JPH0225618B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to a measuring instrument for a female urinary incontinence treatment device.

BACKGROUND OF THE INVENTION Various female urinary incontinence treatment devices have been used in the past to direct urine from female patients suffering from urinary incontinence.
However, it is proposed to collect
Typically, such urinary incontinence treatment devices are associated with problems such as leakage, wearer discomfort, and pressure sensation. One evidence of the ineffectiveness of such conventional urinary incontinence treatment devices is their lack of commercial success.

Problems with conventional urinary incontinence treatment devices include, among other things:
Increased in ambulatory patients. This is because of the complex anatomical changes that occur within the periurethra during locomotion and the lack of devices that accommodate these changes. However, the need for effective female urinary incontinence treatment devices is by no means limited to ambulatory patients. For example, a non-ambulatory female patient with a dorsal chordopathy may respond to existing urinary incontinence treatment devices (indwelling catheters, intermittent catheters, etc.) despite the patient's minimal physical exertion. In the end,
They cannot be well cared for.

A prior patent discloses a female urine collection device that is provided with a positioning element intended to be inserted into the vagina in order to retain the urine collection container in the urinary incontinence treatment device. (U.S. Patent No.
2483079; 2490969; 3116737; 3528423;
3512185; 3776235; 3611155; see specification 4246901). Those structures in which the positioning elements are relatively rigid are obviously not able to match the anatomical changes of the body that occur during movement. Conventional urinary incontinence treatment devices having flexible or deformable butt positioning elements reduce muscle stimulation and improve patient comfort, but nevertheless , the problem of providing an effective seal against leakage along the contact area and preventing leakage remains.

Other related U.S. patents include No. 4270539;
There are specifications 3651810; 4198979 and 3194238.

The present invention is particularly directed to the use of the device for the treatment of female urinary incontinence (see Japanese Utility Model Application Publication No. 50618/1983) filed by the present applicant. One feature of incontinence treatment devices is that effective leak sealing with the surrounding muscles is not possible if the female urinary incontinence treatment device has a periurethral cup that is compressible; configured to retain and allow the periurethral cup to move independently, at least to a limited extent, with respect to the portion of the female urinary incontinence treatment device that makes external contact with the wearer. It lies in the discovery that if it is installed, it will be achieved.

Another feature of this female urinary incontinence treatment device is that if such a shaped compressible element is in the shape of a periurethral cup and has an external pad (which itself is in place) , pants, or a support belt) when the female urinary incontinence treatment device is worn, is operatively connected by a tubular elastic bellow that exerts an upward force on the external pad; , such a combination eliminates the aforementioned problems in conventional female urinary incontinence treatment devices, provided it does not interfere with the limited independent movement of the periurethral cup with respect to the external pad;
Or it can be substantially reduced.

The external pad may be provided with a soft absorbent lining for direct contact with the patient's labia majora, if desired. A flexible conduit may extend from the outlet of the external pad to a leg urine collection bag or other suitable urine collection device. The external pad is preferably held in place by the wearer's undergarments (pants), however other support means in the form of laces or bands may also be used.

SUMMARY OF THE INVENTION The periurethral cups of such female urinary incontinence treatment devices, although soft and compressible, are generally made from shape-retaining materials.
Molded in one piece, the material has a Shore A scale in the range of about 1 to 30, preferably about 5.
It has a hardness in the range of ~20. Elastomeric materials formed such that the outer surface of the periurethral cup is smooth and non-porous have been found to be particularly effective. The periurethral cup is provided with anterior, posterior and lateral wall portions forming upper and lower openings, such wall portions having a substantial wall thickness (approximately 8 to 15 mm). ) and has a smooth rounded surface to create substantial surface contact with the urethral floor and vaginal inlet. The rear wall section extends upwardly beyond the upper limits of the front wall section and the side wall sections so as to form a resilient, insertable projection for turning the floor. This is an important feature for patients whose urethral opening is located within or directly adjacent to the ostium. The urine-directing projection allows for deflection towards and away from the inlet opening of the periurethral cup, but is smoothly rounded and engages the periurethral floor and the inlet. There is no bending or twisting of the curved contact surfaces. This is because the periurethral cup is compressible and has a substantial wall thickness.

