Device and method for tissue examination

Abstract

Provided are devices and methods for examination of tissue by palpation. The devices and methods are useful for breast examination, including but not limited to breast self-examination. The devices and methods are useful for identifying differences in breast tissue, including variations associated with any anatomical features and conditions, including but not limited, to the detection of breast cancer and other abnormalities in a subject.

Description

Attorney Docket No. 35527-100110 DEVICE AND METHOD FOR TISSUE EXAMINATIONCROSS-REFERENCE TO RELATED APPLICATION

[0001] This International Patent Application claims priority to United States Provisional Patent Application No. 63 / 759,820, filed February 18, 2025, which is incorporated by reference herein in its entirety.TECHNICAL FIELD OF THE INVENTION

[0002] The invention pertains to the field of tissue examination and palpation devices and methods for use in both wellness and medical contexts. The devices and methods are useful for tissue examination, including but not limited to breast examination and breast self-examination. The devices and methods are useful for identifying differences in breast tissue, including variations associated with any anatomical features and conditions, including but not limited, to the detection of breast cancer and other abnormalities in a subject.BACKGROUND OF THE INVENTION

[0003] Breast cancer is a significant public health concern. According to the American Cancer Society, after skin cancers, breast cancer is the most commonly diagnosed cancer in women in the United States. Overall, the average risk of a woman in the United States developing breast cancer sometime in her life is about 13%. In recent years, incidence rates have increased by 1% annually, and for 2025, it is estimated that over 300,000 new cases of invasive breast cancer will be diagnosed in the U.S. Breast cancer is the second leading cause of cancer death among women in the U.S., with more than 40,000 deaths estimated annually, corresponding to a lifetime risk of approximately 1 in 43 women dying from breast cancer.

[0004] Globally, breast cancer is the most common form of cancer among women in both developed and less developed countries. In 2022, approximately 2.3 million women worldwide were diagnosed with breast cancer worldwide, resulting in over 670,000 deaths. In many low- and middle-income countries, breast cancer incidence and mortality rates are believed to be underestimated due to limited access to screening and diagnostic resources. Reported data indicate that breast cancer mortality in such regions has increased 8% between 1990 and 2021. In Sub-Saharan Africa alone, for example, the number of new breast cancer cases is projected to reach more than 2.2 million by 2040.Attorney Docket No. 35527-100110

[0005] Early detection of breast cancer is important for treatment outcomes and survival. The US Preventative Services Task Force recommends that all women get screened for breast cancer every other year, starting at the age of 40 and continuing through age 74. When breast cancer is detected at an early, localized stage (i.e., at or before Stages 0 and 1), survival rates exceed 98%. However, survival rates decline significantly when the disease is detected at more advanced stages, such as Stages 3 and 4. The most common screening methods include mammography, breast ultrasound, breast MRI (magnetic resonance imaging), clinical breast examination, and breast self-examination.

[0006] The disparity in access to screening technologies contributes to significant differences in breast cancer outcomes across regions. For example, in South Africa, the number of mammography machines per million people is approximately 1.54, compared to 78.77 machines per million people in the U.S. The cost required to match the mammograph availability ratio by population is estimated to exceed $3 billion just equipment alone. This critical lack of screening infrastructure contributes to worse clinical outcomes in low-income countries. While the average stage of breast cancer detection in the U.S. remains at approximately Stage 2 or Stage 3, women in low-income countries are diagnosed at advanced stages, such as Stage 4 disease, where survival rates are approximately 23.4%. In Sub-Saharan Africa, for example, the five-year survival rate for breast cancer is estimated to be about 40%, compared to 86% in the U.S. These disparities underscore a critical need for reliable, accessible, and cost-effective tools for early detection of breast cancer globally.

[0007] One approach to medical wellness and examination is breast self-examination (BSE), whereby a woman regularly examiners her breasts, by feel to try to identify lumps or other tactile or visual abnormalities. While BSE can support personal awareness, its effectiveness may vary depending on user experience, knowledge, technique, and consistency, and many individuals lack sufficient training to perform breast examination frequently, thoroughly, or correctly to maximize its effectiveness. The devices and methods described herein are intended to assist individuals in conducting wellness and breast examinations in a more objective and consistent manner. In some embodiments, the device may be used in conjunction with other standard screening tools, such as mammograms. In additional embodiments, the device may be used as a first-stage screening or assessment tool to identify any differences in breast tissue, including the detection of breast cancer.

[0008] Several devices and methods have been proposed to assist with the examination or characterization of breast tissue. For example, U.S. Patent No. 10,687,710, to Blank et al., issued June 23, 2020, describes a palpation device for palpation of tissues for characterization (e g., qualification and / or quantification) of subcutaneous structures, such as breast tumors is provided.Attorney Docket No. 35527-100110 The device is described as including a tonometric lens for palpating and viewing the palpated tissue. The device requires an integrated radiation source positioned to illuminate the elastomeric lens and the reflective coating. The tonometric lens appears to be limited to having a reflective coating on the outer surface thereof. Additionally, the device does not seem to have a protective layer over the exterior of the tonometric lens. The device does not seem intended for self-use but requires the intervention of a healthcare professional.

[0009] In an IEEE (Institute of Electrical and Electronics Engineers) conference paper by the same named individuals as the inventors cited on U.S. Patent No. 10,687,710, an optical tonometer based palpation device is described that uses a deformable elastomer and optical imaging to assess differential mechanical stiffness of tissues (Blank, Molly, and James F. Antaki. "Low-cost quantitative palpation device for breast lesion tracking and telehealth." 2014 IEEE Healthcare Innovation Conference (HIC). IEEE, 2014.). Another reference, Ito et al., describes avision-based tactile sensing device employing a transparent acrylic plate, an elastic membrane, and optical imaging with LED illumination to estimate the shape and irregularity of objects (Ito, Yuji, et al. "Vision-based tactile sensing and shape estimation using a fluid-type touchpad." IEEE transactions on automation science and engineering 9.4 (2012): 734-744.). In addition, Johnson et al. describes a vision-based tactile sensor comprising a clear elastomer slab covered with a reflective skin and illuminated by multiple light sources, wherein deformation of the skin is optically imaged and processed to reconstruct surface shape and texture (Johnson, Micah K., and Edward H. Adelson. "Retrographic sensing for the measurement of surface texture and shape." 2009 IEEE Conference on Computer Vision and Pattern Recognition. IEEE, 2009 ).

[0010] The present invention provides improvements over the limitations of the current state of the art. There is a need for providing an improved means for conducting tissue examinations, such as breast exams, particularly in settings where traditional techniques involving mammograms, ultrasound, MR1 (magnetic resonance imaging), or other imaging equipment, are not readily available or desired. In certain embodiments, the present invention does not rely on an integrated light source. The present invention provides a low-cost mechanical device for conveniently conducting a breast self-examination, or alternatively for use by a health care professional or others to use the device to conduct an examination on a subject. In some embodiments, the device can be used as a preliminary screening or for use between regular mammograms to monitor changes associated with a detected medical condition with minimal training.Attorney Docket No. 35527-100110SUMMARY OF THE INVENTION

[0011] This disclosure describes various aspects of various embodiments of the present invention. It should be appreciated that the embodiments described herein are in no way limited by their described features, and any of the disclosed aspects may be combined in various manners which embody the invention.

[0012] The present invention provides a device and methods for examination of tissue by palpation, including but not limited to breast examination, further including breast self-examination.

[0013] The present invention provides a device for external examination of tissue of a subject by palpation, comprising:a) a frame having a substantially circular opening;b) an elastomeric lens disposed within the circular opening of the frame, the elastomeric lens having a substantially solid hemispherical shape defining:a substantially flat proximal surface, anda convex distal surface, wherein the distal surface is configured to (directly or indirectly) contact with and palpate the tissue of a subject; andc) a reflective coating layer.

[0014] In another aspect, the present invention provides a device further comprising a protective layer conforming to the distal surface of the elastomeric lens, wherein the protective layer comprises a proximal inner surface and a distal outer surface.

[0015] In another aspect, the present invention provides a device further comprising a transparent window, wherein the transparent window is disposed on or within the frame and oriented with respect to the proximal surface of the elastomeric lens.

[0016] In another aspect, the present invention provides a device, wherein the transparent window and the elastomeric lens are formed as a single unitary body.

[0017] In another aspect, the present invention provides a device, wherein the frame comprises two separate subframe components, wherein one subframe component is a proximal subframe component and the other is a distal subframe component.

[0018] In another aspect, the present invention provides a device, wherein the two subframe components are secured together by two or more bolts and screws.

