Device for cooling cutaneous and sub-cutaneous tissues and method of manufacture thereof

A device for cooling cutaneous and sub-cutaneous tissues includes an applicator. The applicator has a head and a handle. The head has ports that are operative to dispense a pressurized fluid. The device also has a pressurizing section where the pressurizing section comprises at least one pump. The pump delivers pressurized fluid at a pressure of less than or equal to about 2 bars to the applicator.

BACKGROUND

This disclosure relates to a device that cools cutaneous and sub-cutaneous tissues. This disclosure also relates to a method of manufacturing the device.

Increased cooling in cutaneous and sub-cutaneous tissues can lead to improved blood flow to the cutaneous tissues and sub-cutaneous tissues is useful for maintaining a smooth appearance of the cutaneous tissues and sub-cutaneous tissues and for minimizing wrinkles. It is also useful for a quick recovery from damage to the cutaneous tissues and sub-cutaneous tissues caused by abrasions, cuts, injuries, and the like.

Direct cooling of the cutaneous tissues and sub-cutaneous tissues generally causes vasoconstriction, related to the extent and duration of cooling, that follows a deceivingly simple pattern of an immediate vasoconstriction followed by a slow further reduction in blood flow, disguising the multiplicity of mechanisms acting to bring it about. Although the cutaneous vasoconstriction accompanying local cooling is part of local control, intrinsic to the tissue, important contributions arise from sensory and autonomic nerves. Indeed, local cooling in the presence of blockade of either sensory nerves or sympathetic vasoconstrictor function reverses the vasoconstriction seen at the onset of local cooling to a transient vasodilation. The mechanism for this vasodilation is not known.

Because it is transient and dependent on the rate of cooling, a depletable substance rather than biophysical effects of the lower temperature is suggested. It can be provoked in neurally intact tissue with a sufficient rate and extent of cooling. This implies that sensory nerves, likely originating from cold receptors, inhibit an intrinsic vasodilator response to cooling. The vasodilation can lead to increased blood flow to the site of an injury when it is subjected to cooling.

Often commercially available devices that are used for cooling the cutaneous tissues and sub-cutaneous tissues operate at air pressures that are greater than 5 bars. Such air pressures can further damage the cutaneous tissues and sub-cutaneous tissues. In addition, such devices are heavier than ten pounds and are thus not portable. It is therefore desirable to have a device that can cool the cutaneous tissues and/or sub-cutaneous tissues while using a fluid pressure of less than 1 bar and that are light enough to be portable by the average human being.

SUMMARY

Disclosed herein is a device comprising an applicator; the applicator having a head and a handle; the head having ports that are operative to dispense a pressurized fluid; and a pressurizing section; the pressurizing section comprising at least one pump; wherein the pump delivers pressurized fluid at a pressure of less than or equal to about 2 bars to the applicator.

Disclosed herein too is a method comprising delivering to a patient a pressurized fluid at a pressure of less then or equal to about 2 bars; the pressurized fluid being generated by a device comprising an applicator; the applicator having a head and a handle; the head having ports that are operative to dispense a pressurized fluid; and a pressurizing section; the pressurizing section comprising at least one pump; wherein the pump delivers pressurized fluid at a pressure of less than or equal to about 2 bars to the applicator.

Disclosed herein too is a method comprising disposing an applicator and a pressurizing section to be in fluid communication with one another; where the applicator has a head and a handle; the head having ports that are operative to dispense a pressurized fluid; and wherein the pressurizing section comprises at least one pump; wherein the pump delivers pressurized fluid at a pressure of less than or equal to about 2 bars to the applicator.

DETAILED DESCRIPTION

Disclosed herein is a portable device that is capable of supplying pressurized air to the cutaneous tissues and sub-cutaneous tissues. The portable device generally delivers a fluid to the cutaneous tissues and sub-cutaneous tissues at a pressure of less than or equal to about 2 bars, specifically at a pressure of less than or equal to about 1 bar. Because of the light-weight of the device, it can easily be transported by the average person. It is particularly advantageous in that it can be placed next to the bed of an injured patient, who can then maneuver it for use when necessary. The device can be easily used and manipulated by a patient or an assistant (e.g., a nurse, a doctor, a medical orderly, and the like).

In an exemplary embodiment, the portable device and the applicator can be manipulated by the person using it (i.e., a patient). Its light weight and flexibility permit self treatment and self administration by the patient.

