Methods and systems for an invasive deployable device

Abstract

The invention is titled Methods and systems for an invasive deployable device. A deployable invasive device includes a transducer having a plurality of elements joined by at least one shape memory material configured to move the plurality of elements relative to one another between a first configuration and a second configuration in response to a stimulus. The shape memory material includes at least one active region configured to facilitate a transition between the first configuration and the second configuration. The deployable invasive device includes at least one integrated circuit configured to process signals from at least one of the plurality of elements and a plurality of conductive traces on or in the shape memory material and extending through the active region. The conductive traces are configured to conduct signals to the at least one integrated circuit, wherein the conductive traces are configured to conform as the shape memory material moves the elements between the first configuration and the second configuration.

Description

Background Technology

[0001] The implementation schemes of the topics disclosed in this article involve deployable conduits.

[0002] Invasive devices can be used to obtain information about tissues, organs, and other anatomical regions that may be difficult to collect via external scanning or imaging techniques. The invasive device may be a deployable catheter that can be inserted intravenously into the patient. In one example, the device could be used for intracardiac echocardiography (ICE) imaging, where it is introduced into the heart via, for example, the aorta, inferior vena cava, or jugular vein. The device may include an ultrasound probe with an aperture size consistent with the dimensions that allow the device to be assembled through an artery or vein. Therefore, the resolution and penetration of the ultrasound probe can be determined by the maximum permissible diameter of the invasive device. Summary of the Invention

[0003] This summary is provided to introduce a series of concepts that will be further described in the detailed description below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help limit the scope of the claimed subject matter.

[0004] In one embodiment, the deployable invasive device includes a transducer having a plurality of elements connected by at least one shape memory material configured to move the plurality of elements relative to each other between a first configuration and a second configuration in response to a stimulus. The shape memory material includes at least one effective region configured to facilitate transition between the first and second configurations. The deployable invasive device includes: at least one integrated circuit configured to process signals from at least one of the plurality of elements; and a plurality of conductive traces on or in the shape memory material and extending through the effective region. The conductive traces are configured to conduct signals to the at least one integrated circuit, wherein the conductive traces are configured to conform as the shape memory material moves the elements between the first and second configurations.

[0005] In one embodiment, the transducer for an imaging catheter includes a plurality of elements connected by at least one shape memory material configured to allow the elements to move relative to each other between the first and second configurations, wherein the first configuration has a larger footprint than the second configuration. The shape memory material includes at least one effective region configured to change shape to facilitate movement between the first and second configurations. A plurality of integrated circuits are connected by the at least one shape memory material, each integrated circuit configured to process signals from at least one of the plurality of elements. A plurality of conductive traces are located on or in the shape memory material and extend through the effective region, each of these conductive traces being connected to at least one of the plurality of integrated circuits.

[0006] Various other features, objects, and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings. Attached Figure Description

[0007] The invention will be better understood by referring to the following description of non-limiting embodiments, in which:

[0008] Figure 1 A block diagram of an exemplary imaging system including a deployable catheter is shown.

[0009] Figure 2 Showing more details Figure 1 Deployable catheters, including those for Figure 1 An exemplary imaging catheter tip and transducer of the system shown.

[0010] Figure 3 It shows that it can be included in Figure 2 A first cross-sectional view of an exemplary imaging catheter tip in a deployable catheter.

[0011] Figure 4 yes Figure 2 A schematic diagram of the second cross-sectional view of the deployable conduit.

[0012] Figure 5A and 5B This is a diagram illustrating the multi-path shape memory effect of a transducer incorporating shape memory materials.

[0013] Figure 6A A first example of a transducer in a folded configuration adapted to shape memory materials is shown.

[0014] Figure 6B It shows the configuration in unfolded form. Figure 6A The first example of a transducer.

[0015] Figure 7AA second example of a transducer in a folded configuration adapted to shape memory materials is shown.

[0016] Figure 7B It shows the configuration in unfolded form. Figure 7A The second example of a transducer.

[0017] Figure 7C It shows the folded configuration. Figure 7A A cross-sectional view of a second example of a transducer.

[0018] Figure 8A A perspective view of a third example of a transducer in a folded configuration adapted to shape memory materials is shown.

[0019] Figure 8B It shows Figure 8A The third example end view of the transducer.

[0020] Figure 8C It shows the configuration in the transformation. Figure 8A A perspective view of the third example of a transducer.

[0021] Figure 8D It shows the configuration in unfolded form. Figure 8A A perspective view of the third example of a transducer.

[0022] Figure 9A A perspective view of a fourth example of a transducer in a folded configuration adapted to a shape memory material is shown.

[0023] Figure 9B It shows Figure 9A The fourth example of a transducer is shown in the end view.

[0024] Figure 9C It shows the configuration in the transformation. Figure 9A Perspective view of the fourth example of a transducer.

[0025] Figure 9D It shows the configuration in unfolded form. Figure 9A Perspective view of the fourth example of a transducer.

[0026] Figure 10 Another example of a transducer adapted to a shape memory material forming the backing layer of the transducer is shown.

[0027] Figure 11 A sixth example of a transducer adapted to a shape memory material forming a matching layer of the transducer is shown.

[0028] Figure 12 An integrated circuit and conductive traces of an exemplary embodiment of the transducer are shown.

[0029] Figure 13 An integrated circuit and conductive traces of another exemplary embodiment of the transducer are shown.

[0030] Figures 14A-14D Various embodiments of transducers with different arrangements of integrated circuits and conductive traces relative to shape memory materials are shown.

[0031] Figures 15A-15C Various embodiments of a transducer having ridges formed in a shape memory material and an exemplary arrangement of integrated circuits and conductive traces relative to the shape memory material are shown.

[0032] Figures 16A-16B An implementation scheme of a transducer with layered effective regions is shown.

[0033] Figures 1-4 and Figures 6A-9D It is drawn approximately to scale, although other relative dimensions may also be used. Detailed Implementation

[0034] The following description relates to various implementations of deployable invasive devices. A deployable invasive device can be a deployable catheter within an imaging system and is configured to be inserted into a patient to obtain information about internal tissues and organs. Examples of imaging systems equipped with deployable catheters are provided in [the following section / section / etc.]. Figure 1 As shown in the image. Figure 2 The image depicts a side view of the deployable conduit, and... Figure 3 The internal components of the deployable catheter are shown in a first cross-sectional view. Figure 4 The diagram shows a second cross-sectional view of the deployable conduit. The transition of the transducer, adapted to the shape memory material, between the first and second shapes is illustrated in... Figures 5A-5B As shown, the shape memory material can be included in a deployable conduit. Figure 5A Transducers are shown in both flat planar shapes or configurations and folded shapes or configurations. Additional modes of shape transformation in shape memory materials are also demonstrated. Figure 5B As shown, the additional mode includes the compression of shape memory material along at least one dimension. Examples of transducers incorporating shape memory material at multiple locations relative to the effective region of the transducer and of transducers in different configurations are illustrated herein. For example, shape memory material may be arranged between transducer elements or arrays of transducer elements, such as... Figures 6A-7C As shown, outside the effective area for arranging transducers, such as Figures 8A-9D As shown.

[0035] Medical imaging techniques such as ultrasound imaging can be used to obtain real-time data about a patient's tissues, organs, blood flow, etc. However, it may be difficult to obtain high-resolution data of the lumens of tissues and organs via external scanning of the patient. In such cases, a deployable catheter equipped with a probe can be inserted intravenously into the patient and guided to the target site. Deployable catheters can travel through narrow channels (such as veins or arteries) and therefore can have similar diameters. However, the narrow diameter of the deployable catheter can limit the size of the probe, which in turn can constrain the quality of data provided by the probe and the acquisition speed. For example, when the probe is an ultrasound probe, the resolution and penetration of the ultrasound probe can be determined by the size of the probe's transducer. To improve the quality of the images generated by the ultrasound probe, a transducer larger than that that can be encapsulated within the housing of the deployable catheter may be required. However, the venous or other lumens or channels constrain the size of the transducer, and the size will be constrained by the narrowest part of the path along which the catheter travels from the inlet position to the imaging position.

[0036] Therefore, the inventors have envisioned developing a deployable invasive device, such as a catheter, having a transducer that can change shape or configuration between a first configuration and a second configuration, wherein one of the configurations is more compact and / or has a smaller planar area, and thus can fit through narrower channels or cavities within the body. Once the deployable invasive device reaches its imaging location, the transducer can be converted to an imaging configuration in which multiple elements are positioned for imaging, such as along a flat plane or adjacent to each other in an arc. The imaging configuration occupies a larger planar area or footprint than the configuration used for insertion and / or movement of the catheter between imaging locations. As will be understood by those skilled in the art upon review of this disclosure, an ultrasonic transducer may include one or more transducer elements, which are parts of the ultrasonic transducer that convert ultrasonic energy into electrical energy, such as comprising piezoelectric or single-crystal materials or microelectromechanical systems (MEMS) devices. In various embodiments, multiple elements may be arranged in one or more transducer arrays.

