WO1998031406A1

WO1998031406A1 - Holistic breast patch

Info

Publication number: WO1998031406A1
Application number: PCT/US1997/002461
Authority: WO
Inventors: Samuel E. Baldwin
Original assignee: Baldwin Samuel E
Priority date: 1996-01-21
Filing date: 1997-02-14
Publication date: 1998-07-23
Also published as: AU2276197A

Abstract

This invention is an apparatus and method to 'aid the comfort of breast engorgement pain and the drying of breast milk' after a period of pregnancy. The apparatus (24) comprises a unique adhesive path system with a highly 'Telfa Pad' (22), which is capable of being applied upon the chest region of a woman. The pad (22) is formed of 'Telfa and Carbonyl Group' which is stationary inside the 'Telfa Pad' (22). By wearing this device in a prescribed regimen, it will aid the comfort of breast engorgement pain and the drying of milk from a woman's breasts.

Description

HOLISTIC BREAST PATCH"

BACKGROUND OF THE INVENTION

1. Field of Invention

This invention relates to certain new and useful improvements in aiding the comfort of breast engorgement pain and breast milk suppression and, more particularly, to an improved apparatus and method residing in the provision of a specified patch which is worn over a woman's chest to aid engorgement pain and suppression of breast milk.

2. Brief Description of the Prior Art

After pregnancy, a woman's breast will automatically generate milk for a period of time, while experiencing discomfort due to breast engorgement.

During the transition period in which milk is not being withdrawn, the woman's breast can become engorged and swollen because of the excess milk generation and, indeed, this swelling can become quite uncomfortable, if not painful. To overcome this problem, the current remedy relies and/or relied upon administration of certain medications in the nature of steroids, which will cause a drying up of the milk in the breast and aid the comfort of engorgement pain. In many cases, 'Tare, parlodel, estrogens-

ethinyl estradioi and androgens or bromocriptine mesyliate" was and possibly is still being used to suppress milk productions and resultant breast engorgement. The administration of steroids and other pharmaceutical items does, however, have other side effects which are often undesirable. (Deaths, heart attacks, profuse bleeding, breast cancer, and loss of consciousness). These type of products in some cases, could be a worsening of myopia or a stigmatism and an intolerance to contact lenses. In many cases, nausea, vomiting, abdominal cramps, bloating, diarrhea, constipation, changes in appetite, weight, and bowel ischemia may also occur. Thus, it can be seen that side effects from pharmaceutical products for suppression and engorgement pain can be quite serious.

In recent years, and in the United States, there has been a sharp restriction in the use of pharmaceuticals to aid the suppression of breast milk and engorgement pain. As a result, and due to the fact that most of the formerly used pharmaceutical items are no longer commercially available, there is essentially no recognized mechanism for aiding the comfort of breast milk accordingly, there has been a need for some device or method which will aid the comfort of breast engorgement pain and suppression of breast milk in a safe and efficient manner.

OBJECTS OF THE INVENTION

It is, therefore, one of the primary objects of the present invention to provide an apparatus for aiding the comfort of postpartum engorgement pain and suppression of breast milk in the nature of a breast patch which can be worn over a woman's chest.

It is another object of the present invention to provide an apparatus of the type stated in which the breast patch is provided with "Carbonyl Group", all natural (organic)

compounds.

It is an additional object of the present invention to provide an apparatus of the type stated which is highly efficient and which is yet safe in operation.

It is a further object of the present invention to provide a method of aiding postpartum engorgement pain and the drying of breast milk by locating a breast patch over a woman's chest and which thereby avoids the necessity of administration of medicines.

With the above and other objects in view, my invention resides in the novel features form, construction, arrangement and combination of part presently described and pointed out in the claims.

BRIEF SUMMARY OF THE INVENTION

This invention related to a very surprising discovery that a "Holistic (Carbonyl Group) Breast Patch" worn by postpartum women in a prescribed regimen will be effective in aiding the comfort of engorgement breast pain and the suppression of breast milk during or after a period of pregnancy or nursing. It has been found that milk suppression will readily occur without the necessity of any aiding or other intervention. However, many women desire to suppress the engorgement pain and the breast milk immediately after pregnancy or need during a nursing period in order to avoid the discomfort associated with child birth.

