Lower limb vascular lesion evaluation device and lower limb vascular lesion evaluation method

Abstract

To provide a lower limb vascular lesion evaluation device which can be used suitably to early finding a lower limb vascular lesion with simplicity and high sensitivity.SOLUTION: A lower limb vascular lesion evaluation device 1A comprises a measurement unit 10A and an evaluation unit 20A. The measurement unit 10A measures the local oxygen saturation of a sole 31 of a person to be evaluated. The evaluation unit 20A evaluates a lower limb vascular lesion of the person to be evaluated, based on the measured value of the local oxygen saturation of the sole 31.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an apparatus and method for evaluating vascular lesions in the lower extremities. [Background technology]

[0002] Vascular lesions in the lower limbs, also known as peripheral arterial disease (PAD), are caused by stenosis or blockage of blood vessels in the lower limbs, which impairs circulation and prevents sufficient nutrients and oxygen from reaching the lower limbs, resulting in a variety of disorders. Vascular lesions in the lower limbs are caused by arteriosclerosis and are more likely to occur in people with lifestyle-related diseases such as diabetes, dyslipidemia, hypertension, smoking, hyperuricemia, chronic kidney disease, and obesity.

[0003] Symptoms of lower limb vascular disease begin with numbness and coldness in the legs, followed by pain when walking and pain at rest, and then progress to ulcers and necrosis. Patients with severe lower limb vascular disease have a poor prognosis and often end up with lower limb amputation. It is known that if a dialysis patient's lower limb is amputated, their survival rate is low (for example, the five-year survival rate is 15%). Therefore, early detection and treatment of lower limb vascular disease is important.

[0004] Lower limb vascular lesions are detected as a screening test by checking symptoms and appearance and then conducting an ABI test. The Ankle Brachial Pressure Index (ABI) test calculates the ratio of the systolic blood pressure in the ankle and the upper arm (ankle systolic blood pressure / arm systolic blood pressure), and if this ratio is lower than a certain threshold, it is determined that there is a suspicion of a lower limb vascular lesion (see Non-Patent Document 1). For dialysis patients, foot care is performed at the dialysis facility, and screening tests are also performed. Patients who are determined to have a suspected lower limb vascular lesion in the screening test undergo further detailed tests, such as non-invasive tests (vascular ultrasound, magnetic resonance angiography) or invasive tests (CT with contrast agent, arteriography). [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] Atsuya Shimakura and Masanobu Takada, "Vascular Function Tests - CAVI, PMV, ABI," Journal of the Japanese Society of Internal Medicine, Vol. 102, No. 2, pp. 335-343, February 10, 2013 Summary of the Invention [Problem to be solved by the invention]

[0006] Although the ABI test, which is used as a screening test for lower limb vascular lesions, is a simple method, it has low sensitivity for detecting lesions and may not be able to detect lower limb vascular lesions early. There are other known testing techniques for lower limb vascular lesions besides the ABI test, but none of these are simple methods and are not suitable for use as a screening test.

[0007] The present invention has been made to solve the above problems, and aims to provide a lower limb vascular lesion evaluation device and a lower limb vascular lesion evaluation method that are simple, highly sensitive, and can be suitably used for early detection of lower limb vascular lesions. [Means for solving the problem]

[0008] The lower limb vascular lesion evaluation device of the present invention includes a measurement unit and an evaluation unit. In a first aspect, the measurement unit irradiates near-infrared light onto the sole of a subject, receives near-infrared light scattered or absorbed by tissues inside the sole, and measures the local oxygen saturation of the sole based on the intensity of the received light. The evaluation unit evaluates the lower limb vascular lesion of the subject based on the local oxygen saturation of the sole.

[0009] In a second aspect, the measurement unit irradiates near-infrared light onto the soles of the subject's feet, receives the near-infrared light scattered or absorbed by tissues inside the soles, and measures the local oxygen saturation of the soles based on the intensity of the received light, and also irradiates near-infrared light onto the subject's arms or head, receives the near-infrared light scattered or absorbed by tissues inside the arms or head, and measures the local oxygen saturation of the arms or head based on the intensity of the received light. The evaluation unit evaluates the lower limb vascular lesions of the subject based on the ratio or difference between the local oxygen saturation of the soles and the local oxygen saturation of the arms or head. do. In the second aspect, it is preferable that the measurement unit measures the local oxygen saturation level of the soles of the subject's feet and the local oxygen saturation level of the subject's arms or head during a common period.