[0037] In some examples, shape memory materials are incorporated into deployable catheters and configured to cause or facilitate transitions between a first and a second configuration. The shape memory material may be a shape memory polymer (SMP) configured to alternate between at least two different shapes. When the SMP is coupled to or integrated into a transducer, the footprint of the transducer of the deployable catheter, or the planar area occupied by the transducer, can be selectively increased or decreased. The shape-changing behavior of the SMP within the deployable catheter housing allows the transducer to have, for example, a first shape with a first set of dimensions, such that multiple elements, such as multiple elements arranged in an array of multiple transducers, can be easily inserted into the patient. In response to exposure to a stimulus, the SMP can adjust to a second shape with a second set of dimensions, which increases the size of the transducer and / or its footprint.

[0038] SMPs can be coupled to transducers via more than one configuration, allowing for transducer design flexibility to accommodate available package space and enhance transducer performance. For example, the positioning of the SMP relative to the effective area of ​​the transducer can be altered and / or the SMP can be configured to change shape via more than one mode. This allows the imaging probe to be positioned within the patient in a conformation more favorable for intravenous passage and subsequently magnified upon deployment in the target anatomical region to obtain high-resolution data. By utilizing SMPs to induce shape transformation, the cost of deployable catheters can be kept low while allowing for a wide range of deformations.

[0039] Now go to Figure 1 A block diagram of an exemplary system 10 for medical imaging is shown. It should be understood that although described herein as an ultrasound imaging system, system 10 is a non-limiting example of an imaging system that can acquire medical images using deployable devices. Other examples may include combinations of other types of invasive probes, such as endoscopes, laparoscopes, surgical probes, endovascular probes, etc. System 10 may be configured to facilitate the acquisition of ultrasound image data from a patient 12 via an imaging catheter 14. For example, the imaging catheter 14 may be configured to acquire ultrasound image data representing regions of interest (such as the heart or lungs) within the patient 12. In one example, the imaging catheter 14 may be configured to function as an invasive probe. Reference numeral 16 indicates a portion of the imaging catheter 14 disposed within the patient 12 (e.g., inserted into a vein). Reference numeral 18 indicates... Figure 2 A portion of the imaging catheter 14 is depicted in more detail.

[0040] System 10 may also include an ultrasound imaging system 20 operatively associated with the imaging catheter 14 and configured to facilitate the acquisition of ultrasound image data. It should be noted that while the exemplary embodiments shown below are described in the context of medical imaging systems (such as ultrasound imaging systems), other imaging systems and applications are contemplated (e.g., industrial applications such as nondestructive testing, tubular endoscopy, and other applications where ultrasound imaging can be used in confined spaces). Furthermore, the ultrasound imaging system 20 may be configured to display an image representing the current position of the imaging catheter tip within the patient 12. Figure 1 As shown, the ultrasound imaging system 20 may include a display area 22 and a user interface area 24. In some examples, the display area 22 of the ultrasound imaging system 20 may be configured to display a two-dimensional or three-dimensional image generated by the ultrasound imaging system 20 based on image data acquired via the imaging conduit 14. For example, the display area 22 may be a suitable CRT or LCD display on which ultrasound images can be viewed. The user interface area 24 may include an operator interface device configured to assist the operator in identifying the region of interest to be imaged. The operator interface may include a keyboard, mouse, trackball, joystick, touchscreen, or any other suitable interface device.

[0041] Figure 2 The imaging catheter 14 is shown. Figure 1 An enlarged view of section 18 shown. (See attached image.) Figure 2 As shown, the imaging catheter 14 may include a distal end 26 at the distal end of the flexible shaft 28. The catheter distal end 26 may accommodate a transducer and a motor assembly. The transducer may include multiple transducer elements, such as one or more transducer arrays. The imaging catheter 14 may also include a handle 30 configured to facilitate operator manipulation of the flexible shaft 28.

[0042] Figure 2 Example of catheter tip 26 in Figure 3 As shown in the figure, a set of reference axes 301 indicating the y-axis, x-axis, and z-axis is provided. The conduit end 26 may have a housing 302 surrounding a transducer 304, a capacitor 308, and a conduit cable 310, which may include a plurality of transducer elements arranged in at least one transducer array 306. Figure 3 Other components, not shown, may also be enclosed within housing 302, such as, for example, a motor, a motor retainer, a thermistor, and an optional lens. Furthermore, in some examples, the conduit tip 26 may include a system for filling the tip with a fluid, such as an acoustic coupling fluid.

[0043] As will be understood by one of ordinary skill in the art upon review of this disclosure, each transducer element may operate as a part of a transducer array (e.g., transducer array 306) or as a single transducer element. Similarly, where the term "transducer array" is used in this disclosure, alternative embodiments may alternatively include a single transducer element instead of an array, and any such aspect of this disclosure should be construed as covering both embodiments. In such embodiments, each transducer array 306 (or Figure 5A and Figures 6A-6B Each transducer array 504, 506, 604, 606 discussed herein may alternatively be a single transducer element. Transducer array 306 has several layers stacked along the y-axis and extending along the xz plane. One or more layers of transducer array 306 may be layers of transducer element 312. In one example, transducer element 312 may be a piezoelectric element, wherein each piezoelectric element may be a block formed of a natural material (such as quartz) or a synthetic material (such as lead zirconate titanate), which deforms and vibrates when a voltage is applied, for example, by an emitter. In some examples, the piezoelectric element may be a single crystal with a crystal axis, such as lithium niobate and PMN-PT(Pb(Mg)). 1 / 3 Nb 2 / 3 (O3–PbTiO3). The vibration of the piezoelectric element generates an ultrasonic signal formed by ultrasonic waves emitted from the end 26 of the conduit. The piezoelectric element can also receive ultrasonic waves (such as ultrasonic waves reflected from a target object) and convert the ultrasonic waves into voltage. The voltage can be transmitted to the receiver of the imaging system and processed into an image.

[0044] In another example, transducer element 312 may be a microelectromechanical system (MEMS) device, including flexible MEMS. Such MEMS-based acoustic transducers may be, for example, CMOS (complementary metal-oxide-semiconductor) based MEMS, micromachining ultrasonic transducers (MUTs), including piezoelectric MUTs (pMUTs) and capacitive MUTs (cMUTs).

[0045] An acoustic matching layer 314 may be positioned above the transducer element 312. The acoustic matching layer 314 may be a material positioned between the transducer element 312 and the target object to be imaged. By arranging the acoustic matching layer 314 therebetween, ultrasonic waves can pass through the acoustic matching layer 314 first and be emitted in phase from the acoustic matching layer 314, thereby reducing the likelihood of reflection at the target object. The acoustic matching layer 314 can shorten the pulse length of the ultrasonic signal, thereby increasing the axial resolution of the signal.

[0046] The layer formed by the acoustic matching layer 314 and the transducer element 312 can be cut along at least one of the yx plane and the yz plane to form individual acoustic stacks 316. Each acoustic stack in the acoustic stacks 316 may be electrically insulated from adjacent transducers, but may be fully coupled to a common layer positioned below or above the transducer element relative to the y-axis. For example, each acoustic stack 316 may be coupled to a circuit, as described below.

[0047] Circuitry 318 may be layered below transducer element 312 relative to the y-axis. In one example, the circuitry may be at least one application-specific integrated circuit (ASIC) 318 in direct contact with each acoustic stack in acoustic stack 316. Each ASIC 318 may be coupled to one or more flexible circuits 317 that may extend continuously between transducer array 306 and conduit cable 310. Flexible circuitry 317 may be electrically coupled to conduit cable 310 to enable connection between transducer array 306 and imaging system (e.g., imaging system). Figure 1 Electrical signals are transmitted between the imaging system 20). The electrical signals can be tuned by capacitor 308 during transmission. This document describes various circuit arrangements including the number and location of ASICs 318 and the conductive traces connected to these ASICs.

[0048] The acoustic backing layer 320 can be positioned below the ASIC 318 relative to the z-axis. In some examples, such as... Figure 3 As shown, the backing layer 320 can be a continuous material layer extending along the xz plane. The backing layer 320 can be configured to absorb and attenuate backscattered waves from the transducer element 312. The bandwidth and axial resolution of the acoustic signal generated by the transducer element 312 can be increased by the backing layer 320.

[0049] As described above, the transducer 304, capacitor 308, and catheter cable 310 can be enclosed within the housing 302. Therefore, the size of the components (e.g., diameter or width) can be determined by the inner diameter of the housing 302. The inner diameter of the housing 302 can then be determined by the outer diameter of the housing 302 and the desired thickness. The outer diameter of the housing 302 can be constrained by the area of ​​the patient's body where the imaging catheter is inserted. For example, the imaging catheter could be an intracardiac echocardiography (ICE) catheter used to obtain images of cardiac structures and blood flow within the patient's heart.

