The present teachings relate to devices and methods for dispensing a cryogenic fluid. In particular, the present teachings relate to cryosurgical devices and methods for cooling surfaces by either directly dispensing a cryogenic fluid to a surface to be treated or by dispensing a cryogenic fluid onto an applicator to be placed in contact with a surface to be treated.
A number of procedures have been developed for treating superficial lesions, such as, for example, warts, on human and animal skin. Lesions can be removed, for example, through the localized freezing of the skin lesion tissue by a cooling fluid, such as a liquid refrigerant. Physicians have used liquid nitrogen applications, for example, to freeze and remove lesions from a patient's skin. Conventional methods of treatment, however, may have the disadvantages of requiring specialized equipment to condense the nitrogen gas, the need for specialized storage devices, and the inherent hazards of handling and dispensing materials having very low boiling points, for example, as low as approximately −196° C. in the case of liquid nitrogen.
Cryosurgery is used by medical professionals to treat a variety of lesions. Extreme cold works to destroy tissue through lysis of cells. This may occur through the formation of ice or rapid changes in osmotic pressure. Both can work to increase the overall effectiveness of cryosurgical treatments.
More recently, various methods have been developed to treat skin lesions cryosurgically by employing a cooling fluid (e.g., a cryogenic fluid) contained, for example, in a handheld pressurized container. Such cryosurgical devices generally rely upon a liquefied (compressed) gas, such as, for example, butane, propane, or dimethyl ether (DME), to rapidly cool an applicator tip or “bud” based on the principles of “heat of vaporization.” In other words, as the compressed gas flows to and contacts a surface of an applicator, such as, for example, a porous applicator bud, rapid evaporation of the gas causes the applicator surface to cool to temperatures which are lower than the temperature of the liquefied gas alone. In several such methods, an effective amount of the cryogenic fluid from the pressurized container can be dispensed, for example, into a hollow supply tube having a cotton, fiber and/or plastic foam bud located at the distal end of the supply tube. The cryogenic fluid accumulates in the applicator and upon evaporation, cools the applicator to temperatures well below freezing. The applicator can be placed in contact with the skin surface of the lesion for a period of time sufficient to reduce the temperature of the skin lesion tissue to temperatures that freeze the skin, such that permanent, irreversible rupture of the cellular membranes of the tissue occurs.
Cryosurgical devices currently utilizing the heat of vaporization principal in combination with compressed gases, such as DME for example, can pose various issues. For example, the devices can depend significantly upon the particular gas used and rates of evaportion from the applicator may be relatively long (e.g., on the order of 15-30 seconds). Moreover, the effective temperature of the applicator (i.e., the temperature of the applicator that is sufficient to cause freezing of the skin lesion) may be reached for only a short period of time, particularly once placed in contact with the warmer surface of the skin lesion, thereby limiting effective freezing of the target tissue.
Various additional cryosurgical devices can utilize liquid nitrogen, or other liquefied gases such as, for example, chlorofluoro carbons or nitrous oxide, which have significantly lower boiling points and thus can be dispensed at colder temperatures than some conventional “heat of vaporization” gases such as DME, thereby achieving more aggressive freezing effects. Such cryosurgical devices, however, are generally still relatively complex in their structure, using complicated valving mechanisms and dispensers to deliver the liquefied gas. Accordingly, problems can arise with such devices due to the high pressures exhibited by the gases, the complicated manner in which the cryogenic fluid is moved from the container to the dispensing tip, the ease of use, and/or the cost associated with manufacture and/or assembly of the devices.
Accordingly, it may be desirable to provide a cryosurgical device that is both simple in terms of structure and use, and capable of delivering a variety of cryogenic fluids, including more aggressive cooling agents, such as, for example, nitrous oxide and liquid nitrogen, in an amount sufficient to achieve effective cryosurgical treatment. It may be further desirable to provide a disposable cryosurgical device that can be discarded once spent. It may, therefore, be desirable to provide an economical device with simpler structural components and flow regulation mechanisms, which can also reduce waste of the cryogenic fluid as it is moved from a container, for example to an applicator, for dispensing at a desired location.
