Systems and methods for treating fluid retention
The application of air streams to induce subsurface pressure changes addresses the limitations of existing edema treatments by facilitating rapid, painless, and customizable fluid drainage, enhancing recovery by moving fluids efficiently to natural drainage areas.
Patent Information
- Application Number
- JP2025513476
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-09-01
- Filing Date
- 2023-09-01
- Publication Date
- 2025-09-04
AI Technical Summary
Existing treatments for fluid retention-related edema, such as compression devices and negative pressure devices, are cumbersome, lack customization, and can cause discomfort or damage, while pharmaceutical treatments only mask symptoms, leading to prolonged recovery and increased healthcare costs.
The application of an air stream to the skin induces subsurface pressure changes, using directional and localized air nozzles to shear-thin and move stationary fluids toward natural drainage areas without physical contact, facilitating rapid and painless drainage of lymphatic, vascular, and interstitial fluids.
This method reduces swelling and inflammation faster than traditional methods, allowing earlier intervention post-surgery or trauma, promoting quicker recovery by effectively moving fluids without causing discomfort or skin damage, and providing customizable treatment for various body parts.
Smart Images

Figure 2025529296000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 403,032, filed September 1, 2022, the entire contents of which are incorporated herein by reference in their entirety for all purposes. [Background technology]
[0002]
[0002] The lymphatic system is the body's fluid management system, complementary to the blood circulatory system. Blood passing through capillaries naturally leaks from vascular beds into surrounding tissues, primarily in the form of plasma, some of which remains permanently in the tissue and travels throughout the tissue as interstitial fluid, delivering nutrients to cells. This interstitial fluid is collected by lymphatic vessels and passes through lymph nodes, where it is cleared of cellular debris, bacteria, and other pathogens, and ultimately returned to the blood circulation. The lymphatic system serves the important dual function of combating infection as part of immune defense and of regulating tissue volume and pressure by returning interstitial fluid to the blood circulation (e.g., via the reduction of edema).
[0003]
[0003] Edema is the accumulation of interstitial fluid within tissues, resulting in swelling (often visible) due to an overall condition known as fluid retention. Tissues are normally infused with interstitial fluid, which constantly moves through and is exchanged. However, when fluid removal via the lymphatic system is impaired and / or fluid infiltration is increased (e.g., by anticancer therapeutic agents), an accumulation of interstitial fluid can occur, inducing different types of edema, which can cause pain and discomfort to the patient and / or limit mobility of the affected area.
[0004] The presence of edema often adversely affects the outcome of surgical interventions. Preoperative edema can be present due to concurrent conditions, such as trauma. Excessive mechanical stretching or compression of soft tissues often leads to extravasation of blood / plasma from capillaries and the movement of intercellular fluid. Furthermore, posttraumatic inflammation itself causes lymphocyte infiltration into the affected area, increasing edema. Preoperative edema is a recognized risk factor for the development of postoperative infection, a major complication typically treated with antibiotic therapy and resulting in prolonged healing. Recent studies have shown that patients with lymphedema before total hip replacement surgery have a 7.3% reduced 5-year infection-free survival rate. Similar results have been observed for total knee replacement surgery, making preoperative edema a concern for those undergoing immediate surgery.
[0005] Even when patients enter surgery in the best possible condition, the surgery itself is often traumatic to tissues. Surgery often involves severing capillaries and lymphatic vessels and inflicting mechanical trauma on soft tissues and bone, resulting in fluid extravasation, inflammation, and ultimately edema. Postoperatively, edema (characterized by increased pressure within tissues and reduced fluid circulation) impedes the removal of cellular debris and inhibits the provision of growth factors, thereby impeding healing. Postoperative edema also reduces joint mobility, increasing the length of recovery and rehabilitation.
[0006] Inflammation, edema, and associated pain are poorly understood phenomena in medicine today and are too often treated solely by prescribing medications that merely mask the pain and are often highly addictive. Other non-pharmaceutical solutions, such as cryotherapy and compression, can be extremely uncomfortable and only temporarily effective. Today's active population increasingly seeks to return to normal activities as quickly as possible after surgery and other physical injuries, yet few effective, non-traumatic, non-pharmaceutical options exist. A major shift in how fluid retention-related inflammation and edema are treated is clearly needed. Whether resulting from surgery, cancer treatment, injury, or other causes, inflammation and fluid retention must be mechanistically addressed at their core to achieve immediate, lasting results without simply masking the symptoms. Overall, these conditions represent billions of dollars in losses to the U.S. healthcare system. There has long been a need for a treatment for fluid retention that can effectively and efficiently return patients to their normal selves.
[0007]
[0007] Existing techniques and devices for treating fluid retention-related edema include continuous compression devices, negative pressure devices, and manual massage. Compression devices are typically fully adjunct devices that apply peristaltic action to slowly move edema fluid within the legs or arms proximally. However, compression devices may not be suitable for treating fluid retention in non-elongated areas of a patient, such as the head, axilla, hand, and shoulder areas. Excess edema fluid may also accumulate around the proximal end of the compression device. Another drawback of compression devices may be due to the lack of customization required to accommodate a patient's body size / type and individual needs. Compression devices are also cumbersome to use, which may reduce patient compliance.
[0008]
[0008] Taskinen et al. (U.S. Patent No. 10,973,731) disclose a massage device that utilizes negative pressure to stimulate lymphatic fluid. A major drawback of this type of technology is that it physically interacts with the body by pulling the skin up into a suction cup-type device, which can cause discomfort and damage to the skin. [Prior art documents] [Patent documents]
[0009] [Patent Document 1] U.S. Patent No. 10,973,731 Summary of the Invention
[0010] The following presents a simplified summary of some embodiments of the present technology in order to provide a basic understanding of some embodiments. This summary is not an extensive overview of the invention. It is not intended to identify key / critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments in a simplified form as a prelude to the more detailed description that is presented later.
[0011]
[0010] The systems and methods disclosed herein for treating fluid retention (e.g., edema) use the application of an air stream to a patient's skin to induce subsurface pressure changes that induce the movement of quiescent fluid toward one or more natural drainage areas for uptake / recycling. The systems and methods disclosed herein can produce rapid, visible results and provide relatively painless drainage of stagnant vascular, lymphatic, and interstitial fluid within tissues and blood vessels. The air stream can be applied to any externally exposed part of the patient, and the patient can be positioned in any suitable position (e.g., standing, prone, sitting, etc.). The systems and methods described herein can be used timely after surgery or trauma. With some existing techniques that use direct mechanical manipulation, it can take several weeks for the surgical incision or injury to heal sufficiently to respond to such direct mechanical manipulation without inducing excessive pain, discomfort, or dehiscence. Because the air streams used in the systems and methods described herein interact with the patient in a less traumatic manner than direct mechanical manipulation, the systems and methods described herein can be used sooner, thereby reducing post-operative / post-injury swelling and inflammation and leading to a faster recovery. The systems and methods described herein can provide static fluid movement without physically touching the patient, which is particularly advantageous when treating patients with broken skin that may otherwise be damaged by gentle touch or even direct manual manipulation.
[0012]
[0011] Bodily fluids involved in the development of edema include blood, lymph, and interstitial fluid (collectively referred to herein as "resting fluids," recognizing that one or all of these fluids may not be completely resting at any given time), each of which can be classified as a non-Newtonian fluid (having variable viscosity), or more specifically, a shear-thinning type of non-Newtonian fluid (viscosity decreases with increasing pressure). Due to trauma, illness, cancer treatment, or other reasons, these non-Newtonian fluids can become thickened and resting, often resulting in edema. In many embodiments, pressure changes and / or the application of shear forces are used to reduce the viscosity of resting fluids and induce the movement of less viscous fluids to known areas of drainage.
[0013]
[0012] Accordingly, in one aspect, a system for treating fluid retention includes a directional air stream nozzle, an airflow hose, and an airflow generator. The directional air stream nozzle includes a directional air stream nozzle inlet configured to receive an airflow and a directional air stream nozzle outlet orifice configured to output a directional air stream generated from the airflow. The directional air stream is configured to be directed onto the patient's skin to induce shear thinning of the stationary fluid and movement of the stationary fluid toward one or more natural drainage areas of the stationary fluid. The directional air stream nozzle outlet orifice has a directional air stream nozzle outlet orifice cross-sectional area. The airflow hose is configured to supply an airflow to the directional air stream nozzle. The airflow generator is operable to generate and output an airflow to the airflow hose at a flow rate. The ratio of the flow rate to the directional air stream nozzle outlet orifice cross-sectional area is 0.004(m 3 / min) / mm 2 ~0.020(m 3 / min) / mm 2 The flow rate is at least 0.85 m 3 / min. In many embodiments, the stationary fluid comprises one or more of interstitial fluid, blood, or lymph.
[0014] The flow parameters of the directional air stream can be controlled by the configuration of the directional air stream nozzle and the flow rate of the air stream. For example, in some embodiments, the flow rate is 1.3 m 3 / min ~7.1m 3 / min. In some embodiments, the airflow has a pressure in the range of 10,000 Pa to 35,000 Pa within the directional air stream nozzle upstream of the directional air stream nozzle exit orifice. In some embodiments, the directional air stream nozzle exit orifice has a cross-sectional width and a cross-sectional length that is at least two times greater than the cross-sectional width. In some embodiments, the directional air stream nozzle exit orifice is shaped to conform the directional air stream to the shape of the anatomical region of the patient being treated.
[0015] In some embodiments, the directional air stream nozzle is configured to create a zone of negative pressure below the directional air stream nozzle sufficient to lift the skin toward the directional air stream nozzle. For example, the directional air stream nozzle can be configured to create an external air flow channel extending between the skin and the directional air stream nozzle, through which a secondary air flow is drawn through the air stream, thereby generating a zone of negative pressure via a Venturi effect.
[0016] The directional air stream nozzle can be configured to be pressed against a patient to apply pressure directly to the skin to shear-thin and / or displace stationary fluid. For example, in some embodiments, the directional air stream nozzle includes lower surface protrusions shaped to be applied against the skin to apply pressure to the skin to shear-thin and / or displace stationary fluid. The lower surface protrusions can be provided with an underside having a suitable shape (e.g., flat, convex, concave) that complements the typical shape of the target area of fluid retention. In some embodiments, the directional air stream nozzle includes rollers configured to roll along the skin and apply contact pressure to the skin to shear-thin and / or displace stationary fluid.
[0017] The directional air stream can be shaped to conform to the shape of the area to be treated. For example, in some embodiments, the directional air stream nozzle exit orifice has a curved shape configured to cause the directional air stream to conform to the curvature of an arm or leg.
[0018] The directional air stream nozzle can be configured to interface with the patient to control the position and orientation of the directional air stream relative to the patient. For example, in some embodiments, the directional air stream nozzle includes longitudinally extending side skirts configured to form a negative pressure channel between the directional air stream nozzle and the skin, in which a negative pressure is created as a result of the directional air stream through the negative pressure channel, which functions as a venturi.
[0019] The directional air stream nozzle can be configured to facilitate application of a directional air stream to portions of a patient where space for the directional air stream nozzle is limited, such as certain concave areas of the patient. For example, the directional air stream nozzle can have an upwardly curved distal portion including a directional air stream nozzle outlet orifice, the directional air stream nozzle can include an inlet portion having an inlet centerline, and the directional air stream can be directed transverse to the inlet centerline.
[0020] In some embodiments, the directional air stream nozzle is configured to shape the directional air stream for application to a substantially flat area of the patient. For example, in some embodiments, the directional air stream nozzle exit orifice has a flattened elliptical cross section.
[0021] The directional air stream nozzle can be configured to induce turbulence in the directional air stream. For example, the directional air stream nozzle can include a turbulence channel configured to receive the directional air stream from the directional air stream nozzle exit orifice and induce turbulence in the directional air stream.
[0022] In many embodiments, the system for treating fluid retention further includes a localized air stream nozzle configured to removably attach to the air flow hose. The localized air stream nozzle can include a localized air stream nozzle inlet configured to receive an air flow and a localized air stream nozzle outlet orifice configured to output a localized air stream generated from the air flow. The localized air stream can be configured to be directed onto the skin to induce shear thinning of the stationary fluid. In many embodiments, the localized air stream nozzle outlet orifice has a localized air stream nozzle outlet orifice cross-sectional area. In many embodiments, the ratio of the flow rate to the localized air stream nozzle outlet orifice cross-sectional area is greater than or equal to 0.004 (m 3 / min) / mm 2 ~0.020(m 3 / min) / mm 2 is within the range.
[0023] The flow parameters of the localized air stream can be controlled by the configuration of the localized air stream nozzle and the flow rate of the air stream. For example, in some embodiments, the flow rate is 1.3 m 3 / min ~7.1m 3 / min. In some embodiments, the airflow has a pressure in the range of 10,000 Pa to 35,000 Pa within the localized air stream nozzle upstream of the localized air stream nozzle exit orifice. In some embodiments, the localized air stream nozzle exit orifice has a cross-sectional width and a cross-sectional length that is at least two times greater than the cross-sectional width. In some embodiments, the localized air stream nozzle exit orifice is shaped to conform the directional air stream to the shape of the anatomical region of the patient being treated. In some embodiments, the localized air stream nozzle exit orifice has an oblate elliptical shape. In some embodiments, the localized air stream nozzle includes a rotating assembly that generates a pulsatile component of the localized air stream. In some embodiments, the localized air stream nozzle includes a rotating assembly that generates a directionally varying component of the localized air stream. In some embodiments, the localized air stream nozzle includes an intake shell configured to incorporate a secondary air stream into the localized air stream.
[0024] In some embodiments, the system for treating fluid retention is configured to measure the extent of stationary fluid present in the area of fluid retention for use in assessing the progress of the fluid retention treatment. For example, the system for treating fluid retention may further include a fluid sensor, an output device, and a control unit. The fluid sensor may be configured to generate a fluid sensor output signal indicative of the extent of stationary fluid in the patient's tissue. The control unit may be configured to process the fluid sensor output signal to determine the extent of stationary fluid in the tissue. The control unit may be configured to control operation of the output device to output feedback indicative of the extent of stationary fluid in the tissue. In some embodiments, the fluid sensor includes an impedance sensor.
[0025] In some embodiments, a system for treating fluid retention includes an image sensor, an output device, and a control unit. The image sensor can be configured to generate skin motion image data about an area of the patient's skin having induced motion resulting from directing a directional air stream onto the patient's skin. The control unit can be configured to process the skin motion image data to estimate an extent of stationary fluid in tissue underlying the area of the patient's skin, and the control unit is configured to control operation of the output device to output feedback indicative of the extent of stationary fluid in the tissue.
[0026] In another aspect, a method for treating fluid retention is provided. The method includes outputting a directional air stream from a directional air stream nozzle onto the patient's skin to shear thin the stationary fluid and move the stationary fluid toward one or more areas of natural drainage of the stationary fluid. In many embodiments, the stationary fluid includes one or more of interstitial fluid, blood, or lymphatic fluid. In many embodiments, the method includes moving the directional air stream nozzle toward one or more areas of natural drainage of the stationary fluid one or more times. In many embodiments, the directional air stream nozzle is configured and oriented such that an angle between the direction of the directional air stream exiting the directional air stream nozzle and the skin is in the range of 0 degrees to 60 degrees. In some embodiments of the method, the ratio of the flow rate of the directional air stream to the directional air stream nozzle exit orifice cross-sectional area of the directional air stream nozzle is greater than or equal to 0.004 (m 3 / min) / mm 2 ~0.020(m 3 / min) / mm 2 and the flow rate is at least 0.85 m 3 / min. In some embodiments, the directional air stream nozzle does not contact the patient's skin.
[0027] In many embodiments of the method, the directional air stream has an elongated cross-sectional shape to interact with a corresponding elongated portion of the skin. For example, in some embodiments of the method, the directional air stream nozzle includes a directional air stream nozzle exit orifice for the directional air stream having a directional air stream nozzle exit orifice area with a length at least two times greater than a width of the directional air stream nozzle exit orifice area. In some embodiments of the method, the directional air stream nozzle exit orifice area is shaped to conform the directional air stream to the shape of the anatomical region of the patient being treated.
