Patent Application
20180214125
The present invention relates generally to ultrasound wave transmission, and more specifically to apparatuses and methods for manufacturing ultrasound gel modules.
Ultrasound waves are often described as sound waves having frequencies greater than 20 kHz. Ultrasound has been used in the medical field to observe the interior of the human body in a non-invasive manner. The ultrasound is applied using a transducer that typically comes into contact with the patient's skin. Ultrasound is readily absorbed in air, so gel is often used between the transducer and the skin to enhance the transmission of ultrasound. In some cases, the gel is a liquid substance. In other cases, a gel pad is used where the ultrasound gel is molded into semi-solid disks.
A gel is a solid jelly-like material that can have properties ranging from soft and weak to hard and tough. Gels are defined as a substantially dilute cross-linked system, which exhibits no flow when in the steady-state. By weight, gels are mostly liquid, yet they behave like solids due to a three-dimensional cross-linked network within the liquid. It is the crosslinking within the fluid that gives a gel its structure (hardness) and contributes to the adhesive stick (tack). In this way gels are a dispersion of molecules of a liquid within a solid in which the solid is the continuous phase and the liquid is the discontinuous phase.
Systems and methods for fabricating and using ultrasound gel module assemblies in accordance with embodiments of the invention are illustrated. One embodiment includes an ultrasound gel module assembly including a gel pad attached to a base component, where the gel pad is capable of conducting ultrasound, and a cover component covering a first side of the gel pad and in contact with the base component.
In another embodiment, the base component includes a set of cavities, and the gel pad is attached to the base component by filing the cavities.
In a further embodiment, the base component is circular, and set of cavities includes 12 cavities evenly spaced 30 degrees apart on an inner surface of the base component.
In still another embodiment, the base component includes a flange which retains the gel pad via friction on an inner surface of the flange, and the flange anchors the cover component via friction on an outer surface of the flange.
In a still further embodiment, the base component includes at least one structure for retaining the gel pad selected from the group consisting of a blind hole, a through-hole, a spike, and a bump.
In yet another embodiment, the base component includes a set of attachment points configured to enable the base component to be connected to a holder.
In a yet further embodiment, the set of attachment points includes 4 attachment points symmetrically spaced 90 degrees apart on the base component.
In another additional embodiment, the base component includes at least one structure that deforms the gel pad to modify acoustic lensing properties of the gel pad.
In a further additional embodiment, the cover component is removable to expose the first side of the gel pad.
In another embodiment again, the cover component includes a tab to assist in the removal of the cover component from the base component.
In a further embodiment again, the ultrasound gel module assembly further includes a seal covering a second side of the gel pad and adhered to the base component, wherein the seal is removable to expose the second side of the gel pad.
In still yet another embodiment, the seal includes a sheet of aluminum.
In a still yet further embodiment, the ultrasound gel module assembly is capable of attaching to an ultrasound transducer and conducting ultrasound for use in ultrasound imaging.
In still another additional embodiment, the impedance of the gel pad is within 2% of the impedance of water.
In a still further additional embodiment, the ultrasound gel module assembly is stored in a hygienic package.
In still another embodiment again, the hygienic package is a sealed plastic bag.
In a still further embodiment again, at least one side of the gel pad has a geometry that focuses the shape of an ultrasound field passing through the gel pad.
In yet another additional embodiment, the first side of the gel pad and the second side of the gel pad have geometries that focus the shape of an ultrasound field passing through the gel pad, and the geometries of the first side of the gel pad and second side of the gel pad are different geometries.
In a yet further additional embodiment, an ultrasound gel module assembly includes a gel pad attached to a base component, where the gel pad is capable of conducting ultrasound, a cover component covering a first side of the gel pad and in contact with the base component, where the cover component includes a tab to assist with removing the cover component, and a seal covering a second side of the gel pad and adhered to the base component, wherein the base component is a ring structure comprising a first surface and a second surface, where the first surface includes a structure for retaining the gel pad, and the second surface comprises a set of attachment points.
In yet another embodiment again, a method for using an ultrasound gel module assembly includes removing a cover component from a gel module assembly, where the cover component covers a first side of a gel pad attached to a base component, and the base component includes a set of attachment points configured to enable the base component to be connected to a holder, attaching the base component to the holder using the attachment points, and transmitting ultrasound through the gel pad from an ultrasound transducer connected to the holder.
