Folded ultrasound transducers and related methods

Abstract

Apparatus for folding an ultrasound transducer assembly and methods of using the same are disclosed. The apparatus includes a base defining two pivot channels therethrough, each of which supports a shaft. The folding platform has a first portion pivotally disposed about one axis and a second portion pivotally disposed about the other axis. The folding platform is movable between an open position and a closed position. In the open position, the inner face of the first portion and the inner face of the second portion are substantially aligned in parallel with the top surface of the base. In the closed position, the inner face of each portion is substantially perpendicular to the top surface of the base, and the inner faces define a folding channel. An ultrasound transducer assembly positioned on the folding platform is folded into a generally tacoo-like shape within the folding channel during actuation from an open position to a closed position.

Description

Priority Statement

[0001] This application claims the benefit of priority to U.S. Patent Application Serial No. 18 / 321,111, filed May 22, 2023, the contents of which are hereby incorporated herein by reference. Technical Field

[0002] The embodiments disclosed herein relate to tools and techniques for preparing medical devices for detecting, sampling, staging, and / or treating target tissues within the anatomical structures of a patient, such as the lungs. Some embodiments more specifically relate to tools or tool arrangements for folding transducer assemblies, such as those used in endobronchial ultrasound (EBUS) catheters or devices. Background Technology

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

[0004] Diagnosis of identified SPNs cannot be performed solely based on medical imaging; instead, a biopsy that can be performed via an EBUS device equipped with real-time sampling capabilities is required. Real-time sampling using an EBUS device typically involves navigating the EBUS device through the patient's airway to the target nodule previously identified in medical images, making the target nodule visible in real-time ultrasound (US) images. Then, when the target nodule is observed in the US images, a sampling needle is extended from the working channel of the EBUS device into the target nodule to obtain a sample of the target nodule.

[0005] Existing EBUS devices are too large to reach deep into the secondary airway branches of the lungs, partly due to the difficulty in manufacturing miniaturized US transducers with high quality and high repeatability. SPNs within secondary airway branches that cannot be reached for sampling using existing EBUS devices can be reached percutaneously, but percutaneous sampling is generally not preferred compared to endobronchial sampling.

[0006] Therefore, there is a clinical need for further miniaturization of US transducers suitable for EBUS devices. One technique for reducing the width or profile of the transducer assembly is to essentially fold the assembly in half, making it resemble a "taco" in shape. Folding the transducer assembly in this way almost halves the area occupied by the US transducer assembly, while only slightly increasing its depth (thickness). To provide such a folded transducer assembly, the transducer assembly needs to consist of a flexible substrate on which the US transducer and associated components are mounted, and the tools and techniques required to fold the transducer assembly into the desired taco-like configuration are needed.

[0007] Various aspects of a flexible US transducer assembly are shown and described in U.S. Patent 17 / 970,696, filed October 21, 2022, entitled Low Profile Ultrasound Catheter and System, the entire contents of which are incorporated herein by reference.

[0008] The tools used for folding such a US transducer assembly, the techniques used during the folding process, and the implementation of relevant aspects for ensuring that the transducer assembly retains its reduced profile after folding are shown in the accompanying drawings and described below. Summary of the Invention

[0009] This document discloses an apparatus or tool that receives a US transducer assembly into a folding platform and, when the tool is actuated, folds the US transducer assembly into a tack shape / construction without adversely affecting the components of the US transducer assembly, while ensuring that the assembly maintains a construction capable of performing its intended function.

[0010] The tool consists of a base on which a folding platform (for folding the US transducer assembly) is pivotally mounted. The folding platform consists of two spaced-apart sections, each of which can pivot independently relative to the base. Each section defines half of the folding platform.

[0011] In some embodiments, each portion of the folding platform includes a wing or arm for allowing manual actuation of the portion. Each portion of the folding platform and its associated arm can pivot between a first or open position and a second or closed position. The folding platform is configured such that when a portion is in the first position, the folding platform is in an open configuration that accommodates and is capable of receiving the US transducer assembly in its manufactured or flattened state. Subsequently, when the aforementioned portion of the folding platform pivots to its second position, the folding platform transitions from the open position to a closed or folded position, which forces the US transducer assembly positioned on the folding platform to assume a folded, taco-like shape. In the closed position, the aforementioned portion of the folding platform defines a folding channel.

