WO2020000080A1

WO2020000080A1 - System to prevent and treat the bends and blockages of blood flows

Info

Publication number: WO2020000080A1
Application number: PCT/CA2019/000100
Authority: WO
Inventors: John D. Unsworth
Original assignee: Unsworth John D
Priority date: 2018-06-29
Filing date: 2019-06-28
Publication date: 2020-01-02

Abstract

A system for preventing and treating the bends and blockages of blood flow, such as heart attacks and ischemic strokes. The system comprises the application of ultrasound, with cooling of the affected body area, to break up and reduce in size gas bubbles, blood clots and incipient blood clots in the cardiovascular and interstitial tissues of the body. Simultaneous drug administration may be performed as well, wherein the drugs comprise those that enlarge the walls of blood delivery lumens in the body, those that thin the blood and those that down regulate the immune system.

Description

Patent Application of John D. Uns worth System to Prevent and Treat the Bends and Blockages of Blood Flows

BACKGROUND OF THE INVENTION

Field of the Invention

The field of the invention is the treatment of a medical condition know n as the bends and blockages of blood flows

Description of Prior Art

The bends is a condition suffered mainly by divers that remain for too long at depth causing the effusion of gasses from bodily fluids when they return to the surface too quickly.

The emphasis on the treatment of the bends has been to re-pressurize the stricken diver in a hyperbaric chamber. This has the effect of reducing the size of the bubbles and increasing the rate at which the liberated gases re-fuse into the said bodily fluids.

The difficulty with the present method is that the hyperbaric chamber is not always available in a timely manner. Also, the hyperbaric chamber is very expensive, and requires the attendance of trained technicians and often medical practitioners. What is needed is a system which is portable and inexpensive and can be placed on any dive boat.

It is also important to note that the bubbles themselves in addition to immediately blocking and slowing bodily fluid transport also initiate a thrombotic cascade, which does most of the damage. Therefore, the bends should be more accurately

characterized as“systemic thrombosis".

The systemic thrombosis results in the body cells becoming compromised due to lack of proper blood and fluid flow, and this often results in apoptosis and necrosis; however, many cells, which while compromised, are still viable and would recover, if not for the immune response.

The blockage of blood flow due to thrombosis is also present in heart attacks and ischemic strokes, and the invention herein described is applicable to these occurrences and within the ambit of the invention Although bubbles are not present in these conditions, the drags . their delivery as well as the ultrasonic transducer 4 contained within or on the mattress 1, would all be efficacious and be within the ambit of the invention.

Description of the Invention

What is needed is a system that will reduce the size of the bubbles without a hyperbaric chamber, to prevent and reverse the thrombotic cascade and blood clotting, and finally to dampen the immune response. In the case of heart atacks and ischemic strokes, the following drags would also be efficacious.

The invention is a system which includes a compound drag comprised of the following drugs, which together have a synergistic effect, although some preferred embodiments do not contain all three of the drugs, and thus the synergistic effect is somewhat compromised; and are within the ambit of the invention:

1. Blood thinner/and or clot buster dragfs). These drugs are well known to the art and many different drugs of this type may be used singly or in combination with one another. For example. Warfarin 5 to 10 mg. (marketed as Coumadin by Brystol-Myers Squib). But drags of this type such as aspirin may be utilized and all are within the ambit of the invention. 2. Phosphodiesterase type 5 inhibitor (PDE5 inhibitor Drug(s) to increase blood flow such as Cia!is. eg 50 mg, (Eli Lilly and Company, or Viagra equivalent, Pfizer Inc. There are many drugs that have a similar effect and are well known to the art and any and all, alone or in combination with each other are within the ambit of the invention, including angiotensin II receptor blockers (ARBs).

3. An anti-inflammation, Immuno!-suppression drug, such as methylprcdnisone (Medrol by Pfizer Inc. ). Methylprcdnisone is the Standard of Care drug for acute paralysis (i.e.. 4 mg for first 8 hours following injury to the spinal cord). This class of drugs dampens the immune response and reduces necrosis and apoptosis, which in many cases causes most of the damage to the central nervous system This preferred embodiment of the invention would include ant-rejection drugs which have similar clinical effects.

