Patent Application
20080214965
Ultrasound waves have been widely used in medical applications. For example, ultrasound waves have been used for diagnostic and therapeutic purposes, as well as in many industrial applications. One diagnostic use of ultrasound waves includes using ultrasonic waves to detect underlying structures in an object or a human tissue. In this procedure, an ultrasonic transducer is placed in contact with the object or tissue via a coupling medium and high frequency (1-10 MHz) ultrasonic waves are directed into the tissue. Upon contact with various underlying structures, the waves are reflected back to a receiver adjacent the transducer. By comparison of the signals of the ultrasonic wave as sent with the reflected ultrasonic wave as received, an image of the underlying structure can be produced. This technique is particularly useful for identifying boundaries between components of tissue and can be used to detect irregular masses, tumors, and the like.
In addition to diagnostic uses, ultrasonic energy can also be used for therapeutic purposes. Two therapeutic medical uses of ultrasound waves include aerosol mist production and contact physiotherapy. Aerosol mist production makes use of a nebulizer or inhaler to produce an aerosol mist for creating a humid environment and delivering drugs to the lungs. In particular, ultrasonic nebulizers operate by the passage of ultrasound waves of sufficient intensity through a liquid, the waves being directed at an air-liquid interface of the liquid at a point underneath or within the liquid. Liquid particles are ejected from the surface of the liquid into the surrounding air following the disintegration of capillary waves produced by the ultrasound. This technique can produce a very fine dense fog or mist. Aerosol mists produced by ultrasound are preferred over aerosol mists produced by other methods because a smaller particle size of aerosol can be obtained with the ultrasonic waves. One of the major shortcoming of inhalers and nebulizers is that the aerosol mist cannot be directed to a target area without an air stream, which decreases the efficiency of ultrasound.
Contact physiotherapy applies ultrasonic waves directly to tissue in an attempt to produce a physical change in the tissue. In conventional ultrasound physiotherapy, an ultrasonic wave contacts the tissue via a coupling medium. This direct contact, even if via a coupling medium, may be undesirable for certain medical applications, such as in the treatment of open wounds resulting from, for example, trauma, burns, and surgical interventions.
Commonly-owned U.S. Pat. No. 6,569,099 discloses an ultrasonic device and method for wound treatment, the entire content of which is incorporated herein by reference. This patent discloses, inter alia, a device that sprays liquid particles to a wound via an applicator. The liquid particles provide a medium for propagation of the ultrasonic waves. Commonly-owned U.S. patent application Ser. No. 11/473,934, the entire contents of which is incorporated herein by reference, discloses a removable applicator nozzle for an ultrasound wound therapy device. The disclosed devices and systems can be used in non-contact methods for delivering ultrasonic energy via a liquid mist.
As appreciated, improvements to the applicators used to, for example, deliver ultrasound energy to patient tissue may be desired to produce a more reliable and consistent flow of liquid particles (e.g., liquid particles of a more consistent particle size) to a wound bed or site. Improvements may also be desired to minimize the setup time for operating the devices. Improvements may further be desired to provide devices and methods that can be tailored to the treatment of different types of wounds and/or wounds located in different regions of a patient's body. The present invention provides an improved applicator and kits. These applicators and kits have numerous uses, for example, in methods for delivering ultrasound energy from a non-contact distance.
The present disclosure generally relates to the field of ultrasound wound therapy devices, and more particularly relates to a removable multi-channel applicator for enabling ultrasound energy (with or without a fluid) to be sprayed towards a patient, thus providing a medium for ultrasonic waves to travel through and penetrate the tissue to a beneficial depth to provide anti-bacterial and/or other therapeutic effects. Without being bound by theory, the beneficial properties of the ultrasonic energy and/or fluid may be due to action of the fluid and/or energy on the surface of the wound and/or due to effects of the fluid and/or energy following penetration of the tissue to a beneficial depth.
According to one aspect, the present disclosure provides a removable multi-channel applicator. The applicator is engageable with an ultrasound therapy device and can be used, for example, to deliver ultrasound energy to patient tissue. For example, the applicator can be used with a low frequency ultrasound therapy device in the treatment of wounds.
In a first aspect, the disclosure provides an applicator, comprising a nozzle body. The nozzle body includes a plurality of channels, each channel having an inlet and an outlet. The applicator also includes a nozzle liner having an interior and an exterior surface and being engageable with the nozzle body. The applicator also includes an opening sized and shaped for introducing fluid to the inlets of the plurality of channels. In certain embodiments, the applicator includes a passageway defined by a space between the nozzle body and the nozzle liner.
In certain embodiments, the opening is sized and shaped for introducing fluid to the inlets of the plurality of channels through the passageway. In certain embodiments, the opening is a connector extending from an exterior surface of the nozzle body to an opening on an interior surface of the nozzle body. The connector can permit fluid to flow through the connector into the passageway. In other embodiments, the opening comprises a connection port extending from the nozzle liner.
In certain embodiments, the inlet of at least one of the plurality of channels has a diameter that is larger than a diameter of the outlet of said channel. In other embodiments, the inlet of at least one of the plurality of channels has a diameter approximately equal to a diameter of the outlet of said channel.
In certain embodiments, at least one of the plurality of channels extends distally following a straight line along the nozzle body. In certain embodiments, at least one of the plurality of channels is arranged in a spiral winding fashion about the center axis of the nozzle body.
In certain embodiments, the plurality of channels is on the interior surface of the nozzle body. In certain embodiments, all or a portion of the plurality of channels extends to the exterior surface of the nozzle body.
In certain embodiments, the applicator is sized and shaped for use in treating wounds with an ultrasound therapy device.
In certain embodiments, the nozzle liner further includes a cover, and the opening protrudes from the cover. In other embodiments, the applicator further includes a space created when a horizontal portion of the cover of the nozzle liner is positioned against the nozzle body.
In certain embodiments, the nozzle body further includes a groove for receiving the fluid from the opening, whereby the fluid flows through the groove into the space created by the cover of the nozzle liner and the nozzle body.
In certain embodiments, the applicator further comprises a nozzle face, wherein the nozzle face comprises a proximal portion engageable with a distal opening of the nozzle. In certain embodiments, the nozzle face includes a proximal portion and a distal portion, wherein the diameter of the proximal portion is smaller than the diameter of the distal portion. In other embodiments, the nozzle face includes a proximal portion and a distal portion, wherein the diameter of the proximal portion is larger than the diameter of the distal portion.
