News Column

Patent Issued for Method and Device for Enhanced Blood Flow

July 2, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- A patent by the inventors Nachum, Zvi (Tiberias, IL); Brezel, Yaakov B. (Jerusalem, IL); Lampert, Shalom (Maalot, IL), filed on June 6, 2011, was published online on June 17, 2014, according to news reporting originating from Alexandria, Virginia, by VerticalNews correspondents.

Patent number 8755894 is assigned to Empire Bio-Medical Devices Inc. (Brooklyn, NY).

The following quote was obtained by the news editors from the background information supplied by the inventors: "The present invention relates to a method and device for promoting a localized change in the flow of blood through a blood vessel, and more particularly, to a non-invasive method and device for promoting a localized change in the flow of blood by electrically-induced contractual movement of muscular tissue.

"Current treatments for improving blood circulation and alleviating neural and muscle pain include manual, electrical, and mechanical methods. Manual treatment as practiced in physiotherapy requires massaging to be administered by qualified personnel. The efficacy of this personnel-intensive art varies with the experience and technique of the individual massage therapist, and therefore cannot be prescribed in an adequately standardized form. More importantly, the improvement in blood circulation is also of an extremely limited magnitude.

"Electrical Muscle Stimulation (EMS) has seen widespread use in many applications. The Food and Drug Administration (Section 355.200 Electrical Muscle Stimulators, CPG 7124.26) maintains that EMS devices are recognized in the health care community as being effective for muscle reeducation, relief of muscle spasm, increasing range of motion, disuse atrophy therapy, increased local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. It must be emphasized, however, that the stimulation provided by EMS is very similar to the stimulation achieved by therapeutic massage. Any increase in blood circulation is so modest that it is often undetectable using conventional flow-measuring equipment. EMS is a random excitation of a local tissue area. Hence, EMS methods, like therapeutic massage, hot-water treatments, etc. are incapable of providing a major increase in the localized flow of blood. Moreover, because the excitation is random, EMS methods are fundamentally incapable of providing a decrease in the localized flow of blood.

"Also known is a sequential pneumatic device for the reduction of an edema. The device consists of several overlapping compartments contained in a sleeve assembly. The compartments are inflated in a sequential fashion, from a distal end disposed adjacent to the edema, to a proximal end, such that the edema is pressed in the proximal direction. Each compartment is filled with air by a pump. The cycle starts with the filling of the distal compartment, and subsequently the remaining compartments are filled until all compartments are full. After a deflation period, the cycle is repeated.

"This and other treatments employ electromechanical installations in which electric motors and reciprocating mechanisms create uncomfortable noise and vibration. These treatments are of further disadvantage in that they require various device elements to be contacted with the skin. These elements generally cause discomfort to the patient, and require changing and cleaning after each use in order to ensure good sanitary conditions.

"U.S. Pat. No. 5,674,262 to Tumey teaches a device and method for stimulating blood flow velocity in a leg, in an effective and relatively painless manner, so as to prevent deep vein thrombosis. The device includes a mechanical compressing apparatus for compressing a foot so as to drive a substantial amount of blood from veins of the foot into blood vessels of the leg, and a second apparatus, operatively associated with the compressing apparatus, for electrically stimulating leg muscles as the driven blood from the foot passes therethrough. The resultant muscle activity enhances the blood flow velocity to the point where endothelial derived relaxing factor (EDRF) is produced, which dilates the blood vessel and enables a higher flowrate of blood to be delivered.

"Significantly, U.S. Pat. No. 5,674,262 teaches that electrical stimulation, in and of itself, is not efficacious for stimulating blood flow, and does not bring about EDRF production.

"U.S. patent application Ser. No. 10/451,334 to Nachum teaches treatment methods for promoting a localized increase in the flow of blood through a blood vessel in an area of the body. In these treatment methods, electrical impulses from the signal generator are applied to body tissue, by means of electrodes, so as to subject the adjacent muscular tissue to at least one voltage differential, thereby inducing a repeated, contracting movement of muscular tissue associated with the local blood vessels. This movement of muscular tissue produces a localized increase in the flow of blood through these blood vessels.

"In preferred embodiments, treatment is effected by placing the electrodes at opposite ends of the limb segment, and applying the electrical impulses so as to establish a voltage differential between the electrodes. The voltage differential is made up of two wave forms propagated in opposite directions between the electrodes.

"It would be highly advantageous to have, an improved, efficacious device and method for more efficiently promoting, upon demand, the localized circulation of blood through blood vessels. It would be of further advantage if the device and method would be simple, robust, non-invasive, repeatable, and adjustable to the individual needs of the patient."

