GB2363199A

GB2363199A - Device for the measurement of pelvic organ prolapse

Info

Publication number: GB2363199A
Application number: GB0014008A
Authority: GB
Inventors: Rajiv Varma
Original assignee: Individual
Current assignee: Individual
Priority date: 2000-06-08
Filing date: 2000-06-08
Publication date: 2001-12-12
Anticipated expiration: 2020-06-08
Also published as: GB0014008D0; GB2363199B

Abstract

A device and method to measure the type and degree of pelvic organ prolapse, substantially, in female humans. The device 10, comprises an inner elongate scaled core 11 with a clasping configuration 12 at one end and a handle 15 at an opposite end. The device 10 also comprises an outer hollow elongate transparent tube 16 which has a marker ring 18 movably positioned around the outer tube. In use, one (or more) device(s) 10 is/are attached to a part(s) of the pelvic organ and positions of the device are noted when the patient is in supine and upright positions, the supine position referably used to set a reference point/datum for the measurement.

Description

2363199 PUK00617 DEVICE FOR THE MEASUREMENT OF PELVIC ORGAN PROLAPSE

Background to the Invention

5 This invention relates, in general, to a device for measuring the degree of prolapse of an organ in a mammal. The invention is particularly, but not exclusively, concerned with the measurement of pelvic organ prolapse in female humans in advance of (and by way of assistance in) a medical assessment or diagnosis being performed by a skilled practitioner.

Summarv of the Prior Art

In the female anatomy, the pelvic organ includes the uterus, cervix and vagina. Prolapse of the pelvic organ is a common complaint in which one or more parts of the pelvic organ are displaced (in a generally downward direction) from their 15 correct position. Such pelvic organ prolapse affects approximately 15% of adult females and can have a considerable effect on their quality of life. Incidence of this complaint increases with age and is particularly prevalent in the postmenopausal age group. Also, childbirth is a major predisposing factor.

20 There are a few symptoms which can alert a sufferer or their physician that pelvic organ prolapse has occurred. Such symptoms may include discomfort in the pelvic region, the sensation of an internal lump moving downwards and, possibly, incontinence. In essence, pelvic organ prolapse results from a combination of a weakness in the muscle tissue of the female pelvic floor and 25 the upright posture of humans.

The various types of pelvic organ prolapse include cervix prolapse, prolapse of the front vagina wall (and consequently also the bladder), prolapse of the back vagina wall (and consequently also the back passage), or a combination of 30 these.

PUK00617 As will be appreciated by the skilled artesian, an accurate examination of the part of the pelvic organ which has prolapsed and the degree to which this has occurred is essential for successful treatment of the condition. Surgery is currently the most widely used treatment and the type of operation performed is 5 dependent upon the type of prolapse which has occurred. For example, vaginal prolapse may be remedied with a cystocule repair procedure where the surgeon performs the procedure via the vagina, whereas an operation to correct a prolapse of the cervix may be performed through an incision in the patient's abdomen.

Current examinations occur with the patient in supine (lying down) position and with a speculum inserted into the vagina so that the physician may attempt to view the position of the parts of the pelvic organ. The physician may use an ordinary ruler in this uncomfortable and undignified procedure to measure the 15 position of the relevant anatomical parts to assist in arriving at his diagnosis. Unfortunately, such observations and measurements do not provide an accurate picture of the patient's condition because the symptoms of pelvic organ prolapse occur primarily when the patient adopts an upright position. Generally, patients are not examined in the upright position due to the technical difficulties this 20 presents. Clearly, inaccurate diagnoses can lead to the wrong type of corrective operation being performed and a surgeon may only discover that a diagnosis is incorrect when he has already commenced apparently corrective surgery scheduled by the inaccurate examination and subsequent professional assessment. As a result of inaccurate diagnoses and unsuitable surgical 25 procedures, 30% of patients have a recurrence of their condition.

