Low Frequency Ultrasound Herb Skin Permeation Device

OPERATION GUIDE

Injecting Herbal Medicine with Acoustics-not Needles For Clinic Using

        Patent No.00241525.9

Summary

The Herb Skin Permeation Device is an instrument promoting transdermal medication by physical method. It can make the medicine permeate through the skin, reach sick tissue or organ directly, quantitatively and with a controllable rapidity, even into the blood stream, and perform the local treatment or systematic treatment, so it is called the third generation administration method. It integrates the techniques of electropration, ultrasonography and ion-introduction, and has the combinative effect of the techniques. It has the advantages: 

1. More rapid administration, it can transport the medicine directly to the sick region, and form a effective concentration rapidly at the sick tissue. 

2. It can be metabolized more economically by the body, thereby lowering down the dosage and promoting the efficacy.

3. It prevents the side or toxic effect on the whole body.

4. Stable and lasting efficacy, twice or three time longer than oral administration.

5. Broad applicability, it can apply to chemical drug, high molecular biological medicine and the TCM high molecular colloid granules, and prove to be most applicable to local high concentration medication at deep tissue.

Applicability

The instrument can make the permeable medicine infiltrate the skin into the body and perform its therapeutic effect by the electropration and the introducing effect of ultrasonic and electric pulse.

Mechanism

1.     Establishment of artificial channel for medicine infiltrating

In order to make the medicine components permeate the skin to the sick tissue, the barrier problem of skin, plasma membrane and tissue membrane must be overcame.

① Electropration will puncture the skin tissue by the current pulses to cause the ordered array of lipid particles in plasma membrane and tissue membrane, and the artificial channel will be formed with the removal of the barriers. 

② Ultrasonography will cause the formation of the small vesicles in tissue, which are speeding up in collision causing the enlargement of the intercellular space in the horny layer, prickle-cell layer and tissue cells and the formation of dense pores with the largest diameter of 25um. Also, it will stabilize the pores formed by the electropration and enlarge them to 280um diameter. 

③ The pretreatment of horny layer, including applications of hydrated agent, remover and osmotic promoter will overcome the transdermal barrier effect of the horny layer. All these techniques are applied to establish the artificial channel for medicine osmosis, ensuring the transportation of high molecular components and even the colloid granules.

2.     Activating the Medicine Particles and Oriented Driving

The ultrasonic can attenuate in tissue to produce heat transformation, which leads to increasing of the local temperature and the activation of the medicine particles. The ultrasonic-caused radiation pressure and convection can drive the medicine to achieve oriented transportation. And the ion-introduction technique based on the principle that the charged granules are forced directly in the electric field, generates a specific electric field between the medicine, the skin and the tissue, which can increase the appulsion of the medicine particles, activate them with more energy and orient them with the micro current.

3.     Generalization of many promotion of permeation

Including the biological method, pharmaceutical method, the physical method and the electrochemical method, the medicine is transported into the tissue in many ways, which can increase the medicine osmosis rapidity by dozens of times to hundreds of times. The transportation of the effective components via the plasma membrane can also be improved to promote the efficacy. The regulation of pore formation, operating range, ultrasonic intensity and operating time, can achieve oriented, positioning and rapidity-controllable programmable targeting administration.

System Components

The instrument is comprised by the mainframe, therapeutic terminal, and the gel button.

Functional Parameters

1. Electropration Pulse

1.1 The electropration pulse is comprised by 5 square waves with the duty ratio of 1:1. The pulse width is 0.2 s, and its error is less than ±10%.

1.2 The peak value of the pulse spans 8 bands: band 0: 0 V; band 1: 16V; band 2: 31V; band 3: 45V; band 4: 50V; band 5: 68V; band 6: 80V; band 7: 87V. Its error is less than ±10%. The electropration pulse should be outputted first in the therapeutic approach.

