WO2000047247A1 - Bifurcated method for preventing breast ductal cancer - Google Patents

Abstract

Disclosed is a mammary pump funnel (10), comprising a pliable tubular structure (40) having a plurality of regions of varying thickness (55) disposed within the structure (40) so as to provide variable pressure to a mammary gland (12) during use, and a substantially rigid tubular structure (15) wherein the substantially rigid structure (15) is sealing attached to the pliable tubular structure (40), and at least one stimuli element (30, 35) coupled to at least one wall (18) so as to selectively provide stimulus to a mammary gland (12). Also provided is a mammary gland pad (80) containing a detergent based solution useful in removing keratin plugs from the mammary gland ducts, and a ductal dilator such as capsicum.

Description

BIFURCATED METHOD FOR PREVENTING BREAST DUCTAL CANCER

CROSSREFERENCETORELATEDAPPLICATIONS

This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 60/120,212, filed February 12, 1999, and U.S. Provisional Application Serial No. 60/120,411, filed February 12, 1999.

FIELD OF THE INVENTION

The present invention generally relates to breast pumps but more particularly to breast pump technology designed to obtain breast fluids from non-lactating breasts while stimulating elevated levels of prolactin in the blood.

BACKGROUND Breast cancer is one of the leading causes of disease and death in women, with greater than 90% of breast cancer originating in the epithelial cells of the ducts of the breast. Early detection and treatment of breast cancer has focused on improving prognosis and increasing the survival rates. Renewed focus on prevention and detection of breast cancer has lead to the use of numerous biological indicators in mammary fluid and methods of early detection of breast cancer risk. Such indicators include numerous oncogenic determinants, cytokines, angiogenic factors, proteins and nucleic acids, as well as biochemical products and lipids.

One method used to obtain mammary fluid is with standard breast pumps used in lactting females. Breast pumps have been used to remove milk from a lactating mother's breasts. These breast pumps include both powered and manual versions. In general, a breast pump applies suction to the breast tissue with the intended result being the flow and capture of a quantity of milk for use in feeding a baby. The shape of the breast funnel and performance of the suction unit vary in different models, some being more efficient in pumping than others due to the differences in design and individual breast physiology. However, the pumps designed for obtaining mammary fluid from lactating subjects do not generally draw fluids from non-lactating subject.

A more routine method of obtaining ductal fluid has been the performance of fine needle aspiration methods, as described in U.S. Patent No. 4,697,600 issued to Cardenas et al. on October 6, 1987. Because the needle asporation methods aare painful, women are understandably reluctant to consent to those processes to obtain a ductal fluid sample from their breasts unless they have already been diagnosed with breast cancer or believe to be at very high risk for the disease.

In addition, recent work by Dr. Chandice Covington of Wayne State University has indicated that breast ductal fluid content can be altered to improve health by systematically removing the existing fluid from the ducts on a regular basis, thus increasing fluid turnover in the breast. Such fluid turnover is thought to increase blood flow, hormones, and biological factors which are effective in reducing the risk of breast cancer. Examples of biological factors include carotenoids.

Accordingly, there is a need to improve fluid turnover in the breast of non-lactating women. Current breast pump systems are ineffective for obtaining fluid from non-lactating females and increasing fluid turnover in the mammary gland. Thus, a system that differs greatly from conventional breast milk pumps is needed.

SUMMARY OF THE INVENTION

The invention provides compositions, systems and devices useful in obtaining fluid from the mammary gland of a female subject. The subject can be any mammal including humans. The female will typically be a non-lactating female. The methods systems and devices are useful in removing keratin plugs found in the ducts of the mammary gland and in obtaining fluids from the mammary gland by warming and providing compression or vibration stimuli to the mammary gland. In one embodiment, a mammary gland pad is provided containing a detergent solution or a detergent solution combined with other active ingredients, which is useful in removing keratin plugs from the ductal glands of mammary tissue. This pad can be used alone or in combination with the mammary funnel system of the invention.

In another embodiment, a mammary funnel system is provided which is capable of heating the mammary gland to increase blood flow and reduce viscosity of the mammary fluid. The mammary funnel system is capable of providing additional compression stimuli to the mammary gland to further promote fluid secretion. The mammary funnel system is further capable of providing vibrational stimulation to promote expression of viscous mammary fluid from the breast.