When used in operation with an ultrasound therapy device, in certain embodiments, a fluid is pressurized to flow, through the opening, through the plurality of channels, and onto a plurality of sections of a transducer tip portion of the ultrasound wound therapy device. In certain embodiments, the opening comprises a connector, and a fluid is pressurized to flow through the connector, through an opening of the connector, through the plurality of channels, and onto a plurality of sections of a transducer tip portion of the ultrasound wound therapy device. In other embodiments, the opening comprises a connection port, and fluid is pressurized to flow through the connection port, through the plurality of channels, and onto a plurality of sections of a transducer tip portion of the ultrasound wound therapy device. The fluid may be stored in a fluid source (e.g., container), for example a bag, cartridge, canister, or bottle, and is coupled to the connector via a flexible tubing or other conduit. In certain embodiments, the fluid container is physically separate from the device and interconnected with the transducer assembly or applicator only via flexible tubing or other flexible or rigid conduit. In other embodiments, the fluid container is physically connected to the transducer assembly and/or applicator by something other than just flexible tubing. In still other embodiments, the flexible tubing is coupled to the applicator via an opening, for example via the connector, but is also connected or affixed to the applicator or to the transducer assembly at one or more additional points.
The use of a pressurized system for providing fluid to an opening in the applicator (rather than a gravity-dependent fluid flow system) permits movement of the nozzle body relative to the fluid source without disturbing the fluid flow rate or particle size. For example, the use of a pressurized fluid flow system allows the operator of the wound therapy device to hold the device at any angle relative to the fluid source. Similarly, the fluid source and/or connector portion may be placed at any angle or location relative to a longitudinal axis defined by the nozzle body. This substantially increases the range of wounds and patients that can be successfully treated (e.g., patients with wounds in difficult to access places, patients with restricted mobility). Further, this permits the design and use of lower profile, more streamlined devices and nozzles.
For the foregoing reasons, the use of a pressurized system for providing fluid to an opening in the applicator is preferred. However, in other embodiments, a gravity-dependent fluid delivery system is used to deliver fluid to the applicator described herein. Gravity-dependent fluid delivery systems, for example, the systems described in U.S. patent application Ser. No. 11/473,934, can be readily adapted for use with the improved applicator nozzle described herein.
In other embodiments, the applicator is used to deliver ultrasound energy without a liquid spray or other coupling medium. When used in this manner, fluid is not delivered to the transducer, and thus it is immaterial whether the device is otherwise configured for gravity-fed or pressurized fluid delivery.
When used with an ultrasound wound therapy device, it is envisioned that the transducer tip portion of the ultrasound wound therapy device extends between the distal opening of the nozzle liner and the distal opening of the nozzle body, and that fluid flows through the channels and contacts a plurality of sections around a circumference of the transducer tip portion. In a preferred embodiment, a separation distance from a distal end of the transducer tip portion of the ultrasound wound therapy device to the distal opening of the nozzle body is at most equal to about 0.05 inches or at most equal to about 0.06 inches. In another preferred embodiment, a separation distance from the distal opening of the nozzle liner to the distal end of the transducer tip portion of the ultrasound wound therapy device is between about 0.03 inches and about 0.09 inches or between about −0.065 inches and about 0.09 inches. However, other separation distances are possible and are within the scope of the present disclosure.
In certain embodiments, it is envisioned that an applicator is provided that includes the removable multi-channel nozzle of the present disclosure and a nozzle face. This nozzle face has a proximal portion that is configured to engage with the distal end or distal opening of the nozzle. In one embodiment, the nozzle face is a parabolic energy reflector having a proximal portion and a distal portion, wherein the diameter of the proximal portion of the energy reflector is substantially smaller than the diameter of the distal portion. Without being bound by theory, this parabolic energy collector may aid in creating and/or maintaining a standing ultrasound wave pattern between the applicator and a surface of an object, for example a surface of a wound to be treated. Additionally or alternatively, the nozzle face may be sized and shaped to facilitate treatment of particular types of wounds or wounds in a particular location of a patient's body. In an alternative embodiment, the nozzle face has a proximal portion and a distal portion, wherein the diameter of the proximal portion of the nozzle face is substantially larger than the diameter of the distal portion. Such nozzle face configurations may be particularly useful for delivering ultrasound energy and/or liquid spray to an orifice, to an interior region of a patient, or to another difficult to access surface or interior region of a patient. When a nozzle face is used, the nozzle face can be interfitted to the applicator nozzle or the nozzle face and applicator nozzle can be machined as a single component. For example, the nozzle face can be interfitted to the nozzle body.
It is envisioned that at least one of the nozzle and the nozzle face (when provided) is designed for use with a single patient. In certain embodiments, the applicator comprises means to prevent re-use of all or a portion of the applicator. In addition, at least one of the nozzle and the nozzle face is disposable.
In another aspect, the invention provides an applicator for use in treating a wound. The applicator comprises a nozzle body including a plurality of channels, each channel having an inlet and an outlet; and an opening sized and shaped for introducing fluid to the inlets of the plurality of channels. In other words, in certain embodiments, the applicator does not include a nozzle liner. In certain embodiments, when a nozzle liner is not included, it is envisioned that all or a portion of the plurality of channels extends to the exterior of the nozzle body.
In another aspect, the invention provides a kit. In certain embodiments, the kit comprises an applicator and a fluid container, optionally containing a fluid. In other embodiments, the kit comprises an applicator and flexible or rigid tubing, and optionally comprises a fluid container (with or without a fluid). Kits may also include one or more of sterile wipes, directions for use, and a warning reminding the user that the nozzle is intended for use with a single patient. The applicator is an applicator according to the present invention. For example, the applicator includes a nozzle engageable with a portion of an ultrasound wound therapy device. In certain embodiments, the kit further includes one or more interchangeable nozzle faces each engageable with a portion of the nozzle.
In another aspect, the invention provides methods for treating patient tissue from a non-contact distance. For example, an applicator, as described herein, is interconnected to an ultrasound transducer assembly and used to deliver ultrasound energy (with or without a liquid spray) to patient tissue. In certain embodiments, the method for treating patient tissue is a method for treating a wound from a non-contact distance. In certain embodiments, the ultrasound energy is low frequency ultrasound energy. In certain embodiments, the method comprises delivering ultrasound energy and a liquid spray. In other embodiments, the method comprises delivering ultrasound energy alone and in the absence of a liquid spray or coupling medium.