[0028] In some embodiments of the method, the directional air stream nozzle is configured to create a zone of negative pressure below the directional air stream nozzle sufficient to lift the skin toward the directional air stream nozzle. For example, the directional air stream nozzle can be configured to form an external air flow channel extending between the skin and the directional air stream nozzle, through which a secondary air flow is drawn through the air stream, thereby generating a zone of negative pressure by the Venturi effect.
[0029] In many embodiments, the method further includes evaluating the progress of the treatment. For example, the method can include evaluating the movement of the skin induced by the directed air stream to determine when the skin has a degree of flexibility indicative of a desired amount of stationary fluid having moved toward one or more areas of natural drainage.
[0030] In many embodiments, the method further includes outputting a localized air stream from the localized air stream nozzle onto the skin to condition one or more natural drainage areas for entrainment of quiescent fluid. In some embodiments of the method, the localized air stream includes a pulsatile or directionally varying component. In some embodiments of the method, the localized air stream induces rotation of a rotatable component of the localized air stream nozzle, and the rotation of the rotatable component induces the pulsatile or directionally varying component.
[0031] In many embodiments, the method further includes outputting a localized air stream from the localized air stream nozzle onto the skin to shear thin the stationary fluid. In some embodiments of the method, the localized air stream includes a pulsatile or directionally varying component.
[0032] In many embodiments of the method, the directional air stream nozzle is configured to be pressed against the patient to apply pressure directly to the skin to shear thinning and / or displace the stationary fluid. For example, in some embodiments of the method, the directional air stream nozzle includes lower surface protrusions shaped to be applied against the skin to apply pressure to the skin to shear thinning and / or displace the stationary fluid. The lower surface protrusions can be provided with an underside having a suitable shape (e.g., flat, convex, concave) that complements the typical shape of the target area of fluid retention. In some embodiments of the method, the directional air stream nozzle includes rollers configured to roll along the skin and apply contact pressure to the skin to shear thinning and / or displace the stationary fluid.
[0033] In many embodiments, the method includes providing feedback indicative of the amount of stationary fluid in the treated tissue. For example, the method can include (a) generating, via a fluid sensor, a fluid sensor output signal indicative of the extent of stationary fluid in the treated tissue of the patient, (b) processing the fluid sensor output signal to determine the extent of stationary fluid in the treated tissue, and (c) outputting feedback indicative of the extent of stationary fluid in the treated tissue. In many embodiments of the method, the fluid sensor includes an impedance sensor. In some embodiments, the method includes (a) generating, via an image sensor, skin movement image data of an area of the patient's skin having induced movement induced by the directional air stream, (b) processing the skin movement image data to estimate the extent of stationary fluid in the tissue underlying the area of the patient's skin, and (c) outputting feedback indicative of the extent of stationary fluid in the tissue underlying the area of the patient's skin.
[0034] In some embodiments, the method includes inducing turbulence in the directional air stream within a turbulence chamber of the directional air stream nozzle. For example, the directional air stream nozzle can include a turbulence channel configured to receive the directional air stream from the directional air stream nozzle exit orifice and induce turbulence in the directional air stream.
[0035] In some embodiments, the method includes creating, via the directional air stream, a zone of negative pressure beneath the directional air stream nozzle sufficient to lift the skin toward the directional air stream nozzle. For example, the directional air stream nozzle can be configured to form an external air flow channel extending between the skin and the directional air stream nozzle, through which a secondary air flow is drawn through the air stream, thereby generating the zone of negative pressure via a Venturi effect.
[0036] For a more complete understanding of the nature and advantages of the present invention, reference should be made to the following detailed description and accompanying drawings. [Brief explanation of the drawings]
[0037] [Figure 1] 10A-10C illustrate the directional application of an air stream to induce shear thinning of stationary fluid and induce movement of the stationary fluid toward one or more lymph nodes, one or more drainage points, and / or the heart, according to an embodiment. [Figure 2] 10A-10C illustrate application of an air stream to induce shear thinning of quiescent fluid and / or stimulate / condition one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of quiescent fluid, according to an embodiment. [Figure 3] FIG. 1 is a simplified block diagram of a method for treating fluid retention, according to an embodiment. [Figure 4]1 is a schematic diagram of a human body showing areas for compressive shear thinning, stimulation, and directional movement of stationary fluid throughout the torso area by application of air streams, according to an embodiment. FIG. [Figure 5] 1 is a schematic diagram of a human body showing areas for compressive shear thinning, stimulation, and directional movement of stationary fluid, particularly to the chest and abdomen, by application of air streams, according to an embodiment. FIG. [Figure 6] 1 is a schematic diagram of a human body showing areas for compressive shear thinning, stimulation, and directional movement of static fluid to the upper extremities, specifically by application of air streams, according to embodiments. FIG. [Figure 7] 1 is a schematic diagram of a human body showing areas for compressive shear thinning, stimulation, and directional movement of static fluid to the lower extremities, specifically by application of air streams, according to embodiments. FIG. [Figure 8] FIG. 1 is a schematic diagram of a human foot showing areas for compressive shear thinning, stimulation, and directional movement of stationary fluid by application of air streams, according to an embodiment. [Figure 9] FIG. 1 is a schematic diagram of a human hand showing areas for compressive shear thinning, stimulation, and directional movement of stationary fluid by application of air streams, according to an embodiment. [Figure 10] FIG. 1 is a schematic diagram of the human head and neck region showing areas for compression shear thinning, stimulation, and directional movement of stationary fluid by application of air streams, according to embodiments. [Figure 11] 10A-10C are diagrams of a circular nozzle configured to output a circular air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 12] 10A-10C are diagrams of a circular nozzle configured to output a circular air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 13]FIG. 10 is a cross-sectional view of an intake nozzle configured to output an air stream including an intake air flow for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 14] 1A-1C are diagrams of a flattened oval nozzle configured to output a flattened oval air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 15] 1A-1C are diagrams of a flattened oval nozzle configured to output a flattened oval air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 16] 10A-10C are diagrams of a curved-blade nozzle configured to output a curved-blade air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 17] 10A-10C are diagrams of a curved-blade nozzle configured to output a curved-blade air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 18] 10A-10C are diagrams of an extended curved blade nozzle configured to output a curved blade air stream for application to a patient and operable to apply suction to an area of a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, and to apply suction to an area, according to an embodiment. [Figure 19] 10A-10C are diagrams of an extended curved blade nozzle configured to output a curved blade air stream for application to a patient and operable to apply suction to an area of a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, and to apply suction to an area, according to an embodiment. [Figure 20]19A and 19B illustrate operation of the extended curved-blade nozzle of FIGS. 18 and 19A to apply a curved-blade air stream and suction to a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 21] 10A-10C illustrate an upward nozzle configured to output an upward air stream that can be applied to a concavely shaped region of a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 22] 22A-22C illustrate operation of the upward nozzle of FIG. 21 to apply an upward air stream to a concave area of a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 23] FIG. 10 is a diagram of a bump nozzle having a protruding portion configured to contact a patient to apply direct mechanical compression in combination with an air stream output from the bump nozzle for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 24] FIG. 10 is a diagram of a bump nozzle having a protruding portion configured to contact a patient to apply direct mechanical compression in combination with an air stream output from the bump nozzle for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. [Figure 25] FIG. 10 is a diagram of a roller nozzle having a roller configured to contact a patient to apply direct mechanical compression in combination with an air stream output from the roller nozzle for application to the patient to induce compression shear thinning, stimulation, and directional movement of a stationary fluid, according to an embodiment. [Figure 26] FIG. 10 is a diagram of a roller nozzle having a roller configured to contact a patient to apply direct mechanical compression in combination with an air stream output from the roller nozzle for application to the patient to induce compression shear thinning, stimulation, and directional movement of a stationary fluid, according to an embodiment. [Figure 27]FIG. 10 is a diagram of a roller nozzle having a roller configured to contact a patient to apply direct mechanical compression in combination with an air stream output from the roller nozzle for application to the patient to induce compression shear thinning, stimulation, and directional movement of a stationary fluid, according to an embodiment. [Figure 28] FIG. 10 is an isometric view of a hooded nozzle having a hooded outlet configured to induce turbulence in an air stream output by the hooded nozzle for application to a patient to induce pressure shear thinning, stimulation, and directional movement of a quiescent fluid, according to an embodiment. [Figure 29] FIG. 29 is a cross-sectional view of the hooded nozzle of FIG. 28. [Figure 30] 1 is an isometric view of a curved-blade nozzle having a guide portion configured to contact the skin to control the relative positioning of the curved-blade nozzle to the skin, according to an embodiment. [Figure 31] 10A-10C illustrate a pulsating nozzle configured to output a pulsating air stream by induced rotation of an internal member for application to a patient to induce compression shear thinning, stimulation, and directional movement of a quiescent fluid, according to an embodiment. [Figure 32] 10A-10C illustrate a pulsating nozzle configured to output a pulsating air stream by induced rotation of an internal member for application to a patient to induce compression shear thinning, stimulation, and directional movement of a quiescent fluid, according to an embodiment. [Figure 33] 10A-10C illustrate a pulsating nozzle configured to output a pulsating air stream by induced rotation of an internal member for application to a patient to induce compression shear thinning, stimulation, and directional movement of a quiescent fluid, according to an embodiment. [Figure 34] 10A-10C illustrate a pulsating nozzle configured to output a pulsating air stream by induced rotation of an internal member for application to a patient to induce compression shear thinning, stimulation, and directional movement of a quiescent fluid, according to an embodiment. [Figure 35]10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 36] 10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 37] 10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 38] 10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 39] 10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 40] 10A-10C illustrate a helical output nozzle configured to output a rotating helical air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 41] 10A-10C illustrate a double helix output nozzle configured to output a rotating double helix air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 42] 10A-10C illustrate a double helix output nozzle configured to output a rotating double helix air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 43]10A-10C illustrate a double helix output nozzle configured to output a rotating double helix air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 44] 10A-10C illustrate a double helix output nozzle configured to output a rotating double helix air stream for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. [Figure 45] 1A-1C illustrate exemplary air stream generators and air stream hoses configured to generate and deliver air streams to induce shear thinning of stationary fluid, induce movement of stationary fluid, and / or stimulate / condition one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of stationary fluid, according to embodiments. [Figure 46] 10A-10C illustrate exemplary operating regimes of air streams for inducing shear thinning of stationary fluid, inducing movement of stationary fluid, and / or stimulating / conditioning one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of stationary fluid, according to embodiments. [Figure 47] FIG. 1 is a simplified schematic diagram of a system for treating fluid retention via application of one or more air streams to a patient, according to an embodiment. [Figure 48] FIG. 1 is a simplified schematic diagram of an impedance system for measuring the extent of stationary fluid in a fluid stagnation area, according to an embodiment. [Figure 49] FIG. 10 is a diagram of a directional air stream nozzle including impedance electrodes for use in measuring the extent of quiescent fluid in a fluid stagnation area, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0038]
[0067] In the following description, various embodiments of the present invention are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that the present invention may be practiced without the specific details. Additionally, well-known features may be omitted or simplified so as not to obscure the described embodiments.
[0039]
[0068] In many embodiments, the systems and methods described herein for treating fluid retention (e.g., edema) use a forced airflow device to generate an air stream that is emitted from a treatment nozzle onto a patient's skin, inducing subsurface pressure changes that reduce the viscosity of the stationary fluid and induce movement of the stationary fluid toward known, naturally occurring drainage areas. The systems and methods described herein can be selectively and efficiently applied to various parts of the body to provide treatment for fluid retention by thinning and displacing the stationary fluid. One or more fans can be used to generate the airflow that is transmitted to the nozzle via an airflow hose. In many embodiments, various specially configured nozzles can be selectively used to generate corresponding specialized airstreams for impingement on the patient's skin as described herein. As described herein, one or more feedback mechanisms can be used to provide information indicating the degree of stationary fluid displacement and / or how much stationary fluid remains to be displaced by continued treatment. The airflow generating device can be configured to control one or more parameters of the airflow, such as temperature, flow rate, and / or pulsatility, and include a suitable input device for specifying values for each of the one or more parameters of the airflow. Specially configured nozzles may be removably attachable to the hose for selective use based on the area of the patient being treated and the particular type of treatment. The systems and methods described herein can be used to further enhance and optimize the treatment of fluid retention (e.g., edema) through the movement of stagnant fluid to one or more areas of natural drainage within the patient's body using the techniques described herein.
[0040]
[0069] The systems and methods described herein have broad applications in the management of fluid retention and various edema. Some of these applications include lymphedema, pre- and post-operative edema (especially edema resulting from orthopedic procedures), acute or chronic soft tissue injury edema, peripheral vascular and neurological conditions such as gout, inflammatory skin diseases, generalized edema, fibromyalgia, and other inflammatory diseases. Retention of fluids containing anti-cancer therapeutic agents (chemotherapy), particularly in the extremities, is an application that may or may not explicitly involve edema. Other non-edematous applications include athlete recovery, evaporative cooling, and fever / hyperthermia management. In the case of athlete recovery, the systems and methods disclosed herein may also be effective in removing lactic acid and other by-products of exercise in athletes. The systems and methods disclosed herein may also be effective in removing chemotherapy drugs and other therapeutic agents from distal limbs to prevent pain, peripheral neuropathy, and skin dermatological disorders associated with the accumulation of such drugs. The foregoing list of applications for the systems and methods described herein is intended to be partial and demonstrates some non-limiting examples of the wide range of applications in fluid retention (e.g., edema) management for the systems and methods disclosed herein.
[0041]
[0070] Various methods are proposed herein for providing efficient, comfortable, convenient, and effective treatment of edema and fluid retention. In one embodiment, the method involves applying a localized shear-thinning force from outside the body directly above the clavicle area (left thoracic duct and left subclavian vein, lymphatic main duct, and right subclavian vein) to stimulate blood, lymph, and interstitial fluid to reduce their viscosity and stimulate the lymphatic system. The localized shear-thinning force is generally provided by the system in the form of a column of high-velocity air, which primes the lymphatic / venous interface (at the location noted above) for efficient flow. The method can further include applying a directional air stream onto the skin to further promote shear-thinning and directional movement of quiescent fluid in relation to the anatomical course of lymphatic and vascular pathways. The method can also include applying a directional sweep of the air stream to the skin in a specific pattern / direction according to the lymphatic drainage protocol and vascular pathway of the body area being treated. In many embodiments, the air stream is customized and applied directionally to the skin via a shaped nozzle.
[0042]
[0071] The movement of static fluid as described herein flushes out or influences local concentrations of various cytokines, vasomotors, and other pain-regulating substances, which helps restore local tissue homeostasis. These aforementioned chemicals are present in the development of inflammatory interstitial congestion, colloquially known as "inflammatory soup," which is generally the underlying cause of pain, inflammation, and prolonged recovery in patients with fluid retention. Such restoration of local tissue homeostasis can help reduce swelling and edema, alleviate pain, and accelerate recovery.
[0043]
[0072] Techniques for treating fluid retention (e.g., edema) in specific areas of the body are described herein. For example, in many embodiments, a method for treating fluid retention in the upper extremities first uses the localized application of an air stream to the upper chest / lower neck area below the clavicle, where lymph nodes are located and lymphatic drainage naturally occurs. This is followed by the directed application of the air stream onto the extremities, consistent with the natural lymphatic drainage pathways. The localized application of the air stream can use an air stream that interacts with the skin to apply a localized compressive force to the skin over any suitably shaped area (e.g., circular, elongated oval, square, rectangular). The applied localized compressive force can be applied using a forced air system as described herein, which applies an air stream to the skin that is directed substantially perpendicular to the skin (e.g., at an angle greater than 45 degrees). The locally applied air stream can be applied to the skin in any suitable specific body region to actively reduce the viscosity of the underlying quiescent fluid (shear thinning). Alternatively, the localized compression force may be applied manually by a therapist using a compression massage technique or other compression tool. Following application of the localized compression force, the system may be configured with another nozzle suitable for providing an air stream shaped to conform to the contours of the portion of the patient being treated. For example, the air stream may have an elongated blade configuration with an elongated cross-sectional length or arc length and a narrower cross-sectional thickness transverse to the cross-sectional length or arc length. Regardless of the nozzle used, the air stream may be directionally applied to the skin at an angle (e.g., less than 90 degrees from parallel to the skin) to promote directional movement of stationary fluid in the general direction of the directionally applied air stream. The directionally applied air stream may also generate an undulating motion of the skin. The directionally applied air stream may be applied so that the expansion zone of the air stream on the skin moves directionally along the skin any suitable number of times to induce movement of stationary fluid along lymphatic and vascular pathways.For example, when treating the upper extremities, such as the hand or fingers, the static fluid can first be pushed across the palmar area of the hand to the distal fingertips and between the fingers (via movement of the air stream's deployment zone on the skin). The static fluid can then be pushed down the dorsum of the fingers / hand (via movement of the air stream's deployment zone on the skin), continuously forcing the static fluid proximally up the arm toward the lymphatic axilla and other lymph nodes for drainage. Additional nozzles (described further below) can be used to move the static fluid through specific anatomical structures, such as the fingers, in which case shorter, narrower nozzle outlets with smaller radii can be utilized.