The system, methods and devices of the invention are useful in promoting expression of mammary gland fluids, thereby increasing fluid turnover, reducing accumulation of carcinogenic agents in the breast tissue fluid, stimulating the rise of hormonal levels associated with lactation, and increasing the presence of beneficial biological agents in the mammary gland fluids.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a depiction of the mammary funnel system of the invention having a substantially rigid tubular portion 15 and a pliable tubular structure 40 in contact with a mammary gland 12. FIG. 2 shows the substantially rigid tubular portion 15 in further detail including the stimuli elements 30 and 35, sampling opening 32, and connector regions 60, 65, and 70.

FIG. 3 shows the pliable tubular structure 40 in more detail, including openings 45 and 50 and regions of varying thickness 55. FIG. 4 shows the mammary funnel 10 in use with a mammary gland 12. A. shows the funnel as it is being pressed against the mammary gland. The substantially rigid portion 15 provides resilience as the funnel is pressed against the mammary gland. B. shows the mammary funnel 10 in use with the mammary gland. Once in place a vacuum 65 causes the regions of varying thickness 55 to collapse and exert pressure on the nipple of the mammary gland 12. Fluid is expressed 34, which can be collected through sampling opening 32.

FIG. 5 A shows a mammary gland pad 80.

FIG. 5B shows a mammary gland pad 80 in contact with a mammary gland 12.

Like reference numbers and designations in the various drawings indicate like elements.

DETAILED DESCRIPTION OF THE INVENTION

Recent research by Dr. Chandice Covington at Wayne State University has indicated that the actual composition of ductal fluid may be altered to improve health by systematically removing the existing fluid from the ducts on a regular basis. The researchers experienced great difficulty in obtaining the ductal fluid samples using conventional breast aspiration equipment and assorted makeshift breast aspiration equipment. Success in extracting ductal fluid was approximately 50% and depended greatly upon the skill level of the clinician and the breast-feeding history of the patient. The most consistently positive results came from women who had recently stopped breast-feeding. The research indicates that there may be significant health advantages to mechanically cleansing the breast ducts on a regular basis to extract harmful precancerous cells and allow the ducts to be replenished with healthy, fresh ductal fluid. Without an effective process that can increase the success rate of extracting ductal fluid from 50% to nearly 100%.

Additionally, there is a large body of scientific evidence to suggest that the hormone, prolactin, plays a significant role in the integrity and health of the epithelial lining of the breast duct system and the digestive system. In elevated levels, prolactin triggers the production of breast milk. Prolactin levels are elevated during suckling and, depending upon the frequency of the suckling activity, can either reach lactation levels or remain elevated but below the level needed to trigger lactation. Research indicates that elevated blood serum prolactin levels are consistent with positive changes in the epithelial lining of the breast duct and intestines, possibly rendering them more resistant to disease such as cancer and infection. The ability to manipulate hormone levels though a pre-defined process of nipple stimulation using the devices of the invention may prove to be a useful intervention in breast ductal cancer, and other hormone related diseases. The nipples of the breast serve as somewhat of a "control panel" to the pituitary gland where prolactin, oxytocin and other hormones are manufactured. Since oxytocin and prolactin are both reproductive hormones, the presence of these hormones in high levels indicates the individual's membership in the reproductive population. There is some rationale for health related defensive mechanism that would protect the members of the reproductive population from illness or death in order to increase the chance of survival for offspring.

One hurdle to successfully collecting ductal fluid is the size and shape of the non- lactating breast. The breast in its "resting state" differs greatly from that of the lactating breast due to involution of the milk-making portion of the breast tissue and changes in the amounts of adipose tissue (fat deposits) in the breast. Without maternal fat stores embedded in the breast as in youth and lactation, the glandular (ductal) portion of the breast may be less palpable. Postmenopausal weight gain is often the cause of other changes in the breast, again making the ductal system more difficult to access. Adding to the difficulty of the situation is the presence of keratin plugs in the openings of the ducts at the nipples. These plugs effectively seal the breast contents behind them, making it difficult or impossible for the breast to drain naturally as well as impossible to remove ductal fluid using suction only. The keratin plugs are comprised of basically the same material as earwax, with the same tendency to harden into a solid plug.

