NON-DRUG CARDIO-CEREBROVASCULAR DISEASE THERAPEUTIC APPARATUS
20230001225 · 2023-01-05
Assignee
Inventors
Cpc classification
A61N2/06
HUMAN NECESSITIES
International classification
A61N2/02
HUMAN NECESSITIES
A61N2/06
HUMAN NECESSITIES
Abstract
The present invention provides a non-drug cardio-cerebrovascular disease therapeutic apparatus. A waveform diagram of a pulse current for generating a pulse electromagnetic field includes four characteristic bands in a cycle range of 360° and reciprocates circularly: an abrupt-rising band T1 where a current intensity I(t) abruptly rises, wherein a highest value thereof is slightly lower than a maximum value Imax of an output current; a first slow-rising band T2 where the current intensity I(t) slowly rises to the maximum value Imax; an abrupt-decreasing band T3 where the current intensity I(t) abruptly decreases, wherein a minimum value Imin thereof is slightly higher than a minimum value (Imin) of the output current; and a slow-decreasing band T4 where the current intensity I(t) slowly decreases to the minimum value (Imin). The non-drug cardio-cerebrovascular disease therapeutic apparatus provided by the present invention can significantly improve and treat cardio-cerebrovascular diseases and achieve obvious effects.
Claims
1. A non-drug cardio-cerebrovascular disease therapeutic apparatus, comprising a power supply device, a pulse current generator connected with the power supply device to generate a pulse current, and a pulse magnetic field generator connected with the pulse current generator, wherein the pulse magnetic field generator comprises a magnetic head, the magnetic head comprises an electromagnet and a coil, and the coil is connected with the pulse current generator and receives the pulse current to generate a pulse electromagnetic field that may be applied to a patient, wherein a waveform diagram of the pulse current comprises four characteristic bands in a cycle range of 360° and reciprocates circularly: an abrupt-rising band T1 where a current intensity I(t) abruptly rises, wherein a highest value thereof is slightly lower than a maximum value Imax of an output current; a first slow-rising band T2 where the current intensity I(t) slowly rises to the maximum value Imax; an abrupt-decreasing band T3 where the current intensity I(t) abruptly decreases, wherein a minimum value Imin thereof is slightly higher than a minimum value (Imin) of the output current; and a slow-decreasing band T4 where the current intensity I(t) slowly decreases to the minimum value (Imin).
2. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 1, wherein a sequence of the pulse current in each cycle is T1, T2, T3 and T4.
3. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 2, wherein a waveform formula of the pulse current is:
4. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 3, wherein 0.01 second≤τ≤0.025 second.
5. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 3, wherein 0 mA≤I≤90 mA.
6. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 3, wherein 0.001≤Z≤0.003.
7. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 3, wherein z=0.002.
8. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 1, wherein in an implementation of the present invention, an electromagnetic wave generator applies the pulse electromagnetic field to Laogong acupoint of a left and right hand and/or Yongquan acupoint of left and right feet of the patient.
9. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 1, wherein the pulse current generator adopts an ARM processor.
10. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 1, wherein in an implementation of the present invention, the apparatus further comprises a D/A module which converts a waveform digital signal sent by an ARM processor into an analog pulse current signal so that the magnetic head generates the pulse electromagnetic field.
11. The non-drug cardio-cerebrovascular disease therapeutic apparatus according to claim 1, wherein the power supply device further comprises a current manager.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036] Descriptions corresponding to relevant English expressions in
DETAILED DESCRIPTION
[0037] The non-drug cardio-cerebrovascular disease therapeutic apparatus of the present invention will be described in details with reference to the accompanying drawings.
[0038] As shown in
[0039] As shown in
[0040] The pulse magnetic field generator 3 includes a module A/D (digital-to-analog converter) 31, a driving module 32 and the magnetic head 33. The module A/D 31 converts a waveform digital signal sent by the ARM processor into an analog pulse current signal and inputs the signal to the coil of the magnetic head 33 through the driving module 32 so that the electromagnet generates the pulse electromagnetic field. In the embodiment, a function of the driving module 32 is: enhancing analog waveform power output by ARM to meet the driving power requirement of the magnetic head.