The present teachings may solve one or more of the above-mentioned problems and/or may demonstrate one or more of the above-mentioned desirable features. Other features and/or advantages may become apparent from the description that follows.
One example of the claimed invention includes a self-contained disposable cryosurgical device that sprays a stream of liquid nitrous oxide. Evaporation of the liquefied nitrous oxide gas draws heat from the surroundings. The self-contained disposable cryosurgical device serves as a reservoir for the cryogen-N2O, delivering the liquid gas directly onto a lesion to be treated at −89° C. Following cryo treatment, necrosis of the site can occur. Recovery takes about 10 to 14 days, with new tissue growing inwards from the surrounding epidermis and the more deeply situated adnexa. The lesions that can be treated include genital lesions, molluscum contagiosum, seborrheic keratoses, skin tags, verruca plantaris, verruca vulgaris, verruca plans, actinic keratosis, lentigo, and the like.
In accordance with various exemplary embodiments of the present teachings, a dispensing head for dispensing a cryogenic fluid may comprise a flow passage configured to be placed in flow communication with a reservoir containing a cryogenic fluid, the flow passage defining a flow passage inlet opening configured to receive the cryogenic fluid from the reservoir, and a flow passage outlet opening opposite the flow passage inlet opening. The dispensing head may further comprise a dispensing member configured to dispense the cryogenic fluid, the dispensing member defining a lumen having a lumen inlet opening and a lumen outlet opening; and at least one porous member disposed in the flow passage, the at least one porous member being configured as a primary flow regulation mechanism to limit a flow rate of the cryogenic fluid as it flows from the reservoir to the lumen outlet opening.
In accordance with various additional exemplary embodiments of the present teachings, a dispensing head for dispensing a cryogenic fluid may comprise a flow passage configured to be placed in flow communication with a reservoir containing a cryogenic fluid, the flow passage defining a flow passage inlet opening configured to receive the cryogenic fluid from the reservoir, and a flow passage outlet opening opposite the flow passage inlet opening. The dispensing head may further comprise a dispensing member configured to dispense the cryogenic fluid, the dispensing member defining a lumen having a lumen inlet opening and a lumen outlet opening; and an actuation member configured to move between a first position in which the flow passage outlet opening is not aligned and is blocked from flow communication with the lumen inlet opening, and a second position in which the flow passage outlet opening is aligned with and in flow communication with the lumen inlet opening.
In accordance with various further exemplary embodiments of the present teachings, a method for dispensing a cryogenic fluid may comprise coupling a dispensing head defining a flow passage, a dispensing member, an actuation member, and at least one porous member disposed in the flow passage to a container defining a reservoir. The method may further comprise actuating the dispensing head so as to move an inlet opening of the dispensing member from a first position in which an outlet of the flow passage is not aligned and is blocked from flow communication with the dispensing member inlet opening, to a second position in which the flow passage outlet opening is aligned with and in flow communication with the dispensing member inlet opening. The method may further comprise flowing an amount of cryogenic fluid from the reservoir toward the dispensing member inlet opening through the flow passage and dispensing the cryogenic fluid from a dispensing member outlet opening to a target location, wherein a flow rate of the cryogenic fluid flowing from the reservoir to the dispensing member outlet opening is primarily regulated by passing the cryogenic fluid through at least one porous member.
In accordance with various additional exemplary embodiments of the present teachings, a method for dispensing a cryogenic fluid may comprise placing an application member in contact with a skin surface and supplying a cryogenic fluid to the application member while the application member is in contact with the skin surface. The method may further comprise diffusing the cryogenic fluid through the application member to the skin surface at a temperature that is directly effective to freeze the skin surface such that permanent, irreversible rupture of cellular membranes of cells of the skin surface occurs while the cryogenic fluid is being delivered to the skin surface.
