Patent Grant
11064974
This invention relates generally to the medical technology field, and more specifically to a new and useful patient interface system in the medical technology field.
Early detection of breast cancer and other types of cancer typically result in a higher survival rate. Despite a widely accepted standard of mammography screenings for breast cancer detection, there are many reasons that cancer is often not detected early. One reason is low participation in breast screening, as a result of factors such as fear of radiation and discomfort. In particular, the mammography procedure involves compression of the breast tissue between parallel plates to increase the X-ray image quality by providing a more uniform tissue thickness and stabilizing the tissue. However, this compression is typically uncomfortable, or even painful. Mammography has additional drawbacks, such as limited performance among women with dense breast tissue and a high rate of “false alarms” that lead to unnecessary biopsies that are collectively expensive and result in emotional duress in patients.
Ultrasound tomography is one imaging modality in development that may be a practical alternative to mammography. However, there is a need to create a new and useful patient interface system for scanning a volume of tissue in this manner that is safe and comfortable for patients. This invention provides such a new and useful patient interface system.
The following description of preferred embodiments of the invention is not intended to limit the invention to these preferred embodiments, but rather to enable any person skilled in the art to make and use this invention.
1. System
As shown in
The patient interface system 100 functions to position a patient and volume of tissue in place for an image scan, in order to ensure proper patient positioning and to facilitate a reduction in the amount of unnecessary scans taken (e.g., due to patient misalignment). In one embodiment, as shown in
The patient interface system 100 is preferably modular to provide a customizable interface for various patients of differing builds, and comfortable for patients to encourage regular screenings and early cancer detection. The patient interface system 100 can alternatively be non-modular. Additionally, the patient interface system 100 can be used in conjunction with any suitable imaging modality, or for any suitable purpose involving substantially complete access to volume of tissue (e.g., for scanning using another imaging modality, for biopsy, for surgical procedures, etc.).
The base 110 functions to support the weight of a prone patient, and is preferably configured to provide a surface that spans the entire height and width of the patient, such that the patient's entire body can be supported within the surface of the base. However, the base 110 can alternatively be configured to provide a surface that is shorter that the height of the patient and/or narrower than the width of the patient, such that portions of the patient's body are not supported by the base 110. The base 110 preferably includes a planar portion 112 on which the patient can lie prone, and a frustoconical portion 120 with a sloped inner surface 122 configured to provide comfort and allow the volume of tissue to extend into the base aperture 114. As such, the frustoconical portion 120 preferably terminates at the base aperture 114, which provides an opening into the ultrasound imaging tank 102 configured to receive the volume of tissue and facilitate scanning of the volume of tissue. The base aperture 114 is preferably circular, but in alternative configurations, the base aperture 114 can alternatively be ellipsoidal, oblong, polygonal, or any other suitable shape. In variations, the frustoconical portion 120 and the base aperture 114 are preferably configured to receive and accommodate a single breast of the patient; however, in other variations, the base 110 can be configured to accommodate two breasts and/or multiple protruding tissues (e.g., a face, knees, buttocks, etc.) of the patient, for example, by way of multiple apertures, multiple frustoconical portions, multiple portions displaced from the planar portion 112 of the base, and/or any other suitable element(s) configured to accommodate multiple tissue volumes of the patient. Furthermore, the base 110 can be configured to accommodate a head region of a patient, for instance, with an aperture configured to receive and support a region of a patient's head or face (e.g., a coronal region, a sagittal region, a horizontal region, etc.), as the patient interfaces with the base 110 (e.g., in configuration wherein the patient is lying face down, lying on his/her side, lying face up, and/or in any other configuration).
