阅读说明：本技术 引导超声探头辅助设备放置的装置 (Device for guiding ultrasonic probe auxiliary equipment to be placed ) 是由 苏川杰 卢志文 林勇成 袁文贤 范炳文 阿尔农·哈达斯 多坦·特罗姆 阿夫沙洛姆·申哈 于 2019-08-23 设计创作，主要内容包括：本发明涉及一种用于促进一个对象医学成像的装置。所述装置包括：一个医学成像设备接收器,配置为接收一个医学成像设备；至少一个辅助设备接收器,配置为接收放置在所述对象目标部位的一个辅助设备；以及一个声波操纵模块,布置为引导声波在所述医学成像设备和所述对象之间传输,其中所述目标部分的图像由所述医学成像设备形成,用于引导所述辅助设备的放置。本发明还涉及一种部署所述装置的方法。(The present invention relates to an apparatus for facilitating medical imaging of a subject. The device comprises: a medical imaging device receiver configured to receive a medical imaging device; at least one ancillary device receiver configured to receive an ancillary device placed at the target site of the subject; and a sound wave manipulation module arranged to direct sound waves transmitted between the medical imaging device and the subject, wherein an image of the target portion is formed by the medical imaging device for guiding placement of the auxiliary device. The invention also relates to a method of deploying the device.)

1. An apparatus for facilitating medical imaging of a subject, comprising:

a medical imaging device receiver configured to receive a medical imaging device, at least one auxiliary device receiver configured to receive an auxiliary device for placement at a target site of the subject, and

an acoustic wave manipulation module arranged to direct acoustic waves transmitted between the medical imaging device and the subject, wherein an image of the target portion is formed by the medical imaging device for guiding placement of the auxiliary device.

2. The apparatus of claim 1 wherein the acoustic steering module comprises an acoustic deflecting surface arranged to alter the direction of transmission of at least a portion of the acoustic waves.

3. The apparatus of claim 2, wherein the acoustic wave guide surface is arranged to facilitate at least one of: reflection, refraction, diffraction of acoustic waves.

4. The apparatus of claim 2, wherein the acoustically deflecting surface is formed of a material having an acoustic transmission velocity relative to water in a ratio of 3.0 to 11.0.

5. The apparatus of any of claims 2-4, wherein the acoustic steering module includes an acoustic transmission site arranged to facilitate transmission of the acoustic waves at least between the medical imaging device and the acoustic wave deflector.

6. The apparatus of claim 5, wherein the acoustic transmission site is formed of a material having an acoustic transmission velocity relative to water in a ratio of 0.8 to 5.0.

7. The apparatus of any of claims 5-6, wherein the acoustic transmission interface comprises a gel matrix material.

8. The apparatus of claim 7, wherein the gel matrix material is disposed in a hollow portion of the acoustic wave manipulation module.

9. The apparatus of claim 1 wherein said acoustic steering module is made of a homogeneous material having a speed of acoustic transmission in a ratio of 2.0 to 3.0 relative to water.

10. The apparatus of claim 9, wherein the acoustic wave steering module, the medical imaging device receiver, and the ancillary device receiver are integrally formed as a unitary element.

11. The apparatus of any one of claims 1-10, wherein the at least one ancillary device receiver is configured to facilitate placement of the ancillary device to more than one desired position relative to a substantially plane of the apparatus.

12. The apparatus of any of claims 1-11, wherein the medical imaging device is mounted at a first angle between 0 and 90 degrees relative to a substantially planar surface of the apparatus, and wherein the acoustic wave guide surface is mounted at a second angle between 0 and 90 degrees relative to a substantially planar surface of the apparatus.

13. An apparatus according to any preceding claim, comprising a handle for controlling movement of the apparatus over a body surface of the subject.

14. The apparatus of any of the preceding claims, comprising a locking mechanism for holding the medical device in a desired position relative to a portion of the apparatus.

15. An apparatus as claimed in any preceding claim, comprising a reference mark to indicate the position of the ancillary device.

16. The apparatus of any of the preceding claims, wherein the medical imaging device receiver and the at least one auxiliary device receiver are rotatable relative to each other.

17. The apparatus of any of the preceding claims, further comprising a frame mountable on the subject's body, wherein the frame is arranged to facilitate movement of the medical imaging device receiver and the at least one ancillary device receiver along at least two axes.

18. The apparatus of claim 17, further comprising a plurality of quick release mechanisms to facilitate mounting the frame to the body.

19. The apparatus of claim 18, wherein the quick release mechanism comprises at least one of: suction device, belt and catch, removable adhesive.

20. A method for deploying the apparatus of any of claims 1-16, comprising the steps of:

securing a medical imaging device to the medical imaging device receiver of the apparatus;

placing the device on a body surface of a subject;

moving the device on the body surface to obtain an image of the target portion of the object;

securing an accessory to at least one accessory receiver of the apparatus;

adjusting a position of the auxiliary device based on the image of the target portion and inserting the auxiliary device toward the target portion.

21. A method for deploying the apparatus of any of claims 17-19, comprising the steps of:

mounting the frame of the device to the body of a target subject;

securing a medical imaging device to the medical imaging device receiver of the apparatus;

securing an accessory to at least one accessory receiver of the apparatus;

moving said medical imaging device along a first axis and said auxiliary device along a second axis to obtain an image of a target portion of said subject;

adjusting a position of the auxiliary device based on the image of the target portion and inserting the auxiliary device toward the target portion.

22. The method of claim 21, further comprising the steps of: a) a fixing mechanism that fixes the frame when quick disassembled, and/or b) the fixing mechanism for the medical imaging device or auxiliary device is disassembled to move in the opposite direction.

Technical Field

The present invention relates to an apparatus, system and method for medical imaging.