[0041]
[0042] As shown in
[0043] an abrupt-rising band T1 where a current intensity I(t) abruptly rises, wherein a highest value after abrupt rising is slightly lower than a maximum value Imax of an output current;
[0044] then, a slow-rising band T2 where the current intensity I(t) slowly rises to the maximum value Imax;
[0045] then, an abrupt-decreasing band T3 where the current intensity I(t) abruptly decreases, wherein a minimum value after abrupt decreasing is slightly higher than a minimum value (Imin) of the output current; and
[0046] finally, a slow-decreasing band T2 where the current intensity I(t) slowly decreases to the minimum value (Imin).
[0047] As shown in
[0048] where:
[0049] z is a time factor, with a range of (0.001-0.003),
[0050] f=30 Hz,
[0051] t is a time range of 0-0.03333 second, and
[0052] I is the current intensity provided by the power supply device, and is 0-100 mA.
[0053] Specifically, in
[0054] In a preferred implementation of the present invention, 0.01 second≤τ≤0.025 second.
[0055] In a preferred implementation of the present invention, 0.001≤z≤0.003 (See
[0056] In a preferred implementation of the present invention, 0 mA≤I≤90 mA.
[0057] In an implementation of the present invention, an electromagnetic field generator applies the pulse electromagnetic field to Laogong acupoint of left and right hands and/or Yongquan acupoint of left and right feet of a patient.
[0058] In the embodiment, the maximum value Imax is about 1.3 volts, and the minimum value Imin is zero or close to zero.
[0059] The above pulse current is input to the coil of the magnetic head 33, and the electromagnet generates a corresponding pulse electromagnetic field which may be configured to electromagnetically treat acupoints of a human body, treat the patient's cardio-cerebrovascular disease or improve the patient's cardio-cerebrovascular function.
[0060] Referring to
[0061] Experimental Verification
[0062] I. Experimental Verification of a Non-Drug Cardio-Cerebrovascular Disease Therapeutic Apparatus Provided by the Present Invention
[0063] In the research process of the present invention, the applicant has also done a lot of experiments, comparing, analyzing and experimenting different pulse waveforms, and a pulse magnetic field generated by pulse current waveforms with the T1, T2, T3 and T4 characteristics of the present invention described above has a better therapeutic effect on cardiovascular diseases of a human body, and has an obvious therapeutic effect on the regeneration of human cells. Meanwhile, on this basis, through the following standard comparative experiments, further verification is achieved.
[0064] In a verification test, the applicant entrusted a well-known cardiovascular disease treatment hospital in China, the outpatient department of the Department of Cardiology, Fuwai Hospital of the Chinese Academy of Medical Sciences, to treat 13 patients with coronary microcirculation disorders who were in the hospital from August 2017 to December 2019 as research targets.
[0065] Inclusion criteria of the verification test: patients whose coronary angiography or coronary CTA showed 50-80% stenosis of anterior descending artery, circumflex artery, or main branch of right coronary artery and its first-level branches, and who did not undergo coronary intervention.
[0066] Exclusion criteria: patients with previous history of PCI, PTCA or CABG, myocardial bridge, cardiomyopathy, severe valvular heart disease, history of heart tumor, or congenital heart disease, or patients with ATP contraindications: patients with asthma, atrioventricular block, sinus syndrome, or sinus node insufficiency, or patients taking nicorandil.
[0067] A randomized double-blind controlled study was adopted. On the basis of taking anti-atherosclerosis drugs regularly, an old therapeutic apparatus (the applicant adopted the therapeutic apparatus produced by a WO 2012/048203 technology mentioned in the background art), the therapeutic apparatus of the present invention (with a therapeutic effect) and a comfort machine of the therapeutic apparatus of the present invention (a comfort machine without any therapeutic effect) are respectively used for an experiment group and a control group to be tested and studied. MFR before intervention with the old therapeutic apparatus and the therapeutic apparatus of the present invention (product code “R7”) and 3-6 months after the intervention was detected by nuclide, and the experimental procedure met the corresponding specifications.
[0068] 1. Treatment Method of Pulse Magnetic Field
[0069] A magnetic field emission part was aligned with Laogong acupoint area or Yongquan acupoint area of a subject. The pulse magnetic field was respectively applied to left and right Laogong acupoint areas once, respectively applied to left and right Yongquan acupoint areas once, and then respectively applied to left and right Laogong acupoint areas once, 8 min every time and 1 cycle every day. The course of treatment was 3-6 months.