[0012] In some embodiments, one or two portions of the folding platform and / or arm are provided with stops or protrusions that are sized and positioned to ensure that the width of the folding channel is precisely established when the folding platform is in the closed position, so as to ensure that the US transducer assembly contained therein is folded to the desired extent and configuration.

[0013] In some embodiments, each section of the folding platform is equipped with 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 has opposite polarity to the magnet in the other arm, such that when the arm is in a second position, the opposing magnet will hold the arm in the second position until they are manually pulled open.

[0014] In at least one embodiment, the folding platform in the closed position defines one or more adhesive injection openings communicating with the folding channel. The adhesive injection openings are positioned such that when the US transducer assembly is positioned within the folding channel and adhesive is injected into the folding channel, the adhesive is guided into or within the fold of the US transducer assembly, which has a taco-like shape (fold). Once the adhesive has solidified or cured, it maintains the taco-like folded shape of the US transducer assembly when the US transducer assembly is removed from the tool after the folding process.

[0015] These and other elements and features of the disclosed apparatus and methods are described in more detail in the following description and accompanying drawings. Attached Figure Description

[0016] Figure 1 It is a front perspective view of an embodiment of a folding device or tool having a folding platform and arm shown in the open position.

[0017] Figure 2 This is a top view showing a US transducer assembly in a flat or manufactured state, the US transducer assembly including a test pad.

[0018] Figure 3 yes Figure 1 The front perspective view of the tool shown, in which Figure 2 The US transducer assembly shown is placed on the tool's folding platform.

[0019] Figure 4 yes Figure 3 The tool shown is a front perspective view, with the folding platform and arm positioned in the closed position.

[0020] Figure 5 yes Figure 4 The tool shown is in rear perspective.

[0021] Figure 6 yes Figure 4 The tool shown is shown in a front side view.

[0022] Figure 7 It is shown as being in a folded state (due to the tool being...) Figures 4 to 6 The front perspective view of the US transducer assembly (with the components folded as shown).

[0023] Figure 8 yes Figures 4 to 6 The tool shown is a partial, detailed top perspective view, revealing the location of the adhesive injection opening communicating with the folded channel formed by the folding platform in the closed position.

[0024] Figure 9 yes Figure 7 A side view of the US transducer assembly, depicting an adhesive injected into the fold or interior of the assembly in a folded state. Detailed Implementation

[0025] As mentioned above, embodiments of this disclosure relate to devices or tools for folding a US transducer assembly to reduce its effective width or profile to half of its nominal or manufactured state. Such a reduction in profile allows the assembly to be used as a component of an EBUS device that can be inserted into relatively narrow secondary airway passages in the lungs that conventional EBUS devices cannot pass through. Figure 1 An example of such a tool 10 is shown in the figure. Figure 2 An example of the type of US transducer assembly 100 in which tool 10 is configured to be folded is depicted, wherein assembly 100 is shown in its manufactured or pre-folded state.

[0026] like Figure 1 As shown, tool 10 includes a base 12 and a folding platform 14. The folding platform 14 comprises a first portion 16 and a second portion 18. Portions 16 and 18 are positioned relative to the base 12 to define a gap or space 20 between portions 16 and 18. The base 12 defines two pivot channels 22 through which pivoting members or shafts 24 pass. Each portion 16 and 18 of the folding platform 14 is rotatably or pivotally arranged about one of the shafts 24, such that each portion 16 or 18 can pivot about the shaft 24. The gap 20 is wide enough to allow portions 16 and 18 to pivot relative to each other and relative to the base 12 without interference. With this arrangement, portions 16 and 18 of the folding platform 14 can... Figure 1 The open position shown pivotally transitions to, for example, Figures 4 to 6 The closed position shown.

[0027] The transition between the open and closed positions of the folding platform 14 can be achieved using any of a variety of mechanisms. For example, in some embodiments, the tool 10 includes one or more electric motors, servo mechanisms, or similar devices that are mechanically connected to portions 16 and 18 of the folding platform 14 and, when activated, actuate portions 16 and 18 between the open and closed positions as needed. In other embodiments, the folding platform 14 can be manually actuated by a single technician (not shown).