The planar portion 112 and frustoconical portion 120 are preferably separate pieces configured to couple to one another, through complementary nesting (e.g., frustoconical portion 120 seated within a recessed cavity or on a shelf of the planar portion 112), interlocking joints, fasteners, by press fit, using adhesives, using magnets, using thermal bonding, or in any suitable manner. In variations wherein the planar portion 112 and the frustoconical portion 120 are configured to couple to one another, the planar portion 112 and the frustoconical portion 120 can thus be configured to permanently couple to each other, or can be configured to reversibly couple to each other. In variations involving reversible coupling, the frustoconical portion 120 can be a substitutable portion, such that different frustoconical portions 120 corresponding to different patient morphologies can be provided at the base 110 to enhance patient comfort. Alternatively, the frustoconical portion 120 can be integrally formed (e.g., physically coextensive, of unitary construction) with one or more parts of the planar portion 112 of the base 100, for example, by casting. Furthermore, in some variations, the base 110 can include any one or more of: a planar surface, a contoured surface (e.g., to a patient's body), frustoconical surface, and any other suitable surface of combination of surfaces to suitably support a particular patient size or shape.
In one variation, as shown in
In some embodiments, as shown in
The planar portion 112 of the base preferably includes a rigid material that is compliant with the U.S. Food and Drug Administration (FDA) guidelines; for instance, in a specific example, the planar portion 112 of the base includes Corian® surfaces (e.g., Corian® Whisper surfaces manufactured by DuPont™) that are compliant with FDA regulation 177.1010. The material is preferably biocompatible, non-porous, and sanitizable. Furthermore, the material of the planar portion 112 preferably does not interfere with ultrasound signals transmitted and received using a transducer proximal to the base 110 and/or the volume of tissue. In other variations, however, the material of the base 110 can be configured to facilitate reflection of transmitted ultrasound signals in order to enable enhanced analyses of acoustomechanical properties of the volume of tissue, and/or to function as a shield to protect a patient against, for example, harmful types of radiation (e.g., x-ray radiation). However, the planar portion 112 of the base can additionally or alternatively include any other suitable weight-supportive, biocompatible material.
The frustoconical portion 120 of the base 110 functions to provide a recessed space into which the membrane 150 of the support assembly 130 can deflect, particularly when the membrane 150 of the support assembly 130 supports the body wall of the patient. The frustoconical portion 120 is preferably configured to extend beyond a plane defined by the planar portion 112 of the base 110, and can at least partially define the base aperture 114 configured to receive the volume of tissue. As shown in
Similar to the planar portion 112 of the base 110, the frustoconical portion 120 preferably includes a rigid material that is compliant with the U.S. Food and Drug Administration (FDA) guidelines. In a specific example, the frustoconical portion 120 includes a polyethylene terephthalate glycol-modified (PETG) surface such as a surface manufactured by Curbell Plastics™ (e.g., Spectar®/Vivak® surfaces manufactured by Curbell Plastics™). In another specific example, the frustoconical portion 120 of the base 110 can include Corian® surfaces (e.g., Corian® Whisper surfaces manufactured by DuPont™ that are compliant with FDA regulation 177.1010. The material is preferably biocompatible, non-porous, and sanitizable. Furthermore, the material of the frustoconical portion 120 preferably does not interfere with ultrasound signals transmitted and received using a transducer proximal to the base 110 and/or the volume of tissue. In other variations, however, the material of the base 110 can be configured to facilitate reflection of transmitted ultrasound signals in order to enable enhanced analyses of acoustomechanical properties of the volume of tissue and/or to function as a shield to protect a patient against, for example, harmful types of radiation (e.g., x-ray radiation). However, the frustoconical portion 120 of the base 110 can additionally or alternatively include any other suitable weight-supportive, biocompatible material that can be processed to form the frustoconical portion 120.
In one specific example, as shown in
In some embodiments, the system 100 can additionally include a table topper 116 disposed on the planar portion 112 of the base 110. As shown in
The table topper 116 can additionally be one of a set of multiple table toppers of various sizes, such that a particular table topper can be substituted in a modular manner into the patient interface system 100 to optimally accommodate patients of various morphologies. In alternative variations, the table topper 116 can include a particulate and/or pliable filling that can be manipulated (e.g., molded) to accommodate different users. As such, the particulate filling can be pushed around or molded, for example, within a casing, in order to mold the table topper 116 to the patient's body. The table topper 116 preferably includes an external non-porous surface that can easily be disinfected or wiped clean between patients (e.g., vinyl). However, the table topper 116 can additionally or alternatively be additionally covered with a protective cover that can be disposed of and replaced by a new cover after a patient interfaces with the patient interface system 100.