[0044]
[0073] Fluid retention (e.g., fluid pooling) in the lower extremities can be treated by locally applying an air stream to apply a localized compressive force over the inguinal lymph nodes, followed by locally applying an air stream to the leg and foot area to stimulate and shear-thin the stationary fluid. For treatment of the foot area, a smaller, foot-specific nozzle can be attached to output a higher velocity stream of air that enters the foot area. The smaller, foot-specific nozzle, combined with the sweeping movement of the zone of entry of the higher velocity air stream with the foot, can be used to displace the stationary fluid starting at the bottom / sole of the foot, pushing the stationary fluid distally toward the toes, then around and between the toes and up the foot. The stationary fluid can then be pushed by the sweeping movement of the zone of entry to known drainage areas up the leg and in the groin.
[0045]
[0074] The systems and methods described herein can also be applied to treat fluid retention (e.g., edema) in other areas (e.g., head / neck, chest / abdomen, pelvic floor) using the techniques described herein. In all cases, an air stream can be applied locally to induce stimulation of fluid movement pathways and / or shear thinning of stationary fluid in combination with the directed application of an air stream to induce movement of stationary fluid in the retention area along lymphatic and vascular pathways.
[0046]
[0075] Localized and / or directed application of an air stream to the skin can be achieved to generate skin rippling. Such rippling can enhance the shear-thinning properties of the stationary fluid and increase its movement in a desired direction. It has been observed that as the viscosity and / or volume of the stationary fluid decreases locally in the zone of air stream deployment on the skin, the skin rippling becomes more pronounced. For example, application of an air stream to an area of the body with significant fluid retention generates very few waves. The skin, underlying tissue, and stationary fluid do not move well, and therefore do not generate waves. Continued application of the air stream thins the stationary fluid, causing the tissue local to the zone of air stream deployment to become more flexible and exhibit an increasing level of rippling. Therefore, the magnitude of the skin rippling locally in the zone of air stream deployment on the skin provides feedback to the operator / therapist regarding the progress of stationary fluid movement from the fluid retention area.
[0047]
[0076] Referring now to the drawings, wherein like reference numerals are used to designate like elements in the various views, FIG. 1 illustrates the directional application of an air stream 70 to induce shear thinning of stationary fluid and directional movement of stationary fluid in a direction 78 from areas of fluid stagnation along lymphatic and vascular pathways toward one or more lymph nodes, one or more drainage points, and / or the heart, according to an embodiment. In the illustrated embodiment, the directional application of the air stream 70 is output from a nozzle 50 of a nozzle assembly 16 held and manipulated by an operator 72 to direct the air stream 70 onto a patient's skin 74, applying a compressive force to the skin 74 to generate a subsurface pressure change 76. Attached to the nozzle 50 is an airflow supply hose 14 that delivers airflow from the main unit 22 (shown in FIG. 45 ) to the nozzle 50. The subsurface pressure change 76 comprises a subsurface pressure increase that generates shear thinning of the stationary fluid within the tissue, which increases the mobility of the stationary fluid through the tissue. The air stream 70 is oriented non-perpendicular to the skin 74 so that the air stream 70 has a component directed along the skin 74 in the direction of desired movement of the stationary fluid through the tissue. The air stream 70 can be oriented relative to the skin 74 to apply a compressive force to the skin 74 and to generate a wave-like motion of the skin 74, which can act to increase the variability of the subsurface pressure changes 76 and thereby increase the motive force applied to move the stationary fluid through the tissue. The stationary fluid can be pushed out of the fluid stagnation area by movement of the area of deployment of the air stream 70 along the skin 74 by corresponding movement of the nozzle 50 by the operator 72. The movement of the area of deployment results in a corresponding movement of the subsurface pressure changes 76, which acts to push the stationary fluid in the direction of movement 78 of the subsurface pressure changes 76. The nozzle 50 can be repeatedly moved along the skin 74 in a direction 79 (corresponding to direction 78) to move the subsurface pressure changes 76 through the tissue to move the stationary fluid along lymphatic and vascular pathways.
[0048]
[0077] 2 illustrates the localized application of an air stream 70 primarily to induce shear thinning of stationary fluid and / or stimulate / condition one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of stationary fluid, according to an embodiment. In the localized application of the air stream 70, the air stream can be oriented substantially perpendicular to the skin 74, as opposed to the directional application shown in FIG. 1 , thereby applying an increased compressive force to the skin 74 compared to the directional application of the air stream 70 shown in FIG. 1 . The applied increased compressive force causes a corresponding increase in the magnitude of the subsurface pressure change 76. The increase in the magnitude of the subsurface pressure change 76 can induce a greater reduction in the viscosity of the stationary fluid and a higher level of stimulation / conditioning of one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of the stationary fluid.
[0049]
[0078] The air stream 70 can be output from the nozzle 50 at any suitable volumetric flow rate relative to the nozzle exit area. A suitable ratio of volumetric flow rate to nozzle exit area (in units of m 3 / min) vs mm 2 ) may be in the range of 0.004 to 0.020, more preferably in the range of 0.009 to 0.014. The nozzle 50 may be configured to have a volumetric flow rate of 113 mm for any maximum area suitable for treating the body, as long as the volumetric flow rate to nozzle outlet ratio meets the stated preferred ratio. 2 The presently preferred treatment nozzle opening area is 300 to 700 mm 2 The air stream 70 can be configured to be applied to any particular area of the patient through the selection and use of a nozzle 50 from a collection of nozzles (as described herein). In an embodiment, the airflow supplied to the nozzle 50 and output from the nozzle 50 as the air stream 70 is filtered using a high efficiency particulate air (HEPA) filter.
[0050]
[0079] 3 is a simplified block diagram of a method 80 for treating fluid retention, according to an embodiment. Method 80 can be performed using any suitable system and / or fluid movement pathway within a patient, as described herein.
[0051]
[0080] In operation 82, an air stream is applied locally to the patient's skin (e.g., as shown in and discussed with reference to FIG. 2) to condition / stimulate fluid movement pathways and / or drainage area(s) within the patient (e.g., lymph node(s), lymphatic duct(s), and / or circulatory system) to enhance movement and uptake of quiescent fluid from areas of fluid stagnation and / or along fluid movement pathways within the patient.
[0052]
[0081] In operation 84, an air stream is directionally applied to the patient's skin (e.g., as shown in and discussed with reference to FIG. 1) to induce shear thinning of the stationary fluid and movement of the stationary fluid from areas of fluid stagnation along a fluid movement path to one or more areas of entrapment of the stationary fluid (e.g., one or more lymph nodes, one or more drainage points). As discussed herein, the stationary fluid can be forced out of the fluid stagnation area via movement of the air stream 70 along the skin 74. The nozzle 50 can be moved repeatedly along the skin 74 to move subsurface pressure changes 76 through the tissue to move the stationary fluid along the lymphatic drainage path.
[0053]
[0082] After (and during) the directional application of the air stream in operation 84, treatment progress can be evaluated (operation 86). In many embodiments, evaluating treatment progress includes determining the progress of stationary fluid movement from areas of fluid stagnation, the progress of stationary fluid movement along the fluid movement path to one or more collection / capture areas of stationary fluid, the amount of stationary fluid remaining in the fluid stagnation area, and / or the amount of stationary fluid remaining in the fluid movement path. Evaluation of treatment progress can use any suitable feedback, the most basic of which is visual. For example, the appearance and increase in size and frequency of tissue waves are important feedback mechanisms for evaluating treatment progress. When fluid within a body part is stationary (e.g., when edema is present), the tissue is typically stiffer and resists movement. Tissue waves generated by the air stream when the tissue is stiff and resists movement are generally weak or absent. Once treatment method 80 is achieved, the quiescent fluid may thin out and begin to move away from the area of fluid retention and be replaced with new fluid, which increases the flexibility of the tissue / skin and thereby increases the degree of skin rippling in response to the application of the air stream. In some embodiments, one or more video monitoring sensors are integrated as part of the system to generate one or more video sensor outputs indicative of skin movement within the area of air stream deployment. A system configured to apply treatment method 80 (e.g., a system for treating fluid retention (e.g., edema) described herein) can include a control unit configured to process the one or more video sensor outputs to generate and output feedback indicative of the degree of skin rippling for use in assessing treatment progress. In some embodiments, one or more photoplethysmography (PPG) sensors can be used to assess the status of the fluid retention condition and thus help determine the need for further treatment. In some embodiments, one or more bioimpedance sensors can be used to assess the status of the fluid retention condition and thus help determine the need for further treatment.In some embodiments, one or more ultrasound transducers can be used to assess the status of a fluid retention condition and thus help determine the need for further treatment. Still other embodiments can employ feedback sensors, such as temperature / thermal mapping sensors, for use in generating feedback indicating real-time vascular activity levels, which can indicate the progress of treatment. For example, when using a forward-looking infrared camera (FLIR), areas of high perfusion exhibit a stronger thermal signature that is easily distinguishable from areas of low perfusion. These aforementioned sensors may be integrated into the nozzle or may be integrated into the system as separate components. One or more ultrasound transducers or video sensors may also be integrated to provide user feedback regarding the proper proximity of the nozzle to the treatment area to provide optimal treatment. The user can then use any of this feedback to inform their decision regarding continuing or discontinuing treatment.
[0054]
[0083] Based on the assessment achieved in operation 86, it may be determined whether there is additional quiescent fluid to be moved during the treatment (operation 88). If there is no additional quiescent fluid to be moved during the treatment, the treatment may be terminated (operation 90). If there is additional quiescent fluid to be moved during the treatment, the method 80 may proceed to determine whether additional stimulation and / or adjustment of the fluid pathway is required. If additional stimulation and / or adjustment of the fluid pathway is required, the method 90 may loop back to perform operation 82 to achieve the additional stimulation and / or adjustment of the fluid pathway. If additional stimulation and / or adjustment of the fluid pathway is not required, the method 80 may loop back to operation 84 to induce additional shear thinning of the quiescent fluid and directional movement of the quiescent fluid from areas of fluid stagnation along the fluid movement path to one or more areas of quiescent fluid entrapment. To determine whether additional treatment is required, one skilled in the art would be able to visually distinguish between the tissue condition before and after treatment. A lack of further change to the tissue condition would indicate to the user to modify or stop the treatment. In embodiments, feedback sensors can detect relative parameters before and after treatment and indicate to the user that they should repeat or terminate the treatment.
[0055]
[0084] Fluid movement pathway
[0056]
[0085] The systems and methods described herein can be used to move a stationary fluid along any suitable fluid movement path to move the stationary fluid from an area of fluid stagnation to one or more entrainment areas of the stationary fluid. For example, some suitable fluid paths for the stationary fluid are shown in Figures 4-10.
[0057]
[0086] FIG. 4 is a schematic diagram of the human body showing areas for compressive shear thinning, stimulation, and directional movement of stationary fluid throughout the torso area by the application of air streams, according to an embodiment. The upper torso area houses the majority of lymphatic and interstitial fluid drainage points. While the human body is phenotypically symmetrical, the lymphatic ducts and drainage systems differ on either side of the sagittal midline 150. The right lymphatic main duct 151 on the right side of the body and the thoracic duct 153 on the left side of the body drain into the right subclavian vein (located under the right clavicle) and the left subclavian vein (located under the left clavicle), respectively. The right lymphatic main duct 151, and subsequently the right subclavian vein, receives lymph and interstitial fluid from the right head and neck, right pelvis and abdomen, and right arm, as represented by the shaded area 155. Lymph from the remainder of the body (unshaded) drains into the thoracic duct 153 and subsequently into the left subclavian vein. Considering the differences in lymphatic and drainage systems on either side of the sagittal midline 150, the techniques described herein for drainage of static fluids differ for specific anatomically symmetric areas of the body.
[0058]
[0087] Continuing with reference to FIG. 4 , operation 82 of method 80 can be accomplished through localized application of air stream 70 to an area spanning primary discharge points 152, 154 (designated by bold arrows in FIG. 4 ). While localized application of air stream 70 can be accomplished using any suitable nozzle, such as any of the nozzles described herein, several of the nozzles described herein (e.g., circular nozzle 50-1 shown in FIGS. 11 and 12 , intake nozzle 50-2 shown in FIG. 13 , pulsating nozzle 50-10 shown in FIGS. 31-34 , helical output nozzle 50-11 shown in FIGS. 35-40 , and dual helix output nozzle 50-12 shown in FIGS. 41-44 ) may be particularly suitable for use in generating air stream 70 for localized application of air stream in operation 82 of method 80. In operation 82 of method 80, the nozzle can be oriented relative to the body such that air stream 70 enters the body substantially perpendicular to the body. The distance between the nozzle output and the skin 74 can range from 0 cm to 50 cm, depending on the state of fluid retention and the integrity of the skin. In some localized applications of the air stream 70, the preferred distance between the nozzle output and the body during localized application of the air stream 70 in operation 82 of method 80 is in the range of 10 cm to 30 cm. The nozzle can be moved back and forth laterally across the areas 152, 154 (including just above and below the collarbone) to compress and loosen as much stationary fluid as possible and stimulate the drainage area. The localized application of the air stream to the areas 152, 154 can be used to effectively unclog and prepare the areas 152, 154 for subsequent receipt of stationary fluid transferred to the areas 152, 154 using the techniques described herein. The localized application of the air stream 70 can be repeated on the right side of the body, particularly if the fluid retention area to be treated is located on the right arm or right side of the torso. Additionally, according to operation 82 of method 80, the left axilla 156, which houses the large lymph nodes that drain the rest of the body, can be stimulated by localized application of air stream 70.
[0059]
[0088] 5-10 illustrate fluid movement paths that can be used to perform operation 84 of method 80 to treat fluid retention (e.g., edema) in a corresponding portion of a patient. As described herein, method 80 includes operation 82, which can be used to (1) condition and stimulate one or more drainage areas and shear-thin stationary fluid within the one or more drainage areas, and / or (2) condition and stimulate a treated area of fluid retention and shear-thinning stationary fluid within the treated area of fluid retention. Method 80 also includes operation 84, which can be used to directionally move stationary fluid to the area of fluid retention along any suitable fluid movement path (e.g., any of the localized fluid movement paths shown in FIGS. 5-10 through which stationary fluid can be moved from the area of fluid retention to the fluid drainage area). The directional application of the air stream 70 used in operation 84 of method 80 can be achieved using any suitable nozzle, such as any of the nozzles described herein, although some of the nozzles described herein (e.g., the flat oval nozzle 50-3 shown in FIGS. 14 and 15, the curved blade nozzle 50-4 shown in FIGS. 16 and 17, the extended curved blade nozzle 50-5 shown in FIGS. 18 and 19, the upward nozzle 50-6 shown in FIG. 21, the bump nozzle 50-7 shown in FIGS. 23 and 24, the roller nozzle 50-8 shown in FIGS. 25-27, the hooded nozzle 50-9 shown in FIGS. 28 and 29, the pulsating nozzle 50-10 shown in FIGS. 31-34, the helical output nozzle 50-11 shown in FIGS. 35-40, and the double helix output nozzle 50-12 shown in FIGS. 41-44) may be particularly well-suited for use in generating the air stream 70 for the directional application of the air stream in operation 84 of method 80. As described herein, the directional application of the air stream in operation 84 of method 80 can be achieved by any suitable number of sweeping movements of the area of deployment of air stream 70 across the patient's skin 74 in a direction aligned with the fluid movement path being used. The sweeping movements can include long sweeps and / or short sweeps across the length of the affected area, depending on the location of the fluid retention area being treated.