Background

The following discussion of the technical background is intended to facilitate an understanding of the present invention only. It should be noted that the discussion is not an acknowledgement or admission that any of the material referred to in the discussion was published, known or part of the common general knowledge of a skilled person in any jurisdiction as at the priority date of the invention.

Ultrasound examination is a medical imaging technique that may be applied in a variety of medical diagnostic and examination applications. Such diagnostic and diagnostic applications include tumor detection, providing images of the fetus to assess its development, and monitoring blood flow in various vital organs.

Ultrasound examination is also used to identify anatomical features of individuals, such as the lumbar space of vertebrates, such as but not limited to humans. One known instrument for ultrasound examination is a waveguide, also called an ultrasound probe. In the case of identifying the lumbar space, such waveguide devices typically operate on the principle of ultrasound reflection, identifying the lumbar space before marking on the external skin of the person. The marker can then be used to insert the appropriate device into the gap for guidance. Such devices may include, for example, needles or catheters for administering local or general anesthetics.

In using the waveguide and the marker, it will be appreciated that the user has both hands utilized, i.e., one hand for grasping and moving the waveguide to identify the lumbar space and the other hand for marking the interstitial area/spot on the skin with the marker/identifier. This may impair the overall accuracy of the identification process, since it is ensured that the waveguide is not inadvertently dislodged or moved, depending on the user, when the user marks the void area/spot on the skin.

It is an object of the present invention to ameliorate one or more of the above difficulties.

Disclosure of Invention

According to one aspect of the present invention, an apparatus for facilitating medical imaging of an object is provided. The method comprises the following steps: a medical imaging device receiver configured to receive a medical imaging device; at least one ancillary device receiver configured to receive an ancillary device placed at the target site of the subject; and a sound wave manipulation module arranged to direct sound waves transmitted between the medical imaging device and the subject, wherein an image of the target portion is formed by the medical imaging device for guiding placement of the auxiliary device.

In some embodiments, the acoustic steering module includes an acoustic wave deflecting surface (acoustic wave deflecting surface) arranged to alter a direction of propagation of at least a portion of the acoustic waves.

In some embodiments, the acoustic wave guide surface is arranged to facilitate at least one of: reflection, refraction, diffraction of acoustic waves.

In some embodiments, the acoustically deflecting surface is formed from a material having an acoustic transmission velocity relative to water in a ratio of 3.0 to 11.0.

In some embodiments, the acoustic wave manipulation module comprises an acoustic wave transmission site arranged to facilitate transmission of the acoustic wave at least between the medical imaging device and the acoustic wave deflector.

In some embodiments, the acoustic transmission site is formed from a material having an acoustic transmission velocity relative to water in a ratio of 0.8 to 5.0.

In some embodiments, the acoustic transmission interface (soundwave transmission interface) comprises a gel matrix material.

In some embodiments, the gel matrix material is disposed in a hollow portion of the acoustic wave manipulation module.

In some embodiments, the acoustic steering module is made of a homogeneous material having an acoustic transmission speed relative to water in a ratio of 2.0 to 3.0.

In some embodiments, the sonication module, the medical imaging device receiver, and the ancillary device receiver are integrally formed as a one-piece element.

In some embodiments, the at least one accessory receiver is configured to facilitate placement of the accessory to more than one desired position relative to a substantially plane of the apparatus.

In some embodiments, the medical imaging device is mounted at a first angle between 0 and 90 degrees relative to a general plane of the apparatus, and the acoustic wave guide surface may be mounted at a second angle between 0 and 90 degrees relative to a general plane of the apparatus.

In some embodiments, the device includes a handle for controlling movement of the device over a body surface of the subject.

In some embodiments, the apparatus includes a locking mechanism for maintaining the medical device in a desired position relative to a portion of the apparatus.

In some embodiments, the apparatus includes a reference marker to indicate the position of the ancillary device.

In some embodiments, the medical imaging device receiver and the at least one auxiliary device receiver are rotatable relative to each other.

In some embodiments, the apparatus further comprises a frame mountable on the subject's body, wherein the frame is arranged to facilitate movement of the medical imaging device receiver and the at least one ancillary device receiver along at least two axes.

In some embodiments, the device further comprises a plurality of quick release mechanisms to facilitate mounting the frame to the body.

In some embodiments, the quick release mechanism comprises at least one of: suction device, belt and catch, removable adhesive.

According to another aspect of the invention, a method for deploying an apparatus for facilitating medical imaging is provided. The method comprises the following steps: securing a medical imaging device to the medical imaging device receiver of the apparatus; placing the device on a body surface of a subject; moving the device on the body surface to obtain an image of the target portion of the object; securing an accessory to at least one accessory receiver of the apparatus; adjusting a position of the auxiliary device based on the image of the target portion and inserting the auxiliary device toward the target portion.

According to another aspect of the invention, a method for deploying an apparatus for facilitating medical imaging is provided. The method comprises the following steps: mounting the frame of the device to the body of a target subject; securing a medical imaging device to the medical imaging device receiver of the apparatus; securing an accessory to at least one accessory receiver of the apparatus; moving said medical imaging device along a first axis and said auxiliary device along a second axis to obtain an image of a target portion of said subject; adjusting a position of the auxiliary device based on the image of the target portion and inserting the auxiliary device toward the target portion.

In some embodiments, the method further comprises the steps of: a) a fixing mechanism (catch mechanism) that fixes the frame when quick disassembled, and/or b) disassembling the fixing mechanism for the medical imaging device or auxiliary device to move in the opposite direction.

Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.