The preferred delivery system for this combination of drugs is by sublingual and transmucosal transport. For example, the QuickStrip™, produced by Rapid Dose Therapeutics Inc. located in Burlington, Ontario, Canada, which places the drugs on a polymer strip which is in intimate contact with the dermis in the mouth and allows for quick transport of the drugs into the blood stream. One preferred embodiment of the invention includes a line which is connected to the strip and which allows for removal and control of the placement of the strip, even while the patient is unconscious or having a seizure, so as to avoid clogging the patient^’s airwave.

Other delivery systems, such as pills, patches and nasal sprays or hypodermic needles can also be utilized to deliver the drugs to the subject and all are within the ambit of the invention.

Tn the preferred embodiment of the system, the ice pack may include one or more transducers that emit ultrasound at a frequency which causes the bubbles present in the bodily fluids to break into smaller bubbles, thereby enhancing the natural mobility of the bodily fluids in the body, thus allowing normal nutrient and material transport, and reducing thrombosis. These transducers arc well known to the art. For example, while not relating to the bends or blood flow', a study conducted by T.K. .Tagannathan, R. Nagarajan and K. Ramamurthi, of the Particle Science Laboratory, Department of Chemical Engineering, Indian Institute of Technology, Madras, Chennai 600036, India, tilted:“Effect Of Ultrasound On Bubble Breakup Within The Mixing Chamber Of An Effervescent. Atomizer'’, demonstrated that 20kHz ultrasound transformed bubbles of initial size in the range of 5-10 mm were shown to get disintegrated into clusters of micron and sub-micron sized bubbles. The optimal frequency and amplitude produced by the transducer is the subject of further study but this study noted above, illustrates that a preferred embodiment of the invention comprised of a mattress, containing one or more ultrasonic transducers placed against or in contact with the body, will

significantly reduce bubble size, and possibly clots, reducing blood sequestration, blockage and attendant thrombosis, thereby mimicking the effects of a hyperbaric chamber. This in some preferred embodiments, in combination with cooling, will significantly enhance blood flow and cell viability. The advantage of such a system which may include the application of the type of drags described above, is that this invention is relatively inexpensive, portable and can be applied immediately upon the onset of the bends, or in those circumstances where one could anticipate the immanent onset of the bends, especially where a hyperbaric chamber may be hours or days away.

Some preferred embodiments of the invention include calf and planter muscle electric stimulators and mechanical squeezing devices to increase blood flow' in the lower extremities, and all are well known to the art. This adjuvant therapy, will increase blood flow while the subject is immobilized on the mattress 1.

Brief Description of the Drawings

Fig. I is perspective view that illustrates the mattress 1 with ultrasonic transducer 4. Fig. 2 is a perspective view of the strip upon which is layered a coating of drug(s) for sublingual and/or transmucosa! delivery.

Fig. 3 is perspective views of the cooling means which utilize the cooling effect of the release of pressure of gas contained in a tank, such as a scuba tank. Fig. 3 achieves this with a heat exchanger, which is immersed in the liquid material in the mattress, and the working gas is allowed to escape into the atmosphere through an outlet valve or orifice.

Detailed Description of the Drawings

Fig. 1 which is a perspective view, illustrates a mattress 1, having a water tight sea) 2 connecting the top surface 2a and the bottom surface (not shown for diagrammatical clarity) of mattress 1. The bottom surface 2b of the said mattress 1 is illustrated on Fig. la. The said mattress 1 has a water tight zipper 3 or other convenient means of access to the interior of the mattress to fill and empty its contents, which may include ice 5 and water or other liquid Sa, as illustrated in cross-section Fig, la. The ultrasonic transducer 4, is connected by wire 4a to a controller 4b, which controls the output of the said ultrasonic transducer 4, which may include amplitude, and frequency control, and may also include programmed routines, which optimize the application of the ultrasonic output of transducer 4; for example, on-off cycles.