An outer pad of soft, elastic and flexible material is sized to contact the outer surface of the wearer's labia majora and has an opening extending therethrough. Between this opening and the lower opening of the periurethral cup is a tubular elastic bellow that exerts an upward force on the periurethral cup when the female urinary incontinence treatment device is worn. a rounded contact surface of the periurethral cup, despite the complex anatomical changes or deformations that occur during body movements;
Between the periurethral cup and the surface of the inlet,
Ensure that effective leak protection is maintained.

The present invention provides that when wearing a female urinary incontinence treatment device as characterized above, the length of the elastic bellows is between the periurethral floor and the outer surface of the labia majora for each wearer. A measuring device for determining the length of an elastic bellow in a female urinary incontinence treatment device having the above configuration has been found to vary within certain predetermined limits with the distance The objective is to obtain the following.

Means for Solving the Problem In order to solve this problem, the present invention provides another urethral cup having substantially the same configuration as the periurethral cup of the female urinary incontinence treatment device as described above. a relatively rigid, elongate member secured to and projecting downwardly from said other periurethral cup and having graduations along its outer surface; and another external pad having the same configuration as the elongated member and slidably mounted for vertical movement along the elongate member, the measuring device comprising: It is possible to measure the appropriate length of the elastic bellows for a given patient.

It should be noted that such a measuring device can also be designed with an elongated member as a tubular member to permit endoscopic examination, if required or desired. .

Embodiments Hereinafter, the present invention will be described in detail based on the accompanying drawings showing examples thereof.

First, FIGS. 1 to 6 show an example of a female urinary incontinence treatment device to which the measuring instrument according to the present invention is intended, and the main components of this female urinary incontinence treatment device 10 are as follows: They are a periurethral cup 11, an external pad 12, and a tubular elastic bellows 13. A flexible conduit 14 conveys the urine to a suitable urine collection container 15. For ambulatory patients, the urine collection container 15 may be a leg urine collection bag, such as the urine collection bag disclosed in U.S. Patent Application No. 273,363, filed June 15, 1981. The shape is usually taken.

However, other types of urine collection containers 15
It should be understood that it may be configured to suit the needs and physical conditions of the user. Typically, flexible conduit 14 includes a suitable removable fitting 16. The joint 16 shown in FIG. 2 is shown in U.S. Pat. No. 4,280,498,
Similar to those described, however, other types of joints may be provided.

The periurethral cup 11 is molded in one piece from a soft, compressible, but generally shape-retaining material. Molded elastomeric silicone materials having a smooth, substantially non-porous outer surface have been found to be particularly effective; however, other materials such as resilient foam materials Molded compressible materials can also be used. Irrespective of the material selected, such materials have a Shore A scale of approximately 1 to 30,
It is believed that preferably it should have a hardness within the range of 5-20. Particularly effective results are obtained with materials having a hardness of about 10.

The side walls of the periurethral cup 11 have a substantial thickness and the uppermost surface of the periurethral cup 11 is smoothly curved or rounded as shown in FIGS. 2 and 3. It is also important. More specifically, as shown, the periurethral cup 11 has an upper opening 17 and a lower opening 1, respectively.
8, and an integral side wall 19 surrounds these upper openings 17 and lower openings 18,
The side walls 19 each include a front wall portion 19a,
It consists of a rear wall section 19b and a side wall section 19c. In the area surrounding the upper opening 17, each of these wall portions has a diameter of about 3
It has a thickness d (FIG. 3) in the range .about.15 mm.
The result is a periurethral cup 11 having an upper surface that is in substantial contact with the periurethral floor and the inlet, as explained hereinafter, which periurethral cup 11 is soft and Despite the upward force exerted by the elastic bellows 13, which are compressible, they tend to maintain their shape during use.