[0060]
[0089] FIG. 5 illustrates fluid migration paths within a torso area. Operation 82 of method 80 can be accomplished by treating areas of fluid stagnation within the torso area via localized application of air stream 70 to drainage areas 160, 162 (designated by bold arrows in FIG. 5 ) to stimulate and condition drainage areas 160, 162 for uptake of stationary fluid displaced from areas of fluid stagnation within the torso area. The air stream 70 can be applied to compress and shear thinning the inguinal lymph node area (i.e., drainage area 162). Additionally, areas of fluid stagnation within the torso area being treated can also be compressed and agitated via localized application of air stream 70 in operation 82 of method 80. In operation 84 of method 80, directional application of air stream 70 to the patient is used to displace stationary fluid through fluid migration paths in the torso area (designated by arrows 164 in FIG. 5 ). Some of the nozzles described herein (i.e., the flattened oval nozzle 50-3 shown in FIGS. 14 and 15 , the curved blade nozzle 50-4 shown in FIGS. 16 and 17 , the extended curved blade nozzle 50-5 shown in FIGS. 18 and 19 , the upward nozzle 50-6 shown in FIG. 21 , the bump nozzle 50-7 shown in FIGS. 23 and 24 , the roller nozzle 50-8 shown in FIGS. 25-27 , and the hooded nozzle 50-9 shown in FIGS. 28 and 29 ) are configured such that the resulting air stream 70 is formed as a thinner blade of high-velocity air configured to be applied onto the patient's skin 74, concentrating the induced subsurface pressure change 76 within an elongated region extending transversely to the direction of desired movement of the stationary fluid, thereby sweeping the area of deployment of the air stream 70 in the direction of the desired movement of the stationary fluid to enhance the movement of the stationary fluid in the desired direction. Operation 84 of method 80 for achieving directional movement of stationary fluid within a torso area can be achieved at the front of the body and / or the rear of the body. Any of the nozzles described herein may be used in any order to achieve one or more directional applications of air streams 70 to move stationary fluid across a fluid movement path within the fuselage area.
[0061]
[0090] FIG. 6 shows a schematic diagram of the human body illustrating areas for compressive shear thinning, stimulation, and directional movement of stationary fluid within the left arm. When applying method 80 to the left arm, localized application of air stream 70 in operation 82 of method 80 can be applied to drainage area 170 and the entire left arm (as designated by arrow 172 in FIG. 6). In operation 84 of method 80, directional application of air stream 70 to the patient is used to move stationary fluid proximally along the left arm through lymphatic pathways (as designated by arrow 174 in FIG. 6). As described herein, some of the nozzles described herein are configured such that the resulting air stream 70 is formed as a thinner blade of high-velocity air configured to be applied onto the patient's skin 74, concentrating the induced subsurface pressure change 76 within an elongated region extending transversely to the direction of desired movement of the stationary fluid, thereby sweeping the area of deployment of air stream 70 in the direction of desired movement of the stationary fluid to enhance movement of the stationary fluid in the desired direction. Any of the nozzles described herein can be used in any order to achieve one or more directional applications of air stream 70 to move the stationary fluid across a fluid migration path within the left arm. Proximal migration of the stationary fluid within the left arm can be achieved using a distal-to-proximal sweeping stroke (indicated by arrow 174) that initiates the sweep near the proximal portion of the left arm and acts in a distal direction. By initially sparsely activating the stationary fluid within the proximal arm, the fluid migration path 174 can be effectively tailored to allow the stationary fluid to arrive from more distal portions of the left arm as the stationary fluid moves to the drainage area 170. The treatment method described above is applicable to both the left and right arms.
[0062]
[0091] FIG. 7 is a schematic diagram of the human body illustrating areas for compressive shear thinning, stimulation, and directional movement of quiescent fluid to the lower extremities (i.e., legs) by application of an air stream, according to embodiments. In operation 82 of method 80 applied to the legs, localized application of air stream 70 can be applied to the primary drainage areas 152, 154 (particularly the left primary drainage area 154, since it provides drainage for the lower body), as previously described. Preferably, localized application of air stream 70 is also applied to stimulate and condition inguinal lymph node area 182 and pelvic lymph node area 184, since these also provide drainage for the lower body. Stimulation of areas 152, 154, 182, and 184 in accomplishing operation 82 applied to the legs shear thins quiescent fluid trapped in the main lymphatic trunks, corresponding to the movement of a large volume of quiescent fluid from the legs to the torso via the pelvic area. The localized application of air stream 70 achieved in operation 82 applied to the legs can include localized application of air stream 70 to shear-thin fluid at the dorsal and ventral inguinal lymph nodes in the pelvis. Air stream 70 can be directed perpendicular to the groin and forced diagonally along the groin crease as indicated by arrows 182 and 184, as well as toward the perineum 185. Stationary fluid from each of one or more of the legs can be agitated in a random pattern in the legs by deployment of air stream 70, which can be generated using any suitable configuration and / or size of nozzles based on the size of the patient. Operation 82 of method 80 is performed to enhance the movement of stationary fluid during the subsequent achievement of operation 84 of method 80 and to directly move stationary fluid from areas of fluid stagnation within each of one or more of the legs. Any of the nozzles described herein can be used to generate and directionally apply the air stream 70 to the leg, but it may be preferable to have one of the curved blade nozzle 50-4, extended curved blade nozzle 50-5, upward nozzle 50-6, bump nozzle 50-7, roller nozzle 50-8, or hooded nozzle 50-9 to move stationary fluid in the leg proximally toward the groin.The nozzle is preferably held at an angle such that the air stream 70 emanating from the nozzle is incident on the skin 74 at a suitable angle (e.g., 0-60 degrees) to efficiently induce displacement of the stationary fluid. The angle of incidence of the air stream 70 on the skin 74 can be selected to create a wave-like motion of the skin 74, which can enhance shear-thinning and directional displacement of the stationary fluid. Nozzle attachments or spacers can be used to help maintain suitable positioning and orientation of the nozzle relative to the skin 74. To enhance displacement of the stationary fluid from the leg, fluid in the upper leg can be displaced from the upper leg by first urging the nozzle in a distal-to-proximal direction (indicated by arrow 186), followed by displacing the stationary fluid from the lower leg by urging the nozzle in directions 190, 186.
[0063]
[0092] FIG. 8 shows a schematic diagram of a human foot illustrating areas for compressive shear thinning, stimulation, and directional movement of stationary fluid by application of an air stream, according to embodiments. FIG. 9 shows a schematic diagram of a human hand illustrating areas for compressive shear thinning, stimulation, and directional movement of stationary fluid by application of an air stream, according to embodiments. Due to the complex lymphatic structure of the foot and hand, simple distal-to-proximal movement of stationary fluid is not an optimal approach for treating fluid retention (e.g., edema) in the foot and hand. Instead, to increase the effectiveness of treating fluid retention in the hand or foot, method 80 can be applied to the hand or foot separately to move stationary fluid from the hand or foot through more complex fluid movement pathways in the hand or foot.
[0064]
[0093] Management of fluid retention (e.g., edema) in the feet / toes is ideally performed after method 80 has been achieved in the legs, inguinal lymph nodes, and trunk, ensuring that lymphatic and vascular pathways in the legs are cleared and stimulated to support more effective movement of stationary fluid from the feet to drainage points. Using an appropriately sized flat or curved nozzle, fluid can be pushed from the sole of the foot toward the base of the toes, as indicated by arrow 202, and from the tips of the toes proximal to the base of the toes, as indicated by arrows 204 and 206. Following the lymphatic pathway, stationary fluid can be pushed to the top of the foot between the toes and continue directed proximally, as indicated by arrow 208. In embodiments, this movement of fluid may utilize a small, curved, or oval nozzle specifically designed for the toes. Generally, stationary fluid can be moved from the sole of the foot to the top of the foot, as indicated by arrow 210, and then pushed proximally, as indicated by arrow 212. The area around the heel and midsole may be worked laterally using an appropriately sized nozzle, as shown by arrow 214, ultimately pushing the quiescent fluid, as shown by arrow 216, to stimulate pathways in the top of the foot. Following this procedure, method 80 may again be applied to the leg to move the quiescent fluid through the leg and into the torso for drainage. Application of method 80 to the foot may be effective in preventing nerve damage and subsequent neuropathy from chemical agents (e.g., chemotherapy) and pharmaceuticals.
[0065]
[0094] As can be seen in light of FIG. 9 , application of method 80 to the hand is similar to application of method 80 to the foot. As with the foot, management of fluid retention in the hand is ideally performed after method 80 has been applied to the corresponding arm and 152 or 154 to stimulate the arm and flush fluid from the arm to better accommodate the transfer of stationary fluid from the hand. Using an appropriately sized embodiment of the flattened oval nozzle 50-3, an air stream 70 can be generated and directed toward the hand, moving fluid distally from the wrist to the creases between the fingers. Starting from the palmar side, air stream 70 can be directed toward the hand, displacing fluid using small sweeping motions from the fingertips toward the bases of the fingers, as indicated by arrow 220, and from the center of the palm, as indicated by arrow 222. Each finger can individually expel excess fluid, starting at the distal end of the finger to where the finger joins the hand. The areas between the fingers can then be stimulated distally from the palm to the top of the hand, following the lymphatic pathway indicated by curved arrow 224. The flattened oval nozzle 50-3 can then be used to move the fluid proximally into the arm toward the top of the wrist, as shown by arrow 226. After the fluid has been moved into the arm, the method 80 can be reapplied to the arm to move the stationary fluid proximally through the arm to a corresponding one of the drainage areas 152, 154. Application of the method 80 to the hand can be effective in preventing nerve damage and subsequent nerve disorders from chemical agents (e.g., chemotherapy) and pharmaceuticals.
[0066]
[0095] FIG. 10 shows a schematic diagram of the human head and neck region illustrating areas for compressive shear thinning, stimulation, and directional movement of stationary fluid by application of an air stream, according to embodiments. Application of method 80 to the head and neck region can begin with localized application of air stream 70 to drainage area 230, according to operation 82 of method 80. Following localized application of air stream 70 to drainage area 230, air stream 70 can be used to directionally push stationary fluid from the top of the head toward the outer portions of the face, as indicated by arrow 232, and from the center of the face toward the back, as indicated by arrow 234 (84). This fluid movement technique can be repeated for the occiput, following lymphatic pathways, using a pushing motion directed toward the crease between the neck and shoulder, as indicated by arrow 236. The pushing motion can continue toward the proximal end of the clavicle, as indicated by arrow 238, thereby moving fluid toward the subclavian vein.
[0067]
[0096] Nozzle for treating fluid retention
[0068]
[0097] Each of the nozzles described herein is configured, when supplied with an airflow having a suitable volumetric flow rate, to output an air stream 70 suitably configured to deploy on a patient's skin 74, whereby induced subsurface pressure variations 76 are configured to result in shear thinning of stationary fluid and / or stimulation and conditioning of fluid migration paths and evacuation areas as described herein. Each of the nozzles described herein can be used to perform method 80 and can be selectively used based on the location of the area of fluid stagnation to be treated and / or whether air stream 70 is applied locally (as accomplished in operation 82 of method 80) or directionally (as accomplished in operation 84 of method 80).
[0069]
[0098] In many embodiments, each of the nozzles disclosed herein is removably attachable to an airflow supply hose 14 used to supply the airflow generated by the main unit 12 (shown in FIG. 45 ) to the nozzle. The nozzles described herein provide a method for generating and directing an airstream 70 onto a patient's surface to apply pressure to the patient and induce subsurface pressure changes 76, which are used to induce shear thinning of quiescent fluids and / or stimulate / modulate fluid migration pathways within the patient. Each of the nozzles has an exit orifice with a specific cross-section and contour for configuring the airstream 70 (e.g., cross-sectional shape of the airstream, average flow rate of the airstream at the exit orifice) suitable for application to a portion of the patient to be treated, such as an arm, finger, leg, abdomen, head, or neck area. Each variation of the nozzles described herein can be configured to tailor the airstream 70 (e.g., specific shape, specific average flow rate at the exit orifice) for use in treating fluid retention (e.g., edema) in any one or more regions of the patient. By using a nozzle specifically configured for the corresponding area of the patient being treated, the deployment of the air stream 70 onto the patient can more efficiently displace quiescent fluid into the lymphatic system.
[0070]
[0099] In embodiments, the nozzle may comprise a manual compression element configured to be manually pressed against the patient to directly apply an associated compression pressure to the patient. The manual compression element may have any suitable configuration. For example, the manual compression element may be attached via a fixation mechanism or may be manufactured to be integral with the nozzle. The manual compression element may include a set of rigid or semi-rigid rollers configured to contact the patient's skin 74 and manually apply a compression force to induce shear thinning of stationary fluid within the patient's tissue and / or movement of the fluid to one or more drainage areas. Alternatively, the manual compression element may include one or more soft rollers (e.g., rubber or foam), which may be more comfortable for the patient. In embodiments, the manual compression element is manually pressed against the patient in combination with applying the air stream 70 to the patient during the performance of method 80. In embodiments, the nozzle is configured to generate an area of negative air pressure below and directly behind the nozzle due to a Venturi effect resulting from air flow between the nozzle and the skin 74 induced by the output of the air stream 70 from the nozzle. The area of negative pressure pulls the area of skin 74 exposed to the negative pressure toward the nozzle. Pulling an area of skin 74 towards the nozzle, in combination with a compressive force applied to the patient via the deployment of an air stream onto the patient in front of the nozzle, can have the effect of both inducing shear thinning of quiescent fluid, opening lymphatic vessels to induce and / or accommodate movement of quiescent fluid, and rapidly reperfusing the immediate area behind the nozzle.
[0071]
[0100] In embodiments, the nozzle is configured to output a first air stream and a second air stream (primarily configured to induce shear thinning of stationary fluid and / or stimulation / adjustment of fluid movement pathways) and a second air stream (primarily configured to induce stationary fluid movement). The first air stream can be shaped and oriented to impinge on the skin, preferably at an angle of 20 degrees or less from normal to the skin, to primarily induce shear thinning of stationary fluid and / or stimulation / adjustment of fluid movement pathways. The second air stream can be shaped to have a thin blade configuration and oriented at an acute angle of preferably less than 60 degrees to the skin to induce stationary fluid movement. The nozzle can be configured as a split nozzle, configured to generate the first air stream and the second air stream from a single air flow provided to the split nozzle by a single hose. Alternatively, the nozzle can be configured to be attached to a first air flow supply hose that supplies the first air flow used to generate the first air stream and a second air flow supply hose that supplies the second air flow used to generate the second air stream.
[0072]
[0101] In embodiments, the nozzles used in performing method 80 are customizable to accommodate customization of air stream 70 by customizing the shape and / or size of the nozzle's exit orifice to conform air stream 70 to the patient's anatomy and thus provide a more efficient treatment. In some embodiments, the exit orifice is defined by an exit portion of the nozzle made from a malleable metal or thermoplastic that accommodates reconfiguration of the nozzle's exit portion (via deformation of the malleable metal or application of heat to the thermoplastic) to reshape and / or resize the exit orifice to customize air stream 70.
[0073]
[0102] In many embodiments, each of the nozzles described herein is configured to removably attach to the airflow supply hose 14. Using a quick change nozzle that includes a single air inlet and a set of different nozzle outlets that can be selectively coupled to the air inlet, the configuration of the air stream 70 output by the quick change nozzle can also be selected to provide utility when moving between body parts or forced air functionality (shear thinning only as opposed to directional fluid movement).
[0074]
[0103] 11 and 12 show diagrams of a circular nozzle 50-1 configured to output a circular air stream 70-1 for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. The circular nozzle 50-1 includes a circular outlet orifice (50-1-OO) and an inlet coupling portion (50-1-ICP). The inlet coupling portion (50-1-ICP) and the air flow supply hose 14 can have any suitable coupling features configured to accommodate releasable coupling of the circular nozzle 50-1 to the air flow supply hose 14. For example, in the illustrated embodiment, the inlet coupling portion (50-1-ICP) includes a bayonet-style coupling slot (50-1-SLOTS) shaped to correspond and engage with a complementary shaped bayonet feature on the air flow supply hose 14. The circular outlet orifice (50-1-OO) is 113 mm 2 The cross-sectional area may be any suitable area greater than or equal to 100 mm.