In addition, the ductal fluid is typically thick in non-lactating females. It moves very slowly through the duct to the nipple, further necessitating a system that differs greatly in design from conventional breast milk pumps. Because of the thickness of the fluid and its inability to form a stream, it becomes necessary to capture the fluid in something other than a container.

The methods, systems, and devices envisioned by the inventor include multiple steps or device elements. In some females, not all steps in the process are necessary to achieve the desired results of cleansing the ducts, obtaining ductal fluid and/or elevating prolactin. The inventor believes that the process may be effective on some individuals without utilizing all steps or all elements present in the devices of the invention. In addition, the mammary gland funnel of the invention is applicable to all mammalian females, including for example, humans, exotic mammals, such as rhinos and tigers, as well as to domestic animals including cattle, cats, and dogs. The mammary gland funnel of the invention provides heat, compression stimuli, and suction simultaneously to the breast. In one embodiment, a further stimuli of vibration is added to assist in obtaining breast ductal fluids.

In one embodiment, the invention provides a mammary gland funnel system (10) for obtaining breast ductal fluid from the mammary gland (12) of non-lactating females. The pump has a number of features that overcome the deficiencies of the standard breast pump systems used for lactating females. FIG. 1 shows one embodiment of the invention. The pump has a substantially-rigid tubular structure (15) having a first opening (20) and a second opening (25). The substantially-rigid tubular structure has at least one stimuli element (30 or 35) for delivering a stimulus to mammary gland (12). One or more connector ports (60, 65, or 70) are present at the second end of the substantially-rigid tubular structure. Nested within the substantially-rigid tubular structure (15) is a pliable tubular structure (40) having a first end (45) and a second end (50). The pliable tubular structure (40) has areas of varying thickness (55) in the structure. In one embodiment, the pliable tubular structure (40) is attached at its first end (45) and its second end (25) to the wall (18) of the substantially-rigid tubular structure (15) to form a seal (e.g., a vacuum seal).

FIG. 2 shows the substantially-rigid tubular structure (15) in more detail. The substantially-rigid tubular structure (15) has at least one wall (18) defining a first opening (20) and a second opening (25). The substantially-rigid tubular structure has at least one stimuli element (30 or 35) coupled to the tubular structure (15) for delivering a stimulus to mammary gland (12). One or more connector ports (60, 65, or 70) are present proximate the second opening of the substantially-rigid tubular structure (15). By "substantially-rigid," is meant that the material from which the structure is made is resistant to collapsing under pressure, such materials include, for example, polypropylene, polystyrene and others known to those of skill in the art or easily identified by those of skill in the art. Typically, the substantially-rigid tubular structure (15) is tapered somewhat like a funnel, where the first opening (20) is broader and receives the mammary gland (12). The second opening (25) may have at least one connector for connection to a vacuum (65), and connectors (60 or 70) for connection to stimuli element leads. Stimuli elements (30 or 35) include for example, heating elements (30) and vibrating elements (35). Such elements are useful in providing stimulus to the mammary gland of the female during the process of obtaining breast fluid. The design of such elements include inner pouches molded in the funnel material filled with a liquid that is able to hold a heated temperature for a given period of time. In such instances the funnel can be warmed by preparation in a microwave oven, conventional oven, warm water bath, boiling water, solar power or other methods known in the art. Similarly, small heat elements may be coupled to the funnel or clipped on to the funnel. Such elements include those used in heating blankets and similar devices. The stimuli elements (30 or 35) can be coupled to the wall of the tubular structure (15) in any number of ways. For example, the elements (30 or 35) can be attached to the surface of the wall (18), embedded in the wall (18) or integrally formed within the wall (18) of the tubular structure (15).