In a specific example, the table topper 116 includes a polyurethane foam encased within a vinyl covering, wherein the polyurethane foam and the vinyl covering are compliant with the U.S. Food and Drug Administration (FDA) guidelines. The polyurethane foam is processed to be water repellant, and is biocompatible and sanitizable. Furthermore, the material of the table topper 116 preferably does not interfere with ultrasound signals transmitted and received using a transducer proximal to the base 110 and/or the volume of tissue. In other variations of the specific example, however, the material of the table topper 116 can be configured to facilitate reflection of transmitted ultrasound signals in order to enable enhanced analyses of acoustomechanical properties of the volume of tissue, and/or can function as a shield in variations of the system 100 configured to interface with imaging modalities involving, for example, more harmful forms of radiation (e.g., x-ray radiation). However, the table topper 116 can additionally or alternatively include any other suitable conforming, biocompatible material that facilitates patient comfort when interfacing with the system 100.
The support assembly 130 functions to simultaneously facilitate patient comfort and to allow a volume of tissue of the patient to extend through the base aperture 114 into a tank 102 for tissue scanning. The support assembly 130 includes a frame 140 and a membrane 150 disposed within the frame 140 and configured to conform to the body wall and deflect into the inner surface of the frustoconical portion 120 of the base 110. Preferably, the support assembly 130 is configured to couple to the base 110 such that a membrane aperture 152 of the membrane 150 is aligned with the base aperture 114, and such that a volume of tissue of the patient can pass through both the membrane aperture 152 and the base aperture 114. The support assembly 130 can be one of a set of multiple support assemblies that include membrane apertures of various sizes and/or locations relative to the frame 140, such that a particular support assembly 130 can be reversibly substituted in a modular manner into the patient interface system 100 to accommodate variations in patient morphology. For example, a first support assembly 130 can include a larger membrane aperture 152 for scanning a breast of a patient with larger breasts, and a second support assembly 130 can include a smaller membrane aperture 152 for scanning a breast of a patient with smaller breasts. In other variations, however, the support assembly 130 can be a non-substitutable element of the system 100, and can still accommodate variations in patient morphology in any other suitable manner. For instance, the support assembly 130 can include a set of pre-cut inserts (e.g., inserts with different sized apertures, inserts with different material properties, etc.) that can be positioned superior to or inferior to the membrane 150 and aligned relative to the membrane aperture 152 in any suitable manner, in order to accommodate different sized breasts without requiring the tension of the membrane to be adjusted. In still other variations, however, the support assembly 130 may not be configured to accommodate variations in patient morphology.
In another example, different support assemblies 130 can include different numbers and/or configurations of membrane apertures 152 for accommodating both breasts of a patient and/or other tissues of a patient. In an alternative variation, the patient interface system 100 includes a frame 140 and a membrane 150 that is one of a set of multiple membranes, such that a particular membrane 150 can be swapped in a modular manner to couple to the frame 140. In examples, a first membrane configured to be retained within the frame 140 can include a larger membrane aperture 152 for scanning a breast of a patient with larger breasts, and a second membrane configured to be substituted for the first membrane can include a smaller membrane aperture 152 for scanning a breast of a patient with smaller breasts. In another example of this alternative variation, membranes can include different numbers and/or configurations of membrane apertures 152 for accommodating both breasts of a patient and/or other tissues of a patient. Thus, in these alternative embodiments, the support assembly includes a single frame 140 and replaceable membranes 150 that are configured for different applications. However, the patient interface system 100 can include any suitable number of frames and/or membranes 150 that can be combined in any suitable manner to optimize position, comfort, and/or scanning access to the tissue for various patients.
