Breast implants containing triple helix structures

Abstract

The human breast implant (10) is constructed in the shape of a human breast and has multiple chambers (12) in a sponge-like biotensegrity structure, allowing interstitial fluid in the human body to diffuse naturally into and out of the sponge-like chambers (12). The sponge-like biotensegrity structure has a triple helix structure (14) in interconnected layers similar to fascia, allowing fluid to reduce the buildup of dense collagen tissue surrounding the breast implant (10). Fluid can diffuse naturally into and out of the breast implant (10), in line with the behavior of the interstitium in the human body.

Description

[Technical Field]

[0001] The present invention relates to a human breast implant that includes multiple chambers and allows bodily fluids to diffuse into and out of the multiple chambers. [Background technology]

[0002] Currently known human breast implants often have solid structures filled with non-natural body fluids. For example, they are made entirely of silicone or have a silicone shell filled with a fluid salt / saline composition of, for instance, sodium chloride. This allows the implant and fluid to be accepted by the human body as body neutral. Over the long term, breast implants have been known to leak or implode, causing serious injury, illness, and discomfort to those wearing them.

[0003] Additionally, the solid shell of a breast implant can cause scar tissue to build up around it, accompanied by inflammation that can later lead to dense collagen tissue and fibrosis.

[0004] The prior art is defined by, for example, Patent Documents 1 to 5. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2006282164 [Patent Document 2] US Patent Application Publication No. 2002091443 [Patent Document 3] U.S. Patent No. 3,189,921 [Patent Document 4] US Patent Application Publication No. 2017290650 [Patent Document 5] U.S. Patent No. 2,842,775 [Patent Document 6] U.S. Patent No. 3,366,975

[0006] U.S. Patent No. 6,269,999 (Seastrom) discloses a breast implant, which in one embodiment provides a permeable shell filled with permeable microbeads. The breast implant lacks a rigid structure because the beads can move within the shell. Furthermore, if the permeable shell is damaged or the beads are too small, they may be released from the shell and cause damage to living tissue. To solve the problem of the beads acting as beanbags due to gravity and other forces, the beads are partially supported by strands or channels. Because they are partially supported, the beads may still deform the human breast implant within the area surrounded by the strands and channels. U.S. Patent No. 6,269,999 does not disclose fascia, a triple helix structure, or the natural flow of bodily fluids into and out of the implant.

[0007] Patent Document 2 (Yoon) discloses a prosthetic implant used for augmenting the shape of the human body, including an expandable body member having a first predetermined shape and a first volume in an expanded condition and a second predetermined shape in a second volume smaller than the first volume. The implant is permeable to bodily fluids, but does not have a rigid structure and does not allow for natural flow of fluid into or out of the shell. Bodily fluids are only active in swelling the implant from its smaller volume to its expanded volume; that is, bodily fluids do not naturally flow into or out of the implant.

[0008] U.S. Patent No. 6,299,999 (Pangman) preferably describes a breast implant in which, in one embodiment, a major portion of the implant is pervious or relatively pervious to blood. In another embodiment, a layer of material is provided that is impervious to fluids and has substantially sealed pores. This patent does not teach fascia or the natural flow of bodily fluids into or out of the implant; it simply teaches that the implant is filled with fluid to hold it in place within the body.

[0009] Also, U.S. Patent No. 5,629,999 describes an implant / prosthesis for repairing hernia ruptures using, for example, elongated triple helix stripes with multiple tissue anchoring points to build strength around the rupture, but this is not suitable for spherical structures such as human breast implants. This document does not address the fascia and the natural flow of bodily fluids into and out of the implant, for example, by diffusion.

[0010] Also, U.S. Patent Nos. 5,999,049 and 5,999,052 (Pangman) disclose implants similar to the one cited in the latter, but these documents disclose embodiments in which the implants are impermeable to bodily fluids and therefore do not teach the natural flow of bodily fluids into or out of breast implants. Summary of the Invention

[0011] The present invention relates to a human breast implant that aims to reduce or eliminate the risk of upcoming discomfort / illness as described above.

[0012] Thus, a human breast implant constructed in the shape of a human breast is disclosed, which provides an implant with multiple chambers in a sponge-like structure that is not soaking per se and allows the body's interstitial fluid to diffuse / expand into and out of the sponge-like chambers in a more natural flow. In this way, by allowing fluid expansion in the flow of fluid into and out of the breast implant, mimicking the behavior of the body's interstitial fluid in living tissue, the buildup of dense collagen tissue incapsulating the breast implant is reduced.

[0013] In one preferred embodiment of the present invention, the sponge-like biotensegrity structure is constructed as a triple helix structure.

[0014] Additionally, in one embodiment, a breast implant is provided in which the triple helix chamber and chamber contours align with measurements that match human fascial structures.