Drawings

Embodiments of the invention are illustrated by way of example only in the accompanying drawings, in which:

FIGS. 1 and 2 illustrate an apparatus for facilitating medical imaging for use with a medical imaging device and an accessory device mounted thereon, according to one embodiment;

figures 3 and 4 illustrate an apparatus for facilitating medical imaging according to another embodiment;

FIGS. 5A and 5B illustrate an apparatus for facilitating medical imaging according to another embodiment;

FIGS. 6A and 6B illustrate a device with a frame for facilitating movement of an ancillary device and/or a medical imaging device mounted thereon according to one embodiment;

FIGS. 7A-7D illustrate adjustment of the medical imaging device and the accessory mounted on the apparatus;

FIG. 8 shows an apparatus for use with a medical imaging device of other embodiments;

FIG. 9 illustrates other embodiments of an apparatus for use with and integration with a medical imaging device;

FIG. 10A depicts a method of using the apparatus according to some embodiments;

FIG. 10B depicts a method of using the apparatus according to further embodiments.

Detailed Description

Throughout this document, unless stated to the contrary, the terms "comprising," consisting of, "" having, "and the like are to be construed as non-exhaustive or, in other words, mean" including but not limited to.

Furthermore, throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Throughout the specification, the term "medical image" or "medical imaging" may include images or imaging methods based on a variety of techniques, and includes processes that create visual representations of the interior of the body for clinical analysis and medical interventions, as well as visual representations of certain organ or tissue functions.

In accordance with one aspect of the present invention and referring to fig. 1-6, there is an apparatus 10 for facilitating medical imaging of an object (e.g., a body part of a patient). The apparatus 10 comprises: a medical imaging device receiver 140 configured to receive the medical imaging device 20; a sound wave manipulation module 110 arranged to transmit sound waves between the medical imaging device 20 and the subject along a specified path; and at least one ancillary device receiver 130 configured to receive an ancillary device 22 for placement at a target site of the subject, wherein an image of the target site is formed by the medical imaging apparatus 20 for guiding placement of the ancillary device 22.

In various embodiments, the medical imaging device 20 may be in the form of an ultrasound probe 20. An exemplary ultrasound probe may include a transducer for producing acoustic waves of a particular frequency range that are focused by the shape of the transducer, a lens in front of the transducer, or a complex set of control pulses from a transmit beamformer coupled to the transducer. An arc of sound waves is transmitted from the surface of the ultrasound probe 20 to a target object (e.g., a patient). The waveform and frequency of the acoustic wave may be adjusted so that the acoustic wave may propagate along one or more ultrasound scan lines and may enter a desired depth of the target object. The transducer of the ultrasound probe may be operable to receive acoustic echoes from the target object. The ultrasound probe may also include or may be connected to an image processing module/circuit for interpreting the received echo data to generate an image of the target object.

It should be understood that alternative techniques for generating and controlling ultrasound waves and receiving and interpreting echoes received from ultrasound waves for the purposes of diagnostic medical imaging may also be used with various embodiments of the present invention. For example, other types of transmitters and/or receivers may be used in addition to or in place of the transducers, which may eliminate the need for a transmit beamformer and may allow beamforming to be performed by post-processing the received echoes. It will also be appreciated that various signal processing techniques may be performed on the received echoes. For example, a receive beamformer and/or various digital/analog signal processing techniques may be used to acquire image information from received acoustic echoes and perform three-dimensional image reconstruction from multiple two-dimensional image planes of the target object.

In various embodiments, the auxiliary device 22 may be a tool for assisting in a medical diagnostic procedure. In some embodiments, the ancillary device may be an invasive medical device including, but not limited to, aspiration or biopsy needles, catheters, and endoscopes. In use, a clinician needs to place or insert the auxiliary device 22 towards a specific target on/within the body part of the subject. It is worth noting that in such procedures, the accuracy and speed of placement/insertion of the auxiliary device is critical.

In various embodiments, the apparatus 10 includes a medical imaging device receiver 140 for receiving and/or holding the medical imaging device 20.

In various embodiments, as shown in fig. 1, 2, and 4-5B, the device 10 may include a housing that houses the device components, including the acoustic wave steering module 110. The housing of the apparatus may have a structure (e.g., a molded plastic component) shaped and sized for receiving the medical imaging device receiver 140 of the medical imaging device 20. In use, the medical imaging device 20 (e.g., an ultrasound probe) may be inserted or mounted into the medical imaging device receiver 140. The medical imaging device receiver 140 may be adaptable or include an adaptable structure (e.g., adjustable side, slidable portion) to receive most, if not all, of the commercially available ultrasound probes.

In some embodiments, the medical device receiver 140 may include a disposable interface (not shown). The disposable interface may include an interface attachment and may be a region/feature that maintains sterility.

In some embodiments, the disposable interface comprises or includes various materials, such as polymers. Due to the nature of the material and its limited shelf life, such materials are single-use and disposable. Furthermore, when used with any ultrasound gel and ultrasound probe, some wear may render the part unusable or uneconomical, or not easily cleaned, prepared, and reused.

In some embodiments, the medical device receiver 140 may further provide a locking mechanism 120 for securing/holding the medical imaging device 20 in a desired position relative to the apparatus 10. One non-limiting example of the locking mechanism 120 may be a snap for locking a corresponding protruding edge on the medical imaging device 20. It is understood that various types of snap fasteners including ring, twist, cantilever snap fasteners, the mating design of which may be implemented as the locking mechanism 120 for the stationary medical imaging device 20. The use of the locking mechanism 120 may reduce the looseness of the medical imaging device 20 relative to the apparatus 10 that may introduce noise/interference into the imaging system.

In some embodiments, the apparatus 10 includes a sound wave manipulation module 110 arranged to transmit sound waves between the medical imaging device 20 and the subject (more particularly, the apparatus 10 is placed on the subject's body). In particular, the acoustic steering module 120 includes one or more acoustic components capable of changing at least the direction of acoustic wave transmission.

In various embodiments, the acoustic wave manipulation module 110 can include an acoustic wave guide surface 113 and an acoustic wave transmission portion 116. A deflector material may be provided to perform the function of deflecting or redirecting the acoustic wave at the acoustic wave deflecting surface 113. An acoustically transmissive material may be used to form the acoustic transmission portion 116 to facilitate acoustic transmission therein.