[0050] Imaging catheters can be introduced into the heart via the aorta, inferior vena cava, or jugular vein. In some cases, the imaging catheter can be fed through areas with narrower diameters, such as the coronary sinus, tricuspid valve, and pulmonary artery. Therefore, the outer diameter of the imaging catheter may not exceed 10 Fr or 3.33 mm. The outer diameter and corresponding inner diameter of the imaging catheter housing are... Figure 4 China and Israel along Figure 3The cross-section 400 of the housing 302 of the conduit end 26, taken by line A-A', is shown.

[0051] like Figure 4 As shown, the outer surface 402 of the housing 302 of the imaging catheter may be spaced apart from the inner surface 404 of the housing 302 by a thickness 406. The thickness 406 of the housing 302 may be optimized to provide a target level of structural stability (e.g., resistance to deformation) to the housing 302, which balances flexibility (e.g., the ability to bend when a force is applied). In one example, the outer diameter 408 of the housing 302 may be 3.33 mm, the thickness 406 may be 0.71 mm, and the inner diameter 410 of the housing 302 may be 2.62 mm. In other examples, the outer diameter of the housing may be between 2 mm and 5 mm, the thickness may be between 0.24 mm and 1 mm, and the inner diameter may be between 1 mm and 4 mm. In other examples, the imaging catheter may have various sizes depending on the application. For example, an endoscope may have an outer diameter of 10 mm to 12 mm. It should be understood that the imaging catheter may have various diameters and sizes without departing from the scope of this disclosure.

[0052] The inner surface 404 of the housing 302 may include circular protrusions 412 projecting into the internal volume or cavity 414 of the housing 302. The circular protrusions 412 may be semi-circular protrusions, each enclosing a separate cavity 416 for receiving the manipulation line of the imaging conduit. The arrangement of the transducer 304 of the imaging conduit within the cavity 414 of the housing 302 is indicated by a dashed rectangle. The maximum height aperture 418 of the transducer 304 may be determined based on the inner diameter 410 of the housing 302, and the height 420 of the transducer 304 may be configured to fit between the circular protrusions 412 of the housing 302. In one example, the height aperture 418 may be a maximum of 2.5 mm, and the height 420 may be a maximum of 1 mm.

[0053] As described above, the dimensions of transducer 304 can be determined by the inner diameter 410, thickness 406, and outer diameter 408 of housing 302, which in turn can be determined based on the specific region of the imaging catheter inserted into the patient's anatomy. Constraints imposed on the size of transducer 304 and the diameter 422 of catheter cable 310 can affect the resolution, penetration, and fabrication of transducer 304. Each of these aspects—resolution, penetration, and ease of fabrication—can be enhanced by increasing the size of transducer 304, but the geometry of transducer 304, and therefore its performance, is limited by the dimensions of catheter housing 302 to allow for intravenous catheter deployment across the patient.

[0054] In one example, a transducer can be amplified when deployed at a target site by adapting the transducer with a shape memory material. The shape memory material can be a shape memory polymer (SMP) configured to mechanically respond to one or more stimuli. Examples of SMPs include linear block copolymers such as polyurethane, polyethylene terephthalate, polyethylene oxide, and other thermoplastic polymers (such as polynorbornene). In one example, the SMP can be a powder mixture of silicone and tungsten in an acrylic resin. The SMP can be stimulated by physical stimuli (such as temperature, moisture, light, magnetic energy, electricity, etc.), chemical stimuli (such as chemicals, pH levels, etc.), and biological stimuli (such as the presence of glucose and enzymes). When applied to an imaging catheter, the transducer can incorporate the SMP so that the shape of the transducer can change upon exposure to at least one stimulus. The SMP can have the physical properties provided in Table 1 below, which offer more desirable properties than other types of shape memory materials (such as shape memory alloys). For example, SMPs can have higher elastic deformation capacity, lower cost, lower density, and greater biocompatibility and biodegradability. Specifically, the lower cost of SMP may be desirable for applications in one-off deployable conduits.

[0055] Table 1. Physical properties of shape memory polymers

[0056]

[0057] In one example, the SMP may have bidirectional shape memory, allowing it to adjust between two shapes without reprogramming or applying external forces. For instance, the SMP may transition to a temporary shape in response to a first stimulus and revert to a permanent shape in response to a second stimulus. The first and second stimuli may be of the same or different types; for example, the first stimulus may be a high temperature and the second a low temperature, or the first stimulus may be a humidity level and the second a thermal temperature such as a threshold temperature. This bidirectional shape memory behavior is neither mechanically nor structurally constrained, thus allowing the SMP to switch between temporary and permanent shapes without applying external forces.

[0058] For example, the transducer 502 responds to thermal stimulation by switching between a first shape and a second shape. Figure 5AAs shown in the first figure 500, the transducer 502 includes a first transducer array 504 and a second transducer array 506, wherein the second transducer array 506 is aligned with and spaced apart from the first transducer array 504 along the z-axis. In other words, the transducer 502 has an overall planar shape, wherein the first transducer array 504 and the second transducer array 506 are coplanar with each other along a common plane (e.g., the xz plane). A first step 501 of the first figure 500 depicts an SMP 508 coupled to a backing layer 510 of each of the first transducer array 504 and the second transducer array 506. The SMP 508, configured as a bidirectional memory SMP, is arranged between the transducer arrays along the z-axis and is fixedly attached to the edge of the backing layer 510 and arranged coplanarly with the backing layer 510. For example, the backing layer 510 and the SMP 508 arranged between them may form a continuous planar cell. The transducer element 512 is laminated onto the backing layer 510 of the first transducer array 504 and the second transducer array 506.

[0059] In some examples, the SMP 508 can be formed as a continuous layer completely spanning the transducer 502. For example, the SMP 508 can be an acoustic layer of the transducer 502, such as a matching layer or a backing layer. By incorporating the SMP 508 as an acoustic layer, the assembly and number of transducer components can be simplified without adversely affecting the reduction of the transducer's footprint. Further references are provided below. Figures 10-11 The discussion focuses on implementing SMP as the acoustic layer of a transducer.

[0060] Transducer 502 is exposed to a first temperature T1, and at the second step 503, SMP 508 changes shape in response to T1. SMP 508 can be bent into a semi-circular shape, thereby causing the second transducer array 506 to pivot substantially 180 degrees along a first direction of rotation indicated by arrow 520 (e.g., clockwise). As described herein, bending can be any transformation of a planar structure into a non-planar configuration. Therefore, various deformations of a structure from a configuration aligned with a plane can be considered as bending.

[0061] When the SMP 508 is bent, the transducer 502 can also be bent. While the SMP can be bent through a range of angles, the bending of the SMP causes the two regions of the transducer 502 to stack on top of each other and become substantially parallel, a phenomenon referred to herein as folding. In some examples, the SMP may not be bent to the extent that the transducer is folded. However, folding of the transducer provides the most compact conformation of the transducer, enabling the deployable catheter to pass through an intravenous access.

[0062] Due to the folding of transducer 502, the second transducer array 506 is positioned below the first transducer array 504 in a folded shape relative to the y-axis. When transducer 502 is viewed along the y-axis, the overall planar surface area of ​​transducer element 512 (including transducer element 512 of both the first transducer array 504 and the second transducer array 506) is reduced at the second step 503 compared to the first step 501.

[0063] Transducer 502 is exposed to a second temperature T2, and in response, SMP 508 returns to the planar geometry of the first step 501 at the third step 505 of the first illustration 500. The second transducer array 506 pivots substantially 180 degrees along a second rotational direction opposite to the first rotational direction (e.g., counterclockwise). The second temperature T2 can be higher or lower than T1. Subjecting transducer 502 to T1 again causes SMP 508 to bend, thereby folding transducer 502, such that the second transducer array 506 pivots 180 degrees at the fourth step 507.

[0064] As described above, the transducer 502 can be encapsulated in a housing (such as) at the end of a deployable conduit. Figure 3 and Figure 4 The transducer 502 is housed within a shell 302. To accommodate the unfolding of the transducer 502 into a planar geometry, the shell may be formed of a flexible, elastic material that stretches and deforms as the transducer 502 changes shape. For example, the deployable conduit may be a balloon conduit, and the shell at the end of the conduit may be an inflatable balloon. The balloon may be formed of materials such as polyester, polyurethane, silicone, etc., and may be inflated by filling the balloon with fluid or gas. The balloon may be inflated to allow the transducer 502 to change shape unimpeded before the transducer 502 is fitted into a planar geometry. When the transducer 502 is fitted into a folded conformation, the balloon may contract by expelling gas or fluid.