[0075]
[0104] As described herein, operation 82 of method 80 uses the localized application of an air stream 70 to induce shear thinning of quiescent fluid to stimulate / condition one or more lymph nodes and / or vasculature. A circular nozzle 50-1 is configured for use in achieving the localized application of the air stream 70. With the circular nozzle 50-1 affixed to the airflow supply hose 14, a circular air stream 70-1 (having a circular cross-sectional shape as output from a circular exit orifice (50-1-00)) can be applied at a substantially perpendicular angle to the skin 74. The circular air stream 70-1 has a saturation of 0.004 to 0.020, more preferably 0.009 to 0.014 ((m 3 / min) vs mm 2 The circular exit orifice (50-1-OO) may have an average flow rate ratio of 1 / 2 sq. m to a suitable nozzle area (units of sq. m). Application of the circular air stream 70-1 to the skin 74 substantially perpendicular to the skin 74 can be used to induce subsurface pressure changes 22 applied to quiescent fluid present in one or more lymph nodes, one or more lymphatic vessels, and / or one or more blood vessels, as well as the subcutaneous soft tissue. As discussed herein, the induced subsurface pressure changes 22 reduce the viscosity of the quiescent fluid, aiding in the movement of the quiescent fluid from areas of fluid stagnation through fluid movement pathways to areas of drainage. In addition to the shear-thinning effect on the quiescent fluid, the subsurface pressure changes 76 stimulate lymph nodes and ducts, enhancing the movement of the quiescent fluid through the lymph nodes and ducts.
[0076]
[0105] In the illustrated embodiment, the circular nozzle 50-1 has a linear converging bore between the inlet coupling portion (50-1-ICP) and the circular exit orifice (50-1-OO). Alternatively, the circular nozzle may have diverging bores from the inlet coupling portion (50-1-ICP) and the circular exit orifice (50-1-OO), such as in the form of an inverted funnel. Because the circular nozzle 50-1 can be configured in a wide range of sizes, the circular nozzle 50-1 can be configured for use in treating any particular area of a patient in either operation 82 or operation 84 of method 80. The circular nozzle 50-1 may be particularly well-suited for use in achieving localized application of the air stream 70 in operation 82 of method 80.
[0077]
[0106] In some embodiments, the circular nozzle 50-1 includes an adjustable aperture or restriction that can be adjusted to accommodate changes in nozzle exit diameter on the fly without having to manually change the circular nozzle 50-1 for a different nozzle. Equipping a circular nozzle 50-1 can be used to reduce the number of nozzles used to perform the method 80 on a patient, which may decrease the total treatment time due to the reduced time spent changing nozzles.
[0078]
[0107] FIG. 13 shows a cross-sectional view of an intake nozzle 50-2 configured to output an air stream including entrained airflow for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. The intake nozzle includes a main nozzle portion (50-2-MNP) and an intake shell portion (50-2-ESP). The main nozzle portion (50-2-MNP) includes a circular main nozzle portion outlet orifice (50-2-OO) and an inlet coupling portion (50-2-ICP). The inlet coupling portion (50-2-ICP) and the airflow supply hose 14 can have any suitable coupling features configured to accommodate releasable coupling of the intake nozzle 50-2 to the airflow supply hose 14. For example, in the illustrated embodiment, the inlet coupling portion (50-2-ICP) includes a bayonet-style coupling slot (50-2-SLOTS) shaped to correspond and engage with a complementary shaped bayonet feature on the airflow supply hose 14. The circular main nozzle portion exit orifice (50-2-00) may be of any suitable cross-sectional area (e.g., 300 to 700 mm 2 The intake shell portion (50-2-ESP) surrounds the distal end portion of the main nozzle portion (50-2-MNP). The intake shell portion (50-2-ESP) and the main nozzle portion (50-2-MNP) combine to define an annular intake air stream inlet through which the secondary air flow (50-2-SAF) is entrained into the primary air flow (50-2-PAF) received from the air flow supply hose 14. The intake nozzle 50-2 can be used in carrying out the same or similar method 80 as the circular nozzle 50-1. The primary air stream 50-2-PAF has a range of 0.004 to 0.020, more preferably 0.009 to 0.014 ((m 3 / min) vs mm 2 The nozzle may have an average flow rate ratio of 1 / 3 of the preferred nozzle area for a circular exit orifice (50-2-00).
[0079]
[0108] 14 and 15 show diagrams of a flattened oval nozzle 50-3 configured to output a flattened oval air stream 70-3 for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. The flattened oval nozzle 50-3 has an elongated flattened oval exit orifice (50-3-00) configured such that the flattened oval air stream 70-3 has a relatively thin flattened oval cross-sectional shape, which may be particularly suitable for use in operation 84 of method 80 to induce directional movement of stationary fluid. The flattened oval nozzle 50-3 may also be used in operation 82 of method 80 for localized application of an air stream 70. The flattened oval air stream 70-3 has a saturation coefficient ((m / s)) in the range of 0.004 to 0.020, more preferably 0.009 to 0.014. 3 / min) vs mm 2 The flattened elliptical exit orifice (50-3-00) can have an average flow ratio of 1 / 3 of the preferred nozzle area for a circular exit orifice (50-3-00). The flattened elliptical exit orifice (50-3-00) can have any suitable cross-sectional area (e.g., 300 to 700 mm 2 The elongated flat oval outlet orifice (50-3-OO) can have any suitable length (50-3-L) to width (50-3-W) ratio (e.g., in the range of 2:1 to 10:1). In the illustrated embodiment, the elongated flat oval outlet orifice (50-3-OO) has a length-to-width ratio of 5.4:1. The flat oval nozzle 50-3 can be particularly useful for moving stationary fluids within flat anatomical areas. The flat oval nozzle 50-3 can be configured in a relatively small size for use in moving stationary fluids around smaller anatomical features (e.g., fingers, toes) and in areas where space to accommodate the nozzle 50 is limited. The flat oval opening can also be offset from the centerline or inlet opening to help guide the nozzle tip around the anatomical structure and achieve a generally more parallel angle of the airflow 70-3 relative to the anatomical structure or treatment table surface.
[0080]
[0109] 16 and 17 show diagrams of a curved-blade nozzle 50-4 configured to output a curved-blade air stream 70-4 for application to a patient to induce compression shear thinning, stimulation, and / or directional movement of stationary fluid, according to embodiments. The curved-blade nozzle 50-4 is configured similarly to the flattened oval nozzle 50-3, but has a curved-blade nozzle exit orifice (50-4-000) with a curved profile configured such that the curved-blade air stream 70-4 has a corresponding thin curved-blade cross-sectional shape corresponding to the shape of the exit orifice (50-4-000). The curved-blade air stream 70-4 has a saturation coefficient (μm) in the range of 0.004 to 0.020, more preferably 0.009 to 0.014 (μm). 3 / min) vs mm 2 The curved-blade air stream 70-4 may have an average flow rate ratio of 1 / 2 sq. m to the preferred nozzle area of the circular exit orifice (50-4-OO). The curved-blade air stream 70-4 may be particularly effective for use in achieving operation 84 of method 80 to induce movement of stationary fluid within a curved body region, such as the legs or back, because the curved-blade air stream 70-4 is shaped to better conform to the shape of the curved body region, thereby more uniformly and completely applying to the curved body region, which helps maximize the resulting distribution range of the induced subsurface pressure change 76. The configuration parameters of the curved-blade nozzle exit orifice (50-4-OO) (i.e., exit orifice arc length (50-4-OOAL), exit orifice radius of curvature (50-4-ROC), and exit orifice width (50-4-W)) can be adjusted to configure the curved-blade nozzle 50-4 for use in any particular area of the body. For example, the configuration parameters of the curved blade nozzle 50-4 can be selected to suit the curved blade air stream 70-4 for application to a particular body area (e.g., a large, slightly curved body area such as the back, a small, tightly curved body area such as a finger, or a medium-sized curved body area such as an arm or leg).
[0081]
[0110] 18 and 19 show diagrams of an extended curved-blade nozzle 50-5 configured to output an extended curved-blade air stream 50-5 for application to a patient, according to an embodiment, and operable to apply suction (50-5-S) (illustrated in FIG. 20) to an area of the patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid. The extended curved-blade nozzle 50-5 is configured similarly to the curved-blade nozzle 50-4, but further includes an extended distal end portion (50-5-EDE). The extended curved-blade nozzle 50-5 further includes an extended curved-blade nozzle exit orifice (50-5-OO) having a curved profile configured such that the extended curved-blade air stream 70-5 has a corresponding thin curved-blade cross-sectional shape corresponding to the shape of the exit orifice (50-5-OO). The extended curved-blade air stream 70-5 has a suction pressure (μm) in the range of 0.004 to 0.020, more preferably 0.009 to 0.014 (μm). 3 / min) vs mm 2 The circular exit orifice (50-5-00) can have an average flow ratio of 1 / 3 of the preferred nozzle area to the circular exit orifice (50-5-00). The extended curved blade nozzle exit orifice (50-4-00) can have any suitable cross-sectional area (e.g., 300 to 700 mm). 2The extended curved-blade air stream 70-5 may have a radius (range) of curvature (in the range of 1 / 2 radii) of curvature (in the range of 1 / 2 radii) of curvature (in the range of 1 / 2 radii). The extended curved-blade air stream 70-5 may be particularly effective for use in achieving operation 84 of method 80 to induce the movement of stationary fluid within a curved body region, such as a leg or back, because the extended curved-blade air stream 70-5 is shaped to better conform to the shape of the curved body region, thereby being more uniformly and completely applied to the curved body region, which helps maximize the range of the resulting distribution of the induced subsurface pressure change 76. The configuration parameters (i.e., orifice arc length, orifice radius of curvature, and orifice width) of the extended curved-blade nozzle exit orifice (50-5-OO) can be adjusted to configure the extended curved-blade nozzle 50-5 for use with any particular area of the body. For example, the configuration parameters of the extended curved-blade nozzle 50-5 can be selected to suit the extended curved-blade air stream 70-5 for application to a particular body region (e.g., a large, slightly curved body region such as a back, a small, tightly curved body region such as a finger, or a medium-sized curved body region such as an arm or leg).
[0082]
[0111] When the extended distal end portion (50-5-EDE) contacts a patient, a suction channel (50-5-SC) is formed, extending between the extended distal end portion (50-5-EDE) and the patient's skin 74. The extended curved-blade nozzle 50-5 includes an exit orifice (50-5-OO) through which a curved-blade air stream 70-5 is emitted. The curved-blade air stream 70-5 draws air through the suction channel (50-5-SC), which reduces the pressure of the air flowing through the suction channel (50-5-SC) due to the Venturi effect. The extended distal end portion (50-5-EDE) forms the sidewalls of the suction channel (50-5-SC), thereby helping to increase the magnitude of the pressure drop within the suction channel (50-5-SC).
[0083]
[0112] 20 illustrates the operation of the extended curved-blade nozzle 50-5. In the illustrated configuration, the lower end side of the extended distal end portion (50-5-EDE) contacts the patient's skin 74, thereby forming a suction channel (50-5-SC) extending between the lower surface of the extended curved-blade nozzle 50-5 and the skin 74. The discharge of the curved air stream 70-5 from the exit orifice (50-5-OO) draws a flow of air through the suction channel (50-5-SC), thereby creating suction within the suction channel (50-5-SC), which pulls the skin 74 toward the front of the nozzle 50-5, thereby dilating lymphatic vessels within the tissue local to the suction channel (50-5-SC), which may act to reperfuse the immediate area as the expansion zone of the curved air stream 70-5 is moved along the skin toward the drainage area during the performance of operation 84 of method 80.
[0084]
[0113] 21 illustrates an upward nozzle 50-6 configured to output an upward nozzle air stream 70-6 that can be applied to a concavely shaped region of a patient to induce compressive shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. The upward nozzle 50-6 is configured similarly to either the curved-blade nozzle 50-4 or the flattened-oval nozzle 50-3, but has an upward-nozzle exit orifice (50-6-OO) configured to direct the upward air stream 70-6 with an upward directional component relative to the centerline (50-6-CL) of the upward nozzle 50-6's inlet (50-6-IN). The exit orifice (50-6-OO) can have a straight, flattened-oval shape similar to the flattened-oval nozzle exit orifice (50-3-OO), or a curved profile similar to the curved-blade nozzle exit orifice (50-4-OO). The upward nozzle air stream 70-6 can have any suitable flow rate to nozzle area ratio at the circular exit orifice (50-6-00). For example, the upward nozzle air stream 70-6 can have a flow rate of 0.004 to 0.020 (m 3 / min) vs mm 2 More preferably, the range is 0.009 to 0.014 (m 3 / min) vs mm 2The upward nozzle exit orifice (50-6-00) can have a flow rate to nozzle area ratio in the range of 300 to 700 mm. 2 The upward nozzle exit orifice (50-6-OO) can be configured to conform to the shape of the upward nozzle air stream 70-6 to better match the shape of the curved body region (e.g., behind the knee, inner elbow, etc.), thereby providing a more uniform and complete application to the curved body region, which helps maximize the range of the resulting distribution of the induced subsurface pressure change 76.
[0085]
[0114] 22 illustrates operation of the upward nozzle 50-6 to apply an upward nozzle air stream 70-6 to a concave region of a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. As can be understood in light of FIG. 22 , the upward nozzle air stream 70-6 may be particularly effective for use in accomplishing operation 84 of method 80 to induce movement of quiescent fluid within a concave body region because the upward nozzle air stream 70-6 is output from the upward nozzle 50-6 in a direction corresponding to an orientation of the upward nozzle 50-6 at a greater angle relative to the skin 74, thereby corresponding to application of the upward nozzle air stream 70-6 to a concave area of the body where the adjacent space available to accommodate a treatment nozzle used to accomplish operation 82 and / or operation 84 of method 80 is reduced.
[0086]
[0115] 23 and 24 show diagrams of a bump nozzle 50-7 having a protruding bump (50-7-Bump) configured to contact a patient to apply direct mechanical compression in combination with an air stream 70-7 output from the bump nozzle 50-7 for application to the patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. The bump (50-7-Bump) is configured to contact the patient's skin 74 and press against and along the skin to mechanically stimulate the tissue and aid in subcutaneous fluid movement toward the main drainage area. The bump nozzle 50-7 can be used when fluid retention is extreme (hard skin) and the air stream 70 alone (output from any of the nozzles described herein) does not provide sufficient fluid movement from the fluid retention area. Other than the bump (50-7-Bump), the remainder of the bump nozzle 50-7 can be configured the same or similar to the curved blade nozzle 50-4.
[0087]
[0116] 25, 26, and 27 show diagrams of a roller nozzle 50-8 having a roller (50-8-roller) configured to contact a patient to apply direct mechanical compression in combination with an air stream 70-8 output from the roller nozzle 50-8 for application to the patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to embodiments. The roller (50-8-roller) is configured to contact the patient's skin 74 and be pressed against and rolled along the skin to mechanically stimulate the tissue and induce movement of stationary fluid. The roller nozzle 50-8 can be used when fluid retention is extreme (e.g., tough skin) and the air stream 70 alone (output from any of the nozzles described herein) does not provide sufficient fluid movement from the fluid retention area. Other than the roller (50-8-roller), the remainder of the roller nozzle 50-8 can be configured the same as or similar to the curved-blade nozzle 50-4. In some embodiments, the roller (50-8-roller) is configured to be lightly rolled along the surface of the skin 74 to apply pressure to the skin 74 and induce directional movement of the stationary fluid. The roller (50-8-roller) can optionally be made from a hard, durable material such as plastic or metal. Alternatively, the roller (50-8-roller) can optionally be made from a softer, more pliable material such as rubber or foam, which can better conform to the anatomy and be less traumatic to the skin and tissue.