[0010] A first aspect of the present invention provides a method for evaluating vascular lesions in lower extremities, comprising a measuring step and an evaluating step. In the measuring step, near-infrared light is irradiated onto the sole of a subject, and the near-infrared light scattered or absorbed by tissues within the sole is received, and the local oxygen saturation of the sole is measured based on the intensity of the received light. In the evaluating step, the local oxygen saturation of the sole is compared with a threshold value to obtain an index for evaluating vascular lesions in the lower extremities of the subject.

[0011] A second aspect of the present invention provides a method for evaluating vascular lesions in lower extremities, comprising a first measuring step, a second measuring step, and an evaluating step. In the first measuring step, near-infrared light is irradiated onto the sole of the subject, and the near-infrared light scattered or absorbed by tissues inside the sole is received, and the local oxygen saturation of the sole is measured based on the intensity of the received light. No. 2 In the measurement step, near-infrared light is irradiated onto the arm or head of the person being evaluated, and the near-infrared light scattered or absorbed by tissues inside the arm or head is received, and the local oxygen saturation of the arm or head is measured based on the intensity of the received light. In the evaluation step, an index for evaluating the vascular lesion in the lower limbs of the person being evaluated is obtained by comparing the ratio or difference between the local oxygen saturation of the sole and the local oxygen saturation of the arm or head with a threshold. In the second aspect, it is preferable that the first measurement step and the second measurement step are performed during a common period. [Effects of the Invention]

[0012] According to the present invention, vascular lesions in the lower limbs can be detected early, simply, and with high sensitivity. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a diagram showing the configuration of a lower limb vascular lesion evaluating apparatus 1A according to the first embodiment. [Figure 2] FIG. 2 is a diagram illustrating the probe 11. As shown in FIG. [Figure 3] FIG. 3 is a diagram showing the configuration of a lower limb vascular lesion evaluating apparatus 1B according to the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the description of the drawings, the same elements are designated by the same reference numerals, and duplicate explanations will be omitted. The present invention is not limited to these examples, but is defined by the claims, and is intended to include all modifications within the meaning and scope equivalent to the claims.

[0015] (First embodiment) FIG. 1 is a diagram showing the configuration of a lower limb vascular lesion evaluation device 1A according to a first embodiment. The lower limb vascular lesion evaluation device 1A includes a measurement unit 10A and an evaluation unit 20A. The measurement unit 10A measures the regional oxygen saturation of the sole 31 of the subject. The evaluation unit 20A evaluates the subject's lower limb vascular lesion based on the measured value of the regional oxygen saturation of the sole 31. The regional oxygen saturation (rSO2) indicates the proportion of oxygenated hemoglobin in total hemoglobin. rSO2 has a good correlation with blood flow.

[0016] The measurement unit 10A is used with a probe 11 attached to the sole 31 of the subject's foot and can measure the rSO2 of the sole 31 using near-infrared spectroscopy (NIRS). The main body of the measurement unit 10A and the probe 11 are electrically connected by a flexible cable. As shown in FIG. 2, the probe 11 includes an irradiation unit 13 and detection units 14 and 15, which are spaced apart from each other by a certain distance. The distance between the irradiation unit 13 and the detection unit 14 may be, for example, 30 mm, and the distance between the irradiation unit 13 and the detection unit 15 may be, for example, 40 mm. By setting these distances to appropriate values, tissue information deep within the sole 31 can be obtained. The main body of the measurement unit 10A instructs the irradiation unit 13 to emit light and receives detection results from the detection units 14 and 15.

[0017] The probe 11 irradiates the sole 31 with near-infrared light (preferably near-infrared light having multiple center wavelengths) from the irradiation unit 13. After the near-infrared light is scattered and absorbed by the tissues inside the sole 31, the detection units 14 and 15 receive the near-infrared light. The irradiation unit 13 includes a light source, such as a light-emitting diode, for outputting the near-infrared light and a drive circuit for driving the light source. The detection units 14 and 15 include an element, such as a photodiode, for receiving the near-infrared light and a circuit for outputting an electrical signal corresponding to the intensity of the light received by the element. The measurement unit 10A can measure the rSO2 of the tissues inside the sole 31 (tissue within a range of several centimeters from the surface) based on the light intensity detection results from the detection units 14 and 15. Note that near-infrared light refers to light having a center wavelength in the range of 700 nm to 2,500 nm.

