Dressing for tissue treatment

IS 2 372 166 T3

DESCRIPTION

Bandage for tissue treatment

Field of the invention

The present invention relates to a bandage for treating tissue, in particular the regeneration and repair of injured tissue by applying electrical current to the tissue via electrodes contained in the bandage. For example, the injured tissue can be skin and the injury can be a wound such as a laceration or incision. Alternatively, the injured tissue may be tendons or ligaments and the injury may be caused by overuse or misuse. Furthermore, the present invention relates to a control unit and a gel for use with the bandage. Furthermore, the present invention relates to a method of providing a bandage for treating injured tissue.

Background of the invention

Human or animal tissue is susceptible to many forms of injury. The injury can have many causes including: uncomplicated acute injury, complicated chronic injury, trauma, exercise-related trauma, and pathological injury.

An example of an uncomplicated acute injury is a surgical wound. Complicated chronic wound can include wounds such as diabetic and venous ulcers, bedsores, and burns. Trauma wounds can include lacerations, contusions, incisions, and blunt trauma such as gunshot injuries. Exercise-related trauma can occur to muscles, tendons, and ligaments as a result of overuse, misuse, and abuse. The pathological injury can lead to joint problems such as osteoarthritis and rheumatoid arthritis.

Injured tissue repair involves regeneration of tissue cells that occurs naturally as a result of repair mechanisms in the human or animal body. Often times, natural repair of injured tissue can be a lengthy procedure or does not occur at all as a result of the debilitating effects of infection or permanent injury to tissue repair mechanisms.

The time taken to repair injured tissue can lead to many related problems such as infection or reinfection of the injured tissue, prolonged pain, temporary or permanent disability, scarring, or cosmetic embarrassment for the injured person. For athletes and animals such as horses, tissue injury prevents participation in training or competitions.

Therefore, it is advantageous to provide a device for treating injured tissue that promotes faster tissue repair.

Bandages to promote tissue repair have been known for many years. These bandages are coated with substances that are absorbed into the injured tissue and actively stimulate cell regeneration and prevent infection. However, such dressings only provide a slight improvement in the speed of the healing procedure. In the case of severe trauma or large wound areas, such bandages can be useless and, in some cases, create further injury, for example by preventing oxygen from reaching the wound surface. In the case of muscle, ligament or tendon injury, such bandages have no therapeutic effect at all, except that they act as support for the injured area while repair occurs naturally.

In recent years, electrical treatment of injured tissue has become known as an effective procedure for treating injured tissue. This procedure involves supplying electrical current to a treatment area (that is, both directly to the external wound and to the surface of the skin near the injured tissue). The electrodes are attached to the treatment area and a current generating device is connected to the electrodes. Originally, these devices supplied current at a fixed amplitude ranging from 1 to 10 mA. It was found that supplying current via electrodes to the treatment area significantly improved the time required to repair the injured tissue. However, supplying current at such levels can cause discomfort to the user of the device. Thus, more recent developments have included supplying electrical current to the surface of a treatment area with a constant amplitude waveform that typically has an amplitude in the range of 10 to 800 pA. Electric current in this range is commonly known as "micro-current" and the electrical stimulation it produces cannot generally be detected by a user of the device. Some existing current generating devices for supplying current to electrodes attached to a treatment area are described in PCT Publication Nos. 00/02622, 01/03768, 98/23326 and 98/40121 and US Patent No. 5,395. 398. All current generating devices described in the aforementioned documents comprise a remote unit with attached electrodes. The electrodes should be attached to the treatment area, usually with tape. The wires connect the electrodes to the current generating unit that is remote from the treatment area. Treatment with such devices requires specialized knowledge of the operation of the device and the electrodes, including knowing where to locate the electrodes and how to connect them to the current generating device. This often requires

ES 2 372 166 T3 frequent visits to clinics by a user of the device. Also, there is the hassle of having to carry a separate power generating unit. Generally, the user has to remain immobile while the treatment is carried out.

PCT Publication No. 94/22529 describes an elastic shell with electrodes sewn in specific positions that can be worn by a user. When the housing is worn by a user, the electrodes are in the correct anatomical position for optimal treatment of the tissue to be treated. A current generating unit is attached to the housing by inserting it into a small pocket in the housing. The current generating unit is connected to the electrodes and supplies current to the electrodes with a waveform chosen by the user from several different waveforms using a control pad in the generating unit. Waveforms have constant amplitude and constant frequency.