One example of the claimed invention includes a method for dispensing a cryogenic fluid including opening an activation lever on the cryogen dispensing device to access a cryogenic reservoir compartment, inserting a cryogenic liquid cartridge into the cryogenic reservoir compartment, and returning the activation lever from its extended position to a fully closed position. The method also includes positioning the end of the activation lever into an opening on the device. An audible, tactile, or visual indication can be provided to indicate to a user that the cryogenic liquid cartridge and activation lever are properly seated and positioned on the device, and that the device is ready for use. Similarly, an interlock device can be provided to prevent the activation lever from being moved back from the opening. When fully closed, an eccentric hub on the activation lever displaces the cryogenic liquid cartridge, which is pierced by a pierce pin in the valve assembly to enable the flow of cryogenic material. The cryogen dispensing device can then be used to treat a target lesion. The device is then positioned vertically downwards over the lesion at a distance of approximately 1 cm, and the actuator is activated to initiate the spray of cryogen. In this position, liquid cryogenic material in the cartridge flows through the valve, while gaseous cryogenic material remains in the cartridge. The device can be fixed or moved to cover the lesion area, and the actuator is released to stop the cryogen spray.
In one example of the claimed invention, an activation valve assembly includes a valve body and a valve slide. The valve body includes a flow passage with a flow passage inlet that receives a cryogenic material and a flow passage outlet that delivers the received cryogenic material. The valve slide slidably engages with the valve body. The valve slide includes a lumen with a lumen inlet opening for receiving cryogenic material from the flow passage outlet of the valve body and a lumen outlet opening that delivers the cryogenic material to a target. The target can be a lesion directly, or can be an applicator device, a fluid retaining device, and the like.
The valve slide is engaged with the valve body and is positioned in a dosed position where the lumen inlet opening is offset from the flow passage outlet of the valve body to prevent flow of the cryogenic material. When the cryogenic material is to be delivered to a target, the valve slide is slid along the valve body to engage with the valve body in an open position where the lumen inlet opening of the valve slide is aligned with the flow passage outlet of the valve body to form a flow path to allow the flow of the cryogenic material.
The activation valve assembly can also include a sealing member surrounding the flow passage outlet opening and disposed adjacent the valve slide. For example, the sealing member can be an o-ring or other mechanical gasket. The sealing member can be made using synthetic rubber including Buna rubber, nitrile rubber, styrene-butadiene rubber, nitrile butadiene rubber, or other materials such as silicone, natural rubbers, and the like.
The activation valve assembly can also include a dispensing member disposed in the valve slide. The dispensing member can include the lumen inlet opening and the lumen outlet opening. The dispensing member can be made using polyaryletheretherketone (PEEK), and/or combinations of materials, including, for example, glass, plastic and/or metal and adhesives.
The flow passage inlet opening of the activation valve assembly can include a piercing member. The piercing member can be at least partially disposed in the valve body and configured to puncture a seal on the cryogen reservoir to enable the liquid cryogen to flow to the valve assembly. The piercing member can be a hollow metal member or may be another suitable material configured to puncture the seal of the cryogen reservoir. The piercing member can be configured to puncture the seal of the cryogen reservoir at a right-angle, or can be configured to puncture the seal at an angle, for example using a beveled tip on the piercing member.
The activation valve assembly can also include a filter in the valve body disposed in the flow passage between the flow passage inlet opening and the flow passage outlet opening. The filter can be cylindrical in shape or can be disk-shaped, for example, as well as other shapes suitable to provide a porous member in the flow path of the cryogenic fluid. The filter can provide flow regulation as well as filtration of contaminants or other materials from the cryogenic material,
The filter can be made from a variety of materials depending upon the type, amount, and target of the cryogenic fluid. For example, the filter can include high solid filtration and separation materials, including polyethylene substrates, polyvinylidene difluoride (PVDF) membranes, sintered thermoplastic or metals, and the like.
The activation valve assembly can also include a sealing member surrounding the flow passage inlet opening. The sealing member surrounding the flow passage inlet opening can be an a-ring or other mechanical gasket. The sealing member can be made using synthetic or natural rubbers including Buna rubber, nitrile rubber, styrene-butadiene rubber, nitrile butadiene rubber, or other materials such as silicone, natural rubbers, and the like.
Additional objects and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present teachings. At least some of the objects and advantages may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claims; rather, the claims are entitled to their full breadth and scope, including equivalents.
The present teachings can be understood from the following detailed description either alone or together with the accompanying drawings. The drawings are included to provide a further understanding, and are incorporated in and constitute a part of this specification. The drawings illustrate one or more exemplary embodiments of the present teachings and together with the description serve to explain various principles and operation.