It is therefore desirable to have a measuring device which will enable accurate measurement of the type and degree of prolapse of the pelvic organ when the patient is in an upright position whilst minimising the discomfort suffered by the 30 patient; the measuring device providing an aid to the medical practitioner in formulating a medical opinion.

PUK00617 Summarv of the Invention According to a first aspect of the present invention there is provided a device for the measurement of prolapse of a pelvic organ or the like, the device comprising 5 an elongate core having associated attachment means for securing, in use, the device to a part of the pelvic organ or the like; and means, co- operating with the elongate core, for defining, in use, a datum point of the device relative to the pelvic organ or the like.

10 In a preferred embodiment the device further comprises an outer elongate tube movable relative to the elongate core, the outer elongate tube operably to engage and disengage the attachment means to cause capture and release, in use, of the pelvic organ or the like.

15 In a further embodiment, the means for defining the datum point is at least one of a graduated scale and a marker.

In another embodiment the elongate core is scaled.

In another embodiment the device further comprises at least one s.':dably 20 movable marker ring located on an outer surface of the outer elongate tube.

In a yet further embodiment the attachment means is a pair of prongs located at an end of the elongate core.

25 In another embodiment, the elongate core has a second end which has a diameter greater than the major elongate part.

In a second aspect of the present invention there is provided a method for the measurement of pelvic organ prolapse, the method comprising attaching the 30 device of any preceding claim to a part of the pelvic organ of a patient, and i) establishing the datum point of the device when the patient is in supine AM/mb-31 May 2000 PUK00617 position, and ii) observing a displacement of the device having regard to the datum point when the patient is upright.

Advantageously, the present invention provides a measuring device which 5 enables accurate physical measurements of pelvic organ prolapse in, for example, female humans to be taken. Specifically, the type and degree of prolapse of the pelvic organ can beneficially be measured whilst the patient is in an upright position, thus mitigating the inaccuracies inherent in assessing a patient in supine position. Furthermore, the discomfort experienced by the 10 patient during the examination is minimised. The measurement does not in itself provide a diagnosis, but provides information which must be assimilated by the skilled practitioner to arrive at an opinion.

The present invention is generally applicable to the measurement of pelvic organ 15 prolapse in humans and, whilst being particularly applicable to the measurement of female pelvic organ prolapse, could be employed more widely, such as in the veterinarian field.

Brief Description of the Drawings

20 Exemplary embodiments of this present invention will now be described with reference to the accompanying drawings, in which..

FIG.1 is a diagram of a complete measuring device that can support the inventive concepts of the preferred embodiments of the present invention.

FIG.2 is a diagram illustrating the complete measuring device with prongs 25 retracted.

FIG.3 is a diagram of an inner elongate cylindrical part of the measuring device.

FIG.4 is a diagram of an outer elongate hollow part of the measuring device.

PUK00617 Detailed Description of a Preferred Embodiment

FIG.1 illustrates a complete measuring device 10 which supports the inventive concepts of the present invention. The device 10, in a preferred embodiment, 5 generally comprises at least three separable parts. First, an inner elongate (preferably cylindrical) core or shaft 11 (see also FIG.3) with an associated hook, clamp or spring 12 (at one end) that acts to attach, in use, the inner elongate part to the organ of interest. Preferably, such means of attachment is integrally formed with the elongate core 11, such as may be achieved through an injection 10 moulding process. A nodule 15 (at the other end remote from the means of attachment) functions as a handle that, in use, surrounds the inner elongate core 11. Second, the device 10 preferably includes an outer elongate hollow tube 16 (see also FIG.4) made of a transparent material (such as polythene). The third component, which may be omitted, is at least one marker ring 18 surrounding 15 and movably positionable about the device's outer elongate tube 16.