Combinations of any of the foregoing aspects and embodiments of the disclosure are contemplated.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
a presents a perspective view of a removable multi-channel applicator of the present disclosure including an applicator nozzle. The nozzle is depicted as operatively attached to a transducer of an ultrasound wound therapy device and with a fluid container coupled thereto.
b presents a perspective view of the removable multi-channel applicator of an alternative embodiment including an applicator nozzle and an applicator nozzle face. The applicator is operatively attached to a transducer of an ultrasound wound therapy device and with a fluid container coupled thereto.
a-c present an end view, a perspective view, and a profile view, respectively, of the removable multi-channel applicator of
d presents a cross sectional view of a removable multi-channel applicator of an alternative embodiment.
a-b present perspective views of a plurality of removable multi-channel applicator nozzles of alternative embodiments.
a-c present an end view, a perspective view, and a profile view, respectively, of a removable multi-channel applicator nozzle of yet another alternative embodiment.
a-b present alternative embodiments of a removable multi-channel applicator nozzle.
c-d present perspective views of fluid flow pathways of the removable multi-channel applicator shown in
a presents a perspective view of a transducer assembly showing a groove for receiving a tubing.
b presents a perspective view of the transducer assembly shown in
a presents a perspective view of a removable multi-channel applicator of an alternative embodiment operatively attached to a transducer of an ultrasound wound therapy device.
b presents a cross-sectional view of a portion of the removable multi-channel applicator shown in
a-b present perspective views of a plurality of applicator nozzle faces of alternative embodiments.
Embodiments of the presently disclosed removable multi-channel applicator nozzle will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein and as is tradition, the term “distal” refers to that portion which is farthest from the operator while the term “proximal” refers to that portion which is closest to the operator. Of note, the term “distal” also refers to that portion which is closest to the patient or other surface being treated. Further, as used herein, the word “wound” refers to surface wounds, such as burns and skin lesions; internal wounds, such as ulcers and surgical cuts due to surgery; surgical incisions; injuries, including broken bones; and other conditions or applications requiring treatment using ultrasound wound therapy.
Low frequency, non-contact ultrasound has been used in the treatment of wounds. U.S. Pat. No. 6,569,099, hereby incorporated by reference in its entirety, describes the use of ultrasound in wound therapy. Co-pending U.S. application Ser. No. 11/473,934 describes particular transducer and applicator designs, and provides further description for using non-contact ultrasound in the treatment of wounds. The present disclosure describes additional applicator and nozzle designs and kits that can be used, for example, in non-contact ultrasound therapy. For example, these applicators and nozzle designs can be used with existing or modified transducer assemblies as part of systems and methods for treating wounds using non-contact ultrasound. Additionally, however, the applicators and nozzles described herein may be interconnected with other devices intended to efficiently and effectively deliver fluid and/or ultrasound energy.
As used herein, the term “applicator” is used to refer to an applicator nozzle (also referred to as a nozzle). When a nozzle face is interconnected to an applicator nozzle, the term “applicator” refers to the interconnected unit of an applicator nozzle and nozzle face. Thus, in embodiments where a nozzle face is not interconnected to an applicator nozzle, the terms “applicator”, “nozzle”, and “applicator nozzle” are synonymous and can be used interchangeably. The term “nozzle” or “applicator nozzle” is used to refer to a nozzle body comprising a plurality of channels combined with one or more of a nozzle liner; a passageway defined by a space between the nozzle body and the nozzle liner; and an opening for introducing fluid to the plurality of channels. Thus, for example, in certain embodiments, the “nozzle” comprises a nozzle body comprising a plurality of channels and an opening for introducing fluid to the plurality of channels. In other embodiments, the “nozzle” comprises a nozzle body comprising a plurality of channels; a nozzle liner; and an opening for introducing fluid to the plurality of channels. In still other embodiments, the “nozzle” comprises a nozzle body comprising a plurality of channels; a nozzle liner; a passageway defined by a space between the nozzle body and the nozzle liner; and an opening for introducing fluid to the plurality of channels.
In certain embodiments, an applicator, as described herein, in interconnected with an ultrasound wound therapy device and used to deliver ultrasound energy (in the presence or absence of a liquid spray) to patient tissue. When used in this manner, the ultrasound energy (and liquid spray, if present) is delivered without contact between the applicator and the patient tissue being treated. In other words, the ultrasound energy (and liquid spray, if present) are delivered from a non-contact distance. Once delivered, the ultrasound energy penetrates the treated tissue to provide a therapeutic effect.
In certain embodiments, the ultrasound energy delivered is low frequency ultrasound energy. In certain embodiments, the ultrasound energy delivered is low intensity.
In certain embodiments, low frequency ultrasound is delivered (in the presence or absence of a liquid spray) from a non-contact distance and without causing a substantial increase in the temperature of the treated tissue.
For the treatment of certain conditions, it may be preferable to have treatment conducted in a hospital or doctor's office so that a health care professional can monitor the duration and course of the treatment. Under certain circumstances, however, it may be preferable to allow the patient to be treated at home—either by a visiting health professional or by the patient himself.
By “treating” is meant to include decreasing or eliminating one or more symptoms of a condition or disorder. When used in conjunction with an ultrasound device, low frequency ultrasound energy is administered (with or without a liquid spray) to effected tissue of a patient in need thereof. The low frequency ultrasound energy is administered without contact between the effected tissue and the ultrasound transducer or other components of the device (non-contact distance). The low frequency ultrasound energy penetrates the tissue to provide a therapeutic effect. Regardless of the mechanism of action of the ultrasound energy, these methods can be effectively used to treat patients.
Ultrasound energy can be delivered alone. Such methods are often referred to as delivering ultrasound “dry”. In other words, in certain embodiments, the method comprises delivering low frequency ultrasound alone (from a non-contact distance) and in the absence of a liquid spray or other coupling agent. When used in this way, the ultrasound energy penetrates, for example, the tissue to provide a therapeutic effect. Over one or more treatments, improvement in a patient's condition can be observed. In certain embodiments, the ultrasound energy is low frequency ultrasound energy.
