SYSTEM FOR HANDS-FREE SECUREMENT OF AN ULTRASOUND TRANSDUCER

A system for affixing an ultrasound scanning transducer to a body for use in medicine during needle injection procedures.

TECHNICAL FIELD

The present invention is related to an apparatus that may be used to affix an ultrasound scanning transducer to a body for use in medicine during needle injection procedures.

BACKGROUND OF THE INVENTION

Needle guidance procedures in medicine are numerous and comprise many different procedures including, for example, lumbar punctures, bone marrow biopsies, acute pain analgesia, and chronic pain therapy injections. The techniques available for injection guidance range from a palpation-based approach, where no image guidance is utilized, to guidance under an imaging modality such as ultrasound, computed tomography, or fluoroscopy. The palpation approach is low-cost and accessible at the bedside but suffers from low procedure success rates and higher rates of complications. Conventional ultrasound can improve success rates, and is utilized in some instances, but suffers from limitations including an extended learning curve and workflow barriers resulting from the need to simultaneously manipulate an ultrasound probe and insert a needle, the latter of which is typically a two-handed procedure. X-ray-based approaches, such as computed tomography or fluoroscopy, exhibit high success rates but expose the patient to ionizing radiation and increase procedure cost and are generally inaccessible at the bedside or incompatible with workflow constraints in fields such as emergency medicine.

To overcome the limitations of current state of the art approaches to medical needle guidance procedures, the present invention describes an apparatus that can be used to affix an ultrasound probe to a patient in order to facilitate interventional needle guidance workflow. The apparatus, which, in aspects, can be a single-use sterile consumable and support sterile procedures, can maintain hands-free imaging contact between the probe and the patient while providing minimally obstructed visual field and needle access to the patient anatomy relevant to the procedure such that the clinician may use one or both hands to place and advance the needle. This hands-free approach is an advancement compared to conventional ultrasound where the clinician requires one hand to hold the ultrasound imaging transducer and the second hand to advance the needle, or where an assistant is required to perform part of the procedure so that both hands are available to advance the needle. Various preferred embodiments of the invention are described herein.

SUMMARY OF THE INVENTION

Example embodiments described herein have innovative features, no single one of which is indispensable or solely responsible for their desirable attributes. The following description and drawings set forth certain illustrative implementations of the disclosure in detail, which are indicative of several exemplary ways in which the various principles of the disclosure may be carried out. The illustrative examples, however, are not exhaustive of the many possible embodiments of the disclosure. Without limiting the scope of the claims, some of the advantageous features will now be summarized. Other objects, advantages and novel features of the disclosure will be set forth in the following detailed description of the disclosure when considered in conjunction with the drawings, which are intended to illustrate, not limit, the invention.

In embodiments, the present invention overcomes limitations of existing needle guidance systems by providing hands-free image guidance of needle advancement and providing a form factor compatible with sterile workflow that minimally obstructs the field of view and maximizes needle access. In embodiments, the invention interfaces to an ultrasound probe to stabilize the probe against patient anatomy during real-time imaging, allows for facile probe repositioning, and provides significant access around the perimeter of the probe for the physician to plan and execute the needle insertion. In addition, in aspects, the apparatus supports optional attachment of components to the ultrasound probe to guide the needle trajectory.

Ultrasound imaging transducer assemblies are used in a variety of medical or clinical applications to enable medical imaging functions. In this non-limiting example, an ultrasound imaging transducer is disposed within a transducer assembly to deliver a pulse, tone, sequence or programmed energy signal into a target location to be imaged. A specific example is one or more ultrasound transducer elements that deliver an ultrasound signal into a patient's body and detect a return signal so as to form a computer-generated image of the target region. Different ultrasound imaging modes can be utilized, depending on a given application and design as known to those skilled in the art. The present disclosure can be used in medical ultrasound applications but is not limited to this application. Those skilled in the art will appreciate that a variety of types of transducers, signal transmitters and/or receivers and other arrays can also benefit from the present invention, which are comprehended hereby. The preferred embodiments herein describe needle guidance. Those skilled in the art will appreciate that the present invention may be used to guide a variety of medical instruments including, but not limited to, a catheter, trocar, ablation instrument, or therapy applicator. The present invention can be utilized, in a preferred embodiment, with systems and methods previously disclosed by Mauldin et al. (PCT/US2019/012622), which is incorporated by reference herein, for automated three-dimensional detection, guidance, and visualization of ultrasound-based therapy guidance procedures.

