Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
SENSOR PATCH FOR CANCER SCREENING
Document Type and Number:
WIPO Patent Application WO/2022/130305
Kind Code:
A1
Abstract:
A sensor patch (100) for breast cancer screening is described. In an example, the sensor patch (100) includes a plurality of sensing elements (104) for acquisition of temperature response data from breasts of a subject. The sensor patch (100) further includes a 2-dimensional (2D) flexible substrate (102) that serves as a base for the plurality of sensing elements (104), where the 2D flexible substrate (102) includes a plurality of cuts (106, 108) to transform the sensor patch (100) into a desired breast geometry.

Inventors:
PANDA SIDDHARTHA (IN)
PANDA BISWANATH (IN)
TRIVEDI SHIVAM (IN)
BHARGAVA ROHIT (IN)
SINGH UTKARSHA K (IN)
MALHOTRA KARUN (IN)
RAGASH THACHAT (IN)
Application Number:
PCT/IB2021/061897
Publication Date:
June 23, 2022
Filing Date:
December 17, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
INDIAN INSTITUTE OF TECH KANPUR (IN)
MURATA MANUFACTURING CO (JP)
International Classes:
A61B5/01; A61B5/06
Domestic Patent References:
WO2019001594A12019-01-03
Foreign References:
US4651749A1987-03-24
US6086247A2000-07-11
Attorney, Agent or Firm:
LAKSHMIKUMARAN, Malathi et al. (IN)
Download PDF:
Claims:
We Claim:

1. A sensor patch (100) for breast cancer screening, the sensor patch (100) comprising: a plurality of sensing elements (104) for acquisition of temperature response data from breasts of a subject; a 2-dimensional (2D) flexible substrate (102) serving as a base for the plurality of sensing elements (104), wherein the 2D flexible substrate (102) comprises a plurality of cuts to transform the sensor patch (100) into a desired breast geometry.

2. The sensor patch (100) as claimed in claim 1, wherein the plurality of cuts comprises radial cuts (106) to transform the 2D flexible substrate (102) into a 3- dimensional (3D) kirigami structure, wherein each of the radial cuts (106) extends from a center to an outer edge of the of the 2D flexible substrate (102).

3. The sensor patch (100) as claimed in claim 2, wherein the radial cuts (106) comprise an adjustability slit factor (106-1, 106-2, 106-n), wherein the adjustability slit factor (106-1, 106-2, 106-n) allows the sensor patch (100) to be folded to fit commercially available brassiere sizes.

4. The sensor patch (100) as claimed in claim 1, wherein the plurality of cuts comprises spiral cuts (108) to transform the 2D flexible substrate (102) corresponding to a shape of the breasts of the subject.

5. The sensor patch (100) as claimed in claim 4, further comprising conductive wirelines (110) embedded between successive spiral cuts (108), wherein the conductive wirelines (110) facilitate transmission of power to the plurality of sensing elements (104) and collection of temperature response data from the plurality of sensing elements (104). 6. The sensor patch (100) as claimed in claim 5, further comprising conductive bond pads (112) for affixing the plurality of sensing elements (104) on the 2D flexible substrate (102), the conductive bond pads (112) being connected to the conductive wirelines (110) to the facilitate transmission of power to the plurality of sensing elements (104) and collection of temperature response data from the plurality of sensing elements (104).

7. The sensor patch (100) as claimed in claim 1, further comprising stiffeners (114) affixed beneath the conductive bond pads (112) to provide mechanical strength to a region of attachment of the plurality of sensing elements (104) on the 2D flexible substrate (102).

8. The sensor patch (100) as claimed in claim 1, further comprising an adhesive tape (116) affixed on the sensor patch (100), wherein the adhesive tape (116) is fixed over the plurality of sensing elements (104) on a side facing a skin surface of the subject.

9. The sensor patch (100) as claimed in claim 8, wherein the adhesive tape (116) comprises a cut-out to expose each of the plurality of the sensing elements (104) to the skin surface.

10. The sensor patch (100) as claimed in claim 1, wherein each of the plurality of sensing elements (104) is encapsulated by a metallic bead (118).

