Foldable ultrasonic transducer and related methods

Abstract

An apparatus and method for folding an ultrasonic transducer assembly are disclosed. The apparatus includes a base that defines two pivot channels, each supporting an axle. The folding platform has a first part pivotably positioned around one axle and a second part pivotably positioned around the other axle. The folding platform is movable between an open position and a closed position. In the open position, the inner surfaces of the first and second parts are aligned substantially parallel to the top surface of the base. In the closed position, the inner surfaces of each part are substantially perpendicular to the top surface of the base, and the inner surfaces define the folding channels. During operation from the open position to the closed position, the ultrasonic transducer assembly positioned on the folding platform folds into a substantially taco-like shape within the folding channels.

Description

Technical Field

[0001] [Priority Claim] This application claims the benefit of priority of U.S. Patent Application No. 18 / 321,111, filed on May 22, 2023, the content of which is incorporated herein by reference.

[0002] The embodiments disclosed herein relate to tools and techniques for the preparation of medical devices used in detecting, sampling, staging and / or treating target tissue within a patient's anatomical structure, such as the lungs. Some embodiments relate more specifically to tools or tooling utilized for the folding of transducer assemblies, such as those of the type utilized in endobronchial ultrasound (EBUS) catheters or devices.

Background Art

[0003] A solitary pulmonary nodule (SPN) is an isolated mass in the lung less than 3 cm in diameter, surrounded by normal tissue. SPNs can be identified by common medical imaging techniques such as computed tomography (CT) scans and positron emission tomography (PET) scans. In most cases, SPNs and other lung nodules are merely benign tumors. In other cases, these SPNs are malignant tumors and must be treated to prevent early death.

[0004] Diagnosis of identified SPNs cannot be made solely through medical imaging; instead, it requires a biopsy performed via an EBUS device with real-time sampling capabilities. Real-time sampling using an EBUS device typically involves navigating the EBUS device through the patient's airway to a previously identified target nodule in medical imaging so that the target nodule is visible in the real-time ultrasound image. Then, while viewing the target nodule in the ultrasound image, a sampling needle is inserted into the target nodule through the working channel of the EBUS device to collect a sample. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2023 / 0129187 [Overview of the project] [Problems that the invention aims to solve]

[0006] Existing EBUS devices are too large to reach deep into the secondary airway branches of the lung, partly due to the difficulties in manufacturing miniaturized ultrasonic transducers with high quality and reproducibility. While percutaneous sampling can reach subcutaneous pulmonary nephrocyte neural tubes (SPNs) within secondary airway branches that cannot be reached with existing EBUS devices, percutaneous sampling is generally less preferable than intrabronchial sampling.

[0007] Therefore, there is a clinical need for further miniaturization of ultrasonic transducers suitable for use in EBUS devices. One technique for reducing the width or contour of the transducer assembly is to essentially fold the assembly in half so that its shape resembles a "taco." By folding the transducer assembly in this manner, the area occupied by the ultrasonic transducer assembly is reduced by almost half, and its depth (thickness) increases only slightly. To provide such a folded transducer assembly, a flexible substrate on which the ultrasonic transducer and related components are mounted, as well as tools and techniques for folding the transducer assembly into the desired taco-like configuration, are required. [Means for solving the problem]

[0008] Embodiments of a flexible ultrasonic transducer assembly are shown and described in Patent Document 1, filed October 21, 2022, entitled "Low Profile Ultrasound Catheter and System," the entire contents of which are incorporated herein by reference.

[0009] Tools for folding such ultrasonic transducer assemblies, embodiments of techniques used during the folding procedure, and relevant aspects for ensuring that the transducer assembly retains its reduced contour configuration after folding are shown in the accompanying drawings and described below.

[0010] Disclosed herein is an apparatus or tool that can accept an ultrasonic transducer assembly onto a folding platform and, when the tool is activated, folds the ultrasonic transducer assembly into a taco shape / configuration without adversely affecting the components of the ultrasonic transducer assembly, while ensuring that the assembly maintains a configuration that allows it to perform its intended function.

[0011] This tool consists of a base to which a foldable platform (for folding an ultrasonic transducer assembly) is pivotally mounted. The foldable platform consists of two spaced parts, each of which is independently pivotable relative to the base. Each part defines half of the foldable platform.