In the embodiment of the present invention for medical applications of needle guidance described herein, an objective of the device is to stabilize the ultrasound probe against the patient anatomy such that the physician can remove their hands from the device while acoustic coupling is maintained for image guidance of needle insertion. In embodiments, additional objectives include minimal visual obstruction of the underlying anatomy relevant to the medical procedure, minimal obstruction of access to needle insertion points, (in aspects, simple) repositioning and reorientation of the ultrasound probe, and compatibility with a sterile workflow. In embodiments, the invention is comprised of one or more base component that can be removeably affixed to a patient near or adjacent to a patient anatomy relevant to the medical procedure. The base component may comprise rigid, semi-rigid, or substantially rigid materials, such as plastics or metals, and provides an anchor point to secure the ultrasound transducer in contact with the patient anatomy. In embodiments, the invention is comprised of one or more securing component that can be attached to the one or more base component and the ultrasound transducer and provides a directed force that maintains contact between the ultrasound transducer and the patient anatomy. The one or more securing component may comprise flexible or substantially flexible materials, such as rubber, some plastics, or fabric, or may comprise rigid, semi-rigid, or substantially rigid materials, such as plastics or metals. In embodiments, the invention provides a mechanism for adjusting a position of the ultrasound transducer affixed to the patient anatomy by the apparatus, which may comprise an arrangement of one or more base component and one or more securing component designed so that a user may manually reposition the ultrasound probe within the apparatus, such as by applying force to the ultrasound probe handle, one or more securing component, or one or more base component.

In an exemplary embodiment, an apparatus is depicted inFIG.1A. The apparatus has a base component100that affixes to the patient anatomy. Non-limiting examples of the method of affixing the base component100to the patient anatomy include incorporation of an adhesive layer on the patient contact side, incorporation of straps around the patient anatomy, suction mechanisms, magnetic mechanisms or other approaches that would secure the position of100on the patient anatomy. In this non-limiting example, the base component is depicted to have rectangular shape with rounded corners, but other shapes are envisioned. The design may be of configurations that conform to specific patient anatomy and provide visual access and needle access, including but not limited to circular or semi-circular shaping. Fiducial markers101can provide measurements to the user for planning of the procedure and probe positioning. In aspects, a component102can be used to attach rubber bands103or straps along the perimeter of the apparatus that secure an ultrasound probe within the apparatus.

In a non-limiting embodiment depicted inFIG.1B, the apparatus100may conform with a sterile workflow in which the apparatus is applied over a sterilized portion of the patient anatomy104and can be uncovered for imaging interrogation and needle insertion while a sterile drape105(e.g., procedural drape) that covers the non-sterile patient anatomy is incorporated with or into the outer edge of the apparatus100. In embodiments, the drape can be of the same size and material used during epidural and spinal anesthesia, or other similar needle guidance, procedures.

In a non-limiting embodiment depicted inFIG.1C, an ultrasound probe106and ultrasound cable107can be integrated into the device and can be retained within the securing bands103by positioning guides108that limit lateral movement. The positioning guides108can be incorporated directly into the ultrasound probe106, or in other non-limiting embodiments may consist of sterile components that clip onto the ultrasound probe housing. In a non-limiting embodiment, an ultrasound signal cable107connects the ultrasound probe106to a computer processor, with alternative embodiments including wireless transmission of signals or incorporation of a computer processor and display directly into the probe housing.

A schematic illustration of a procedure involving a patient's spinal anatomy is depicted inFIG.2. In this non-limiting embodiment, the underside of the apparatus100contains medical-grade adhesive designed to affix the base component of the apparatus to the patient's skin, centered over the region the needle is to be inserted. After interrogating the sterilized anatomy with the ultrasound probe106, the physician leaves the ultrasound probe in position and uses one or both hands to insert the needle within the “window” provided by the apparatus100.

