WO2009099543A2

WO2009099543A2 - Device for perineal massage and method of use

Info

Publication number: WO2009099543A2
Application number: PCT/US2009/000559
Authority: WO
Inventors: Roger Young
Original assignee: The University Of Vermont And State Agriculture College
Priority date: 2008-02-06
Filing date: 2009-01-27
Publication date: 2009-08-13
Also published as: WO2009099543A3

Abstract

A number of studies have been performed that demonstrate beneficial effects of perineal dilation and/or massage during pregnancy to reduce episiotomy and perineal trauma at birth. The invention includes a perineal massage device including a retractor portion attached to the unified end of a bifurcated handle. The device can be held anteriorly or posteriorly by the user. The device facilitates perineal massage during the last portion of pregnancy when the enlarged abdomen restricts easy access by the woman to her vagina. The invention further includes methods of use of the device of the invention.

Description

DEVICE FOR PERINEAL MASSAGE AND METHOD OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS

The instant application claims priority to U.S. Provisional Patent Application Serial No. 61/026,534 filed on February 6, 2008. The application is incorporated by reference herein in its entirety.

BACKGROUND

Cesarean section rates have risen to nearly 30% in the US. There are currently strong movements to decrease this rate and encourage vaginal birth. However, many women fear the birth process, especially vaginal stretching and tearing during delivery. This is particularly true of first births.

A number of studies have been performed on the effects of perineal dilation and/or massage during pregnancy and labor to reduce episiotomy and perineal trauma at birth (see, e.g., J. S. Cohain, MIDIRS Midwifery Dig. 14:37-44. 2004; M. Labrecque et al., 5MJ. 323:753-754. 2001 ; and G. Stamp et al., 5MJ. 322:1277-1280. 2001). These studies have demonstrated a reduction in the number of episiotomies and tears during birth. When surveyed, women typically had a positive response to the use of antenatal dilation or massage. Devices and methods for perineal dilation have been long known. For example, in

Uganda, it is common for mothers-to-be to use a series of gourds of increasing size to stretch the pelvic floor in preparation for birth. Inflatable perineal dilators have also been designed to serve the same purpose. The device is inserted into the vaginal and inflated to stretch the vaginal opening (see, e.g., US Patent Application Publication 20030087734). Devices for mechanical dilation and vibration are also known (see, e.g., US Patent 6,159,170). Digital massage can also be performed either by the mother-to-be or by a partner. However, proper digital massage is difficult to perform, requires instruction, and is often done incorrectly even after instruction.

Studies suggest that dilation and massage should be practiced late in the pregnancy. It can be difficult for the mother-to-be to properly insert the device or comfortably perform self-massage due to the size of her abdomen. In turn, this may reduce the practice of dilation or massage by the mother-to-be. SUMMARY OF THE INVENTION

The invention includes a device for perineal and posterior vaginal massage. In an embodiment, the device is designed to be held behind the back of the individual (posteriorly) during use. The device includes a retractor portion for contact with the perineum attached to the unified end of a bifurcated handle having a grip portion on each of the split ends of the bifurcated handle, most distal from the retractor portions. The bifurcated handle is shaped to allow the user to readily reach the grips, one with each hand, when the retractor portion is in contact with the perineum and the device is held behind the user. The retractor portion is preferably attached to the bifurcated handle by a stem at the end opposite the grips. The stem can have an adjustable length, or the device can be made in a number of sizes to allow for the device to be used by individuals of different sizes. Similarly, the position of the grips can be adjusted, either simultaneously or independently.

The invention includes a device for perineal and posterior vaginal massage. In an embodiment, the device is designed to be held in front of the individual (anteriorly) during use. The device includes a retractor portion for contact with the perineum attached to the unified end of a bifurcated handle having a grip portion on each of the split ends of the bifurcated handle, most distal from the retractor portions. The bifurcated handle is shaped to allow the user to readily reach the grips, one with each hand, when the retractor portion is in contact with the perineum and the device is held in front of the user. The retractor portion is preferably attached to the bifurcated handle by a stem at the end opposite the grips. The stem can have an adjustable length, or the device can be made in a number of sizes to allow for the device to be used by individuals of different sizes. Similarly, the position of the grips can be adjusted, either simultaneously or independently.