The separate components are assembled in the manner illustrated in FIGA, wherein the inner cylindrical core 11 is located substantially within the outer elongate tube 16 and one or more markers 18 are movably positioned around 20 the outer elongate tube 16. In an exemplary embodiment, the total length of the device (as determined by the inner cylindrical core 11, including the attachment means 12 and handle 15, may be around 28cm (although other lengths may be desirable dependent upon specific use and application). The device 10 generally has a slightly shorter outer elongate tube 16, typically measuring 25 around 25cm in length and possibly 0.5cm in diameter. The length of the inner cylindrical core 11 is marked at regular intervals, such as in a metric centimetre scale 20. In the current embodiment the intervals may be marked with spacings of 1cm and possibly also sub-divisions thereof. When assembled, the outer elongate tube 16 can undergo relative movement with respect to the core 11 30 such that there is a sliding movement of the outer elongate tube 16 over the inner cylindrical core 11 In one embodiment, it is desirable for the movement to be slightly resistive in nature.

PUK00617 The device 10 is generally made from plastic, although the attachment means 12 may be formed from, for example, metal or plastic. Generally, this attachment means 12 comprises a sprung-pair of thin, rigid elongate 5 components (which may also be referred to as "prongs"), each component generally being substantially straight 13 with a short end portion 14 angled inwards to accentuate firm attachment/g ripping.

In use, the device 10 of the present invention has the facility to retract the 10 attachment means 12 completely into the transparent outer tube 16 when the user moves the inner 11 and outer 16 parts relative to each other such that the outer elongate tube 16 entirely covers the attachment means 12 (see FIG.2).

The issue addressed by the present invention relates particularly, but not 15 exclusively, to the accurate measurement of female pelvic organ prolapse in TM humans. The inventive device 10, known as V-Scale, is intended for use during an examination of a patient with known or suspected pelvic organ prolapse. A physician or technician would generally utilise said device in the following way.

The patient is initially examined in supine position and a speculum is inserted into the patient's vagina. This enables the physician to view the pelvic organ parts such as the uterus, cervix and vagina walls. As prolapse is generally most evident when the patient is in an upright position, it is unlikely that this initial view 25 will provide the physician with the information required.

Whilst still in supine position, the device 10 of a preferred embodiment of the present invention, with the attachment means 12 fully retracted, is inserted via the hollow interior of the specuium into the patient. The user holds the handle 30 15 in one hand and slides the outer elongate tube 16 of the device towards the handle 15 with the other hand, thus releasing the attachment means 12. If, for example, the user intends to measure the degree of prolapse of the front vagiha PUK00617 wall, then the device is positioned such as to engage some tissue of the front vagina wall between the attachment means 12. Whilst holding the inner core 11 steady, the outer elongate tube 16 is moved relative to the inner core 11 in order to close the prongs 12 (i.e. the attachment means) securely onto the tissue. The 5 handle 15 also serves to stop the inner core becoming detached from the outer elongate tube when the device 10 is attached in the patient. At this point in the process the speculum may be removed from the patient's body, and the marker ring 18 (which is preferably of an easily distinguishable colour) moved along the outer elongate tube of the device 10 until it is level with the vagina] orifice or 10 other datum (i.e. base reference) point.

The patient then stands upright, which action may, of itself, cause the prolapse to become evident. Further, the patient is required to artificially create a strain in the pelvic organ (such as may be experienced by the patient when lifting a 15 heavy weight or through fatigue) by coughing vigorously or holding their breath and creating a tension in the abdomen. This action should cause the organ to prolapse to its maximum degree and consequently the attached device will also move in a downward direction relative to the pelvic organ as a whole. The user then observes the device 10 in its newlsecond position and, specifically, notes 20 and records the scale reading 20 where the device 10 exits the vaginal orifice. Clearly, the difference between the location of the marker ring 18 and the second reading is equal to the change in position (that is, the degree of prolapse) of the organ under examination.

25 Finally, the device 10 is held by the handle 15 and the outer elongate tube 16 is moved downwards relative to the inner core 11 in order that the grasped tissue be released from the attachment means 12. After moving the end of the device away from the tissue, the inner core 11 and outer elongate tube 16 are, once again, moved relative to each other so that the prongs 12 are completely 30 retracted and the narrow device 10 can be removed from the patient with a minimum of discomfort. If the device is a single-use device it will then be PUK00617 disposed of by the user. Alternatively, if the device is to be used repeatedly it may be subject to sterilization in an autoclave or the like.