[0028] In this manually actuated implementation, such as the one shown in this figure, 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 to allow a person (not shown) to grasp arms 26 and 28 by hand and to engage arms 26 and 28 in… Figure 1 and Figure 3 The opening position shown and Figures 4 to 6 The movement between the closed positions shown (i.e., manually actuating the arms) actuates the folding platform 14 while the arms 26 and 28 are actuated.

[0029] The first portion 16 and the second portion 18 (as well as arms 26 and 28) of the folding platform 14 have inner surfaces 30 and 32, respectively. Figure 1 In the open position shown, the inner surface 30 of the first portion 16 and the inner surface 32 of the second portion 18 are aligned along a common plane. In the open position, each inner surface 30 and 32 is substantially parallel to the top surface 34 of the base 12. When portions 16 and 18 are in... Figures 4 to 6 In the closed position shown, the inner surface 30 of the first part 16 and the inner surface 32 of the second part 18 are positioned substantially parallel to each other, spaced apart from each other, and aligned with each other, but both are substantially perpendicular to the top surface 34 of the base 12.

[0030] Note: The term "substantially" as used above is intended to reflect the imprecise nature of machine tolerances and normal irregularities that occur when assembling and / or using many types of equipment. For example, with terms such as "substantially parallel" or "substantially perpendicular," the described elements may actually be parallel or perpendicular to each other, depending on the specific circumstances, but variations in the elements' structure or assembly may also result in relationships that are not perfectly parallel or perpendicular, but are still substantially so.

[0031] The actuation of arms 26 and 28, and the transition of folding platform sections 16 and 18 from the open to the closed position, are achieved by each arm 26 and 28 pivoting (relative to the corresponding axis 24) from their nominal rest position on the top surface 34 of the base 12 about a relative 90-degree arc of motion until at least some portions of the inner surfaces 30 and 32 of arms 26 and 28 are... Figures 4 to 6 They are achieved by contacting each other in the manner shown.

[0032] 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 protrusions or stops 36 that project vertically from the surrounding inner surfaces 30 or 32, such that when arms 26 and 28 are in the closed position, they engage with the inner surfaces of the opposing arms. The position, size, and construction of such stops or stops 36 can vary to allow portions 16 and 18 of the folding platform 14 to be held closer or further apart as needed when in the closed position.

[0033] As discussed above, the primary function of tool 10 is to remove the US transducer assembly 100 from its flat or manufactured state (as shown in the example in...). Figure 2 (As shown in the diagram) Folded into a folded structure, thereby the tool 10 applies, for example, pressure to the component. Figure 7 and Figure 9 The shape shown is similar to a taco.

[0034] The US transducer assembly is a complex electronic component used in the EBUS device. Figures 2 to 9 An exemplary embodiment of the US transducer assembly 100 shown includes a flexible substrate 102 divided into two regions or pads, namely an operation pad 104 and a test pad 106; the test pad 106 is used to electronically test the operating characteristics of components mounted to the operation pad 104 and can be removed from the operation pad after the test has occurred.

[0035] The components mounted to the operating pad 104 include piezoelectric micromechanical ultrasonic transducer (PMUT) elements, all mounted on the same side of the flexible substrate 102. Figure 2 The array is shown as a single array 108, one or more application-specific integrated circuits (ASICs) 110, and one or more capacitors 112. Each of the PMUT 108, ASIC 110, and capacitor 112 is electrically connected to a contact (not visible, but which will be understood by those skilled in the art as an electrical contact or trace between the aforementioned components including the assembly) on the same side of the flexible substrate 102.

[0036] The flexible substrate may include multiple traces electrically connecting each ASIC 110 to multiple different elements of the PMUT 108. For example, in at least one embodiment, the US transducer assembly 100 may have four ASICs 110 and sixteen electrical traces, as well as a ground trace connected to each ASIC 110, such that each ASIC 110 controls sixteen elements 114 on the PMUT 108, and the PMUT 108 has a total of sixty-four individually controllable elements 114 (example elements 114 are shown in...). Figure 7 (See in the middle).