The invention includes a method for perineal massage using a device of the invention. The method includes providing a device including a retractor portion for contact with the perineum attached to a bifurcated handle having a grip portion at each of the handle spilt ends most distal from the retractor portions. The bifurcated handle is shaped to allow the user to readily reach the grips, one with each hand, when the retractor portion is in contact with the perineum. The device can be held in front of or behind the user depending on the orientation of the retractor portion. The retractor portion is preferably attached to the bifurcated handle by a stem at the end opposite the grips. The device is held by the user, placing the retractor portion in contact with the perineum; and applying pressure to the perineum by moving the grips held by the user. DEFEVITIONS

As used herein, "bifurcated handle" is understood to be any form of a pair of handles attached directly or indirectly to a retractor portion. The bifurcated handle can have a V- shape, a Y-shape, a U-shape, a squared off shape, or any other essentially symmetrical shape such that when the hands of the user are held in the same relative positions to the left and right side of the body, the retractor portion of the device is near the centerline of the body.

Each of the ends of the split end of the bifurcated handle includes a grip portion at or near the end of handle most distal from the end at which the retractor portion is attached. The handles may be in a fixed position or may be adjustable. The exact position of the grips relative to the retractor portion can be determined by the user for optimal utility of the device. The retractor portion is proximal to the unified end of the bifurcated handle. Exemplary embodiments are provided schematically in Figures 1 and 2.

As used herein, "essentially symmetrical" is understood to mean that when the device is held by the user, either behind or in front of the body, with one grip in each hand and the users hands at about the same distance relative the midline of the body in the sagittal plane, when the retractor portion and the stem also essentially fall on about the midline of the body in the sagittal plane.

As used herein, "grip portion" is understood as one of the two portions of the bifurcated handle at the split end of the handle, distal to the retractor portion. The grip portions can be at or near the ends of the bifurcated handle. The grip portions are optionally textured, coated, or otherwise covered with material to make them easier or more comfortable to grip. For example, the grip portions can be covered with soft foam or rubberized material.

Such materials are well known to those skilled in the art. The grip portions can also include handles made of plastic, metal, cloth, or other appropriate material attached to the ends of the split ends of the bifurcated handle to facilitate gripping of the device. The use of handles is well known in the art. The grip portions may be adjustable, either simultaneously or independently, for comfortable use of the device.

As used herein, "perineal massage" is used as a simplified term to include both perineal massage and posterior vaginal massage unless otherwise obvious from context. As used herein, "retractor portion" is the element of the device for contacting the perineum and insertion into the vaginal opening. The retractor portion should be appropriately sized and shaped for contact with the perineum and insertion into the vagina.

That is, the portion should be sized and shaped to allow for insertion into the vagina to a depth of about 5 to 8 cm. The surfaces of the retractor portion are both smooth and blunt. The retractor portion is preferably shaped like a portion of a speculum for contact with the perineum, such as the portion for contact with the perineum of a Sim's speculum, having an elongated rectangular portion that is curved along the short axis with a smooth rounded tip as shown in Figure 3. Speculums and retractors for contact with the perineum and insertion into the vaginal opening are well known.

As used herein, "stem" is the connector between the retractor portion and the unified end of the bifurcated handle. The stem is of an appropriate length to allow the handles to be easily grasped by the user while the retractor portion is in contact with the perineum. The stem can be curved, straight, or include bends or hinges to allow for adjustment. The stem can be adjustable, for example adjustable in length, or can be made in a variety of lengths and shapes to allow for comfortable use by individuals of different sizes.