[0019] In another aspect, the present invention provides a device, wherein the elastomeric lens is transparent.Attorney Docket No. 35527-100110

[0020] In another aspect, the present invention provides a device, wherein the elastomeric lens of the device is contacted with and palpate the tissue indirectly through the protective layer.

[0021] In another aspect, the present invention provides a device, wherein the transparent window is essentially flush with the frame.

[0022] In another aspect, the present invention provides a device, wherein the transparent window rises above the frame and is configured with straight, rounded or angled sides.

[0023] In another aspect, the present invention provides a device, wherein the transparent window comprises a polymeric material, wherein the polymeric material is selected from acrylic, glass, polycarbonate, polyethylene terephthalate (PET), cyclic olefin copolymers, or combinations thereof.

[0024] In another aspect, the present invention provides a device, wherein the transparent window comprises acrylic.

[0025] In another aspect, the present invention provides a device, wherein the protective layer comprises a flexible rubber-like material.

[0026] In another aspect, the present invention provides a device, wherein the protective layer comprises a material selected from natural rubber (latex), silicone elastomers, thermoplastic elastomers, thermoplastic polyurethanes, styrene-ethylene-butylene-styrene (SEBS) and styrene-butadiene-styrene (SBS), nitrile butadiene rubber (NBR), fluorosilicone elastomers, polyurethane elastomers, or combinations thereof.

[0027] In another aspect, the present invention provides a device, wherein the protective layer comprises nitrile butadiene rubber (NBR).

[0028] In another aspect, the present invention provides a device, wherein the reflective coating is disposed on the distal surface of the elastomeric lens, on the proximal surface of the protective layer, or on both.

[0029] In another aspect, the present invention provides a device, wherein the reflective coating comprises particles selected from metals comprising chromium, copper, gold, iron, nickel, platinum, silver, zinc, or stainless steel; metal alloys comprising brass, bronze, or chrome pewter; metal salts, metal oxides, and inorganic compounds comprising iron oxide, titanium dioxide, zinc oxide, aluminum oxide, silica, or calcium carbonate; minerals comprising talc, mica, alumina, clays, and flake-based materials; glass and ceramic materials; pigments comprising inorganic pigments, organic pigments, white pigments, colored pigments, pearlescent pigments, interference pigments, or structural color pigments; polymeric and elastomer-compatible reflective materials comprising polymer-based paints, inks, or reflective composites; multilayer materials comprising pigment-Attorney Docket No. 35527-100110 polymer composites, metal-polymer composites, multilayer dielectric materials, Bragg reflectors, or distributed Bragg reflectors; microstructured and nanostructured optical materials comprising photonic crystal structures, optically anisotropic materials, birefringent materials, or sub-wavelength surface features; diffractive and holographic materials comprising diffractive optical elements, holographic films, volume holograms, or surface-relief diffraction gratings; scattering and diffusive materials comprising hollow microspheres, glass microspheres, polymer microspheres, or platelet structures; organic materials comprising natural fibers, synthetic fibers, starches, or sugars; and combinations thereof.

[0030] In another aspect, the present invention provides a device, wherein the reflective coating comprises a dispersion of particles.

[0031] In another aspect, the present invention provides a device, wherein the particles have a median particle size (D50) from about 5 pm to about 250 pm.

[0032] In another aspect, the present invention provides a device, further comprising a measuring grid for positioning the device and locating and measuring one or more features of the tissue in contact with the elastomeric lens and the protective layer.

[0033] In another aspect, the present invention provides a device, wherein the measuring grid is a reticle.

[0034] In another aspect, the present invention provides a device, wherein the measuring grid comprises one or more concentric rings.

[0035] In another aspect, the present invention provides a device, wherein the measuring grid further comprises crosshairs centered on the concentric rings.

[0036] In another aspect, the present invention provides a device, wherein the one or more concentric rings are spaced about 10 mm apart.

[0037] In another aspect, the present invention provides a device, wherein the innermost of the concentric rings has a diameter of about 20 mm.

[0038] In another aspect, the present invention provides a device, wherein the measuring grid comprises six concentric rings and a crosshair centered on the innermost concentric ring, and wherein:the innermost concentric ring has a diameter of about 20 mm,each successive concentric ring increases in diameter by about 10 mm,the concentric rings from the innermost to the outermost rings are each labeled 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, and 60mm, andAttorney Docket No. 35527-100110 crosshairs centered on the concentric rings.

[0039] In another aspect, the present invention provides a device, wherein the measuring grid further comprises tick marks every 1 mm, and optionally wherein the tick mark at each 5 mm position is substantially larger than the other tick marks.

[0040] In another aspect, the present invention provides a device, wherein the elastomeric lens is made from a material selected from thermoplastic elastomers; silicone elastomers; polyurethane and polyurea elastomers; polyisoprene-based elastomers; rubber and rubber-like elastomers; optically clear gels and gel-like materials; hydrogels; viscoelastic polymers; elastomeric resins; composite and engineered elastomeric materials; polymeric materials comprising latex, rubber silicone, silicone acrylics, polyacrylic acid, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamides, polylactic acid, polybenzimidazole, polycarbonate, polyether sulfone, polyoxymethylene, polyether ether ketone, polyetherimide, polyethylene, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, polyurethanes, polyesters comprising polyethylene terephthalate, or vinyl ester resins; flexible glass-like or film materials; and combinations thereof.

[0041] In another aspect, the present invention provides a device, wherein the elastomeric lens has a Young’s modulus, wherein the Young’s modulus for the elastomeric lens is greater than a stiffness of surrounding healthy tissue and lower than a stiffness of a subsurface abnormal tissue, such that differential deformation of the elastomeric lens is enhanced during palpation.

[0042] In another aspect, the present invention provides a device, wherein the subsurface abnormal tissue comprises a tumor, lesion, cyst, abscess, nodule, or lump.

[0043] In another aspect, the present invention provides a device, wherein the Young’s modulus is within a range of approximately 1 kPa to approximately 5 MPa.

[0044] In another aspect, the present invention provides a device, wherein the elastomeric lens further has a Poisson’s ratio greater than approximately 0.40.

[0045] In another aspect, the present invention provides a device, wherein the frame further comprises one or more handles for positioning, holding, and / or moving the device against the tissue to contact the distal surface of the elastomeric lens against the tissue.

[0046] In another aspect, the present invention provides a device, wherein the frame further comprises an adjustable mirror for viewing a reflection from the proximal surface of the elastomeric lens or the reflective coating.

[0047] In another aspect, the present invention provides a device, wherein the tissue is breast tissue.Attorney Docket No. 35527-100110

[0048] In another aspect, the present invention provides a method of using the device for conducting a breast tissue examination.

[0049] In another aspect, the present invention provides a method, wherein the elastomeric lens of the device is contacted with the tissue.

[0050] In another aspect, the present invention provides a method, wherein the elastomeric lens of the device is contacted with the tissue indirectly through a protective layer.

[0051] In another aspect, the present invention provides a method, wherein the examination is a selfexamination.

[0052] In another aspect, the present invention provides a method of using the device for conducting a breast tissue examination on a subject by an individual other than the subject.

[0053] In another aspect, the present invention provides a method for conducting an examination of a surface tissue in a subject comprising the steps of:A. applying a device comprising an elastomeric lens to the surface tissue of the subject, B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueC. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

[0054] In another aspect, the present invention provides a method for conducting an examination of a surface tissue in a subject comprising the steps of:A. applying a device comprising an elastomeric lens and a reflective coating to the surface tissue of the subject,B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueC. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

[0055] In another aspect, the present invention provides a method for conducting an examination of a surface tissue in a subject comprising the steps of:A. applying a device comprising an elastomeric lens, a reflective coating, and a protective layer to the surface tissue of the subject,B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueAttorney Docket No. 35527-100110 C. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

[0056] In another aspect, the present invention provides a method, wherein the elastomeric lens comprises a body having a stiffness selected to be less stiff than an abnormality embedded in the surface tissue and more compliant than surrounding healthy tissue.

[0057] In another aspect, the present invention provides a method, further comprising applying pressure to the device such that the elastomeric lens deforms preferentially in response to regions of the surface tissue having increased stiffness.

[0058] In another aspect, the present invention provides a method, further comprising repositioning the device to multiple locations on the surface tissue and repeating steps of A-C.

[0059] In another aspect, the present invention provides a method, wherein the device further comprises a measuring grid to estimate a position, size, location of the abnormality identified observed at the multiple locations.

[0060] In another aspect, the present invention provides a method for conducting a breast selfexamination by a subject, comprising the steps of:A. applying, by the subject, a device comprising an elastomeric lens to a surface of breast tissue of the subject;B. identifying, by the subject, a deformation of the elastomeric lens once the device is applied to the breast tissue; andC. identifying, by the subject, an abnormality embedded in the breast tissue based on the deformation of the elastomeric lens.