11. The sensor patch (100) as claimed in claim 8, further comprising a circular strip (120) placed beneath each of the plurality of sensing elements (104) for maintaining thermal resistance of the plurality of sensing elements (104), wherein the circular strip (120) is placed on a side opposite to the side facing the skin surface of the subject. 15

12. A method for manufacturing a sensor patch (100) for breast cancer screening, the method comprising: processing a 2-dimensional (2D) flexible substrate (102) for transformation of the sensor patch (100) into a desired geometry, wherein the processing comprises performing radial cuts (106) and spiral cuts (108) on the 2D flexible substrate (102); embedding a plurality of sensing elements (104) on the 2D flexible substrate (102) for acquisition of temperature response data from breasts of a subject; folding the 2D flexible substrate (102) along the radial cuts (106) to transform the 2D flexible substrate (102) into a 3-dimensional (3D) kirigami structure; and folding the 2D flexible substrate (102) along the spiral cuts (108) to transform the 2D flexible substrate (102) corresponding to a shape of the breasts of the subject.

13. The method as claimed in claim 12, wherein performing the radial cuts (106) comprises performing the radial cuts (106) with an adjustability slit factor (106-1, 106-2, 106-n) to allow the sensor patch (100) to be folded to fit commercially available brassiere sizes.

14. The method as claimed in claim 12, wherein embedding a plurality of sensing elements (104) on the 2D flexible substrate (102) comprises embedding the plurality of sensing elements (104) between successive spiral cuts (108).

15. The method as claimed in claim 13, further comprising skipping the embedding of the plurality of sensing elements in an overlapping area along the adjustability slit factor (106-1, 106-2, . . 106-n) on the sensor patch (100).

Description:
SENSOR PATCH FOR CANCER SCREENING

BACKGROUND

[0001] Breast cancer is one of the major diseases responsible for female mortality in the countries worldwide. Breast cancer occurs when some cells in breasts begin to grow abnormally rapidly than other healthy cells, thereby creating lumps in the breasts. If not diagnosed in an early stage, the abnormal growth of cells can spread from the breasts to lymph nodes, thereby spreading throughout the body.

BRIEF DESCRIPTION OF DRAWINGS

[0002] The following detailed description references the drawings, wherein: [0003] Figures 1(a), 1(b) and 1(c) illustrate a sensor patch, in accordance with examples of the present subject matter,

[0004] Figure 2 illustrates the sensor patch, in accordance with another example of the present subject matter,

[0005] Figure 3 illustrates the sensor patch, in accordance with yet another example of the present subject matter,

[0006] Figure 4 illustrates the sensor patch, in accordance with yet another example of the present subject matter,

[0007] Figure 5 illustrates the sensor patch, in accordance with yet another example of the present subject matter,

[0008] Figures 6(a) and 6(b) illustrate the sensor patch, in accordance with other examples of the present subject matter,

[0009] Figure 7 illustrates a brassiere for incorporating the sensor patch, in accordance with an example of the present subject matter, and

[00010] Figure 8 illustrates a method of manufacturing the sensor patch, in accordance with another example of the present subject matter.

DETAILED DESCRITPION

[00011] Breast cancer is a widespread disease which can be fatal if not diagnosed early and an early breast cancer diagnosis can drastically reduce mortality rate and increase chances of survival. One of the conventionally used techniques for determining the presence of cancerous cells in breasts include mammography. In mammography, a breast is compressed and put between two plates. A low energy X-ray is then passed through the breast and an image is recorded on an X-ray film placed under the breast. The recorded image indicates the cancerous cells in higher contrast as compared to normal cells.

[00012] However, for subjects having higher breast density, mammography is less sensitive in early stages. Further, there may be situations, where a subject may be reluctant in putting the breast between the plates and may not fully co-operate during the process. This may lead to recording a non-clear image, thereby compromising with the efficiency of the diagnosis.

[00013] Other tools and techniques for determining the presence of the cancerous cells in breasts include electrical impedance scanning (EIS), mammary ductoscopy, breast thermography, and breast thermometry. Among the above- mentioned tools and techniques, the breast thermography and breast thermometry include devices that aim at detecting the presence of cancerous cells in breasts based on an elevation in temperature of the breasts. It is a well-established principle in the field of medical science that local temperature in and around cancerous cells are generally elevated in comparison to the normal cells. The breast thermography includes recording an infrared (IR) thermogram of the breast using an IR camera followed by analysis of the infrared thermogram for determining the presence of the cancerous cells. In breast thermography, since the images obtained by the IR camera are captured from a distance, they have reduced sensitivity in determination of the temperature of the cells at early stages, especially when the temperature elevation is lower. As a result, the breast thermography is rendered ineffective in determination of the presence of the cancerous cells at early stages.