A problem with the device of PCT Publication No. 94/22529 is that it is difficult to obtain good conductivity between the electrode and the treatment area. Since the electrodes are sewn into the housing, they are not necessarily properly attached to the treatment area even when the housing is worn correctly. The size and shape of the treatment area around which the carcass is worn can vary from user to user and even change shape or size over time. Additionally, the treatment area itself may change its physical condition as it is repaired. In particular, infection levels, temperature, and pH can vary over time. Therefore, a treatment program chosen for a particular patient when treatment is started may need to be varied as treatment progresses. Furthermore, it is evident that supplying alternating current with a simple waveform having constant amplitude and frequency is not necessarily the most efficient waveform for stimulating cell regeneration.

Accordingly, an objective of the present invention is to provide an improved device for treating injured tissue that increases the rate of cell regeneration.

Another objective of the present invention is to provide an improved device for treating injured tissue that integrates separate elements into a single device that can be easily applied to a treatment area by an unknowledgeable user and that has improved conductivity between the electrodes and the area of treatment.

It is still a further objective of the present invention to provide an improved device for treating injured tissue that integrates separate elements into a single device that can be easily applied to a treatment area by an unknowledgeable user and that tailors their treatment schedule according to the condition physics of the treatment area.

Summary of the invention

The present invention is explained in the appended claims.

According to the aforementioned objectives, in a first aspect, a bandage for treating injured tissue is provided, the bandage incorporating:

a pair of electrodes; and a conductive gel between the electrodes, such that, in use, an electrical current passes between the electrodes through the gel to repair injured tissue.

In one embodiment of the present invention, the bandage further incorporates a support for supporting a control unit, the support comprising means for connecting the control unit to the electrodes.

In another embodiment of the present invention, the bandage further incorporates a control unit connected to the electrodes.

The bandage has the advantage of being easily adjusted to the treatment area of ​​a human or animal body without requiring specialized assistance. The conductive gel provides a good electrical connection between the electrodes and a treatment area.

Preferably, the dressing further comprises pockets on the surface adapted to contain the gel, such that the gel is forced out of the pockets onto a treatment area when the dressing is applied to the treatment area.

Therefore, the gel is contained in the bandage before use and is automatically applied to the treatment area when the bandage bandages the body.

Preferably, the gel is a conductive hydropolymer that contains at least one type of a plurality of treatment molecules that are released when an electrical current from the electrodes passes through the gel.

IS 2 372 166 T3

The gel enters the wound or tissue surrounding the injured tissue to provide good electrical conductivity between the electrodes and the injured tissue. Activators in the gel enhance the regeneration of cells from the injured tissue. Activators can be oxygen molecules.

In one embodiment of the present invention, the bandage further comprises:

interlocking air pockets on the surface; and a valve linked to the air pockets, such that when the bandage is attached to a treatment area, the air supplied to the valve causes the pockets to expand and press the bandage against the treatment area.

Thus, the improved connection between the injured tissue and the electrodes is obtained by forcing the bandage against the treatment area by expanding the air pockets. In addition, the bandage conforms to the shape of the part of the body to which it is applied, thus making it comfortable to wear.

In a second aspect of the present invention a bandage is provided for treating injured tissue, the bandage incorporating:

a pair of electrodes;

a sensor for detecting an environmental parameter on the injured tissue, such that, in use, an electrical current passes between the electrodes through the gel to repair the injured tissue according to the detected parameter.

Preferably, the sensor is adapted to produce a signal indicative of the environmental parameter.

Therefore, specialized assistance is not required to fit a sensor to injured tissue. The electrical current delivered to the electrodes can be controlled according to different environmental conditions that can vary from patient to patient and change as injured tissue is repaired.

The environmental parameter can be one of oxygen, pH, bacterial infection, or temperature level.

Preferably, the connection means comprises:

a pair of contact electrodes on the holder; and a pair of wires incorporated into the substrate, each wire connecting one of the contact electrodes to one of the pair of electrodes.

The electrodes can be carbon fiber electrodes and can be formed from a plurality of secondary electrodes connected together.

In a third aspect of the present invention there is provided a control unit for use with the bandage comprising:

a casing;

electronic circuits in the housing;

output electrodes connected to electronic circuits.

Preferably, the electronic circuits comprise a memory that stores at least one program to determine the amplitude, frequency and waveform of the alternating current supplied to the output electrodes. The memory can be EEPROM which can be updated with different programs.