[0061] In another aspect, the present invention provides a method for conducting a breast examination on a subject by an individual other than the subject, comprising the steps of:A. applying, by the individual, a device comprising an elastomeric lens to a surface of breast tissue of the subject;B. identifying, by the individual, a deformation of the elastomeric lens once the device is applied to the breast tissue; andC. identifying, by the individual, an abnormality embedded in the breast tissue based on the deformation of the elastomeric lens.

[0062] In another aspect, the present invention provides a kit for performing examination and palpation of a tissue in a subject comprising the device and instructions for use.Attorney Docket No. 35527-100110

[0063] These and other aspects of the present invention will become apparent from the disclosure herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0064] FIG. l is a perspective view of an examination device including a frame holding a transparent window and an elastomeric lens with a reflective coating and a protective layer (the reflective coating and the elastomeric lens are not visible because the protective layer is covering it).

[0065] FIG. 2 is a bottom perspective view of the examination device of FIG. 1 showing the distal end of the device, wherein components are retained between subframe components secured together by one or more screws.

[0066] FIG. 3 is a bottom perspective view of the examination device of FIG. 1 shown at an angle.

[0067] FIG. 4 is a perspective view of the examination device of FIG. 1, wherein the device is oriented at an approximately 45-degree angle, with the distal end facing upward, thereby showing a portion of the transparent window.

[0068] FIG. 5 is an exploded view of the examination device of FIG. 1 arranged from proximal to distal, illustrating a proximal subframe component, heatset insert, a transparent window, an elastomeric lens, a reflective coating (not illustrated), a protective layer, a distal subframe component, screws and plugs.

[0069] FIG. 6 is a top perspective view of an examination device, showing the proximal end of the device, including the transparent window and a measuring grid having four concentric rings, each spaced apart by 10 mm.

[0070] FIG. 7 is a perspective view of an examination device comprising one or more handles and an adjustable mirror attached to a mirror holder, with the mirror in an open, deployed position.

[0071] FIG. 8 is an exploded view of the examination device of FIG. 7 illustrating the adjustable mirror, mirror holder, handle(s), elastomeric lens, proximal subframe component, and distal subframe component.

[0072] FIG. 9 is a side perspective view of the examination device of FIG. 7, with the adjustable mirror in an open position.

[0073] FIG. 10 is a rear side perspective view of the examination device of FIG. 7 with the adjustable mirror in a closed position.Attorney Docket No. 35527-100110

[0074] FIG. 11 is a top perspective view of an examination device, illustrating the adjustable mirror held by the mirror holder, handle(s), and a measuring grid comprising 6 concentric rings spaced 10 mm apart from 10 mm to 60 mm, and crosshairs.

[0075] FIG. 12 is a cutaway schematic view of an examination device during palpation of surface tissue of a subject (shown in phantom), wherein an elastomeric lens indirectly contacts the tissue through a reflective coating and a protective layer and is deformed in response to an abnormality embedded within a subcutaneous layer of the tissue (shown in phantom).

[0076] FIG. 13Ais a photograph of an examination device configured as a simple, reliable, mechanical device having few components, suitable for efficient production and designed for low-cost scaling.

[0077] FIG. 13B is an exploded representation of the examination device of FIG. 13 A, from proximal to distal, a proximal subframe component formed from PLA, heatset inserts, an acrylic transparent window, a thermo-elastomeric lens, a reflective coating, a nitrile protective layer, a distal subframe component formed from PLA, screws and PLA plugs, wherein the oval shape at the bottom of the image depicts a shadow created by the examination device.

[0078] FIG. 14 is a photograph of an examination device showing the adjustable mirror, mirror holder, handle(s), and measuring grid with concentric rings, wherein the adjustable mirror reflects the measuring grid toward the viewer.

[0079] FIG. 15 is a photograph of the examination device of FIG. 14 with the adjustable mirror in a closed position.

[0080] FIG. 16 is a representation of an examination device comprising one or more handle(s) and an adjustable mirror attached to a mirror holder, with the adjustable mirror in an open position.

[0081] FIG. 17 is a drawing of an exploded representation of an examination device, illustrating the adjustable mirror (having a mirror frame and a mirror), mirror holder, handle(s), transparent window, measuring grid, elastomeric lens, proximal subframe component, reflective coating, protective layer, and distal subframe component.

[0082] FIG. 18 is a photograph showing a side of an examination device with the adjustable mirror in an open position.

[0083] FIG. 19 is a photograph showing a side and top view of the examination device of FIG. 18 with the adjustable mirror in a closed position.DETAILED DESCRIPTIONAttorney Docket No. 35527-100110

[0084] The present invention provides a device and methods for external examination of tissue of a subject, including devices and methods for breast tissue examination. In certain embodiments, the device is configured for use in breast self-examination (BSE). In other embodiments the device and methods can be used for examination of other parts of the body for detecting or monitoring other abnormalities in surface or subcutaneous tissue.

[0085] Furthermore, the use of the device is not intended to be limited solely to women, as men and younger individuals such as girls and boys can develop breast cancer or other abnormalities. While the device is suitable for self-use by a subject, the device can be used by another individual, such as a healthcare professional, caregiver, or trained technician, to conduct an examination on a subject. For example, the device could be used for rapid and convenient screening of large numbers of women in less sophisticated clinics and settings in areas with limited access to healthcare or low-to-middle income countries.

[0086] The following Table l is a compilation of the components and features of an examination device of the present invention with the assigned reference numbers. The table includes the following information: the reference number assigned to the component, and a description of the component. It should be noted that some of the components are shown in more than one figure, and that the reference number is not used to call out each occurrence of the component in every figure.Table 1: Compilation of the Components and Features of the Examination Device.Attorney Docket No. 35527-100110Attorney Docket No. 35527-100110

[0087] Note: Subject tissue 13 on which the device 1 is illustrated as being tested is shown in phantom using dotted lines. The depicted subsurface abnormality 13B within the subcutaneous layer 13A, which are both shown in phantom using dotted lines, is schematic and illustrative and is shown for purposes of illustrating device operation rather than to depict an actual clinical condition or anatomical configuration.Examination Device

[0088] The examination device 1 is designed to palpate tissue 13 and to distinguish healthy tissue from areas exhibiting different mechanical characteristics, such as increased stiffness or higher Young’s modulus, consistent with breast tumors, non-cancerous benign lumps, cysts, fibrocystic changes, fibrodenoma, or other abnormalities 13B.

[0089] FIGs. 1-19 provide various drawings and photographs of the examination device 1 of the present invention. The examination device 1 of the present invention is intended to be light-weight, mechanically simple, and portable. It is designed for examination of a subject, by being applied to the skin surface such as the area of the breast. The device provides an alternative or initial screening by not requiring conventional, expensive, and not readily portable medical equipment such as X-rayAttorney Docket No. 35527-100110 and ultrasound machines and mammography equipment. In additional embodiments, the device is configured to be used an adjunct screening tool, including between regularly scheduled clinical imaging procedures.

[0090] The device 1 is defined as having a proximal end 1A and a distal end IB. The proximal end 1A of the device is that portion of the device that is closest to the visual field of the user or observer during use. The distal end IB of the device is that portion of the device that is intended to be positioned against and to contact or palate the tissue of the subject to be examined.

[0091] The overall device 1 comprises a plurality of components arranged along a proximal -to-distal axis and supported by a frame 2 defining a substantially circular opening 4E. At the proximal end 1 A of the device, a transparent window 5 is disposed on the frame 2 and oriented to allow viewing into the interior of the device. Positioned beneath the transparent window 5 and within the circular opening 4E of the frame 2 is an elastomeric lens 6 having a substantially solid semi-hemispherical shape, with the proximal end defining the inner side of a semi-hemisphere and the distal end defining the outer side of the semi-hemisphere. The elastomeric lens defines a substantially flat proximal surface 6A and a convex distal surface 6B. A reflective coating 7 is provided on the proximal surface 6A of the elastomeric lens 6, on a protective layer 8, or on both, to enhance visual observation of deformation 12 during use. At the distal end IB of the device, a protective layer 8 conforming to the distal surface 6B of the elastomeric lens 6 is provided for placement in contact with the skin or tissue of a subject for use. The device 1 is intended to be deformable when pressure is applied to the device when in contact with the tissue of a subject 13, allowing examination by palpation. Each of these components as well as additional elements and their functions are described in further detail below.Frame

[0092] The frame 2 of the device defines the circular opening 4E that receives and supports the elastomeric lens 6 and other components. In some embodiments, the frame 2 is constructed from two ring-shaped subframe components, including a proximal subframe component 3 and a distal subframe component 4, which are secured together during assembly. Components such as the elastomeric lens 6, transparent window 5, and protective layer 8 may be retained between the subframe components 3, 4.