Ranges provided herein are understood to be shorthand for all of the values within the range. For example, a range of 1 to 50 is understood to include one or more values independently selected from the group consisting of 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 , 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, and 50, including any range within 1 to 50.

Unless specifically stated or obvious from context, as used herein, the term "or " is understood to be inclusive. Unless specifically stated or obvious from context, as used herein, the terms "a", "an", and "the" are understood to be singular or plural.

As used herein, "about" in regard to length or specific angles is understood to be within a variance of less than or equal to 20%, less than or equal to 15%, less than or equal to about 10%, or less than or equal to 5%. It is understood that some portions of the device will be more tolerant of dimensional variation (e.g., handle length) wherein others will not (e.g., retractor portion width).

Any one device or method can be combined with any other device or method . described herein.

All references and patents cited in are hereby incorporated by reference as if they were incorporated by reference individually.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a representation of a side view of an embodiment of the device; Figures 2 A-C are representations of a disassembled view of an embodiment the device;

Figures 3A-C are representations of top, front, and side views, respectively, of a Sim's speculum.

DETAILED DESCRIPTION

The invention includes a device for perineal massage and a method for its use. The device is composed of essentially two elements, a retractor portion and a bifurcated handle portion, further optionally including a stem portion to connect the retractor and handle portions. In an embodiment, the handle portion can be connected directly to the retractor portion. Two embodiments of the invention are shown in Figures 1 and 2. It is understood that the drawings are exemplary embodiments of the invention and do not limit the invention. The device shown in the drawings is an embodiment designed to be held behind the user. In an embodiment to be held in front of the user, the retractor portion would be rotated 180 degrees around the long axis of the retractor portion to allow for comfortable placement of the retractor portion on the perineum. Such modifications are well within the ability of those of skill in the art. The drawings are not to scale.

The invention includes a perineal massage device having a retractor portion for contact with the perineum attached to a bifurcated handle having a unified end proximal to the attachment site for the retractor portion, and a first grip portion and a second grip portion on a split end of the bifurcated handle, distal to the attachment site for the retractor portion, wherein the device is shaped to allow a user to grasp the first grip portion with a first hand and the second grip portion with a second hand when the retractor portion is contacting a perineum of the user and the device is held posteriorly. In an embodiment, the retractor portion is attached to the unified end of the bifurcated handle by a stem.

In an embodiment, the stem can include an adjustable portion to provide a stem that has a length that is adjustable. The stem can additionally or alternatively include joints to allow the stem to be bent.

In a preferred embodiment, the bifurcated handle is essentially symmetrical so that when the device is held by the user, either behind or in front of the body, with one grip in each hand and the users hands at about symmetrical positions relative the midline of the body in the sagittal plane, the retractor portion also essentially falls on about the midline of the body in the sagittal plane. In an embodiment, the position of each the first grip portion and the second grip portion are adjustable. The grip portions can be independently adjustable. Alternatively, adjustment of one grip portion can cause adjustment of the second grip portion to maintain the essentially symmetrical shape of the bifurcated handle.

The invention further provides a method for the use of a device of the invention. The method includes holding a device of the invention by the user with the first grip portion in the first hand of the user and the second grip portion in the second hand of the user; contacting a perineum of the user with the retractor portion; and applying pressure the perineum by moving the first hand and the second hand of the user. Pressure can be applied by moving the hands to the side or by pulling up or back away from the user. The device can be held in front of or behind the user.

Figure 1 is a representation of a side view of the device 1 of the invention to be held posteriorly by the user. The device is shown with the bifurcated handle portion 3 at the top, and the retractor portion 5 at the bottom. The bifurcated handle is connected to the retractor portion by a stem 7 which is shown with includes a hatched portion 9 in the center to indicate that the length of the stem can be adjusted. Alternatively, or additionally, the stem can include at least one joint or hinge to allow the stem to be bent.