The invention resides in the wearing of a breast patch which is comprised with a

"Carbonyl Group" content.

It has been found that the breast patch should be worn about a woman's chest.

Moreover, and of some significance is the fact that the woman should start wearing the breast patch within about 24 hours after child delivery if there are no plans to nurse the child. Thereafter, it should be worn generally continuously until engorgement pain and milk generation ceases.

The present invention is highly effective in that it causes essentially no harm whatsoever to the user. Further, no warnings and precautions are required. However, it is recommended that children and infants should not wear the device.

This breast patch is worn by postpartum women, generally in the form of (Inactive ingredients:) "Telfa, gauze, and vinyl - (active ingredients - ("Formula" R-Co-R) nickel, manganese, phosphorus, silicon, sulphur, and carbon). This formula is called "Carbon Group".

The scientific method of the "Holistic Breast Patch" is called "Transdermal". The "Carbonyl Group" square plate is worn by the woman, is generally in the form of a "Holistic Breast Patch" having a high carbon steel interior core surrounded by an outer nickel layer. The core should preferably have a thickness of 49.7 mils, although this can range from 49.7 mils to about 49.9 mils. The outer layer of nickel which is essentially a pure nickel, should have a thickness of about 0.3 mils, although this thickness of the outer layer may range from about 0.1 mils to about 1.0 mils.

The "Carbonyl Group" square plate is adapted to be seated between gauze and vinyl for wearing about the chest.

This invention possesses many other advantages and has other purposes which will be made more full apparent from a consideration of the forms in which it may be embodied. One of these forms is illustrated in the following detailed description of the invention and in the accompanying drawings. However, it is to be understood that this detailed description and the drawings are set forth only for the purpose of illustrating the general principals of the invention and are not to be taken in a limiting sense. BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the invention in general terms, reference will now b e made

o the accompanying drawings is which:

Figure 1 is a front elevation view of the "Carbonyl Group" plate constructed in accordance with and embodying the present invention; Figure 2 is a side elevation view of the "Carbonyl Group" plate of Figure 1. Figure 3 is a horizontal sectional view taken along line 3-3, Figure 1 ; Figure 4 is a vertical sectional view through the interior of the "Carbonyl Group" plate

taken along 4-4 of Figure 1 ;

Figure 5 is a vertical sectional view through the interior of the "Carbonyl Group" plate

taken along line 5-5 Figure 3;

Figure 6 is a bottom elevational view of the square plate of Figure 5; Figure 7 is a vertical sectional view through the interior of the "Carbonyl Group" square

plate taken along line 7-7 of Figure 5.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Referring now in more detail and by reference characters to the drawings which illustrate a preferred embodiment of the present invention, a designates suppression aid device in the nature of a "Carbonyl Group", the latter of which is constructed initially as a thin, flat plate 10. The "Carbonyl Group" plate 10 has an upper straight edge. Further,

the plate 10 of the "Carbonyl Group" carbon steel flat plate is provided with a flat front face 12 and a flat rear face 14.

The apertures 16 serve as air holes and also serve as relief for the "Carbonyl Group" to bend to conform to the different chest curvatures of a woman user. Extending between front face 12 and the rear face 14 of the plate 10 are a plurality of elongate groves or openings 22 which extend vertically along and through the plate. The grooves 22 extend through the plate from the rear surface, but not to extend through plate 10.

In this latter case, the grooves would be depressed to a dimension of about 25 mils, although they could be depressed into the plate 10 for a depth of about 40 mils.

By reference to Figure 7 of the drawings, it can e seen that the plate 10 is comprised of an inner core 18 of a carbon steel containing a high carbon content and which is enclosed within an outer nickel layer 20. The outer nickel layer is substantially

pure nickel.

The entire plate preferably has an overall thickness of about 50 mils, that is, from the front face to the back face. This thickness is preferred since the plate will then have the necessary structural integrity, although it will not be unduly heavy. However, it should be understood that the thickness of the plate could vary, depending upon the desired thickness of the interior core and of the outer layer, as hereinafter described.