In various implementations, the acoustic wave guide surface 113 may be arranged to change a direction of transmission of at least a portion of the acoustic wave. In use, the medical imaging device 20 (e.g., an ultrasound probe) is placed beside or in close proximity to the acoustic steering module 110 such that ultrasound waves generated from the medical imaging device 20 are directed to propagate toward the acoustic deflector 113.

In various embodiments, the medical imaging device may be mounted at a first angle between 0 and 90 degrees relative to the general plane 15 of the apparatus 10, and the acoustic waveguide 113 may be disposed at a second angle between 0 and 90 degrees relative to the general plane 15 of the apparatus 10. In use, the substantially planar surface 15 of the device may rest on a surface 43 of the body part of the subject (i.e. the body surface 43), or may be substantially parallel to the body surface 43 and close to the body surface 43. When the apparatus 10 (with the medical imaging device 20 attached thereto) is placed on the body surface 43, the medical imaging device 20 does not emit acoustic energy or emits acoustic waves directly to the body surface 43.

The acoustic wave deflecting surface 113 functions as an acoustic wave redirector, allowing acoustic waves to propagate towards the subject's body part and echoes from the body part back to the ultrasound probe for image construction. The transmission of the acoustic wave follows a specified path or a specified propagation trajectory. More specifically, as shown in FIG. 2, the acoustic wave propagates from the ultrasonic probe 20 to the acoustic wave deflection surface 113 in a first direction substantially along the substantially planar surface 15 of the device 10. The acoustic waveguide 113 may be positioned at an angle relative to the base plane 15. When an acoustic wave (e.g., in the form of a longitudinal acoustic array) impinges on the acoustic wave deflector, at least a portion of the acoustic wave is deflected to propagate in a second direction and towards the body part of the subject, the direction being where the substantially planar surface 15 of the apparatus 10 is positioned. The acoustic echo from the subject's body part is transmitted towards the acoustic deflector surface 113 and redirected to propagate along a similar or identical propagation trajectory towards an ultrasound probe receiver.

In some embodiments, the acoustic wave deflecting surface 113 may be configured to operate based on the principles of wave reflection, wave refraction, or wave diffraction. In particular, there are several ways to redirect the ultrasound. These methods include: a. diffraction when the ultrasonic waves pass through one or more openings (gratings), (if present) or around a barrier; b. when ultrasound waves pass through materials of different properties, they are refracted, i.e. pass through different layers or inhomogeneous media. Examples of such properties may be the density of the material, the acoustic impedance or the acoustic transmission speed of the material.

In some embodiments, the acoustically deflecting surface 113 is formed of a deflector material (deflective material) having a substantially different acoustic transmission velocity than the acoustic transmission material of the acoustically transmitting portion 116. Alternatively, the acoustic propagation velocity of the deflector material is in a substantially different range compared to the acoustic transmission material. In some embodiments, suitable deflector materials may have an acoustic transmission speed in a ratio range of 3.0 to 11.0 relative to water.

The acoustic wave is deflected at the interface of two different media, namely the deflector material and the acoustic transmission material. Due to the difference in the speed of sound wave propagation between the deflector and the sound transmitting material, the sound wave is deflected at the sound wave deflector plane. In this way, the propagation path/trajectory of the acoustic wave can be changed. It will be appreciated that the desired degree of variation in the propagation direction (i.e. the degree of acoustic wave deflection) may be achieved by selecting a suitable deflecting material, and/or by positioning and shaping (shaping) the acoustic wave deflecting face 113 in a suitable manner.

In some embodiments, one or more reflective surfaces may be provided in place of or in addition to the deflector material for the purpose of effective acoustic wave deflection. The reflecting surface may be made of a suitable material for consistent and efficient reflection of the ultrasonic waves. The shape or texture of the reflective surface may also be designed to reshape or focus the wave pattern to improve the clarity or efficiency of wave reception through acoustic manipulation.

In some embodiments, the reflective surface may comprise one or more rigid materials, such as polypropylene (PP), Polycarbonate (PC), glass, metal, or a suitable polymer. The following modifications may be made to one or more of the above materials: suitable coating materials can be chemically deposited or electroplated with various metals, such as gold, nickel, copper, chromium, and the like. The reflecting surface may comprise or consist essentially of a microstructure or patterned texture to steer the ultrasound waves to achieve proper focusing or beam forming. The reflective surface may be comprised of a porous or non-porous internal structure of the material.

In some embodiments, the reflective surface may be supplemented by one or more diffractive mechanisms (e.g., an ultrasonic grating). In some embodiments, the plurality of reflective surfaces may be arranged at various angles with respect to each other to achieve optimal reflection.

In some embodiments, the acoustic waveguide 113 may be a replaceable portion. Different configurations or different wave forming features may be mounted to the device 10 and deployed as acoustic wave redirectors. For example, for different thicknesses of skin or body structure, replaceable components that will affect the acoustic wave pattern differently may be used to generate images in a more efficient manner.

In various embodiments, the acoustic manipulation module 110 can further compress the acoustic transmission portion 116, the acoustic transmission portion 116 being arranged to promote efficient transmission of acoustic waves within the acoustic manipulation module 110. More specifically, the acoustic transmission portion 116 is arranged as a medium for acoustic waves to propagate between the medical imaging device 20 (e.g., ultrasound probe transmitter/receiver end) and the acoustic guide surface 113, and between the acoustic guide surface 113 and the target portion of the subject, according to a specified transmission or propagation trajectory controlled by the acoustic guide surface 113.