In the embodiment shown, the device bends at approximately right angles to allow the retractor portion to be at an appropriate angle when the grips 11 are held behind the back of the user, on in each hand. It is understood that the stem can be designed being bent or curved in any manner to allow for comfortable and convenient use of the device. Similarly, the length of and distance between the handles, and angle of the handles to the stem can be varied, either during manufacture or by making the device adjustable. For example, the handles could be hinged or jointed at 13 and/or 15 to allow adjustment of the handles by the individual user. The joints at 13 can also allow for rotational adjustment of the grips, bringing them towards or away from the body. The distance between the ends of the bifurcated handle can be adjusted along 17 to make the grips further apart and to allow for users who are wider across the back or have limited shoulder flexibility; or the handles can be made longer along 19 based on user preference. The grip portions can also be covered with padding or other material such as foam or soft rubber to make the ends of them easier or more secure to grip.

Similarly, the device can also be adjustable at or near the retractor portion. For example, an adjustable hinge or joint can be included at 21. In an embodiment, the retractor portion and/or the attachment point at 21 can be made of a flexible material such as certain types of metal or plastic. In an embodiment, the device includes a swivel at 21 to allow for rotation of the speculum portion such that the device can be held in front of the body by the user. Alternatively, a spring to allow movement through a narrow range can be incorporated into the device at 13 to provide flexibility in the device. The retractor portion 5 is a size, shape, and smoothness appropriate for contact with the perineum and insertion by the user into the vagina. Such considerations are well understood by those skilled in the art. Speculums and other devices used for such purposes are well known.

The adjustable portions of the device can be designed to allow for adjustment only by a trained individual (e.g., nurse, midwife, physician) by requiring, for example, a specific tool, or by the end user, requiring no specialized tools.

Figure 2A-C are representations of the components of the device. The ability to disassemble the device into any specific portions or at all is not a limitation of the invention. Figure 2A is a side view representation of a removable, double-ended retractor 101 for attachment to a stem or bifurcated handle as shown in Figure 2C. For clarity, the retractor is discussed for insertion of a single end into the stem or bifurcated handle of the device in a single orientation. However, it is understood that the retractor can be inserted in either orientation. The angle 103 between the retractor portion for contact with the perineum 105 and the adjacent portion of the double-ended retractor 107 can be variable and flexible. In a preferred embodiment, the angle is about 70-100 degrees, about 85-95 degrees, preferably about 90 degrees. The length of the retractor portion 109 and 111 can vary from about 2 cm to about 10 cm, preferably about 3 cm to about 7 cm. The adjacent retractor portion 113 can vary in length substantially from about 7 cm to about 40 cm preferably from about 10 cm to about 30 cm. It is understood that upon attachment to the stem portion, the device can form essentially a continuous curve from the retractor portion to or through the bifurcated handle portion of the device. The device does not require the inclusion of a stem portion, and the retractor can be inserted directly into the unitary end of the bifurcated handle.

Figure 2B is a representation of a Y-shaped bifurcated handle portion 151. The handle portion has an attachment point at the unified end 153 proximal to the retractor portion, such as an opening, for the stem. The central portion stem 155 (in Figure 2C) is indicated by a dashed line to show that the length of the stem can vary and optionally adjustable. The length of the handles can vary as well as the angle between the handles. In an embodiment, the space between the split ends of the bifurcated handle 157 is narrower than the width of the back of the user, about 10 cm to about 30 cm, preferably about 15 to about 20 cm. The angle between the handles 159 can vary and optionally be adjustable from about 30 degrees to about 160 degrees, preferably about 45 degrees to about 135 degrees.

Figure 2C is a representation of the retractor of Figure 2 A attached to the end of the stem 161 of the device. In Figure 2C, the flexible angle of the device 103 is at the angle closest to the elongated stem of the device rather than at the point where the retractor portion and the stem are joined 163.

