Spectron IR Medical Infrared Imaging System
FDA 510(k) Indications for Use
FDA 510(k) #KO32471
Indications for use: The Spectron IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic and inflammatory conditions.
CLINICAL APPLICATIONS – MEDICAL INFRARED IMAGING STUDIES
Over the years there have been numerous studies conducted validating the use of medical thermography for various clinical conditions. We have selected some of the more recent studies to provide examples of how thermography can be used in the medical field.
These studies are from various credible sources internationally including: The American Journal of Surgery; Rheumatology, European Journal of Applied Physiology and Journal of Urology; and involving some of the most noted research centres including: Duke University, North Shore LIJ Research Institute, Department of Obstetrics and Gynecology, Rabin Medical Center, Tel Aviv Israel, Department of Internal Medicine, State University of New York and Department of Cardiology, and the University Clinic Essen, Germany.
Specific Thermographic Changes During Walker 256 Carcinoma Development: Differential Infrared Imaging Of Tumor, Inflammation And Haematoma.
Poljak-Blazi M, Kolaric D, Jaganjac M, Zarkovic K, Skala K, Zarkovic N.
Infrared imaging measures spatial variations in the skin temperature aiming to determine pathological processes; hence possible use of this non-invasive analytical method in cancer detection is emerging.
Infrared thermal imaging was used to detect changes in rat skin surface temperature associated with experimental cancer development (Walker 256 carcinoma), inflammation (upon s.c. Sephadex injection) and haematoma (provoked by s.c. blood coagulate injection). Infrared camera with a geometric resolution of 76,800 pixels, spectral range of 8-14 microns and the minimal detectable temperature resolution of 0.07 degrees C with spatial resolution of 0.48 mm at measuring distance of 30 cm was used to obtain computerized thermal scans. Genuine ThermoWEB software developed for remote internet control as open source software was used.
The raise of peripheral temperature was observed after induction of local inflammation or haematoma. Opposite to that, transient decrease of the skin surface temperature was observed after tumor transplantation. Progressive growth of tumor was associated with the raise of the skin surface temperature from the 10th day after tumor inoculation, when the tumors developed supportive neoangiogenic blood supply, as verified by histology.
While the raise of peripheral temperature in advanced tumor was caused by neoangiogenesis, the reduction in skin surface temperature in an early period after tumor cell inoculation indicated a decay of transplanted tumor cells due to the immune response and the lack of blood supply. Thus, infrared thermal imaging may have considerable value in evaluation of the tumor development and discrimination of cancer from inflammation and haematoma.
Contemporary Applications Of Infrared Imaging In Medical Diagnostics
Mikulska D. Katedra i Klinika Chorób Skórnych
Thermal imaging is a non-contact, non-invasive diagnostic method for study human body temperature. Therefore infrared thermal imaging finds increasing application in clinical medicine.
The aim of this paper was to present and discuss the history and applications of thermal imaging in medicine.
MATERIAL AND METHODS:
The literature dealing with the history and applications of thermal imaging in medicine has been reviewed.
Medical thermography was born in 1957 when a surgeon, Dr. R. Lawson discovered that his breast cancer patients had higher skin temperature over the cancer area. Since the 1970’s thermography has been used in many areas of medicine. Early problems such as low detector sensitivity, but most significantly, poor training of thermography technicians was the source of error in thermography and retarded the acceptance of this technique until 1990. Since that time, thermographic equipment has evolved significantly. Modern thermal imaging systems comprise technically advanced thermal cameras coupled to computers with sophisticated software solutions. The recorded images are now of good quality and may be further processed to obtain reliable information. Thermography can be applied as a diagnostic tool in oncology, allergic diseases, angiology, plastic surgery, rheumatology, and elsewhere. Contemporary thermal imaging must be performed according to certain principles aimed at reliability and reproducibility of results.
1. Thermography is a safe, accurate and, most importantly, a non-invasive diagnostic method in clinical medicine. 2. Ignoring any of the principles worked out by the European Association of Thermology leaves thermography open to error and thus reduces acceptance of this technique in medical diagnostics.
Ocular Surface Temperature In Diabetic Retinopathy: A Pilot Study By Infrared Thermography.
Sodi A, Giambene B, Miranda P, Falaschi G, Corvi A, Menchini U.
To compare ocular surface temperature (OST) measures in patients with nonproliferative diabetic retinopathy (NPDR) and healthy controls.
A total of 51 consecutive patients with different severity degrees of NPDR and 53 age-and gender-matched healthy volunteers were recruited. OST was evaluated by infrared thermography in five conjunctival (points 1, 2, 4, 5) and corneal (point 3) points.
In diabetic eyes, OST values were lower than in controls at all the studied points (p<0.001 at points 1, 2, 3, 4, and p=0.003 at point 5).
Ocular surface temperature measurements, by estimating ocular blood flow, may be helpful in the management of patients with diabetic retinopathy.