In addition to the background information obtained for this patent, VerticalNews journalists also obtained the inventors' summary information for this patent: "According to the teachings of the present invention there is provided a non-invasive method for promoting a localized change in a flow of blood through a blood vessel in a limb segment of a body by a series of electrically stimulated contractions of muscle tissue in the limb segment, the method including the steps of: (a) providing a device including: (i) a plurality of electrodes including at least a first electrode, a second electrode, and a third electrode, each of the electrodes for operatively contacting the limb segment of the body; (ii) a signal generator, operatively connected to each electrode, for producing a series of electrical impulses to the limb segment via the plurality of electrodes, the signal generator for connecting to a power supply, and (iii) a control unit, associated with the signal generator, for controlling the signal generator so as to produce the series of electrical stimulation impulses, the impulses being of pre-determined voltage differential, form, and duration; (b) positioning the plurality of electrodes on the limb segment; applying at least one of the electrical impulses so as to induce a substantially radial contraction of a first portion of the muscular tissue in the limb segment; and (d) applying at least one of the electrical impulses so as to induce a substantially longitudinal contraction of a second portion of the muscular tissue in the limb segment, such that the muscular tissue acts upon the blood vessel to produce the localized change in the flow of blood through the limb segment.

"According to further features in the described preferred embodiments, the device further includes: (iv) a switching mechanism, responsive to the control unit, designed and configured for switching electrical connections between the signal generator and each of the electrodes, according to a pre-determined sequence.

"According to further features in the described preferred embodiments, the substantially radial contraction is induced by providing at least a first voltage differential between the first electrode and the second electrode, and wherein the substantially longitudinal contraction is induced by providing at least a second voltage differential between the second electrode and the third electrode.

"According to further features in the described preferred embodiments, the method further includes the step of: switching electrical connections, by means of the switching mechanism, between the signal generator and each of the electrodes, so as to deliver the series of electrical stimulation impulses.

"According to further features in the described preferred embodiments, the localized change is an increase in the flow of blood through the blood vessel.

"According to further features in the described preferred embodiments, the localized change is a decrease in the flow of blood through the blood vessel.

"According to further features in the described preferred embodiments, the series of electrical impulses includes a plurality of voltage differential peaks, each of the peaks having a duration of 80-1200 microseconds.

"According to further features in the described preferred embodiments, the series of electrical impulses includes a plurality of voltage differential peaks, each of the peaks having a duration of 100-600 microseconds.

"According to further features in the described preferred embodiments, the device further includes: (iv) a switching mechanism, responsive to the control unit, designed and configured for switching electrical connections between the signal generator and each of the electrodes, according to a pre-determined sequence, so as to deliver the series of electrical stimulation impulses by providing at least a first voltage differential between the first electrode and the second electrode, a second voltage differential between the second electrode and the third electrode, and a third voltage differential between the third electrode and another electrode of the plurality of electrodes.

"According to further features in the described preferred embodiments, steps and (d) are performed such that the longitudinal contraction is induced while the first portion of the muscular tissue remains at least partially contracted.

"According to still further features in the described preferred embodiments, the radial contraction is effected upstream of the longitudinal contraction.

"According to still further features in the described preferred embodiments, the method further includes the step of: (e) applying at least one of the electrical impulses so as to induce a second substantially radial contraction of a third portion of the muscular tissue in the limb segment.

"According to still further features in the described preferred embodiments, the second radial contraction is effected downstream of the longitudinal contraction.

"According to still further features in the described preferred embodiments, the 'another electrode', referred to hereinabove, is a fourth electrode of the plurality of electrodes.

"According to another aspect of the present invention there is provided a non-invasive device for promoting a localized increase or decrease in a flow of blood through a blood vessel in a limb segment of a body, the device including: (a) a plurality of electrodes including at least a first electrode, a second electrode, and a third electrode, each of the electrodes for operatively contacting the limb segment of the body; (b) a signal generator, operatively connected to each electrode, for providing a series of electrical impulses to the limb segment via the plurality of electrodes, the signal generator for connecting to a power supply; a control unit, associated with the signal generator, for controlling the signal generator so as to produce the series of electrical stimulation impulses, the impulses being of pre-determined voltage differential, form, and duration, and (d) a switching mechanism designed and configured for switching electrical connections between the signal generator and each of the electrodes, according to a pre-determined sequence, so as to provide a first voltage differential between the first electrode and the second electrode, a second voltage differential between the second electrode and the third electrode, and a third voltage differential between the third electrode and another electrode of the plurality of electrodes.