[00014] The issues related to sensitivity in determination of the temperature are addressed by breast thermometry which involves recording the temperature through multiple sensing elements which are in direct contact with the breasts. The multiple sensing elements are accessed by individual sets of bare insulated cables that are used for transmission of the temperature response data. However, when these sensing elements are attached to the breasts , multiple cables meet a subject’s body resulting in an entangled set of complex wires around the breast area, thereby creating a discomforting situation. In such a situation, the subject may not stay still during the screening procedure, resulting in damaged sensor joints and loose wirelines resulting in erroneous temperature response data. Moreover, attaching multiple sensing elements with cables on the breasts for collection of temperature response data from multiple subjects is a cumbersome task.

[00015] According to example implementations of the present subject matter, a breast cancer screening sensor patch for determining the presence of cancerous cells in breasts is described.

[00016] In an example, the breast cancer screening sensor patch for breast cancer screening is described. For the ease of reference, the breast cancer screening sensor patch is hereinafter referred to as ‘a sensor patch’. According to example implementation of the present subject matter, the sensor patch may be embedded with multiple sensing elements for acquisition of temperature response data from the breasts of a subject for determining the presence of cancerous cells in the breasts.

[00017] The sensor patch may include a 2-dimensional (2D) flexible substrate that serves as a base for the multiple sensing elements. For the ease of reference, the 2D flexible substrate has been referred to as the ‘substrate’, hereinafter. The substrate may have a design that allows transformation of the sensor patch into a desired breast geometry. The design may include ‘2’ types of pattern cuts which are utilized to transform the substrate into the desired breast geometry, where the ‘2’ types of pattern cuts may include radial cuts and spiral cuts.

[00018] A radial cut from a centre of the substrate to an outer edge thereof may allow the substrate to be transformed into a 3 -dimensional (3D) kirigami structure by folding along the radial cuts. The radial cut may further have an adjustability slit factor which may allow folding along multiple marked edges to fit commercially available brassiere sizes. Further, the spiral cuts may provide the sensor patch with an ability to transform the sensor patch corresponding to a shape of a breast. [00019] Accordingly, the sensor patch formed with the radial and spiral cuts may efficiently accommodate to breast geometry of the subject, thereby allowing higher degree of contact between subject’s skin surface and the sensing elements. Consequently, accuracy of the temperature response data received from the sensing elements is improved, thereby improving the efficiency in indicating the possible presence of cancerous cells in breasts.

[00020] The sensor patch may further include conductive wirelines to facilitate power transmission and collection of temperature response data from the sensing elements. In an example, the conductive wirelines may be connected to a data acquisition system (DAQ) via a connector. In said example, the conductive wirelines may be embedded between successive spiral cuts either by additive or subtractive methods, such as printing or etching, respectively. The conductive wirelines so embedded may not create any user discomfort, thereby facilitating collection of the temperature response data in an accurate way.

[00021] The above techniques are further described with reference to Figure 1 to Figure 7. It would be noted that the description and the Figures merely illustrate the principles of the present subject matter along with examples described herein and would not be construed as a limitation to the present subject matter. It is thus understood that various arrangements may be devised that, although not explicitly described or shown herein, embody the principles of the present subject matter. Moreover, all statements herein reciting principles, aspects, and implementations of the present subject matter, as well as specific examples thereof, are intended to encompass equivalents thereof.

