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EP-4739191-A1 - OPTICAL ARRANGEMENT, DEVICE AND NON-INVASIVE METHOD FOR ANALYZING A SKIN SAMPLE

EP4739191A1EP 4739191 A1EP4739191 A1EP 4739191A1EP-4739191-A1

Abstract

According to embodiments of the present invention, an optical arrangement is provided. The optical arrangement includes a first fiber optic probe configured to measure Raman spectra of a skin sample; a second fiber optic probe configured to measure diffuse reflectance spectra of the skin sample; and an imaging camera configured to capture a reflectance image of the skin sample. The first fiber optic probe, at least part of the second fiber optic probe and the imaging camera are arranged adjacent to one another. Based on at least one selected from the measured Raman spectra, the measured diffuse reflectance spectra, or the captured reflectance image, the optical arrangement is configured to interrogate a pre-determined depth below a surface of the skin sample, and/or tissue chromophores of the skin sample at the pre-determined depth. According to further embodiments, a device and non-invasive method for analyzing a skin sample are also provided.

Inventors

  • TEO, Xinhui, Valerie
  • UNNIMADHAVA KURUP SOUDAMINI AMMA, DINISH
  • BALASUNDARAM, Ghayathri
  • OLIVO, Malini Carolene Devapiriyai
  • ZHANG, Ruochong
  • CHOOLANI, MAHESH
  • LOGAN, SUSAN

Assignees

  • Agency for Science, Technology and Research
  • National University Hospital (Singapore) Pte Ltd
  • National University of Singapore

Dates

Publication Date
20260513
Application Date
20240704

Claims (20)

  1. 1. An optical arrangement comprising: a first fiber optic probe configured to measure Raman spectra of a skin sample; a second fiber optic probe configured to measure diffuse reflectance spectra of the skin sample; and an imaging camera configured to capture a reflectance image of the skin sample, wherein the first fiber optic probe, at least part of the second fiber optic probe and the imaging camera are arranged adjacent to one another, the optical arrangement is configured to acquire at least one selected from the Raman spectra, the diffuse reflectance spectra, or the reflectance image in a location of the skin sample, and based on the at least one selected from the acquired Raman spectra, the acquired diffuse reflectance spectra, or the acquired reflectance image, the optical arrangement is configured to interrogate a pre-determined depth below a surface of the skin sample at the location, or tissue chromophores of the skin sample at the pre-determined depth, or both.
  2. 2. The optical arrangement according to Claim 1, where the optical arrangement is configured to acquire a combination of at least two selected from the Raman spectra, the diffuse reflectance spectra, or the reflectance image sequentially in the location of the skin sample.
  3. 3. The optical arrangement according to Claim 1 or 2, wherein the first fiber optic probe, the second fiber optic probe and the imaging camera integrally form the optical arrangement in a single probe.
  4. 4 The optical arrangement according to any one of Claims 1 to 3, wherein the first fiber optic probe comprises a first optical fiber configured to deliver laser energy to excite the skin sample; and a first plurality of optical fibers configured to detect and measure the Raman spectra of the skin sample.
  5. 5. The optical arrangement according to Claim 4, wherein the first optical fiber is centrally arranged along the first fiber optic probe, and the first plurality of optical fibers is arranged substantially surrounding the first optical fiber.
  6. 6. The optical arrangement according to Claim 4 or 5, wherein each optical fiber of the first plurality of optical fibers is arranged adjacent to and spaced apart from a neighbouring optical fiber of the first plurality of optical fibers.
  7. 7. The optical arrangement according to any one of Claims 4 to 6, wherein the first optical fiber comprises a first optical fiber bundle, and each optical fiber of the first plurality of optical fibers comprises an optical fiber bundle.
  8. 8. The optical arrangement according to any one of Claims 4 to 7, wherein the first optical fiber or each of the first plurality of optical fibers includes a single mode fiber, or a multimode fiber, or a combination of a single mode fiber and a multimode fiber.
  9. 9. The optical arrangement according to any one of Claims 4 to 8, wherein the first optical fiber has a core size ranging from 150-800 pm and a cladding size of 160-800 pm.
  10. 10. The optical arrangement according to any one of Claims 4 to 9, wherein the first optical fiber has a transmission range of 350 nm to 2400 nm.
  11. 11. The optical arrangement according to any one of Claims 1 to 10, wherein the second fiber optic probe comprises a second optical fiber configured to deliver light to the skin sample; and a second plurality of optical fibers configured to detect and measure the diffuse reflectance spectra of the skin sample.
  12. 12. The optical arrangement according to Claim 11, wherein the second optical fiber is centrally arranged along the second fiber optic probe, and the second plurality of optical fibers is arranged substantially surrounding the second optical fiber.
  13. 13. The optical arrangement according to Claim 11 or 12, wherein each optical fiber of the second plurality of optical fibers is arranged adjacent to and spaced apart from a neighbouring optical fiber of the second plurality of optical fibers.
  14. 14. The optical arrangement according to any one of Claims 11 to 13, wherein the second optical fiber comprises a second optical fiber bundle, and each optical fiber of the second plurality of optical fibers comprises an optical fiber bundle.
  15. 15. The optical arrangement according to any one of Claims 11 to 14, wherein the second optical fiber or each of the second plurality of optical fibers includes a single mode fiber, or a multimode fiber, or a combination of a single mode fiber and a multimode fiber
  16. 16. The optical arrangement according to any one of Claims 11 to 15, wherein the second optical fiber has a core size ranging from 150-800 jtm and a cladding size of 160- 800 gm.
  17. 17. The optical arrangement according to any one of Claims 11 to 16, wherein the second optical fiber has a transmission range of 350 nm to 2400 nm.
  18. 18. The optical arrangement according to any one of Claims 11 to 17, wherein each optical fiber of the second plurality of optical fibers is arranged at a distance ranging between 2700 gm and 6000 gm from the second optical fiber.
  19. 19. The optical arrangement according to Claim 18, wherein the optical arrangement is configured to interrogate the pre-determined depth below the surface of the skin sample ranging between 1300 gm and 3000 gm.
  20. 20. The optical arrangement according to any one of Claims 11 to 17, wherein each optical fiber of the second plurality of optical fibers is arranged at a distance ranging between 500 gm and 1000 gm from the second optical fiber.