The present teachings contemplate devices that are both relatively simple in structure and use, and capable of dispensing cryogenic fluid at sufficiently cold temperatures and pressures for a sufficient period of time so as to effect cryosurgical treatment. Devices and methods in accordance with the present teachings may dispense, for example, a sufficient and substantially uniform amount of a cryogenic fluid to an applicator to be placed in contact with a target freeze area, such as, for example, the tissue of a skin lesion. Devices in accordance with the present teachings may effectively treat and/or remove various types of skin lesions, including but not limited to, for example, verruca (warts), keratoses, achrocordon, molluscum contagiosum, age spots, dermatofibroma, keloids, granuloma, annulare, porokeratosis plantaris, angioman, lentigo discreta, chondrodermatitis, epithelial nevus, leokoplakia, granuloma pyogenicuni, and/or kaposi's sarcoma.
To dispense the cryogenic fluid, dispensing heads in accordance with various exemplary embodiments of the present teachings may be used in conjunction with containers defining reservoirs containing a cryogenic fluid. The dispensing heads may provide, for example, an actuation member configured to move between a first position and a second position. When in a first position, the actuation member can block a flow passage outlet opening, thereby preventing the flow of the cryogenic fluid from the reservoir containing the cryogenic fluid and a dispensing member. When moved into a second position, however, the actuation member can align the flow passage outlet opening with a lumen inlet opening of the dispensing member, thereby placing the flow passage outlet opening in flow communication with the lumen inlet opening and allowing flow of the cryogenic fluid from the reservoir to the dispensing member.
To limit and/or regulate the flow rate of the cryogenic fluid, dispensing heads in accordance with various exemplary embodiments of the present teachings may utilize at least one porous member in the flow path of the cryogenic fluid. The at least one porous member may, for example, be configured as a primary flow regulation mechanism to limit the flow rate of the cryogenic fluid flowing from the reservoir through the porous member. As used herein, the term “primary flow regulation mechanism” refers to the main and/or sole mechanism for regulating the flow rate of the cryogenic fluid during dispensing of the cryogenic fluid from the reservoir and out of the device. As used herein, a “primary flow regulation mechanism” regulates the cryogenic fluid flow rate when the device is actuated (i.e., when the device is turned “on”) so as to dispense the cryogenic fluid in an amount and at a rate sufficient to safely and effectively effectuate treatment (e.g., without which the flow rate would be too great to effectively use the device for its intended purpose). Thus, as used herein, “primary flow regulation” refers to regulating the cryogenic fluid flow rate once the device is turned on, as opposed to controlling activation of the device (i.e., turning the device “on” and “off” thereby respectively allowing and disallowing fluid flow from the reservoir to be dispensed to a treatment location). In other words, in at least some exemplary embodiments the flow path of the cryogenic fluid may be substantially free of other flow regulation mechanisms, such as, for example, needle valves, orifices, and/or finely cut dispensing tip diameters, other than the at least one porous member and thus flow regulation during actuation and dispensing occurs via the at least one porous member alone. In other exemplary embodiments, if additional flow regulation mechanisms are provided to regulate the flow rate of cryogenic fluid during dispensing of the fluid from a reservoir to a treatment location, such additional flow regulation mechanisms when used with a porous member as a “primary flow regulation mechanism” serve as a secondary regulation of the flow rate of the cryogenic fluid.
Those skilled in the art would understand that due to the relatively high internal pressures of the container 20, the cryogenic fluid 21 may be in the form of a liquid or a gas/liquid mixture. Those skilled in the art would further understand that the cryogenic fluid 21 may comprise various mixtures of cryogenic substances, which can, for example, permit lower internal pressures of the container 20 to achieve a desired boiling point.
The container 20 is configured to maintain the cryogenic fluid 21 under pressure by a seal 27, as shown in
In various exemplary embodiments of the present teachings the container 20 and other components of the device 10 may be disposable such that the entire device 10 can be thrown away when the cryogenic fluid 21 is used up. In various additional exemplary embodiments, the container 20 may be configured to be recharged with cryogenic fluid upon depletion. In various further exemplary embodiments, the container 20 may be replaced with a new container with cryogenic fluid upon depletion, and remaining components of the device 10 may be reusable.