Additional embodiments and features are set forth in part in the description that follows, and in part will become apparent to those skilled in the art upon examination of the specification or may be learned by the practice of the invention. A further understanding of the nature and advantages of the present invention may be realized by reference to the remaining portions of the specification and the drawings, which forms a part of this disclosure.
Turning now to the drawings, ultrasound gel module assemblies, and methods of manufacturing and using ultrasound gel module assemblies are illustrated.
Ultrasound has a wide array of applications across a variety of fields. In the medical field, ultrasound is used to sense the interior of a patient's body in a non-invasive manner. Ultrasound is performed on a patient by bringing an ultrasound transducer in contact with the patient's skin, using said transducer to pulse ultrasound waves into the body, and detecting the reflection of the ultrasound waves. However, ultrasound is readily absorbed in air, and therefore, in order to achieve high fidelity imaging, a gel is often used between the skin and the transducer to remove any pockets of air. In some cases, the gel is semi-solid and formed into disks, but still retains the ability to readily transmit ultrasound.
When in the field, it is difficult for Emergency Medical Technicians (EMTs) to quickly diagnose strokes and other types of brain disorders. Ultrasound gel module assemblies can be used to enhance the speed and quality of field ultrasounds. In many embodiments, ultrasound gel module assemblies have attachment points which can be used to quickly attach the ultrasound gel module assembly to an ultrasound transducer (often via an attachment mechanism). In numerous embodiments, ultrasound gel module assemblies have cover components which keep the gel in a clean or sanitary state prior to usage. Cover components can be quickly and easily removed by a user without displacing or damaging the ultrasound gel or the ultrasound transducer. While much of the description that follows utilizes the example of gel module assemblies developed for use in stroke detection, gel module assemblies in accordance with different embodiments of the invention are not limited to this application and can be utilized in any of a variety of ultrasound applications as appropriate to their specific requirements.
Ultrasound gel module assemblies can be constructed out of components, including, but not limited to, a base component, an ultrasound gel, a cover component, and a seal. In a plurality of embodiments, the base component is constructed in such a way that it can retain the ultrasound gel with minimal chance of the ultrasound gel slipping out of the base component. Base components can have a variety of structures to achieve this, including, but not limited to, blind holes, through-holes, spikes, bumps, and/or any other structure to promote the retention of the ultrasound gel. In numerous embodiments, the base component is embedded in the ultrasound gel.
Base and cover components can be constructed out of solid materials ranging from thermoplastic polymers such as nylon or HDPE, to thermoset polymers such as acrylics or epoxies to metals such as aluminum or brass. However, any number of materials can be used in accordance with the requirements of a given application. In many embodiments, base components and cover components are vacuum formed using thermoplastic sheets. Alternate methods of production include, but are not limited to, injection molding, machining, 3D printing, and casting, or any other production method as appropriate to the requirements of a given application. Base components and cover components can then be fitted together to create monolithic structures which form a mold cavity that defines the size and shape of the gel pad. The cover and base can mechanically coupled using “snap” features, interference press fit, screw threads, among others. The combined base component and cover component can be filled with an ultrasound gel. The opening opposite the cover component can be sealed with a seal. In numerous embodiments, the seal is made of a foil. However, seals can be made of a variety of materials, including, but not limited to, lined paper, lined cardboard, aluminum, or any other material as appropriate to the requirements of a given application. In a plurality of embodiments, once the assembly of the combined base component and cover component with an ultrasound gel is complete and sealed, the assembly can be die cut from the plastic sheets to create a finished ultrasound gel module assembly with a removable seal and cover.
Although the figures and following discussion will provide a detailed description of a number of exemplary embodiments of the ultrasound gel module assembly, it should be understood that any number of different configurations and/or manufacturing processes could be used to achieve the basic goals of the system. For example, any number of shapes and forms could be used in order to better match the surface that ultrasound is being used on. In addition, it should be understood that the figures are merely schematic, and that the relative dimensions of the various elements and their relative spacing are merely exemplary and could be varied by one of ordinary skill in the art while remaining within the bounds of this disclosure.
Ultrasound gel module assemblies can be quickly used in the field to perform ultrasounds on patients. By removing the seal of the ultrasound gel module assembly, then attaching to an ultrasound transducer and removing the cover, the exposed ultrasound gel can be used between the patient's skin and the ultrasound transducer to mediate the ultrasound scan. In many embodiments, the ultrasound gel module assembly is secured to an ultrasound transducer using a holder configured to hold both the assembly and the transducer.