Description

OPTICAL ARRANGEMENT, DEVICE AND NON-INVASIVE METHOD FOR ANALYZING A SKIN SAMPLE Cross-Reference T o Related Application [0001] This application claims the benefit of priority of Singapore patent application No. 10202301934V, filed 6 July 2023, the content of it being hereby incorporated by reference in its entirety for all purposes. Technical Field [0002] Various embodiments relate to an optical arrangement, a device and a non-invasive method for analyzing a skin sample. Background [0003] By 2025, it is estimated that over 1 billion women around the world (constituting 12% of the entire world population) would be experiencing menopause. Menopause is accompanied by several symptoms affecting physical and mental wellness and quality of life (QoL) and is estimated to cost USD 3 billion in annual health expenditure. By 2027, the costs may increase to USD 60 billion in view of a global aging/longevity/silver economy. Symptoms affecting the estrogen-receptor rich areas of women’s lower genitourinary tract (LGT) include the Genitourinary Syndrome of Menopause (GSM), affecting at least 84% of menopausal women. The actual prevalence is likely to be higher due to increasing prevalence with aging. GSM refers to oestrogen deficiency associated genital, sexual, and urinary changes in the lower genital tract of menopausal women. Typical symptoms include vulvovaginal dryness, itch, irritation and burning, vaginal discharge; decreased lubrication; painful sex; dysorgasmia; postmenopausal bleeding; urinary frequency, urgency and urge incontinence, dysuria, nocturia and urinary tract infections. [0004] Without effective treatment, GSM and postmenopausal complications evolve chronically affecting both QoL as well as the functional and structural aspects of the urogenital tissue. As per a survey, vaginal dryness had a QoL index of 0.566, similar to that of stroke patients and patients with multiple comorbidities. [0005] Diagnosis of GSM is usually clinical, based on medical history and pelvic examination. However, findings at physical examination do not always correlate with the presence or severity of symptoms. Laboratory testing is not typically undertaken, although cultures or biopsies can be performed if the diagnosis is in question, or there is nonresponsiveness to treatment. Invasive methods, such as vulva or vaginal biopsy are the gold standard for diagnosis but are least acceptable to patients due to invasiveness, pain, potential complications, and cost. Vaginal Maturation Index (VMI) objectively quantifies the estrogen status of the vaginal epithelium and related structures (vulva, urethra, and bladder). However, it is invasive, requires cytological expertise, is costly and has not gained widespread use beyond research labs. Furthermore, most clinical settings have moved to automation which does not report on cell maturation. Colposcopy just increases magnification without chromophore information and ultrasound is not validated in GSM and unsuitable in those who have not been sexually active. Both require machines that are bulky, costly and not widely available. [0006] Currently, estrogen therapy is prescribed as “one size fits all” approach for GSM patients, without available objective tech to compare the efficacy of treatment longitudinally, quantify the dosage and inter patient variation. As per studies, 60% of women aged 51-57 years have taken hormone replacement therapy (Br J Gen Pract. 2002; 52:835-837), with 45% having tried it by the time they are 50 (Br J Obstet Gynaecol. 1997; 104:923-933). In the US, about38% of postmenopausal women take hormone replacement therapy. In 2000, 46 million prescriptions were written for Premarin (conjugated equine estrogens), making it the second most frequently prescribed drug in the United States. [0007] Both systemic and topical application of estrogen is contraindicated for breast cancer patients. Emerging treatment methods such as moisturizers, laser therapy, ultrasound heating, injection of adipose tissue, amongst others are yet to be fully explored and validated. Their efficacy is yet to be studied extensively, partly due to lack of objective assessment technique. [0008] There is an unmet need for a device that offers cost effective, objective, non- invasive and timely assessment to track the clinically relevant treatment outcomes and their safety for GSM therapy, thereby addressing at least the problems described above. The proposed technology aims to bring objectivity and personalized assessment and treatment response monitoring for estrogen therapy for menopausal women suffering from GSM. Summary [0009] According to an embodiment, an optical arrangement is provided. The optical arrangement may include a first fiber optic probe configured to measure Raman spectra of a skin sample; a second fiber optic probe configured to measure diffuse reflectance spectra of the skin sample; and an imaging camera configured to capture a reflectance image of the skin sample. The fi