[0018] The probe 11 may be configured to include an irradiation unit 13 and one detection unit, but is preferably configured to include an irradiation unit 13 and multiple detection units. When the probe 11 is configured to include multiple detection units, it can measure rSO2 at multiple locations on the sole 31. In this case, any one of the rSO2 measurements at each of the multiple locations may be used, or an average value may be used. Furthermore, if any of the rSO2 measurements at each of the multiple locations is determined to be abnormal, the abnormal value may be eliminated and the other measurement values ​​may be used.

[0019] The measurement unit 10A can easily measure plantar rSO2 non-invasively and continuously (or at very short time intervals). Devices capable of measuring rSO2 are commercially available from Hamamatsu Photonics K.K. and other companies.

[0020] Measurement of plantar rSO2 is preferably performed when the subject is at rest. If the plantar rSO2 measurement value fluctuates over time, it is preferable to perform the measurement over a fixed period (e.g., 1 minute), and the average value of the measurements over that fixed period is preferably used as the plantar rSO2 measurement value. Alternatively, the maximum, minimum, or median value of the measurements over that fixed period may be used as the plantar rSO2 measurement value.

[0021] The evaluation unit 20A evaluates the subject's lower limb vascular lesions based on the plantar rSO2 measurement values ​​obtained by the measurement unit 10A. Since rSO2 has a good correlation with blood flow, and a lower plantar rSO2 measurement value indicates poorer blood circulation in the tissues within the sole 31, the subject's lower limb vascular lesions can be detected early based on the plantar rSO2 measurement values.

[0022] The evaluation unit 20A may present an index for evaluating the subject's lower limb vascular lesion by comparing the plantar rSO2 measurement value with a threshold. Alternatively, multiple thresholds may be set and the plantar rSO2 measurement value may be compared with each threshold to present an index for evaluating the subject's lower limb vascular lesion in detail. By obtaining such an index, doctors and others can easily evaluate the likelihood that the subject has a lower limb vascular lesion.

[0023] The evaluation unit 20A includes a calculation unit that performs calculations including the above comparison, a memory unit that stores plantar rSO2 measurements, thresholds, evaluation results, etc., as well as required programs, an input unit that receives instructions such as to start measurement and to set measurement conditions, and a display unit that displays plantar rSO2 measurements and evaluation results, etc. The evaluation unit 20A can be configured as a computer, a tablet, or the like.

[0024] The display unit of the evaluation unit 20A preferably sequentially displays the results of plantar rSO2 measurements taken by the measurement unit 10A at each time during the measurement period, and preferably sequentially displays the average value of measurements taken over a certain period prior to that time. The display unit also preferably displays the results of a comparison between the plantar rSO2 measurement and a threshold value, thereby indicating the degree of the subject's lower limb vascular lesion. If the plantar rSO2 measurement is lower than the threshold value, the evaluation unit 20A preferably evaluates the subject as being in a state of disease worsening and displays this information on the display unit. If the plantar rSO2 measurement is equal to or higher than the threshold value, the evaluation unit 20A preferably evaluates the subject as being in a state of disease improvement or suspected disease maintenance and displays this information on the display unit.

[0025] The lower limb vascular lesion evaluation method of the first embodiment includes a measurement step and an evaluation step. In the measurement step, the plantar rSO2 of the evaluation subject is measured. The processing of the measurement step is performed using the measurement unit 10A. In the evaluation step, the lower limb vascular lesion of the evaluation subject is evaluated based on the plantar rSO2 measurement value. The processing of the evaluation step may be performed using the evaluation unit 20A, or a doctor or the like may perform the same processing content as that of the evaluation unit 20A.