[0065] The steps shown in the first figure 500 can be repeated multiple times. For example, before inserting an imaging catheter adapted to transducer 502 into a patient, the transducer may be initially exposed to one or more stimuli to fold and reduce the size of transducer 502. The folded transducer 502 may be fitted within the housing of the imaging catheter and inserted intravenously into the patient. When transducer 502 reaches the target site in the patient, transducer 502 can be expanded and / or otherwise magnified by subjecting the array to T2. An image can be acquired as transducer 502 expands and increases in size. For example, expanding transducer 502 may increase the height of the transducer 502.

[0066] When the scan is complete, the transducer 502 can be exposed to the stimulus again or to a different stimulus, causing it to fold and shrink. The imaging catheter can then be withdrawn from the site and removed from the patient or deployed to another site for imaging within the patient. Thus, the shape and size of the transducer 502 can be adjusted multiple times between a planar configuration and a folded configuration during an imaging session.

[0067] Figure 5B The second illustration 1200 shows a second embodiment of a transducer that includes an SMP and is configured to change shape between an insertion shape occupying a smaller footprint and an imaging shape in which the transducer array is positioned for imaging. It should be understood that... Figure 5A and Figure 5B The configurations of transducers 502 and 1202 shown are non-limiting examples of shapes in which the transducers can transform therebetween. Other examples may include transducer 502 being in a non-planar geometry (such as a slightly bent or curved shape) at a first step 501, becoming more bent or curved at a second step 503, and alternating between less bent / curved and more bent / curved shapes upon exposure to one or more stimuli. Additionally, transducer 502 may be folded such that the first transducer array 504 and the second transducer array 506 are not parallel to each other. In other examples, the first transducer array 504 and the second transducer array 506 may be of different sizes.

[0068] Furthermore, when the SMP 508 forms an entire layer across transducer 502 rather than forming segments between the backing layers 510 of the first transducer array 504 and the second transducer array 506, the SMP 508 can be adapted to change shape only in the region between the transducer arrays. In one example, the SMP 508 may be able to change shape via more than one type of transformation. For example, the SMP 508 may bend upon exposure to one type of stimulus and contract upon exposure to another type of stimulus. In another example, the SMP 508 may comprise more than one type of shape memory material. For example, the SMP 508 may be formed from a first type of material configured to bend and a second type of material configured to contract. Other variations in shape transformation, material combinations, and positioning of the SMP 508 within the transducer have been envisioned.

[0069] Although temperature change is described as being used to induce Figure 5AThe first illustration 500 illustrates a stimulus for shape change in the SMP, but it should be understood that the first illustration 500 is a non-limiting example of how the SMP deformation is triggered. Other types of stimuli, such as humidity, pH, UV light, etc., can be used to induce mechanical changes in the SMP. More than one type of stimulus can be applied to the SMP to achieve similar or different shape modifications. Furthermore, the deformation of the SMP can include other shape changes besides bending. For example, the SMP can curl into a core configuration or shrink along at least one dimension. Details of mechanical deformation are described further below.

[0070] Now for reference Figure 5B The transducer 1202 is configured to change shape via more than one transition path, which can be caused by the SMP 1206 being exposed to more than one stimulus type or intensity. For example, the SMP can fold in response to a first stimulus and contract along at least one dimension in response to a second stimulus. The SMP can have a large deformability, for example, up to 800%. By using an SMP suitable for contracting along at least one dimension in response to a stimulus, the distance between transducers can be reduced. Figure 5B As shown in the second figure 1200, the transducer 1250 has a first transducer array 1202 and a second transducer array 1204 spaced apart from the first transducer array 1202 by an SMP 1206. The transducer 1250 is depicted in a first folded configuration 1201, wherein the effective area and occupied area of ​​the transducer 1250 are reduced relative to a second unfolded configuration 1203.

[0071] Upon exposure to a first stimulus S1, SMP 1206 transforms into a second configuration 1203. The first stimulus S1 can be any of the aforementioned stimuli. The effective area of ​​transducer 1250 (e.g., the total surface area of ​​transducer 1250 facing the same direction along the y-axis) is doubled relative to the first configuration 1201. The first transducer array 1202 is spaced apart from the second transducer array 1204 by SMP 1206, which has a first width 1208 in the second configuration 1203 defined along the x-axis, which can also be the height direction of transducer 1250. Therefore, the planar area or footprint occupied by the transducers increases between the first configuration 1201 and the second configuration 1203.

[0072] SMP 1206 may be exposed to a second stimulus S2, different from the first stimulus S1, which causes SMP 1206 to contract along the x-axis. In one example, the first stimulus S1 may be temperature, and the second stimulus S2 may be humidity. In other examples, the first stimulus S1 and the second stimulus S2 may be any combination of various chemical, physical, and biological stimuli. The contraction of SMP 1206 along the height direction transforms transducer 1250 into a third contraction configuration 1205. In the third configuration 1205, SMP 1206 has a second width 1210 smaller than the first width 1208. This reduces the distance between the first transducer array 1202 and the second transducer array 1204. Consequently, the planar area or footprint occupied by the transducers is reduced between the second configuration 1203 and the third configuration 1205.

[0073] Transducer 1250 can be converted from a third configuration 1205 to a second configuration 1203 and from a second configuration 1203 to a first configuration 1201 by exposing SMP 1206 to more than one stimulus. SMP 1206 can be similarly applied to transducers having more than two transducer arrays, such as those described below. Figures 9A-9D The aforementioned transducer.

[0074] To return transducer 1250 to the first configuration 1201, transducer 1250 may be exposed to a variation of the second stimulus S2 to cause SMP 1206 to expand along the x-axis. For example, if the second stimulus S2 is pH, SMP 1206 may be subjected to a first lower pH to induce contraction and to a second higher pH to promote expansion. Transducer 1250 may then be exposed to a variation of the first stimulus S1 to induce bending of SMP 1206, thereby folding transducer 1250. For example, if the first stimulus S1 is humidity, transducer 1250 may be exposed to lower humidity to drive SMP 1206 to bend and to higher humidity to trigger straightening of SMP 1206.

[0075] The shrinking and expanding of the SMP 1206 allows for adjustment of the spacing between transducer arrays based on the SMP 1206's response to stimuli. For example... Figures 6A to 7B As shown, when the SMP 1206 is configured as a segment arranged between and coupled to the inner edge of the transducer array, the entire segment of the SMP can be contracted and expanded. Furthermore, in some examples, the SMP 1206 can be configured to contract and expand along an azimuth direction other than or replacing the height direction. By constraining the contraction and expansion regions, undesirable separation of the SMP from the transducer components coupled to it can be mitigated.

[0076] It should be understood that the examples of shape transformations (e.g., bending and tightening) described above are non-limiting examples. Various other modalities of shape transformation for use in deployable catheters have been envisioned. For example, in addition to bending and tightening, SMPs may also coil, twist, and / or expand. SMPs can be configured to change shape via more than one modality depending on the applied stimulus and the desired level of complexity.

[0077] Thus, transducers for deployable catheters can be easily passed intravenously through the patient and provide enhanced field of view, resolution, penetration, and image update rate. The transducer arrays of the transducers can be interconnected and / or mounted on the SMP, and as a result of the SMP being exposed to stimulation, the transducers can transform between at least a first folded shape and a second unfolded shape. In alternative embodiments, the SMP can be positioned between and connect the multiple transducer elements together, and is configured to allow the multiple transducer elements to move relative to each other. The effective area of ​​the transducer can be selectively increased, thereby enhancing the transducer's performance. The SMP can be incorporated into the transducer via more than one configuration. For example, the SMP can be attached to the edge of the transducer array and extend between the transducer arrays. Alternatively, the SMP can form a continuous common acoustic layer of the transducer arrays and bend at the region between the transducer arrays. To reduce the distance between transducer arrays during data acquisition, the SMP can be configured to contract along at least one dimension. Furthermore, when the package space is available along the azimuth aperture of the transducer, the SMP can be located outside the effective area of ​​the transducer, which also leads to a reduction in the distance between transducer arrays. Therefore, it is possible to cost-effectively allow the transducers to be fitted into a conformation that facilitates the intravenous passage of deployable catheters, increasing the data quality and data acquisition speed of the transducers.

[0078] In some examples, such as Figure 5A and Figure 5B As shown, the transducer for the deployable conduit may include two segments or two transducer arrays. Each transducer array may include one or more acoustic stacks, including those referenced above. Figure 2 The aforementioned matching layer and / or backing layer. An ASIC may be coupled to each transducer array. Alternatively, one ASIC may be coupled to two or more transducer arrays. An exemplary transducer 602, incorporating SMP to enable modification of the effective region of transducer 602, in... Figure 6A and Figure 6B As shown in the diagram. Transducer 602 in Figure 6A The first fold configuration 600 is shown in the middle, and in Figure 6B The second unfolded configuration 650 is shown in the middle.