An ultrasound procedure using an ultrasound gel module assembly in accordance with an embodiment of the invention is shown in
Prior to use in an ultrasound procedure, the gel of an ultrasound gel module assembly can be protected by the seal and/or cover components. In numerous embodiments, ultrasound gel module assemblies have their cover components and or seals removed prior to the user performing the ultrasound procedure on the patient. In numerous embodiments, once the seal and cover is removed, the ultrasound gel module assembly effectively transmits ultrasound from the ultrasound transducer to the patient's body.
Turning now to
In
In many embodiments, ultrasound gel pad 230 is made out of gels such as platinum cured silicones or aqueous based materials like Aquaflex® manufactured by Parker Laboratories, Inc. of Fairfield, N.J. However, any number of ultrasound gels can be used as appropriate to the requirements of a given application. In numerous embodiments, ultrasound gel pad has a composition and geometry such that the acoustic impedance between the transducer and the patient is similar to the resulting impedance if water filled the gap between the transducer and the patient, or an impedance that otherwise is in an acceptable range for the application. Further, with properly matched durometer of the gel pad and design of the base, the ultrasound gel pad can maintain its approximate shape, size, and retention to the base component. In numerous embodiments, ultrasound gel pad 230 has at least a portion of base component 220 embedded inside of the gel. Base component 220 can have one or more protuberances or cavities to assist in retaining the ultrasound gel pad 230. In numerous embodiments, the protuberances are spikes which embed in the ultrasound gel pad 230. In many embodiments, the cavities are through-holes. However, any kind of appropriate protuberance, cavity, or mix of protuberances and cavities can be used as appropriate to the specific gel and/or application in accordance with various embodiments of the invention. In this way, ultrasound gel pad 230 can be attached to base component 220.
Further, in numerous embodiments, base components include structures to modify the acoustic properties of the gel pad. For example, the ultrasound gel module assembly can acquire acoustic lensing properties by changing the structure and form of the base component and/or the gel pad. In numerous embodiments, the base component thickness can be increased or decreased to change the propagation of ultrasound. In a variety of embodiments, structures such as, but not limited to, rings, slats, grids, or any other shape can be utilized to modify acoustic lensing properties of the ultrasound gel module assembly. In many embodiments, materials selection are also varied to modify acoustic impedance. For example, materials of varying acoustic impedance may be applied in layers so that reflective boundaries are formed. In numerous embodiments, when the ultrasound gel is injected during manufacturing to form the gel pad, the structures can change the shape of the pad, further modifying the acoustic properties.
Examples of different types of acoustic lensing structures are illustrated in
In many embodiments, ultrasound gel module assemblies have base components which retain ultrasound gel modules. The ability to retain ultrasound gel modules within a base component allows EMTs to rapidly connect ultrasound gel modules to ultrasound transducers (either directly or using transducer holders). This increase in speed allows for quick diagnosis and/or triage of patients. In order to retain an ultrasound gel within a base component, a variety of mechanisms can be used in accordance with various embodiments of the invention.
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Ultrasound gel module assemblies can be quickly socketed into transducer holders and/or attached to appropriately configured transducers. In many embodiments, transducer holders are utilized that have a socket for an ultrasound gel module assembly and a socket for an ultrasound transducer. One or more attachment points on base components can be formed that match complementary attachment points on transducer holders, allowing quick and stable connections. Attachment between the ultrasound gel module assembly and the transducer holder can be sufficiently strong to allow the quick removal of the cover component, allowing an EMT to rapidly begin the ultrasound procedure. In certain embodiments, transducer holders are part of a positioning apparatus such as (but not limited to) a positioning headband, or positioning garment.
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Ultrasound gel module assemblies can be manufactured in such a way as to greatly enhance the cohesion between the ultrasound gel and the base component. Further, manufacturing processes in accordance with many embodiments of the invention can be efficient and economical due to the design of the cover component and the base component. In certain embodiments, the cover component is used to shape the ultrasound gel. In many embodiments, the base component is filled with an ultrasound gel in such a way that the ultrasound gel forms around the base component, enabling the base component to retain the ultrasound gel. As can be readily appreciated, the specific components utilized in the construction of gel module assemblies and the manner in which they are manufactured is largely dependent on the requirements of a given application.