The rear wall portion 19b projects upwardly beyond the upper limits of the front wall portion 19a and the side wall portions 19c and forms an elastic, insertable urine diversion projection 20. . The essential purpose of this urine diversion protrusion 20 is that the urethral orifice of an estimated 15% to 20% of the female population is located within or directly adjacent to the vaginal opening. Its purpose is to serve as a urine diversion device for women who are pregnant. Any function that the urine diversion projection 20 performs in placing and holding the periurethral cup 11 in place is of secondary importance. As will be explained in detail later, the wide, smoothly rounded contact surface of the compressible periurethral cup 11, combined with the gentle upward force exerted by the elastic bellows 13, primarily This serves to maintain the cup 11 in its working position.

As shown in FIGS. 1-3, the rounded upper surface 20a of the urine-directing projection 20 is connected to the remaining side wall portion 19c of the periurethral cup 11.
and transitions smoothly and gradually into the front wall portion 19a. In particular, the protrusion 2 for diverting urine
The surface of the upper front portion of 0 transitions into the upper surface of side wall portion 19c along a curve that is depicted in FIG. 2 as having a substantial radius r. This radius r is typically in the range of about 5 to 12 mm. Protrusion 2 for diverting urine
0, as represented by the dashed line in Figure 2,
Even when pushed forward, at radius r,
No bending or twisting of the walls occurs. This is because the periurethral cup 11 is made of a compressible material. Therefore, an effective leaktight barrier between the upwardly projecting upper surface of the periurethral cup 11 (which includes the urine-directing projection 20) and the patient's contact surface is maintained even during normal body movements. It tends to be maintained between

The external pad 12 may be formed from the same soft, compressible material as the periurethral cup 11, or in any case from an elastic, flexible synthetic resin material. .
External pad 12 is generally oval in external profile, is substantially larger than periurethral cup 11, and has an opening 21 extending therethrough (FIG. 2). . As shown, the outer pad 12 has an upper surface 12a, which is preferably concave or dish-shaped, and
If desired, top surface 12a may include a backing 22 (FIG. 2) made of non-woven cotton fibers or other suitable absorbent material. The outer pad 12 may be provided with attachment means 23 along its lower surface 12b in the form of a nylon hook or loop-carrying fabric of the type marketed under the name Velcro Patch. good. If such attachment means 23 are used, then the patient has a nylon back panel provided with barbs to engage and connect with the attachment means 23. Pants may also be worn to help maintain the external pad 12 against the outer surface of the labia majora.

The elastic bellows 13 can be formed from any suitable elastomeric material and, in its uncompressed or expanded state, assumes the appearance shown in FIGS. 1-3. For a given urine collection container 15 used, the number of waves or volutes 13a of the elastic bellows 13 is determined by the number of waves or volutes 13a of the elastic bellows 13 that correspond to the labia majora of the wearer on whom the female urinary incontinence treatment device 10 is to be worn; Depending on the distance between the periurethral floor and the periurethral floor, this causes the waves to be compressed or axially reduced as shown in FIGS. 4 and 6 when worn. Typically, for an adult wearer, the number of waves will range between 2 (FIG. 2) and 6, and the undeformed length of the waves will be: 10 to 30 mm, and three selected dimensions within those ranges are
Meets more than 90% of requirements. The elastic bellows 13 can be formed from any elastomer such as polyurethane, silicone rubber, latex, or a wide variety of other materials having similar properties.
A particularly effective material is manufactured by Dow Corning.
It was discovered that the silicone material is commercially available under the name Q7-4840. The company's other available one is the MDX4-4210. In the illustrated example, the elastic bellows 13 and the periurethral cup 11 are formed separately and the upper end of the elastic bellows 13 is then attached to the lower opening by adhesive or other suitable means. It is secured to the periurethral cup 11 around 18. However, it should be understood that these two elements may be integrally formed if desired. The lower end of the elastic bellows 13 is connected to the flexible conduit 14 at the upper end of the opening of the outer pad 12 by an upwardly enlarged extension 25 thereof. The extension 25 of the flexible conduit 14 may be joined to the walls of the elastic bellows 13 and the outer pad 12 by adhesive, heat sealing, or any other means.

