, bl and a2, b2 hold the measurement base in place in the hollow of the speculum 1. The means al, bl and a2, b2 are placed on the speculum 1 and the measurement base 3 respectively and are constituted according to the construction materials and also in dependence of whether the measurement base 3 is intended to be removable from the speculum after its use. Fig. 6 also shows the detent/ratchet mechanism 6, 7 that locks the reference slider in place.

hi Fig. 7 is seen how a linear encoder (4a, 5 a) fitted to the combination reference slider 4 and ruler 5 provides an electronic signal that is stored in a data logger for combination with data, such as date, identity of person, etc. The data transmission may be by cable or by means of an RFED-type data transmission, i.e. from a passive, externally energised variable device combined with the linear encoder (4a, 5a).

To sum up, the invention concerns a device for measurement of pelvic organ prolapse that consists of a single-bladed speculum, to which is fitted a measurement base carrying a reference point slider that in itself carries a ruler. The measurement base is lockable when a zero setting for measurement is obtained, and the measurement may be read off the ruler.

Claims

C L A I M S

1. A device for anatomical measurements taken in relation to female pelvic organ prolapse comprising an extensible measuring rod and a single-bladed speculum (1) characterised in that said speculum is provided with a measurement base (3) carrying said rod taking the form of an indexed ruler (5), and a reference point slider (4).

2. A device according to claim 1, characterised in that the measurement base (3) is releasable by means of a dove-tail joint to the edge (Ia) of the speculum (1) and that said measurement base (3) is slid onto the end of said speculum (1).

3. A device according to claim 1, characterised in that said measurement base is fixed to the inside of the hollow of said speculum (1) by means of interactive elements (al, a2; bl, b2) placed on the measurement base (3) and in the hollow of the speculum (1) respectively.

4. A device according to claim 2 or 3, characterised in that said reference point slider (4) is disposed longitudinally slideable inside said measurement base (3) and that a detent mechanism (6, 7) is able to maintain a desired longitudinal position of said reference point slider (4) with respect to said measurement base (3) as a zero setting.

5. A device according to claim 4, characterised in that said ruler (5) is disposed slideably inside the reference point slider and that at the obtaining of the zero setting said ruler (5) locks the detent mechanism (6, 7) to fix the desired longitudinal position of said reference point slider (4).

6. A device according to claim 3, characterised in that the longitudinal axis of said ruler (5) is angled towards the handle (2) of the speculum with respect to the longitudinal axis of the speculum (1), at least near said handle.

7. A device according to any of the above claims, characterised in that said reference point slider (4) and said ruler (5) form part of an electronic linear encoder (4a, 5a), and that distances encoded are taken to a data logger for storing and monitoring.

8. A device according to any of the above claims, characterised in that said measurement base, said ruler, and said reference point slider are made in a disposable material.

9. A device according to claim 5, characterised in that the disposable material is sterile when it is releasably applied to said speculum.

10. Use of a device according to any of the above claims for collecting anatomical data.