In other embodiments, ultrasound energy can be delivered via a liquid spray. Such methods are often referred to as delivering low frequency ultrasound “wet”. In other words, a combination of ultrasound energy and a liquid spray is delivered (from a non-contact distance) to the tissue. The energy, and to some extent the liquid spray, penetrate the tissue to provide a therapeutic effect. Exemplary liquids that can be used to generate a liquid spray include saline or water. Alternatively, the liquids used to generate the spray can themselves be (or contain) a therapeutic agent, such as an antibiotic, analgesic, antiseptic, and the like. In certain embodiments, the ultrasound energy is low frequency ultrasound energy.
In certain embodiments, the method comprises very local delivery of ultrasound energy (in the presence or absence of a liquid spray) to effected tissue. In other words, the goal is to treat, to the extent possible, only effected tissue and not asymptomatic tissue. In other embodiments, the method comprises local delivery that includes effected tissue, as well as adjacent tissue—even if such adjacent tissue is asymptomatic. The patient's health professional can select the appropriate treatment approach, including the number of treatments, the duration of each treatment, and whether the treatment should be “dry” or “wet”.
In certain embodiments, the method for treating a patient, for example a patient with a wound, comprises multiple treatments. For example, patients may receive doses of ultrasound two or more times per week, for one, two, three, four, or more than four weeks. The appropriate number of treatments, and the duration of each treatment, can be determined by a health care provider based on, for example, the particular condition being treated, the severity of the condition, and the overall health of the patient. Furthermore, the health care provider can determine whether treatment should be “wet” or “dry”.
In certain embodiments, the low frequency ultrasound energy delivered is approximately 10-100 kHz, approximately 20-80 kHz, approximately 20-40 kHz, approximately 35-60 kHz, or approximately, 40-50 kHz.
In certain embodiments, the low frequency ultrasound energy is also low intensity ultrasound energy. Intensity refers to the amount of energy transferred to the tissue. In certain embodiments, the low frequency, low intensity energy has an intensity of approximately 0.1 to 2.2 W/cm2.
In certain embodiments, non-contact distance between the distal most surface of the applicator (either the distal most end of the nozzle or, when present, the distal most end of the nozzle face) and the tissue or surface being treated is a non-contact distance of at least 0.1 inches (2.5 mm). In other embodiments, the non-contact distance is from about 2.5 mm to about 51 cm. In other embodiments, the non-contact distance is from about 15 mm to about 25 mm. Regardless of the exact distance, non-contact treatment means that there is no contact between the applicator and the effected tissue or surface that is being treated. It should be noted that non-contact refers to the absence of contact with the tissue or surface that is being treated. However, in certain embodiments, it is possible that components of the applicator or device may contact the tissue or surface that is not being subjected to treatment. For example, to facilitate delivery of the ultrasound energy, a handle of the device may be affixed to a patient's arm, thereby alleviating the need for an operator to hold the device throughout treatment. Such contact with other patient tissue that is not being subjected to treatment does not alter the characterization of the treatment as “non-contact”.
In certain embodiments, the low frequency ultrasound energy does not significantly decrease the viability of human cells of the effected tissue.
Combinations of one or more of any of the foregoing or following aspects and embodiments of the disclosure are contemplated. For example, any of the applicator designs disclosed herein can be used, for example, with an ultrasound device. Further, any of the applicator designs disclosed herein can be used in a therapeutic method to deliver ultrasound energy and/or a liquid spray to patient tissue.
Further exemplary features of the applicators are described below with reference to the figures.
a illustrates, among other components, an applicator 100 having a nozzle 102 (
In certain embodiments, it is envisioned for the applicator 100 of the present disclosure to be designed for use with an ultrasound wound therapy device, such as the device described in U.S. Pat. No. 6,569,099, the entire content of which is incorporated herein by reference. The present disclosure is also related to U.S. Pat. Nos. 6,478,754 and 6,663,554 and U.S. patent application Ser. Nos. 09/684,044 and 11/473,934, the entire content of both patents and both patent applications is incorporated herein by reference.
Briefly, the foregoing patents and applications teach that delivery of ultrasound energy and a liquid mist to a wound, such mist generated by contacting a vibrating ultrasound transducer with drops of liquid, promotes wound healing and decreases the healing time of wounds. Without being bound by theory, the ultrasound energy and/or liquid mist penetrate the tissue to a beneficial depth to provide a therapeutic effect even though the energy is provided to the wound at a non-contact distance (e.g., without contact between the ultrasound transducer and the patient or wound).
The foregoing patents and applications provide various ultrasound transducers and transducer assemblies, treatment algorithms, and exemplary nozzle and fluid delivery designs. Furthermore, the foregoing patents and applications teach the delivery of numerous fluids including, but not limited to sterile water, saline solution (including sterile saline solution), antibiotics, antifungal agents, growth factors, and other medicaments. In certain preferred embodiments, the liquid consists essentially of saline solution or sterile saline solution. In other words, in certain preferred embodiments, saline solution that does not contain a therapeutic medicament is the liquid delivered.
The present invention provides an alternative applicator for use with the ultrasound wound therapy methods, transducers, assemblies, and other components disclosed in the foregoing patents and applications. The invention contemplates combinations of any of the aspects and embodiments of the applicator and fluid container disclosed herein with any of the aspects and embodiments of the ultrasound wound therapy methods, transducers, assemblies, and other components disclosed in the foregoing patents and applications. Additionally, the present disclosure contemplates that the applicator provided herein may be used in other methods of treating patient tissue and/or in combination with other devices or systems for delivering ultrasound and/or fluid to patient tissue.
a-b illustrate an exemplary ultrasound wound therapy device having an applicator 100 connected to a transducer assembly 108, which, in turn, operatively connects to a generator 110. The generator 110 includes various components necessary to supply power to the transducer assembly 108. The generator 110 may also contain a graphical user interface (GUI) for displaying information helpful to the operator. The generator 110 consists of three major functional sections: the AC MAINS, the main board, and the GUI board. The AC MAINS is connected to an appliance inlet with a hospital grade detachable power cord. The appliance inlet is a power entry module listed for medical applications. In certain embodiments, the appliance inlet is a power entry module with an 115 V/230V voltage selection, and is designed to operate on 115 V ac and 60 Hz (e.g., for operation in North America) or 230V ac and 50 Hz (e.g., for operation in Europe).