[0026] Next, the results of measurements conducted by the present inventors to compare the detection sensitivity of lower limb vascular lesions using the evaluation methods of the Examples and Comparative Examples will be described. In the Examples, the plantar rSO2 of each evaluation subject (dialysis patient) was measured using the lower limb vascular lesion evaluation method of the present embodiment described above within one hour of the start of dialysis, one minute after the pulse wave stabilized in the supine position. The plantar rSO2 measurement was performed over one minute, and the average of the measurements over that one minute was used as the plantar rSO2 measurement value. In the Comparative Examples, the ratio of systolic blood pressure at the ankle and upper arm (ankle systolic blood pressure / arm systolic blood pressure) was measured for each evaluation subject using an ABI test in accordance with the ACC / AHA guidelines (guidelines of the American College of Cardiology and the American Heart Association).

[0027] For both the Examples and Comparative Examples, measurements were taken on each of 71 lower limbs of 36 dialysis patients (one of whom had a right lower limb amputation) as evaluation subjects. The lesion criterion was set as "occlusion of one or more below-knee arteries and no blood flow velocity in the dorsalis pedis artery." This lesion criterion serves as a guide for early detection of lower limb vascular lesions. As a result of lower limb arterial ultrasound examination, 12 of the 71 lower limbs met this lesion criterion.

[0028] For each of the examples and comparative examples, the detection sensitivity for these lesion criteria was analyzed by receiver operating characteristic (ROC) analysis to determine the cutoff value and AUC value. ROC (receiver operating characteristic) analysis is a statistical analysis method for analyzing the usefulness of a diagnostic method. In ROC analysis, the sensitivity and specificity when a specific cutoff value is set are plotted on the vertical and horizontal axes, respectively, and connected by a broken line to create a curve (ROC curve). The AUC value, which is quantified by the area under the curve (AUC), is closer to 1. The higher the discriminatory ability, the higher the discriminatory ability.

[0029] In the Comparative Example, the AUC value was 0.527 for a cutoff value of 0.74. In contrast, in the Example, the AUC value was 0.803 for a cutoff value of 33. These results demonstrate that the method for evaluating vascular lesions in the lower limbs according to this embodiment can detect lesions with higher sensitivity than ABI testing for early detection of vascular lesions in the lower limbs.

[0030] For each of the above evaluation subjects (71 lower limbs of 36 dialysis patients), the dorsum of the foot rSO2, calf ankle rSO2, and tibial ankle rSO2 were measured, and the detection sensitivity for the above lesion criteria was analyzed by ROC analysis to determine the cutoff value and AUC value. As a result, for the dorsum of the foot rSO2, the AUC value was 0.594 for a cutoff value of 25. For the calf ankle rSO2, the AUC value was 0.501 for a cutoff value of 37. For the tibial ankle rSO2, the AUC value was 0.684 for a cutoff value of 42. Although the plantar, dorsum of the foot, tibial ankle, and tibial ankle are all areas of the ankle and beyond, the lower limb vascular lesion evaluation method of this embodiment, which measures plantar rSO2, demonstrates high sensitivity and early detection of lesions compared to measurements of the dorsum of the foot rSO2, calf ankle rSO2, or tibial ankle rSO2.

[0031] The present inventors also treated dialysis patients using the Rheocarna (registered trademark) adsorption-type blood purifier manufactured by Kaneka Medix Corporation, and measured the plantar rSO2 of the dialysis patients during the treatment period using the lower limb vascular lesion evaluation method of the present embodiment to observe the changes in plantar rSO2 measurements over the course of treatment. Rheocarna is expected to improve peripheral arteriolar blood circulation by adsorbing LDL cholesterol (low-density lipoprotein cholesterol) through the action of dextran sulfate immobilized on cellulose beads and fibrinogen through the action of L-tryptophan. Continuous treatment with Rheocarna showed a tendency for lesions to improve visually, and plantar rSO2 measurements measured using the lower limb vascular lesion evaluation method of the present embodiment tended to gradually increase.

[0032] From the above, it can be seen that the lower limb vascular lesion evaluation device and lower limb vascular lesion evaluation method of this embodiment can easily and sensitively detect lower limb vascular lesions early, and can be suitably used as a screening test.