Appearance Of Human Meridian-Like Structure And Acupoints And Its Time Correlation By Infrared Thermal Imaging.
ang HQ, Xie SS, Hu XL, Chen L, Li H.
Key Laboratory of OptoElectronic Science and Technology for Medicine of Ministry of Education, Institute of Laser and OptoElectronics Technology, Fujian Normal University, Fuzhou 350007, China.
The meridians and acupoints of human bodies at natural condition are investigated among 30 healthy volunteers by infrared thermal imaging technique. The results give clear evidence of the existence of infrared radiant tracks along human meridian courses. The time dependent evolution of the infrared radiant track is observed for the first time. The time rhythm of acupoints is also studied. Our findings not only support the view that infrared radiant tracks along human meridian courses is a normal vital and physiological phenomenon appearing in human beings, but also offer a potential method for non-invasive diagnostic by studying the physiological function and pathological change of meridians or acupoints by means of thermography.
Varicocele, Hypoxia And Male Infertility. Fluid Mechanics Analysis Of The Impaired Testicular Venous Drainage System.
Gat Y, Zukerman Z, Chakraborty J, Gornish M
Varicocele is a bilateral vascular disease, involving a network of collaterals and small, retro-peritoneal bypasses. It was considered a predominantly unilateral (left-sided) disease. Its pathophysiology has not been clearly delineated and the treatments offered do not seem to be effective. Based on our findings (i) varicocele is a bilateral disease; (ii) the disease is expressed earlier in the left side and is more intense because the blood column is longer in the left side than the right; (iii) partial treatment to the left side only and ignoring bypasses is not adequate to correct the problem; (vi) thermography alone or combined with ultrasonography with special attention to the bilaterality of the disease are the best non-invasive tools for its detection.
Residual Heat Of Laparoscopic Energy Devices: How Long Must The Surgeon Wait To Touch Additional Tissue?
Govekar HR, Robinson TN, Stiegmann GV, McGreevy FT. Department of Surgery, University of Colorado Denver School of Medicine, 12631 East 17th Ave., MS C313, Aurora, CO, 80045, USA.
… Thermal imaging quantified instrument and tissue temperature ex vivo usingmonopolar coagulation, argon beam coagulation, ultrasonic dissection, and bipolar tissue fusion devices. … Conclusions: Ultrasonic energy instruments have greater residual heat than monopolar electrosurgery, bipolar tissue fusion, and argon beam. The ultrasonic energy instrument tips heated tissue more than 20°C from baseline even 20 s after activation; whereas all the other energy sources raised the tissue temperature less than 20°C by 5 s. These practical findings may alter a surgeon’s usage of these common energy devices.
Infrared Thermography As An Access Pathway For Individuals With Severe Motor Impairments.
Memarian N, Venetsanopoulos AN, Chau T.
Institute of Biomaterials and Biomedical Engineering,University of Toronto, Toronto Canada.
People with severe motor impairments often require an alternative access pathway, such as a binary switch, to communicate and to interact with their environment. A wide range of access pathways have been developed from simple mechanical switches to sophisticated physiological ones. In this manuscript we report the inaugural investigation of infrared thermography as a non-invasive and non-contact access pathway by which individuals with disabilities can interact and perhaps eventually communicate.
Our method exploits the local temperature changes associated with mouth opening/closing to enable a highly sensitive and specific binary switch. Ten participants (two with severe disabilities) provided examples of mouth opening and closing. Thermographic videos of each participant were recorded with an infrared thermal camera and processed using a computerized algorithm. The algorithm detected a mouth open-close pattern using a combination of adaptive thermal intensity filtering, motion tracking and morphological analysis.
High detection sensitivity and low error rate were achieved for the majority of the participants (mean sensitivity of all participants: 88.5% +/- 11.3; mean specificity of all participants: 99.4% +/- 0.7). The algorithm performance was robust against participant motion and changes in the background scene.
Our findings suggest that further research on the infrared thermographic access pathway is warranted. Flexible camera location, convenience of use and robustness to ambient lighting levels, changes in background scene and extraneous body movements make this a potential new access modality that can be used night or day in unconstrained environments.
Dynamic Infrared Thermography Of The Nasal Vestibules: A New Method.
Kastl KG, Wiesmiller KM, Lindemann J.
Department of Otorhinolaryngology,University of Ulm, Ulm Germany.
The surface temperature distribution within the nasal vestibule and the nasal cavity strongly depends on the exact intranasal detection site and point of time during the respiratory cycle. Therefore, conventional temperature measurements e.g. with thermocouples only provide selective measurements. The use of infrared thermography cameras could present a new contactless method with a high spatiotemporal resolution. The aim of the present study was to evaluate the use of infrared thermography camera systems for measurements of the nasal surface temperature during respiration.