The steel which is employed as the inner core 18 contains a substantially high carbon content, as aforesaid, and this carbon content could be 0.7% by weight to about 1.5% by weight. In a more preferred range, the amount of carbon would range from about 0.6% to about 0.9%. The remaining content of the interior core would be formed of a basic steel material which would include some minor amounts of manganese and chromium, and possibly a minor amount of nickel. The minor amounts of these other components, such as manganese and chromium, and chromium, and possibly even nickel, would be less than about 1.0%.

In a slightly different embodiment of the invention, the metal which is used in the formation of the plate would include the steel and the nickel, as well as the carbon, in the percentages as aforesaid. However, minor amounts of other elements are also in the composition and these include, for example, phosphorus in an amount of 0.6% by weight, and siiicon in an amount of 0.30% by weight. Manganese may be present in an amount of about 0.60% by weight. Vanadium, molybdenum and chromium may also be present in minor trace amounts. The phosphorus can actually range from about 0.4% to about 1.0%. The manganese can also range from about 0.1% to about 0.8%, and the silicon can also range from about 0.1% to about 0.8%.

The aforesaid composition provides plate of substantial harness. However, it is not unduly brittle, and moreover, it still has a moderately light weight so that it can be worn comfortably and easily by a user. The nickel layer is preferably plated so that it is relatively smooth and provides no surface irregularities which could abrade the skin of a user.

Figures 1-4 illustrate the embodiment of the invention in which the grooves 16 constitute openings which extend from 25 - 40 mils between faces 12 and 14. Figure 5 illustrates an embodiment in which the grooves are located on one flat surfaces of the medallion, but do not extend all the way through from flat surface to flat surface.

The milk suppression aid medallion is preferably constructed by forming a piece of high carbon content steel into the shape of a medallion, as illustrated in Figure 1 , and this forming may be by stamping same from a sheet of such metal. The distance between each of the grooves 16 is preferably about 0.025 inches and the width of each groove 16 itself is about 0.075 inches, in connection with the invention, it has been found that the grooves 16 should have the same horizontal dimension, that is the width, as the space between each of the grooves 16.

One of the important aspects of the plate of the present invention is that it does not provide any adverse effects or, for that matter, any adverse side effects. The use of

the plate is for the purposes of aiding the drying of breast milk, has been explored in conjunction with interaction with other drugs which are commonly used. The interaction, if any, is set forth below:

1. Ampicillin - no proven problems;

2. Anticoagulants - no proven problems;

3. Anticonvulsant hydantoin - no proven problems;

4. antidepressants tricyclic (TEA) - no proven problems;

5. Antidiabetic agents - no proven problems; 6. Antihistamines - no proven problems;

7. Barbiturates - no proven problems;

8. Chloramphenicol - no proven problems;

9. Clofibrate - no proven problems;

10. Dextrothyroxine - no proven problems;

11. Guanethidine - no proven problems;

12. Hypoglycemic (oral) - no proven problems;

13. Insulin - no proven problems;

14. Meperidine - no proven problems;

15. Meprobamate - no proven problems;

16. Mineral oil - no proven problems;

17. Non-steroidal anti-infiammatory drugs (NSAID's) - no proven problems;

18. Rifampin - no proven problems;

19. Sulfadiazine and pyrimethamine - no proven problems;

20. Terazosin - no proven problems;

21. Tetracyclic - no proven problems;

22. Urosodiol - no proven problems;

23. Vitamin A - no proven problems;

24. Vitamin E - no proven problems;

25. Anticoagulants (oral) - no proven problems;

26. Antidiabetic (oral) - no proven problems;

27. Carbamazepine - no proven problems; 28. Phenobarbital - no proven problems;

29. Primidone - no proven problems;

30. Tamoxifen - no proven problems;

31. Thyriodhormones - no proven problems;

32. Bromocriptine - no proven problems;

33. Hypoglycemic (oral) - no proven problems;

34. Oxyphenbutazone - no proven problems;

35. Phenothiazines - no proven problems; and

36. Phenyibutazone - no proven problems.

The use of milk lactating medallion of the invention has also been explored for possible interaction with other substances. The interaction with several substances, or lack thereof, is set forth below.