[0012] In some embodiments, each part of the folding platform includes a wing or arm to enable manual operation of that part. Each part of the folding platform and its associated arm is pivotable between a first position, i.e., an open position, and a second position, i.e., a closed position. The folding platform is configured such that when these parts are in the first position, the folding platform is in an open configuration that can accommodate and receive an ultrasonic transducer assembly in its manufactured or flattened state. When the part of the folding platform is then pivoted to the second position, the folding platform moves from the open position to a closed or folded position, thereby forcing the ultrasonic transducer assembly positioned on the folding platform to take a folded taco-like shape. In the closed position, the part of the folding platform defines a folding channel.

[0013] In some embodiments, a stopper or projection is provided on one or both parts of the folding platform and / or arm, which is sized and positioned such that when the folding platform is in the closed position, the width of the folding channel is precisely established and the ultrasonic transducer assembly housed therein folds to the desired degree and configuration.

[0014] In some embodiments, each part of the folding platform includes at least one retaining mechanism configured to hold the folding platform in a closed position. In at least one embodiment, each arm includes a magnet. The magnet in one arm is polarized opposite to the magnet in the other arm such that when the arm is in a second position, the opposing magnet holds the arm in the second position until it is pulled away by hand.

[0015] In at least one embodiment, the folding platform defines one or more adhesive injection openings communicating with a folding channel when in the closed position. The adhesive injection openings are positioned so that when the ultrasonic transducer assembly is positioned within the folding channel and the adhesive is injected into the folding channel, the adhesive is directed towards the inside or folds of the taco-like shape of the (folded) taco. Once set or cured, the adhesive maintains the folded taco-like shape of the ultrasonic transducer assembly even after it has been removed from the tool following the folding procedure.

[0016] These and other elements and features of the disclosed apparatus and method are described in more detail in the following description and accompanying figures. [Brief explanation of the drawing]

[0017] [Figure 1] A front perspective view of an embodiment of a folding device or tool having a folding platform and arm shown in the open position, wherein the arm is shown in the open position. [Figure 2] This is a top view of an ultrasonic transducer assembly, including a test pad, shown in a flat or manufactured state. [Figure 3] Figure 1 is a front perspective view of the tool, and Figure 2 shows the ultrasonic transducer assembly mounted on the tool's foldable platform. [Figure 4] Figure 3 is a front perspective view of the tool shown, with the foldable platform and arm in the closed position. [Figure 5] It is a rear perspective view of the tool shown in FIG. 4. [Figure 6] It is a front view of the tool shown in FIG. 4. [Figure 7] (As a result of folding the assembly such that the tool is as shown in FIGS. 4 - 6) It is a front perspective view of the ultrasonic transducer assembly shown in a folded state. [Figure 8] It is a partial detailed top perspective view of the tool shown in FIGS. 4 - 6, showing the position of the adhesive injection opening communicating with the folding channel formed by the folding - type platform in the closed position. [Figure 9] It is a side view of the ultrasonic transducer assembly of FIG. 7, showing the state where adhesive is injected into the fold or inside of the assembly in the folded state.

Embodiments for Carrying Out the Invention

[0018] As described above, embodiments of the present disclosure are directed to an apparatus or tool for folding an ultrasonic transducer assembly and reducing its effective width or profile to effectively halve its nominal or manufactured state. Such a reduction in the outer shape enables the assembly to be utilized as a component of an EBUS device that can be inserted into relatively narrow secondary airway passages of the lungs that conventional EBUS devices cannot pass through. An example of such a tool 10 is shown in FIG. 1. FIG. 2 shows an example of a type of ultrasonic transducer assembly 100 configured such that the tool 10 folds, in which case the assembly 100 is shown in the manufactured state or the state before folding.

[0019] As shown in FIG. 1, the tool 10 includes a base 12 and a folding platform 14. The folding platform 14 includes a first portion 16 and a second portion 18. The portions 16 and 18 are positioned relative to the base 12 and define a gap or space 20 between the portions 16 and 18. The base 12 defines two pivot channels 22 through which a pivot member or axle 24 passes. Each portion 16 and 18 of the folding platform 14 is rotatably or pivotably disposed about one of a plurality of axles 24 such that each portion 16 and 18 can pivot about the axle 24. The gap 20 has a width sufficient to allow the portions 16 and 18 to pivot relative to each other and relative to the base 12 without interference. With this configuration, the portions 16 and 18 of the folding platform 14 can pivot and transition from the open position shown in FIG. 1 to the closed position as shown in FIGS. 4-6.

[0020] The movement between the open and closed positions of the folding platform 14 can be achieved by any of a variety of mechanisms. For example, in some embodiments, the tool 10 includes one or more electric motors, servos, or similar devices that are in mechanical communication with the portions 16 and 18 of the folding platform 14 and, when actuated, cause the portions 16 and 18 to move between the open and closed positions as desired. In other embodiments, the folding platform 14 may be manually actuated by an individual technician (not shown).