The MAIN board converts the secondary output voltage from the MAINS transformer to the low voltage power rails for the internal electronics and the drive voltage for the drive electronics to the transducer assembly 108. The MAIN board contains a microprocessor that controls, measures, and monitors the drive electronics. The transducer assembly 108 connects to the MAIN board. The microprocessor, referred to as the engine, monitors the performance of the system and communicates the information to a second microprocessor located on the GUI board. In certain embodiments, the engine communicates to the second microprocessor via a RS-232 communication link. In certain embodiments, the electronics drive the ultrasound portion of the drive electronics with a push-pull converter that has a feedback loop with a Phase Locked Loop (PLL) to track the center frequency of the ultrasound components.
The GUI board provides the graphical user interface for the operator. A custom membrane switch panel with, for example 6 keys, allows the operator to select the functions and operating parameters of the system. A purchased graphical LCD display, connected to the GUI board, can be used to display information to the operator. For example, information about the system's status, mode of operation, and treatment time can be displayed via the GUI. The GUI may have a back light generator for the LCD on it. The GUI microprocessor runs the system by controlling the human interface and running the various algorithms to control the operation of the system. For example, a treatment algorithm can be run on the GUI microprocessor. In certain embodiments, the ultrasound wound therapy device may include one or more of a timer to record total treatment time, a timer to count-down from a selected treatment time to zero, and an alarm to indicate that the total treatment time has elapsed or that there is a problem with some component of the device.
a depicts an applicator 100 having a nozzle 102. In an alternative embodiment, as shown in
a-b also show a switch 112a that may control one or more of the power supplied to the transducer assembly 108, the flow of fluid, or the fluid flow rate. Also shown is a fluid source 114 and tubing 116 that interconnects the fluid source 114 to the nozzle 102 via a connector 210. As depicted, the connector comprises an opening in communication with the plurality of channels in the interior of the nozzle body, such that fluid can flow from the fluid source to the plurality of channels.
Although not shown in
In use, the transducer tip portion is shielded by the applicator such that neither an operator nor a patient can readily contact the transducer tip portion. The entire transducer tip portion, including the distal most end, is shielded by the applicator once the applicator is interconnected to the transducer assembly (See, elements 706 and 704 of
a-c illustrate an exemplary applicator 100 including a multi-channel applicator nozzle 102 and a nozzle face 104. The nozzle 102 includes a connector 210, a nozzle liner 208, a nozzle body 206 coaxially disposed around the nozzle liner 208, and a distal nozzle opening 212 defined by a distal end of the nozzle body 206. The nozzle 102 also includes a plurality of channels 214 in the interior surface 222 of the nozzle body 206. These channels may be injection molded in place during the manufacture of the nozzle. In some embodiments, the channels may be etched or machined. The nozzle body 206 and the nozzle liner 208 may be injection molded using thermoplastic ABS (Acrylonitrile-Butadiene-Styrene).
As depicted in
In some embodiments, the nozzle liner 208, which may have a truncated conical shape, is snap fitted to the nozzle body 206, which may also have a truncated conical shape. In certain embodiments, when the nozzle liner 208 is fitted to the nozzle body 206, a space is created between the nozzle liner 208 and the nozzle body 206. In some embodiments, a passageway 228 is defined by this space. The space is enclosed by the nozzle liner 208 and the nozzle body 206. In some embodiments, the passageway 228 has a ring shape with a triangular cross section (shown in
d shows a cross sectional view of the inlets 226 of the channel 214 being in contact with the passageway 228. As the pressurized fluid fills the enclosed passageway 228, the fluid flows into the multiple channels 214 through the respective inlets 226 of the channels 214.
When the fluid exits from the plurality of channels 214 via respective channel outlets 230, the fluid contacts a tip portion 706 of the transducer assembly 108 at multiple sections around a circumference of the tip portion 706. The inlets 226 and outlets 230 of the channels 214 may be appropriately sized to allow an even coating around the entire circumference of the tip portion 706. In some embodiments, the tip portion 706 of the transducer assembly 108 wicks the fluid around its circumference. In some embodiments, having a plurality of evenly spaced channels 214 around the circumference of the tip portion 706 of the transducer assembly 108 may shorten the time needed for the fluid to coat the circumference of the tip portion 706 before the transducer assembly 108 is activated. In certain embodiments, once the fluid begins to flow onto the transducer assembly 108 from the multiple channels 214 of the nozzle 102, almost no time is delayed for the fluid to fully coat the tip portion 706 of the transducer assembly 108.
The connector 210 of the nozzle 102 is configured to receive the fluid into the interior of the nozzle 102. In certain embodiments, the fluid is pressurized to enter the nozzle 102 via the connector 210 once a user unclamps the tubing 116 that interconnects the fluid container 114 to the connector 210 or otherwise begins the flow of fluid from the fluid container 114. Such unclamping can be performed manually by the user. In some embodiments, a peristaltic pump is used. A peristaltic pump at least includes a rotor and rollers or other tube-engaging members movable within a housing relative to the clamped flexible tubing. A peristaltic pump typically includes between four to six rollers. The rollers compress the clamped flexible tubing. As the rotor turns, the part of the tube under compression gets pinched and the pinching motion forces the fluid to move through the tube. The rollers relax the clamped flexible tubing as the rotor turns and the flexible tubing opens to its original state to induce fluid flow.
In some embodiments, the pressurized fluid is delivered to the connector and to the nozzle at a constant flow rate regardless of the quantity of fluid in the fluid container, the angle or orientation of the transducer assembly 108 or applicator 100, or the position of the fluid container 114 relative to the transducer assembly 108. Hence, the use of a pressurized delivery system such as a peristaltic pump may allow the connector 210 to be placed at any angle or orientation relative to the nozzle 102. For example, the center axis defined by the connector may be substantially perpendicular, parallel or at an angle in relation to the longitudinal axis of the nozzle. In addition, the connector may be placed upright in relation to the transducer assembly, as depicted in
In certain nozzle designs, the circumference of the nozzle 102 decreases distally. In other words, the diameter of the distal opening 212 of the nozzle 102 may be smaller than the diameter of the proximal portion 202 of the nozzle 102. In certain embodiments, the diameter of the distal opening 212 of the nozzle 102 is approximately 60% the diameter of the proximal portion 202. In certain embodiments, the diameter of the distal opening 212 is approximately 50%, 40%, 33%, 30%, 27.5%, or 25% the diameter of the proximal portion.