[0093] In certain embodiments, the frame 2 includes one or more fastening features for securing the proximal subframe component and the distal subframe component, intended to securely retainAttorney Docket No. 35527-100110 internal components of the device. Such fastening features may include, without limitation, fastener 4B, fastener openings 4C, heatset inserts 4A, and the like. The fasteners 4B may comprise screws, bolts, pins, or other mechanical attachment elements suitable for repeated assembly and disassembly. In some embodiments, the frame 2 further includes plugs, caps, or covers 4D configured to conceal fasteners 4B or fastener receiving openings 4C after assembly.

[0094] Optional handles 10 may be provided on the frame for positioning, holding, and moving the device, particularly when the device is used by another individual such as a healthcare professional on a subject (FIGs. 7, 9-11, and 14-19). An optional adjustable mirror 11 or reflective element may also be provided on the frame to assist in viewing the proximal surface 6A of the elastomeric lens 6 or other internal features during use.

[0095] The frame 2 can be made from a variety of rigid materials such as various plastics and polymeric materials, carbon fiber, metal, or porcelain. Examples of polymeric materials include polylactic acid (PLA), polypropylene (PP), polyoxymethylene (POM), nylon (polyamide), thermoplastic elastomers (TPE), acrylonitrile butadiene styrene (ABS), glass-fiber reinforced plastic (GFRP), G-10, cellulose acetate, polyurethane (PU), polymorph (poly caprolactone), or other related materials. A particularly useful material from which the frame can be made is polylactic acid (PLA).

[0096] The frame 2 can be made as a single construct, however, for ease of manufacturing and assembly, it is found that the frame can be constructed from two rings between which the elastomeric lens 6, transparent window 5, protective layer 8, and other components are positioned.Transparent Window

[0097] In certain embodiments, the device comprises a rigid, transparent window 5 disposed on the frame at the proximal end of the device. The transparent window is positioned with respect to the proximal end of the elastomeric lens and provides a means for the user or a healthcare professional other than the subject to view the elastomeric lens as it deforms during palpation and in contact with the tissue of the subject.

[0098] The transparent window 5 can be rigid, optically clear, and scratch resistant. The transparent window 5 can be made from a variety of materials including polymeric materials and glass.Examples of polymeric materials include polycarbonate, acrylic (polymethyl methacrylate, also known as PMMA), polyethylene terephthalate (PET), cyclic olefin copolymers (COC and / or COP), or other related materials. A particularly useful material from which the transparent window can be made is acrylic.Attorney Docket No. 35527-100110

[0099] In certain embodiments, the proximal surface of the transparent window comprises curved or beveled edges 5A along a peripheral region of the transparent window. Such curved or beveled edges 5A are configured to increase or enhance the transmission of light into the interior of the device, including light entering the device. The geometry of the curved or beveled edge 5A may minimize internal reflection losses and redirect incident light toward the elastomeric lens and reflective coating, thereby improving visibility of deformation during use. In some embodiments, an angle defined between a surface of the transparent window and an edge of the transparent window is selected to facilitate light entry, refraction, or redirection toward the elastomeric lens and / or reflective coating, and may vary depending on material selection, thickness and overall geometry of the device.

[0100] In alternative embodiments, the transparent window 5 and the elastomeric lens 6 are formed as portions of a single, unitary body, such that the transparent window 5 constitutes an integral, optically clear portion of the same body as the elastomeric lens 6, rather than as a separate component. In such embodiments, transparent window 5 provides a proximal viewing region of the elastomeric lens 6 and is integrally formed together with or bonded with, for instance, by molding, casting, or overmolding, to form a continuous structure. Such continuous structure comprises a proximal viewing portion (i.e., transparent window) and a deformable distal elastomeric portion (i.e., elastomeric lens).Elastomeric Lens

[0101] In certain embodiments, the device comprises an elastomeric lens 6. The elastomeric lens 6 is flexible, transparent, elastomeric, deformable configured to make direct or indirect contact with or palpate tissue and to translate subsurface mechanical features into optically observable deformation. As used herein, the term “elastomeric” refers to a material that is capable of deformation when pressure is applied and that substantially returns to its original shape when the pressure is removed. The stiffness and flexibility of the elastomeric lens are selected such that the lens deforms during palpation while maintaining sufficient structural integrity for examination. The elastomeric lens can have various dimensions, including thickness, selected to achieve desired deformation characteristics.

[0102] The elastomeric lens 6 defines a substantially flat proximal surface 6A facing the transparent window and a convex distal surface 6B facing the tissue, having a solid bowl hemisphere shape. In certain embodiments, the elastomeric lens 6 is formed as a substantially solid hemispheric,Attorney Docket No. 35527-100110 domed, or otherwise curved body composed of a compliant, optically clear material that undergoes reversible elastic deformation under applied manual pressure. In use, the elastomeric lens 6 is configured such that deformation 12 occurs preferentially in response to regions of tissue exhibiting increased stiffness relative to surrounding healthy tissue. In particular, the stiffness, thickness, and elastic properties of the elastomeric lens are selected so that the lens exhibits minimal deformation when applied to healthy or normal tissue, while exhibiting greater or more localized deformation when applied to regions associated with higher stiffness or Young’s modulus, consistent with breast tumors, non-cancerous benign lumps, cysts, abscess, nodule, or other abnormalities 13B. In certain embodiments, deformation 12 of the elastomeric lens 6 during examination by palpation provides a mechanical contrast between healthy tissue and regions of altered mechanical properties, facilitating and assisting with detecting or monitoring potential abnormalities.

[0103] When the elastomeric lens 6 is pressed against tissue 13, localized variations in underlying stiffness or geometry induce nonuniform deformation of the elastomeric lens, resulting in spatial variations in surface curvature, thickness, and internal optical path length that are visually detectable through the elastomeric lens and the transparent window. The elastomeric lens 6, thereby, functions as a passive mechanical-optical transducer that converts mechanical displacement into visible contrast without electronic sensing or active image processing.

[0104] The elastomeric lens 6 can be opaque, transparent, or semi-opaque. In certain embodiments, the elastomeric lens is optically clear to facilitate visual observation of deformation during examination by palpation.

[0105] In certain embodiments, the elastomeric lens 6 may be formed from thermoplastic elastomers (TPE), silicone elastomers, polyurethane and polyurea elastomers, polyisoprene-based elastomers, rubber and rubber-like elastomers, optically clear gels or gel-like materials, hydrogels, viscoelastic polymers, elastomeric resins, or composite and engineered materials, formulated to achieve the mechanical property ranges described herein. In some embodiments, the elastomeric lens may incorporate additives, plasticizers, oils, crosslinking modifiers, or fillers, selected to tune compliance, recovery, damping, and optical clarity.

[0106] Some examples of thermoplastic elastomers include styrenic block copolymers (SBCs), including styrene-ethylene-butylene-styrene (SEBS), styrene-butadiene-styrene (SBS), styrene-isoprene-styrene (SIS), thermoplastic polyurethanes (TPU), thermoplastic vulcanizates (TPVs), polyolefin elastomers (POEs), copolyester elastomers, polyamide elastomers, or medicalgrade and optical-grade TPE formulations. Some examples of silicone-based elastomers includeAttorney Docket No. 35527-100110 polydimethylsiloxane (PDMS), platinum-cured silicone elastomers, addition-cured silicone elastomers, condensation-cured silicone elastomers, silicone gels, optical-grade silicone rubbers, or fluorosilicone elastomers. Some examples of polyurethane and polyurea elastomers include aliphatic polyurethane elastomers, aromatic polyurethane elastomers, cast polyurethane elastomers, thermoset polyurethane elastomers, polyurea elastomers, or optical-grade polyurethane gels. Some examples of rubber and rubber-like elastomers include synthetic polyisoprene, natural rubber processed for optical clarity, butyl rubber, isoprene-based elastomers, or hydrogenated rubber formulations. Some examples of gel and gel-like materials include ballistic gels, oil-extended elastomeric gels, viscoelastic polymer gels, silicone gels, polymeric gel composites, or physically or chemically crosslinked gels. Some examples of hydrogel materials include polyvinyl alcohol (PVA) cryogels, polyacrylamide hydrogels, polyethylene glycol (PEG) hydrogels, agarose or agar-based gels, gelatinbased hydrogels, or hybrid hydrogel-elastomer systems. Some examples of composite and engineered materials include elastomeric matrices with embedded fillers, elastomer-gel composites, elastomers with refractive-index-matching additives, elastomers with plasticizers, oils or softeners, multilayer elastomeric stacks, graded-stiffness elastomeric structures, or anisotropic or patterned elastomeric materials. Some examples of additives and modifiers include plasticizers, silicone oils, mineral oils, crosslinking agents, UV stabilizers, anti-oxidants, anti-yellowing agents, refractive index modifiers, or optical clarifiers.