Suitable sound transmitting materials having desired acoustic properties (e.g., a desired sound transmission speed) can be used to form the sound wave transmitting portion 116. In some embodiments, the acoustically transmissive material can have an acoustic transmission velocity relative to water in a ratio range of 0.8 to 5.0. In some embodiments, the acoustically transmissive material can have an acoustic transmission speed relative to water in a ratio range of 2.0 to 3.0.

In some embodiments, the acoustic transmission module may be formed in a clear and uniform structure. The structure may be transparent or translucent. Artifacts within the acoustic transmission portion 116 are minimized or eliminated so as to promote efficient transmission of acoustic waves therein. Artifacts within the acoustic transmission portion 116 are minimized or eliminated to promote efficient transmission of acoustic waves therein.

In some embodiments, suitable acoustically transmissive materials for forming the acoustically transmissive portion 116 include, but are not limited to, poly (methyl methacrylate) or PMMA, polycarbonate or PC, polyamide (e.g., nylon), polyvinyl chloride or PVC, polystyrene or PS, polypropylene or PP, silicone or polysiloxane, natural or synthetic rubber.

In some embodiments, the acoustic transmission section 116 may be formed of a water-based material or a gel-based material that causes the propagation velocity of the ultrasound waves to be similar to that of water or soft tissue. Such water-or gel-based acoustically transmissive materials may include, but are not limited to, water, gelatin, polyvinyl alcohol, agarose, and polyacrylamide. The water-based or gel-based acoustic wave transmissive material may be provided in the form of a gel pad. The gel pad may be placed at the hollow portion or cavity of the acoustic wave manipulation module 110. The form and shape of the gel pad acoustic transmission material may be adjusted according to the internal contour of the hollow portion/cavity of the acoustic steering module 110. Advantageously, any gaps, air pockets or other irregularities (in the form of gel pads disposed in the hollow portion) that may interfere with the propagation of the acoustic waves within the acoustic wave propagating portion 116 may be minimized.

In some embodiments, the acoustic steering module 110 may be supplemented by one or more interface materials. In use, one or more interface materials may be disposed at an interface between the medical imaging device 20 and the acoustic transmission portion 116 (i.e., probe-device interface 141) and/or at an interface between the acoustic transmission portion 116 and the subject's body part.

Similar to the sound-transmitting material used to form the gel pad form acoustic transmission 116, the primary (core) component of the interface material may be water-based (e.g., gelatin, polyvinyl alcohol, agarose, polyacrylamide), which results in a propagation velocity of ultrasound similar to that of water or soft tissue. Additionally, scattering agents may be suspended in a buffer/gel medium to produce backscatter that enhances ultrasound imaging. The scattering agent typically comprises particulate matter, and may include graphite particles, silica particles, and polystyrene spheres.

Interface materials may be provided to improve efficiency and compatibility with existing ultrasound probes (i.e., for ultrasound buffers). The interfacing material may comprise an acoustic material, including a gelatin-based material (i.e., a gel) containing various additives to provide true acoustic properties that enhance or control the Ultrasound (US) waves. The additives may be micron-sized silica particles or the like to cause acoustic scattering and percentage (range) of fat emulsion to vary ultrasound attenuation. It will be appreciated that the interface material may generally be modified to achieve an optimal or optimal range of speed, acoustic attenuation and acoustic backscatter of ultrasound propagating through the medium.

In some embodiments, the acoustic transmission section 116 may also include a buffer material that improves the efficiency of transmission of acoustic waves through various media to the ultrasound probe receiver by providing an interface with this feature. The buffer material may be a disposable component that can be attached to and compatible with a variety of probe shapes.

In various embodiments, the apparatus 10 includes at least one auxiliary device receiver 130 for receiving at least one auxiliary device 22. The auxiliary device 22 may be disposed on or otherwise coupled to the acoustic deflecting surface 113 of the acoustic steering module 110.

In various embodiments, the ancillary device receiver 130 is shaped and dimensioned to receive an ancillary device for insertion toward and/or into the body part of the subject.

The accessory receiver 130 provides a method for holding and/or guiding an accessory. For example, as shown in fig. 1-4, the ancillary device receiver 130 may be in the form of an aperture/channel shaped and dimensioned for insertion of the ancillary device 22 (e.g., a needle or catheter).

The ancillary device receiver 130 may be configured to receive most, if not all, of the commercially available aspiration/biopsy needles and catheters.

In some embodiments, the at least one ancillary device receiver 130 may be configured to facilitate placement of ancillary devices in a plurality of positions relative to the substantially planar surface 15 of the apparatus 10. For example, the apparatus 10 may have a plurality of apertures/channels of different shapes and sizes for receiving different types of auxiliary devices 22. Furthermore, as shown in fig. 4, the apertures/channels for receiving the auxiliary devices 22 may be arranged at different angles with respect to the general plane 15 of the apparatus 10. This allows the placement/insertion of the auxiliary device 22 from different directions, with reference to the substantially plane of the apparatus 15 or the body surface 43.

The shape and size of the aperture/channel may substantially correspond to the shape and size of a needle or catheter, which allows insertion of the needle or catheter along the longitudinal axis of the aperture/channel, while allowing some degree of lateral or rotational movement of the needle/catheter within the aperture/channel. In other words, the aperture/channel and the auxiliary device are not closely arranged. When the needle/catheter is inserted into the aperture/channel, a gap is left between the needle/catheter and the inner wall of the aperture/channel, so that the needle/catheter is not completely restricted by the aperture/channel and the position of the needle/catheter can be adjusted to a certain extent. In some embodiments, the inserted needle or catheter is capable of angular and/or lateral movement within the aperture/channel. For example, the needle/catheter held by the aperture/channel can be moved angularly about the central axis of the aperture or the longitudinal axis of the channel by-20 ° to 20 °.

In some embodiments, the device 10 further comprises a handle for controlling the movement of the device over the body surface 43 of the subject. For example, the handle 121 may be a projection provided on the upper surface of the device 10, as shown in FIG. 2. In particular, the handle 121 provides convenience to a user (e.g., a medical practitioner) to move the device 10 through the body surface 43 to identify a target portion.