[0079] Transducer 602 has a first transducer array 604 and a second transducer array 606. The first transducer array 604 and the second transducer array 606 have similar dimensions and are each rectangular and longitudinally aligned with the x-axis; for example, the length 608 of each transducer array is parallel to the x-axis. SMP 610s are arranged between the transducer arrays along the z-axis. In other words, as... Figure 6B As shown, the first transducer array 604 and the second transducer array 606 are spaced apart by the width 612 of the SMP 610. The width 612 of the SMP 610 may be smaller than the width 614 of each of the first transducer array 604 and the second transducer array 606, while the length of the SMP 610 defined along the x-axis may be similar to the length 608 of the transducer array.

[0080] The SMP 610 can be attached to the inner edge of the backing layer 616 of each of the first transducer array 604 and the second transducer array 606. For example, the SMP 610 can directly contact and adhere to the longitudinal inner edge 618 of the backing layer 616 of the first transducer array 604, such as the edge of the backing layer 616 facing the second transducer array 606 and aligned with the x-axis, and directly contact and adhere to the longitudinal inner edge 620 of the backing layer 616 of the second transducer array 606, such as the edge of the backing layer 616 facing the first transducer array 604 and aligned with the x-axis. The thickness of the SMP 610 can be similar to the thickness of the backing layer 616 of each of the first transducer array 604 and the second transducer array 606, which is defined along the y-axis. A mating layer 622 is stacked on top of the backing layer 616 of each transducer array in the transducer array. Components (e.g., piezoelectric elements) may be arranged on the mating layer 622 and the backing layer 616. Figure 6A and Figure 6B (not shown in the text)

[0081] When in such a situation Figure 6A In the first configuration 600 shown, the SMP 610 is bent into a semi-circular shape. The second transducer array 606 is stacked directly above the first transducer array 604 relative to the y-axis and spaced apart from the first transducer array, such that the two transducers remain coplanar with the xz plane. Transducer 602 is... Figure 6A The transducer 602 is folded in such a way that each matching layer 622 of the transducer array faces outward and away from each other, and the backing layers 616 of the transducer array face each other. The backing layers 616 may be spaced apart from each other by a distance 630 similar to the diameter of a semicircle formed by the SMP 610. However, in other examples, the transducer 602 may be folded in the opposite direction such that the backing layers 616 of the transducer array face each other and the matching layers 622 face away from each other.

[0082] As transducer 602 transitions between a first configuration 600 and a second configuration 650, at least one transducer array in the transducer array pivots, for example, by 180 degrees relative to the other transducer array. For example, when adjusting from the first configuration 600 to the second configuration 650, the first transducer array 604 may pivot in a first rotational direction to become coplanar with the second transducer array 606. Alternatively, the second transducer array 606 may pivot by 180 degrees in a second rotational direction opposite to the first rotational direction. The first transducer array 604 may pivot in the second rotational direction, or the second transducer array 606 may pivot in the first rotational direction to return transducer 602 to the first configuration 600. In another example, the two transducer arrays may pivot by 90 degrees to achieve the transition between the first configuration 600 and the second configuration 650. It should be understood that the description of transducer arrays pivoting by 180 degrees is for illustrative purposes, and other examples may include transducer array pivots greater than or less than 180 degrees.

[0083] In the first configuration 600, the width 624 of transducer 602 is reduced compared to the width 626 of transducer 602 in the second configuration 650. The effective area of ​​transducer 602 can be equal to the surface area of ​​either the first transducer array 604 or the second transducer array 606. In the second configuration 650, with the first transducer array 604 and the second transducer array 606 coplanar and side-by-side, the effective area of ​​transducer 602 is doubled compared to the first configuration 600. Therefore, when unfolded into the second configuration 650, the height aperture of transducer 602 is at least doubled, thereby increasing the resolution and transmittance of transducer 602.

[0084] In another example, the transducer of the imaging probe may include more than two segments or a transducer array. A second example of transducer 702 is shown in... Figure 7A and Figure 7C The first fold configuration 700 is shown in the middle, and in Figure 7B The second deployment configuration 750 is shown in the figure. The transducer 702 includes a first transducer array 704, a second transducer array 706, and a third transducer array 708. All three transducer arrays may have similar dimensions and geometries and may be connected by a first SMP 710 and a second SMP 712.

[0085] For example, in Figure 7B In the second configuration 750, the transducer arrays are spaced apart from each other but coplanar and aligned along the x-axis and z-axis. The first transducer array 704 is spaced apart from the second transducer array 706 by a first SMP 710, and the second transducer array 706 is spaced apart from the third transducer array 708 by a second SMP 712. As described above, for Figures 6A to 6BIn a first example of transducer 602, the SMP can be directly connected to the longitudinal inner edge of the transducer array along the backing layer 714 of each transducer array. The SMP can be coplanar and have a similar thickness to the backing layer 714 of the transducer array. A matching layer 716 for each transducer array is positioned above the backing layer 714 and aligned with each backing layer 714 along the y-axis. Therefore, the matching layer 716 protrudes above the first SMP 710 and the second SMP 712 relative to the y-axis. Elements can be arranged on the matching layer 716 and the backing layer 714 (…). Figure 7A and Figure 7B (not shown in the text)

[0086] exist Figure 7A In the first configuration 700, when viewed along the x-axis, the transducer 702 folds into an S-shaped geometry, as shown below. Figure 7C As shown. In the S-shaped geometry, the first SMP 710 is bent into a semicircle, thus forming the right half of the circle. The first transducer array 704 can pivot relative to the second transducer array 706 in a first rotational direction, such that the second transducer array 706 is stacked above and aligned with the first transducer array 704 relative to the y-axis. Although the backing layers 714 of the second transducer array 706 and the backing layers 714 of the first transducer array 704 face each other without positioning other components of the transducer 702 between them, the backing layers 714 of the transducer arrays are spaced apart by a distance 718 similar to the diameter of the semicircle formed by the first SMP 710.

[0087] The second SMP 712 is bent in the opposite direction to the first SMP 710 to form a semicircle, which is the left half of the circle. The bending of the second SMP 712 causes the third transducer array 708 to stack above the second transducer array 706 along the y-axis. The third transducer array 708 is pivoted by a second rotation direction opposite to the first rotation direction, such that the third transducer array 708 is aligned along the y-axis with both the first transducer array 704 and the second transducer array 706, and the matching layer 716 of the third transducer array 708 faces the matching layer 716 of the second transducer array 706. The matching layers 716 of the second transducer array 706 and the third transducer array 708 are separated by a gap smaller than the distance 718 between the backing layers 714 of the first transducer array 704 and the second transducer array 706.

[0088] As transducer 702 transitions between a first configuration 700 and a second configuration 750, the first transducer array 704 and the third transducer array 708 can pivot by 180 degrees relative to the second transducer array 706 in opposite rotational directions. For example, when adjusting from the first configuration 700 to the second configuration 750, the first transducer array 704 can pivot in a first rotational direction to become coplanar with the second transducer array 706. The third transducer array 708 can pivot in a second rotational direction opposite to the first rotational direction so that it also becomes coplanar with the second transducer array 706. To return transducer 702 from the second configuration 750 to the first configuration 700, the first transducer array 704 can pivot 180 degrees in the second rotational direction, and the second transducer array 706 can pivot 180 degrees in the first rotational direction. Alternatively, in other examples, the transducer arrays can pivot in the opposite direction to the above transition. It should be understood that the description of the transducer array pivoting through 180 degrees is for illustrative purposes, and other examples may include the transducer array pivoting through more or less than 180 degrees.

[0089] like Figure 7A As shown, the width 720 of the transducer 702 in the first configuration 700 can be narrower than the width 722 of the transducer 702 in the second configuration 750. When the transducer 702 is adjusted from the first configuration 700 to the second configuration 750, the effective area of ​​the transducer 702, defined by the total transducer array surface area along the xz plane, can be increased by a factor of three. Therefore, when the transducer is formed by three transducer arrays (hereinafter referred to as 3-segment transducers), and the deployed 3-segment transducers (e.g., Figure 7B The second configuration (750) is equal in size to an expanded transducer with two transducer arrays (hereinafter referred to as a 2-segment transducer), for example... Figure 6B The second configuration 650 features a 3-segment transducer array that is narrower in width than the 2-segment transducer array. When folded, the 3-segment transducer can have a smaller footprint than the 2-segment transducer and can thus be inserted through a narrower channel.

[0090] Alternatively, the transducer arrays of the 3-segment transducer and the 2-segment transducer can be similar in size. When folded, the two transducers can have similar footprints. However, when deployed and unfolded at the target scanning site, the 3-segment transducer can have a larger effective area, thus allowing the 3-segment transducer to have greater resolution and penetration than the 2-segment transducer. Furthermore, Figures 6A to 7C The first and second examples of transducers shown are non-limiting examples. Other examples may include transducers with more than three segments, or transducers and transducer arrays with different geometries and dimensions than those shown.