A flow diagram of an embodiment for the present invention used in a clinical needle guidance procedure is depicted inFIG.3. At block301, the user first sterilizes the patient anatomy around the intended injection site. At block302, the user places the sterile drape component105of the apparatus over the non-sterile patient anatomy, leaving an open window over the sterilized anatomy. The base component of the apparatus100is then affixed to the patient anatomy by an adhesive layer incorporated into the component. At block303the ultrasound probe is integrated into the apparatus as depicted inFIG.2at the desired imaging position and coupled to the patient's body using ultrasound coupling gel or other lubricant compatible with medical ultrasound and known to those skilled in the art. Next, at block304an image acquisition is initiated by the user. At block305, the ultrasound image acquisitions are transmitted to a computer system and the reconstructed image is displayed real-time on a monitor. At block306, the user may translate the ultrasound probe106manually within the apparatus until the desired anatomy is within the imaging plane. At block307, the user removes their hands from the ultrasound probe106, leaving the probe secured in the apparatus100while continuing to display real-time anatomical images. In block308, the user uses one or both hands to insert the needle and monitors the trajectory of the needle entering the real-time imaging display. At block309, if the real-time imaging display indicates the needle is no longer in view, the user may reposition the ultrasound probe106within the apparatus100to regain visualization of the needle. At block310, the user completes the procedure by advancing the needle to the target site, confirmed by real-time image display.

In a non-limiting embodiment depicted inFIG.4A, a unique split-array ultrasound probe400with a U-slot402for facile in-plane needle access, the subject matter of U.S. patent application Ser. No. 17/950,399 (incorporated herein by reference), is integrated into or otherwise attached or connected to the previously described apparatus100. The device is retained within the securing bands103by positioning guides403that limit lateral movement. The positioning guides403may be incorporated directly into the ultrasound probe400, or in other non-limiting embodiments may consist of sterile components that clip onto the ultrasound probe housing. In a non-limiting embodiment, an ultrasound signal cable401connects the ultrasound probe400to a computer processor, though alternative embodiments may include wireless transmission of signals or incorporation of a computer processor and display directly into the probe housing. In a non-limiting embodiment, the interface between the ultrasound probe400and the ultrasound signal cable401is angled relative to the ultrasound probe body400as to minimize the vertical profile of the ultrasound probe relative to the patient anatomy, improve stability within the apparatus, and/or maximize procedure access around the base of the ultrasound probe400. Non-limiting examples include a probe-cable interface that angles between 30 degrees and 90 degrees away from the probe body, a probe-cable interface with said angling that is centered or off-centered along the front or back of the ultrasound probe body, and a probe-cable interface with said angling that is centered or off-centered along either side of the probe body.

In a preferred embodiment, an apparatus is depicted inFIG.4B. In this non-limiting example, the base component is circular, but may be designed in other configurations that conform to specific patient anatomy and provide visual access and needle access. A second component404provides a rotation ring by which the inner components of the apparatus can rotate to reposition the ultrasound probe while the base component100remains secured to the patient. Fiducial markers405and406provide indications of degree of rotation to the user. In a non-limiting embodiment, a position tracking clip407that secures the ultrasound probe within the apparatus is attached to a component102on the base apparatus. In a non-limiting embodiment, the position tracking clip407contains electrical components that enable determination of the probe position within the clip. Fiducial markers408can provide an indication of the position along the position tracking clip407. Illustration of the ultrasound probe400incorporated into the apparatus is depicted inFIG.4C. The ultrasound probe400can incorporate sensors that read the position of the probe within the position tracking clip407and transfer these signals to the imaging system through the ultrasound probe cable401. In preferred embodiments, the position measurement is accomplished through magnetic/inductive or resistive methods. In one such embodiment, passive, non-self-powered elements of the sensor system are incorporated in the position tracking clip407, while active powered sensors are incorporated in the ultrasound probe400. In a non-limiting embodiment, a needle guide409supplied with the apparatus is inserted into the U-slot402of the ultrasound probe400to guide needle trajectory within the apparatus and facilitate in-plane needle delivery during the procedure.

