GB2026322A - Apparatus for stimulating growth of damaged bone and soft tissue cells - Google Patents

Abstract

Apparatus for stimulating growth of damaged bone and soft tissue cells has a generator 12 producing an alternating current carrier treatment signal which is continuously amplitude modulated by more than 100% with an audio frequency signal, and the modulated signal is coupled by electrodes 14b, 16b to an area of a living body to be treated without surgical invasion. The electrodes may both be bare, or both insulated or one of each type. The carrier frequency may be 15 to 60 KHz and the modulating signal, which is continuously swept in frequency, may be in the range 100 to 4000 Hz. The greater than 100% modulation gives a pulsing characteristic so that the modulated signal has a triangular envelope and a 1 second or less pulsing cycle. The carrier frequency automatically changes as a function of body capacitance so that the electrode system maintains a series resonance with the body. The applied signal is apparently rectified so that a negative D.C. charge is developed at the treatment site to induce natural growth. <IMAGE>

Description

SPECIFICATION Apparatus for stimulating growth of dam aged bone and soft tissue cells This invention relates to apparatus useful for enhancing the recovery oftraumatized bone cartilage and tissue in the facial area caused either by injury, bone resorbtion as in peridontal pathology and trauma in those areas aris ing from, for example, dental surgery, an impact or blow to this area, or corrective or cosmetic surgery to the nasal area. More particularly, this invention relates to apparatus for the non-invasive treatment of these areas to induce more rapid recovery by reducing oedema initially derived from the trauma and reoccurring oedema, for example, arising after removal of fixation devices utilized for treat ment.

It is known that the regeneration of damaged bone and soft tissue occur naturally by the mitotic activity of periosteal and endosteal stem cells in the undamaged areas immediately adjacent the damaged area. At the time of damage, and before recovery takes place, either naturally or in induced fashion, the damaged area has an electrical potential which is positive. It is known, further, that once the natural regenerative action is underway, a highly negative potential is observed.

The invention here relates to apparatus for imposing in the damaged area a highly negative potential for inducing natural cell growth and for increasing and stimulating cellular activity in the damaged area for increasing the speed of the healing process. Specifically, the apparatus is adapted so that the traumatized area is energized with a pulsed electrical signal of the so-called "transdermal hearing system" type to develop the desired negative potential.

The signal is an amplitide modulated carrier, over modulated (that is, more than 100%) to achieve pulsing characteristics. The device of the invention includes two electrodes which are each capacitively coupled in non-invasive fashion to the body. The carrier signal is over modulated by audio frequencies within the range of between about 100 and 400 Hz. The pulsing treatments signal has a generally triangular envelope and a pulsing cycle on the order of one second or less. The application of the "transdermal" treatment signals (that is, signals of the type which have heretofore been applied transdermally to patients to enhance electrotherapeutically their ability to hear) results in the apparent rectification of the applied signal, and the development of a negative D.C. charge on the site of the desired regenerative activity.

The applied transdermal signal controls oedema to the extent that it will subside much more rapidly as compared to previous methods of fracture treatment, for example, and will reduce reoccurring oedema, as mentioned above. This control of reoccurring oedema is most important after dental surgery, for example, because the mandibular joint will become stiff and steadily stiffer, if healing does not take place rapidly, due to fibrinous serum soaking into the tissues, in a manner similar to ankle tissues. The imposed transdermal signal helps to elimiate this phenomenon because it increases the vasoconstriction activity on the surface of the tissue, increases the vaso dilatation activity in deeper muscles to cause an increase in blood flow, and polarizes dormant cells due to physiological depolarization during pathological processes.An electromagnetic exercise is imposed by the electromagnetic field imposed by the signal involved which causes every cell to behave or show piesoelectric characteristics. Also, there is peripheral neural regeneration due to the imposed signal which speeds along the above processes. Because of these imposed results due to the use of the apparatus of the invention here, there is a reduction in adhesion formation because the patient is not immobilized for a long period of time. Indeed, use of the present apparatus can eliminate many pathological problems and reduce normal healing time by 50%.