In one embodiment of the present invention, the control unit further comprises an I / O port connected to the electronic circuits, so that an external device can connect to the control unit via the I / O port and update the memory and control the control unit operation.

In another embodiment of the present invention, the control unit further comprises a wireless transceiver connected to the electronic circuits, so that an external device can wirelessly connect to the control unit via the I / O port and update the memory and control the operation. control unit. The wireless transceiver can communicate with an external device by infrared or radio communication.

Advantageously, the control unit can comprise:

a pair of activation electrodes; Y

ES 2 372 166 T3 a detachable tab that includes a metal strip connecting the trigger electrodes, in which the electronic circuits detect when a current can pass between the trigger electrodes and only supplies current to the output electrodes when the tab is remove so that no current passes between the activation electrodes. The reed is disposable. Thus, the control unit can easily be activated for single use.

In a fourth aspect of the present invention there is provided a device for treating injured tissue comprising:

a bandage to apply to a treatment area;

a pair of electrodes attached to a treatment surface of the bandage;

a conductive gel applied to a section of the treatment surface; and a control unit connected to the electrodes and adapted to pass electrical current to the treatment area via the electrodes.

In a fifth aspect of the present invention there is provided a device for treating injured tissue comprising:

a bandage to be applied to a treatment area;

a pair of electrodes attached to a treatment surface of the bandage;

a sensor attached to the dressing to detect an environmental parameter in the treatment area; and a control unit connected to the electrodes and to the sensor and adapted to pass electrical current to the treatment area through the electrodes according to the detected parameter.

Preferably, the control unit is attached to the bandage and the sensor is integrated into the control unit.

In a sixth aspect of the present invention there is provided a device for treating injured tissue comprising:

a bandage to be applied to a treatment area;

a pair of electrodes attached to a treatment surface of the bandage;

a control unit connected to the electrodes and adapted to pass alternating current to the treatment area via the electrodes, in which the control unit constantly varies the amplitude and frequency of the alternating current.

It has been found that constantly varying the amplitude and / or frequency of the alternating current provides an enhancement of tissue regeneration relative to previously known methods of electrical tissue stimulation.

Preferably, the alternating current is varied between 50 and 500 microamps. Additionally, the frequency of the alternating current can be varied between 10 and 900 Hertz. Furthermore, the time period between each amplitude and / or frequency variation can be 0.1 s. These parameters provide the fastest rate of tissue regeneration without the electrical stimulation being noticeable by a user of the device.

Preferably, the alternating current has a ramp waveform.

In one embodiment of the present invention, the control unit is etched into the substrate. Therefore, an integrated device including a control unit can be easily manufactured.

In an alternative embodiment of the present invention, the control unit comprises:

a casing;

electronic circuits in the housing;

output electrodes connected to electronic circuits; and a power supply in the housing connected to the electronic circuits.

In a seventh aspect of the present invention there is provided a gel for use in treating injured tissue comprising:

ES 2 372 166 T3 a conductive hydropolymer; and a plurality of treatment molecules configured to be released from the gel when an electrical current passes through the gel.

Brief description of the drawings

Specific embodiments of the invention are now described with reference to the following drawings in which:

Figure 1a is a planar cross-sectional view of a tissue treatment device according to a first embodiment of the present invention;

Figure 1b is a plan view of the device of Figure 1a;

Figure 2a is a perspective view of a bandage for treating injured tissue according to a second embodiment of the present invention;

Figure 2b is a front view of the dressing of Figure 2a prior to application;

Figure 3a is a side plan view of one embodiment of a control unit for use with the bandages of Figures 1a, 1b, 2a and 2b;

Figure 3b is a front plan view of the control unit of Figure 3a;

Figure 3c is a side plan view of the control unit of Figure 3a;

Figure 3d is a rear plan view of the control unit of Figure 3a;

Figure 4 is a plan view of an alternative embodiment of a control unit for use with the bandages of Figures 1a, 1b, 2a and 2b;

Figure 5 is a representation of the components of the control unit of Figures 3a, 3b, 3c, 3d and 4; and Figure 6 is a representation of the variation in amplitude and frequency output by the control units of Figures 3a, 3b, 3c and 5.