FIG. 3 shows the pliable tubular structure (40) in more detail. The pliable tubular structure has at least one wall (42) defining a first end (45) and a second end (50). By

"pliable" is meant that the wall (42) of the tubular structure (40) is capable of collapsing under pressure (e.g., vacuum pressure). The tubular structure (40) typically will be larger at one end and tapered to the opposite end more or less in the shape of a funnel. The wall (42) has a plurality of regions of varying thickness (55). These regions of varying thickness (55) are typically integral with the wall (42). The regions of varying thickness (55) can be formed in any number of ways and include varying the thickness of the polymer material from which the wall (42) is made, by providing liquid filled regions within the wall (42), or by providing air filled regions within the wall (42). Other methods for creating regions of varying thickness (55) will be recognized by those of skill in the art. The regions of varying thickness (55) are designed to collapse at a different pressure than the remainder of the wall (42). By varying the degree of collapse the degree of compression on the mammary gland can be modulated. The second end (50) can be designed to be in vacuum communication with vacuum source, such as, for example, a hand held pump or portable pump or a wall vacuum with a regulator.

FIG. 4 diagrammatically shows the mammary gland funnel system (10) in use. During use, the funnel system (10) is aligned with the nipple and mammary gland (12) and is forcibly pressed inwardly towards the mammary gland (12) sufficient to cause the nipple to be inserted into the opening (45) of the pliable tubular structure (40). The substantially-rigid tubular structure (15) provides sufficient resilience to prevent collapse under the pressure of forcing the funnel onto the mammary gland. The pliable tubular structure (40) receives the nipple of the mammary gland (12) through opening (45). The stimuli elements (30 or 35) may be activated prior to contact with the mammary gland (e.g., the funnel system (10) may be pre-warmed by a heating element (30)) or may be warmed after the funnel system (10) is contacted with the mammary gland (12).

Once the funnel system (10) is pressed against the mammary gland (12) pressure is exerted on the nipple of the mammary gland (12) by a vacuum source in vacuum communication with the funnel system at opening (50). The pressure causes the pliable tubular structure (40) and the regions of varying thickness (55) to compress against the nipple of the mammary gland (12) thereby drawing ductal fluids from the mammary gland (12). In addition, the vacuum pressure assists in drawing ductal fluids (34) from the mammary gland (12). The ductal fluids (34) can be sampled through sampling port (32) using a capillary pipette, filter paper or other devices useful in obtaining or measuring a biological fluid sample. In another embodiment, the invention provides a mammary gland pad useful in removing keratin plugs present in the ducts of the mammary gland. The pad can be of any shape, but typically will be of a shape that fits comfortably over the breast of a female. For example, where the female is human, the pad can be designed to fit within the brassier. The pad has disposed within it a detergent solution, which may include other active ingredients (e.g., capsicum or other vasodilators), useful in removing keratin plugs and dilating nipple ducts. A typical solution ratio will be about 1/8 teaspoon of baking soda per 1/2 cup of water. Other detergent solutions will be readily identifiable in the art (e.g., liquid detergents such as IVORY). Various amounts of the solution can be used in the pad. The solution can be disposed in a pocket of the pad (as described more fully below) or integral to one or more layers of the pad. The pad will typically be applied to the mammary gland, particularly the nipple of the mammary gland for about 10 minutes to 24 hours or for a sufficient time to assist in dissolving or removal of keratin plugs.

FIG. 5 is a diagram showing the mammary gland pad of the invention. FIG 5 A shows a typical pad (80) comprising at least two walls. A first wall (100) and a second wall (200) are fixedly connected. The walls can be connected at their periphery or throughout the area of each wall. Where walls (100 and 200) are connected only at the periphery a pocket or pouch (230) is formed between the two walls. This pouch or pocket can be used to hold a detergent solution useful to remove keratin plugs. Alternatively, a detergent based solution can be integrally applied to the fibers or composite material (250) of at least one wall (200). FIG. 5B shows the pad of the present invention during use. During typical use one wall (200) is in contact with the mammary gland (12). Wall (200) will typically contain or be permeable to liquids, and in particular permeable to a detergent solution, present within the pad. Wall (100) may be impermeable to liquids to avoid staining or wetting of clothing or garments that may be in contact with the pad (80).