The frame 140 of the support assembly 130 functions to provide structural support to the membrane 150 and couples the membrane 150 to the base 110. The frame 140 can additionally function to maintain the membrane 150 in tension at a peripheral portion of the membrane 150, such that the membrane 150 provides a counteracting force in response to the weight of the patient's body. However, in some variations, the frame 140 may not be configured to retain the membrane 150 in tension. The frame 140 is preferably annular, forms a closed perimeter about the membrane 150, and can be circular or ellipsoidal; however, the frame 140 can alternatively form an open perimeter about a portion of the membrane 150 and/or define any other suitable shape (e.g., regular polygonal shape, irregular polygonal shape, irregular curvilinear shape).
As shown in
The membrane 150 is preferably coupled in tension across the frame 140 of the support assembly 130 and configured to be positioned over the frustoconical portion 120 of the base 110 when the support assembly 130 is coupled to the base 110, and preferably defines a membrane aperture 152 that receives the volume of tissue. In one variation, the membrane 150 includes a flexible polymer such as urethane and can be coupled to the support assembly 130 using, for example, mechanical fasteners, an adhesive, coupling using magnetic elements, and/or thermal welding. However, the membrane 150 can alternatively include any suitable material and be coupled with any suitable fixation method. When a patient lies prone on the table surface and the volume of tissue (e.g., a volume of breast tissue) extends through the membrane aperture 152, the membrane 150 preferably deflects downward into the inner sloped surface 122 of the frustoconical portion 120 of the base 110 and conforms to the body wall around the volume of tissue, due to the weight of the patient on the support assembly 130. The membrane 150 is preferably one of a set of membranes with varying dimensions, such as in size, shape (e.g., circular, ellipsoidal, rectangular), number of apertures, and location (e.g., centered or off-centered relative to the frame 140 or relative to the base 110) of the membrane aperture 152. The set of membranes can additionally or alternatively vary in any suitable aspect, such as material type or thickness. For example, material type can vary to accommodate patients with skin contact allergies, or can be stronger (e.g., have a higher tensile modulus, have greater fracture resistance) to provide extra patient support without requiring a substantially thicker membrane 150.
As shown in
The bezel 144 is preferably proximal to a superior surface 149 of the frame base 142 by a series of rivets or other mechanical fasteners 141 distributed around the border of the support assembly 130. The rivets/mechanical fasteners can provide a compressive force that retains the membrane 150 between the bezel 144 and the frame base 142, and/or can pass through openings in the membrane 150 to lock the membrane in place relative to the bezel 144 and the frame base 142. The series of mechanical fasteners 141 are preferably arranged uniformly about the border of the support assembly 130, but can additionally or alternatively include fasteners that are clustered or randomly distributed about the border of the support assembly 130. For example, in one variation, a series of mechanical fasteners sandwiches the membrane 150 between the bezel 144 and the frame base 142, thereby securing the membrane 150 to the support assembly 130. However, the series of mechanical fasteners may not provide a compressive force, but may instead bias the bezel 144 toward the frame base 142 while coupling a peripheral portion of the membrane 150 between the bezel 144 and the frame base 142 (e.g., a fastener can be configured to pass through an opening in the membrane that is aligned with openings in the bezel 144 and the frame base 142). Additionally or alternatively, the bezel 144 can couple to the frame 140 with a snap fit, an adhesive, magnetic couplers, or any suitable fastening mechanism. The bezel 144 preferably includes the same material as the frame base 142, but can alternatively include one or more materials that are different from the frame base 142.