Detailed description of the drawings

The present invention will now be described with respect to a specific embodiment. Those skilled in the art will appreciate that the present invention can be implemented in a number of different applications and embodiments and is not specifically limited in its application to the particular embodiment described herein. In particular, the present invention will now be discussed in connection with the treatment of humans, although those of ordinary skill will recognize that the device could be modified for use in treating animals.

Figure 1a is a planar cross-sectional view of a device (100) for treating injured tissue according to a first embodiment of the present invention. Device 100 can be used in place of a conventional bandage and applied to an external tissue wound and attached to tissue using, for example, conventional adhesive or bandage.

The device (102) comprises a conventional bandage (102) that supports a pair of carbon fiber electrodes (104a, 104b) on a treatment surface (101). There is a conductive electrode gel (106a, 106b) on the electrode treatment surfaces (104a, 104b). The electrode gel (106a, 106b) melts at 35 ° C (that is, when applied to the surface of human tissue), thus releasing conductive gel on the surface of a treatment area to which the bandage (102 ) between the electrodes (104a, 104b) and the tissue. The conductive electrode gel (106a, 106b) ensures good electrical contact with the tissue.

The bandage (102) also comprises a tissue gel (108) and mesh material (112) fixed on the tissue gel (108). The mesh material (112) allows exudates from a wound to which the bandage is applied to absorb into the bandage (102) while allowing the tissue gel (108) to flow through it so that it can be absorbed by a wound being treated.

On a side opposite the treatment surface (101), a control unit (114) is attached to the bandage (102). The control unit (114) is connected to the electrodes (104a, 104b) by wires (116a, 116b). In operation, electrical current flows from a first electrode (104a) through the electrode gel (106a) through the tissue and electrode gel (106b) to the second electrode (104b). The control unit (114) will be described below in more detail with reference to Figures 3a, 3b, 3c and 4-6. However, it should be appreciated that when the control unit is permanently attached to the bandage (102) as shown shown in Figure 1a, this can be achieved by etching the control unit (114) directly onto the bandage (102). As a result, the size of device 100 can range from very small "microcapsules" equivalent to the size of a grain of rice to

ES 2 372 166 T3 a size that can cover large areas of human or animal tissue.

The tissue gel (108) is a conductive hydropolymer gel with chemical activators that release oxygen molecules when an electrical current flows through the tissue gel (108). The tissue gel (108) is absorbed by the wound being treated so that an electrical current can more easily pass through the wound. The oxygen molecules are absorbed by the tissue being treated and enhance the cell regeneration process, thus reducing the time required for the wound to heal.

Gel 108 is made up of two different types of constituent substances, each type being contained in a separate layer of matrix material. There are three layers of matrix material arranged side by side in a sandwich configuration. A common component of all layers is hydrocolloid particles with 70% water saturation. In addition, the intermediate layer contains 1000 mg / cm² of ascorbic acid and silver particles at 500 mg / cm². The middle layer is also saturated with 100% oxygen. All of the gel (108) that includes the matrix material is pH neutral.

The entire device (100) is designed to be disposable once it has been used. This may be when the treatment is over, when the dressing (102) needs to be replaced so that the wound can be examined or cleaned, or when a battery in the control unit (114) has been exhausted.

Figure 1b is a plan view of the device of Figure 1a.

Figure 2a is a perspective view of a dressing 200 for treating injured tissue according to a second embodiment of the present invention. Bandage 200 is in the form of an elastic cuff that can be used in place of a conventional elastic support. Bandage 200 can be applied to both an external tissue wound and a treatment area in which there is an internal injury to tendons, muscles, or ligaments.

The bandage (200) comprises a substrate (202) that is held in place over a treatment area on a body member (250) by velcro strips (204) attached to an outer surface (205) of the substrate (202 ). There is a support (206) in the form of a pocket formed on the outer surface of the substrate (202) to receive a control unit (114). Substrate (202) is formed from an elastic blend comprising 78% neoprene rubber, 20% stretched nylon, and 2% memoflex weave. The substrate (202) is formed to fit snugly and snugly around a particular part of the body. The part of the body shown in Figure 2a is the ankle of a human.

Figure 2b is a cross-sectional view of the dressing (200) of Figure 2a and shows the internal components of the dressing (200) on a treatment face of the substrate (202). Carbon fiber fabric electrodes (210a, 210b) are incorporated into a treatment surface (208) of the substrate (202). The tissue electrodes (210a, 210b) are connected by wires (211a, 211b) to the input electrodes (212a, 212b) on the holder (206). The input electrodes (212a, 212b) extend the full length of the holder (206) through one side of the pocket and are adapted to connect with corresponding output electrodes on an external surface of a control unit (114) ( see below).