2. Iontophoresis Pulse

2.1 The basal wave of the conductance pulse is the square wave of 2,000 Hz, its error is less than ±5%.

2.2 Several halfsinusoid pulses with the period of 10 ms comprise a wave group, of which the frequency spans 7 bands: band 0: 0.5 Hz; band 1: 1 Hz; band 2: 2 Hz; band 3: 3 Hz; band 4: 4 Hz; band 5: 5 Hz; band 6: 6 Hz. The error of the frequency is less than ±5%.

2.3 The intensity of the Iontophoresis is decided by the halfsinusoid number of wave groups: band 1: 1; band 2: 2; band 3: 3; band 4: 4; band 5: 5; band 6: 6; band 7: 7; band 8: 8; band 9: 9; band 10: 10.

3. Ultrasonic

3.1 The driving frequency of the ultrasonic is constantly 1 MHZ, the allowable error should be less than ±2%, the driving peak voltage is 100 V_P-P, its allowable error should be less than ±10%.

3.2 The ultrasonic output is a interval output, whose frequency is: band 0: 0.5 Hz; band 1: 1 Hz; band 2: 2 Hz; band 3: 3 Hz; band 4: 4 Hz; band 5: 5 Hz; band 6: 6 Hz, the error is less than ±5%.

3.3 The period of the ultrasonic output spans: band 0: no output; band 1: 20 ms; band 2: 40 ms; band 3: 60 ms; band 4: 80 ms; band 5: 100 ms; band 6: 120 ms; band 7: 140 ms; band 8: 160 ms; band 9: whole output, the error is less than ±5%.

3.4 The effected area by the ultrasonic radiation is 3.14 cm², the allowable error should be less than ±5%, the area is unfocused and Doppler circular radiation plane.

3.5 The effective output power of the ultrasonic is 1.5 W, the allowable error is less than ±20%.

4 The therapeutic time spans 

From 5 min～60 min, the step size is 1 min, the error of setting time is less than ±5%.

Environmental Conditions

1. Environmental temperature: 5℃～40℃

2. Relative humidity: ≤80%

3. Power supply: AC 220 V±22 V, 50±1 Hz

System Installation

• Unpack the package, take out the instrument, check whether it was broken and whether it is intact.

• Check whether the components are intact.

• The instrument must be lain on the horizontal railing desk or pushcart.

• Plug the power line to the power input on the back of the instrument. 

• Plug the therapeutic terminal to the output, and tighten the screws.

Regulation and Manipulation

Parameter displaying—There are labeled the IP, SP, output frequency, therapeutic time and EP on the instrument panel, whose values are displayed below respectively.

Key—The parameter regulation can be inputted by 4 keys, which are: model, start, ▲ and ▼.

Choosing Position—Choose the flat and untouched positions close to the sick region.

Skin Preparation—The skin within the treatment region should be neat, dry, and intact, without injury, the superficial sweat, grease and dirt should be cleared and wiped up.

Setting Patch—Take two patches, remove the cover on the convexity, set the patch with the convexity to the concaved of the terminal and press tightly around it.

Setting Gel Button—Remove the cover on the concave of the patch, set the two gel buttons to the concave of the patch.

Setting Medicine—Inject 2-2.5 ml of the prepared the solution, oil or emulsion of the medicine into the two gel buttons.

Immobilization—Paste the patch and its therapeutic terminal to the skin of sick region.

Immobilization of therapeutic terminal—Use elastic belt or others to tighten the two therapeutic terminals.

Turing on the Power—Turn on the power on-off on the back of the instrument (with 1 and 0 indicating on and off respectively).

Parameter Regulation—The displayed values after turning on the power are parameter defaults, if you need to regulate them where there is a new situation, you can alter the parameter value according to the program below:

1)     Press the model to shift the curser to the parameter that need to regulate.

2)     Press the ▲ or▼ key to set the parameter to a certain value.

Starting Therapy—Press the start key to start therapy, with short prompting sound and counter-clocking time.

Polarity Inversion—There is a polarity inversion every 5 minutes in therapeutic procedure with prompting sound.