4-6 illustrate the anatomical position of the female urinary incontinence treatment device 10 under normal conditions of use. The external pad 12 presses the outer surface of the labia majora 30 upward, and the external pad 12
and are connected by an annular velcro patch 23 (if provided) and retained by the pants or other means (not shown). Periurethral cup 1
1 extends upwardly between the labia minora 31, and the soft, rounded front and side wall portions 19a and 19c have an upper surface 11a that extends upwardly between the labia minora 31.
3 engages the periurethral bed 32. The urine diversion projection 20 extends a small distance upwards into the inlet of the tube 31. Therefore, the gently rounded upper surface 20 of the periurethral cup 11
a and 11a, even in the case of a small number of patients where the patient's urethra is curved backwards and in direct communication with the entrance (represented by dashed line 35 in Figure 4). Make a resilient, leak-tight contact with the surface. The wide, smoothly rounded upper surface of the periurethral cup 11 creates a positive surface contact with the wearer and greatly reduces the possibility of force localization, which may cause discomfort. , may also create a risk of pressure baiting. The thickness of the wall of the periurethral cup 11 creates a structure that retains the foam despite the softness and compressibility of the material from which the periurethral cup 11 is made. If limited deformation of the periurethral cup 11 occurs during use (for example, as shown in phantom in FIG. 2),
Due to the compressibility of the material of the periurethral cup 11, such deformation is possible without bending or twisting, which may cause leakage or may cause irritation and discomfort to the muscles of the body. and,
It can be accommodated without relative movement with the surface of the periurethral cup 11.

The shape-retaining periurethral cup 11 is forced upwardly into leak-tight contact with the periurethral floor and the inlet, but this is due to the expansion exerted by the elastic bellows 13 made of elastomer. It is by force. When the female urinary incontinence treatment device 10 is properly worn, the elastic bellows 13 are in a partially compressed state, as best shown in FIGS. 4 and 6. The external pad 12 is immovable with respect to the labia majora 30, and acts as a base on which the expansion force of the elastic bellows 13 is applied downwardly toward the external pad 12. The upward force exerted by the external pad 11 towards the periurethral surface is therefore, in magnitude and direction,
relatively constant.

The elastic bellows 13 simply attaches to the periurethral cup 11.
In order to maintain the periurethral cup 11 in the position shown, it not only exerts a constant gentle upward force on the periurethral cup 11, but also twists it so as to adapt to the changes resulting from the dynamics of the body's movements. Bending and deflection are also possible. FIG. 5 shows a periurethral cup 11 and an external pad 12 for exercise of the wearer.
is arranged laterally but nevertheless retains its shape, however, in combination with the substantial contact surface between the compressible periurethral cup 11 and the periurethral surface, the elastic It shows what is believed to be a typical condition in which the inflation force applied by bellows 13 still maintains periurethral cup 11 in leak-tight contact with the wearer.

Now, FIG. 7 shows an elastic bellow 1 required for a wearer to properly wear the female urinary incontinence treatment device 10, an example of which was explained above based on the drawings.
3 shows an embodiment of a measuring instrument 40 according to the invention, which can be conveniently used for determining the length of 3. The periurethral cup 111 is of substantially the same size and shape as the periurethral cup 11 described above, with the substantial difference that the periurethral cup 111 does not extend from the elastic bellows 13; First, it is fixed to or formed on the upper end of a relatively rigid tube 41 provided with a scale. The external pad 112 is
It may be similar to the external pad 12 described above and is formed from a resilient elastomeric material (Dow
Corning's Q7-4840 has been found to be particularly effective) and are also of substantially the same dimensions.
The main difference is that instead of being fixed to the elastic bellows 13 and the flexible tube 14, the external pad 112
However, a sleeve 42 is provided which slidably receives a relatively rigid graduated tube 41. The outer pad 112 can therefore be slid along the length of the relatively rigid tube 41 and its position is aligned with the graduation line 43.
It can be determined by referring to the and numerical markings 44.