In some embodiments, the medical imaging device 140 and the at least one ancillary device receiver 130 are relatively rotatable to achieve an optimal view of the ancillary device 22 (when present) and a clear path to the target object. More specifically, the ultrasound probe 20 and/or the ancillary device receiver 140 may be rotated about a portion (point) on the base surface 15 of the apparatus 10 to provide angular adjustment. A medical practitioner can adjust the position of the ultrasound probe 20 and the ancillary device receiver 40 to obtain an optimal ultrasound image.

Advantageously, the aforementioned apparatus 10 provides an arrangement for effectively redirecting ultrasound waves by reflection or diffraction techniques to provide a clear view of an auxiliary device (when present), such as a needle, for insertion into an identified location of an object. This arrangement also provides a clear path and an optimal view of the auxiliary device 22 to the identified location of the object.

Furthermore, by referring to the real-time image of the target location formed by the medical imaging device, the medical practitioner can accurately place or insert an auxiliary device on or into the target portion of the subject. The steps of marking the placement/insertion location of the auxiliary device and removing the ultrasound probe in preparation for placement/insertion of the auxiliary device into the target portion may be omitted.

It will be appreciated that the described arrangement of the various components of the apparatus 10 may be implemented in a variety of suitable ways.

In some embodiments as shown in fig. 1 and 2, one of the ancillary device receiver 130 and the medical imaging device receiver 140 may be formed as part of the housing of the apparatus 10. For example, these features may be integrally formed with the housing of the device using plastic molding techniques. The housing may include adaptable structure for placement and/or attachment of other components of the device 10, including the acoustic deflector 113 and acoustic transmission portion 116.

In some other embodiments, as shown in fig. 3 and 4. The apparatus 10, and in particular the acoustic wave manipulation module 110, the medical device receiver 140 and the ancillary device receiver 130, may form an integral element. For example by using a plastic moulding process. If desired, one or more other shaping processes may be used to form the structure for mounting/receiving the medical imaging device 20 and the ancillary device 22. Such a device 10 may be referred to as a "mono-block" design or a "mono-block" device 10.

In some embodiments, the monolithic device (mono-block apparatus)10 is shaped and dimensioned such that sound waves propagate within the monolithic device along a specified path. In particular, the acoustic wave guide surface 113 may be arranged at an appropriate angle in order to redirect acoustic waves to the target body part or acoustic wave echoes to the medical imaging device 20 (or ultrasound probe). Further, the integrated device 10 may be formed to extend along a suitable length from the probe-device interface 141 to the acoustic wave guide surface 113, for example in the range of 5mm to 60 mm.

As can be seen from fig. 3 and 4, in the overall design, the interface 113 between the bulk material and the air forms and functions as an acoustically deflecting surface 113.

Materials having suitable acoustic transmission speeds that allow the trajectory of the acoustic wave to be deflected at the acoustic deflector 113 at a desired angle may be used to form the integrated device 10. Such materials may include the aforementioned acoustically transmissive materials, such as polymethylmethacrylate or PMMA, polycarbonate or PC, polyamide (e.g. nylon), polyvinylchloride or PVC, polystyrene or PS, polypropylene or PP, silicone or polysiloxane, natural or synthetic rubber.

In some embodiments, the material used to form the integrated device 10 may have a sound transmission speed relative to water in a ratio range of 2.0 to 3.0. Accordingly, the acoustic waves transmitted from the medical imaging device 20 and the echoes from the body surface may be deflected towards a monolithic material (mono-block material) at a desired angle when striking the acoustic deflecting surface 113. In various embodiments, the unitary apparatus 10 may form a clear and homogeneous structure with which artifacts (e.g., air pockets, impurities) are minimized or eliminated, thereby minimizing interference with acoustic waves propagating therein. The acoustic wave guide surface 113 and the probe-device interface 141 are smooth and homogenous surfaces formed with minimal surface roughness/irregularities. Advantageously, an efficient acoustic transmission within the overall device 10 and an efficient acoustic diffraction at the acoustic guide plane 113 can be achieved.

In some embodiments, as shown in fig. 5A and 5B, the ancillary device receiver 130, the housing, and other components of the apparatus, including the acoustic deflector surface 113, the medical imaging device receiver 140, and the acoustic transmission module 116, may be formed as separate components, assembled/connected together. It can be seen that the hollow portion 212 can be formed when the top piece 214, bottom piece 216 and fixture 217 are combined together. The hollow portion 212 can be used to house an acoustic wave transmitting material, such as a gel pad comprising a gel matrix material. A plurality of attachment means (e.g., through the use of screws, rivets, adhesive materials, mechanical interlocking structures) may be used to attach/assemble the above components to form the device 10.

In this configuration, the acoustically deflecting surface 113 and other components of the device may be replaced. The selection of an appropriate acoustic deflector 113 may be based on the particular application of the device, for example, based on the desired image resolution and focal point. In addition, damaged or worn parts may also be replaced.

In some embodiments, illustrated in fig. 6A and 6B and fig. 7A to 7D, the apparatus 10 may further comprise a frame 412 mountable on the body part of the subject, wherein the frame is arranged to facilitate movement of the medical image apparatus receiver 140 and the at least one ancillary device receiver 130 along at least two axes.

The frame 412 may be mounted to the subject's body part, such as a person's back. The frame 412 includes a first portion 414 for receiving the medical imaging device 20 and a second portion 416 for receiving the auxiliary device 22. The medical imaging device 20 may be an ultrasound probe and the ancillary device 22 may be a needle or catheter inserted into the body part at a designated location of the body part. The fastening/adjustment device may be used to fix the ultrasound probe 20 at an angle.