[0021] In a manually operable embodiment, such as the embodiment shown in this drawing, the first portion 16 of the folding platform 14 includes a first actuating arm 26 and the second portion 18 includes a second actuating arm 28. The arms are sized and configured such that a person (not shown) can grip and move the arms 26 and 28 by hand (i.e., manually actuate the arms) between the open position shown in FIGS. 1 and 3 and the closed position shown in FIGS. 4-6, thereby allowing the folding platform 14 to be actuated simultaneously with the actuation of the arms 26 and 28.

[0022] The first portion 16 and the second portion 18 (and the arms 26 and 28) of the folding platform 14 each have inner surfaces 30 and 32, respectively. In the open position shown in Figure 1, the inner surface 30 of the first portion 16 and the inner surface 32 of the second portion 18 are aligned in a straight line along a common plane. In the open position, each inner surface 30 and 32 is substantially parallel to the upper surface 34 of the base 12. When portions 16 and 18 are in the closed position shown in Figures 4 to 6, the inner surface 30 of the first portion 16 and the inner surface 32 of the second portion 18 are aligned in a straight line, substantially parallel to each other but spaced apart, and both are substantially perpendicular to the upper surface 34 of the base 12.

[0023] Note: The term “substantially” as used above is intended to reflect the imprecise nature of mechanical tolerances and normal irregularities that arise when many types of devices are assembled and / or used. For example, with respect to such terms as “substantially parallel” or “substantially perpendicular,” the elements described may, in some cases, actually be parallel or perpendicular to each other, but the elements may also have variations in their structure or assembly that result in a relationship that is not perfectly parallel or perpendicular but substantially so.

[0024] The operation of arms 26 and 28, and the transition of parts 16 and 18 of the folding platform 14 from the open position to the closed position, is achieved by pivoting each of arms 26 and 28 around opposite 90-degree arcs of motion from the nominal resting position on the upper surface 34 of the base 12 (relative to their respective axles 24) until at least some of the inner surfaces 30 and 32 of arms 26 and 28 come into contact with each other as shown in Figures 4 to 6.

[0025] To ensure that portions 16 and 18 of the folding platform 14 are folded only to the necessary or desired extent, in some embodiments, one or both of the arms 26 and 28 are provided with projections or stoppers 36 that project vertically from the surrounding inner surface 30 or 32, and that engage with the inner surface of the opposing arm when the arms 26 and 28 are in the closed position. The position, size, and configuration of the stoppers 36 can be modified to allow portions 16 and 18 of the folding platform 14 to be held closer or further apart as desired when in the closed position.

[0026] As described above, the main function of tool 10 is to fold the ultrasonic transducer assembly 100 from a flattened or manufactured state into a folded configuration, an example of which is shown in Figure 2, so that tool 10 gives the assembly a taco-like shape as shown in Figures 7 and 9.

[0027] An ultrasonic transducer assembly is a complex electronic component used in an EBUS device. An exemplary embodiment of an ultrasonic transducer assembly 100 shown in Figures 2 to 9 includes a flexible substrate 102 divided into two regions or pads, namely an operational pad 104 and a testing pad 106, the testing pad 106 being used to electronically test the operational characteristics of components attached to the operational pad 104 and can be removed from the operational pad after the test is performed.

[0028] The components mounted on the operating pad 104 include a piezoelectric micromachined ultrasonic transducer (PMUT) element (shown as a single array in Figure 2) 108, one or more application-specific integrated circuits (ASICs) 110, and one or more capacitors 112, all mounted on the same side of the flexible substrate 102. The PMUT 108, ASIC 110, and capacitor 112 are each electrically connected to contacts on the same side of the flexible substrate 102 (invisible but, as will be understood to those skilled in the art, including electrical contacts or traces between the aforementioned components of the assembly).

[0029] The flexible substrate may include multiple traces that electrically connect each ASIC 110 to multiple different elements of the PMUT 108. For example, in at least one embodiment, the ultrasonic transducer assembly 100 may have four ASICs 110 and 16 electrical traces, in addition to ground traces connected to each ASIC 110, such that each ASIC 110 controls 16 elements 114 of the PMUT 108, and the PMUT 108 has a total of 64 individually controllable elements 114 (exemplary elements 114 are shown in Figure 7).