Between the tissue electrodes (210a, 210b) and incorporated into the treatment surface (208) of the substrate (202) is a first region (215) of gel pockets (214). The pockets (214) are formed of cotton fabric on the treatment surface (208) of the substrate (202). The pockets contain tissue gel 108 as described above with reference to Figures 1a and 1b. The tissue gel (108) is forced out of the pockets (214) when the bandage (200) is taped tightly to the body. If the treatment area includes an external wound, then tissue gel 108 is absorbed into the wound area as described above with reference to Figures 1a and 1b. If the tissue injury is internal, then the tissue gel (108) can be adapted to be absorbed through the skin into the injured tissue to improve electrical conduction through the internally injured tissue.

The width of the first region (215) of the gel pockets (214) is substantially the same as the width of the tissue electrodes (210a, 210b) and in the embodiment shown in Figure 2b, this width is approximately 15mm . Thus, the entire first region (215) between tissue electrodes (210a, 210b) is a first region (215) of gel pockets (214). Therefore, the injured tissue should be located between the tissue electrodes (210a, 210b) so that electrical conductivity through the injured tissue is enhanced.

Extending along each side of the tissue electrodes (210a, 210b) and the first region (215) of the gel pockets (214) is a second region (217) of interlocking air pockets (218). The width of the second region is approximately 25mm. The air pockets (218) are interlocked so that the air inserted by a valve (219) at one end of the substrate (202) causes all the air pockets (218) to expand, thus forcing the tissue electrodes ( 210a, 210b) and to the gel pockets (214) against the treatment area of ​​the body around which the bandage (200) is attached.

Referring to Figures 3a, 3b, 3c and 3d there is shown an embodiment of a control unit (114) for use with the bandages of Figures 1a, 1b, 2a and 2b. In the embodiment shown in Figures 1a and 1b, the control unit is permanently attached to the bandage (100), while in Figures 2a and 2b the control unit (114)

ES 2 372 166 T3 is designed to be removable from the support (206). However, the control unit (114) can either be permanently integrated with the device (100) of Figures 1a and 1b or be removably integrated with the bandage (200) of Figures 2a and 2b. In either of these two embodiments, the control unit (114) functions in exactly the same way for both the device (100) and the bandage (200).

The control unit (112) comprises a housing (302) on which a bipolar power switch (304) is mounted. The housing contains electronic circuitry (not shown) and a power supply (not shown). The output electrodes (306a, 306b) connected to the electronic circuits are mounted on the housing (302). For the embodiment shown in Figures 2a and 2b, the position of the output electrodes (306a, 306b) corresponds to the position of the input electrodes (212a, 212b) mounted on the support (206) of the bandage (200) . For the device (100) of Figures 1a and 1b, the wires (116a, 116b) will be directly integrated into the electronic circuits.

One or more of the led indicators (308) are mounted on an upper portion of the housing (302) so that when the control unit (114) is inserted into the bracket (206) of Figures 2a and 2b, one or more of the LED indicators (308) protrude from the top of the support (308) so that they can be seen by a user of the bandage (200). A front surface of the control unit (114) has a tab (310) that is temporarily attached over two trigger electrodes (not shown). The tab (310) includes a metal strip that connects the two trigger electrodes when locked in place.

When the switch (304) is in an 'on' position, the led indicator (308) glows continuously and the power supply operates the electronic circuits, passing an electrical current through the metal strip. However, the electrical current does not exit through the output electrodes (306a, 306b) until the control unit (114) is activated by removing the tab (310) and the electronic circuits detect that no current is now passing between the two electrodes. activation.

Additionally, there is an opening in the housing (302) to an I / O port (312). The i / o port (312) is connected to the electronic circuits and allows an external device, such as a personal computer, to reprogram an EEPROM in the control unit (114). The EEPROM contains programs to supply current in a variety of different waveforms to tissue through the output electrodes (306a, 306b).

A sensor port (not shown) is mounted on the housing (302). A variety of different sensors can be connected to the sensor port. Electronic circuits can measure the output of a sensor connected to the sensor port and adjust the waveform of the electrical current that leaves the output electrodes (306a, 306b) depending on the value of the parameter that is measured by the sensor. Different types of sensor can be connected to the sensor port, with each type of sensor measuring one or more different parameters, for example, one or more oxygen, pH, bacterial infection, or temperature levels.