[0107] In additional embodiments, the elastomeric lens 6 can be made from a variety of materials including polymeric materials and flexible glass-like or film materials. Examples of polymeric materials include latex, rubber, silicone rubber, silicone acrylics such as polyacrylic acid (PAA) and poly(methyl methacrylate) (PMMA), acrylonitrile butadiene styrene (ABS), polyamides, such as Nylon, polylactic acid (PLA), polybenzimidazole (PBI), polycarbonate (PC), polyether sulfone (PES), polyoxymethylene (POM), polyether ether ketone (PEEK), polyetherimide (PEI), polyethylene (PE), polyphenylene oxide (PPO), polyphenylene sulfide (PPS), polypropylene (PP), polystyrene (PS), polyvinyl chloride (PVC), polyurethanes (PU), polyesters such as polyethylene terephthalate (PET), and vinyl ester resins, and combinations thereof. In certain embodiments, the elastomeric lens formed from TPE is optically clear and deformable to exhibit pronounced elastic deformation during examination by palpation while substantially returning to its original shape when pressure is removed. In further aspects, the elastomeric lens comprises a transparent, deformable elastomer, comprising thermoplastic elastomers (TPEs) (e.g., styrenic block copolymers such as SEBS-based systems), silicone elastomers (e.g., PDMS or LSR), polyurethane elastomers (e.g., TPUAttorney Docket No. 35527-100110 or cast polyurethane), transparent nitrile or rubber-modified elastomer systems, or combinations thereof.

[0108] In certain embodiments, the elastomeric lens 6 may comprise a material having a Young’s modulus, selected to enable deformation under modest applied force while maintaining elastic recovery, for example, within a range of approximately 1 kPa to 5 MPa, and in some embodiments, within a range of approximately 5 kPa to 500 kPa., to enhance sensitivity to localized subsurface stiffness variations. In further embodiments, the Young’s modulus of the elastomeric lens is selected to be greater than that of surrounding healthy tissue while remaining lower than the anticipated stiffness of a subsurface abnormality, thereby amplifying differential deformation and visual contrast.

[0109] In some embodiments, the elastomeric lens material exhibits a Poisson’s ratio characteristic of elastomeric or gel-like materials, for example, greater than approximately 0.40, and in some embodiments, between approximately 0.45 and 0.50, such that the material behaves in a substantially incompressible manner and produces pronounced surface curvature changes in response to localized displacement. In some embodiments, the Young’s modulus and Poisson’s ratio are substantially uniform throughout the elastomeric lens. Alternatively, the elastomeric lens comprises spatially varying mechanical properties, including radially graded, layered, or patterned stiffness profdes, to preferentially enhance deformation sensitivity or to tune optical response. In some embodiments, the elastomeric lens may be formed as a homogeneous body or as a multilayer structure comprising regions of differing mechanical and optical properties while maintaining overall optical transparency and repeated elastic recoverability.

[0110] In some embodiments, the elastomeric lens 6 is manufactured using a gravity-casting process, in which the thermoplastic elastomer is cast into a mold. Non-limiting examples of suitable molds include metal molds, such as preheated aluminum molds, which facilitate formation of the desire semi -hemispherical geometry and surface characteristics. Other manufacturing techniques may include molding, casting, injection molding, compression molding, curing, overmolding, additive manufacturing, or hybrid processes, and may be bonded or coupled to adjacent components while maintaining optical transparency and elastic performance over repeated cycles of deformation and use.Reflective Coating

[0111] The devices of the present invention comprise a reflective coating 7. In general, the reflective coating 7 may be provided as a separate layer, an arrangement of elements, a dispersion, or other configuration suitable for visually enhancing the deformation feature 12 of the elastomeric lensAttorney Docket No. 35527-100110 6 during use. The reflective coating 7 is on the proximal surface 6A of the elastomeric lens 6, on the proximal surface of a protective layer 8, or on both. The reflective coating 7 comprises a reflective material, which is either applied directly to elastomeric lens or the protective layer. In certain embodiments, the reflective material is provided in the form of a dispersion of particles within a carrier material, such as a polymeric material or solvent. The dispersion of particles may be applied to the proximal surface 6A of the elastomeric layer 6, or on the proximal surface 8A of the protective layer 8, or on both.

[0112] The dispersion of particles may be applied to the proximal surface 6A of the elastomeric layer 6, or on the proximal surface of the protective layer 8, or on both. In some embodiments, the particles of the reflective material have a D50 (also known as median particle size) from approximately 5 pm to approximately 250 pm, which may be optimized for enhanced optical contrast, reflectivity, and visualization of deformation of the elastomeric lens during use. The particle size and density may be adjusted depending on the desired performance and application methods.

[0113] In certain embodiments, the reflective coating 7 is configured to exhibit a change in reflected light intensity, spectral distribution, and / or apparent color as a function of local surface deformation. During use, the elastomeric lens 6 alters local surface slope, curvature, thickness, or optical path length, thereby modifying the angle of light incidence and producing a visually perceptible hotspot characterized by increased brightness and / or a change in color relative to surrounding regions, corresponding to underlying tissue exhibiting increased stiffness or other mechanical differences. In certain embodiments, the reflective coating 7 provides a substantially diffuse baseline reflectance across the visible spectrum while exhibiting controlled angular sensitivity such that oblique illumination or variations in surface orientation caused by deformation enhance visual contrast during observation. The apparent color or intensity change may arise from angle-dependent reflectance, interference effects, scattering phenomena, diffraction, polarization effects, or combinations thereof. In certain embodiments, the reflective coating is configured to produce angle-dependent variation in reflected light intensity or color in response to localized deformation of the elastomeric lens under ambient illumination.

[0114] In certain embodiments, the reflective material can be made from a variety of materials including metals, metal oxides alloys, carbonaceous materials, silica-based materials, minerals, glasses, ceramics, pigments, polymeric materials, composite materials, optically anisotropic materials, and combinations thereof. Examples of reflective materials include metalsAttorney Docket No. 35527-100110 such as chromium, copper, gold, iron, nickel, platinum, silver, zinc and stainless steel; metal alloys such as brass, bronze, chrome pewter, and other metal alloys; metal salts, oxides, and compounds such as iron oxide, titanium dioxide, zinc oxide, aluminum oxide, silica, and calcium carbonate; and minerals and other substances such as silica, talc, mica, alumina, clays, and flake-based materials. The reflective materials may further comprise inorganic or organic pigments, including white pigments (e.g., titanium dioxide, zinc oxide), colored pigments, pearlescent pigments, interference pigments, structural color pigments, polymer-based reflective paints or inks, elastomer-compatible reflective composites, and multilayer pigment-polymer or metal-polymer composites. In some embodiments, the reflective material comprises thin metallic films, sputtered or vapor-deposited metal coatings, thin-film interference coatings, multilayer dielectric stacks, Bragg reflectors or distributed Bragg reflectors, optical cavity structures, microstructured or nanostructured reflective surfaces, diffuse reflector surfaces, photonic crystal structures, sub -wavelength surface features, polymer-based reflective coatings (e.g., reflective polymer paints, reflective inks, elastomercompatible reflective coatings, UV-curable reflective coatings, printed optical coatings, or laminated reflective films), diffractive and holographic elements (e.g., diffractive optical elements, holographic films, volume holograms, or surface-relief diffraction gratings), and scattering or diffusive reflector media (e.g., scattering fillers, hollow microspheres, glass microspheres, polymer microspheres, embedded platelet structures). The reflective material may additionally comprise hollow, glass, coated or embedded microspheres or platelets, embedded platelet structures, natural fibers (e.g., cotton, flax, hemp, and the like) or synthetic fibers, organic compounds such as starches or sugars, or optically anisotropic or birefringent materials including birefringent polymers, polarizationdependent reflective materials, cholesteric liquid crystal materials, nematic liquid crystal materials and liquid-crystal polymer films. The reflective material may additionally comprise composite and hybrid optical systems, including pigment-polymer composites, metal-polymer composites, multilayer elastomer-reflector systems, reflective layers embedded within elastomers, reflective layers bonded or laminated to deformable substrates. In further aspects, the reflective material or the particle comprises titanium dioxide (TiO2)-coated mica (e.g., pearlescent / interference pigments), multilayer silica or TiCh interference flakes (e.g., synthetic mica or silica-based platelets), silica- or alumina-coated aluminum flake pigments, polymeric glitter flakes (e.g., metallized PET), and combinations thereof.