As illustrated in
Various exemplary embodiments of the present teachings contemplate various additional piercing mechanisms to puncture seal 27. Those of ordinary skill in the art would understand, therefore, that the hollow piercing member 28 as shown and described herein is exemplary only and not intended to limit the scope of the present teachings. Also, although in the exemplary embodiment of
Various exemplary embodiments of the present teachings (not shown) further contemplate that the dispensing head 12 can engage directly with container 20, which could eliminate the need for the housing 11. For example, to first use the device, an operator may engage screw threading provided on an inner portion of the dispensing head 12 onto screw threading provided on an outer portion of the container 20. As above, when the dispensing head 12 is tightened down onto the container 20, the hollow piercing member 28 can puncture the seal 27, placing the reservoir 35 in flow communication with the dispensing head 12.
As illustrated in
Those ordinarily skilled in the art would understand that the material, size and configuration of the flow passage 30 can be chosen based on the type of cryogenic fluid used, resistance to corrosion from contact with the cryogenic fluid, cost, efficiency and other such factors. To allow the cryogenic fluid 21 to travel in an effective and relatively short (Le., direct) path between the flow passage net opening 29 and the flow passage outlet opening 24, various exemplary embodiments of the present teachings contemplate using a substantially straight flow passage 30.
As illustrated by
The at least one porous member 25 may be formed from any suitable material and/or combination of materials, including, for example, glass, plastic and/or metal. In various exemplary embodiments, the at least one porous member 25 may be a frit. Various exemplary embodiments in accordance with the present teachings, for example, contemplate that the at least one porous member 25 can be formed from a synthetic fluoropolymer, such as, for example, polytetrafluoroethylene (PTFE). Those ordinarily skilled in the art would understand that the type of material may be chosen based on efficiency, resistance to corrosion from contact with the cryogenic fluid 21, ability to withstand the internal pressures and temperatures that are generated and other factors. Various exemplary embodiments of the present teachings, for example, contemplate that the at least one porous member 25 may withstand a pressure of less than or equal to about 750 psi and a temperature ranging from about 0° C. to about −110° C.
Those ordinarily skilled in the art would further understand that the at least one porous member 25 can be cut and/or shaped as desired to properly fit and function within the flow passage 30, and need not be disk-shaped. For example, various exemplary embodiments of the present teachings contemplate that the at least one porous member 25 can be formed within the hollow portion 30′ of the hollow piercing member 28.
Various exemplary embodiments of the present teachings consider that the at least one porous member 25 can both limit the flow rate of the cryogenic fluid 21 and filter contaminants out of the cryogenic fluid 21. The at least one porous member 25 may be configured to regulate the rate at which the cryogenic fluid 21 flows from the reservoir 35 to the outlet of the dispensing head 12 (e.g., to outlet 18 of a dispensing member 14) in order to achieve a desired flow rate of the cryogenic fluid 21 for dispensing to a desired location, whether that location is a lesion to be treated or an application member. In the case of cryosurgical applications, it may be desirable to meter the amount of cryogenic fluid that is dispensed during the time period in which the actuation member 13 is in the open position and the device is being used for cryosurgical freezing. Such regulation over the amount of fluid that flows from the dispensing member 18 can help to ensure that sufficient freezing takes place to effect the desired cryosurgical treatment, without over freezing and/or uncontrolled dispensing so as risk contacting locations other than the target location with the cryogenic fluid.
Various exemplary embodiments of the present teachings contemplate, for example, that the at least one porous member 25 is the only mechanism for regulating the flow rate of the cryogenic fluid 21 flowing from the reservoir 35 through the dispensing head 12 to the outlet of the lumen 31, for example, without valves or other similar active flow regulation mechanisms. Various additional exemplary embodiments of the present teachings further consider using various supplemental flow regulation techniques in combination with the at least one porous member 25. For example, in various exemplary embodiments the inner diameter of the flow passage 30 and/or of a lumen 31 in the dispensing member 14 can also help to regulate the flow rate and supplement the use of the at least one porous member 25 as the primary flow regulation mechanism.