Fig. 7A and 7B illustrate a medical imaging device 20 in the form of an ultrasound probe and an ancillary device receiver 130 in the form of a needle holder 134. An acoustically deflecting surface 113 (e.g., in the form of one or more acoustically reflective surfaces) can be located on the needle holder 134. The acoustic waveguide 113 may be replaceable for different configurations or for wave manipulation methods as described above. The needle holder 134 includes at least one aperture/channel shaped and dimensioned to receive a needle or catheter.

In various embodiments, the frame 412 may be a rectangular frame having two opposing ends 412a,412b that serve as guides for slidably receiving the medical imaging device 20. The opposing ends 412a,412b include a track 432 or other suitable mechanism such as gear teeth (gear teeth) arranged to allow the first portion 414 to move along the track 432 along an axis such as the Y-axis. The first portion 414 may include a plate on which the ultrasound probe 20 is placed.

In some embodiments, the first portion 414 can include a securing mechanism (not shown) that interacts with the track 432 such that when the first portion 414 is moved along the track 432 (in a first direction) to a first position, it can be held in the first position by the securing mechanism (e.g., by friction and/or other quick release fasteners). To move to the second position along track 432, first portion 414 may continue to move in a first direction (Y1), which may be a forward direction (Y1). However, if second portion 416 is not in the first direction, but is, for example, in a direction opposite the first direction (i.e., Y2), then the securing mechanism needs to be released before first portion 414 can move to second portion 416.

In various embodiments, the frame 412 may include a plurality of fasteners 418 for connecting to the body portion. Such fasteners 418 may be, for example, suction cups, releasable bands (e.g., velcro @)^TMTypes), belt and buckle arrangements, removable adhesives, and combinations of one or more of the foregoing.

In various embodiments, the first portion 414 may be a plate mounted on a rail 432 of the frame 412. The first portion 414 is shaped and dimensioned to support an ultrasound probe 20 mounted thereon. The first portion 414 may include grooves, flanges, and/or fasteners arranged to correspond to the shape of one or more types of ultrasound probes.

In various embodiments, the second portion 416 may be mounted on the first portion 414. In some embodiments, the second portion 416 is slidably movable along the first portion 414. The second portion 416 includes a cradle that is operably configured to receive an ancillary device (e.g., needle, catheter) for insertion at a particular location on the body portion. The second portion 416 is configured to move in an approximately perpendicular direction relative to the first portion 414. For example, if the first portion 414 is configured to move along the y-axis, the second portion 416 is configured to be movable along the x-axis.

In some embodiments, the second portion 416 may move along the first portion 414. The second portion 416 is movable by the user to a direction (X1), which may be a forward direction, to a desired position. However, if the user wishes to move in the opposite direction (X2), the securement mechanism (not shown) needs to be released before the second portion 416 can move in the direction of X2.

The position of the ancillary device receiver 130 can be adjusted to obtain the best ultrasound image quality. In some embodiments, the ancillary device receiver 130 and acoustic deflector 113 mounted thereon may be further configured to rotate relative to the ultrasound probe 20.

In some embodiments, referring to fig. 7A-7D, the apparatus 10 can include a sub-assembly 134 that is rotatable to rotate the ultrasound probe 20 and the ancillary device receiver 130 relative to each other. This function has at least the following advantages: (a) the angle of the acoustic deflector surface 113 can be adjusted to obtain the best ultrasound image quality and/or to adjust the focus of the image. The image quality can be further improved by adjusting the distance of the ultrasound guide 113, i.e. by moving the ultrasound probe 20 towards or away from the acoustic guide. (b) When mounted on the frame 412, the rotatable subassembly 134 provides rotational movement of the needle (when present) to facilitate accurate targeting of the auxiliary device 22, and/or to account for body contours prior to insertion.

In some embodiments, the first portion 414 may include one or more fiducial markers 415 to indicate the position of the ancillary device 22 relative to the ultrasound probe 20 (when both are present). The fiducial mark 415 may be opaque to acoustic waves such that the waveform and/or propagation trajectory of the acoustic waves is not affected by the fiducial mark 415.

It will be appreciated that the arrangement of the various components of the apparatus 10 described above is a non-limiting example, and that other suitable arrangements are contemplated to achieve the same effect of redirecting sound waves using the sound manipulation module, allowing real time images of the subject to be formed to guide insertion/placement of ancillary equipment. Two other non-limiting examples of the device 10 are shown below and in fig. 8 and 9.

As shown in fig. 8, the ultrasound probe may be mounted on an adhesive patch 460 via a probe holder 462 (a particular form of the medical imaging device receiver 130). The adhesive patch 460 is attached to the user during use, and the ultrasound probe 20 is held at an angle by the probe holder 462. The acoustic deflector surface 113 is arranged opposite to the direction of movement of the ultrasound probe 20 in order to provide guidance to the user identifying the precise location of needle insertion. The acoustic wave guide surface 113 may be in the form of a reflective surface (e.g., a mirror) and includes an aperture shaped and sized to fit the accessory to be inserted.

After insertion, an ultrasonic gel may be used in certain embodiments to serve as the acoustic transmission portion 116 as well as the ancillary device receiver 116. The needle or other ancillary device may be held in place by the ultrasound gel, which also facilitates the transmission of ultrasound waves between the ultrasound probe 20 and the target object. The probe may be mounted at a first angle between 0 and 90 degrees relative to the plane of the adhesive patch and the deflector surface 113 may be mounted at a second angle between 0 and 90 degrees relative to the plane of the adhesive patch. The deflector surface 113 may be integrated into the adhesive plate.