With reference now to theFIGS. 1 and 2, the device100comprises an applicator102that is in fluid communication with a pressurizing section104. In one embodiment, the applicator102and the pressurizing section104are in physical communication with each other in a single piece. The applicator102and the pressurizing section104are detachably attached and can be separated from one another when desired as shown in theFIG. 2. A flexible hose112contacts both the pressurizing section104and the applicator102. The flexible hose112permits a pressurized fluid from the pressurizing section104to be delivered to the applicator102. In one embodiment, the pressurized fluid is air. The flexible hose112can be folded into a casing (not shown) that houses the pressurizing section104. The flexible hose112can be connected to the applicator102and the pressurizing section104using a quick connect coupling116, thus allowing the flexible hose112to be quickly attached or detached from the applicator102and/or the pressurizing section104.

The flexible hose112can be manufactured from an elastomer. Examples of suitable elastomers are polybutadiene, polyisoprene, nitrile rubbers, perfluoroethylene elastomers, polysiloxanes, polychloroprenes, or the like, or a combination comprising at least one of the foregoing elastomers. Exemplary elastomers for use in the hose are perfluoroethylene elastomers or polysiloxanes because of their ability to resist bioadhesion.

As noted above, the pressurized fluid is air. In one embodiment, the pressurized fluid can be an inert gas such as helium, argon, xenon, nitrogen, or the like. In another embodiment, which will be discussed later, the pressurized fluid can have entrained in it a biologically active agent.

The applicator102is shown in theFIG. 3. TheFIG. 3depicts a top view and a side view of the applicator102. TheFIG. 3depicts a section of the applicator taken along AA′ in the top view. The applicator102comprises a head132and a handle130. The head can have a cross-sectional area that is about 2 to about 3 times the cross-sectional area of the handle. The handle130is a conduit136that is fixedly attached or detachably attached to the head132. The head132has a number of ports134disposed in the surface. The ports134are in fluid communication with the pressurizing section104via the conduit in the handle130and the flexible hose112. The ports are generally about 5 millimeters or less in diameter, specifically about 3 millimeters or less in diameter, more specifically about 1.5 millimeter of less in diameter, and more specifically up to about 100 micrometers of less in diameter. The head can have up to at least about 50 ports, specifically up to at least about 35 ports, more specifically up to at least about 20 ports, and more specifically up to at least about 5 ports.

As seen in theFIG. 3, the ports in the head132can be inclined at an angle θ to the axis CC′ of the conduit136. In another embodiment, the ports in the head132are parallel to the axis CC′ of the conduit136. The ports can be fixed in shape or can have a variable shape. The ports can be nozzle-shaped with a diameter than is gradually reduced towards the outer surface138from the inner surface of the head132. When the ports are nozzle-shaped such that the diameter is gradually reduced towards the outer surface138from the inner surface, the volume of pressurized fluid emanating from the ports is reduced. However, the velocity of the pressurized fluid and the amount of cooling provided by the pressurized fluid is increased.

The ports can also be nozzle shaped with a diameter than is gradually reduced towards the inner surface from the outer surface of the head132as shown in theFIG. 5. TheFIG. 5depicts another exemplary cross-sectional view of the applicator from the section AA′ in theFIG. 3. In one embodiment, the head132can have a diameter that is constant throughout the port as can be seen in theFIG. 4. TheFIG. 4depicts another exemplary cross-sectional view of the applicator from the section AA′ in theFIG. 3. The ports direct pressurized fluid from pressurizing section104to the cutaneous tissues and sub-cutaneous tissues or to other parts of the body as desired.

In one embodiment, the diameter and the shape of the ports can be changed during the operation of the device100. As shown in theFIG. 5, a slideable throttle140can be moved in and out of a slot in the applicator102to increase or decrease the flow of the pressurized fluid to the cutaneous tissues and sub-cutaneous tissues. The throttle140has ports similar to the size of the ports disposed in the head of the applicator. By moving the throttle such that its ports are concentrically aligned with the ports in the head, the volume of pressurized fluid can be maximized. On the other hand, by moving the throttle such that its ports are eccentrically aligned with the ports in the head, the flow of pressurized fluid can be reduced or minimized. The throttle can have screw threads on its outer surface and can be rotated to slide in or out of the slot in the applicator102thereby changing the size of the fluid channel in the port.

With reference to theFIG. 5, the applicator102can also have a port142on the side. The port140can be in fluid communication to a storage vessel that contains biologically active agents. One or more biologically active agents can be supplied to the cutaneous and sub-cutaneous tissues by the applicator102as a result of the venturi action brought about by the flow of the pressurized fluid in the conduit136. The biologically active agent can be in the form of a fluid (e.g., a liquid, a gas, a suspension, a solution, a dispersion, droplets, a mist, an aerosol, and the like), a cream, a paste, a powder, or the like. In one embodiment, one or more biologically active agents can be drawn in to the conduit136by the venturi action along with one or more liquids and the mixture of the biologically active agents and the liquids can undergo mixing in the conduit136prior to being delivered to the cutaneous or sub-cutaneous tissue.