Turning now to
In numerous embodiments, base sheet 600 can be die cut to form the base component 610 shape. In certain embodiments, base sheet 600 is made using injection. In many embodiments, base sheet 600 is formed using compression molding. In several embodiments, base sheet 600 is formed using thermoforming. In several embodiments, base sheet 600 is formed using stamping techniques, However, one of ordinary skill in the art would appreciate that any number of fabrication techniques, including, but not limited to, 3D printing or machining processes could be used to form sheet 600 into a base component 610 shape. Base component 610 can be held to the remainder of the plastic sheet 600 by one or more attachment points 620.
Base sheets and cover sheets can be constructed separately and out of different materials. In many embodiments, both sheets can be fit together in a base-cover assembly which forms a mold for the ultrasound gel. In this way, a separate process that removes the gel pad from the mold and then inserts the cover can be eliminated. Further, using the combined sheets as a mold for the ultrasound gel can allow the ultrasound gel to form to the base component, strengthening the cohesion between the ultrasound gel and the base component.
Turning now to
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Molding Ultrasound Gel with Combined Base-Covers
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In numerous embodiments, varying amounts of ultrasound gel 830 is introduced into the space between base sheet 810 and cover sheet 820 in order to change the thickness of ultrasound gel 830. By varying the thickness of ultrasound gel 830, the focal distance of the ultrasound gel module assembly can be modified in order to vary the location of the penetration of ultrasound. In several embodiments, an additional molding component is added to the exposed surface of ultrasound gel 830 in order to change the shape of ultrasound gel on the top. The additional molding component can be made of plastic, metal, or any other material as appropriate to the requirements of specific applications in accordance with various embodiments of the invention. In many embodiments, the additional molding component forms the exposed surface of ultrasound gel 830 into a convex shape, however the additional molding component can form the surface of the ultrasound gel 830 into a variety of shapes as appropriate to the requirements of specific applications in accordance with various embodiments of the invention.
In a multitude of embodiments, a first ultrasound gel is molded to a desired shape. The first ultrasound gel can be molded by a cover sheet, by a separate mold, by a combination of a cover sheet and a separate mold, or by any other process as appropriate to the requirements of specific applications in accordance with various embodiments of the invention. A second ultrasound gel can be introduced to the space between base sheet 810 and cover sheet 820. The first ultrasound gel can then be introduced into the space between base sheet 810 and cover sheet 820 such that the first ultrasound gel and the second ultrasound gel are both retained by the base component. In this way, an ultrasound gel module assembly can be created with variable geometries on both faces of the ultrasound gel. Variable geometries can allow for conformance to various surfaces of the body with different shapes, and/or focusing of the shape of the ultrasound beam for superior sensing. In many embodiments, a covering is placed over the ultrasound gel and base component, opposite of the cover component. In many embodiments, the covering is made of a thin sheet of metal. In a variety of embodiments, a wax or metal lined paper is used. Molded ultrasound gel module assemblies can be extracted as individual units. Methods for extracting ultrasound gel module assemblies are described below.
Once formed, ultrasound gel module assemblies can be extracted from the base-cover assembly. In many embodiments, the extracted base-cover assembly is a finished unit. The process for manufacturing of ultrasound gel module assemblies allows quick extraction of the units from the base-cover assemblies. In numerous embodiments, only one cut is needed to extract ultrasound gel module assemblies. The ease of removal of a completed product enhances the speed of manufacture, as well as lowering the cost of manufacture by increasing efficiency.
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As noted above, ultrasound gel module assemblies can be manufactured in a variety of ways as appropriate to the requirements of specific applications in accordance with embodiments of inventions. Turning now to
Ultrasound gel module assemblies can be quickly attached to transducer holders, which can allow EMTs or any other user to perform ultrasound procedures rapidly and accurately in the field and/or in a clinical setting. Turning now to
Although the present invention has been described in certain specific aspects, many additional modifications and variations would be apparent to those skilled in the art. In particular, any of the various processes described above can be performed in alternative sequences in order to achieve similar results in a manner that is more appropriate to the requirements of a specific application. It is therefore to be understood that the present invention can be practiced otherwise than specifically described without departing from the scope and spirit of the present invention. Thus, embodiments of the present invention should be considered in all respects as illustrative and not restrictive.
This application claims priority to U.S. Provisional Application No. 62/452,253 filed Jan. 30, 2017. The disclosure of U.S. Provisional Application No. 62/452,253 is fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62452253 | Jan 2017 | US |