[0091] The folding of the transducer driven by SMP can be utilized (as shown in Figure 5 to 10). Figure 7C (as shown) to allow the transducer to be deployed in conduits (such as...) Figure 1 This is achieved in the imaging catheter 14) without hindering the deployment of the catheter through narrow arteries and veins. Therefore, the transducer can be selected based on the required footprint of the folded and / or unfolded transducer. For example, when a 3-segment transducer and a 2-segment transducer have similar footprints in a folded configuration, the 3-segment transducer can be used when the target imaging site has a larger volume than when using a 2-segment transducer.

[0092] like Figures 6A-7C As shown, positioning the SMP between each transducer array of the transducer allows the transducer size to vary along the height direction of the transducer. However, if the distance between the transducer arrays of the transducer is too large, the image quality generated by the transducer may be degraded. For example, to maintain the enhanced performance of the transducer provided by increasing the effective area of ​​the transducer, the distance between each transducer array can cumulatively not exceed a threshold percentage of the total effective height aperture of the transducer, such as 5%. Therefore, minimizing the distance between the transducer arrays during data acquisition at the transducer is desirable. However, as Figures 5A-5B , Figure 6A and Figure 7A As shown, folding the transducer along the azimuth aperture can be a shape transformation that offers minimal complexity and ease of initiation. To facilitate efficient transducer encapsulation via folding, a total spacing between transducer arrays may be required that is greater than a threshold percentage of the total active height aperture.

[0093] Figure 5B An example of a system and configuration for reducing the distance between transducer arrays is shown. Another way to reduce the distance between transducer arrays when the transducers are deployed is by positioning the SMP outside the effective area of ​​the transducers. This arrangement is referred to below as an external arrangement of the SMP. Repositioning the SMP outside the effective area along the azimuth aperture of the transducer allows the transducer to be bent out of the transducer array, thereby reducing the requirement for a minimum distance between the transducer arrays to achieve full bending of the SMP. A first example of a transducer 802 equipped with an externally arranged SMP is shown in... Figures 8A to 8D As shown in the diagram. Transducer 802 in Figure 8A The folded configuration is shown in perspective view 800, and in Figure 8B As shown in end view 830. Transducer 802 is in Figure 8C The perspective view 850 further illustrates the transducer 802 in a transformed configuration, and... Figure 8D A perspective view 870 further shows the transducer 802 in its deployed configuration.

[0094] like Figure 8A As shown, transducer 802 includes a first transducer array 804, a second transducer array 806, and an SMP 808 positioned at one end of the first transducer array 804 and the second transducer array 806 along an x-axis, which can also be the azimuth direction of transducer 802. The transducer arrays can be longitudinally aligned with the azimuth direction and parallel to each other. The first transducer array 804 and the second transducer array 806 are not directly coupled to each other; for example, the transducer arrays may contact each other during shape transitions, but are not attached to each other at any point. Each transducer array has a mating layer 810 and a backing layer 812. Figure 8A As shown, the first transducer array 804 and the second transducer array 806 may have similar widths 814 and similar lengths 816, and may be aligned longitudinally with the x-axis and parallel to each other.

[0095] For example, such as Figure 8A , Figure 8C and Figure 8D As shown, the SMP 808 is coupled to the first edge 818 of the backing layer 812 of each transducer array in the transducer array via adhesive. However, in other examples, when the SMP has attenuation characteristics, such as when the SMP is constructed as a matching layer, the SMP can be part of the transducer array, for example, integrated into the transducer array. The first edge 818 is parallel to the z-axis and extends along the width 814 of each transducer array. Figure 8D As shown, the thickness of SMP 808 can be less than the thickness of each transducer array in the transducer array, defined along the y-axis, such that the matching layer 810 protrudes above SMP 808 along the y-axis. The effective region 820 of SMP 808 is not attached to the transducer array and is configured as follows: Figure 8A , Figure 8B and Figure 8C The bending is shown. The effective region 820 is located between planar regions 822 of the SMP 808, which are not bent because the planar regions 822 are coupled to the first edge 818 of the backing layer 812 of each transducer array in the transducer array.

[0096] exist Figure 8A and Figure 8B In the folded configuration shown, the SMP 808 is bent such that the planar regions 822 are stacked on top of each other along the y-axis, and the effective region 820 forms a semicircle. The bending of the SMP 808 causes the first transducer array 804 to fold below the second transducer array 806 so that it is stacked below the second transducer array 806 along the y-axis. For example, the first transducer array 804 may be folded relative to the unfolded configuration as shown in the figure. Figure 8DThe first rotation direction indicated by arrow 824 (e.g., counterclockwise) pivots by 180 degrees. In some examples, the first transducer array 804 may pivot greater than 180 degrees, such as 190 or 210 degrees, or any angle less than 180 degrees. It should be understood that while the pivoting of the first transducer array 804 is described, in other examples, the second transducer array 806 may be pivoted instead.

[0097] like Figure 8B As shown, when adjusted to the folded configuration, the backing layers 812 of the first transducer array 804 and the second transducer array 806 can face each other, separated by a distance equal to the diameter 826 of the semicircle formed by the effective region 820 of the SMP 808. In the folded configuration, the effective region of transducer 802 can be the total surface area of ​​the transducers facing one direction. Therefore, the effective region can be equal to the region of one transducer array in the transducer array.

[0098] In the folded configuration, the transducer 802 can have a sufficiently small footprint to fit within the outer housing of a deployable catheter for intravenous passage. Upon reaching the target imaging site, the transducer 802 can expand to... Figure 8D The deployed configuration is shown. When transducer 802 is deployed, the straightening of SMP 808 causes the first transducer array 804 to rotate in a second rotational direction (e.g., clockwise) opposite to the direction indicated by arrow 824, thereby transmitting power through... Figure 8C The transformation configuration is shown. The first transducer array 804 and the second transducer array 806 are separated by a gap extending longitudinally between the transducer arrays until the transducer 802 is in position. Figure 8D The unfolded configuration.

[0099] like Figure 8D As shown, transducer 802 is planar, for example, coplanar with the xz plane, and includes a first transducer array 804, a second transducer array 806, and an SMP 808. The effective region 820 or central region of the SMP 808 is coplanar with the planar region 822, thus forming together a rectangular extension of transducer 802 along the x-axis. The width 834 of the SMP 808 may be similar to the sum of the widths 814 of the transducer arrays, and the length 832 of the SMP 808 is less than the length 816 of the transducer arrays.

[0100] In the deployed configuration, the first transducer array 804 and the second transducer array 806 can be positioned very close to each other; for example, the first transducer array 804 and the second transducer array 806 are adjacent, without any other transducer components arranged in the space between the transducer arrays. The area between the transducer arrays can be defined or demarcated by the inner edges of the transducer arrays and the edges of the transducer arrays perpendicular to the azimuth direction. The transducer arrays can be separated by a small gap, or in some examples, the inner edges of the backing layer 812 of each transducer array can contact each other when the transducer 802 is deployed. The effective area of ​​the transducer 802 can be doubled relative to the folded configuration, and the distance between the transducer arrays can be less than the distance in the case where the SMP is positioned between the transducer arrays. For example, the total distance between the transducer arrays can be less than 5% of the height aperture of the transducer 802.

[0101] By adapting transducers to more than two transducer arrays, the effective area of ​​the transducer can be more than doubled. For example... Figures 9A to 9D As shown, a second example of a transducer 902 equipped with two externally arranged SMPs may include a first transducer array 904, a second transducer array 906, and a third transducer array 908. The transducer arrays may be longitudinally aligned with each other in the azimuth direction (e.g., the x-axis) and parallel to each other. The transducer 902 in... Figure 9A The folded configuration is shown in perspective view 900, and... Figure 9B As shown in end view 930. Transducer 902 is in Figure 9C A perspective view 950 further illustrates the transducer 902 in a transformed configuration, and... Figure 9D A perspective view 970 further shows the transducer 902 in its deployed configuration.

[0102] Transducer 902 may include a first SMP 910 positioned at a first end 912 of transducer 902 and a second SMP 914 positioned at a second end 916 of transducer 902. The first SMP 910 and the second SMP 914 may each be attached to two transducer arrays in a transducer array and may be formed of the same or different materials. More specifically, the first SMP 910 is coupled at the first end 912 to a first transducer array 904 and a second transducer array 906, and the second SMP 914 is coupled at the second end 916 to the second transducer array 906 and a third transducer array 908. Figure 9AAs shown, each transducer array in the transducer array has a matching layer 918 and a backing layer 920, and may each have a similar width 922 and a similar length 924. Each transducer array may be longitudinally aligned with the x-axis. The thickness of each of the first SMP 910 and the second SMP 914 may be similar to each other and less than the thickness of each transducer array in the transducer array, which is defined along the y-axis, such that the matching layer 918 protrudes higher along the y-axis than... Figure 9D SMP in the expanded configuration.