As the pressurized fluid is transported through the conduit136some of the biologically active agent is drawn into the applicator as a result of the vacuum created in the port140by the Bernoulli effect (venturi action). The pressurized fluid entrained with the biologically active agent is then disposed on the cutaneous tissues and/or sub-cutaneous tissues of the patient to effect a cure.

In one embodiment, the applicator102can have a plurality of application points through which pressurized air can be applied to the body of a patient. The applicator102can also be provided with vibratory characteristics and can be used to provide heat to the point of contact on the skin. The applicator102may also be a smart applicator having a positioning system enclosed therein. The smart applicator can be used to provide relief at precise locations within the body of a living being. An example of smart applicator is one that contains communication equipment that permits the applicator to communicate with global positioning systems.

An example of such an applicator102may be seen in theFIG. 6. TheFIG. 6shows the applicator102having and handle130and legs202that are in communication with the handle. Each leg202is fitted with a head132through which pressurized air may be released. As seen in theFIG. 6, each head132has a port134through which pressurized air may contact the skin of a patient. The flexible hose112can contact the applicator102via a quick coupling116as detailed above with respect toFIGS. 1 and 2.

The applicator may be provided with a plurality legs202. The applicator102can have 2, 3, 4, 6 or more legs, where each leg is fitted with a head132having ports134through which pressurized air is released. The head may also contain heaters (not shown) for heating the surface of the skin.

The applicator may have a motor (not shown) that can transmit vibrations to the body of the patient. The handle of the applicator may also house communications equipment that can communicate with global positioning systems to help improve location of tissues on the body so that the pressurized air and/or vibrations and/or heat can be accurately applied.

The applicator102can be manufactured from a wide variety of metals, ceramics, polymers or combinations thereof. It is generally desirable for the applicator102to have a smooth outer surface138so that it does not abrade any tissue as it is passed along the surface of the body. Examples of metals that can be used in the applicator are stainless steel, aluminum, copper, brass, or the like, nickel titanium shape memory alloys, or the like, or a combination comprising at least one of the foregoing metals. Examples of suitable ceramics are silica, quartz, alumina, titania, zirconia, or the like, or a combination comprising at least one of the foregoing ceramics. Examples of suitable polymers are polyolefins, polycarbonates, polymethylmethacrylates, polyacrylates, polyetherimides, polyetherketones, polyesters, polytetrafluoroethylenes, polysiloxanes, polyether ether ketones, or the like, or a combination comprising at least one of the foregoing polymers. An exemplary metal is aluminum. An exemplary polymer is polytetrafluoroethylene. In one embodiment, the exemplary metal is aluminum with a coating of polytetrafluoroethylene or polysiloxane. The polytetrafluoroethylene coating or polysiloxane coating is detachable from the metal head. It can be reattached to the head by thermoforming or by using an adhesive. Alternatively, the original coating can be removed and a new coating can be sprayed onto the head. Using a removable coating on the head allows for disinfection of the coating and the head to prevent the transfer of disease carrying bacteria or viruses from one patient to another.

In one embodiment, the legs202of the applicator shown in theFIG. 6or the handle of the applicator shown in theFIG. 3may be made of a flexible material such as an elastomer. The surface of the applicator may also be textured if desired to provide an ability to gently scratch the skin. Scratching can provide comfort against irritation that is generally encountered after irritation.

The pressurizing section104generally contains a pump110that can deliver pressurized fluid to the applicator at a pressure of up to about 2 pounds, specifically at a pressure of up to about 1 pound. In one embodiment, the pressurizing section104contains a plurality of pumps. The plurality of pumps can be operated simultaneously or sequentially. In an exemplary embodiment, the pressurizing section104contains at least two pumps.

The pressurized fluid output from both pumps is delivered to the conduit136of the applicator104. By delivering the pressurized fluid at a pressure of less than or equal to about 1 pound, damage to tissue is avoided. The pressurizing section104and the applicator102may contain valves (not shown) to facilitate control of the pressurized fluid.

The pressurized fluid is delivered to the applicator at a substantially constant temperature over an extended period of time during the use of the device. By delivering the pressurized fluid at a constant temperature over an extended period of time, the patient receives a constant supply of a fluid that cools the cutaneous tissues and sub-cutaneous tissues and increases circulation. An extended period of time as defined herein refers to time periods of greater than or equal to about 30 minutes, specifically greater than or equal to about 60 minutes.

While the pressurized fluid is generally delivered to cutaneous tissues and/or subcutaneous tissues at a fairly constant temperature, the applicator may be used to deliver a cooled fluid or a heated fluid to a patient. This can be done when the therapeutic benefits of delivering a cooled fluid or a heated fluid to a patient exceed the benefits of delivering a fluid that is at an ambient temperature.