Although the said ultrasonic transducer 4 is connected by wire 4a to the said controller 4b. it should he understood that this connection can be wireless and still remain within the ambit of the invention. It should also be understood that the mattress 1 can be any convenient size or shape and may in fact be incorporated into a vest, a pair of pants or any other garment; and although Fig. 1 illustrates only one ultrasonic transducer 4, some preferred embodiments have any number of them. Fig. 1 illustrates the ultrasonic transducer on the inner surface of the said top surface 2a, the said ultrasonic transducer(s) may be located on the inner surface of bottom surface 2b, or any other convenient location; and all are within the ambit of the invention. Fig. la illustrates a cross-sectional view lb, of said mattress 1, along the line l_.a as shown on Fig. ] The ultrasonic transducer 4 in this preferred embodiment is located on the inner surface of the top surface 2a, which brings its output in intimate contact with the selected part of the body of the subject which is lying on the mattress 1, or in contact with the mattress. Fig. la also illustrates the ice 5 and water or other liquid 5a, which may be contained within the mattress 1. It is to be understood that the said mattress 1. might not contain any material at all and rely solely on the ultrasonic transducer 4 for therapeutic effect, or may contain materials that are commonly found in pre-coolcd icepacks. Also, some preferred embodiments include active means of cooling such as is found in refrigerators, all well known to the art. All such embodiments described above are within the ambit of the invention.

Fig 2. is a perspective view of the strip 6 upon which is layered a coating of drug(s) for sublingual and/or transmucosal delivery and includes a line 7 which can be used to control and remove the said strip from the subject’s mouth. Said strip may contain one or any combination of drags as described above.

Fig. 3 is a perspective view' of the mattress 1, which contains a tank 8, which contains a compressed gas, such as a scuba tank which cools the medium within the mattress such as water or other liquid 5a, when the compressed gas is returned to at or near atmospheric pressure ln this embodiment illustrated .in Fig. 3, the gas in the tank 8 is delivered through valve 9 to a flexible hose 10 and thence to a pressure control valve 11, which may incorporate a thermocouple and thermal control means, well known to the art, which regulates the flow of gas to maintain a prescribed temperature of the said water or other liquid 5a. Said pressure control valve 11 then releases the pressure of the gas. allowing it to expand and flow' into the heat exchanger 12, which is made of a suitable thermally conductj-ve material, well known to the art and which in turn cools the w'ater or other liquid 5a. The said gas 14 then exits of mattress 1, by means of an orifice or control valve 13, into the atmosphere While a number of preferred embodiments for the invention have been described, each having certain elements, it is to be understood that other preferred embodiments can incorporate any number or combination of these elements and come within the ambit of this invention.

While the present invention has been described in conjunction with preferred embodiments, it is to be understood that modifications and variations may be resorted to without departing from the spirit and scope of the invention as those skilled in the art will readily understand. Such modifications and variations are considered to be within the purview and scope of the inventions and appended claims.

Claims

1.

A system to reduce bodily damage due to the bends and blockages of blood flow, by breaking up and thereby reducing the size of gas bubbles, incipient blood clots and blood clots in the cardiovascular system and interstitial tissues of the body; by bringing the subject's body or body parts into intimate contact with a cooling device, such as a mattress containing water, ice and/or a cool or cooling liquid, hereinafter referred to as "cool material"; in combination with the application of ultrasound to the body or parts thereof, of such frequencies that such bubbles, incipient blood clots and blood clots, are broken up and reduced in size thereby together increasing blood flow and increasing the infusion of gasses into body fluids as well as reducing oxygen demand of body cells, and thereby reducing necrosis, apoptosis and physical damage to bodily cells.

2.

The claim in 1, where said cool material is contained within a mattress; and said mattress may have a water tight zipper or other water tight means of access to the said mattress; such that cool material can be introduced into the interior of said mattress and removed from it.