Figure 3A-C is a representation of a Sim's speculum which is still used for performing pelvic exams. The speculum provides an example of a device appropriately shaped and sized for contact with the perineum and insertion into the vagina. Figure 3A is a view of the top 201 of the device. The speculum appears substantially similar when viewed from the bottom. Figure 3B is a front view of the speculum. The speculum is about 5 cm wide at the widest portion and each of the retractor portions 203 and 205 is curved along the short axis 207 to fit into the vaginal opening against the perineum. The side view in Figure 3C shows that the two retractor portions of the speculum are of different sizes, approximately 7 and 9 cm. In a preferred embodiment, the devices of the invention are made from a light, sturdy, easy to clean material or materials such as plastic, or a lightweight metal such as aluminum, or a combination thereof. Grips can be made of material that is comfortable and easy to hold such as foam or soft rubber. Appropriate materials can be readily selected by those of ordinary skill in the art. The specific materials used to manufacture the device are not a limitation of the invention.

The device is typically used in a standing position. However, it is also possible to use the device while sitting on a donut shaped object that would allow for manipulation of the device in the vaginal opening. The device can also be used in a kneeling, squatting, or reclining position. The user holds the device behind her back or in front of her body, depending on the orientation of the retractor portion, with the retractor portion facing towards the body. A mirror can be used to guide the proper insertion of the retractor portion of the device into the vaginal opening, with the convex surface of the retractor portion towards the perineum and posterior vaginal wall. The user grasps one grip of the bifurcated handle in each hand. The user moves the handles by pulling or pushing to the front, back, side or upwards to permit stretching of the perineal area. The device facilitates perineal massage during the last portion of pregnancy when the enlarged abdomen restricts easy access by the woman to her vagina.

Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Each reference, patent application, or patent cited herein is hereby incorporated by reference as if each document were incorporated individually.

Claims

I claim:

1. A perineal massage device comprising: a retractor portion for contact with the perineum attached to a bifurcated handle comprising: a unified end proximal to the attachment site for the retractor portion, and a first grip portion and a second grip portion on a split end distal to the attachment site for the retractor portion, wherein the device is shaped to allow a user to grasp the first grip portion with a first hand and the second grip portion with a second hand when the retractor portion is contacting a perineum of the user.

2. The device of claim 1 , wherein the retractor portion is attached to the unified end of the bifurcated handle by a stem.

3. The device of claim 2, wherein the stem has a length that is adjustable.

4. The device of any of claims 1 to 3, wherein the bifurcated handle is essentially symmetrical.

5. The device of any of claims 1 to 4, wherein the position of each the first grip and the second grip are adjustable.

6. The device of any of claims 1 to 5, wherein the device is designed to be held posteriorly by the user.

7. The device of any of claims 1 to 5, wherein the device is designed to be held anteriorly by the user.

8. The device of any of claims 1 to 5, wherein the retractor portion can be rotated to allow for use of the device anteriorly or posteriorly by the user.

9. A method for perineal massage comprising: providing a device for perineal massage comprising: a retractor portion for contact with the perineum attached to a bifurcated handle having a unified end proximal to the attachment site for the retractor portion, and a first grip portion and a second grip portion on a split end distal to the attachment site for the retractor portion, wherein the device is shaped to allow a user to grasp the first grip portion with a first hand and the second grip portion with a second hand when the retractor portion is contacting a perineum of the user; holding the device posterior to the user with the first grip portion in the first hand of the user and the second grip portion in the second hand of the user; contacting a perineum of the user with the retractor portion; and applying pressure the perineum by moving the first hand and the second hand of the user while in contact with the grip portions of the bifurcated handles.

10. The method of claim 9, wherein the retractor portion is attached to the unified end of the bifurcated handle by a stem.

11. The method of claim 10, wherein the stem has a length that is adjustable.

12. The method of any of claims 9 to 11, wherein the bifurcated handle is essentially symmetrical.

13. The method of any of claims 9 to 12, wherein the position of each the first grip and the second grip are adjustable.

14. The method of any of claims 9 to 13, wherein the device is held anteriorly by the user.

15. The method of any of claims 9 to 13, wherein the device is held posteriorly by the user.

- l l -