[0070] 2. Efficacy Evaluation
[0071] At baseline and after 3 months or 6 months of treatment, the subjects were examined by SPECT-CT myocardial perfusion imaging, and the percentage of area of stress myocardial ischemia was recorded.
[0072] 3: Experimental Test Result
[0073] As shown in Table 1 below, experiment results of the 13 subjects (3 cases in old therapeutic apparatus experiment group: subjects 1-3; 7 cases in experiment group of the non-drug cardio-cerebrovascular disease therapeutic apparatus provided by the present invention: subjects 4-10; and 3 cases in control group: subjects 11-13) are as follows:
TABLE-US-00001 TABLE 1 Test Result Chart Percentage of Percentage of Reduced myocardial ischemia myocardial ischemia ischemia Subject before treatment after treatment percentage Subject 1 10.90% 8.46% 22.39% Subject 2 38.81% 31.95% 17.68% Subject 3 6.35% 5.69% 10.39% Subject 4 21.12% 0.76% 96.40% Subject 5 10.37% 0 .sup. 100% Subject 6 33.76% 8.88% 73.70% Subject 7 9.52% 0 .sup. 100% Subject 8 10.05% 2.06% 79.5% Subject 9 8.79% 2.21% 74.86% Subject 10 18.17% 10.11% 44.36% Subject 11 3.24% 12.32% −280.25% Subject 12 18.06% 35.84% −98.45% Subject 13 59.19% 98.51% −66.43%
[0074] As shown in
[0075] Specific experimental data and actual experimental test images of the above 13 subjects are as follows:
[0076] Subject 1
[0077] The percentage of myocardial ischemia before using the old therapeutic apparatus for treatment was 10.9%.
[0078] The percentage of myocardial ischemia after using the old therapeutic apparatus for treatment was 8.46%.
[0079] The myocardial ischemia was reduced by 22.39% using the old therapeutic apparatus for treatment compared with that before treatment.
[0080]
[0081]
[0082] Subject 2
[0083] The percentage of myocardial ischemia before using the old therapeutic apparatus for treatment was 38.81%.
[0084] The percentage of myocardial ischemia after using the old therapeutic apparatus for treatment was 31.95%.
[0085] The myocardial ischemia was reduced by 17.68% using the old therapeutic apparatus for treatment compared with that before treatment.
[0086]
[0087]
[0088] Subject 3
[0089] The percentage of myocardial ischemia before using the old therapeutic apparatus for treatment was 6.35%.
[0090] The percentage of myocardial ischemia after using the old therapeutic apparatus for treatment was 5.69%.
[0091] The myocardial ischemia was reduced by 10.39% using the old therapeutic apparatus for treatment compared with that before treatment.
[0092]
[0093]
[0094] Subject 4
[0095] The percentage of myocardial ischemia before using R7 for treatment was 21.12%.
[0096] The percentage of myocardial ischemia after using R7 for treatment was 0.76%.
[0097] The myocardial ischemia was reduced by 96.40% using R7 for treatment compared with that before treatment.
[0098]
[0099]
[0100] Subject 5
[0101] The percentage of myocardial ischemia before using R7 for treatment was 10.37%.
[0102] The percentage of myocardial ischemia after using R7 for treatment was 0.
[0103] The myocardial ischemia was reduced by 100% using R7 for treatment compared with that before treatment.
[0104]
[0105]
[0106] Subject 6
[0107] The percentage of myocardial ischemia before using R7 for treatment was 33.76%.
[0108] The percentage of myocardial ischemia after using R7 for treatment was 8.88%.
[0109] The myocardial ischemia was reduced by 73.70% using R7 for treatment compared with that before treatment.
[0110]
[0111]
[0112] Subject 7
[0113] The percentage of myocardial ischemia before using R7 for treatment was 9.52%.
[0114] The percentage of myocardial ischemia after using R7 for treatment was 0.
[0115] The myocardial ischemia was reduced by 100% using R7 for treatment compared with that before treatment.
[0116]
[0117]
[0118] Subject 8
[0119] The percentage of myocardial ischemia before using R7 for treatment was 10.05%.
[0120] The percentage of myocardial ischemia after using R7 for treatment was 2.06%.
[0121] The myocardial ischemia was reduced by 79.5% using R7 for treatment compared with that before treatment.
[0122]
[0123]
[0124] Subject 9
[0125] The percentage of myocardial ischemia before using R7 for treatment was 8.79%.