The measuring instrument 40 is handled by a physician or medically trained person and is inserted into the periurethral cup 111.
into the position occupied by the periurethral cup 11 in FIG. It is used in the same way as described, by sliding it up until it rests against the labia majora. If it is considered desirable that the test requires that the periurethral cup 11 be placed correctly relative to the periurethral floor and the inlet, or if the test If this is necessary for other reasons, the physician may insert the stem of a conventional endoscope through the passageway 45 of the relatively rigid tube 41, thereby causing the objective lens of the endoscope to It extends into the open periurethral cup 112.
Once, the periurethral cup 111 and the external pad 1
12 are properly positioned, the measuring device 40 is removed and the length of the elastic bellows 13 for the female urinary incontinence treatment device 10 to be used by the patient can be determined using the scale lines 43 and the numbers. It is made from the marking 44.

While one embodiment of the present invention has been described above for purposes of illustration, along with an example of a female urinary incontinence treatment device for which it is intended for use, those skilled in the art will appreciate that
It is understood that many changes may be made to this embodiment without departing from the spirit of the invention.
I want to be understood.

Effects of the Invention Since the present invention has the above-described configuration and operation, when a female patient wears the female urinary incontinence treatment device as exemplified above, the female urinary incontinence treatment device can be used. , which can be worn under optimal conditions adapted to the specific dimensions of the female patient.

[Brief explanation of drawings]

FIG. 1 is a perspective view showing an example of a female urinary incontinence treatment device to which the present invention is intended to be used, FIG. 2 is a longitudinal sectional view thereof, and FIG. 3 is a line taken along line 3-3 in FIG. FIG. 4 is a schematic cross-sectional view showing the female urinary incontinence treatment device shown in FIG. cross-sectional view showing the relative displacement between the external pad and the periurethral cup during movement;
6 is a side view of the female urinary incontinence treatment device shown in FIG. 1 in a worn state, and FIG. 7 is a partially cutaway front view showing one embodiment of the measuring instrument according to the present invention. 10...Female urinary incontinence treatment device, 11...periurethral cup, 12...external pad, 13...elastic bellows, 14...flexible conduit, 15...urine collection container, 16...fitting, 17 ...Top opening, 1
8... Lower opening, 19... Side wall, 19a... Front wall portion, 19b... Rear wall portion, 19c... Side wall portion, 20... Urine diversion projection, 22... Lining, 23... ...Velcro patch, 40...Measuring instrument, 41...Relatively hard tube, 42...Sleeve, 43...Graduation line, 44...Numeric indicator, 11
1...periurethral cup, 112...external pad.

Claims (1)

Claims: 1. An external pad made of a flexible, elastic material having an opening therethrough that contacts the outer surface of the wearer's labia majora; a periurethral cup having an upper opening formed by a smoothly rounded contact surface adapted to engage the periurethral floor and vaginal inlet of the wearer and also having a lower opening; , extending between the lower opening of the periurethral cup and the opening of the external pad and directing the periurethral cup to the periurethral floor and vaginal inlet when the external pad is held against the labia majora. a measuring device for a female urinary incontinence treatment device comprising a tubular elastic bellow for pressing into engagement; a relatively rigid elongated member secured to and projecting downwardly from said other periurethral cup and having graduations along its outer surface; A measuring device for a female urinary incontinence treatment device, characterized in that it has a contour and comprises another external pad slidably attached to said elongate member for vertical movement therealong. . 2. A measuring device for a female urinary incontinence treatment device according to claim 1, wherein said relatively hard elongated member comprises a tubular member.