[00022] Figures 1(a), 1(b), and 1(c) illustrate a sensor patch 100, in accordance with examples of the present subject matter. The sensor patch 100 may be accommodated in a brassiere which may be worn by a subject to bring the sensor patch in contact with the breasts of a subject. The sensor patch 100 may include a substrate 102 and multiple sensing elements 104-1, 104-2, 104-n embedded on the substrate 102. For the sake of reference, the multiple sensing elements 104-1, 104-2, 104-n have been collectively referred to as the sensing elements 104, hereinafter. [00023] The substrate 102 may have a design that allows transformation of the sensor patch into desired breast geometry. Specifically, the design may include ‘2’ types of pattern cuts which may transform the substrate into the desired breast geometry. The ‘2’ types of pattern cuts may include radial cuts 106 and spiral cuts 108. The radial cuts 106 may extend from a centre of the substrate to an outer edge thereof. The radial cuts 106 may allow the substrate to be transformed into a 3D kirigami structure by folding along the radial cuts. Further, the spiral cuts 108 may allow the substrate 102 to be extended vertically in a direction perpendicular to a plane of the substrate to transform the substrate 102 corresponding to a shape of the breasts of the subject.

[00024] In an example, the substrate 102 may have a circular shape with a gap 102-1 at the centre. The substrate 102 may have a 2-dimensional geometry and may be flexible in nature. The substrate 102 may further have a thermal mass lesser than a threshold thermal mass, where the thermal mass may be defined as a material’s ability to store heat energy around the sensing elements 104. In an example, the threshold thermal mass for the substrate may be decided based on a tolerance of the sensing elements embedded thereon. In said example, the thermal mass may not be higher than the tolerance of the sensing elements embedded on the substrate. The thermal mass lesser than the threshold thermal mass may avoid alteration in the temperature response data acquired by the sensing elements due to temperature of the surroundings. The substrate may further have a mechanical strength higher than a threshold mechanical strength to withhold any damage caused due to wear and tear. Examples of substrate 102 may include, but are not limited to, polyimide flex, polyamide fabric (nylon & silk), cotton brassiere, and microfiber brassiere.

[00025] The number of sensing elements 104 embedded on the substrate 102 may vary as per requirements. In an example, the number of sensing elements can be varied from 16 to 256 with the help of a suitable data acquisition system. In said example, each of the sensing elements embedded on the substrate 102 may have a tolerance of around 0.5% - 1%, power dissipation in range of 50 - 150 milli-watts, and a temperature measurement range varying from -40 ° C to 150 ° C. Further, in said example, each of the sensing elements may have a package size smaller than a threshold size. In an example, the threshold size may be a size of the sensing elements that does not affect the flexibility of sensor patches when the sensing elements are embedded into the sensor patches. For instance, each of the sensing elements may have a length of around 1.5 - 1.8 milli-metre (mm), width of around 0.5 -1.0 mm, and height of around 0.5 - 1 mm. Further, to enhance portability of the sensor patches, each of the sensing elements 104 may be light weight and weigh around 4.7 milli-grams. Further, the small package size of the sensing elements may also contribute to user comfort such the subject does not feel any extra protrusion in the brassiere.

[00026] In an example, the radial cuts 106 may have an adjustability slit factor 106-1, 106-2, 106-n which may allow the sensor patch 100 to be folded to fit commercially available brassiere sizes. The substrate 102 may further have an overlapping area along the adjustability slit factor 106-1, 106-2, 106-n. The overlapping area may not include any sensing elements thereon to avoid covering of the sensing elements 104 while folding the substrate 102.

[00027] The sensing elements 104 may be coupled to a data acquisition system through various conductive wirelines 110. In an example, the conductive wirelines 110 made of a material providing a low resistive path, such as copper or silver, may be used in the sensor patch 100.

[00028] In an example, the spiral cuts 108 have circular and smooth edges. Figure 1(b) illustrates an exemplary design of the sensor patch 100, where the spiral cuts have circular and smooth edges.

[00029] Further, as shown in figure 1(c), the sensor patch 100 may also include bond pads 112-1, 112-2, 112-n for affixing the sensing elements 104 on the substrate 102. For the ease of reference, the bond pads 112-1, 112-2, 112-n have been referred to as bond pads 112, hereinafter. The dimensions of the bond pads 112 may be equal to the dimensions of electrodes of the sensing elements. The bond pads 112 may be made of conductive metallic pads, such as copper, and may be connected to the conductive wirelines 110 in the sensor patches. The conductive wirelines 110 along with bond pads 112 may be embedded on the sensor patches via additive or subtractive methods, such as printing or etching, respectively. The sensing elements 104 may be affixed on the bond pads 112 via various bonding technologies, such as soldering or anisotropic bonding.