In another embodiment, the device is supplied with two marker rings 18 5 (preferably of different colours), a first to be utilised as directed above and a second to be used to record the second position of the device when the patient is standing (thus, equivalent to the observed second scale reading described above). In this way, the physician is left with a permanent indication of the degree of prolapse of the organ being assessed.

In patients suffering from pelvic organ prolapse it is common for more than one part of the pelvic organ to suffer from prolapse and therefore it is preferable to take measurements from each part in a single assessment. Advantageously, the present invention enables several such measuring devices to be utilised 15 simultaneously. For example, one device 10 could be attached to the cervix whilst another could be attached to the front vaginal wall. Each device 10 should display different colour marker ring(s) 18 in order that they can be easily differentiated. In this way a complete and accurate measurement of the pelvic organ prolapse is recorded by the physician. Further analysis of the results by a 20 trained physician will lead to a precise assessment for the patient's condition and the most effective type of treatment can then be prescribed.

In summary, a measuring device of the present invention enables, for example, accurate measurement of female pelvic organ prolapse in humans. Specifically,

25 the type and degree of prolapse of each part of the pelvic organ can be measured whilst the patient is in an upright position. Due to the very small lateral cross-sectional area of this device 10 (typically no larger than about 0.2CM2 or ideally smaller) the discomfort suffered by the patient is minimised.

30 It will be appreciated that the above description has been given by way of example only and that modifications in detail may be made within the scope of the invention. For example, whilst the inner core 11 and outer elongate tube 16

PUK00617 have generally been described as cylindrical forms, the underlying inventive concept can clearly be applied to a measuring device with a non- cylindrical form. Also, the attachment means is not limited to a pair of prongs 12, nor are the construction materials limited to plastic and metal. Further, the intervals 20 5 marked on the inner cylindrical part 11 of the device 10 may be in divisions other than centimetres and may also include numerals.

The exemplary embodiment detailed in the above description utilises the friction between the outer edges of the prongs 12 and the end edge of the outer

10 elongate tube 16 to hold the prongs 12 in position when they are attached to tissue. However, there are clearly alternative means of achieving this effect, such as the addition of a moveable but closefitting ring located just above the handle 15 on the inner elongate core 11. Such a ring would then be moved along the inner core 11 to stop the outer elongate tube 16 from sliding back 15 towards the handle 15 and allowing the attachment means to open too far.

PUK00617

Claims

Claims

1. A device for the measurement of prolapse of a pelvic organ or the like, the device comprising..

an elongate core having associated attachment means for securing, in use, the device to a part of the pelvic organ or the like., and means, cooperating with the elongate core, for defining, in use, a datum point of the device relative to the pelvic organ or the like.

2. The device of claim 1, further comprising an outer elongate tube movable 10 relative to the elongate core, the outer elongate tube operabiy to engage and disengage the attachment means to cause capture and release, in use, of the pelvic organ or the like.

3. The device of claim 1 or 2, wherein the means for defining the datum 15 point is at least one of a graduated scale and a marker.

4. The device of claim 1 or 2, wherein the elongate core is scaled.

5. The device of claim 2, further comprising, at least one sfidably movable marker ring located on an outer surface of the outer elongate tube.

6. The device of any preceding claim, wherein the attachment means Is a pair of prongs located at an end of the elongate core.

7. The device of any preceding claim, wherein the elongate core has a second end which has a diameter greater than the major elongate part.

AM/mb-31 May 2000 PUK00617 11 8. A method for the measurement of pelvic organ prolapse, the method comprising..

attaching the device of any preceding claim to a part of the pelvic organ of a patient; and 5 i) establishing the datum point of the device when the patient is in supine position, and ii) observing a displacement of the device having regard to the datum point when the patient is upright.

10 9. A device substantially as herein described with reference to the accompanying drawings.

10. A method for the measurement of pelvic organ prolapse substantially as herein described with reference to the accompanying drawings.