[0037] In order to transfer the US transducer assembly 100 from Figure 2 The flat, pre-folded state shown is folded into Figure 7 The taco-like shape shown is first used to place the operating pad 104 of component 100 with... Figure 3 The tool 10 is positioned on the folding platform 14 as shown. In at least some embodiments, the body 12 of the tool 10 defines a notch 38. Figure 1 As shown in the diagram, when the operating pad 104 is correctly positioned on the folding platform 14, the test pad 106 can extend outward from the tool 10 through the notch 38.

[0038] 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 with a corresponding inner surface 30 or 32 of the portion 16 or 18 that is a part thereof.

[0039] Functionally, this overlap between the inner surface 30 or 32 and the retaining tab 40 forms a space that, when the operating pad 104 is positioned on the folding platform 14, the edge 116 of the flexible substrate 102 of the US transducer assembly 100 ( Figure 2 (See image) is engaged into this space. The retaining tab 40 ensures that the operating pad 104 remains properly positioned within the folding platform 14 during the folding process.

[0040] Once the operating pad is 104 Figure 3 Positioned on the folding platform 14 as shown, portions 16 and 18 of the folding platform 14 are actuated from their open position to their closed position (e.g., by physical manipulation of arms 26 and 28 or by other actuation mechanisms) in the manner previously described. Figures 4 to 6 As portions 16 and 18 of the folding platform converge due to their respective pivoting about axis 24, the flexible substrate 102 of the US transducer assembly 100 will gradually fold into the shape shown in the diagram. Figure 7 The desired shape, similar to a taco, is shown in the diagram.

[0041] As previously mentioned, when portions 16 and 18 of the folding platform 14 are in, for example Figure 1 and Figure 3 When in the open position shown, the corresponding faces 30 and 32 of portions 16 and 18 are substantially parallel and aligned along a common plane. When portions 16 and 18 pivot to... Figures 4 to 6 In the closed position shown, the aforementioned common plane of surfaces 30 and 32 transitions into a folded channel 44, which contains the now-folded operating pad 104 of the US transducer assembly 100 (in... Figure 6 As can be seen in, and in Figure 7 The portion is depicted as being removed from the range of tool 10. Although the flexible substrate 102 of the component is indeed flexible enough to allow the operating pad 104 to be folded as shown and described above, in the illustrated embodiment, without the use of adhesive or configured to fold the flexible (now folded) substrate 102 at opposite sides 118 and 120 ( Figure 7 and Figure 9 In the case of some other mechanisms that are held together (as shown in the diagram), the material of the substrate 102 is unable to keep the operating pad 104 in a folded state.

[0042] In some implementations, channel 44 is essentially U-shaped.

[0043] In some embodiments, the flexible substrate 102 is composed of a shape memory material that is programmed to hold the flexible substrate 102 in a folded state once the operating pad 104 is placed in the position via the tool 10.

[0044] In embodiments where adhesive is required to hold the operating pad 104 of the US transducer assembly 100 in its folded state, it may be necessary to hold or otherwise maintain the assembly 100 in a folded state while the adhesive is applied appropriately. In some embodiments, arms 26 and 28 may simply be held together by the operator of the tool (not shown). In at least one embodiment, the tool 10 is provided with a securing mechanism, such as a latch, lock, or similar mechanism, to hold portions 16 and 18 of the folding platform 14 in a closed position, even against any biasing resistance that the folding assembly 100 may exert.

[0045] exist Figures 4 to 6 In the embodiment shown, the fixing mechanism takes the form of a first magnet 46 and a second magnet 48. The first magnet 46 is positioned along a 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 a 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 on their respective portions 16 and 18 such that their opposite poles are closest to each other when the folding platform 14 is in the closed position. Therefore, when portions 16 and 18 are in the closed position, the opposite polarities of magnets 46 and 48 will hold portions 16 and 18 in the closed position for the desired length of time without the need to apply other types of manual holding force. The closed position can be maintained until opposing forces are applied to arms 26 and 28 to overcome the magnetic attraction of magnets 46 and 48.

[0046] In at least one embodiment, the first portion 16 and the second portion 18 of the folding 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.