Another possible configuration of the apparatus 10 is shown in fig. 9, in which the medical imaging device 20 is in the form of an ultrasound probe. The acoustic steering module 110 (in the form of a cushioning material) and the ancillary device receiver 130 (in the form of an aperture, channel, or needle holder secured to the cushioning material) are integrated with the ultrasound probe 20 to provide a convenient experience to the user. Generally, the engineering of the ultrasound buffer (and the angle at which the ultrasound rays are refracted) should ensure that the needle does not need to pass through the buffer or interfere with the sound waves, while real-time ultrasound imaging is performed as the needle is inserted. The stitches either pass through the holes in the buffer or do not pass through the buffer.

The apparatus 10 is described in the context of a method for facilitating medical imaging. The method may be suitably used to identify the lumbar space of an individual, but it will be appreciated that the method may be used for other types of medical imaging known to the skilled person.

According to one embodiment, a method for deploying the device 10 may comprise the steps of:

the medical imaging device 20 is first secured to the apparatus 10 by the medical imaging device receiver 140 (step s 101). The acoustic steering module 110 is then placed on a body surface of an object, such as an individual's back, preferably by qualified medical personnel (step s 102). The substantially planar surface 15 of the device 10 may be placed on a body surface 43.

The position of the apparatus 10 may be adjusted to obtain an image of the target object (step S104), by means of the medical imaging device 20 (step S103). The medical imaging device 20, i.e. the ultrasound probe, is opened and the apparatus 10 can be moved over the body surface 43 and through the body surface 43, whereby a target portion can be identified for further procedures to be performed by the auxiliary device 22. For example, the user may move the apparatus 10 and the ultrasound probe 20 to locate the subject's lumbar gap, which may be, but is not limited to, the L2-L3 gap, the L3-L4 gap, the L4-L5 gap.

An ancillary device 22 (e.g., a needle, catheter or endoscope) may be secured to the apparatus 10 via at least one ancillary device receiver 130 (step s 104). The apparatus 10 may include more than one ancillary device receiver 130, and a suitable ancillary device receiver 130 may be selected based primarily on the size and shape of the ancillary device 22.

Once the target portion is identified, the auxiliary device 22 may be inserted toward the target portion. The real-time image formed by the medical imaging device 20 may be used to guide the placement/insertion of the ancillary device 22 (step s 105). In this process, the position of the auxiliary device 22 may be adjusted based on the real-time image of the target portion. In this way, accurate and rapid placement of the auxiliary device 22 can be achieved.

According to another embodiment, a method of deploying the device 10 may comprise the steps of:

the frame 412 is first mounted on a body part of a subject, preferably by qualified medical personnel (step s 302). Next, the medical imaging device 20, i.e., the ultrasound probe 20, is opened and a user moves the ultrasound probe 20 (which has been mounted on the first portion 414) to locate the lumbar gap, which may be, but is not limited to, the L2-L3 gap, the L3-L4 gap, the L4-L5 gap (step s 304).

After identifying the desired lumbar space, the practitioner then positions the needle/catheter over the second portion 416 (step s 306). The second portion 416 is then adjusted to the desired position over the lumbar space. The adjustment may include an angular adjustment by rotating the subassembly (step s 308).

Once the first and second portions 414, 416 are in place, the procedure may continue through insertion of a catheter, or if other types of auxiliary devices 22 are used, the procedure may continue through use of the auxiliary devices 22 (step s 310).

In some embodiments, a portion of the device 10 may be disposable to maintain hygiene standards.

For example, the disposable portion of the frame 12 may be made of molded polypropylene or polycarbonate or similar plastic. Some parts, such as accessory features, may be suction cups made of silicone or rubber, or nylon fabric straps and buttons.

Essentially, the rectangular frame needs to be ergonomic-when performing lumbar puncture, the patient is rolled up when lying on their side and bowed forward when sitting-thus this can be problematic when we want to secure the 4 ends of the patient. Another option is a support with a flexible robotic arm to which the probe is attached. Both solutions need to ensure that the contact between the probe and the patient's skin is always good.

As described herein, apparatus for use with medical imaging devices, such as ultrasound waveguide devices, have been considered. The medical imaging device and one or more accessory holders are arranged in different positions relative to each other to achieve an optimal view of the accessory (if present) and a path to a target site of an object (e.g., a patient).

Various embodiments are advantageous for providing a quick release, body-mountable multi-axis tracking device for guiding ultrasound probes and needles to improve the accuracy of such procedures, as well as releasing a user's hand by holding the aforementioned instruments in the guided position and orientation. The guidance is adjustable and meets the user-triggered motion requirements with active friction locking, enabling hands-free operation.

It will be appreciated by persons skilled in the art that the above invention is not limited to the described embodiments. In particular, modifications and improvements may be made without departing from the scope of the invention.

It will be further appreciated by those skilled in the art that one or more of the above mutually non-exclusive modifications or improvements may be further combined to form further embodiments of the invention.

Reference to

10 apparatus (appaatus)

15 basic plane (base plane)

20 medical imaging device (medical imaging device)

22 auxiliary equipment (auxiliary equipment)

40 target object (target subject)

43 body surface (body surface)

110 sound wave operating module (sound wave simulation module)

113 Acoustic wave deflection surface (sound wave deflection surface)

116 Sound Transmission site (sound wave transmission site)

120 locking mechanism (locking mechanism)

121 handle (handle)

130 auxiliary equipment receiver (auxiliary equipment receiver)

134 needle holder (needle holder)

140 medical imaging device receiver (medical imaging device receiver)

141 Probe-device interface (probe-apparatus interface)

212 hollow part (hold port)

214 Top block (top block)

215 bottom block (bottom block)

216 Sound Transmission location (sound wave Transmission location)

217 fastener (catch)

412 frame (frame)

412a,412b at opposite ends of the frame (open ends of the frame)

413 acoustic wave deflecting surface (sound wave deflecting surface)

414 first part (first part)

415 fiducial marks (fiducial mark (s))

416 second part (second part)

418 fastener (fastner)

432 track (rail)

460 pasting board (packer plate)

462 Probe holder (probe holder)