In the illustrative embodiment of
In certain embodiments, the nozzle body includes a plurality of channels, each of which has the same or approximately the same cross-sectional channel size. In other embodiments, at least one of the plurality of channels has a cross-sectional channel size that differs from at least one other of the plurality of channels.
In an alternative embodiment, as shown in
The flow rate of the fluid may be controlled by the diameter of the inlets and outlets of the channels and/or the applied fluid pressure. In certain embodiments, the diameter of the inlet and the outlet of the channel may be reduced to minimize the amount of fluid that drips from the applicator 100. In such situations, the applied fluid pressure may be increased to maintain the flow rate with the reduced diameter of the channel.
In certain embodiments, it is envisioned for the diameter of the connector opening 224 of the connector 210 to be about 0.035 inches or greater. In certain embodiments, the diameter may be about 0.08 inches. It is envisioned for the diameter of the channel inlets 226 to be about 0.05 inches. In certain embodiments, the diameter of the channel outlets 230 may vary with the number of channels in the nozzle. For example, the diameter of the channel outlets 230 for the four-channel nozzle design of
The nozzle liner 308, in some embodiments, includes a snap-fit locking feature (not shown) to create a snap-fit between the nozzle liner 308 and the nozzle body 306. In certain embodiments, the nozzle body 306 includes horizontal walls 314 for receiving the nozzle liner 308 as shown in
In some embodiments, the inlets 226 may be aligned away from the space 326 (
In this embodiment, the nozzle body 306 additionally includes a snap-fit indent (not shown) for locking the nozzle liner 308 in place. However, in other embodiments, the nozzle liner 308 may be welded to the nozzle body 306 to create a tight seal between the nozzle liner 308 and the nozzle body 306.
a illustrates an exemplary ultrasound wound therapy device having an applicator 100 connected to a transducer assembly 108.
b also shows a distal end 704 of the transducer tip portion 706 of the transducer assembly 108 extending longitudinally past the distal opening 232 of the nozzle liner 208, but not to a location that is distal to the distal opening 212 of the nozzle 102. That is, when the applicator 100 is engaged to the transducer assembly 108, the distal end 704 of the transducer assembly 108 extends between the distal opening 232 of the nozzle liner 208 and the distal opening 212 of the nozzle 102. In other words, the distal end 704 of the transducer assembly 108 does not protrude out of the nozzle 102 (the distal end 704 of the transducer assembly 108 is proximal to the distal most portion of the applicator). In such embodiments, an operator or patient cannot inadvertently contact the transducer tip portion 706. Given that the transducer tip portion 706 (including the distal end 704) vibrates during use, inadvertent contact with the vibrating transducer tip portion 706 may cause injury to a user or damage the device.
In certain embodiments, a longitudinal separation distance 708, shown in
Referring to
In certain embodiments, a longitudinal separation distance between the distal end 704 of the tip portion 706 of the transducer assembly 108 and the surface or object to be sprayed is a non-contact distance of at least 0.1 inches (2.5 mm). Preferably, the separation distance is from about 2.5 mm to about 51 cm, more preferably, from about 15 mm to about 25 mm. In certain embodiments, as shown in
In certain implementations, a nozzle face 104 is further coupled to the wound therapy device. A nozzle face 104 of the applicator 100, such as an energy reflector depicted in
As depicted in
In some embodiments, the proximal portion 216 of the nozzle face 104 slides over a distal portion 204 of the nozzle 102 and is secured into place via, for example, aligning slots (not shown) and aligning pins (not shown) disposed over surfaces of the energy reflector 104 and the nozzle 106, respectively. By way of further example, the nozzle face 104 and the nozzle 102 may be coupled by a snap fit or a half-turn closure.
Nozzle faces 104 of different shapes and sizes may be used to provide different treatment conditions or to treat different types of wounds. A nozzle face 104 may also further decrease the likelihood of inadvertent contact between the tip portion 706 of the transducer assembly 108 and a patient or an operator of the transducer assembly 108. In one example, a nozzle face 104 having a parabolic shape, such as the parabolic nozzle face 104 of
The foregoing examples are merely illustrative of the range of nozzle faces that can be used in combination with the nozzle provided herein. Any of the foregoing nozzle faces can be readily used to optimize treatment of a particular patient or a particular type of wound. In certain embodiments, the applicator comprises a nozzle interconnected to a nozzle face. For example, the nozzle face may be interconnected to the nozzle body via the distal opening, distal portion, or distal end of the nozzle body.
Although not depicted, the fluid container may also be directly affixed to or housed within the transducer assembly. For example, a disposable or refillable fluid cartridge may be directly affixed to or housed within the transducer assembly. Regardless of whether the fluid container is a bag (such as a standard IV bag), a cartridge, or a bottle, fluid flow to the applicator can be modulated with, for example, a clamp, a valve, a peristaltic pump, or the like. In certain embodiments, fluid flow is regulated by an on/off switch located on the transducer assembly or the generator. In certain embodiments, a single on/off switch controls fluid flow and the ultrasound transducer. In other embodiments, separate switches or mechanisms control fluid flow and the ultrasound transducer.
The fluid provided to and sprayed from the transducer assembly may be of any appropriate carrier, such as saline, water (regular or distilled), or oil (such as a vegetable, peanut, or canola oil), optionally with a soluble pharmaceutical (e.g., an antibiotic), antiseptic, conditioner, surfactant, emollient, or other active ingredient. The fluid can also be a combination of two or more fluids and/or substances having microscopic particles, such as powder and the like. Exemplary fluids include, but are not limited to, sterile water, saline solution, oil, oxygenated water, or other isotonic or hypertonic solutions. Exemplary fluids may, in certain embodiments, further include drugs (e.g., therapeutic agents) such as antibiotics, anti-fungals, anti-virals, growth factors, analgesics, narcotics, and the like, formulated in any of the foregoing fluids or in other pharmaceutically acceptable fluids appropriate for the formulation of the particular drug. However, in certain embodiments, the fluid does not include a therapeutic drug. The fluid may be sterilized so that, in use, a spray of a sterile solution can be administered to patients. In certain embodiments, the fluid further includes one or more preservatives appropriate for extending the shelf-life of the fluid.