[0103] The second transducer array 906 is positioned between the first transducer array 904 and the third transducer array 908, and the transducer arrays are not directly coupled to each other. Instead, the transducer arrays are connected by a first SMP 910 and a second SMP 914, and the transition of the transducer 902 between a folded configuration and an unfolded configuration is guided by the SMPs. Each SMP includes a central region or effective region 926 configured to flex and a planar region 928 disposed on the opposite side of the effective region 926. The planar region 928 shares edge contact with the edge of the backing layer 920 of the transducer array and is fixedly coupled to the edge of the backing layer 920.

[0104] When adjusted to Figure 9A and Figure 9B In the folded configuration shown: the first SMP 910 is bendable, such that the first transducer array 904 relative to... Figure 9D The first SMP 904 is pivoted, for example, by 180 degrees along a first rotational direction, to become stacked below the second transducer array 906 along the y-axis. The second SMP 914 may be bent in the opposite direction to the first SMP 910, such that the third transducer array 908 is pivoted, for example, by 180 degrees along a second rotational direction opposite to the first rotational direction, to become stacked above the second transducer array 906 along the y-axis. As described above, other examples may include the first transducer array 904 and the third transducer array 908 rotating by more or less than 180 degrees. Furthermore, in other examples, the transducer 902 may be folded in the opposite configuration, for example, with the first transducer array 904 above the second transducer array 906 and the third transducer array 908 below the second transducer array 906. Figure 9B As shown, in the folded configuration, the stacked transducer arrays are aligned along the y-axis but spaced apart from each other.

[0105] Figure 9BEnd view 930 shows the S-shaped geometry of the transducer. The backing layers 920 of the first transducer array 904 and the second transducer array 906 face each other in the folded configuration, while the matching layers 918 of the second transducer array 906 and the third transducer array 908 face each other. The first transducer array 904 and the second transducer array 906 are spaced apart by a distance similar to the diameter 932 of the semicircle formed by the first SMP 910. The second transducer array 906 and the third transducer array 908 are spaced apart by a distance smaller than the diameter of the semicircle formed by the second SMP 914. Therefore, when the transducer 902 is in the folded configuration, the transducer arrays do not contact each other.

[0106] When the transducer changes from a folded configuration to an unfolded configuration, the first SMP 910 can be straightened, thereby causing the first transducer array 904 to pivot via, as shown in the image. Figure 9B The second rotation direction is indicated by arrow 934. The second SMP 914 can also be straightened, thereby causing the third transducer array 908 to rotate in the direction indicated by arrow 934. Figure 9B The first rotational direction indicated by arrow 936 in the diagram oscillates. Transducer 902 can pass through... Figure 9C The transformation configuration shown is in which the transducer arrays remain spaced apart and do not contact each other.

[0107] exist Figure 9D In the illustrated deployment configuration, the first SMP 910 and the second SMP 914 become aligned with the xz plane (e.g., flat). The SMPs form rectangular extensions along the x-axis on opposite sides of the transducer 902 and are offset from each other along the x-axis. For example, the first SMP 910 has a width 972 similar to or slightly larger than the combined width 922 of the first transducer array 904 and the second transducer array 906, and is positioned at a first end 912 of the transducer 902. The second SMP 914 has a width 974 similar to or slightly larger than the combined width 922 of the second transducer array 906 and the third transducer array 908, and is positioned at a second end 916 of the transducer 902. The second SMP 914 is positioned higher than the first SMP 910 relative to the z-axis.

[0108] In the deployed configuration, the transducer arrays are aligned along the x, y, and z axes and coplanar with each other along a common plane. The transducer arrays are depicted as being spaced apart by a small gap smaller than the distance between the transducer arrays in the case where SMPs are alternatively arranged between them. In some examples, the transducer arrays may share edge contact in the deployed configuration; for example, the inner edges of the transducer arrays may contact each other. (As described above for...) Figures 8A to 8DAs shown in transducer 802, when transducer 902 is deployed, the first transducer array 904, the second transducer array 906, and the third transducer array 908 are arranged adjacent to each other, without any other transducer components arranged in the space between the transducer arrays. The space between the transducer arrays may be defined or delimited by the inner edges of the transducer arrays and the edges of the transducer arrays perpendicular to the azimuth direction.

[0109] With similar transducer array sizes, the effective area of ​​transducer 902 when unfolded can be three times larger than when the transducer is folded. By placing the SMP outside the effective area, the transducer arrays are positioned closer together, so the total distance between transducer arrays can be less than 5% of the height aperture of the transducer. External placement of the SMP allows for a reduction in the distance between transducer arrays without introducing additional complexity to the shape transformation of the SMP or the manufacturing process of the transducer. When the package space along the azimuth direction of the transducer is unrestricted, the SMP can be arranged outside the effective area of ​​the transducer.

[0110] Figure 5 to Figure 9D As shown, the SMP can be attached to the backing layer of the transducer, for example, to a separate backing layer for each transducer array. Alternatively, in some examples, the SMP can be similarly coupled to a matching layer for each transducer array. The material of the SMP can be chosen to be physically compatible with the material of the backing layer to reduce the possibility of separation between the SMP and the matching layer or backing layer during shape transitions. However, fabrication and material selection can be simplified by incorporating the SMP as an acoustic layer of the transducer. Therefore, as... Figures 10-11 As shown, SMP can form the backing layer or matching layer of the transducer.

[0111] Figure 10A first example of a transducer 1000 having an SMP forming a backing layer is shown. The transducer 1000 has a first transducer array 1002 and a second transducer array 1004, which are spaced apart from each other along the x-axis, separating the space between them for the location of the active region. An SMP 1006 extends between the transducer arrays and across the entire width 1008 of the transducer 1000, and also across the length of the transducer and thus across a region of the transducer 1000, forming a continuous backing layer. Thus, each transducer array is coupled to a common backing layer, and the remaining components of the acoustic stack of each transducer array, such as a matching layer 1010 and element 1012, can be laminated onto the SMP 1006. The transducer 1000 can be cut downwards relative to the y-axis from the top of the matching layer 1010 through element 1012 to the top of the SMP 1006. When forming the backing layer of transducer 1000, SMP 1006 may include additives to provide SMP 1006 attenuation characteristics. For example, SMP 1006 may have increased density and / or contain organosilicon and tungsten as additives.

[0112] Alternatively, the SMP can form the matching layer of the transducer. A second example of transducer 1100 is shown in... Figure 11 As shown, SMP 1102 forms a continuous matching layer extending completely across the width 1104 of transducer 1100. Transducer 1100 has a first transducer array 1106 and a second transducer array 1108. The transducer arrays are spaced apart from each other along the x-axis, with SMP 1102 extending between the transducer arrays. Transducer 1100 may be cut upward relative to the y-axis from the bottom of backing layer 1110 through element 1112 to the bottom of SMP 1102. When forming the matching layer of transducer 1100, SMP 1102 may be formed from a matrix polymer.

[0113] By implementing the SMP as the acoustic layer of the transducer, rather than as a connector between the transducer arrays, adhesion between the SMP and the backing layer (or matching layer) of the transducer array is eliminated. Therefore, fewer materials and components are required for the manufacturing process, thus reducing costs. Furthermore, the shape-changing properties provided by the SMP are incorporated into the transducer without increasing its thickness. This maintains (e.g., without increasing) the transducer's thickness and footprint while enhancing its gain.

[0114] Figure 12 Another embodiment is depicted in which SMP 1262 provides a backing layer for the entire area or at least substantially the entire area of ​​transducer 60. Figure 12 Only a portion of transducer 1260 is shown. The transducer array is not shown in the figure, making integrated circuits 1268a–1268c visible. Also... Figures 14A-14DAs shown, the integrated circuit provides a mounting surface on which the transducer array is mounted. Therefore, integrated circuits 1268a-1268c can be positioned between the SMP 1262 and the transducer array (not shown here).

[0115] The integrated circuits 1268a-1268c can be, for example, application-specific integrated circuits (ASICs) or general-purpose integrated circuits, such as microprocessors. Each ASIC 1268a-1268c is configured to receive and process signals from a corresponding transducer array. Therefore, Figure 12 The example shown here has a 1:1 ratio between the integrated circuit and the transducer array. In other embodiments, one integrated circuit 1268 may be associated with multiple transducer arrays. To provide only one example, an embodiment with three transducer arrays (such as those described above) is also shown. Figures 7A-7C and Figures 9A-9D Those (described herein) may have only one ASIC 1268 configured to receive and process acoustic signals from all three transducer arrays. In other embodiments, two ASICs may be provided for the three transducer arrays, wherein the transducer signals are divided between the two ASICs. In still other embodiments, a greater number of ASICs than transducer arrays may be provided, wherein signals from one or more of the transducer arrays are divided between two or more ASICs.