[0088]
[0117] FIG. 28 shows an isometric view of the hooded nozzle 50-9, including the exit orifice (50-9-OO) and the hood (50-9-HOOD). FIG. 29 shows a cross-sectional view of the hooded nozzle 50-9. The hood (50-9-HOOD) partially defines a turbulent flow channel (50-9-TC) through which the air stream 70-9 is emitted from the exit orifice (50-9-OO). An end portion of the hood (50-9-HOOD) can contact the patient's skin 74, which, in combination with the hood (50-9-HOOD), defines the turbulent flow channel (50-9-TC). The turbulent flow channel (50-9-TC) has a larger cross-sectional area than the exit orifice (50-9-OO), creating a larger low-pressure zone and causing turbulence. The turbulence added to the air stream 70-9 can increase the resulting variability of the induced subsurface pressure changes 76, thereby enhancing the associated shear thinning, creating more intense / frequent wave dynamics, stimulation / adjustment of fluid migration paths, and / or directional migration of quiescent fluid.
[0089]
[0118] Any of the directional air stream nozzles described herein may include a guide portion configured to interface with the patient to control the position and orientation of the exit orifice and the air stream output therefrom relative to the zone of air stream deployment. For example, FIG. 30 shows an isometric view of a curved-blade nozzle (50-4-WGP) with a guide portion configured to output a curved-blade air stream 70-4 for application to a patient to induce compressive shear thinning of stationary fluid, stimulation / adjustment of a fluid migration path and / or a natural evacuation area of stationary fluid, and / or directional migration of stationary fluid, according to an embodiment. The curved-blade nozzle (50-4-WGP) with a guide portion is configured similarly to the curved-blade nozzle 50-4, except that it includes an inlet coupling portion (50-4-ICP-WGP) that includes a guide portion (50-4-GP) that forms a lower protruding portion of the inlet coupling portion (50-4-ICP-WGP). The guide portion (50-4-GP) has one or more outer surfaces configured to interface with the patient and control the position and orientation of the nozzle (50-4-WGP) relative to the patient, thereby controlling the distance and orientation of the air stream curved blade air stream 70-4 relative to the zone of deployment of the air stream 70-4 on the skin. In the illustrated embodiment, the nozzle (50-4-WGP) has a grip portion (50-4-Grip) distal to the inlet coupling portion (50-4-ICP-WGP) to accommodate grasping the grip portion (50-4-Grip) and extending fingers around the grip portion (50-4-Grip) without interference from the guide portion (50-4-GP).
[0090]
[0119] 31, 32, 33, and 34 show a pulsating nozzle 50-10 configured to output a pulsating air stream 70-10 for application to a patient to induce compression shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. The pulsating air stream 70-10 has a periodically varying flow rate and velocity induced by the pulsating nozzle 50-10. The pulsating nozzle 50-10 includes an outlet housing (50-10-OH), an inlet housing (50-10-IH), an airflow modulation member (50-10-AMM), and a rotational bearing (50-10-RB). The pulsating nozzle 50-10 can be assembled by installing both rotary bearings (50-10-RB) into the airflow modulation members (50-10-AMM) at either end, pressing them flush with the bearing seats, then inserting this subassembly into the outlet housing (50-10-OH), and then attaching the inlet housing (50-10-IH) to the outlet housing (50-10-OH). The axial position of the airflow modulation members (50-10-AMM) is maintained by engagement with the rotary bearings (50-10-RB). The outlet housing (50-10-OH) contains a primary airflow outlet (50-10-PAO) and a bypass airflow outlet (50-10-BAO). The airflow modulation member (50-10-AMM) is mounted for rotation relative to the outlet housing (50-10-OH) via a rotational bearing (50-10-RB) and defines an airflow modulation channel (50-10-AMC). The inlet housing (50-10-IH) includes an air inlet (50-10-INLET) configured to receive the supplied airflow 18 and deliver the supplied airflow 18 into the airflow modulation channel (50-10-AMC). The airflow modulation channel (50-10-AMC) includes an inner surface shaped to induce rotation of the airflow modulation member (50-10-AMM), thereby inducing rotation of the supplied airflow 18 about the centerline of the nozzle body. The air flow modulation channel (50-10-AMC) has an air flow modulation channel outlet (50-10-AMCO) (shown in FIG. 33) having an elongated cross-sectional shape that extends transversely to the axis of rotation of the air flow modulation member (50-10-AMM).In the configuration shown in FIG. 32, the airflow modulation channel outlet (50-10-AMCO) is fluidly connected to the primary airflow outlet (50-10-PAO) and not to either of the bypass airflow outlets (50-10-BAO). Rotation of the airflow modulation member (50-10-AMM) creates a periodic fluid connection between the airflow modulation channel outlet (50-10-AMO) and the bypass airflow outlet (50-10-BAO) for a limited period of time, thereby exhausting a portion of the supplied airflow 18 through the bypass airflow outlet (50-10-BAO), thereby imparting a pulsed axial flow fluctuation to the airstream 70-10 output from the primary airflow outlet (50-10-PAO). This exhausted air serves to maintain a constant system backpressure when the PAO is not fully open, thereby extending system / motor life. The pulsating axial flow fluctuations of the air stream 70-10 induce corresponding fluctuations in the induced subsurface pressure changes 76, thereby enhancing the resulting compression shear thinning of the quiescent fluid, stimulating and / or adjusting the fluid migration path, and / or directional migration of the quiescent fluid. The air stream 70-10 generated by the pulsating nozzle 50-10 may be used as the air stream 70 in operation 82 of the method 80 and / or as the air stream 70 in operation 84 of the method 80.
[0091]
[0120] 35, 36, 37, 38, 39, and 40 show a helical output nozzle 50-11 configured to output a rotating helical air stream 70-11 for application to a patient to induce compressive shear thinning, stimulation, and directional movement of quiescent fluid, according to an embodiment. The helical output nozzle 50-11 includes an outlet housing (50-11-OH), an inlet housing (50-11-IH), a helical airflow member (50-11-HAM), and a rotational bearing (50-11-RB). The spiral output nozzle 50-11 can be assembled by placing both rotational bearings (50-11-RB) on the spiral airflow member (50-11-HAM) at either end, pressing them flush with the bearing seats, then inserting this subassembly into the outlet housing (50-11-OH), and then attaching the inlet housing (50-11-IH) to the outlet housing (50-11-OH). The axial position of the spiral airflow member (50-11-HAM) is maintained by engagement with the rotational bearings (50-11-RB). The spiral airflow member (50-11-HAM) is mounted for rotation relative to the outlet housing (50-11-OH) via the rotational bearings (50-11-RB) and defines a spiral airflow channel (50-11-HAC). The inlet housing (50-11-IH) includes an air flow inlet (50-11-INLET) configured to receive the supplied air flow 18 and deliver the supplied air flow 18 into the helical air flow channel (50-11-HAC). The helical air flow channel (50-11-HAC) includes an interior surface shaped to induce rotation of the helical air flow member (50-11-HAM), thereby inducing rotation of the supplied air flow 18 about the nozzle body centerline. The helical air flow channel (50-11-HAC) has a helical air flow channel outlet (50-11-HACO) that is radially offset from the rotational centerline of the helical air flow member (50-11-HAM) (as shown in FIG. 37). Rotation of the helical air flow member (50-11-HAM) rotates the helical air flow channel outlet (50-11-HACO) about the rotational centerline of the helical air flow member (50-11-HAM), thereby generating a helically rotating configuration of the rotating helical air stream 70-11.The spirally rotating configuration of the rotating helical air stream 70-11 generates corresponding positional variations in the location of the area of deployment of the rotating helical air stream 70-11 on the patient's skin 74 (as shown in FIG. 38 ), thereby inducing corresponding variations in the induced subsurface pressure changes 76, thereby enhancing the resulting compression shear thinning of the quiescent fluid, stimulation and / or adjustment of fluid movement paths, and / or directional movement of the quiescent fluid. The air stream 70-11 generated by the helical air stream nozzle 50-11 can be used as the air stream 70 in operation 82 of method 80 and / or the air stream 70 in operation 84 of method 80.
[0092]
[0121] Figures 41, 42, 43, and 44 show a double helix output nozzle 50-12 configured to output a rotating double helix air stream for application to a patient to induce compression shear thinning, stimulation, and directional movement of stationary fluid, according to an embodiment. The double helix output nozzle 50-12 includes an outlet housing (50-12-OH), an inlet housing (50-12-IH), a double helix airflow member (50-12-HAM), and a rotating bearing (50-12-RB). The double helix output nozzle 50-12 can be assembled by installing both rotating bearings (50-12-RB) into the double helix airflow member (50-12-HAM) at either end and pressing them flush with the bearing seats, then inserting this subassembly into the outlet housing (50-12-OH), and then attaching the inlet housing (50-12-IH) to the outlet housing (50-12-OH). The axial position of the double helical airflow member (50-12-HAM) is maintained by engagement with a rotational bearing (50-12-RB). The double helical airflow member (50-11-HAM) is mounted for rotation relative to the outlet housing (50-12-OH) via the rotational bearing (50-12-RB) and defines a double helical airflow channel (50-12-DHAC). The inlet housing (50-12-IH) includes an air flow inlet (50-12-INLET) configured to receive the supplied airflow 18 and deliver the supplied airflow 18 into the double helical airflow channel (50-12-DHAC). The double helical airflow channel (50-12-DHAC) includes an inner surface shaped to induce rotation of the double helical airflow member (50-11-HAM), thereby inducing rotation of the supplied airflow 18 about the nozzle centerline. The dual helical airflow channel (50-11-DHAC) has two separate helical airflow channel outlets (50-12-HACO) that are radially offset from the rotational centerline of the dual helical airflow member (50-12-HAM) (as shown in FIG. 41). Rotation of the dual helical airflow member (50-12-HAM) causes the two helical airflow channel outlets (50-12-HACO) to rotate about the rotational centerline of the dual helical airflow member (50-12-HAM), thereby generating a helically rotating configuration of the rotating dual helical air stream 70-12.The helically rotating configuration of the rotating double helical air stream 70-12 generates corresponding positional variations in the location of the area of deployment of the rotating double helical air stream 70-12 on the patient's skin 74 (as shown in FIG. 42 ), thereby inducing corresponding variations in the induced subsurface pressure changes 76, thereby enhancing the resulting compression shear thinning of the quiescent fluid, stimulation and / or adjustment of fluid movement pathways, and / or directional movement of the quiescent fluid. The rotating double helical air stream 70-12 generated by the helical air stream nozzle 50-12 can be used as the air stream 70 in operation 82 of method 80 and / or the air stream 70 in operation 84 of method 80.
[0093]
[0122] In some embodiments, a deformable nozzle is used to generate the air stream 70 used in operation 82 of method 80 and / or the air stream 70 used in operation 84 of method 80. The deformable nozzle can be configured with a deformable nozzle portion that can be selectively deformed to tailor the air stream 70 to better fit the contours of the patient's treatment area. In some embodiments, the deformable nozzle is formed from a suitable thermoplastic that can be heated to a heated state and reshaped in the heated state to reconfigure the air stream 70 to better fit the contours of the patient's treatment area. In some embodiments, the deformable nozzle is made from a malleable metal or thermoplastic that can be deformed to reshape the deformable nozzle to reconfigure the air stream 70 to better fit the contours of the patient's treatment area. The deformable nozzle can be configured similarly to any of the nozzles described herein, but has a deformable portion that can be selectively reshaped to tailor the air stream 70 to better fit the contours of the patient's treatment area, which can be a beneficial attribute because not all patient anatomies share the same dimensions.
[0094]
[0123] In some embodiments, the one or more internal features include one or more blades or flow guiders. Many of the nozzles and hoses described herein have smaller cross-sectional areas or non-circular shapes, which can induce turbulence in the airflow passing through the nozzle. Any of the nozzles, nozzle grips, or hoses described herein can further include one or more internal features within the nozzle to guide the airflow and create a more laminar, faster flow.
[0095]
[0124] Any of the systems described herein can include a quick nozzle change system configured to accommodate quick exchange from one embodiment of an air stream nozzle 50 attached to the air flow supply hose 14 to a different embodiment of an air stream nozzle 50 attached to the air flow supply hose 14. Any suitable quick nozzle change can be used. For example, in some embodiments, the quick nozzle change system includes a rotatable assembly (e.g., similar to the optical magnification system of a microscope) including multiple nozzles removably mounted to a rotating assembly. The rotatable assembly can be selectively rotated to change which nozzles are fluidly coupled to the air flow supply hose 14. As another example, the quick nozzle change system can include a slidable linear assembly including multiple nozzles removably mounted to the slidable linear assembly. The slidable linear assembly can be selectively translated to change which nozzles are fluidly coupled to the air flow supply hose 14.
[0096]
[0125] System for treating fluid retention
[0097]
[0126] 44 illustrates an exemplary blower unit 22 and airflow supply hose 14 configured to generate and deliver a supplied airflow 18 to a nozzle 50 to generate an airstream 70 to induce shear thinning of stationary fluid, induce movement of stationary fluid, and / or stimulate / condition one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of stationary fluid, according to embodiments. In many embodiments, the supplied airflow 18 is generated from filtered room temperature air. In many embodiments, the supplied airflow 18 is transported from the blower unit 22 to the nozzle 50 via the airflow supply hose 14.
[0098]
[0127] The blower unit 22 is intended for use in managing fluid retention (e.g., edema). The airflow supply hose 14 is flexible and has a distal end portion 15 configured to selectively couple to any selected one of the nozzles described herein. The blower unit 22 includes a blower motor drivingly coupled to an airflow impeller operable to generate an airflow 18. In many embodiments, the blower unit 22 controls the supplied airflow 18 to a value in the range of 0.004 to 0.020, more preferably 0.009 to 0.014 ((m 3 / min) vs mm 2 The airflow 18 is delivered to the airflow supply hose 14 at a preferred average flow rate to nozzle area ratio of 1 / 2 sq. m / s (units of sq. m / s). The optimum volumetric flow rate of the airflow 18 depends on the nozzle configuration used and on the configuration parameters of the airflow supply hose 14 related to the pressure drop along the airflow supply hose 14, such as length and inner diameter.
[0099]
[0128] In a preferred embodiment, the blower unit 22 includes a housing that encloses the motor and airflow impeller. The housing can be made of any suitable material, such as metal or plastic. Preferably, the blower unit 22 includes sound-deadening features and / or materials disposed within the housing to reduce the intensity level of sound generated through operation of the blower unit 22. For example, the blower unit 22 can include a high-density acoustic barrier textile, such as mass-loaded vinyl, disposed within the housing to surround the motor and airflow impeller. Alternatively or additionally, the motor and airflow impeller may be disposed within a secondary housing design to suppress sound transmission. In some embodiments, the blower unit 22 includes noise-reducing features to mitigate the sound generated by the fan motor 40 and impeller 42. Noise reduction features may include, for example, sound-deadening materials (such as various forms of foam), sound-limiting fan blade designs, active noise canceling units consisting of a microphone and speaker, sound-deadening motor mounts, external baffles that attenuate air entering the motor unit's intake, and / or features on the nozzle 50 configured to limit the intensity of sound produced as the air stream 70 exits the nozzle's exit orifice.
[0100]
[0129] In many embodiments, blower unit 22 includes a filtration assembly and a blower assembly configured to be operable to draw airflow 18 through the filtration assembly to remove contaminants from airflow 18 before it is received by the blower assembly. In many embodiments, the blower assembly includes a motor-driven airflow impeller that pushes and transports filtered airflow 18 into airflow supply hose 14. Filtration of airflow 18 by the filtration assembly is used to ensure that airstream 70 is substantially free of contaminants. In many embodiments, the filtration assembly includes a HEPA filter or an N95 filter, as both filter grades are rated for capturing particulates.
[0101]
[0130] In many embodiments, the airflow supply hose 14 has a length and flexibility that accommodates ease of manipulation around the treatment target. For example, the airflow supply hose 14 can optionally have a length ranging from 3 to 20 feet, can optionally be made from highly flexible rubber or plastic, and can have a flexible exterior configuration (e.g., accordion, corrugated). The hose may be composed of a set of hoses of different diameters that neck down near the distal end using a fitting. The distal hose should be as short as possible while still being maneuverable by the clinician to reduce backpressure within the system. The airflow supply hose 14 has a distal end portion 15 configured to removably couple to a treatment nozzle 50 (which may be any of the treatment nozzles described herein). In embodiments, the airflow supply hose 14 is made from a material with a suitably high thermal conductivity to cool the airflow 18 as it flows through the airflow supply hose 14. In an embodiment, the airflow supply hose 14 is made from a rubber material having a suitably high thermal conductivity and / or includes copper wiring configured to transfer heat from the airflow 18 to the ambient air surrounding the airflow supply hose 14 to cool the airflow 18.