3.

The claim in 1, in which the cool material in the said mattress is wholly or partly actively cooled by refrigeration means, well known to the art,

4.

The claim in 1, in which active refrigeration means of the mattress is effected by:

the delivery of compressed gas, stored in a portable pressure tank, such as a SCUBA tank, which tanks are readily available on dive boats into a control valve which releases the pressurized gas into a heat exchanger which is located inside the mattress, and immersed in the cool material, the volume of such release, and the degree of cooling occasioned thereby, being governed by a pre-set routine programmed in control valve. in cooperation with a connected thermocouple(s) immersed in the cool material; such low-pressure gas is then vented, through an orifice or control valve in the said mattress, into the atmosphere.

5.

A system which includes transducers placed within intimate contact with the body of the subject,

which broadcasts ultrasound of various frequencies: which causes gasses, incipient blood clots and blood clots the break up into smaller objects; and reduce their capacity to block or impede fluid flows within the body.

6

The claim in 1, in which the ultrasound is generated by means of one or more ultrasound transducer, well known to the art; and said transducer(s) are located on the inner or outer surface of the said mattress that is in contact with the subject; or located so as to act through the material contained within the said mattress; such that the ultra-sound waves propagate through the surface of the said mattress in contact with the subject and thence into the subject's body.

7.

The claim in 1, in which the frequencies and amplitudes of the ultrasound that are applied are such that they break up and thereby reduce the size of gas bubbles, incipient blood clots and blood clots, within the body of the subject.

8

The claim in 1, in which the ultrasound frequency is approximately 20 kHz.

9.

The claim in 1, in which the drug(s) are contained within a dissolving strip which is applied sublingually; and attached to the said strip is a line which allows an operator to secure the position of the strip beneath the tongue, thus preventing the subject from swallowing it before it completely dissolves.

10. The claim in 1, in combination with the application of electro stimulation to the calf and/or the plantar muscle to increase blood flow through the lower extremities to reduce the emergence of blood clots, concomitant with the bends.

11.

The claim in 1, in combination with the administration to the subject of a combination of three drugs, each of which can be selected from those three classes of drugs which: enlarge the lumens of the cardiovascular system, thin the blood, and down regulate the immune system, thereby together increasing blood flow and increasing the infusion of gasses into body fluids as weil as reducing oxygen demand of body cells. and thereby reducing necrosis, apoptosis and physical damage to bodily cells.

12.

A system to reduce bodily damage due to the bends and blockages of blood flow, by breaking up and thereby reducing the size of gas bubbles, incipient blood clots and blood clots in the cardiovascular system and interstitial tissues of the body; by the application of ultrasound to the body or parts thereof, of such frequencies that such bubbles, incipient blood clots and blood clots, are broken up and reduced in size thereby together increasing blood flow and increasing the infusion of gasses into body fluids as well as reducing oxygen demand of body cells, and thereby reducing necrosis, apoptosis and physical damage to bodily cells.

13.

The claim in 12, in which the ultrasound frequency is approximately 20 k

14.

The claim in 12, in combination with the application of electro stimulation to the calf and/or the plantar muscle to increase blood flow through the lower extremities to reduce the emergence of blood clots, concomitant with the bends.

15,

A system which includes the administration of drugs which: increase blood flow by enlarging the walls of blood delivery lumens in the body; in combination with drugs which thin the blood; and in combination with drug(s) which down regulate the immune system; thereby reducing apoptosis of compromised bodily cells, while they are still viable and allowing time for them to recover their normal function.

16.

A system which includes the administration of drugs which: increase blood flow by enlarging the walls of blood delivery lumens in the body; for example: 50 mg. of Cialis. in combination with drugs which thin the blood; for example: 5 to 10 mg. of Warfarin and in combination with drug(s) which down regulate the immune system; for example: 4 mg. methylprednisone thereby reducing apoptosis of compromised bodily cells, while they are still viable and allowing time for them to recover their normal function.