"According to further features in the described preferred embodiments, the control unit is designed and configured such that when the plurality of electrodes is disposed on the limb segment, the first, second and third voltage differentials promote a localized change in the flow of blood through the blood vessel.

"According to still further features in the described preferred embodiments, the switching mechanism is responsive to the control unit.

"According to still further features in the described preferred embodiments, the control unit and the switching mechanism are configured such that a frequency of the series of electrical stimulation impulses delivered to the electrodes is 1-30 periods per minute, and more preferably, 5-20 periods per minute.

"According to still further features in the described preferred embodiments, the signal generator and the control unit are designed and configured such that the series of electrical impulses has a cycle frequency in the range of 0.5-20 Hz, and more preferably, in the range of 6-15 Hz.

"According to still further features in the described preferred embodiments, the control unit is designed and configured such that when the plurality of electrodes is disposed on the limb segment, the first, second and third voltage differentials induce at least one substantially radial contraction of a first portion of the muscular tissue in the limb segment, at least partially followed by substantially longitudinal contraction of a second portion of the muscular tissue in the limb segment, so as to effect the localized change in the flow of blood through the blood vessel.

"According to yet another aspect of the present invention there is provided a non-invasive device for promoting a localized change in a flow of blood through a blood vessel in a limb segment of a body, the device including: (a) a plurality of electrodes including at least a first electrode, a second electrode, and a third electrode, each of the electrodes for operatively contacting the limb segment of the body; (b) a signal generator, operatively connected to each electrode, for providing a series of electrical impulses to the limb segment via the plurality of electrodes, the signal generator for connecting to a power supply; a control unit, associated with the signal generator, for controlling the signal generator to produce the series of electrical stimulation impulses, the impulses being of pre-determined voltage differential, form, and duration, wherein the control unit is designed and configured whereby, when the plurality of electrodes is disposed on the limb segment, the series of electrical stimulation impulses induces at least one substantially radial contraction of a first portion of the muscular tissue in the limb segment, the radial contraction at least partially followed by a substantially longitudinal contraction of a second portion of the muscular tissue in the limb segment, so as to effect the localized change in the flow of blood through the limb segment.

"According to yet another aspect of the present invention there is provided a non-invasive method for promoting a localized increase in a flow of blood through a blood vessel in a limb segment on a lower leg of a body of a subject by a series of electrically stimulated contractions of muscle tissue in the limb segment, the method including the steps of: (a) providing a device including: (i) at least a first electrode, a second electrode, and a third electrode, each of the electrodes adapted to operatively contact the limb segment; (ii) a signal generator, operatively connected to each electrode, adapted to produce a series of electrical impulses to the limb segment via the plurality of electrodes, the signal generator connecting to a power supply, and (iii) a control unit, associated with the signal generator, adapted to control the signal generator to produce the series of electrical impulses, the impulses being of pre-determined voltage differential, form, and duration; (b) positioning the plurality of electrodes on the limb segment, wherein the first electrode is positioned on a lower end of the lower leg, the second electrode is positioned on the lower leg, and the third electrode is positioned on an upper end of the lower leg, whereby the first electrode and the third electrode are disposed on opposite ends of the lower leg, and the second electrode and one of the first and third electrodes are disposed on a same end of the lower leg; effecting a sequence of muscular contractions of the lower leg, by operations including: (i) applying at least a first electrical impulse of the electrical impulses between the electrodes on the same end of the lower leg to induce a first muscular contraction of a first portion of the tissue in the lower leg; and (ii) applying at least a second electrical impulse of the electrical impulses between the first and third electrodes to induce a longitudinal muscular contraction of a second portion of the muscular tissue in the lower leg; and (d) repeating operations (i) and (ii), to repeatedly induce at least the first muscular contraction and the longitudinal muscular contraction, to effect the localized increase in the flow of blood.

"According to still further features in the described preferred embodiments, the frequency of a sequence including steps and (d) is 1-60 periods per minute (ppm), 2-60 ppm, 3-60 ppm, or 5-30 ppm.

"According to still further features in the described preferred embodiments, the device further includes: a compression unit, adapted to at least partially envelope the limb segment, said electrodes physically attached to the compression unit and at least partially disposed thereunder, the compression unit having an inside face adapted to deliver, to a surface of the limb segment, a superatmospheric pressure that is substantially constant over time, the pressure equaling at least 5 mmHg, at least 8 mmHg, at least 12 mmHg, or at least 16 mmHg.