Malfunctions—If there is a consecutive alert sound in the therapeutic procedure, you should modify the indicated replacement of the therapeutic terminal, loosening or bad-touching immediately.

End Prompt—There will be a consecutive prompt sound and automatic shutdown when therapy is over, and the instrument will be restored to waiting condition.

Pause—You can press stop to pause therapy and press start to continue it.

Resetting Parameters—Press the start for over 5 seconds, the parameter will be restored to the default value and can be reset.

Finish Manipulation—Take away the therapeutic terminal when it finished, then remain the patch or remove it.

Dealing with Malfunction and Maintaining

• There is no display after turning on power.

1. See if the plug is tightened, tighten it if loosened or change the electrical outlet.

2. Check the fuse, change it if melted.

3. Contact the specialized maintenance man.

• There comes a continuing alert in the therapeutic approach.

1. See if the therapeutic terminal falls off or is loosened, reset it and immobilize it.

2. See if the patch is well-placed, replace it correctly.

3. See if the electrode of the therapeutic terminal is dirty or oxidated, wipe it up if it is.

4. Contact the specialized maintenance man.

• It is guaranteed to repair for 2 year, you must stop using it if there is a malfunction when using it ordinarily, please contact the maintenance man of the manufacturer if you can’t solve it according to the method above, so as to treat it in time.

Attentions for Maintaining and Using

• Checking

1. The operator should do it every day before using it or after maintaining.

2. See if the instrument is damaged, if it is placed stably.

3. See if the power line and output line are intact, if the plug and the outlet are tightened.

4. See if the electrode of the therapeutic terminal is damaged or dirty.

5. See if screen displays normally after turning on the power, if the parameters are set normally.

6. See if there is sound prompting to work after pressing the start, if it begins counter-clocking.

7. See if the prompt sound disappears when you hold the electrode of the therapeutic terminal with your palms.

8. You should use it if there is any abnormality against the items above.

• Maintaining

1. Keep the electrode of the therapeutic terminal clean, from being dirty, you can wipe it up with cloth or soft paper if there is any dirt.

2. Don’t wipe with sand paper, don’t wash it with water to prevent it from damaging components.

3. Please check the instrument after maintaining according to that before you use it.

4. You need not to pull out the plug of the power line and output line, you can place the therapeutic terminal on the instrument and cover it with cloth.

5. Place the instrument properly, prevent it from collision or falling, keep it away from fire, water and any insecurity.

• Attentions

1. The users should be the specialized personnel of the medical units.

2. The user must be trained or learn the instruction carefully.

3. The user must manipulate it strictly according to the operating program.

4. The patch should be set well, or the therapeutic terminal and the patch, the patch and you skin will be bad-touched, which could cause a stronger current and scorch you skin.

5. You should not use it beyond the temporal limitation proscribed in the instruction. The conformation to heat caused by ultrasonic attenuation could preserve heat and scorch your skin.

6. You should not use unsafe power supply, which could do harm.

7. You should not use the improper patch, or it will be bad-touched and do harm.

8. You should not place the patch or anything instead directly on the electrode of the therapeutic terminal and start treatment, or it will injure the therapeutic terminal and do harm.

9. The instruction should be duplicated and be put on records in the department of equipment.

10. The unskilled and untrained are not allowed to use.

11. The therapeutic terminal should be tightened with belt, or it will be bad-touched and do harm.

12. Shocking the same point with electricity could cause skin reaction, you should avoid it.

Valid Period

• The fuse is located on the back of the instrument, you should change it according to the rated type and rated current.

• The rated working hours of the Sono-transducer in the therapeutic terminal are 800 hours, and the output will be unstable beyond it, you should contact the manufacturer to change it in time.

Changing Component

• It is valid for 10 years, and should be abandoned after the valid period.  