In an exemplary embodiment, an apparatus is depicted inFIG.5A. The apparatus has two base components500and502that affix to a patient drape504. Non-limiting examples of the method of affixing the base components500and502to the patient drape include incorporation of an adhesive layer on the patient contact side, suction mechanisms, magnetic mechanisms or other approaches that would affix the positions of500and502on the patient drape. In this non-limiting example, the base components are depicted to have a rounded shape that conform to the top and bottom positions of the patient drape opening506, but other shapes and positions of incorporation along the patient drape opening506are envisioned. The design may be of configurations that conform to specific patient anatomy and provide visual access and needle access, including but not limited to circular or semi-circular shaping. Securing components508may be used to secure elastic bands510, straps, or other flexible materials, connect the two base components500and502across the patient drape opening506for the purpose of securing an ultrasound transducer.

In a non-limiting embodiment depicted inFIG.5B, an ultrasound probe512and ultrasound signal cable514can be integrated into the device and can be retained within the securing bands510by positioning guides516that limit lateral movement. The positioning guides516can be incorporated directly into the ultrasound probe512, or in other non-limiting embodiments may consist of sterile components that clip onto the ultrasound probe housing, or may consist of sterile components attached to an ultrasound probe sheath that can be attached to the ultrasound probe housing. In a non-limiting embodiment, an ultrasound signal cable514connects the ultrasound probe512to a computer processor, with alternative embodiments including wireless transmission of signals or incorporation of a computer processor and display directly into the probe housing.

In a non-limiting embodiment depicted inFIG.5C, the base components500and502may conform with a sterile workflow in which they are applied over a sterilized portion of the patient anatomy506and can be uncovered for imaging interrogation and needle insertion while a sterile drape504(e.g., procedural drape) that covers the non-sterile patient anatomy is incorporated with or into the base components500and502. In embodiments, the drape can be of the same size and material used during epidural and spinal anesthesia, or other similar needle guidance, procedures. Affixing components518and520are incorporated into the patient drape for the purpose of securing the drape504to the patient anatomy. Non-limiting examples of the affixing components518and520include adhesive layers, straps, suction mechanisms, magnetic mechanisms or other approaches that would secure the position of the patient drape504on the patient anatomy.

In a non-limiting embodiment depicted inFIG.5D, the base components500and502are attached to the patient drape504with affixing components522and524, while the patient drape504is affixed to the patient anatomy with affixing components518and520. Non-limiting examples of the affixing components522and524include adhesive layers, straps, suction mechanisms, magnetic mechanisms or other approaches that would secure the position of the patient drape504on the patient anatomy.

In a non-limiting embodiment depicted inFIG.6A, a unique split-array ultrasound probe512with a slot for facile in-plane needle access, the subject matter of U.S. patent application Ser. No. 17/950,399, is secured within the apparatus using elastic bands510and configured, such as through manual manipulation, to hold an angulation that allows a straight angle of entry of a needle600relative to the patient anatomy602. InFIG.6B, the angulation of the ultrasound probe512within the positioning apparatus516is reconfigured, such as through manual manipulation, to provide an angled needle600entry relative to the patient anatomy602. Non-limiting examples include an apparatus that allows a needle angulation of between 0 and 20 degrees relative to the straight angle of entry depicted inFIG.6A.FIG.6Cdepicts a front-facing view of the depiction inFIG.6A, with the needle600placed in a U-slot604for facile in-plane needle access.FIG.6Ddepicts a front-facing view of the depiction inFIG.6B, in which the needle angulation has been adjusted by user manipulation and the securing components510and positioning components516stabilize the ultrasound probe against the patient anatomy602.