[0126] The percentage of myocardial ischemia after using R7 for treatment was 2.21%.
[0127] The myocardial ischemia was reduced by 74.86% using R7 for treatment compared with that before treatment.
[0128]
[0129]
[0130] Subject 10
[0131] The percentage of myocardial ischemia of the subject 10 before using R7 for treatment was 18.17%.
[0132] The percentage of myocardial ischemia after using R7 for treatment was 10.11%.
[0133] The myocardial ischemia was reduced by 44.36% using R7 for treatment compared with that before treatment.
[0134]
[0135]
[0136] Subject 11
[0137] The percentage of myocardial ischemia of the subject 11 before using R7 for treatment was 3.24%.
[0138] The percentage of myocardial ischemia after using R7 for treatment was 12.32%.
[0139] The myocardial ischemia was increased by 280.25% using R7 for treatment compared with that before treatment.
[0140]
[0141]
[0142] Subject 12
[0143] The percentage of myocardial ischemia before using R7 for treatment was 18.06%.
[0144] The percentage of myocardial ischemia after using R7 for treatment was 35.84%.
[0145] The myocardial ischemia was increased by 98.45% using R7 for treatment compared with that before treatment.
[0146]
[0147]
[0148] Subject 13
[0149] The percentage of myocardial ischemia before using R7 for treatment was 59.19%.
[0150] The percentage of myocardial ischemia after using R7 for treatment was 98.51%.
[0151] The myocardial ischemia was increased by 66.43% using R7 for treatment compared with that before treatment.
[0152]
[0153]
[0154] Experiment Conclusion:
[0155] This shows that through comparison of the experimental test data above, the non-drug cardio-cerebrovascular disease therapeutic apparatus provided by the present invention can significantly improve myocardial ischemia of the patients with coronary heart disease and effectively restore blood perfusion. Current medical methods are limited in blood perfusion for restoring myocardial blood supply, and the technology has become a new technology for high-efficiency intervention of cardiovascular diseases.
[0156] Similarly, the applicant also discovered through research that, by using the non-drug cardio-cerebrovascular disease therapeutic apparatus provided by the present invention, through magnetic field action on human blood vessels especially acupoint accessories with rich effects and rich blood flow according to the characteristics of the pulse waveform disclosed and limited by the present invention, regeneration treatment of human cells can be significantly improved and significant effects are achieved. Compared with the prior art, the present invention realizes essential improvements in the patients with coronary heart disease and myocardial ischemia, and can be widely used for treating or improving symptoms of overall cardio-cerebrovascular diseases.
[0157] II. Comparative Experimental Verification of the Non-Drug Cardio-Cerebrovascular Disease Therapeutic Apparatus Provided by the Present Invention and the Prior Art (WO 2012/048203)
[0158] The technology disclosed by the prior art (WO 2012/048203) is a product of a previous generation (“old product”). After the old product, the applicant carried out continuous research and development according to users' using effect, and through continuous tests and comparisons, obtained the non-drug cardio-cerebrovascular disease therapeutic apparatus of the present invention (product code “R7”) which achieves a better effect in treating cardio-cerebrovascular diseases.
[0159] Angina is a common symptom of cardio-cerebrovascular diseases. Therefore, in the comparison experiment of effects of cardio-cerebrovascular therapeutic apparatuses, the “Seattle Angina Questionnaire” in Table 2 below is often used to test the subjects' indicators so as to compare instrument therapeutic effects of the two test subjects:
TABLE-US-00002 TABLE 2 SAQ-7 Seattle Angina Questionnaire 1. Below is a list of activities that people often do in a week. Although for some people with multiple diseases, it is difficult to define what limits them, please carefully check the activities listed below and explain how much you were limited due to chest pain, chest tightness, or angina in the past 4 weeks. Limit for Severe Moderate Mild Slight other Activity limit limit limit limit No limit reasons a. Walking on indoor flat 1 point 2 points 3 points 4 points 5 points 6 points ground b. Gardening, vacuuming 1 point 2 points 3 points 4 points 5 points 6 points or carrying groceries c. Lifting or moving 1 point 2 points 3 points 4 points 5 points 6 points heavy objects (such as furniture, a child) 2. In the past four weeks, how many times on average did you have chest pain, chest tightness, or angina? I had chest pain, chest tightness, or angina . . . 4 times or 3 times or more None in more on a 1-3 times on every week, but 1-2 times 1 time for the past daily basis a daily basis not every day every week 1 week 4 weeks 1 point 2 points 3 points 4 points 5 points 6 points 3. In the past four weeks, how many times on average did you have to take nitroglycerin tablets for chest pain, chest tightness, or angina? I took nitroglycerin tablets . . . 4 times or 3 times or more None in more on a 1-3 times on every week, but 1-2 times 1 time for the past daily basis a daily basis not every day every week 1 week 4 weeks 1 point 2 points 3 points 4 points 5 points 6 points 4. In the past four weeks, to what extent did chest pain, chest tightness, or angina affect your enjoying life? Severe limit Moderate limit Mild limit Slight limit No limit 1 point 2 points 3 points 4 points 5 points 5. If you have to live the rest of your life with your current chest pain, chest tightness or angina, what would you think? Absolutely Frequently Slightly Mostly Highly unsatisfied unsatisfied satisfied satisfied satisfied 1 point 2 points 3 points 4 points 5 points
[0160] The applicant adopted item 2 in Table 2 above, used the “old therapeutic apparatus” in the prior art to conduct follow-up tests on 6 patients (test subjects) for 6 months, and obtained experiment data in Table 4 based on scores in Table 3.