Low Frequency Ultrasound Herb Skin Permeation Device  

Reference

Part 1

The Comparison between Passive Diffusion and Forced Transportation of the Transdermal Administration

 

	Passive Diffusion	Forced Transportation
Types	Patch, Ion-introduction	Laser millipore Ultrasonography Electropration
Artificial Channel	No	Yes
Oriented Transport	No	Yes
Pharmacokinetics	Enter blood stream via capillary vessel	Directly to targeting tissue
Deepness	Under skin	Deep tissue
Applicability	High-activity micro molecular ionic medicine	Almost no limitation

Part 2

Parameter Regulation Reference for different age spans (Table 1)

 

Age	IP	SP	HZ	T	EP
Infant  4-12 m	2	1	1	15 minutes	2
Infant 1-3 y	3	2	1-2	20 minutes	3
School-before age 3-7 y	4	3	2	25 minutes	4
School age 7-14 y	5	4	3	30 minutes	4
Adult	5	4	3	30 minutes	5

** Choose the whole output alteration on the back of the instrument if adult, and the half output alteration if child younger than 12 years. 

Parts 3

Indications and Contraindications 

A. Indications

Pediatrics

Orthopedics: intervertebral disk herniation, cervical spondylosis, chronic osteomyelitis, ankylosing spondylitis, aseptic necrosis of femoral head, arthritis, acute closed parenchyma trauma, chronic parenchyma trauma, prevention from osteofascial syndrome, healing after vertebral column surgery and etc.  

Oncology: local chemotherapy of solid tumor, enhancing radiosensitivity, enhancing thermosensitivity, synergy of hypothermia therapy, cancer acesodyne, cancer infection, prevention from leucopenia after chemotherapy or radiotherapy and etc.

Gynecology and Obstetrics: pelvic inflammation, adnexitis, endometritis, endometriosis, oophoritic cyst, inflammatory sterility, postpartum retention of urine and etc.

Internal Medicine: respiratory infection, chronic colitis, ulcer, nephritis, nephropathy, rheumatism, hypertension, diabetes and etc.

General surgery: mastopathy, cholecystitis, acute or chronic appendicitis, angitis, coelom abscess and etc.

Urology: acute or chronic prostatitis, spermatocystitis, prostatic hyperplasia and etc.

Infectious Diseases: viral hepatitis, hepatocirrhosis, intractable tuberculosis and etc.

Otorhinolaryngology: acute faucitis, nasosinusitis and etc.

**Attention: According to the indication’s specificity of the local medications, the advantageous ones should be chosen.

B. Contraindications

It is not suitable to injured skin region, the patients with cardiac pacemaker, artificial bracket, artificial valve and the patients with serious cardiac failure and breath failure should not use it, and the pregnant women and the newborns should use it cautiously.

Part 4   

Recommended Positions for Therapy (Table 2)

Part 5

⑴ Recommended Medicine: It is suitable to different transdermal medicines, including chemical drug, biological product, TCM effective components. For the medicine’s form, there are ordered solution, oil, suspension, emulsion and aquiform gel with their infiltrative rate decreasing.

Medicine Suitable To Transdermal Delivery (Table 3)

⑵ Recommender Medicines for Different Departments

Gel button types applied to paediatrics and recommended medicines (Table 4)

* If skin-tuberculosis is needed, you should check whether the result is (-).

Gel button types applied to Otorhinolaryngology (Table 5)

* If skin-tuberculosis is needed, you should check whether the result is (-).

Gel button types applied to oncology and recommended medicines (Table 6)

* If skin-tuberculosis is needed, you should check whether the result is (-).

Gel button types applied to gynecology and obstetrics and recommended medicines (Table 7)

* If skintuberculosis is needed, you should check whether the result is (-).

Gel button types applied to internal medicine and recommended medicines (Table 8)

* If skintuberculosis is needed, you should check whether the result is (-).

Gel button types applied to orthopedics and recommended medicines (Table 9)

* If skintuberculosis is needed, you should check whether the result is (-).

Gel button types applied to surgery and recommended medicines (Table 10)

* If skintuberculosis is needed, you should check whether the result is (-).

Memo: There are recommended some example medicines in these tables, physicians should adopt them according different diseases and different conditions.