The walls of the pad (80) can be formed of any number of materials. For example, wall (100) will typically be formed of a thin thermoplastic film, such as polyethylene film, which is substantially impermeable to liquid. This functions to prevent the detergent solution contained in the pad from wetting or soiling the wearer's clothing, bedding, or other materials contacting pad. The wall may be, for example, a polyethylene film having an initial thickness of from about 0.5 mil (0.012 millimeter) to about 5.0 mil (0.12 millimeter). Other alternative constructions for the pad wall include woven or nonwoven fibrous webs that have been constructed or treated to impart the desired level of liquid impermeability, or laminates formed of a woven or nonwoven fabric and thermoplastic film. The walls may optionally be composed of a vapor or gas permeable, microporous "breathable" material that is permeable to vapors or gas yet substantially impermeable to liquid. Breathability can be imparted to polymer films by, for example, using fillers in the film polymer formulation, extruding the filler/polymer formulation into a film and then stretching the film sufficiently to create voids around the filler particles, thereby making the film breathable. Generally, the more filler used and the higher the degree of stretching, the greater the degree of breathability.

In another embodiment, kits are provided, containing the mammary gland pad of the invention. The pad of the invention is ideally suited for a kit for assisting in the removal of keratin plugs from the mammary gland. Such a kit comprises a container containing a mammary gland pad containing a detergent based solution for application to the mammary gland of a female. In another embodiment, a kit of the invention contains one or more containers compartmentalized to hold a mammary gland pad and a mammary gland funnel system. The kit may further include instructions for use in obtaining mammary gland fluid from non-lactating females.

A number of embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A breast pad, comprising a first wall; a second wall, having the same configuration as the first wall, and being in alignment with the first wall; the first wall fixedly second wall fixedly connected; and a detergent based solution contained within the wall of the breast pad.

2. The breast pad of claim 1, wherein the first wall is a liquid impermeable wall.

3. The breast pad of claim 1 , wherein the second wall is a liquid permeable wall.

4. The breast pad of claim 1 , wherein the fist wall and second wall are fixedly connected and form a pouch.

5. The breast pad of claim 1 , wherein the detergent solution is water and one or more of the following compounds selected from the group consisting of baking soda, peroxide, defatted soap and combinations thereof.

6. The breast pad of claim 5, wherein the detergent is an aqueous solution of water and baking soda.

7. The breast pad of claim 6, wherein the ratio of water to baking soda is 1/8 teaspoon of baking soda: 1/2 cup of water.

8. The breast pad of claim 4, wherein the detergent solution is contained in the pouch.

9. The breast pad of claim 1, wherein the detergent solution is impregnated in at least one wall of the breast pad.

10. The breast pad of claim 1 , further comprising a ductal- or vaso-dilator.

11. The breast pad of claim 10, wherein the dilator is capsicum.

5 12. A mammary pump funnel, comprising: a pliable tubular structure having: at least one wall; a first end having an opening therein to receive a mammary gland; a second vacuum communication end; and o a plurality of regions of varying thickness disposed within the at least one wall so as to provide variable pressure to a mammary gland during use; a substantially -rigid tubular structure having: at least one wall defining a hollow interior space; a first end; 5 a second end; wherein the substantially-rigid structure is designed to receive therein the pliable tubular structure such that the substantially-rigid tubular structure is sealingly attached to the pliable tubular structure at their respective first and second ends; and at least one stimuli element coupled to the at least one wall so as to selectively 0 provide stimulus to the mammary gland.

13. The mammary pump funnel of claim 12, wherein the at least one stimuli element is a vibrating element.

5 14. The mammary pump funnel of claim 12, wherein the at least one stimuli element is a heating element.

15. The mammary pump funnel of claim 12, wherein the at least one element is two elements comprising a heating element and a vibrating element. 0

16. The mammary pump funnel of claim 12, wherein the plurality of regions of varying thickness are a pluarity of pouches filled with air.

17. The mammary pump funnel of claim 12, wherein the plurality of regions of varying thickness are a plurality of pouches filled with a liquid.

18. The mammary pump funnel of claim 12, wherein the plurality of regions of varying thickness are regions of varying thickness of silicone.

19. A kit, comprising at least one container being compartmentalized to contain a mammary gland pad containing a detergent based solution.

20. A kit, comprising at least two containers being compartmentalized to contain a mammary gland pad containing a detergent based colution and a mammary gland funnel system.