It has been found, in accordance herewith, that a specific comparatively small electrical potential is necessary for enhancing the normal healing time, as is discussed above. Indeed, the level of current necessary to produce a marked and significant mitotic response is within a range of approximately 2 and 20 milliamps. In this connection, the two electrodes of the present apparatus to be applied at the treated site will be either both bare, both coated with a dialectric covering, such as Mylar (Registered Trade Mark), for example, or one bare and one coated with Mylar. Mylar is polyethylene terephthalate, a polyester product of DuPont. The current to be generated with two bare electrodes will be in the range of 2-4 milliamps, with one bare and one coated 12-15 milliamps, and with both coated 18-20 milliamps. The carrier signal in the unit will be 35KHz.

The potential developed by the applied treatment signal simulates natural electrical phenomena, stimulates regenerative growth and perhaps more importantly in many cases, as disscussed above in relation to reduction of oedema, the developed potential at the sight of trauma tends to overcome inabilities of bone and soft tissue to otherwise generate adequate electrical potential to establish the requisite cellular base for satisfactory bone deposition and soft tissue healing. For example, in rebuilding an injured facial area in which the bone has been badly shattered it is customary to reposition the pieces much like pieces in a jigsaw puzzle. When viewing the completed fixation under a microscope, the fracture cites show only shattered bone and renewed tissue formation even after an extended period.Any increase in speed by which new bone cells develope reduces the constant problem of improper fixation caused by dislocation. Use of the apparatus of the invention can cause rapid deposition of bone in relation to the naturally occurring healing process.

In accordance with the present invention, the proper electrical potential is developed at the trauma site imparted thereto by providing means for capacitively coupling the output of a "transdermal bearing therapy" apparatus, for example, of the type described in greater detail in British Patent No. 1,248,799 which is hereby incorporated by reference. The treatment signal developed by this device comprises a carrier signal, normally of an audio frequency of approximately between 15 and 60 KHz, which carrier signal is more than 100% amplitude modulated with a continuously swept low frequency pure tone of approximately 100-400 HZ. The carrier signal changes its frequency as a function of body capacitance and is, therefore, changing automatically on a continuous basis so that the electrode system maintains a continuous series resonance at all times with the body.The selected treatment signal can be coupled to the traumatized area of the patient, for example, by placing the electrodes on opposite sides of the area to be treated, or otherwise positioning the electrodes adjacent the area to be treated.

The present invention will now be further described with reference to the accompanying drawings, in which: Figure 1 is a schematic representation of the head of a patient illustrating the positioning of electrodes for applying of a device of this invention for the treatment of a traumatized area in the maxillary and/or mandibular arch; and Figure 2 is a schematic illustration of the plcement of electrodes in accordance herewith for treatment of a traumatized area in the vicinity of the nose.

Referring to the drawings in which like numbers refer to like parts through out the two views thereof, the head 10 of a patient to be treated has fitted thereon electrodes 1 4b, 1 6b covering in a non-evasive manner and lying over, respectively, the maxillary and mandibular arches of the patient being treated. The electrodes 1 4b, 1 6b may be of a flexible metal or metallic cloth. Moreover, they may be bare metal or one or both may be enclosed in a dialectric coating such as Mylar, for example, as discussed above. The thick ness of the coating may be 1 mil. The elec 4 trodes 1 4b, 1 6b are shown fitted to the head and held in place by an elastic connection 22b.Electrode 1 4b is connected through a suitable conductor 18 to the output of a "transdermal hearing signal" generating source 12 of the type described in British Patent No. 1,248,799, while electrode 16b is connected in the same manner to source 12 by conductor 20. The applied treatment signal from source 12 is a carrier signal modulated by a swept low frequency audio tone, as discussed above.

In the illustration shown in Fig. 2, a nasal treatment device is shown with opposed electrodes 14, 16 applied to either side of a nose 26 of the patient 10. The electrodes 14, 16 are joined by a curved dialectric base 24, formed to the contour of the nose. An elastic band 22 or other arrangement is utilized to hold the electrodes in place by encircling the head. As with the illustration of Fig. 1, electrodes 14, 16 are joined through conductors 18, 20, respectively, to a source 12 for the treatment signal.

As discussed above, the electrodes, 16, 16 are comprised of a metallic conducting material which is sufficiently flexible or pliable to conform to the contours of the area to be treated.