As noted above, the pressurizing section104is detachably attached to the applicator102. In one embodiment, the pressurizing section104is not attached to the applicator and is in fluid communication with the applicator102via the hose112. The pressurizing section104and the pumps contained therein are ventilated so as to avoid heating. The use of the pump110is advantageous in that the air supplied to the patient is at a constant temperature. The pumps do not heat up upon being operated significantly for extended periods of time (e.g., time periods exceeding 30 minutes to 2 hours). In one embodiment, the pressurizing section104is effectively ventilated to supply pressurized air for a period of over 30 minutes at a temperature that does not fluctuate by an amount of ±1° C. In another embodiment, the pressurizing section104is effectively ventilated to supply pressurized air for a period of over 60 minutes at a temperature that does not fluctuate by an amount of ±2° C.

The pumps are not subjected to special cooling (such as cooling fluids) and operate at a given temperature only as a result of passive cooling provided by ambient air.

The pump110or the plurality of pumps110are light enough to be portable. In one embodiment, the pumps110are less than or equal to about 10 pounds apiece, specifically less than or equal to about 5 pounds apiece, and more specifically less than or equal to about 2 pounds apiece, while delivering pressurized fluid at about 2 bars or less, specifically at about 1 bar or less at a constant temperature for a period of greater than or equal to about 30 minutes, specifically for a period of greater than or equal to about 60 minutes.

In one embodiment, the pump110is a fixed pressure pump with no pressure regulating abilities. In another embodiment, the output pressure of the pump110may be regulated. The use of a fixed pressure pump110has a number of advantages over other devices including compressors. The pump110, when used in the pressurizing section104does not use a particulate filter or an oil filter. The pressurizing section104and the pump110does not store pressurized air as does a compressor. As a result, the pressurizing section104and the device100is very light and can be easily transported and manipulated. The pump generally has a weight less than or equal to about 15 pounds, specifically less than or equal to about 12 pounds and more specifically less than or equal to about 10 pounds.

The device100and the pressurizing section104are very silent and operate without any vibration. As a result, they can be used in a hospital room without disturbing neighboring patients. They can also be used indoors without disturbing the household. The pump110generally produces less than 50 dB of noise, specifically less than or equal to about 47 dB, specifically less than or equal to about 45 dB, and more specifically less than or equal to about 40 dB at a distance of 1 meter from the center of the pump. The pumps have minimal vibration. In one embodiment, the pump110and the pressurizing section104display a vibration of less than or equal to about 60 Hz, and specifically less than or equal to about 50 Hz. In short, the pressurized air is pulsed at a rate of frequency input that is less than or equal to about 60 Hz, and specifically less than or equal to about 50 Hz.

The pump110may be a diaphragm pump, a linear pump, a centrifugal pump, a piston driven pump, a rocking piston pump, or the like. An exemplary pump is a linear pump. A commercially available version of the pump is manufactured by GAST.

In one embodiment, the pressurizing section104can be a cabinet that houses the pumps. In another embodiment, the pressurizing section104can be a cabinet that comprises an electrical cabinet section and a pneumatic cabinet section (not shown) that are separated from each other. The electrical cabinet section contains electrical wires and other electrical accessories for the pumps. The pneumatic cabinet section contains the pumps and associated valves. This arrangement is advantageous in that any heat generated in the electrical cabinet section is kept away from the pumps contained in the pneumatic cabinet section. A grill type vent may be provided on both the electrical cabinet section and the pneumatic cabinet section to permit heat to escape.

The pressurizing section104generally comprises a boxed enclosure having a height or width of greater than or equal to about 20 inches, specifically greater than or equal to about 25 inches and more specifically greater than or equal to about 30 inches. If the height is greater than or equal to about 20 inches, then the width is less than or equal to 30 inches, specifically less than or equal to about 25 inches and more specifically less than or equal to about 20 inches.

The design shown in theFIGS. 1-5is advantageous in that it is light-weight and capable of being transported by an average-sized human being. The device100can supply pressurized fluid containing an optional biologically active agent at a pressure of less than or equal to about 1 bar. The pressurized fluid can be supplied for an extended period of time exceeding 30 minutes without any substantial fluctuation in temperature. In one embodiment, the housing section104can be mounted on wheels to aid in the portability of the device100.

In one embodiment, the device can be manufactured by connecting an applicator having a plurality of ports disposed thereon to a pressurizing section. The pressurizing section contains at least one pump that delivers pressurized fluid at a constant temperature at a pressure of less than or equal to about 2 bars, specifically less than or equal to about 1 bar. The pressurizing section and the applicator are in fluid communication via a flexible hose. The use of light weight pumps permits the device100to do away with filters, condensation units and the like, which are typically used in units or devices that employ air compressors. The pressurized air delivered to a patient from an applicator is clean without any entrained oils and fuels and is delivered at a substantially constant temperature and pressure.