As illustrated in
In various exemplary embodiments, the degree to which the actuation member 13 moves between the first and second positions can be controlled. For example, in the exemplary embodiment of
As illustrated in
In various exemplary embodiments the actuation member 13 may be biased, such as, for example, to move into a closed position when the actuation member 13 is not held in an open position. In other exemplary embodiments, the actuation member 13 may stay in the first or second position once moved there until a user moves the actuation member 13 back to the other position.
As illustrated, for example, in
As before, in various exemplary embodiments, the degree of movement of the actuation member 43 between the first and second position may be controlled based on the configuration of the actuation member 43. For example, the size (e.g., length) and configuration of screw holes 46 and 47 and an alignment pinhole 48 can regulate how much the actuation member 43 moves between the first position and the second position. For example, in various embodiments, the size and configuration of the screw holes 46 and 47 and the alignment pinhole 48 can be chosen based on the degree of slide desired for actuation member 43. As illustrated in
Those ordinarily skilled in the art would understand that the type, size and configuration of screws 52 and 53 and an alignment pin 54 can be chosen based on the size and configuration of the screw holes 46 and 47 and the alignment pinhole 48, cost, efficiency and other such factors. In various exemplary embodiments, for example, the alignment pinhole 48 and the alignment pin 54 may be replaced, for example, with an additional screw hole and screw.
In various exemplary embodiments of the present teachings, the actuation member 43 may be biased, such as, for example, to move into a closed position when the actuation member 43 is not held in an open position. As illustrated in
Remaining components of the cryosurgical device of the exemplary embodiment of
With reference again to
As illustrated in
With reference now to
As illustrated in
The dispensing member 14 defines a lumen 31 having a lumen inlet opening 19 and a lumen outlet opening 18. As described above, and illustrated in
As shown best in
The dispensing member 14 may be made of any suitable material and/or combination of materials, including, for example, glass, plastic and/or metal. Various exemplary embodiments in accordance with the present teachings contemplate, for example, that the dispensing member 14 can be made of the organic polymer polyaryletheretherketone (PEEK). Those skilled in the art would understand, therefore, that a variety of materials may be chosen for the dispensing member 14 based on cost, efficiency, resistance to corrosion from contact with the cryogenic fluid 21, ability to withstand the temperatures that are generated and other factors.
The dispensing member 14 can dispense the cryogenic fluid 21 via the lumen outlet opening 18. Various exemplary embodiments of the present teachings, for example, contemplate that the dispensing member 14 can dispense the cryogenic fluid 21 at a temperature ranging from about −20° C. to about −100° C. at the lumen outlet opening 18. In various exemplary embodiments, the dispensing member 14 can dispense the cryogenic fluid 21, for example, directly onto a target freeze area, such as, for example, a skin lesion. In various additional exemplary embodiments, the dispensing member 14 can dispense the cryogenic fluid 21 onto an outer surface portion of an applicator that is separate from the device 10 for subsequent application to the skin lesion via the applicator. Yet further exemplary embodiments contemplate that the dispensing member 14 can dispense the cryogenic fluid 21 to an applicator, for example, into a central portion of an applicator, attached in flow communication with the lumen outlet opening 18. Accordingly, the dispensing member 14, including the lumen outlet opening 18, can have various sizes, shapes and/or configurations based upon a desired application and/or treatment. Those ordinarily skilled in the art would understand, therefore, that the dispensing member 14, as depicted in
For direct dispensing applications, for example, an inner diameter of the lumen outlet opening 18 can control the spray and/or jet pattern of the cryogenic fluid 21. For this purpose, various exemplary embodiments of the present teaching consider the lumen outlet opening 18 having an inner diameter ranging from about 0.003 inches to about 0.030 inches. Various exemplary embodiments of the present teachings further consider a variety of hollow fluid retaining and/or constricting devices, such as, for example, a contact cone or receiver, which can be used in conjunction with the device 10, to pool the cryogenic fluid and limit the spread of the freeze to a directed location. Disposable fluid retaining devices 90, such as, for example, neoprene cones or commonly available otoscopic cones, can attach directly to the lumen outlet opening 18, as depicted in
As mentioned above, the dispensing member 14 can also dispense (e.g., spray and/or drip) the cryogenic fluid 21 onto an applicator separate from the device 10 for subsequent application to a skin lesion via the applicator.