[0115] In certain embodiments, the reflective coating 7 may be deposited, coated, printed, embedded, molded, laminated, sputtered, vapor-deposited, painted, brushed on, or otherwise formedAttorney Docket No. 35527-100110 such that it maintains its optical response under repeated elastic deformation and normal use, thereby enabling intuitive visual identification of subsurface features without electronic sensing or active image processing. In some embodiments, the reflective coating 7 may be incorporated into the elastomeric lens 6 directly during the manufacturing of the elastomeric lens 6.Protective Layer

[0116] In some embodiments, the device of the present invention comprises a protective layer 8 conforming to the distal surface 6B of the elastomeric lens 6. The protective layer 8 has a proximal inner surface 8A and a distal outer surface 8B and is intended to prevent direct contact between the elastomeric lens 6 and the tissue of the subject 13 while providing a sanitary interface. The protective layer 8 further provides a means for medically safe, sanitary, flexible, and aesthetically acceptable protection of the elastomeric lens 6 during use. In some embodiments, the protective layer 8 is configured to allow for cleaning with conventional hospital cleaning and sanitizing agents, which is an important consideration when the device is used consecutively on multiple subjects

[0117] In certain embodiments, the protective layer 8 comprises flexible rubber-like materials. Flexible rubber-like materials, as used herein, refer to compliant, flexible, and elastomeric materials configured to protect the underlying elastomeric lens, while preserving its deformability, optical performance, and tactile response. Such materials are capable of elastic deformation under applied pressure and recovery to their original shape or form upon load removal, while providing resistance to and protection from abrasion, tearing, puncture, oils, moisture, and repeated cleaning or disinfection. Some examples of flexible rubber-like materials include, without limitation, natural rubber (latex), silicone elastomers, thermoplastic elastomers, thermoplastic polyurethanes, styrenic block copolymers such as styrene-ethylene-butylene-styrene (SEBS) and styrene-butadiene-styrene (SBS), nitrile butadiene rubber (NBR), fluorosilicone elastomers, and polyurethane elastomers. In certain embodiments, the protective layer material may be optically clear or translucent, biocompatible, and selected to minimize optical distortion while maintaining sufficient softness and elasticity to transmit surface deformation of the elastomeric lens to the user. The protective layer may be formed as a thin coating, film, membrane, or overmolded layer that is bonded to, laminated onto, or otherwise coupled with the elastomeric lens.

[0118] In certain embodiments, the protective layer 8 comprises a nitrile butadiene rubber (NBR). The nitrile layer, when present, is located as a separate layer or sheet on the exterior surfaceAttorney Docket No. 35527-100110 of the distal end IB of the device 1. In other words, the nitrile layer is located on the distal surface of the elastomeric lens. The nitrile layer is made from nitrile butadiene rubber, which is a synthetic rubber made from acrylonitrile and butadiene and which is characterized by chemical resistance, durability, and flexibility.

[0119] The nitrile layer is intended for contact with the tissue of the subject. The nitrile layer functions as a biocompatible contact surface with the subject or patient. The nitrile layer is intended to be hypoallergenic, to minimize potential issues with allergic reactions as can be situation with materials such as latex rubber. The nitrile layer can also be cleaned and sanitized with conventional hospital cleaning and sanitizing agents, which is an important consideration when the device is used consecutively on multiple subjects. In alternative embodiments, for ease of manufacturing, the nitrile layer can be applied directly to the distal surface of the elastomeric lens by spraying or dipping rather than being added as a preformed sheet or layer.Measuring Grid

[0120] In some embodiments, the device of the present invention comprises a measuring grid 9 or measuring rings (FIGs. 6 and 11). The measuring grid 9 is useful for positioning the device and for determining or estimating the position, location, or size of a feature, such as a lump, when using the device. The measuring grid 9 is analogous to the measuring grid as in an optical instrument such as can be found for binoculars, a telescope, or a rifle scope. The measuring grid 9 for optical instruments is formally known as “reticles” which a series of fine lines or fibers are used as a measuring scale or an aid in locating objects or for aiming. “Reticle” also refers to a scale on a transparent material. In certain embodiments, the measuring grid 9 is centered along a central axis of the device and is aligned with the proximal-to-distal axis of the overall device to provide consistent spatial reference during use.

[0121] In the present invention, the measuring grid 9 can be a series of one or more concentric rings 9A, such as in some embodiments 1, 2, 3, 4, 5, 6, 7, or 8 concentric rings 9A, and can also further have two perpendicular lines intersecting to forming “crosshairs” 9B at the center of the concentric rings. “Crosshairs” are known as a pair of fine lines or wires crossing at right angles at the focus of an optical instrument. The concentric rings 9A can also be labeled with the distance between each ring. For example, a nonlimiting arrangement for the measuring grid can be a series of 6 concentric rings 9A each spaced 10 mm apart and each labeled from the center or from the innermost ring with 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, and 60 mm. Furthermore, theAttorney Docket No. 35527-100110 crosshairs 9B can be marked with tick marks showing gradations every 1 mm, with the tick mark that is midway between each ring being, for instance, a 5 mm distance from the rings, being larger than the other tick marks. FIGs. 6 and 11 show an example of a measuring grid useful in the present invention.

[0122] In certain embodiments, the measuring grid 9 may be printed or formed on a flat, optically clear sheet such as a transparent polymer film or rigid transparent substrate. In some embodiments, the measuring grid may be applied on the proximal side of the transparent window at the proximal end of the device. In alternative embodiments, the measuring grid 9 is displaced between the transparent window 5 and the elastomeric lens 6 as a separate layer (FTG. 17). In further embodiments, the measuring grid 9 is applied closer to the patient’s skin, including but not limited to being applied on a proximal 6A or distal surface 6B of the elastomeric lens 6 prior to any addition of reflective coating 7. In such embodiment, the measuring grid 9 may be printed on a flexible membrane or printed directly on the elastomeric lens 6.Adjustable Mirror

[0123] In certain embodiments, the device further comprises an adjustable mirror 11, configured to provide a viewer, such as the subject user or an individual other than the subject, with a selectable viewing angle of the elastomeric lens 6 and / or the subject tissue 13 during use (FIGs. 7, 9-11, 14-19). The adjustable mirror 11 may be supported by a mirror holder 11A, the mirror holder being mechanically coupled to a proximal subframe component 3 of the device or to the one or more handle(s) 10 of the device. In some embodiments, the mirror holder 11A is secured to the device 1 by two or more fasteners 11B, such as screws, bolts, pins, or other mechanical attachment elements, thereby providing a stable, detachable, and adjustable mounting arrangement. In some embodiments, the adjustable mirror 11 is provided as a mirror assembly, comprising a separate frame Ila holding the mirror lib, wherein the mirror assembly is coupled to the mirror holder 11A (FIG. 17). The adjustable mirror 11 may be pivotable, tiltable, or rotatable, relative to the mirror holder 11A, enabling the viewer to selectively orient the mirror to improve visibility and ease of examination.Light Source

[0124] Unlike some earlier devices, the examination device of the present invention does not include or incorporate an integrated light source, such as an incandescent lamp, light-emitting diode (LED), laser, or other internal illumination element for providing illumination. Rather, when in use,Attorney Docket No. 35527-100110 the device can depend on external or ambient light sources, including, by way of example, external lamps, head lamps, flashlights, and natural light sources such as sunlight. In additional embodiments, the device optionally includes an integrated light or radiation source.

[0125] The light source, whether external or optionally part of the device, enables illumination of the device and its components to allow the user to visually see or photographically capture an image when the device is in use, particularly if a tumor, lesion, or other structure in the tissue is detected.Methods of Manufacturing

[0126] This section describes exemplary methods for constructing and manufacturing the device of the present invention, with reference to exploded views and top-to-bottom assembly sequences. The manufacturing approaches described are illustrative and are not intended to limit the scope of the invention.