The surface temperature profiles within the nasal vestibules of healthy volunteers were recorded with infrared thermography cameras during several breathing cycles. Two different types of infrared thermography standard systems were used.
The recordings allowed a display of temperature alterations within the nasal vestibules in a high spatiotemporal resolution synchronous to the breathing cycle. During inspiration, the vestibular surface cooled down presenting a non-homogenous distribution (range, 24.7 to 30.2 degrees C). During expiration, the vestibular surface was warmed again with a non-homogenous distribution (range, 33.1 to 36.2 degrees C). The results of both camera systems were comparable.
Infrared thermography cameras allow the exact mapping of nasal surface temperature within the nasal vestibules with a high spatiotemporal resolution without surface contact.
Periorbital Thermal Signal Extraction And Applications.
Shastri D, Tsiamyrtzis P, Pavlidis I. Computational Physiology Lab, University of Houston, Houston, TX
We propose a novel method that localizes the thermal footprint of the facial and ophthalmic arterial-venous complexes in the periorbital area. This footprint is used to extract the mean thermal signal over time (periorbital signal), which is a correlate of the blood supply to the ocular muscle. Previous work demonstrated that the periorbital signal is associated to autonomic responses and it changes significantly upon the onset of instantaneous stress. The present method enables accurate and consistent extraction of this signal. It aims to replace the heuristic segmentation approach that has been used in stress quantification thus far. Applications in computational psychology and particularly in deception detection are the first to benefit from this new technology. We tested the method on thermal videos of 39 subjects who faced stressful interrogation for a mock crime. The results show that the proposed approach has improved the deception classification success rate to 82%, which is 20% higher compared to the previous approach.
Images In Plastic Surgery: Digital Thermographic Photography (“THERMAL Imaging”) For Preoperative Perforator Mapping.
Chubb D, Rozen WM, Whitaker IS, Ashton MW.
The Taylor Laboratory, Jack Brockhoff Reconstructive Plastic Surgery Research Unit, Department of Anatomy and Cell Biology, The University of Melbourne, Parkville, Victoria 3050, Australia.
Preoperative imaging to identify the location of individual perforators has been shown to improve operative outcomes, and while computed tomographic angiography (CTA) and magnetic resonance angiography are currently the most widely used modalities, these have substantial limitations. Such limitations include the need for intravenous access, the need for iodinated contrast media, radiation exposure with CTA, and long scanning times with magnetic resonance angiography. Complications from the use of contrast media are also noteworthy, and can include anaphylactoid reactions and renal toxicity. In a move to avoid these problems, we have recently introduced a technique that is readily available and easy to implement for preoperative imaging, and may show an accuracy that matches the more advanced imaging modalities. Thermal imaging is a readily performed technique, and can be undertaken by the reconstructive surgeon themselves at the initial consultation, enabling prompt operative planning, and avoiding the need for delays in imaging, confusion in the interpretation of a radiologist report, and the need for an intermediary radiologist altogether. In our experience thus far, the technique matches the accuracy for location of CTA, and a larger clinical trial of the technique is underway.
Repeatability Of Infrared Plantar Thermography In Diabetes Patients: A Pilot Study
Luciane Fachin Balbinot, M.D., Ph.D., Caroline Cabral Robinson, P.T., Ms.C., Matilde Achaval, M.D., Ph.D., Milton Antônio Zaro, Ph.D., and Marcos Leal Brioschi, M.D., Ph.D.
Infrared (IR) thermography has been used as a complementary diagnostic method in several pathologies, including distal diabetic neuropathy, by tests that induce thermoregulatory responses, but nothing is known about the repeatability of these tests. This study aimed to assess the repeatability of the rewarming index in subjects with type 2 diabetes mellitus (T2DM) and nondiabetic control subjects.
Using an IR camera, plantar IR images were collected at baseline (pre-) and 10 min after (post-) cold stress testing on two different days with 7 days interval. Plantar absolute average temperatures pre- and post-cold stress testing, the difference between them (ΔT), and the rewarming index were obtained and compared between days. Repeatability of the rewarming index after the cold stress test was assessed by Bland–Altman plot limits of agreement.
Ten T2DM subjects and ten nondiabetic subjects had both feet analyzed. Mean age did not differ between groups (p = .080). Absolute average temperatures of plantar region pre- (p = .033) and post-cold stress test (p = .019) differed between days in nondiabetic subjects, whereas t hey did not differ in T2DM subjects (pretest, p = .329; post-test, p = . 540). Δ T and rewarming index did not differ between days for both groups, and the rewarming index presented a 100% agreement of day-to-day measurements from T2DM subjects and 95% with nondiabetic subjects.
The rewarming index after cold stress testing presented good repeatability between two days a week in both groups. Despite T2DM subjects presenting no differences on absolute temperature values between days, ΔT or rewarming index after cold stress testing remain recommended beside absolute temperature values for clinical use.
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