The control unit (114) in Figure 3c is shown in the bracket (206) of Figures 2a and 2b. There is a transparent cover (380) attached to the top of the bracket that functions to hold the control unit (114) in place on the bracket (206) and allow one or more of the led indicators (308) to be displayed. externally from the holder (206) by the user.

Figure 4 is a plan view of an alternative embodiment of a control unit for use with the bandages of Figures 1a, 1b, 2a and 2b. The casing (302) of the control unit (114) is made of plastic and is the size and shape of a conventional credit card (i.e. approximately 5mm thick, 85mm long and 52mm wide ). In this way, the control unit (114) is portable and can be carried, for example, by a user in their purse or wallet. At the front of the control unit (114) there is a power switch (304) and one or more led indicators (308) which have already been described above. There may also be a separate battery indicator (440) to show when the battery is low. The control unit (114) of Figure 4 is designed to be disposable after a treatment program has been completed.

Figure 5 is a representation of components (500) of the control unit of Figures 3a, 3b, 3c and 4. A microcontroller (502) is powered by a battery (504). The microcontroller generates current of variable amplitude and frequency and supplies it to the electrodes (306a, 306b) depending on the program that is selected by the switches (508). A plurality of switches (508) including the switch (304) allow interaction with the microcontroller (502) to determine if the device is on and what current program is being supplied to the electrodes (306a, 306b). The programs are stored in the EEPROM (506) which is bi-directionally connected to the microcontroller (502). Programs can be changed (that is, removed, updated, and edited) by interacting with an external device via the i / o port (312). A sensor port (514) allows one or more different sensors to be connected to the microcontroller (502) to provide feedback of external environmental parameters to determine the way the current is output to the electrodes (306a, 306b). The current output form will vary depending on the selected program and the detected parameter value.

Figure 6 is a representation of the alternating current waveform output by the units of

ES 2 372 166 T3 control of Figures 3a, 3b, 3c, 3d and 4. In experiments carried out by the Applicant it has been determined that the scanning program shown in the following Table 1 (that is, a program in which the amplitude and / or the frequency of the alternating current that is delivered to the injured tissue is varied) is the most effective in stimulating the regeneration of tissue cells and hence the repair of injured tissue. The program is programmed in the EEPROM (506) inside the control unit (114). As mentioned above, additional programs can also be programmed into the EEPROM (506) and selected using a multi-way switch (not shown) or other switches (508) on the control unit (114).

Table 1: Variation of current amplitude and frequency in a sweep program

<td>Stage</td><td>Amplitude I / pA</td><td>Frequency / Hertz</td><td>Stage</td><td>Amplitude I / pA</td><td>Frequency / Hertz</td>

<td> 1</td><td> 500</td><td> 900</td><td> 11</td><td> 50</td><td> 900</td>

<td> 2</td><td> 450</td><td> 800</td><td> 12</td><td> 100</td><td> 800</td>

<td> 3</td><td> 400</td><td> 700</td><td> 13</td><td> 150</td><td> 700</td>

<td> 4</td><td> 350</td><td> 600</td><td> 14</td><td> 200</td><td> 600</td>

<td> 5</td><td> 300</td><td> 500</td><td> 15</td><td> 250</td><td> 500</td>

<td> 6</td><td> 250</td><td> 400</td><td> 16</td><td> 300</td><td> 400</td>

<td> 7</td><td> 200</td><td> 300</td><td> 17</td><td> 350</td><td> 300</td>

<td> 8</td><td> 150</td><td> 200</td><td> 18</td><td> 400</td><td> 200</td>

<td> 9</td><td> 100</td><td> 100</td><td> 19</td><td> 450</td><td> 100</td>

<td> 10</td><td> 50</td><td> 10</td><td> 20</td><td> 500</td><td> 10</td>

The waveform of alternating current is a ramping waveform and the time period for each stage is 0.1 s. Optimal regeneration occurs by running the program for 30 minutes.

An alternative program that can also be programmed into control unit 114 is one that uses an alternating current of constant amplitude and frequency with a rectified waveform using positive polarity. With an amplitude of 40 pA and a frequency of 10 Hertz, this alternative program has been shown to provide optimal electrostimulation for fibroblast regeneration and collagen production.