[0033] (Second embodiment) 3 is a diagram showing the configuration of a lower limb vascular lesion-evaluating device 1B according to the second embodiment. The lower limb vascular lesion-evaluating device 1B includes a measurement unit 10B and an evaluation unit 20B. The measurement unit 10B measures the rSO2 of the soles 31 of the evaluation subject 30 and also measures the rSO2 of the arms 32 of the evaluation subject 30. The evaluation unit 20B evaluates the lower limb vascular lesion of the evaluation subject 30 based on the rSO2 measured values ​​of the soles 31 and the arms 32.

[0034] Compared with the measurement unit 10A in the first embodiment, the measurement unit 10B in the second embodiment differs in that it measures the plantar rSO2 using a probe 11 provided on the sole 31 of the subject 30, and also measures the arm rSO2 using a probe 12 provided on the arm 32 of the subject 30. The probes 11 and 12 in the second embodiment have the same configuration as the probe 11 in the first embodiment.

[0035] Measurement of arm rSO2 is also preferably performed when the subject is at rest. If the arm rSO2 measurement value fluctuates over time, it is preferable to perform the measurement over a certain period (e.g., 1 minute), and the average value of the measurements over that period is preferably used as the arm rSO2 measurement value. Alternatively, the maximum, minimum, or median value of the measurements over that period may be used as the arm rSO2 measurement value.

[0036] Since rSO2 can be measured stably in muscle-containing areas of the arm, it is preferable to measure rSO2 on the outside of the upper arm, and it is also preferable to measure rSO2 on the forearm (especially the outside near the elbow).

[0037] The evaluation unit 20B evaluates the lower limb vascular lesion of the evaluation subject 30 based on the ratio or difference between the sole rSO2 measurement value and the arm rSO2 measurement value obtained by the measurement unit 10B. The sole rSO2 measurement value represents the degree of blood flow in the tissues in the soles 31, and the arm rSO2 measurement value represents the degree of blood flow in the tissues in the arms 32. As the lower limb vascular lesion progresses, the sole rSO2 measurement value decreases, whereas the arm rSO2 measurement value is thought to remain unchanged regardless of the degree of progression of the lower limb vascular lesion. Therefore, based on the ratio or difference between the sole rSO2 measurement value and the arm rSO2 measurement value, the lower limb vascular lesion of the evaluation subject 30 can be detected early and with high accuracy.

[0038] The evaluation unit 20B may present an index for evaluating the lower limb vascular lesion of the evaluation subject 30 by comparing the ratio or difference between the sole rSO2 measurement value and the arm rSO2 measurement value with a threshold value. Alternatively, multiple threshold values ​​may be set and the ratio or difference between the sole rSO2 measurement value and the arm rSO2 measurement value may be compared with each threshold value to present an index for detailed evaluation of the lower limb vascular lesion of the evaluation subject 30. By obtaining such an index, doctors and the like can easily evaluate the likelihood that the evaluation subject 30 has a lower limb vascular lesion.

[0039] The evaluation unit 20B includes a calculation unit that performs calculations including the above comparison, a memory unit that stores the sole rSO2 measurement values, arm rSO2 measurement values, the ratio or difference between them, threshold values, evaluation results, etc., as well as the required programs, an input unit that receives instructions such as to start measurement and the measurement conditions, and a display unit that displays the sole rSO2 measurement values, arm rSO2 measurement values, evaluation results, etc. The evaluation unit 20B can be configured as a computer, a tablet, etc.

[0040] The display unit of the evaluation unit 20B preferably sequentially displays the results of the plantar rSO2 and arm rSO2 measurements taken by the measurement unit 10B at each time during the measurement period, and preferably sequentially displays the average values ​​of each measurement over a certain period prior to that time. The display unit also preferably displays the results of a comparison between the ratio or difference between the plantar rSO2 measurement and the arm rSO2 measurement and a threshold value, thereby indicating the degree of the subject's lower limb vascular disease. If the ratio or difference between the plantar rSO2 measurement and the arm rSO2 measurement is lower than the threshold value, the evaluation unit 20B preferably evaluates the subject as being in a state of disease worsening and displays this information on the display unit. If the ratio or difference between the plantar rSO2 measurement and the arm rSO2 measurement is equal to or greater than the threshold value, the evaluation unit 20B preferably evaluates the subject as being in a state of disease improvement or suspected disease maintenance and displays this information on the display unit.