[0102]
[0131] In many embodiments, the blower unit 22 is configured to be operable to select and control one or more airflow parameters of the airflow 18 supplied by the blower unit 22 to the airflow supply hose 14. The one or more airflow parameters may include, but are not limited to, any combination of one or more of the following: the temperature of the airflow; the pressure of the airflow 18 delivered to the airflow supply hose 14; the flow rate of the airflow 18 delivered to the airflow supply hose 14; a change in the flow rate of the airflow 18 delivered to the airflow supply hose 14 (to impart a pulsating motion to the air stream 70 output from the nozzle 50); and the magnitude and frequency of the change in the flow rate of the airflow 18. The ability to select and control the temperature of the airflow 18 may be used to ensure patient comfort and / or to increase the temperature of the skin 74 to increase the mobility of quiescent fluids out of the area of fluid accumulation being treated and / or through the fluid pathway to the drainage area; and / or to set a lower temperature for conditions that do not require heat, such as lymphedema. The ability to select and control the flow rate, flow rate changes, and / or frequency of flow rate changes of the air flow 18 delivered to the air flow supply hose 14 can be used to select and control the adaptive parameters of the air stream 70 output from the nozzle 50. The flow rate or velocity of the air stream 70 is an important air flow parameter to control because different areas of the body may require different velocities for optimal treatment. For example, a lower air velocity may not provide sufficient fluid movement, while having an excessively high air velocity may cause discomfort to the patient, or may be desirable when treating areas such as the head. Various specific settings of the blower unit 22 may be pre-programmed and / or recommended for different specific body areas being treated for the operator's convenience.In some embodiments, the blower unit 22 is configured to be operable to vary the flow rate of the air flow 18 delivered to the air flow supply hose 14 at a suitable frequency and by a suitable magnitude, so that the air stream 70 has a corresponding suitable pulsatile flow rate / velocity to generate corresponding variations in induced subsurface pressure changes 76, which can assist in shear thinning of quiescent fluid, stimulating / conditioning fluid movement paths, and / or enhancing the discharge area through which fluid is directionally moved.
[0103]
[0132] In embodiments, the blower unit 22 includes various control mechanisms for controlling various parameters. For example, the blower unit 22 may include an airflow rate control mechanism operable to set the airflow rate of the airflow 18 delivered to the treatment nozzle 50 via the airflow supply hose 14. In some embodiments, power supplied to the motor is controlled via an airflow rate control mechanism, which may optionally include a dial or rheostat that may have settings corresponding to a selectable flow rate of the airflow 18 (or a selectable speed of the airflow 18 or air stream 70) and / or a setting corresponding to an airflow rate of the airflow 18 for treating a particular body region to be treated using the selected airflow rate of the airflow 18. For example, the blower unit 22 may include an airflow rate selection dial that includes settings for treating a particular body region, such as, for example, a "face" setting and a "leg" setting. The "face" setting may be used to select a reduced airflow rate of the airflow 18 appropriate for treating the face so as to avoid harming the more sensitive structures of the face, as opposed to the "leg" setting, which may provide a more powerful stream of air to better move fluid through the legs.
[0104]
[0133] Any of the systems for treating fluid retention described herein can optionally be configured to select and control the temperature of the air stream 18. If the temperature of the air stream 70 is too cold or too hot, deployment of the air stream 70 at the patient may cause discomfort to the patient and / or may interfere with the movement of stationary fluid. Preferably, the selected temperature of the air stream 70 is in the range of 20°C to 45°C at the nozzle opening for treating fluid retention (e.g., edema). To induce evaporative cooling (as described herein), the selected temperature may be in a lower temperature range (e.g., 5°C to 20°C).
[0105]
[0134] Any of the systems for treating fluid retention described herein can optionally be used to induce evaporative cooling in a subject. For example, an air stream 70 can be directed at a subject to induce an accelerated evaporative cooling effect on the skin 74. The system can optionally be configured to receive a temperature selection and control the temperature of the air stream 70 according to the temperature selection, which can be within a temperature range suitable for evaporative cooling (e.g., 5°C to 20°C). Inducing evaporative cooling can be beneficial in a variety of situations. For example, as a result of physical exercise, a subject may become hot and sweat due to muscle contraction and / or higher blood perfusion. Cooling of a hot, sweating subject can be induced by directing an air stream 70 (preferably at a suitable low temperature, preferably in the range of 5°C to 20°C) at the subject to interact with sweat on the body and rapidly evaporate the sweat. In sports medicine and recovery settings, inducing evaporative cooling as described herein can be used to rapidly cool a subject, thereby shortening post-exercise recovery time and increasing the subject's ability to return "on the spot" more quickly. Additionally, blowing cool air onto the subject may affect the sympathetic nervous system's control over the body's sweating, which can inhibit sweating after treatment. Optionally, a liquid coolant (water or alcohol) can be applied to the skin 74 before or during application of the air stream 70 to increase the rate of evaporative cooling.
[0106]
[0135] In some embodiments, the blower unit 22 is configured (controllable) to generate the airflow 18 in an airflow configuration selected from selectable airflow configurations. The selectable airflow configurations can include a constant flow configuration (i.e., having a constant flow rate of the airflow 18) and a pulsating airflow configuration (i.e., having pulsatile variations in the flow rate of the airflow 18). Any suitable technique can be used by the blower unit 22 to generate the pulsating airflow configuration. For example, the blower unit 22 can be configured to control the operation of a motor to vary the speed of an airflow impeller to implement the pulsating airflow configuration. Alternatively or additionally, the blower unit 22 can include (and be configured to control) an electrically operated valve for controlling the flow rate of the airflow 18 to implement the pulsating airflow configuration. The blower unit 22 can control the pulsation of the airflow 18 via a software algorithm. The flow rate of the airflow 18 can be pulsated many times per second to increase agitation of quiescent fluid via the air stream 70 for enhanced shear thinning and fluid movement. Pulsation, temperature, rate, and other fluid control parameters can be easily controlled via analog switches or dials on the blower housing or nozzle, or can be managed using a touchscreen display or other digital means.
[0107]
[0136] The systems for treating fluid stasis described herein can be configured to generate and output feedback indicative of one or more of the following: the relative position of the nozzle 50 with respect to the deployment zone of the air stream 70 on the patient; the relative orientation of the nozzle 50 with respect to the patient; the temperature of the skin 74 adjacent to the nozzle 50; the angle of the air stream 70 with respect to the skin 74 within the deployment zone of the air stream 70 on the patient; the size and frequency of the undulating motion of the skin 74 at or near the deployment zone of the air stream 70 on the patient; or the amount of stasis fluid remaining in the tissue. The feedback is configured to provide information to the therapist performing the fluid stasis treatment for use in performing the treatment and to monitor the progress of the treatment in real time. In some embodiments, the systems for treating fluid stasis described herein include an electrical impedance sensor used to measure the amount of fluid in the tissue. The use of an electrical impedance sensor to detect fluid stasis is a proven methodology, particularly for detecting lymphedema. Each of the nozzles described herein can include an integrated electrical impedance sensor configured to contact the skin 74 to generate an electrical impedance sensor signal that is processed to determine the amount of fluid remaining in a localized area of the skin 74. This embodiment may appear similar to a bump nozzle, with electrodes attached to the front of the bump at either end. During treatment, the clinician temporarily places these electrodes over the patient's edematous area, takes a bioimpedance reading, and modifies treatment based on this. In embodiments, the blower system reads this bioimpedance reading, shows treatment progress and recommendations on a digital screen, and can modify / terminate treatment based on this feedback. Alternatively, the electrical impedance sensor may be part of a separate subsystem rather than being integrated into the nozzle 50.
[0108]
[0137] The systems for treating fluid retention described herein can be configured for use in stationary and / or mobile environments. For example, in some embodiments, blower unit 22 can be configured for use in a dedicated stationary treatment facility. Alternatively or additionally, blower unit 22 can be configured as a mobile unit that includes movable features (e.g., handles, wheels, body straps, backpack straps, etc.).
[0109]
[0138] 46 illustrates an exemplary operating regime for the nozzle opening area and flow rate of air stream 70 to induce shear thinning of stationary fluid, induce displacement of stationary fluid, and / or stimulate / condition one or more lymph nodes, one or more lymphatic ducts, and / or blood vessels for transport and / or uptake of stationary fluid, according to embodiments. As shown, the systems and methods for treating fluid retention described herein provide for a total operating range of at least 113 mm for the air stream 70. 2 An air stream nozzle with an exit orifice cross-sectional area of 2.7 m can be used. The expected optimum treatment range (OTR) is 2.7 m. 3 / min~4.2m 3 / min range with flow rates in the range of 300mm 2 From the minimum exit orifice cross-sectional area of 6.2m 3 / min ~ 9.8m 3 / min range and a maximum outlet orifice cross-sectional area of 700 mm2. In contrast, U.S. Patent No. 3,163,161 relates to a traveling wave air massage method that uses a smaller nozzle outlet and compressed air to direct air at a low angle to the skin.
[0110]
[0139] 47 is a simplified schematic diagram of a system 10 for treating fluid retention, according to an embodiment. System 10 includes a main unit 12, an air flow supply hose 14, and a nozzle assembly 16. Main unit 12 is configured to generate and supply air flow 18 to nozzle assembly 16 via air flow supply hose 14. Nozzle assembly 16 is configured to receive air flow 18 and output air flow 18 as air stream 20 that is used to perform operations 82 and / or 84 of method 80, as described herein.
[0111]
[0140] Main unit 12 includes blower assembly 22, filter assembly 24, one or more input devices 26, and one or more output devices 28. Main unit 13 may optionally further include an airflow temperature control unit 30, a control unit 32, and / or a communications unit 34. Control unit 32 may include one or more processors 36 and a tangible memory 38 that stores non-transitory instructions executable by processor(s) 36 to control the operation of blower unit 22, airflow temperature control unit 30, and / or communications unit 34. One or more input devices 26 are user-operable to input control signals to main unit 12 for use in setting operating parameters of blower assembly 22 and / or airflow temperature control unit 30. One or more output devices 28 are operable to display selected or current operating parameters of blower assembly 22 and / or airflow temperature control unit 30. The blower assembly 22 includes an impeller motor 40 and an airflow impeller 42 drivingly coupled to the impeller motor 40. The impeller motor 40 rotates the airflow impeller 42, thereby drawing the airflow 18 through the filter assembly 13 and delivering the airflow 18 to the airflow temperature control unit 30. The airflow temperature control unit 30 includes a heating element 44, an airflow cooling unit 46, an airflow temperature sensor 48, and an airflow pressure sensor 49. The airflow temperature sensor 48 is configured to generate an airflow temperature signal indicative of the temperature of the airflow 18 downstream of the airflow temperature control unit 30. The control unit 32 controls the heating element 44 based on the temperature signal to heat the airflow 18 to a temperature selected for the airflow 18 downstream of the airflow temperature control unit 30, as needed. The control unit 32 controls the heating element 44 based on the temperature signal to heat the airflow 18 to a temperature selected for the airflow 18, as needed. In some embodiments, the cooling unit 46 is configured as an air-to-air heat exchanger through which the airflow 18 passes and an electric fan for generating a cooling air stream across the air-to-air heat exchanger.Alternatively, cooling unit 46 may be configured as an air conditioning unit having an evaporator for removing heat from air flow 18. Control unit 32 may control electric fan or air conditioning unit 46 to cool the air flow to a selected temperature for air flow 18, as needed. From air flow temperature control unit 30, air flow 18 is output to air hose 14 for delivery to nozzle assembly 16. Air flow pressure sensor 49 is configured to generate an air flow pressure signal indicative of the pressure of air flow 18 output to air flow supply hose 14. In some embodiments, control unit 32 is configured to control operation of fan motor 40 to control the pressure of air flow 18, thereby controlling the flow rate of air flow 18. In some embodiments, input device(s) 26 are operable to specify a flow rate for air flow 18, which may be controlled by control unit 32 via the pressure signal provided by air flow pressure sensor 49.
[0112]
[0141] Nozzle assembly 16 includes a nozzle 50, which may be any of nozzles 50-1 through 50-12 described herein. Nozzle assembly 16 may further include any selection of additional components, including one or more of a video camera 52, a fluid sensor 54, an orientation sensor 58, one or more input devices 60, a temperature sensor 62, a communication unit 64, one or more output devices 66, or a proximity sensor 68. Video camera 52 may be mounted on nozzle 50 and oriented to monitor the movement of skin 74 in the area of deployment of air stream 70 thereon. Output from video camera 52 may be transmitted wirelessly (or via wire) from communication unit 64 of nozzle assembly 16 to communication unit 34 of main unit 12 for processing by control unit 32 to estimate the amount of quiescent fluid in tissue in the area of deployment. The control unit 32 can then output feedback indicating the estimated amount of stationary fluid in the tissue in the area of deployment to a user of the system via one or more output devices 28 of the main unit 12 and / or via one or more output devices 66 of the nozzle assembly 16. The fluid sensor 54 can be configured to generate a fluid sensor signal indicative of the amount of stationary fluid in the tissue. The fluid sensor 54 can have any suitable configuration. For example, in some embodiments, the fluid sensor 54 includes an electrical impedance sensor including two or more electrodes (preferably a total of four, with two signal electrodes and two sensing electrodes) configured to contact the skin 74 and generate an electrical impedance signal indicative of the impedance of the tissue between the two sensing electrodes. The fluid sensor 54 can be mounted on the nozzle 50 or can be deployed separately. The fluid sensor signal can be transmitted wirelessly (or via wire) from the communication unit 64 of the nozzle assembly to the communication unit 34 of the main unit 12 for processing by the control unit 32 to estimate the amount of stationary fluid in the tissue in the area of deployment.The control unit 32 can then output feedback indicative of the estimated amount of quiescent fluid in the tissue in the area of deployment to a user of the system via one or more output devices 28 of the main unit 12 and / or via one or more output devices 66 of the nozzle assembly 16. The pressure sensor 56 can be configured to generate a pressure signal indicative of the pressure of the airflow 18 in the nozzle 50 upstream of the output orifice of the nozzle 50. The pressure signal can be transmitted wirelessly (or over a wire) from the communication unit 64 of the nozzle assembly 16 to the communication unit 34 of the main unit 12 for processing by the control unit 32 for use in controlling the fan motor 40 to control the flow rate of the airflow 18 through the nozzle 50. The orientation sensor 58 (e.g., an accelerometer) can be used to generate an orientation signal indicative of the orientation of the nozzle 50 with respect to gravity. The orientation signal can be transmitted wirelessly (or over a wire) from the communication unit 64 of the nozzle assembly 16 to the communication unit 34 of the main unit 12 for processing by the control unit 32 to determine the orientation of the nozzle 50 with respect to gravity. The control unit 32 can then output feedback indicating the orientation of the nozzle 50 to a user of the system via one or more output devices 28 of the main unit 12 and / or via one or more output devices 66 of the nozzle assembly 16.
[0113]
[0142] The angle at which the air stream 70 contacts the skin 74 can be controlled for optimal movement of the stationary fluid to enhance treatment effectiveness. Preferably, the angle of the air stream 70 relative to the skin 74 is between 0 and 60 degrees, depending on the proximity of the air stream 70 to the skin 74. The angle of the air stream 70 relative to the skin 74 can be selected to provide a suitable balance between pressure fluid thinning and directional movement of the stationary fluid. The angle of the air stream 70 relative to the skin 74 can be selected to maximize the undulating motion of the skin 74 and enhance shear thinning and directional movement of the stationary fluid. To provide feedback to the clinician operating the nozzle assembly 16, the nozzle assembly 16 can be configured with an orientation sensor 58 to measure the orientation of the nozzle 50 and provide feedback to the user regarding the orientation of the nozzle 50. The orientation sensor 58 can have any suitable configuration. For example, the orientation sensor 58 can be configured similar to a typical architect's level air bubble sensor. Alternatively or additionally, the orientation sensor 58 can include an accelerometer configured to generate an accelerometer output signal indicative of the orientation of the nozzle 50 relative to gravity, as described above. The nozzle 50 may also include a simple guide configured as part of the underside of the nozzle 50 or as an attachment to the nozzle 50. The guide may be configured such that when the guide is positioned flush with the patient, the nozzle 50 is oriented relative to the skin 74 to output the air stream 70 onto the skin 74 at a preferred angle relative to the skin 74.