In one variation, as shown in
The amount of membrane tension can be fixed and dependent on, for example, the thickness of the tensioning ring 146, and/or of a spacer 148 configured to displace the tensioning ring 146 from the frame base 142, wherein an increased height of the spacer 148/tensioning ring 146 can result in greater tension and a decreased height of the spacer 148/tensioning ring 146 can result in reduced tension. In some variations, the tensioning ring 148 and/or the spacer 148 can be substitutable elements, such that the amount of tension across the membrane can be manipulated by using tensioning rings 146 and/or spacers 148 of different thicknesses. The spacer 148 is preferably annular and configured to match a footprint of the tensioning ring 146; however, the spacer 148 can alternatively be defined by any other suitable geometry and/or footprint. For example, the spacer 148 can define a non-continuous surface that abuts the tensioning ring 146 at certain locations. The amount of membrane tension can additionally or alternatively be adjustable, such as to maintain a particular desired amount of tension over repeated stress on the membrane 150 due to repeated uses of the support assembly 130. For example, the thickness or elevation of the tensioning ring 146 and/or of the spacer 148 can be adjusted (e.g., using a mechanism to expand the thickness of the tensioning ring 146 and/or the spacer 148) to obtain a suitable amount of membrane tension. The tensioning ring 146 and/or spacer 148 can include the same material as the frame base 142, but can alternatively include one or more materials that are different from the frame base 142. The support assembly 130 can, however, include any other suitable element(s) for maintaining and/or adjusting tension across the membrane 150.
In a variation omitting a spacer 148, the membrane 150 can be configured to be retained at one of a set of peripheral regions 157, as shown in
In one embodiment of the system 100, as shown in
In some variations, the electrical subsystem can include a conditioning module 164, which functions to preprocess signals generated by the pressure sensor array 160 prior to transmission to a processor 170. The conditioning module 164 preferably comprises signal conditioning elements, including one or more of: an analog-to-digital converter (e.g., to convert analog signals from the pressure sensor array 160), an amplifier, and a filter for processing signals prior to transmission. In some variations, the conditioning module 164 can include a microprocessor configured to direct signal conditioning functionalities of the conditioning module 138 and a voltage regulator configured to protect elements of the electrical subsystem from overvoltage and/or under-voltage states.
In one variation, the pressure sensor array 160 can be used to confirm application of approximately uniform pressure at the membrane 150 (e.g., at a peripheral portion of the membrane, across the membrane) from the patient weight. For example, the pressure sensor array 160 can be used to confirm that the body wall of the patient is seated as evenly on the membrane 150 as possible and the volume of tissue is extended as fully as possible through the membrane aperture 152, thereby facilitating a complete imaging scan of the volume of tissue. Alternatively, the pressure sensor array 160 can be calibrated to a certain non-uniform pressure distribution that provides a desired patient configuration relative to the patient interface system 100, which can be used to maintain any suitable position of the patient to achieve good scanning results. In still other variations, the pressure sensor array 160 can be used for any suitable purpose, or variations of the system can entirely omit the pressure sensor array 160. Furthermore, the electrical subsystem can additionally or alternatively include any other suitable electrical components.
In variations of the system 100 including a pressure sensor array 160, the system 100 can include a processor 170, which functions to receive a set of signals from the pressure sensor array 160 and/or the signal conditioning module 164, and to generate an analysis of the set of signals in order to guide patient placement at the patient interface system 100. The processor 170 can thus comprise a first module 171 configured to receive the set of signals from the pressure sensor array 160, and a second module 172 configured to generate an analysis from the set of signals. In a first example, the analysis can confirm a uniform pressure distribution resulting from the patient's weight at the patient interface system 100. In a second example, the analysis can confirm a desired non-uniform pressure distribution resulting from the patient's weight at the patient interface system 100. In another example, the analysis can confirm an undesired uniform pressure distribution and/or an undesired non-uniform pressure distribution resulting from the patient's weight at the patient interface system 100. A uniform pressure distribution and/or a non-uniform pressure distribution confirmed by the analysis can then be used to guide or adjust the patient's configuration (e.g., torso position, body wall position, etc.) in order to facilitate scanning.