A component-level view of an exemplary securing component designed as a dual-array housing700is depicted inFIG.7A. An exploded component-level view of the exemplary dual-array housing700is depicted inFIG.7B. The imaging device can contain dual ultrasound arrays702and associated electromechanical components familiar to those skilled in the art which are packaged in mechanical housings. The imaging device can include acoustic lenses704and acoustic couplants706, which may be discrete parts or integral to other mechanical housing(s), for optimized transmission of acoustic energy from the arrays702. In a non-limiting embodiment, the lenses704and acoustic couplants706may comprise sterile single-use components that can be used to impose a sterile barrier between the ultrasound arrays702and patient anatomy. Additional ultrasound arrays, matrix transducer arrays, or C-MUT arrays may be used in place of the two ultrasound arrays702in order to improve field of view or image acquisition speeds. A sterile single-use assembly708may encapsulate the assembly of arrays702, acoustic couplants706, and lenses704. In a non-limiting embodiment, the probe housing may comprise sterile single-use components that can be used to impose a sterile barrier between the ultrasound arrays702and patient anatomy. In a non-limiting embodiment, the sterile single-use assembly708may acoustically couple to the lenses704using an acoustic coupling component710, which may comprise an adhesive film, an aqueous material, such as acoustic gel, an oil, or a sponge designed to retain and dispense an aqueous material or an oil. In a non-limiting embodiment, the probe housing708may comprise securing components attached to a sterile probe drape, such as through an adhesive material incorporated into the sterile single-use assembly708. In a non-limiting embodiment, the sterile single-use assembly708may comprise a securing component712that is designed to secure the dual-array housing700within the sterile single-use assembly708. In aspects, the disposable needle guide409inserts into the sterile single-use assembly708to provide either sterile or non-sterile needle trajectory guidance. In a non-limiting embodiment, the sterile single-use assembly708may comprise an acoustic coupling component714that provides an acoustically transmissive medium between the sterile single-use assembly708and the patient anatomy. The acoustically coupling component may comprise an adhesive film, an aqueous material, such as acoustic gel, an oil, or a sponge designed to retain and dispense an aqueous material or an oil.

An exploded, component-level view of an exemplary dual-array ultrasound probe400is depicted inFIG.8. The imaging device can contain dual ultrasound arrays800and associated electromechanical components familiar to those skilled in the art which are packaged in mechanical housings. Ultrasound probe400electronics may incorporate a position encoder, signals of which are relayed through the ultrasound probe cable401to a computer processor to instruct linear position changes to the linear actuator, image acquisition from the ultrasound arrays800, and signal or image processing steps applied to the acquired ultrasound image signals. The imaging device can include acoustic lenses and acoustic couplants801, which may be discrete parts or integral to other mechanical housing(s), for optimized transmission of acoustic energy from the arrays800. In a non-limiting embodiment, the lenses and acoustic couplants801may comprise sterile single-use components that can be used to impose a sterile barrier between the ultrasound probe400and patient. Additional ultrasound arrays, matrix transducer arrays, or C-MUT arrays may be used in place of the two ultrasound arrays800in order to improve field of view or image acquisition speeds. In aspects, the disposable needle guide409inserts into the probe housing to provide either sterile or non-sterile needle trajectory guidance. The needle guide409can constrain the location of the needle at the base of the U-slot402to allow accurate needle placement in the desired anatomic location and within the ultrasound imaging plane. The needle guide409may allow removal of the needle from the anatomy and imaging device400through the length of the U-slot402. The needle guide409can be configured to either constrain or allow removal of the needle through mechanisms including but not limited to rotation, opening, or removal of the needle guide. The entire ultrasound probe assembly may be covered by a sterile sheath before being incorporated into the stabilization apparatus to support sterile procedures.