[0047] As mentioned above, the operating pad 104 in the folded state has opposing sides 118 and 120, which define a taco-like fold or interior 122 (in) that the operating pad 104 presents in the folded state. Figure 7 (Best shown in the diagram). In those embodiments where adhesive is required to hold sides 118 and 120 together, it is necessary to inject or otherwise apply adhesive into the interior space 122. To facilitate the injection of adhesive into the interior 122 of the operating pad 104, examples of which are shown in the diagram. Figure 8 As shown, the folding platform 14 of tool 10 defines at least one injection port 50, which is in fluid communication with the interior 122 of the folding channel 44 and any operating pads 104 contained therein. Adhesive 124 ( Figure 9 As shown, the adhesive 124 can be injected into the interior 122 of the operating pad 104 through port 50. Portions 16 and 18 of the folded platform 14 are held in the closed position for the required length of time to allow the adhesive 124 to dry, cure, or otherwise achieve a state sufficient to hold the operating pad 104 in place. Figure 9 The permanent fold shown is in a shape similar to a taco.

[0048] In some implementations, the injection port 50 is simply the gap between the correspondingly positioned retaining tabs 40 of each portion 16 and 18 of the folding platform 14.

[0049] Based on the foregoing description, many features and advantages of this disclosure are apparent. Many modifications and variations will readily occur to those skilled in the art. Because such modifications are possible, this disclosure is not limited to the exact construction and operation shown and described above. Rather, this disclosure should be limited only to the following claims.

Claims

1. A folding medical device, comprising: A base having a top surface, the base defining two pivot channels; The first axis and the second axis, each passing through one of the pivot channels; A folding platform having a first portion and a second portion, the first portion and the second portion being separated by a gap, the first portion being pivotally disposed about a first axis and the second portion being pivotally disposed about a second axis, the first portion defining an inner surface of the first portion and the second portion defining an inner surface of the second portion; The folding platform is movable between an open position and a closed position, wherein in the open position, the inner surfaces of the first and second portions are substantially parallel and aligned with the top surface of the base. In the closed position, the inner surfaces of the first portion and the second portion are each substantially perpendicular to the top surface of the base, and the inner surfaces of the first portion and the second portion define a folding channel.

2. The device according to claim 1, wherein the base defines a notch communicating with the folded channel.

3. The device according to claim 1, wherein, The first portion and the second portion each define a perimeter, and at least one engaging tab is positioned along the perimeter of each of the first portion and the second portion.

4. The device according to claim 1, wherein, The first portion includes a first actuating arm, and the second portion includes a second actuating arm, wherein at least a portion of the first actuating arm includes the inner surface of the first portion, and at least a portion of the second actuating arm includes the inner surface of the second portion. At least one protrusion extends vertically from at least one of the inner surfaces of the first portion and the second portion. The at least one protrusion is constructed and arranged to prevent the inner surfaces of the first portion and the second portion from directly contacting each other in the closed position.

5. The device according to claim 1, wherein, The folded channel is essentially U-shaped.

6. The device according to claim 1, wherein, In the closed position, the first portion and the second portion define at least one port in fluid communication with the folded channel.

7. The device according to claim 1, wherein, The first portion and the second portion each define a perimeter, and a plurality of engaging tabs are positioned along the perimeter of each of the first portion and the second portion, the plurality of engaging tabs being spaced apart from each other.

8. The device according to claim 7, wherein, In the closed position, each of the plurality of engaging tabs in the first portion contacts the opposing engaging tab in the plurality of engaging tabs in the second portion.

9. The device according to claim 8, wherein, At least one of the spaces between the plurality of engaging tabs defines a port in fluid communication with the folded channel.

10. The device according to claim 9, wherein, The medical device is an ultrasound (US) transducer assembly.

11. The device according to claim 10, wherein, The folding platform is constructed and arranged to receive at least a portion of the US transducer assembly in its manufacturing state.

12. The device according to claim 11, wherein, The at least portion of the US transducer assembly defines an edge, which is engaged by the plurality of engagement tabs when the at least portion of the US transducer assembly is received by the folding platform.

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

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

15. The device of claim 14, further comprising an adhesive injected into the interior through the port.

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