[0015] Also provided in one embodiment is a breast implant constructed from materials known to be non-body repellent that are used in the manufacture of human implants / prostheses, including fine polyurethane foam, silicone rubber, and other materials known to those skilled in the art.

[0016] Additionally, in another embodiment, the structure of the breast implant comprises a conductive material, for example, gold, silver, or copper, in the entire shape or in part, to mimic the function of the triple helix in real fascia.

[0017] Additionally, a method for constructing a human breast implant in accordance with the above teachings is presented. [Brief explanation of the drawings]

[0018] Hereinafter, throughout this specification, reference will be made to the accompanying drawings for a better understanding of the embodiments and given examples of the present invention. [Figure 1a] 1A and 1B are schematic diagrams illustrating a breast implant according to one embodiment of the present invention from one perspective. [Figure 1b] FIG. 1b shows a schematic view of the embodiment of a breast implant of FIG. 1a in another view. DETAILED DESCRIPTION OF THE INVENTION

[0019] definition As used throughout this specification, the following definitions are believed to have their established academic meaning as expressed.

[0020] The academic definition of the interstitium is described as the fluid-filled space between and around all cells that is conveyed through in and between all tissues and organs throughout the body, for example, of a human / mammal. This can be summarized as a closed, continuous flow that does not provide voids but is instead held in place by a network of fibrous proteins, primarily collagen of different thicknesses and densities.

[0021] The following scientific papers are examples that describe the stroma: Evidence for continuity of interstitial spaces across tissue and organ boundaries in humans, Odise Cenaj, Douglas HR Allison, Rami Imam, Briana Zeck, Lilly M. Drohan, Luis Chiriboga, Jessica Llewellyn, Cheng Z. Liu, Young Nyun Park, Rebecca G. Wells & Neil D. Theise. Retrieved from https: / / www.nature.com / articles / s42003-021-01962-0. and, Structure and Distribution of an Unrecognized Interstitium in Human Tissues, Petros C. Benias, Rebecca G. Wells, Bridget Sackey-Aboagye, Heather Klavan, Jason Reidy, Darren Buonocore, Markus Miranda, Susan Kornacki, Michael Wayne, David L. Carr-Locke & Neil D. Theise. Scientific Reports volume 8, Article number: 4947 (2018). This article is retrieved from the URL https: / / www.nature.com / articles / s41598-018-23062-6.

[0022] The following academic papers are examples that define tensegrity / biotensegrity: Tensegrity I. Cell Structure and Hierarchical Systems Biology, Donald E. Ingber, URL https: / / journals.biologists.com / jcs / article / 116 / 7 / 1157 / 27541 / Tensegrity-I-Cell-structure-and-hierarchical-systems. Bruno Bordoni, DPT, DO, PhD, https: / / orcid.org / 0000-0002-4949-5126, Fabiola Marelli, DPT, DO, [...], and Roberto Castagna, DPT, DO, https: / / journals.sagepub.com / doi / full / 10.1177 / 2515690X18792838. Bruno Bordoni, David Lintonbon, and Bruno Bordoni Morabito is available at https: / / assets.cureus.com / uploads / review_article / pdf / 13292 / 1612427996-1612427993-20210204-18590-1of320f.pdf.

[0023] Knowledge about structured water, EZ water, comes from, for example, Professor Pollack, and is taught, for example, at URL https: / / www.pollacklab.org / research, and is discussed in Exclusion Zone Phenomena in water—A critical Review of Experimental Findings and Theories, Elton et al., URL https: / / www.ncbi.nlm.nih.gov.

[0024] Within collagen networks and cells, there exists a flow of water containing, among other things, various molecules. The water itself is structured, meaning, among other things, that it carries a negative charge and therefore contributes to electrical conductivity. When structured water, particularly in association with proteins, is exposed to infrared (IR) light, H+ atoms separate from H2O, and the molecules structure into a honeycomb-like cake layer. In summary, the resulting mixture is H3O2- (H2O+OH-), with the free H+ forming the anode. Structured water forms a crystalline gel-like mixture, which Professor Pollack calls the fourth dimension of water. This structured water is present throughout the interstitial flow of the body between fibers and cells. It is also present within cells and within the cytoplasm. Therefore, this flow is an important part of the human body's signaling and communication systems.

[0025] There are studies that discuss fluid diffusion into and out of openings, particularly in fascia, including one provided in the paper "Structure and Distribution of an Unrecognized Interstitium in Human Tissues" by Petros C. Benias et al., which was published in 2018 at www.nature.com as paper number 4947 and will be referred to hereafter as Benias.

[0026] In summary, Benias describes "the anatomy and histology of previously unrecognized, yet widespread, macroscopic, fluid-filled spaces within and between tissues, and a new expansion and specification of the concept of the human interstitium."