In an alternative exemplary embodiment, the dispensing member 14 can dispense the cryogenic fluid 21 to an applicator in flow communication with the lumen outlet opening 18.
Application members in accordance with various exemplary embodiments of the present teachings, such as, for example, bud-shaped tips 103 and 203 and disk-shaped tip 303, can be made of any suitable porous and/or absorbent material, such as, for example, porex®, cotton wool, open-celled foams, a sintered thermoplastic, a sintered metal, a glass or ceramic frit, or a polyolefin or polyester non-woven fabric. Those ordinarily skilled in the art would further understand that the above disclosed bud-shaped tips 103 and 203 and disk-shaped tip 303 are exemplary only and that application members in accordance with the present teachings can have various shapes and sizes without departing from the scope of the present teachings. Those ordinarily skilled in the art would understand, for example, that the material, size, shape and/or configuration of the applicator used can be chosen based upon the desired treatment and/or temperature requirements. For example, in various exemplary embodiments, the dispensing member 14 can dispense the cryogenic fluid 21 to an application member configured to cool through heat of vaporization.
In accordance with various exemplary embodiments of the present teachings, an exemplary method for using the device 10 of the exemplary embodiment of
The operator may then invert the device 10 such that the cryogenic liquid in the reservoir 35 is closer to the flow passage inlet opening 29 than is a gas in the reservoir 35. The operator may actuate the dispensing head 12, for example, by rotating the actuation member 13 in the direction of arrow A in
In various additional exemplary embodiments, the operator may actuate the dispensing head 42, for example, by sliding the actuation member 43 toward a center of the device from a first position, in which an outlet 24 of the flow passage 30 is not aligned and is blocked from flow communication with a dispensing member inlet opening 49, to a second position, in which the flow passage outlet opening 24 is aligned with and in flow communication with the dispensing member inlet opening 49. Upon actuation, an amount of cryogenic fluid 21 may flow from the reservoir 35 toward the dispensing member inlet opening 49 through the flow passage 30, wherein the flow rate of the cryogenic fluid is primarily regulated by passing the cryogenic fluid 21 through at least one porous member 25 in the flow passage 30. The operator may then dispense the cryogenic fluid from the dispensing member 44 to a target location.
Various exemplary embodiments of the present teachings contemplate, for example, dispensing the cryogenic fluid 21 directly onto a surface to be treated from the dispensing outlet 18, or flowing or dispensing the cryogenic fluid to an applicator first for subsequent application to the surface to be treated.
For example, in accordance with various exemplary embodiments of the present teachings, an exemplary method for dispensing a cryogenic fluid via an applicator of the exemplary embodiment of
As also shown in
As above, the container 1920 and other components of the device 1910 can be disposable such that the entire device 1910 can be thrown away when the cryogenic fluid 1821 is used up. In additional examples of the claimed invention, the container 1920 can be configured to be recharged with cryogenic fluid upon depletion. Likewise, the container 1920 can be replaced with a new container with cryogenic fluid upon depletion, and remaining components of the device 1910 can be reused or thrown away.
As shown in the exploded view of the device 1910 illustrated in
Returning to
Valve assembly 2107 also includes a valve slide 2192 machined to slide over and engage the valve body 2191 when the valve assembly 2107 is engaged with housing 1911 and dispensing head 1912 of the device 1910. Valve slide 2192 can incorporate a number of different geometries to provide a slidably engageable fit over valve body 2191. In one example of the claimed invention shown in
Additionally, the o-ring 2184 sealing member surrounding the flow passage outlet opening that is disposed adjacent to the valve slide can be made using synthetic rubber including Buna rubber, nitrile rubber, styrene-butadiene rubber, nitrile butadiene rubber, silicone, and the like. These materials provide a positive seal at the lower operating temperatures of about −90° C. to about −110° C. and are not as susceptible to freezing or losing their mechanical seal than other materials. Other materials such as silicone and natural rubbers can also be used.