[0127] In one embodiment, the examination device 1 is assembled from top to bottom (or proximal to distal) as viewed in an exploded configuration (FIGs. 5 and 13B). A proximal subframe component 3 of the frame 2, formed from PLA, includes heatset inserts 4A configured to secure a transparent window 5, such as an acrylic transparent window, to the frame 2. Beneath the transparent window 5, an elastomeric lens 6 is positioned such that a proximal surface 6A of the elastomeric lens 6 fits against a distal surface 6B of the transparent window 6. The elastomeric lens 6 is formed from a thermoplastic elastomer and is optically clear and highly deformable. A protective layer 8 comprising nitrile butadiene rubber is positioned to cover the distal surface 6B of the elastomeric lens 6. In certain embodiments, the nitrile layer includes a reflective coating on an interior or exterior surface facing the elastomeric lens. A distal subframe component 4 of the frame 2, also formed from PLA, supports the structure and includes a plurality of screw holes 4C. The distal subframe component 4 is secured to the proximal subframe component 3 using screws 4B, thereby holding the device components together. In certain embodiments, the screws are covered with PLA plugs 4D to provide a smooth exterior surface. The overall design is intended to be simple, reliable, and primarily mechanical with few components, prioritizing efficient assembly and suitability for low-cost and large-scale production (FIGs. 1-4 and 13A).

[0128] In an alternative embodiment, the device includes additional components such as a one or more handles 10, adjustable mirror 11 (FIGs. 7, 9-11, and 14-19) and measuring grid 9 (FIGs. 6 and 11). The assembly from top-to-bottom (FIGs. 8 and 17) includes an adjustable mirrorAttorney Docket No. 35527-100110 11 and a mirror holder 11A that is detachable from either the handle(s) 10 or the proximal subframe component 3. In addition, the handle 10 is coupled to the proximal subframe component 3. A measuring grid 9 may be positioned above the transparent window 5 to facilitate positioning and measurement during use. Beneath the transparent window 5, the elastomeric lens 6 is positioned in the same manner as described above, followed by the protective nitrile butadiene rubber layer 8 on the distal surface 6B of the elastomeric lens 6. The components that make up the device structure include the top and bottom subframe components made from PLA. These subframe components are required to be rigid, aesthetically pleasing, and suitable for injection molding. In certain embodiments, the subframe components 3, 4 are made using 3D-printing followed by sanding and surface finishing. The distal subframe component 4 may include four or more screw holes 4C for securing the assembled structure.

[0129] As a non-limiting example, injection mold designs for the subframe components 3, 4 may include a wall thickness of approximately 3 mm, a draft angle of approximately 2 degrees on vertical faces, and a shrinkage allowance of approximately 1%. Ribs and bosses may be designed to be approximately 60% of the wall thickness. Corner radii may be at least 0.5 mm, fillet transitions may be approximately 1 mm, and ejector flats may be greater than or equal to 10 mm in diameter. The parting line may be flat, central, and accessible, with no undercuts. Suitable materials for molded components include ABS and polypropylene (PP).

[0130] The transparent window 5 is required to be optically clear, rigid, and scratch resistant. In some embodiments, the transparent window 5 may be manufactured using automated computer numerical control (CNC) routing, applying laser cutting and table routing, followed by automated polishing techniques.

[0131] As a non-limiting example, the elastomeric lens 6 is formed from a thermoplastic elastomer (TPE) and is required to be optically clear and highly deformable. In some embodiments, the elastomeric lens 6 may be manufactured using a gravity-casting process, in which the thermoplastic elastomer is cast into a metal mold. Non-limiting examples of a suitable molds include preheated aluminum molds.

[0132] In some embodiments, the protective layer 8 comprises a nitrile butadiene rubber sheet with a reflective coating on an interior or alternatively exterior surface. The nitrile layer is required to be medically safe, sanitary, protective, flexible, and aesthetically pleasing. The nitrile layer and reflective coating 7 may be applied using spray-coating technique, nitrile dipping processes, or combinations thereof.Attorney Docket No. 35527-100110

[0133] The overall device is designed to be manufactured with an emphasis on mechanical simplicity, reliability, and scalability. The methods described herein enable efficient production, ease of assembly, and cost-effective manufacturing suitable for large-scale deployment.Methods of Examining and Palpating Tissue in a Subject

[0134] The present invention further provides methods for externally examining and palpating tissue of a subject 13 in need thereof, using the device described herein (FIG. 12). The methods are suitable for use in breast tissue examination and may also be applied to examine other surface or subcutaneous tissues.

[0135] In use, the device 1 is positioned against the surface of tissue to be examined, such as but not limited to breast tissue of a subject. The device is oriented such that the distal outer surface of the protective layer contacts the skin of the subject. The protective layer provides a medically safe, protective and flexible interface between the device and the subject while preventing direct contact between the elastomeric lens and the tissue.

[0136] The device 1 may be positioned by the subject during self-examination or by another individual, such as a healthcare professional, caregiver, or trained personnel, when conducting an examination on the subject. Optional handles on the frame may be used to assist with positioning and movement of the device as well as applying pressure and palpating the tissue.

[0137] After the device 1 is positioned, pressure is applied to the device toward the tissue 13.The applied pressure causes the elastomeric lens 6 to deform while contacting the tissue, preferably indirectly through the protective layer 8. The magnitude of pressure may be adjusted by the user to achieve sufficient deformation of the elastomeric lens for palpation without causing discomfort to the subject.

[0138] The elastomeric lens 6 is configured such that deformation 12 occurs preferentially and selectively in response to regions of tissue exhibiting increased stiffness relative to surrounding healthy tissue. As pressure is applied, the elastomeric lens 6 exhibits minimal deformation over healthy or normal tissue while greater or more localized deformation occurs over regions associated with breast tumors, noncancerous lumps, cysts, or other abnormalities 13B having higher stiffness or Young’s modulus.

[0139] During palpation, deformation 12 of the elastomeric lens 6 is visually observed through the transparent window 5, when present, is positioned at the proximal end of the device. In some embodiments, deformation 12 of the elastomeric lens 6 alters the appearance of the reflectiveAttorney Docket No. 35527-100110 coating 7, enhancing contrast and visibility of deformation patterns. The user may observe, measure, and monitor the shape, extent, and location of deformation 12 of the elastomeric lens 6 as an indication of underlying tissue characteristics. Such observation may assist in identifying regions of interest, estimating the relative size or location of a tumor, lump, cyst, or other abnormalities 13B within the subcutaneous layer 13A having different mechanical properties. Alternatively, mirrors or reflective elements 11 mounted on the device may be used to assist viewing when the device is operated by the subject or by an individual other than the subject.

[0140] In certain embodiments, the measuring grid 9 is used to assist in positioning the device and in determining or estimating the position, size, or location of a detected feature within the tissue. The measuring grid 9 may include concentric rings 9A and crosshairs 9B that provide visual reference points.

[0141] The device 1 may be repositioned across multiple locations on the tissue surface, and the steps of positioning, applying pressure, and observing deformation may be repeated as needed to examine a larger area of tissue. The user may vary the applied pressure or orientation of the device 1 to further assess characteristics of detected deformations 12. Examinations may be repeated over time to monitor changes in deformation characteristics, such as changes in size, location, or stiffness of a previously identified feature.

[0142] After use, the protective layer 8 may be replaced or sanitized using conventional hospital cleaning and sanitizing agents.INCORPORATON BY REFERENCE

[0143] The entire disclosure of each of the patent documents, including certificates of correction, patent application documents, scientific articles, governmental reports, websites, and other references referred to herein is incorporated by reference herein in its entirety for all purposes. In case of a conflict in terminology, the present specification controls.EQUIVALENTS

[0144] The invention can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are to be considered in all respects illustrative rather than limiting on the invention described herein. In the various embodiments of the present invention, where the term comprises is used with respect to the recited components or steps of the methods, it is also contemplated that the components and methods consistAttorney Docket No. 35527-100110 essentially of, or consist of, the recited components or steps. Furthermore, the order of steps or order for performing certain actions is immaterial so long as the invention remains operable. Moreover, two or more steps or actions can be conducted simultaneously.

[0145] In the specification, the singular forms also include the plural forms, unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In the case of conflict, the present specification will control.

[0146] All percentages and ratios used herein, unless otherwise indicated, are by weight.

Claims

Attorney Docket No. 35527-100110CLAIMSWhat is claimed is:

1. A device for external examination of tissue of a subject by palpation, comprising:a) a frame having a substantially circular opening;b) an elastomeric lens disposed within the circular opening of the frame, the elastomeric lens having a substantially solid hemispherical shape defining:a substantially flat proximal surface, anda convex distal surface, wherein the distal surface is configured to contact with and palpate the tissue of a subject; andc) a reflective coating layer.

2. The device of claim 1, further comprising a protective layer conforming to the distal surface of the elastomeric lens, wherein the protective layer comprises a proximal inner surface and a distal outer surface.

3. The device of claim 1, further comprising a transparent window, wherein the transparent window is disposed on the frame and oriented with respect to the proximal surface of the elastomeric lens.

4. The device of claim 3, wherein the transparent window and the elastomeric lens are formed as a single unitary body.

5. The device of claim 1, wherein the frame comprises two separate subframe components, wherein one subframe component is a proximal subframe component and the other is a distal subframe component.