In an exemplary embodiment depicted inFIG.9, the ultrasound probe400can be connected by an electrical signal cable401to a mobile cart900to allow the imaging device to be moved to the bedside and positioned at the required or desired orientation for acquiring images of the patient's anatomy. The cart900can include an enclosure901which may contain a computer processor and monitor902, battery903, and other associated electronics familiar to those skilled in the art which are needed to power and communicate with the imaging device400. The cart900can be outfitted with additional input/output devices such as a keyboard, mouse, or monitor902, which may also be a touchscreen display. The monitor902may be positionally adjustable about the cart in order to orient the imaging device400and monitor in various relative positions for the needle guidance procedure. In a preferred embodiment, the enclosure901may simultaneously contain the monitor902, the computer processor, and the ultrasound front-end electronics. A computer processor within the enclosure901may be used to perform ultrasound signal and image processing steps required to form an ultrasound image reconstruction that can be displayed on the monitor602. Such processing steps are known to those skilled in the art of medical ultrasound and may include but are not limited to: beamforming, bandpass filtering, scan conversion, and image rendering. Two and three-dimensional images may be rendered using various techniques, including simultaneous display, as described in Mauldin et al., U.S. Pat. No. 11,504,095 (incorporated herein by reference). In a preferred embodiment, the computer processor in the enclosure601can receive signals from the ultrasound probe400indicating the position of the probe in the apparatus, which can be used for interpreting spatial position of the real-time image data acquired. In a preferred embodiment, the registration of spatial position of the imaging data can be used to reconstruct 3-dimensional ultrasound images that are functionally equivalent to fluoroscopic imaging of skeletal anatomy.

A flow diagram of an exemplary embodiment for the present invention used in a clinical needle guidance procedure is depicted inFIG.10. At block1001, the user first affixes the apparatus base component100to the patient over the desired needle insertion location. At block1002the ultrasound probe is integrated into the apparatus as depicted inFIG.4at the desired imaging position and coupled to the patient's body using ultrasound coupling gel or other lubricant compatible with medical ultrasound and known to those skilled in the art. Next, at block1003an image acquisition is initiated by the user. Initiation may be achieved through the monitor902, user interface buttons, or by other means known to those of skill in the art. At block1004, the ultrasound image acquisitions are transmitted to the computer system within the enclosure901and the reconstructed image is displayed on the monitor902. In an embodiment where the ultrasound probe400is contained within the position tracking clip407illustrated inFIG.4C, the user may translate the probe manually along the position tracking clip to acquire 3-dimensional images. In the same embodiment, in block1005the position of the ultrasound probe400is registered during image acquisition in order to build a 3-dimensional image volume. In block1006, the live image is registered against a representation of other imaging anatomy for the procedure, such as an ideal imaging anatomy for the procedure, which may be derived from 3-dimensional ultrasound data or other representations of the anatomy. In block1007a determination is made whether the current image meets criteria indicating the needle guide is aligned with the needle injection target. This assessment may be produced automatically by a processing algorithm run on the computer system, such as described by Mauldin et al., U.S. Pat. No. 11,504,095 (incorporated herein by reference), or it may be achieved by the user through visual assessment of the rendered imaging results. If these criteria are not met, block1008guides the user to adjust position of the ultrasound probe400to provide better alignment with the target anatomy, providing guidance to address challenges that may be encountered in carrying out the procedure. If the criteria are met, block1009guides the user to proceed to needle placement. In aspects, user initiation of the needle guidance mode1010results in a transition in software to an imaging mode that enhances real-time visualization of the needle during insertion1011. Finally, at block1012, the user advances the needle through the needle guide409and the needle is visualized within the ultrasound image rendering displayed on the monitor901as it advances to the needle target.

Embodiments of the invention also include a computer readable medium comprising one or more computer files comprising a set of computer-executable instructions for performing one or more of the calculations, steps, processes, and operations described and/or depicted herein. In exemplary embodiments, the files may be stored contiguously or non-contiguously on the computer-readable medium. Embodiments may include a computer program product comprising the computer files, either in the form of the computer-readable medium comprising the computer files and, optionally, made available to a consumer through packaging, or alternatively made available to a consumer through electronic distribution. As used in the context of this specification, a “computer-readable medium” is a non-transitory computer-readable medium and includes any kind of computer memory such as floppy disks, conventional hard disks, CD-ROM, Flash ROM, non-volatile ROM, electrically erasable programmable read-only memory (EEPROM), and RAM. In exemplary embodiments, the computer readable medium has a set of instructions stored thereon which, when executed by a processor, cause the processor to perform tasks, based on data stored in the electronic database or memory described herein. The processor may implement this process through any of the procedures discussed in this disclosure or through any equivalent procedure.