In using the present device, the transdermal treatment signal is applied to healthy tissue adjacent the traumatized site to develope a highly negative potential at the trauma site through the applied signal, thereby causing stimulation of tissue cells, blood cells and an increase in blood flow and in turn causing them to manifest beneficial piezoelectric properties, thus causing a contraction and expansion of the living cells. Not only does such application reduce oedema and pain in the traumatized site, but also by this very reduction, the healing process takes place more rapidly. The applied negative potential enables the cells to experience more normal physiological behavior including their responses to oxygen affinity, enzyme and other nutritional necessities, along with a more balanced and improved sodium potassium exchange.

A A related and further useful application of the device of the invention relate to healing of soft tissue ulcers and to dental implants. In dental implant applications, the objective sought is the rapid deposition of new bone in the gaps between the dental implant and the internal walls of an empty tooth socket, or in a channel prepared for reception of an implant. The newly deposited bone, of course, secures the implant in place despite stresses of applied vertical and lateral forces present during chewing. Heretofore, dental implants have often been doomed to failure because these have caused inflamatory processes and ensuing breakdown in the bone surrounding the implant causing the implant to loosen.

In periodontal applications, a pyorrhetic condition is the formation of a purulent inflammation of the sockets of teeth, which usually leads, in turn to loosening and ultimately to loss. After correction by removal of depos its in the sockets, application of the "transdermal signal" of the invention here has the effect of reducing the mobility of the teeth in the sockets, thus lessening the possibility of loss.

With respect to orthodontia, the destruction of bone cells on one side of the teeth moved and the resulting empty area on the opposite side causes a substantial number of failures even after long application of braces. The application of the invention here reduces the time involved in which braces must be worn, and reduces the number of failures due to incomplete new bone formation adjacent the moved teeth.

With respect to Rhinoplastics, either for repair, córrection, or for cosmetic purposes, the reduction in oedema and pain at a very early stage is achieved, in accordance herewith.

The foregoing description of the practice of the device of the invention here is for illustration only rather than limitation. It will be apparent to those skilled in the art that the recited advantageous parameters apply to the specific treatment illustrated and may be varied without departing from the scope of the invention. For example, the apparatus may be adapted to generate a carrier signal in the range from 15 to 60KHz, and the modulating tones may range from 100 to 4,000 Hz. As will be appreciated, choice of values within these ranges depend upon several factors, including the type and size of the site being treated, the severity of the trauma and the general health of the patient, and advantageously the present apparatus is adapted to enable selection of desired specific values within the broader ranges mentioned. Of course, it should be noted that significant features of the device here is the capability for non-invasive application of treatment, that the electrodes utilized are each adapted to be capacitively coupled to the body and that the electrode system is adapted to continuously and automatically maintains a series resonance with the body.

Claims (8)

1. Apparatus for stimulating natural cellular growth and healing in bone and soft tissue without invasive entry into a body, comprising means for generating an alternating current carrier treatment signal; means for continuously modulating the amplitude of said signal over 100% with a low frequency audio signal; means for capacitively coupling said treatment signal to an area of a living body to be treated without surgical invasion; means for maintaining a series resonance with a body; and means for developing a negative charge in said maintaining means to stimulate normal cellular growth processes in said bone and soft tissue.

2. Apparatus according to Claim 1, wherein said carrier signal generating means is adapted to generate a carrier signal with a frequency of 45 KHz and the envelope of said signal has a pulsing interval of about one second.

3. Apparatus according to Claim 1 or Claim 2, wherein said low frequency audio signal is continuously swept and pulsed.

4. Apparatus according to any preceding claim, wherein said coupling means is adapted to generate current within the range of from 2 to 20 milliamps.

5. Apparatus according to any preceding claim, wherein said modulating means generates a low frequency audio signal with a frequency within the range of from 100 to 400 Hz.

6. Apparatus according to any preceding claim, wherein said coupling means comprise a a pair of flexible electrodes adapted to be placed over and in non-invasive contact with, the maxillary and mandibular arches, respectively, of a patent to be treated.

7. Apparatus according to any one of Claims 1-5, wherein said coupling means comprise a pair of electrodes adapted to be applied to either side of a nose of a patient to be treated and in non-invasive contact with the face.

8. Apparatus according to Claim 6 or Claim 7, wherein one or both of said electrodes is enclosed in a dielectric coating.