6. The device of claim 5, wherein the two subframe components are secured together by two or more bolts and screws.

7. The device of claim 1, wherein the elastomeric lens is transparent.Attorney Docket No. 35527-100110 8. The device of claim 2, wherein the elastomeric lens of the device is contacted with and palpates the tissue indirectly through the protective layer.

9. The device of claim 3, wherein the transparent window is essentially flush with the frame.

10. The device of claim 3, wherein the transparent window rises above the frame and is configured with straight, rounded or angled sides.

11. The device of claim 3, wherein the transparent window comprises a polymeric material, wherein the polymeric material is selected from acrylic, glass, polycarbonate, polyethylene terephthalate (PET), cyclic olefin copolymers, or combinations thereof.

12. The device of claim 11, wherein the transparent window comprises acrylic.

13. The device of claim 2, wherein the protective layer comprises a flexible rubber-like material.

14. The device of claim 2, wherein the protective layer comprises a material selected from natural rubber (latex), silicone elastomers, thermoplastic elastomers, thermoplastic polyurethanes, styrene-ethylene-butylene-styrene (SEBS) and styrene-butadiene-styrene (SBS), nitrile butadiene rubber (NBR), fluorosilicone elastomers, polyurethane elastomers, or combinations thereof.

15. The device of claim 14, wherein the protective layer comprises nitrile butadiene rubber (NBR).

16. The device of claim 2, wherein the reflective coating is disposed on the distal surface of the elastomeric lens, on the proximal surface of the protective layer, or on both.

17. The device of claim 16, wherein the reflective coating comprises particles selected from metals comprising chromium, copper, gold, iron, nickel, platinum, silver, zinc, or stainless steel; metal alloys comprising brass, bronze, or chrome pewter; metal salts, metal oxides, and inorganic compounds comprising iron oxide, titanium dioxide, zinc oxide, aluminum oxide, silica, or calcium carbonate; minerals comprising talc, mica, alumina, clays, and flake-based materials; glass andAttorney Docket No. 35527-100110 ceramic materials; pigments comprising inorganic pigments, organic pigments, white pigments, colored pigments, pearlescent pigments, interference pigments, or structural color pigments; polymeric and elastomer-compatible reflective materials comprising polymer-based paints, inks, or reflective composites; multilayer materials comprising pigment-polymer composites, metal-polymer composites, multilayer dielectric materials, Bragg reflectors, or distributed Bragg reflectors; microstructured and nanostructured optical materials comprising photonic crystal structures, optically anisotropic materials, birefringent materials, or sub-wavelength surface features; diffractive and holographic materials comprising diffractive optical elements, holographic films, volume holograms, or surface-relief diffraction gratings; scattering and diffusive materials comprising hollow microspheres, glass microspheres, polymer microspheres, or platelet structures; organic materials comprising natural fibers, synthetic fibers, starches, or sugars; and combinations thereof.

18. The device of claim 16, wherein the reflective coating comprises a dispersion of particles.

19. The device of claim 17, wherein the particles have a median particle size (D50) from about 5 pm to about 250 pm.

20. The device of claim 2, further comprising a measuring grid for positioning the device and locating and measuring one or more features of the tissue in contact with the elastomeric lens and the protective layer.

21. The device of claim 20, wherein the measuring grid is a reticle.

22. The device of claim 20, wherein the measuring grid comprises one or more concentric rings.

23. The device of claim 22, wherein the measuring grid further comprises crosshairs centered on the concentric rings.

24. The device of claim 22, wherein the one or more concentric rings are spaced about 10 mm apart.Attorney Docket No. 35527-100110 25. The device of claim 22, wherein the innermost of the concentric rings has a diameter of about 20 mm.

26. The device of claim 22, wherein the measuring grid comprises six concentric rings and a crosshair centered on the innermost concentric ring, and wherein:the innermost concentric ring has a diameter of about 20 mm,each successive concentric ring increases in diameter by about 10 mm,the concentric rings from the innermost to the outermost rings are each labeled 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, and 60mm, andcrosshairs centered on the concentric rings.

27. The device of claim 26, wherein the measuring grid further comprises tick marks every 1 mm, and optionally wherein the tick mark at each 5 mm position is substantially larger than the other tick marks.

28. The device of claim 1, wherein the elastomeric lens is made from a material selected from thermoplastic elastomers; silicone elastomers; polyurethane and polyurea elastomers; polyisoprene-based elastomers; rubber and rubber-like elastomers; optically clear gels and gel-like materials; hydrogels; viscoelastic polymers; elastomeric resins; composite and engineered elastomeric materials; polymeric materials comprising latex, rubber silicone, silicone acrylics, polyacrylic acid, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamides, polylactic acid, polybenzimidazole, polycarbonate, polyether sulfone, polyoxymethylene, polyether ether ketone, polyetherimide, polyethylene, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, polyurethanes, polyesters comprising polyethylene terephthalate, or vinyl ester resins; flexible glass-like or film materials; and combinations thereof.

29. The device of claim 1, wherein the elastomeric lens has a Young’s modulus, wherein the Young’s modulus for the elastomeric lens is greater than a stiffness of surrounding healthy tissue and lower than a stiffness of a subsurface abnormal tissue, such that differential deformation of the elastomeric lens is enhanced during palpation.Attorney Docket No. 35527-100110 30. The device of claim 29, wherein the subsurface abnormal tissue comprises a tumor, lesion, cyst, abscess, nodule, or lump.

31. The device of claim 29, wherein the Young’s modulus is within a range of approximately 1 kPa to approximately 5 MPa.

32. The device of claim 29, wherein the elastomeric lens further has a Poisson’s ratio greater than approximately 0.40.

33. The device of claim 1, wherein the frame further comprises one or more handles for positioning, holding, and / or moving the device against the tissue to contact the distal surface of the elastomeric lens against the tissue.

34. The device of claim 33, wherein the frame further comprises an adjustable mirror for viewing a reflection from the proximal surface of the elastomeric lens or the reflective coating.

35. The device of claim 1, wherein the tissue is breast tissue.

36. A method of using the device of claim 1 for conducting a breast tissue examination.

37. A method of claim 36, wherein the elastomeric lens of the device is contacted with the tissue.

38. A method of claim 37, wherein the elastomeric lens of the device is contacted with the tissue indirectly through a protective layer.

39. The method of claim 36, wherein the examination is a self-examination.

40. A method of using the device of claim 34 for conducting a breast tissue examination on a subject by an individual other than the subject.

41. A method for conducting an examination of a surface tissue in a subject comprising the steps of:Attorney Docket No. 35527-100110 A. applying a device comprising an elastomeric lens to the surface tissue of the subject, B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueC. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

42. A method for conducting an examination of a surface tissue in a subject comprising the steps of:A. applying a device comprising an elastomeric lens and a reflective coating to the surface tissue of the subject,B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueC. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

43. A method for conducting an examination of a surface tissue in a subject comprising the steps of:A. applying a device comprising an elastomeric lens, a reflective coating, and a protective layer to the surface tissue of the subject,B. identifying a deformation of the elastomeric lens once the device is applied to the surface tissueC. identifying an abnormality embedded in the surface tissue based on the deformation of the elastomeric lens.

44. The method of claim 41, wherein the elastomeric lens comprises a body having a stiffness selected to be less stiff than an abnormality embedded in the surface tissue and more compliant than surrounding healthy tissue.

45. The method of claim 44, further comprising applying pressure to the device such that the elastomeric lens deforms preferentially in response to regions of the surface tissue having increased stiffness.Attorney Docket No. 35527-100110 46. The method of claim 44, further comprising repositioning the device to multiple locations on the surface tissue and repeating steps of A-C.

47. The method of claim 46, wherein the device further comprises a measuring grid to estimate a position, size, location of the abnormality identified observed at the multiple locations.

48. A method for conducting a breast self-examination by a subject, comprising the steps of:A. applying, by the subject, a device comprising an elastomeric lens to a surface of breast tissue of the subject;B. identifying, by the subject, a deformation of the elastomeric lens once the device is applied to the breast tissue; andC. identifying, by the subject, an abnormality embedded in the breast tissue based on the deformation of the elastomeric lens.

49. A method for conducting a breast examination on a subject by an individual other than the subject, comprising the steps of:A. applying, by the individual, a device comprising an elastomeric lens to a surface of breast tissue of the subject;B. identifying, by the individual, a deformation of the elastomeric lens once the device is applied to the breast tissue; andC. identifying, by the individual, an abnormality embedded in the breast tissue based on the deformation of the elastomeric lens.

50. A kit for performing examination and palpation of a tissue in a subject comprising the device of claim 1 and instructions for use.

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