As can be appreciated, the apparatus, as described, is compatible for use with a pressurized system for delivering pressurized fluid to the transducer assembly 108. An exemplary pressurized system is depicted in
A gravity feed system may also be utilized with the devices of the present disclosure. For example, the applicator 100 may additionally include a cup that is designed to hold a fluid bottle in a relative upright position above the nozzle 102. This cup may be coupled to the nozzle 102 via the connector 210 which may include a valve structure for controllably supplying the fluid from the bottle to the nozzle 102. Alternatively, a fluid bottle or other fluid source may be directly interconnected to the connector or other opening in the absence of a cup, but optionally including a valve. An exemplary gravity-feed system is described in detail in U.S. patent application Ser. No. 11/473,934, the entire contents of which is incorporated by reference herein.
However, using a fluid container 114 and a pressurized fluid delivery system (e.g., pump 404 shown in
In certain other embodiments, a fluid container of virtually any size or shape is contemplated. However, given that larger containers are relatively heavy when filled with fluid, the fluid container may be placed on a counter-top, cart, or hung from a pole. In one implementation, the fluid container rests or is affixed to the same cart upon which the ultrasound wound therapy device sits.
Additionally, in certain embodiments, the applicators 100 are disposable, and can be readily removed from the transducer assembly 108 and changed between patients or changed between each use even for the same patient. In certain embodiments, an applicator 100 is changed between each patient. Changing the applicator 100 between uses, such that each wound is treated with a fresh applicator 100, prevents contamination between patients or between wound sites on the same patient.
In certain embodiments, the applicator 100 and/or ultrasound wound therapy device contain means for encouraging or requiring that the applicator 100 be replaced following a single use. In other words, the applicator 100 and/or the ultrasound wound therapy device comprises means such that, once an applicator is engaged to a transducer assembly and then removed, the operator is prevented or discouraged from subsequently re-engaging the same applicator to a transducer assembly. Single use of the applicator 100 is recommended by the manufacturer to prevent non-sterile use and/or cross-contamination between patients. For example, a message can be displayed by an LCD or other display located on the ultrasound wound therapy device to remind and encourage user compliance with the recommended use of the applicator 100. Alternatively or additionally, the applicator 100 or ultrasound wound therapy device may include means for preventing nozzle re-use. In other words, the applicator 100 or ultrasound wound therapy device may include a mechanism that inhibits or prevents an operator from using a single applicator 100 to treat multiple patients and/or multiple wounds. Exemplary mechanisms for providing such preventive measures, including for example, an IC chip, a timer, an expanding foam, and/or a radio frequency tag, are described in detail in the U.S. patent application Ser. No. 11/473,934, the entire contents of which are incorporated herein by reference.
In certain embodiments, the nozzle 102 may include a locking device to prevent re-coupling of the transducer assembly 108 to the applicator 100. The locking device may be pre-assembled to the nozzle 102 and remain in a ready-to-be used position prior to use. In some embodiments, as the transducer assembly 108 couples to the applicator 100, the locking device shifts to an open position and remains in this position during the operation. Following the de-coupling of the transducer assembly 108 from the applicator 100, the locking device shifts to a closed position. In the closed position, an arm from the locking device may protrude through an aperture (not shown) located on the nozzle 102 to prevent the transducer assembly 108 from coupling to the applicator 100 again.
In certain embodiments, the liquid spray from the ultrasound wound therapy device provides significant improvements for wound care and patient comfort during treatment. Specifically, the fluid spray produced from the applicator 100 has a uniform particle size, thus enhancing the efficiency with which the ultrasound energy is carried to the wound site. In addition, the non-contact distance from which the ultrasound energy and the fluid spray is delivered to the wound site results in beneficial effects including, but not limited to, decreased healing time, improved healing (e.g., more complete wound closure), and decreased incidence of infection. Without being bound by theory, this may be due to the ability of the emitted ultrasound energy and/or the fluid spray to penetrate the wound tissue to a beneficial depth. Additionally, action of the ultrasonic energy and/or the fluid spray at the wound surface may contribute to the therapeutic effect. Furthermore, the liquid spray may be delivered at a temperature that does not result in substantial heating of the wound tissue, which minimizes aggravation of the wound.
The applicator 100 or ultrasound wound therapy device may optionally be provided with a laser or ultrasonic transducer for measuring the non-contact distance or stand-off distance from a wound surface. A feedback control mechanism can also be provided for indicating whether the measured non-contact distance is suitable for effecting optimum beneficial bactericidal, therapeutic and/or other effects. The feedback assembly is integrated with the transducer assembly 108 and corresponding electronics housed within an ultrasonic generator 110 for obtaining the measured non-contact distance data and processing the data to determine whether the measured non-contact distance is optimum for treatment purposes. If the non-contact distance is determined not to be the optimum non-contact distance, the feedback control mechanism can sound an audible alarm or display a message on a display, such as an LCD display. The alarm or message can indicate if the non-contact distance should be decreased or increased. If the nozzle 102/ultrasound wound therapy device is mounted to a robotic arm, the feedback control mechanism can in turn control the robotic arm for increasing or decreasing the non-contact distance.
Regardless of the particular mechanism of action, the delivery of ultrasonic energy and a fluid spray at a non-contact distance improves wound healing and decreases infection. Briefly, emitted energy and the fluid spray are applied to the wound. In certain embodiments, the energy and fluid spray are applied for a treatment time proportional to the size of the wound. For example, the approximate size of the wound can be inputted into the ultrasound wound therapy device and the device sets a treatment time based on the size of the wound. The ultrasound wound therapy device may also be able to recommend an appropriate applicator nozzle face for providing the suitable ultrasonic energy pattern and/or intensity to treat such wound. Generally, treatment times vary from approximately 5 minutes to approximately 30 minutes. However, shorter and longer treatment times are contemplated. As described above, nozzle faces 104 of different sizes and shapes may also be used to treat different types of wounds. For example, a small wound situated in an area of the body that is difficult to reach may be treated with a nozzle face 104, as depicted in
According to one illustrative treatment regimen, once emitted energy and fluid spray are emerging from the applicator 100, the operator can direct the energy and spray to the wound. In one recommended embodiment, the wound is treated by slowly moving the applicator 100 head back and forth and/or up and down (at a non-contact distance) across the wound. The spray pattern may be, for example, serpentine or substantially checkerboard in pattern. This delivery method has two advantages. First, this method helps insure that ultrasonic energy and liquid spray are delivered to the entire wound. Second, this method may help prevent operator fatigue that would likely result if the device was held in substantially the same place throughout the treatment. In one embodiment, the applicator 100 is held such that the ultrasonic energy and liquid spray are delivered substantially normal to the surface of the wound. In an alternative embodiment, the applicator 100 can be held at any position in relation to the surface of the wound. Additionally, the spray pattern may include moving the applicator 100 in-and-out relative to the wound surface (e.g., varying the distance from the wound while maintaining a non-contact distance). Such a spray pattern helps ensure that a wound, which varies in depth across its surface area, is treated at an effective distance. The spray pattern may also be varied by using an appropriate nozzle face 104 designed to facilitate the production of certain spray pattern.