[0114]
[0143] In some embodiments, the nozzle assembly 16 includes a proximity sensor 68 for measuring the proximity of the outlet orifice of the nozzle 50 to the area of deployment of the air stream 70 on the skin 74. The proximity sensor 68 may have any suitable configuration. For example, in some embodiments, the proximity sensor 68 includes an ultrasonic or laser distance sensor configured to generate a proximity sensor signal indicative of the distance between the outlet orifice of the nozzle 50 and the area of deployment of the air stream 70 on the skin 74. The proximity sensor signal may be transmitted wirelessly (or via a wire) from the communication unit 64 of the nozzle assembly 16 to the communication unit 34 of the main unit 12 for processing by the control unit 32 to estimate the distance between the outlet orifice of the nozzle 50 and the area of deployment of the air stream 70 on the skin 74. The control unit 32 may then output feedback indicative of the estimated distance between the outlet orifice of the nozzle 50 and the area of deployment to a user of the system via one or more output devices 28 of the main unit 12 and / or via one or more output devices 66 of the nozzle assembly 16. Feedback can be configured to guide the user in achieving optimal positioning of the nozzle 50 relative to the area of deployment for optimal shear thinning and movement of stationary fluid. The optimal nozzle distance depends on the nozzle type, speed, the patient's skin integrity and sensitivity, and the state of fluid stagnation. The optimal distance can vary approximately from 0 cm to 50 cm. In some cases, depending on the patient's tolerance and skin integrity, it may be beneficial to have the skin in direct contact with the nozzle 50 exit orifice. In embodiments, a physical or electronic nozzle spacer can be utilized to set the distance between the nozzle 50 exit orifice and the skin 74.
[0115]
[0144] In some embodiments, the nozzle assembly 16 includes a temperature sensor 62 for measuring the skin temperature and / or the temperature of the air stream 70. The temperature of the air stream 70 can be used to ensure a suitable temperature of the air stream 70 for patient comfort and / or treatment effectiveness. The temperature of the skin 74 can indicate the amount of stationary fluid movement that is occurring.
[0116]
[0145] As mentioned above, the video camera 52 may be integrated into the nozzle assembly 16 to detect various changes occurring in the skin 74 with respect to the undulating motion of the skin 74 induced by the application of the air stream 70 to the skin 74. For example, the control unit 32 may implement a software algorithm to detect changes in the height and / or frequency of ripples or perturbations occurring in the skin, which may indicate the amount of quiescent fluid remaining in the tissue.
[0117]
[0146] In embodiments, the output device 66 of the nozzle assembly 16 (or any other part of the system) includes a display screen for the purpose of providing a user with quantitative data resulting from the use of the aforementioned sensors. Similarly, simple LED lights may be utilized to provide user feedback regarding the sensors. For example, a green LED on the nozzle may be illuminated when a laser sensor detects that the output orifice of the nozzle 50 is within a predetermined distance from the area on the patient's skin 74 where the air stream 70 is to be applied.
[0118]
[0147] FIG. 48 is a simplified schematic diagram of an impedance-based static fluid measurement system 300 that can be used with the fluid retention treatment system 10, according to an embodiment. The static fluid measurement system 300 includes an impedance unit 302, signal electrodes 304, 306, and sensing electrodes 308, 310. The signal electrodes 304, 306 are configured to be spaced apart and in contact with a patient's skin to transmit an electrical signal through the patient's tissue disposed between the signal electrodes 304, 306. The sensing electrodes 308, 310 can be positioned on either side of the area of fluid retention 312 to monitor the resulting electrical potential across the area of fluid retention 312 induced by the signal electrodes 304, 306. The impedance unit 302 includes a signal generator 314, a signal processor 316, a control unit 318, one or more input devices 320, one or more output devices 322, and a communication unit 324. The control unit 318 includes one or more processors 324 and a memory 326. The signal generator 314 generates and supplies electrical signals to the signal electrodes 304, 306 for application to the patient. The signal processor 316 processes the resulting electrical potential across the area of fluid accumulation 312 measured by the sensing electrodes 308, 310 and generates impedance data indicative of the impedance of the area of fluid accumulation 312. The memory stores non-transitory instructions executable by the one or more processors 316 to perform the operations described herein. The one or more processors 316 process the impedance data generated by the signal processor 316 and estimate the amount of stationary fluid in the area of fluid accumulation 312 based on the impedance data generated by the signal processor 316 using any suitable known technique. The one or more processors 316 control one or more output devices 322 to provide feedback to an operator of the fluid accumulation treatment system 10 indicative of the amount of stationary fluid disposed in the area of fluid accumulation 312, which can be used to evaluate the progress of the fluid accumulation treatment. The one or more input devices 320 can be configured to control the operation of the stationary fluid measurement system 300.The signal electrodes 304, 306 and the sensing electrodes 308, 310 can have any suitable configuration, such as, for example, as individually attachable electrodes. As another example, one or more of the sensing electrodes 308, 310 can be integrated into the air stream nozzle to facilitate application to the patient, such as in the curved-blade directional air stream nozzle (50-4-IMP) shown in FIG. 49. The curved-blade directional air stream nozzle (50-4-IMP) is configured similarly to the curved-blade nozzle with guide portion (50-4-WGP), except that it further includes a sensing electrode (50-4-SE) corresponding to one of the sensing electrodes 308, 310.
[0119]
[0148] Other variations are within the spirit and scope of the invention. Accordingly, while the invention is susceptible to various modifications and alternative constructions, specific illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the particular form(s) disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined by the appended claims.
[0120]
[0149] Use of the terms "a," "an," and "the" and similar referents in the context of describing the present invention (particularly in the context of the claims below) should be construed to encompass both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" should be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise indicated. The term "connected" should be construed as partially or wholly encompassed, attached, or joined together, even if there is intervening material. Recitation of ranges of values herein is merely intended to serve as a shorthand method of individually referring to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to better illuminate embodiments of the invention and does not limit the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[0121]
[0150] Preferred embodiments of the present invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of these preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is covered by the invention unless otherwise indicated herein or clearly contradicted by context.
[0122]
[0151] All references cited in this specification, including publications, patent applications, and patents, are herein incorporated by reference to the same extent as if each reference was individually and specifically indicated to be incorporated by reference and was set forth in its entirety herein.
Claims
1. 1. A system for treating fluid retention, comprising: a directional air stream nozzle comprising: a directional air stream nozzle inlet configured to receive an air stream; and a directional air stream nozzle outlet orifice configured to output a directional air stream generated from the air stream, the directional air stream configured to be directed onto a patient's skin to induce shear thinning of the stationary fluid and movement of the stationary fluid toward one or more natural drainage areas of the stationary fluid, the directional air stream nozzle outlet orifice having a directional air stream nozzle outlet orifice cross-sectional area; an air flow hose configured to supply the air flow to the directional air stream nozzle; an air flow generator operable to generate and output the air flow to the air flow hose at a flow rate, wherein the ratio of the flow rate to the directional air stream nozzle exit orifice cross-sectional area is 0.004 (m 3 / min) / mm 2 ~0.020 (m 3 / min) / mm 2 and the flow rate is in the range of at least 0.85 m 3 an air flow generator having a flow rate of 1 / min; A system comprising:
2. The system of claim 1 , wherein the quiescent fluid comprises one or more of interstitial fluid, blood, or lymphatic fluid.
3. The flow rate is 1.3 m 3 / min ~ 7.1m 3 10. The system of claim 1, wherein the frequency is in the range of 1 / min.
4. The system of claim 3 , wherein the airflow has a pressure in the range of 10,000 Pa to 35,000 Pa within the directional air stream nozzle upstream of the directional air stream nozzle exit orifice.
5. The system of claim 1 , wherein the directional air stream nozzle exit orifice has a cross-sectional width and a cross-sectional length that is at least two times greater than the cross-sectional width.
6. 6. The system of claim 5, wherein the directional air stream nozzle exit orifice is shaped to conform the directional air stream to the shape of the patient's anatomical region being treated.
7. 6. The system of claim 5, wherein the directional air stream nozzle is configured to create a zone of negative pressure below the directional air stream nozzle sufficient to lift the skin toward the directional air stream nozzle.
8. 6. The system of claim 5, wherein the directional air stream nozzle comprises underside protrusions shaped to apply pressure against the skin to shear thinning and / or displace stationary fluid.
9. 6. The system of claim 5, wherein the directed air stream nozzle comprises a roller configured to roll along the skin and apply contact pressure to the skin to shear thinning and / or displace stationary fluid.
10. 6. The system of claim 5, wherein the directional air stream nozzle exit orifice has a curved shape configured to cause the directional air stream to conform to the curvature of an arm or leg.
11. 6. The system of claim 5, wherein the directional air stream nozzle comprises longitudinally extending side skirts configured to create a negative pressure channel between the directional air stream nozzle and the skin, wherein a negative pressure is created in the negative pressure channel as a result of the directional air stream through the negative pressure channel functioning as a venturi.
12. the directional air stream nozzle having an upwardly curved distal portion with the directional air stream nozzle exit orifice; the directional air stream nozzle comprises an inlet portion having an inlet centerline; The system of claim 1 , wherein the directional air stream is directed transversely to the inlet centerline.
13. The system of claim 5 , wherein the directional air stream nozzle exit orifice has a flattened elliptical cross section.
14. 6. The system of claim 5, wherein the directional air stream nozzle comprises a turbulence channel configured to receive the directional air stream from the directional air stream nozzle exit orifice and induce turbulence in the directional air stream.
15. a localized air stream nozzle configured to be removably attached to the air flow hose; the localized air stream nozzle comprising a localized air stream nozzle inlet configured to receive the air flow and a localized air stream nozzle outlet orifice configured to output a localized air stream generated from the air flow; the localized air stream is configured to be directed onto the skin to induce shear thinning of quiescent fluid; the localized air stream nozzle exit orifice has a localized air stream nozzle exit orifice cross-sectional area; The ratio of the flow rate to the localized air stream nozzle exit orifice cross-sectional area is 0.004 (m 3 / min) / mm 2 ~0.020 (m 3 / min) / mm 2 The system of claim 1 , wherein the range is:
16. 16. The system of claim 15, wherein the air flow has a pressure in the range of 10,000 Pa to 35,000 Pa within the localized air stream nozzle upstream of the localized air stream nozzle exit orifice.
17. The system of claim 15 , wherein the localized air stream nozzle exit orifice has a flattened elliptical shape.
18. 16. The system of claim 15, wherein the localized air stream nozzle comprises a rotating assembly that generates a pulsating component of the localized air stream.
19. 16. The system of claim 15, wherein the localized air stream nozzle comprises a rotating assembly that generates a directionally varying component of the localized air stream.
20. The system of claim 15 , wherein the local air stream nozzle comprises an intake shell configured to incorporate a secondary air stream into the local air stream.
21. a fluid sensor configured to generate a fluid sensor output signal indicative of the degree of quiescent fluid within the patient's tissue; An output device; a control unit configured to process the fluid sensor output signal to determine the extent of the stationary fluid in the tissue, the control unit being configured to control operation of the output device to output feedback indicative of the extent of the stationary fluid in the tissue; The system of claim 1 further comprising:
22. The system of claim 21 , wherein the fluid sensor comprises an impedance sensor.
23. an image sensor configured to generate skin motion image data about an area of the patient's skin having induced motion resulting from directing the directional air stream onto the patient's skin; An output device; a control unit configured to process the skin motion image data to estimate an extent of stationary fluid in tissue underlying the area of skin of the patient, the control unit being configured to control operation of the output device to output feedback indicative of the extent of stationary fluid in the tissue; The system of claim 1 further comprising:
24. 1. A method of treating fluid retention, comprising: A method comprising outputting a directional air stream from a directional air stream nozzle onto the patient's skin to shear-thin the quiescent fluid and move the quiescent fluid towards one or more areas of natural drainage of the quiescent fluid.
25. 25. The method of claim 24, wherein the quiescent fluid comprises one or more of interstitial fluid, blood, or lymphatic fluid.
26. 25. The method of claim 24, further comprising moving the directional air stream nozzle toward the one or more natural discharge regions of quiescent fluid one or more times.
27. 25. The method of claim 24, wherein the directional air stream nozzle is configured and oriented such that the angle between the direction of the directional air stream exiting the directional air stream nozzle and the skin is in the range of 0 degrees to 60 degrees.
28. 28. The method of claim 27, wherein the directional air stream nozzle comprises a directional air stream nozzle exit orifice for the directional air stream having a directional air stream nozzle exit orifice area having a length at least two times greater than a width of the directional air stream nozzle exit orifice area.
29. 30. The method of claim 28, wherein the directional air stream nozzle exit orifice area is shaped to conform the directional air stream to the shape of the patient's anatomical region being treated.
30. The ratio of the directional air stream flow rate to the directional air stream nozzle exit orifice cross-sectional area of the directional air stream nozzle is 0.004 (m 3 / min) / mm 2 ~0.020 (m 3 / min) / mm 2 and the flow rate is in the range of at least 0.85 m 3 27. The method of claim 26, wherein the saturation is 1 / min.
31. 27. The method of claim 26, wherein the directional air stream nozzle is configured to create and apply a negative pressure to the skin beneath the directional air stream nozzle to lift the skin toward the directional air stream nozzle.
32. 27. The method of claim 26, wherein the directional air stream nozzle does not contact the skin.
33. 27. The method of claim 26, further comprising evaluating the movement of the skin induced by the directional air stream to determine when the skin has a degree of flexibility indicative of a desired amount of stationary fluid having moved toward the one or more natural drainage areas.
34. 25. The method of claim 24, further comprising outputting a localized air stream from a localized air stream nozzle onto the skin to condition the one or more areas of natural drainage for entrainment of quiescent fluid.
35. 35. The method of claim 34, wherein the localized air stream includes a pulsatile or directionally varying component.
36. 36. The method of claim 35, wherein the localized air stream induces rotation of a rotatable component of the localized air stream nozzle, the rotation of the rotatable component inducing the pulsating component or the directionally varying component.
37. 25. The method of claim 24, further comprising outputting a localized air stream from a localized air stream nozzle onto the skin to shear thin the stationary fluid.
38. 38. The method of claim 37, wherein the localized air stream includes a pulsatile or directionally varying component.
39. 25. The method of claim 24, wherein the directional air stream nozzle comprises protrusions shaped to contact the skin, and further comprising pressing the protrusions against the skin while moving the directional air stream nozzle along the skin to move stationary fluid toward the one or more areas of natural drainage.
40. 40. The method of claim 39, wherein the directional air stream nozzle comprises a roller that is rolled along the skin while moving the directional air stream nozzle along the skin to move stationary fluid toward the one or more areas of natural drainage.
41. generating, by a fluid sensor, a fluid sensor output signal indicative of the degree of quiescent fluid within the treated tissue of said patient; processing the fluid sensor output signal to determine the extent of the stationary fluid in the treated tissue; outputting feedback indicative of the extent of the quiescent fluid in the treated tissue; 25. The method of claim 24, further comprising:
42. 42. The method of claim 41, wherein the fluid sensor comprises an impedance sensor.
43. generating, via an image sensor, skin movement image data of the area of the patient's skin having induced movement induced by the directional air stream; processing the skin motion image data to estimate the extent of stationary fluid in tissue underlying the area of skin of the patient; outputting feedback indicative of the extent of the quiescent fluid in the tissue underlying the area of skin of the patient; 25. The method of claim 24, further comprising:
44. 25. The method of claim 24, further comprising inducing turbulence in the directional air stream within a turbulence chamber of the directional air stream nozzle.
45. 25. The method of claim 24, further comprising creating, via the directional air stream, a zone of negative pressure below the directional air stream nozzle sufficient to lift the skin toward the directional air stream nozzle.
Citation Information
Patent Citations
US10,973,731