[0027] Triple helix structures are common in the human body; DNA, for example, is built on two nucleic acid strands that complement each other in a helix, known as a double helix. Similarly, collagen molecules consist of three amino acid chains twisted / intertwined into a triple helix structure. Collagen is the most common protein, forming a network that surrounds and provides a structural framework for cells and organs in the body. This provides the framework and structure that allows movement and communication between the body's cells.

[0028] Benias teaches that the human fascial system of the human body, among other organs and tissues, is subject to human interstitial expansion findings, which are encompassed by the breast implants of the present invention.

[0029] It is understood that the breast implants of the present invention in one embodiment are constructed as sponge-like articles, which as used herein means plastic / shaping, i.e., not suction-able. As will be explained in the examples below with reference to the accompanying drawings, the implants are constructed according to the fascia collagen triple helix structure.

[0030] The mobility within the triple helix structure for collagen molecules and fibers is built into so-called "three-chains," defined as three helices entangled / twisted in one direction. One chain is followed by three chains entangled in the other direction, and so on. This structure, like a tangled / braided hemp rope, gives the structure the ability to move, stretch, and return to its original configuration, and is the structure that the present invention mimics.

[0031] FIG. 1a shows a schematic view of a breast implant 10 according to one embodiment of the present invention. Here, multiple openings / chambers 12 allow free expansion of interstitial fluid in a natural flow around and through the implant, into and out of the implant, mimicking the function of collagen triple helices 14 in actual fascia. The natural flow of interstitial fluid inhibits / reduces the likelihood of dense collagen tissue upbuild. As used herein, the term "natural / constant flow" refers to how the human interstitium behaves. Natural flow in this context can be provided by, for example, diffusion, blood pressure, osmosis, and / or the exclusion-zone water (EZ) phenomenon.

[0032] Diffusion is a spontaneous process of transport / expansion of elements (herein body fluids) induced by random changes in the inherent motion of the atoms / molecules of the elements due to the energy content of the molecules. Furthermore, the natural flow of the present invention also includes the biological theory of EZ water properties and its electrical / signaling assets as factors co-occurring with diffusion / blood pressure / osmosis, as mentioned above.

[0033] Fascia is a network / mesh / matrix that covers and permeates all organs and human / mammalian body parts, providing support for the structure and biotensegrity of organs and the entire body, among other things. Biotensegrity is generally defined by the term biological-tension-integrity, which determines the body's self-stabilization. The principles for almost all living organisms require tensegrity: a support structure built on tension and compression, with the interstitium flowing between them. Biotensegrity, in conjunction with the interstitium of fascia, provides what is considered flexibility / movement in the triple helix structure.

[0034] Furthermore, fascia structures are constructed from collagen fibers, which are composed of collagen molecules and, in their basic form, are shaped like a mesh or braid, forming triple helices 14 to facilitate the conduction of current / electricity / energy / charge, e.g., electrical pulses. Therefore, in one embodiment, the present invention provides that the material of the sponge-like triple helical structure 14 of breast implant 10 comprises a conductive material, e.g., gold, silver, or copper, throughout or in part of the triple helical structure 14 to mimic the function of actual fascia. Furthermore, in one embodiment, the electrical conductor is thin enough that the material of breast implant 10 is able to overcome the forces of the metal and not deform when implant 10 is subjected to stress, movement, etc. Importantly, in one embodiment of the present invention, the introduction of metal strands embedded in the implant's helices allows electrical signals to be transmitted in a manner similar to how fascia behaves, thereby providing the possibility of fully complying with the EZ water theory.

[0035] Thus, in one embodiment, the breast implant 10 of the present invention combines the natural softness of a natural sponge with a biotensegrity structure to retain the implant's shape, resist implosion, and provide elasticity / plasticity. An exemplary shape of the breast implant is a teardrop, although other shapes known in the art are possible.

[0036] By mimicking fascia, the present invention, in one embodiment, provides for interstitial flow to operate within the breast implant 10, which more closely resembles living tissue within the body, making the implant 10 more likely to be considered a natural part of the body rather than artificial, thereby reducing or preventing encapsulation of malignant tissue, such as dense collagen tissue buildup.

[0037] In summary, the findings behind the present invention in one embodiment of the present invention make it possible to fabricate breast implants that support fluid and energy flow through biotensegrity and conductive structures.

[0038] FIG. 1b shows a schematic view of the embodiment of breast implant 10 of FIG. 1a from another perspective, illustrating that the stroma moves into implant 10 from all directions around implant 10 and moves throughout the circumference of breast implant 10 in all possible directions in a spherical manner.