"According to still further features in the described preferred embodiments, the method further includes the steps of positioning the compression unit on the limb segment, to at least partially cover the portions of the tissue, and exerting, on a surface of the limb segment, by means of the compression unit, a superatmospheric pressure that is substantially constant over time, the pressure equaling at least 5 mmHg, at least 8 mmHg, at least 12 mmHg, or at least 16 mmHg.

"According to still further features in the described preferred embodiments, the plurality of electrodes includes a fourth electrode, preferably positioned on an upper end of the lower leg.

"According to still further features in the described preferred embodiments, the sequence includes a muscular contraction of a third portion of the tissue in the lower leg, the contraction of the third portion of the tissue effected by applying at least one of the electrical impulses between the third electrode and the fourth electrode, positioned on an upper end of the lower leg.

"According to still further features in the described preferred embodiments, the repeating sequence of muscular contractions includes a second longitudinal contraction of a third portion of the tissue in the lower leg, the second longitudinal contraction of the third portion of the tissue effected by applying at least one of the electrical impulses between the fourth electrode and at least one electrode disposed on the lower end of the lower leg.

"According to still further features in the described preferred embodiments, the repeating sequence of muscular contractions includes a second longitudinal contraction of a fourth portion of the tissue in the lower leg, the second longitudinal contraction of the fourth portion of the tissue effected by applying at least one of the electrical impulses between the fourth electrode and at least one electrode disposed on the lower end of the lower leg.

"According to still further features in the described preferred embodiments, the device further includes a wound treatment assembly including a wound cover adapted to cover an area above a wound on the body, a sealing arrangement, associated with the cover, adapted to contact and at least partially seal a volume beneath the cover from an ambient environment, and a vacuum mechanism fluidly communicating with the volume, and adapted to produce a sub-atmospheric pressure between about 0.01 and 0.95 bar, absolute, within the volume; and a control unit, adapted to connect to a power supply and operatively connected to the wound treatment assembly and further adapted to control an operation of the treatment assembly.

"According to still further features in the described preferred embodiments, the method further includes the steps of disposing the wound cover over the wound; contacting the sealing arrangement with skin surrounding the wound; and activating the vacuum mechanism to produce the sub-atmospheric pressure within the volume.

"According to still further features in the described preferred embodiments, the method further includes the steps of providing the control unit with at least one of an ankle-brachial index (ABI) and an ankle blood pressure of the desired limb of the subject, and responsive to at least one of the ABI and the ankle blood pressure of the desired limb, controlling the apparatus, using the control unit, to treat the subject.

"According to still further features in the described preferred embodiments, when at least one of the ABI and the ankle blood pressure is below a pre-determined value, the control unit is configured to perform at least one safety operation.

"According to still further features in the described preferred embodiments, the method is effected on a subject having an ankle-brachial index (ABI) below 0.7.

"According to still further features in the described preferred embodiments, the electrical impulses of the series of electrical impulses are time-distinct impulses.

"According to still further features in the described preferred embodiments, at least the first electrical impulse is applied in a radial direction with respect to the lower leg.

"According to still further features in the described preferred embodiments, the first electrode is positioned above an ankle of the leg.

"According to still further features in the described preferred embodiments, the lower leg has a particular length, and the electrodes are positioned at opposite ends of the lower leg, whereby the longitudinal contraction is effected over substantially the particular length of the lower leg.

"According to still further features in the described preferred embodiments, the sub-atmospheric pressure within the volume is between 0.03 bar and 0.3 bar absolute, or between 0.05 and 0.25 bar absolute.

"According to still further features in the described preferred embodiments, the muscular contraction of the first portion of the tissue is effected upstream of the longitudinal contraction.

"According to still further features in the described preferred embodiments, the muscular contraction of the third portion of the tissue in the lower leg is effected downstream of the longitudinal contraction.

"According to still further features in the described preferred embodiments, the muscular contraction of the first portion of the tissue is effected downstream of the longitudinal contraction."

URL and more information on this patent, see: Nachum, Zvi; Brezel, Yaakov B.; Lampert, Shalom. Method and Device for Enhanced Blood Flow. U.S. Patent Number 8755894, filed June 6, 2011, and published online on June 17, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8755894.PN.&OS=PN/8755894RS=PN/8755894

Keywords for this news article include: Hematology, Venous Thrombosis, Risk and Prevention, Deep Vein Thrombosis, Empire Bio-Medical Devices Inc..

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Source: Journal of Engineering


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