[0041] The lower limb vascular lesion evaluation method of the second embodiment includes a first measurement step, a second measurement step, and an evaluation step. In the first measurement step, the rSO2 of the sole 31 of the evaluation subject 30 is measured. In the second measurement step, the rSO2 of the arm 32 of the evaluation subject 30 is measured. The processing of the first measurement step and the second measurement step is performed using the measurement unit 10B. The first measurement step and the second measurement step may be performed in tandem, but are preferably performed during a common period. In the evaluation step, the lower limb vascular lesion of the evaluation subject 30 is evaluated based on the ratio or difference between the sole rSO2 measurement value and the arm rSO2 measurement value. The processing of the evaluation step may be performed using the evaluation unit 20B, or a doctor or the like may perform the same processing content as that of the evaluation unit 20B.

[0042] Generally, rSO2 measurements using NIRS are considered to have insufficient reproducibility. However, in this embodiment, lower limb vascular lesions can be evaluated based on the ratio or difference between sole rSO2 measurements and arm rSO2 measurements, enabling stable and highly accurate early detection of lower limb vascular lesions.

[0043] The measurement unit 10B may measure the rSO2 of the head (particularly the forehead) instead of the arm 32, and the evaluation unit 20B may evaluate the vascular lesions in the lower limbs of the subject based on the ratio or difference between the measured rSO2 values ​​for the soles of the feet and the measured rSO2 values ​​for the head. In this case, vascular lesions in the lower limbs can be detected early, stably, and with high accuracy. [Explanation of symbols]

[0044] 1A, 1B... lower limb vascular lesion evaluation device, 30... evaluation subject, 31... sole of foot, 32... arm, 10A, 10B... measurement unit, 11, 12... probe, 13... irradiation unit, 14, 15... detection unit, 20A, 20B... evaluation unit

Claims

1. a measuring unit that irradiates near-infrared light onto the sole of the subject's foot, receives the near-infrared light scattered or absorbed by tissues inside the sole, and measures the local oxygen saturation of the sole based on the intensity of the received light; an evaluation unit that evaluates a lower limb vascular lesion of the subject based on the local oxygen saturation of the sole; A lower limb vascular lesion evaluation device comprising:

2. a measuring unit that irradiates near-infrared light onto the soles of the subject's feet, receives the near-infrared light scattered or absorbed by tissues inside the soles, and measures the local oxygen saturation of the soles based on the intensity of the received light, and also irradiates near-infrared light onto the subject's arms or head, receives the near-infrared light scattered or absorbed by tissues inside the arms or head, and measures the local oxygen saturation of the arms or head based on the intensity of the received light; an evaluation unit that evaluates a lower limb vascular lesion of the subject based on the ratio or difference between the local oxygen saturation of the sole and the local oxygen saturation of the arm or the head; A lower limb vascular lesion evaluation device comprising:

3. the measurement unit measures the local oxygen saturation of the sole of the subject and the local oxygen saturation of the arm or the head of the subject during a common period. The lower limb vascular lesion evaluation device according to claim 2 .

4. a measuring step of irradiating near-infrared light onto the sole of the subject's foot, receiving the near-infrared light scattered or absorbed by tissues inside the sole, and measuring the local oxygen saturation of the sole based on the intensity of the received light; an evaluation step of comparing the local oxygen saturation of the sole with a threshold value and obtaining a result of the comparison as an index for evaluating a vascular lesion in the lower limb of the subject; A method for evaluating vascular lesions in the lower limbs.

5. a first measuring step of irradiating near-infrared light onto the sole of the subject's foot, receiving the near-infrared light scattered or absorbed by tissues inside the sole, and measuring the local oxygen saturation of the sole based on the intensity of the received light; a second measuring step of irradiating near-infrared light onto the arm or head of the subject, receiving the near-infrared light scattered or absorbed by tissues inside the arm or head, and measuring the local oxygen saturation of the arm or head based on the intensity of the received light; an evaluation step of comparing the ratio or difference between the local oxygen saturation of the sole and the local oxygen saturation of the arm or the head with a threshold, and obtaining the result of the comparison as an index for evaluating a vascular lesion in the lower limbs of the subject; A method for evaluating vascular lesions in the lower limbs.

6. the first measuring step and the second measuring step are performed during a common period of time; The method for evaluating vascular lesions in the lower limbs according to claim 5.

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