[0039] The triple helix structure 14 in Figures 1a and 1b is considered an exemplary embodiment of other embodiments possible within the scope of the appended claims. For example, other embodiments of the present invention may include all known possible variations of the triple helix structure 14 in layers to construct the breast implant 10. As seen in the accompanying drawings, the breast implant 10, when viewed from above, exhibits a helical triple helix structure / strand 14 in the peripheral asymptotic region, with four contact points between each three helix that, when connected, mimic a fascial network. The triple helix helices are connected in series via the four contact points / anchor points. In accordance with the present invention, the spaces between the four anchor points and consecutive triple helix helices in the layer constitute chambers. The triple helix helices are intertwined / woven in the layer like braided hemp rope to construct the breast implant body.

[0040] The braids may be knotted differentially / variably, for example, in one embodiment, looser or tighter in different areas of the implant, or uniformly depending on how flexible / elastic the breast implant should be in different areas. Chambers are presented between the braids and braid layers. These chambers communicate with each other throughout the breast implant in accordance with the present invention, allowing for the natural flow of bodily fluids. The size / measurements / dimensions of the chambers may be similar or different throughout the implant.

[0041] To understand the entire breast implant 10 as a triple helix structure 14, the layers of interconnected helices should be interpreted as existing as triple strand layers, for example, in Figures 1a and 1b.

[0042] As described with reference to Figures 1a and 1b, in one elaborate version of the triple helix structure 14 of the present invention, the breast implant 10 is constructed with braided layers of multiple connected triple helices 14 at a density such that the breast implant is elastic and not rigid, as taught in the latter.

[0043] The implant 10 may, in one embodiment, vary in density, for example, having a denser core. Other density shape variations are also possible.

[0044] The manufacture of the breast implants of the present invention can be by 3D printing, molding, casting, casting, ie, methods known to those skilled in the art for manufacturing 3D articles.

[0045] In one construction embodiment, the chamber dimensions of the breast implant 10 can resemble Mediterranean sponges. In another embodiment of the invention, the chamber dimensions of the breast implant 10 can correspond to, for example, average human fascia aperture dimensions or a chosen preferred dimension thereof, which may be in the nm to mm range.

[0046] For example, human fascia dimensions can be derived from Otsuka et al., "Site specificity of mechanical and structural properties of human fascia lata and their gender differences: A cadaveric study.", ScienceDirect, Journal of Biomechanics, volume 77, 22 August 2018, pages 69-75.

Claims

1. A human breast implant (10) constructed in the shape of a human breast, having multiple chambers (12) in a sponge-like biotensegrity structure, allowing interstitial fluid in the human body to diffuse naturally into and out of the sponge-like chambers (12), The sponge-like biotensegrity structure has a triple helix structure (14) in interconnected layers like fascia, allowing the fluid to reduce the buildup of dense collagen tissue encasing the breast implant (10), allowing the fluid to diffuse with the natural flow of fluid into and out of the breast implant (10) in line with the behavior of the interstitium within the human body. Human breast implants (10).

2. The chambers (12) and the contours of the chambers (12) of the triple helix structure (14) mimic dimensions corresponding to human fascial structures, said dimensions being within a range of values ​​of average human fascial opening sizes or a selected preferred size within said values, said values ​​being within a range of nm to mm. The human breast implant (10) according to claim 1.

3. The triple helix structure (14) of the breast implant (10) comprises a conductive material, for example, gold, silver, or copper, in its entirety or in part, to mimic the function of the actual fascia and transmit signals from the EZ water properties of the natural flow.

3. The human breast implant of claim 1 or 2.

4. A method relating to a human breast implant (10), comprising: constructing and manufacturing said human breast implant (10) in the shape of a human breast, and providing said human breast implant (10) with multiple chambers (12) in a sponge-like biotensegrity structure, thereby allowing human bodily fluids to diffuse in and out of said sponge-like chambers (12) in a continuous, natural flow; Including, The sponge-like biotensegrity structure is constructed as a triple helix structure (14) in layers interconnected like fascia through the interstitial fluid of the human body, thereby reducing the construction of collagen tissue encasing the breast implant (10). A method relating to a human breast implant (10).

5. The sponge-like biotensegrity structure is a triple helix structure (14) with four contact points between each helix in layers interconnected like fascia. The method of claim 4.

6. The chambers (12) and contours of the chambers (12) of the sponge-like biotensegrity structure mimic dimensions corresponding to human fascial structures, the dimensions being within a range of values ​​of average human fascial opening sizes, or a selected preferred size within said values, the values ​​being within a range of nm to mm. The method of claim 4.

7. The triple helix structure (14) of the breast implant (10) comprises a conductive material, for example, gold, silver, or copper, in its entirety or in part, to mimic the function of the actual fascia and transmit signals from the EZ water properties of the natural flow. The method according to any one of claims 4 to 6.

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