In some variations, guidance can be provided, as facilitated by the analysis generated by the processor 170, using visual and/or audio means for transmitting information. In one example, the analysis can be used to generate a rendering at a user interface 185 including a display configured to depict a current position of the patient, and a desired position of the patient that will produce a more desired pressure distribution. In another example, the analysis can be used to provide audio or text-based instructions to the patient and/or an operator (e.g., using a visual display, using a speaker), wherein the instructions facilitate adjustment of the patient's configuration relative to the patient interface system 100. In another example, the instructions can provide suggested system 100 configurations including one or more of: tilt angles of the planar portion 112 and/or the frustoconical portion 120 of the base 110, expanded and/or contracted configurations of the base 110, appropriate membrane sizes, appropriate membrane aperture sizes, appropriate tensioning ring 146 and/or spacer 148 thicknesses to achieve a desired tension across the membrane 150, and any other suitable configuration of any element of the system 100. Furthermore, in some variations of the example, the instructions can be provided to a controller 178 configured to automatically adjust system element configurations (e.g., tilt angles of the planar portion 112 and/or the frustoconical portion 120 of the base 110, expanded and/or contracted configurations of the base 110, appropriate membrane sizes, appropriate membrane aperture sizes, appropriate tensioning ring 146 and/or spacer 148 thicknesses, etc.) using an actuation subsystem 179 configured to manipulate a configuration of at least one element of the system 100.
As shown in
Preferred embodiments of the preferred patient interface system 100 include every combination of the base 110, the support assembly 130, the processor 170, the controller 178, the actuation subsystem 179, and the restraining module 180, and their respective components, including the planar portion 112 and the frustoconical portion 120 of the base 110, the table topper 116, frame 140, the membrane 150, the tensioning ring 146, the spacer 148, the pressure sensor array 160, and the conditioning module 164 of the support assembly 130. Furthermore, the system 100 can omit any one or more of the above described elements. For example, variations of the system 100 can omit the pressure sensor array 160, and can additionally or alternatively omit the tensioning ring(s) 146, the spacer(s) 148, and any other element configured to facilitate tensioning of the membrane 150.
2. Exemplary Use
In an exemplary use of an embodiment of the patient interface system, the patient interface system positions the breast of a patient to be scanned for ultrasound tomography. This example implementation is for illustrative purposes only, and should not be construed as definitive or limiting in scope of the claimed invention. In this example, a system operator or other translates various measurements of the patient into a selection of a suitable support assembly to be coupled to the base. These measurements can include any one or more of: breast size, patient weight, patient height, torso width, torso length, and any other suitable measurement, and correspond to a support assembly with at least a particular size of membrane aperture, and possibly to a particular set of adjustments to the base. The patient lies prone, stomach-side down, on the cushion of the base, and is positioned such that the breast to be scanned extends through the membrane aperture (and the aligned one or more apertures associated with the base) and into an imaging tank filled with water and an ultrasound transducer. Data generated from a pressure sensor array embedded in a flexible sheet coupled to the membrane and analyzed by a processor can be used to confirm proper positioning of the patient, and/or can be used to reposition the patient relative to the patient interface system, in order to improve data quality captured using the ultrasound transducer. The processor can generate a rendering that is displayed at a user interface accessible to at least one of the patient and the system operator, in order to guide positioning and/or repositioning of the patient at the patient interface system. The ultrasound transducer can then be activated to scan the breast tissue while the patient interfaces with the patient interface system, and acoustic data from the transducer can be analyzed by the processor and/or any suitable other processor to generate renderings of the breast based on one or more acousto-mechanical parameters including: acoustic reflection, acoustic attenuation, acoustic speed, and combinations thereof.
As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to the preferred embodiments of the invention without departing from the scope of this invention defined in the following claims.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application is a Continuation application of Ser. No. 14/208,181, filed Mar. 13, 2014, now U.S. Pat. No. 10,123,770, which claims the benefit of U.S. Provisional Application Ser. No. 61/778,985, filed Mar. 13, 2013, which are each incorporated herein by reference in their entirety.
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| 20190038255 A1 | Feb 2019 | US |
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