In other embodiments of the invention, files comprising the set of computer-executable instructions may be stored in computer-readable memory on a single computer or distributed across multiple computers. A skilled artisan will further appreciate, in light of this disclosure, how the invention can be implemented, in addition to software, using hardware or firmware. As such, as used herein, the operations of the invention can be implemented in a system comprising a combination of software, hardware, or firmware.

Embodiments of this disclosure include one or more computers or devices loaded with a set of the computer-executable instructions described herein. The computers or devices may be a general purpose computer, a special-purpose computer, or other programmable data processing apparatus to produce a particular machine, such that the one or more computers or devices are instructed and configured to carry out the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of this disclosure. The computer or device performing the specified calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of this disclosure may comprise at least one processing element such as a central processing unit (i.e., processor) and a form of computer-readable memory which may include random-access memory (RAM) or read-only memory (ROM). The computer-executable instructions can be embedded in computer hardware or stored in the computer-readable memory such that the computer or device may be directed to perform one or more of the calculations, steps, processes and operations depicted and/or described herein.

Additional embodiments of this disclosure comprise a computer system for carrying out the computer-implemented method of this disclosure. The computer system may comprise a processor for executing the computer-executable instructions, one or more electronic databases containing the data or information described herein, an input/output interface or user interface, and a set of instructions (e.g., software) for carrying out the method. The computer system can include a stand-alone computer, such as a desktop computer, a portable computer, such as a tablet, laptop, PDA, or smartphone, or a set of computers connected through a network including a client-server configuration and one or more database servers. The network may use any suitable network protocol, including IP, UDP, or ICMP, and may be any suitable wired or wireless network including any local area network, wide area network, Internet network, telecommunications network, Wi-Fi enabled network, or Bluetooth enabled network. In one embodiment, the computer system comprises a central computer connected to the internet that has the computer-executable instructions stored in memory that is operably connected to an internal electronic database. The central computer may perform the computer-implemented method based on input and commands received from remote computers through the internet. The central computer may effectively serve as a server and the remote computers may serve as client computers such that the server-client relationship is established, and the client computers issue queries or receive output from the server over a network.

The input/output interfaces may include a graphical user interface (GUI) which may be used in conjunction with the computer-executable code and electronic databases. The graphical user interface may allow a user to perform these tasks through the use of text fields, check boxes, pull-downs, command buttons, and the like. A skilled artisan will appreciate how such graphical features may be implemented for performing the tasks of this disclosure. The user interface may optionally be accessible through a computer connected to the internet. In one embodiment, the user interface is accessible by typing in an internet address through an industry standard web browser and logging into a web page. The user interface may then be operated through a remote computer (client computer) accessing the web page and transmitting queries or receiving output from a server through a network connection.

The present invention has been described with reference to particular embodiments having various features. In light of the disclosure provided above, it will be apparent to those skilled in the art that various modifications and variations can be made in the practice of the present invention without departing from the scope or spirit of the invention. One skilled in the art will recognize that the disclosed features may be used singularly, in any combination, or omitted based on the requirements and specifications of a given application or design. When an embodiment refers to “comprising” certain features, it is to be understood that the embodiments can alternatively “consist of” or “consist essentially of” any one or more of the features. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention.

It is noted that where a range of values is provided in this specification, each value between the upper and lower limits of that range is also specifically disclosed. The upper and lower limits of these smaller ranges may independently be included or excluded in the range as well. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It is intended that the specification and examples be considered as exemplary in nature and that variations that do not depart from the essence of the invention fall within the scope of the invention. Further, all of the references cited in this disclosure are each individually incorporated by reference herein in their entireties and as such are intended to provide an efficient way of supplementing the enabling disclosure of this invention as well as provide background detailing the level of ordinary skill in the art.

As used herein, the term “about” refers to plus or minus 5 units (e.g., percentage) of the stated value.

As used herein, the term “substantial” and “substantially” refers to what is easily recognizable to one of ordinary skill in the art.

It is to be understood that while certain of the illustrations and figure may be close to the right scale, most of the illustrations and figures are not intended to be of the correct scale.