[0030] To fold the ultrasonic transducer assembly 100 from a flat, pre-folded state shown in Figure 2 to a taco-like shape shown in Figure 7, the operating pad 104 of the assembly 100 is first positioned on the folding platform 14 as shown in Figure 3. In at least some embodiments, the body 12 of the tool 10 defines a notch 38 (shown in Figure 1) through which the test pad 106 can extend outward from the tool 10 when the operating pad 104 is properly positioned on the folding platform 14.

[0031] In some embodiments, each portion 16 and 18 of the folding platform 14 includes one or more raised retaining tabs 40 positioned around the outer perimeter 42 of each portion 16 and 18 of the folding platform 14. A given retaining tab 40 partially overlaps the respective inner surface 30 or 32 of the portion 16 or 18 to which they are part.

[0032] Functionally, this overlap between the inner surface 30 or 32 and the retaining tab 40 forms a space into which the edge 116 (visible in Figure 2) of the flexible substrate 102 of the ultrasonic transducer assembly 100 engages when the operating pad 104 is positioned on the folding platform 14. The retaining tab 40 ensures that the operating pad 104 remains properly seated within the foldable platform 14 during the folding process.

[0033] Once the operating pad 104 is positioned on the folding platform 14 in the manner shown in Figure 3, portions 16 and 18 of the folding platform 14 are actuated from the open position to the closed position (shown in Figures 4 to 6) by physical manipulation of the arms 26 and 28, or by other actuation mechanisms in the manner described above. As portions 16 and 18 of the folding platform converge as a result of their respective pivots around the multiple axles 24, the flexible substrate 102 of the ultrasonic transducer assembly 100 is gradually folded into the desired taco-like shape shown in Figure 7.

[0034] As previously mentioned, when portions 16 and 18 of the folding platform 14 are in the open position, as shown in Figures 1 and 3, the respective faces 30 and 32 of portions 16 and 18 are aligned substantially parallel to a common plane. As shown in Figures 4 to 6, when portions 16 and 18 are pivoted to the closed position, the common plane of the aforementioned faces 30 and 32 transitions into a folding channel 44 containing the folded operating pad 104 of the ultrasonic transducer assembly 100 (seen in Figure 6 and shown removed from the constraints of the tool 10 in Figure 7). The flexible substrate 102 of the assembly is indeed flexible enough to allow the operating pad 104 to be folded in the manner shown and described, however, in the illustrated embodiment, the material of the substrate 102 cannot maintain the operating pad 104 in a folded state without the use of an adhesive or some other mechanism configured to hold together the opposing sides 118 and 120 of the flexible (folded) substrate 102 (shown in Figures 7 and 9).

[0035] In some embodiments, the channel 44 is substantially U-shaped.

[0036] In some embodiments, the flexible substrate 102 is made of a shape memory material programmed to maintain the flexible substrate 102 in a folded state once the operating pad 104 is positioned thereon via the tool 10.

[0037] In embodiments where an adhesive is required to maintain the operating pad 104 of the ultrasonic transducer assembly 100 in its folded state, it is necessary to hold the assembly 100 in the folded state or otherwise maintain it while the adhesive is properly applied. In some embodiments, the arms 26 and 28 may simply be held together by a tool operator (not shown). In at least one embodiment, the tool 10 includes a locking mechanism, such as a latch, lock, or similar mechanism, that holds the portions 16 and 18 of the folding platform 14 in the closed position regardless of any biasing force that the folded assembly 100 may exert.

[0038] In the embodiment shown in Figures 4 to 6, the fixing mechanism is in the form of a first magnet 46 and a second magnet 48. The first magnet 46 is positioned along the first portion 16 of the folding platform 14. In the illustrated embodiment, the first magnet 46 is held on the first arm 26. Similarly, the second magnet 48 is positioned along the second portion 18 of the folding platform 14. In the illustrated embodiment, the second magnet 48 is held on the second arm 28. The first magnet 46 and the second magnet 48 are positioned in the respective portions 16 and 18 such that their opposing poles are closest to each other when the folding platform 14 is in the closed position. As a result, when portions 16 and 18 are in the closed position, the opposite polarity of the magnets 46 and 48 holds portions 16 and 18 in the closed position for the desired duration without the need to apply any other type of manual holding force. The closed position can be maintained until a counteracting force is applied to the arms 26 and 28 to overcome the magnetic attraction of the magnets 46 and 48.

[0039] In at least one embodiment, the first portion 16 and the second portion 18 of the foldable platform 14 are magnetically attracted to each other. In at least one embodiment, at least a portion of the first arm 26 and at least a portion of the second arm 28 are magnetically attracted to each other.