[00030] Figure 2 illustrates the sensor patch 100 in accordance with yet another example of the present subject matter. As shown, the sensor patch 100 may include stiffeners 114 beneath the bond pads to avoid misplacement or removal of sensing elements 104 from the bond pads. The stiffeners 114 may provide mechanical strength to a region of substrate 102 where the sensing elements 104 are attached.

[00031] Figure 3 illustrates the sensor patch 100 in accordance with yet another example of the present subject matter. The sensor patch 100 may include a medical grade adhesive tape 116 affixed on a top side, i.e., a side facing a skin surface of the subject and over the sensing elements 104 embedded on the sensor patch. The adhesive tape 116 may either be placed manually or using an automated process. The adhesive tape 116 may either be single sided or double-sided. For single sided adhesive tape, the sensor patch may be applied with an adhesive layer during manufacturing process. The adhesive layer may have greater adhesive strength as compared to the medical grade adhesive so that the sensor patches along with medical grade adhesive may be easily peeled off the skin surface without any discomfort. On the other hand, the double-sided medical grade adhesive tape may have differential release forces on its two sides. The side with less strength may be affixed on the skin surface.

[00032] In an example, a no sting barrier film solution may be applied on the skin surface to avoid any medical adhesive related skin injury (MARSI) before wearing the brassiere along with the flexible sensor patches.

[00033] As shown in figure 3, the adhesive tape 116 may be transformed into a similar dimensional geometry as of sensor patch 100 before being placed on top of sensor patch 100. In an example, the adhesive tape 116 may have cut-outs to expose the sensing elements 104 directly to the skin surface. In said example, the cut-outs may be square shaped. The adhesive tape 116 may have a peel off layer which may be peeled off prior to the application of the sensor patch on the skin surface. The medical grade adhesive may remove any air gaps between the skin surface and the sensing elements and therefore, may reduce a possibility of detection of false skin surface temperature.

[00034] Figure 4 illustrates the sensor patch 100 in accordance with yet another example of the present subject matter. As shown in figure 4, each of the sensing elements 104 may be encapsulated by a thermally conductive glue (not shown) and a metallic bead 118 on top of the thermally conductive glue. It would be noted that effective encapsulation of thermal sensors may further improve the temperature response time and stabilize the results.

[00035] Figure 5 illustrates the sensor patch 100 in accordance with yet another example of the present subject matter. The sensor patch 100 may include circular strips 120 placed at the back of the sensing elements on a bottom side of the sensor patch, i.e., a side opposite to the skin surface of the subject. In an example, the circular strips 120 may be placed beneath the thermally conductive glue and the metallic bead 118. The circular strips 120 may be made from a suitable material, such as a fabric cloth. The circular strips 120 so affixed may minimize thermal resistance between the skin surface and the sensing elements, which may decrease temperature response time while also maximizing the thermal resistance from the substrate to the surrounding air.

[00036] Figures 6(a) and 6(b) illustrate the sensor patch 100 in accordance with examples of the present subject matter. The sensor patch 100 may be integrated in any commercially available brassiere. In said example, the sensor patch 100 may be packaged in the brassiere with a disposable material 122 that may be sterilized by techniques which may include, but are not limited to, steam, low-temperature- steam-formaldehyde (LTSF) sterilization, and Ethylene Oxide Sterilizer (ETO). Examples of the disposable material 122 may include, but are not limited to, crepe paper, nonwoven fabric sheet, and medical grade paper-plastic pouch. Figure 6(a) illustrates the sensor patch 100 sandwiched between two layers of the disposable material 122. Further, figure 6(b) illustrates a layer diagram of the sensor patch 100 along with the disposable material 122.

[00037] Figure 7 illustrates a brassiere 700 for incorporating the sensor patch 100, in accordance with an example of the present subject matter. Generally, a commercially available brassiere includes a breast cup, a band attached to the breast cup, and a strap attached to the breast cup and the band. The band runs around the rib cage of the subject, the breast cup holds the breast volume and is attached to the front of the band, and the strap is sewn directly onto the band, such that, the strap connects to the band at one end and an upper part of the breast cup at another end. It is worth noting that there exists around ‘40’ commercially available brassiere sizes. The volume of breast tissue each cup holds varies based on a cup size of the brassiere, such as A, B or C and a band size of the brassiere, such as 30, 32 or 42. Accordingly, it would be appreciated by a person skilled in the art that the integration of the sensor patch 100 in any brassiere would entail different sizes of sensor patch 100. It has also been noted that brassieres having different sizes may hold the same volume of breast tissue though a shape of the breast cup and a length of band may vary. Such brassieres are called to have sister sizes. Table 1 tabulates a family of such sister sizes for different commercially available brassieres.