As shown in
Returning to
Referring again to
Once the container 1820 is inserted in recess 1823 and activation lever 1802 is fully closed, a user can initiate the delivery of the cryogenic fluid 1821 to the patient. To effect delivery of the cryogenic fluid 1821 to the patient, a user actuates the valve assembly 1807. In the example of the claimed invention shown in
In one embodiment of the claimed invention, the degree to which the button 1859 moves between a first and a second position can be controlled. Likewise, the degree of movement of the valve spring 1885 is affected by the degree of movement of the button 1859, thereby affecting the amount of cryogenic material flows through flow lumen inlet opening 19 (shown in
As illustrated above with regard to
Likewise, the porous members 2194, 2195 can be selected based on efficiency, resistance to corrosion from contact with the cryogenic fluid 1821, ability to withstand the internal pressures and temperatures that are generated and other factors. For example, the porous member 2194, 2195 in the example of the claimed invention illustrated in
The porous members 2194, 2195 can be formed from any suitable material and/or combination of materials, including, for example, glass, plastic, metal, synthetic fluoropolymers, such as, polytetrafluoroethylene (PTFE), and the like. For example, one or more of the porous members 2194, 2195 can be a frit.
As above, the porous members 2194, 2195 can both limit the flow rate of the cryogenic fluid 1821 and filter contaminants out of the cryogenic fluid 1821. The porous members 2194, 2195 can be configured to regulate the rate at which the cryogenic fluid 1821 flows from the reservoir 1835 to the outlet of the dispensing head 1812 to achieve a desired flow rate of the cryogenic fluid 1821 for dispensing to a desired location, whether that location is a lesion to be treated or an application member.
As discussed above, the present teachings contemplate devices that are capable of dispensing a regulated flow of a cryogenic fluid sufficiently cold enough for effective cryosurgical treatment, without over-freezing and/or undesired contact of the cryogenic fluid with other surfaces, such as, for example, healthy tissue or skin surrounding a lesion. To verify the flow regulation capabilities of devices and methods in accordance with exemplary embodiments of the present teachings, various laboratory tests were conducted with and without a porous member disposed in the flow passage. A dispensing head in accordance with the present teachings (i.e., with at least one porous member disposed in the flow passage), for example, demonstrated a flow rate of about 0.035 grams/second, whereas a dispensing head with an unobstructed flow passage (i.e., without a porous member disposed in the flow passage) demonstrated a flow rate of about 0.248 grams/second. Accordingly, given an 8 gram container of cryogenic fluid, a device which utilized the dispensing head without at least one porous member depleted its supply of cryogenic fluid much faster than a device which utilized the dispensing head with at least one porous member (e.g., 32 seconds vs. 228 seconds). Assuming a treatment time of 3 seconds per application, the device which utilized the dispensing head without at least one porous member could, therefore, only perform approximately 10 treatments, whereas the device which utilized the dispensing head with at least one porous member could perform approximately 76 treatments. The tests, therefore, demonstrated that the devices and methods in accordance with exemplary embodiments of the present teachings can dispense a regulated flow of a cryogenic fluid in order to achieve a desired treatment regime.
To further verify the cooling efficiency of devices and methods in accordance with exemplary embodiments of the present teachings, various additional laboratory tests were conducted with the results being illustrated in
In
As illustrated by the TIP thermocouple data in
In
As illustrated by the TIP thermocouple trace in
In
As illustrated by the TIP thermocouple trace in
Accordingly,
For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities, percentages or proportions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about” if they are not already. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present teachings. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the present teachings are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges subsumed therein.
It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.
It should be understood that while the invention has been described in detail with respect to various exemplary embodiments thereof, it should not be considered limited to such, as numerous modifications are possible without departing from the broad scope of the appended claims.
This application is a continuation-in-part application of U.S. patent application Ser. No. 12/489,875, entitled Devices and Methods for Dispensing a Cryogenic Fluid filed on Jun. 23, 2009. This applications claims priority to U.S. patent application Ser. No. 12/489,875, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
Parent | 12489875 | Jun 2009 | US |
Child | 12974430 | US |