[0040] As described above, the folded operating pad 104 has opposing sides 118 and 120, which define the taco-like fold or interior 122 that the operating pad 104 takes when folded (best shown in Figure 7). In embodiments where an adhesive is required to fix the sides 118 and 120 together, it is necessary to inject or otherwise apply the adhesive into the space of this interior 122. To facilitate the injection of adhesive into the interior 122 of the operating pad 104, in some embodiments illustrated in Figure 8, the folding platform 14 of the tool 10 defines at least one injection port 50 that fluidly communicates with the interior 122 of any operating pad 104 contained therein in a folding channel 44. The adhesive 124 (shown in Figure 9) can be injected into the interior 122 of the operating pad 104 through the (multiple) ports 50. The parts 16 and 18 of the foldable platform 14 are kept in the closed position for as long as necessary to allow the adhesive 124 to dry and harden, or otherwise reach a state sufficient to hold the operating pad 104 in the permeable, folded taco-like shape shown in Figure 9.

[0041] In some embodiments, the injection port 50 is simply a gap between correspondingly positioned retaining tabs 40 of each portion 16 and 18 of the foldable platform 14.

[0042] Many of the features and advantages of this disclosure are evident from the above description. Those skilled in the art will readily conceive of numerous modifications and variations. Because such modifications are possible, this disclosure should not be limited to the exact structure and operation illustrated and described. Rather, this disclosure should be limited only by the following claims.

Claims

1. A folding device for medical equipment, A base having an upper surface and defining two pivot channels, A first axle and a second axle, each axle passing through one of the pivot channels, the first axle and the second axle, A folding platform comprising a first part and a second part, wherein the first part is separated from the second part by a gap, the first part is pivotably positioned around a first axle, the second part is pivotably positioned around a second axle, the first part defines the inner surface of the first part, and the second part defines the inner surface of the second part. It is equipped with, The folding platform is movable between an open position and a closed position, and in the open position, the inner surfaces of the first portion and the inner surfaces of the second portion are aligned substantially parallel to the upper surface of the base. In the closed position, the inner surfaces of the first portion and the second portion are substantially perpendicular to the upper surface of the base, and the inner surfaces of the first portion and the second portion define a folding channel.

2. The apparatus according to claim 1, wherein the base defines a notch that communicates with the folding channel.

3. The apparatus according to claim 1, wherein each of the first and second portions defines an outer circumference, and at least one engaging tab is disposed along the outer circumference of each of the first and second portions.

4. The first portion includes a first operating arm, the second portion includes a second operating arm, at least a part of the first operating arm includes the inner surface of the first portion, and at least a part of the second operating arm includes the inner surface of the second portion. It has at least one projection extending perpendicularly from at least one of the inner surface of the first portion and the inner surface of the second portion, The apparatus according to claim 1, wherein the at least one protrusion is configured and positioned to prevent the inner surface of the first portion and the inner surface of the second portion from coming into direct contact in the closed position.

5. The apparatus according to claim 1, wherein the folding channel is substantially U-shaped.

6. The apparatus according to claim 1, wherein in the closed position, the first portion and the second portion define at least one port that is in fluid communication with the folding channel.

7. The apparatus according to claim 1, wherein each of the first and second portions defines an outer circumference, and a plurality of engaging tabs are arranged along the outer circumference of each of the first and second portions, the plurality of engaging tabs being spaced apart from each other.

8. The apparatus according to claim 7, wherein in the closed position, each of the plurality of engaging tabs of the first portion is in contact with the opposing engaging tab of the plurality of engaging tabs of the second portion.

9. The apparatus according to claim 8, wherein at least one of the spaces between the plurality of engagement tabs defines a port that has fluid communication with the folding channel.

10. The apparatus according to claim 9, wherein the medical device is an ultrasonic transducer assembly.

11. The apparatus according to claim 10, wherein the folding platform is configured and arranged to receive at least a portion of the ultrasonic transducer assembly in its manufactured state.

12. The apparatus according to claim 11, wherein at least a portion of the ultrasonic transducer assembly forms a rim, which is engaged by the plurality of engaging tabs when at least a portion of the ultrasonic transducer assembly is received by the folding platform.

13. The apparatus according to claim 12, wherein at least a portion of the ultrasonic transducer assembly includes a flexible substrate, and in the closed position, at least a portion of the flexible substrate of the ultrasonic transducer assembly is folded into a taco-like shape.

14. The apparatus according to claim 13, wherein the taco-like shape of the flexible substrate defines opposing inner surfaces, the opposing inner surfaces define an interior, and the interior is in fluid communication with the port.

15. The apparatus according to claim 14, further comprising an adhesive, the adhesive being injected into the interior through the port.

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