In one embodiment, the need for a human operator is eliminated. The transducer assembly 108 is affixed to a robotic arm programmed to direct the emitted energy and liquid spray to the wound.
As outlined above, in certain embodiments the emitted ultrasonic energy and fluid spray are applied to the wound for a treatment time proportional to the size of the wound. In one embodiment, the invention provides a treatment algorithm for selecting treatment time based on the size of the wound. The time for each treatment is selected based on the area of the wound. For example, the area of the wound is calculated by measuring the length of the wound (at its greatest point) and the width of the wound (at its greatest point and perpendicular to the length). The length and width of the wound can be measured, for example, in centimeters. The area of the wound (in square centimeters) is calculated by multiplying the length times the width of the wound. The treatment time is proportional to the area of the wound.
Based on the algorithm, the following approximate treatment times may be selected based on wound size: 3 minutes for wounds with an area of less that 10 cm2; 4 minutes for wounds with an area of 10-20 cm2; 5 minutes for wounds with an area of 20-30 cm2; 6 minutes for wounds with an area of 30-40 cm2; 7 minutes for wounds with an area of 40-50 cm2; 8 minutes for wounds with an area of 50-60 cm2; 9 minutes for wounds with an area of 60-70 cm2; 10 minutes for wounds with an area of 70-80 cm2; 11 minutes for wounds with an area of 80-90 cm2; 12 minutes wounds with an area of 90-100 cm2.
In certain embodiments, the ultrasonic wound therapy device is programmed with the algorithm. The operator enters the wound size into the device using a keypad. A treatment time is selected based on the wound size. In certain embodiments, the ultrasound wound therapy device includes a timer that counts down from the treatment time. When the treatment time has elapsed (e.g., the timer has ticked down to zero), the ultrasound wound therapy device may automatically shut off. In other words, after the treatment time has elapsed, the power shuts off and the transducer stops vibrating. It is appreciated that a timer and automatic shut off mechanism have utilities apart from their use in conjunction with treatment times proportional to wound size. Such timers may be used even in the absence of a treatment time algorithm (e.g., a timer can be used when the total treatment time is selected by the individual operator). Additionally or alternatively, an alarm may sound to alert the operator when the treatment time has elapsed.
The above algorithm does not direct the frequency (total number or number/week) of treatments. Furthermore, as the wound heals, the treatment time may be reassessed and recalculated in accordance with the decreasing size of the wound. Additionally, the above treatment algorithm is only one way to select an appropriate treatment time. Wounds may be treated for a longer or shorter period of time than that recommended based on the treatment algorithm.
Further, the above algorithm is merely exemplary. Other treatment algorithms can be used based on, for example, the severity of the wound, the cause of the injury, the area of the body effected, and the health of the patient. Moreover, other treatment algorithms may be appropriate when the applicator is used with an ultrasound therapy device, but for non-wound indications.
The foregoing describes methods for using an applicator 100 with an ultrasound wound therapy device to deliver ultrasound energy and a liquid spray. However, as detailed throughout, an applicator 100 can also be used in methods for treating tissue in which ultrasound energy is delivered in the absence of a liquid spray or coupling agent. The foregoing exemplary features, including the use of a treatment algorithm, various means for preventing re-use of the applicator, and components for determining and maintaining the appropriate non-contact distance from the patient tissue, are equally applicable when the applicator is used in the absence of a liquid spray or coupling medium.
The present invention contemplates a variety of kits. In one embodiment, a kit includes one or more of an applicator 100 (e.g., a nozzle 102, and optionally one or more nozzle faces 104), a fluid bag 114, and flexible or non-flexible tubing 116 sized and shaped to interconnect the fluid bag 114 to the connector 210 of the nozzle 102. The kit may optionally include directions for use and/or one or more sterile swabs. The sterile swabs can be used to wipe, prior to or after use, one or more of: the fluid bag 114, all or a portion of the applicator 100, all or a portion of the tubing 116, all or a portion of the transducer assembly 108, and all or a portion of the ultrasound wound therapy device. In certain examples, the fluid bag 114 includes a sterile fluid suitable for use in the treatment of a wound. Any of the foregoing kits may be sterilized prior to packaging such that the contents of the kit are sterile. The kits can be marked to indicate that they are intended for use with a single patient.
In another embodiment, the kit does not include the fluid bag 114. In certain embodiments, the kit includes the applicator nozzle and tubing, and the operator may use any appropriate fluid bag. In certain other embodiments, the applicator 100 includes a nozzle, a valve and a cup. This kit may be specifically intended for use in conjunction with a bottle. Optionally, this applicator 100 may be packaged with a bottle including a fluid, where the bottle is sized and shaped to fit onto the cup of the applicator 100. This kit may optionally include directions for use and/or one or more sterile swabs.
Kits containing an applicator and any one or more of the foregoing kit components are contemplated. Additionally, kits can be packaged and/or sold alone or with an ultrasound therapy device.
It is to be understood that the foregoing description is merely a disclosure of particular embodiments and is in no way intended to limit the scope of the disclosure. All operative combinations of any of the foregoing aspects and embodiments are contemplated and are within the scope of the invention. Other possible modifications will be apparent to those skilled in the art.
This application claims the benefit of priority to U.S. provisional application Ser. No. 60/878,621, filed Jan. 4, 2007. The disclosure of the foregoing application is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60878621 | Jan 2007 | US |