[00038] In an example of the present subject matter, the brassiere incorporating the sensor patch 100 includes a strap extender 702. The strap extender 702 may be used to cover corresponding sister sizes of the brassiere, such as 36D, 38C, 40B, and 42A, by extending the length of the strap. Thus, the strap extender 702 may allow ‘40’ commercially available brassiere sizes to be covered using ‘ 12’ brassieres.

[00039] Figure 8 illustrates a method 800 of manufacturing of the sensor patch 100 in accordance with an example of the present subject matter. The order in which the method 800 is described is not intended to be construed as a limitation, and any number of the described method blocks may be combined in any order to implement the method 800, or an alternative method.

[00040] It would be noted that the method of manufacturing the sensor patch described herein is merely exemplary and should not be construed as a limitation. The sensor patch may also be manufactured by other methods, such as 3D printing. [00041] At block 802, a substrate of the sensor patch may be processed for transformation of the sensor patch into a desired geometry, where the processing includes performing radial cuts and spiral cuts on the substrate. The radial cuts may be made from a centre of the substrate to an outer edge thereof. Further, the radial cuts may be made with an adjustability slit factor which may allow folding along multiple marked edges to fit commercially available brassiere sizes. The substrate may further have an overlapping area along the adjustability slit factor. The radial cuts and the spiral cuts may be performed using any suitable cutting processes, such as laser cutting.

[00042] In an example, subsequent to the processing of the substrate, conductive wirelines may be incorporated on the substrate. In said example, the conductive wirelines may be incorporated on the substrate between successive spiral cuts. The conductive wirelines may be incorporated using suitable additive or subtractive methods, such as printing or etching. The conductive wirelines may be incorporated in a manner, such that, the conductive wirelines may offer least resistive path and avoid cross path with the radial and spiral cuts. In an example, the conductive wirelines are incorporated in the substrate to facilitate power transmission and data collection from sensing elements that would be embedded on the substrate in next step of manufacturing the sensor patch.

[00043] At block 804, the sensing elements may be embedded on the substrate. The sensing elements may be embedded on the substrate for acquisition of temperature response data from breasts of a subject. Further, the sensing elements may be embedded on the substrate in several ways. In an example, the sensing elements may be printed on the substrate. In another example, commercially available sensing elements may be embedded on the substrate. In said example, multiple bond pads may be affixed on the substrate, followed by affixing of the sensing elements on the bond pads. The affixing of the sensing elements on the bond pads may be carried out via a robust bonding technology, such as soldering or anisotropic bonding.

[00044] In an example, stiffeners may be embedded on the substrate prior to affixing the bond pads and the sensing elements on the substrate. The embedment of the stiffeners may provide mechanical strength to a region of the substrate where the sensing elements are affixed.

[00045] In another example, subsequent to affixing of the bond pads on the substrate, an adhesive tape may be affixed on the sensing elements. The adhesive tape may be affixed on the sensing elements on a side facing a skin surface of a subject. The adhesive tape may be certified medical grade adhesive tape. In an example, the adhesive tape may be transformed to have cut-outs corresponding to sensing element in a manner, such that, when the sensor patch meets the skin surface, the sensing elements are exposed directly to the skin surface. In said example, the cut-outs may be square shaped. Further, in said example, the transformation of the adhesive tape may be carried out by laser cutting technique.

[00046] At block 806, the substrate may be folded along the radial cuts for transformation of the sensor into the 3D kirigami structure. [00047] Subsequently, at block 808, the substrate may be folded along the spiral cuts to transform the substrate to acquire the shape of the breast and ensure good contact of the sensing elements with the skin surface.

[00048] Although examples of the present subject matter have been described in language specific to methods and/or structural features, it is to be understood that the present subject matter is not limited to the specific methods or features described. Rather, the methods and specific features are disclosed and explained as examples of the present subject matter.