Allentown and Mount Bethel , Pennsylvania , United States

610-433-0600 , 610-428-2173

FREQUENTLY ASKED QUESTIONS

 

How does the device operate?


A lumedica Probe is used to generate the OCT image, while a speaker is used to generate vibrations in the sample. Using Spectral domain OCT the recorded information is extracted, to identify the displacement in the sample corresponding to the applied frequency. Maximum displacement corresponds to the resonant frequency, which can then be used to calculate the modulus.



What are the potential applications of the device?


1. Mechanical Testing  - Changes in ECM are observed with the progression of a diseased state. By tracking the mechanical properties in dermis and tissues, early diagnosis can be possible. Dermis, sclera, corneal tissues, implants, breast lesions and scars can be studied using VOCT.

2. Virtual biopsies for Moh's surgical Procedure -  Cancerous and noncancerous tissues have different moduli due to a change in tissue stiffness. In order to determine the depth of the lesions, a virtual biopsy can be performed using VOCT to determine margins of extraction.

3. Identification of change in tissue stiffness for Cancerous lesions 

4. Characterization of tissues and implants - Implant failure occurs due to tissue and implant moduli mismatch.With the help of VOCT different tissues and implants used can be characterized based on moduli to reduce the mismatch.

5. Margins for skin lesions 

6. Identification of lesion types - A difference in composition of tissues is characterized by different resonant frequencies and moduli. Different lesions can thus be identified through their characteristic resonant Frequencies.

7. Identification of breast tissue biopsies

8. Identification of corneal and scleral pathology - Experimental studies on human and porcine eyes indicate that Resonant frequency increases slightly with increase in pressure. Corneal and scleral pathology and changes in pressure can be tracked with the help of VOCT.

9. Quantitative assessment of carotid artery behavior

10. Identification of injection site blood vessels

11. Quantification of tissue water content

12. Analysis of dermal wound healing



How long does it take to perform the test?


 It takes about a minute to record patient data and and a processing time of about 10 minutes after the patient leaves



Which faculties of healthcare can this device benefit?

1. Ophthalmology - Corneal and Scleral pathology and change in pressure can be tracked. This can help identify and provide an early diagnosis.

2. Dermatology -  A study of different dermal fillers, their characterization and determination of  ideal filler based on the properties of injection site will improve the results and increase success rate.  

3. Orthopedics - A characterization for tissues and implants will provide a guide on the ideal moduli to reduce implant failure.  

4. Ear Nose and Throat doctors

5. Moh's Surgeons - Identification of Margins for surgical Extraction.

6. Plastic Surgeons

7. Geriatric general Practitioners

8. Breast Cancer surgeons - Tissue stiffness changes with progression of cancer. As the stiffness changes the modulus is affected. Virtual biopsies can thus be performed to determine presence of lesions.

9. General Surgeons



What is the status of regulatory approvals for the device?


  FDA 510 clearance documentation is in preparation



Is this a patented process?


 Yes.
 US patent Number :  10,488,277
 EU Patent Pending: Europe # 16866811.9



Is the device safe?


Low power infrared light is used for imaging and an audible sound less than 60 dB is utilized for generating vibrations. These are within the limits determined as safe for use.