Possible interaction with other substances:

Possible Interaction Combined Effect

1. Alcohol None

2. Beverages None

3. Cocaine None

4. Foods/salt None

5. Marijuana None

6. Tobacco/all forms None EXAMPLES

The invention is further illustrated, but not limited to, the following examples:

Example 1

This milk suppression aid device was constructed by forming a piece of high- carbon content steel into the shape illustrated in Figure 1. The plate had the overall dimension of .500 inches between the spaced-apart opening 16 (center-line to center- line). The width of the spaces between each of the grooves 16 was 0.075 inches and the width (horizontal dimension) of each of grooves itself was 0.075 inches. The radius at the

lower ends of each of the shorter and outer grooves 22 was 2.1250 inches. The distance between the uppermost margin of each of the grooves 22 and the upper margin 12 was also 0.125 inches.

The overall device had a thickness of 50 mils. The grooves 22 have a depth into the device of 20 mils on each of the flat faces. The thickness of the center core of high- carbon steel is about 49.7 mils and the thickness of the outer layer of nickel was about

0.3 mils.

Example I

The aid device prepared in accordance with Example I is used by a group of ten women. Each of the women is provided with the device within about 24 hours after giving birth. In each case, the birth is a normal birth, whether or not by a caesarian or vaginal delivery. After wearing the device for about three to five days over the chest region, each of the women find that milk is suppressed and further, any engorgement of the breasts is reduced.

Example II

The aid device prepared in accordance with Example I is again used by a group of ten women. Each of the women is provided with the device almost immediately after given birth. In each case, the birth was a normal birth, whether or not by caesarian or vaginal delivery. After wearing the device for about three to five days over the chest region, each of the women engorgement of the breasts is reduced.

Thus, there has been illustrated and described a unique and novel apparatus and method for aiding suppression of milk after pregnancy and which, therefore, fulfills all of the objects and advantages which have been sought. It should be understood that many changes, modifications, variations and other uses and applications will become apparent to those skilled in the art after considering this specification and the accompanying drawings.

Therefore, any and all such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention.

Claims

CLAIMSHaving thus described my invention, what I desire to claim and secure y letters patent is: .

1. An apparatus for aiding suppressing milk after pregnancy, said apparatus

comprising a "Carbonyl Group Plate" sized for wearing over the chest region of a woman, said comprising a plate having a core of high-carbon content steel and surrounded by an outer layer of relatively pure nickel.

2. The apparatus of claim I further characterized in that the core is comprised of high- carbon steel with a carbon content of about 0.190 to about 1.5% by weight.

3. The apparatus of claim I further characterized in that the core has a carbon content of about 0.7% by weight.

4. The apparatus of claim I further characterized in that the plate has a core thickness of about 49.0 mils of about 49.9 mils and an outer layer has a thickness of about 0.01 mil

to about 1 mil thickness.

5.

The apparatus of claim I further characterized in that the plate has a core thickness of about 49.7 mils and the outer layer has a thickness of about 0.3 mil.

6. The apparatus of claim I further characterized in that a plurality of vertically- arranged, generally parallel grooves are formed in the plate.

7. The apparatus of claim I further characterized in that said grooves are formed as depressions in the surfaces of said plate.

8. The apparatus of claim I further characterized in that said grooves extend through said plate from one fiat surface to an opposite flat surface.

9. The apparatus of claim I further characterized in that each of the grooves in the plate are spaced apart by ridges which have substantially the same width as each of the grooves.

10. The apparatus of claim I further characterized in that a pair of openings are located

along the opposite sides of the plate.

11. A method for suppressing milk lactation in a woman immediately after or shortly after pregnancy, said method comprising locating a milk lactation suppress aid device

over the chest region of the woman and which device is comprised of a metal plate having a high-carbon content steel interior core surrounded by a nickel layer.

12.

The method of claim II further characterized in that said method comprised starting the wearing of the device within no later than about twenty-four to seventy-two hours after pregnancy.

13.

The method of claim II further characterized in that the device used in the method comprises a high-carbon steel content interior core having a content of about 0.1% to about 1.5% by weight.

14.

The method of claim II further characterized in that the device used in the method comprises an inner high-carbon steel content core having a thickness of 49.0 mils and an outer nickel layer which has a thickness of about 0.01 mil to about 0.1 mil.