TABLE-US-00003 TABLE 3 Comparison of Effects on Coronary Heart Disease between the Therapeutic Apparatus and the Old Therapeutic Apparatus Using “Angina stable state” Scores in the Seattle Angina Questionnaire as Basis In the past four weeks, how many times on average did you have chest pain, chest tightness, or angina? I had chest pain, chest tightness, or angina . . . 4 times or 3 times or more None in more on a 1-3 times on every week, but 1-2 times 1 time for the past daily basis a daily basis not every day every week 1 week 4 weeks 1 point 2 points 3 points 4 points 5 points 6 points
TABLE-US-00004 TABLE 4 Scoring of Subjects after 6 Months (Experiment Data) Old therapeutic apparatus Patient Before use After use Improvement Zhang XX 3 3 0 Wang XX 4 5 1 Wang XX 3 4 1 Li XX 3 4 1 Wu XX 1 3 2 Gao XX 1 2 1 Average improvement 1 New therapeutic apparatus Patient Before use After use Improvement Tang XX 3 6 3 Huang XX 2 6 4 Wang XX 4 6 2 Gao XX 2 6 4 Wu XX 1 4 4 Wang XX 2 6 4 Zhao XX 1 6 5 Average improvement 4.3
[0161] (The test results show that the subjects using the new therapeutic apparatus of the present invention achieve much better effect than those using the old therapeutic apparatus)
[0162] Experimental analysis data shows that: most of the improvement effect indicators are “1”, and the best is “2” which is very few. Follow-up tests were conducted on 7 patients (part of the test subjects are the same) using the therapeutic apparatus of the present invention for 6 months, and the experiment data in Table 4 was obtained. It shows that most of the improvement effect indicators are “4”, the worst is “2” and the best is “5”.
[0163] Therefore, based on the comparison of technical effects between the therapeutic apparatus of the present invention and the prior art (WO2012/048203) (the original “old therapeutic apparatus” of the applicant) according to the experiment data in Table 4, it is easy for those skilled in the art to see that the technical effect achieved by the non-drug cardio-cerebrovascular disease therapeutic apparatus of the present invention is particularly significant.
[0164] Especially, for the non-drug cardio-cerebrovascular disease therapeutic apparatus provided by the present invention, the overall waveform characteristics of a pulse current waveform composed of the above waveform characteristics T1, T2, T3 and T4 are quite different from waveforms of existing magnetic field therapeutic apparatuses (including WO2012/048203), especially in the introduction of the waveform characteristics T3 and T4. Compared with waveform characteristics of the prior art, the non-drug cardio-cerebrovascular disease therapeutic apparatus has particularly significant technical characteristics and therefore achieves a significant technical effect.
[0165] The foregoing displays and describes basic principles, main features, and advantages of the present invention. A person skilled in the art may understand that the present invention is not limited to the foregoing embodiments. Descriptions in the embodiments and this specification merely illustrate the principles of the present invention. Various modifications and improvements are made in the present invention without departing from the spirit and the scope of the present invention, and such modifications and improvements shall fall within the protection scope of the present invention. The protection scope of the present invention is defined by the appended claims.