[0116] Each ASIC 1268a-1268c is electrically connected to a plurality of conductive traces 1270. The conductive traces 1270 are configured to conduct signals to one or more of the ASICs 1268a-1268c. The plurality of conductive traces 1270 are configured according to the arrangement of one or more ASICs 1268 in the transducers 1260. The transducers 1260 may include any number of conductive traces, and in some examples may include between 30 and 100 conductive traces 1270 connected to one or a subset of the plurality of ASICs 1268a-1268c or between one or a subset of the plurality of ASICs 1268a-1268c. In some embodiments, more than 100 conductive traces may be provided, and the number of conductive traces will depend on the arrangement of the ASICs 1268 and the transducer array.

[0117] Various conductive traces 1270 can provide different communication purposes for one or more ASICs among multiple ASICs 1268a-1268c, and the number of conductive traces 1270 will depend on the arrangement of one or more ASICs on transducer 1260. For example, conductive traces 1270 can be configured to conduct analog acoustic signals from a transducer array to ASIC 1268. Alternatively or additionally, conductive traces 1270 can be configured to conduct digital signals between ASICs. A first subset 1271 of the multiple conductive traces can be configured to communicate between a first ASIC 1268A and a second ASIC 1268B. A second subset 1272 of the multiple conductive traces on transducer 1260 can be configured to conduct signals between a second ASIC 1268B and a third ASIC 1268C.

[0118] The first subset 1271 and the second subset 1272 of the multiple conductive traces may each be a directional or dedicated connection only between subsets of ASICs 1268a-1268c. In some embodiments, ASICs 1268a-1268c may include multiplexing circuitry to combine signals transmitted from adjacent ASICs with information received from the respective transducer arrays. In one embodiment, one of the multiple ASICs 1268a-1268c may be designated as the leader ASIC and may receive signals from all the other ASICs in transducer 1260. In another embodiment and arrangement, ASICs 1268a-1268c may be configured in a cascaded arrangement in which signals are passed in a chain from, for example, a first ASIC 1268a to a second ASIC 1268b, and then all signals are passed to a third ASIC 1268c. In this example, the third ASIC 1268c is configured to pass all signals received from the other two ASICs 1268a and 1268b to the leader ASIC of the imaging system. In other embodiments, processing and transmission may be distributed such that each ASIC 1268a-1268c processes the signal and transmits the signal from its respective array to a designated leading ASCI, or even directly to an imaging system in which the signal is subsequently correlated to form a single ultrasound image.

[0119] One or more common conductive traces 1273 may be configured to extend to and transmit signals to all of the plurality of ASICs 1268a-1268c, such as for providing power to each of the ASICs and / or for status monitoring and / or transmitting reset signals.

[0120] Similar to the embodiments described above, SMP 1262 may include one or more active regions 1266 configured to change shape to adjust the configuration of transducer 1260, such as between folded and planar shapes. SMP 1262 may also include one or more planar regions 1264 configured to remain relatively flat in various configurations, conforming to the flat shape of ASIC 1268 and / or the transducer array. Conductive traces 1270 are configured to conform to the active regions 1266 of SMP 1262, allowing ASICs 1268a-1268c (and corresponding transducer arrays) to move between one or more different configurations. In various embodiments, conductive traces 1270 are configured to be flexible and thus bend and straighten, such as between folded and folded configurations, as active regions 1266 grow and flatten. Alternatively or additionally, conductive traces 1270 may be configured to conform to the effective regions 1266 as they contract and expand or shrink and stretch. As described above, the SMP 1262 can be configured to change between an expanded shape and a contracted shape, as described above regarding... Figure 5B As shown and described in the examples. In such embodiments, the conductive trace 1270 may be configured to adjust for such expansion and contraction, such as having a coiled or serpentine shape.

[0121] exist Figure 12 In one example, conductive trace 1270 is located on the top surface 1261 of SMP 1262. ASICs 1268a-1268c are also adhered to the top surface 1261 of SMP 1262. In various examples, the conductive trace may be printed on the top surface 1261, such as printed silver ink with nanoparticles, printed high-conductivity metal, or any other conductive metal that can be applied to the top surface 1261 by printing. In other embodiments, conductive trace 1270 may be deposited on the top surface 1261 by low-temperature deposition. In yet another embodiment, conductive trace 1270 may be formed by laminating or otherwise adhering a conductive sheet to the top surface 1261, followed by etching away non-conductive areas. In yet another embodiment, conductive trace 1270 may be formed on a wire or film laminated to the top surface 1261 of SMP 1262. In some examples, ASICs 1268a-1268c may also be adhered to a wire or film laminated to the top surface 1261, which in some examples may be a pre-formed single sheet that is then adhered to the top surface 1261 of SMP 1262.

[0122] Figure 13The arrangement of conductive traces 1370 on an embodiment of a transducer 1360 having an external arrangement of SMP 1362 is depicted. In this example, the external arrangement is a discrete arrangement in which a first segment of SMP 1362a is connected between a first ASIC 1368a and a second ASIC 1368b, and a second segment of SMP 1362b is connected between the second ASIC 1368b and a third ASIC 1368c. As described above, other external arrangements of the SMP can be provided, such as where a continuous segment of the SMP is connected between all of the plurality of ASICs 1368a-1368c. In this example, each ASIC 1368a-1368c is connected to one or more of the SMP segments 1362a and / or 1362b at a connection region 1378a. For example, the board of the ASIC may extend and connect to the corresponding SMP segments 1362a, 1362b.

[0123] Each conductive trace in conductive trace 1370 is connected to one or more of the plurality of ASICs 1368a-1368c and is configured to conduct signals thereto. Conductive trace 1378b is printed or otherwise applied to the top surface 1361 of the SMP, such as by any of the methods described above. Alternatively or additionally, one or more conductive traces in conductive trace 1370 may be integrated into or otherwise embedded within SMP 1362, examples of which are described below.

[0124] Each segment 1362a, 1362b of the SMP includes at least one effective region 1366, which is a segment configured to bend or change shape to the maximum extent possible for the SMP. One or more planar regions 1364 are configured to remain relatively flat in various configurations and thus conform to the coupled ASICs 1268a-1268c and / or transducer arrays.

[0125] The first segment 1362a of the SMP manages a first subset 1371 of multiple conductive traces 1370. The second segment 1362b of the SMP holds a second subset 1372 of the conductive traces 1370. The conductive traces in each subset 1371, 1372 pass through the effective region 1366 of the corresponding SMP segment 1362a, 1362b. Therefore, each conductive trace 1370 is configured to conform to the shape transformation of the effective region 1366, and is configured to bend, straighten, stretch, compress, and otherwise conform to the changing shape of the effective region 1366.

[0126] Figures 14A-14DAdditional embodiments of transducers 1460a-1460d are depicted, these transducers having various arrangements of ASIC 1468 and conductive trace 1470 on or within SMP 1462. In these examples, two transducer arrays 1404a and 1404b are provided, each transducer array having a corresponding ASIC 1468a and 1468b. As described above, any number of transducer arrays 1404 and ASIC 1468 can be combined in transducer 1460, and Figures 14A-14C The quantities and arrangements depicted are merely exemplary. SMP 1462 includes one or more active regions 1466 configured to change shape or form between one or more locations to alter the configuration of transducers 1460a-1460d. SMP 1462 also includes one or more planar regions 1464 configured for mounting or otherwise holding ASICs 1468a, 1468b and corresponding transducer arrays 1404a, 1404b.

[0127] exist Figure 14A In this embodiment, each of ASICs 1468a and 1468b is mounted to the top surface 1461 of SMP 1462. Each ASIC 1468a and 1468b is configured to receive and process acoustic signals from corresponding transducer arrays 1404a and 1404b. Each transducer array 1404a, 1404b includes a plurality of transducer elements 1412 that communicate signaling with ASICs 1468a, 1468b.

[0128] Conductive trace 1470a conducts signals between ASICs 1468a and 1468b, such as transmitting processed acoustic data and / or other signals between the ASICs. Conductive trace 1470a is applied to the top surface 1461 of SMP 1462 and electrically connected between ASICs 1468a and 1468b. Various embodiments for applying the conductive trace to the aforementioned top surface 1461 include printing, cryogenic deposition, and lamination of a wire or film to the top surface 1461.

[0129] Figure 14BAnother example of transducer 1460b is shown, wherein ASICs 1468a and 1468b are embedded in SMP 1462. Conductive trace 1470b is also embedded within SMP 1462, and specifically within the effective region 1466 of SMP 1462. For example, SMP 1462 can be layer-formed, wherein a first layer 1462' is formed to cover the entire surface area of ​​transducer 1460b. ASICs 1468a, 1468b and conductive trace 1470b can then be applied to the first layer 1462', wherein exemplary application methods and processes are described above. A second SMP layer 1462'' can then be applied on top of conductive trace 1470b and / or a portion of ASICs 1468a, 1468b. For example, the second layer 1462'' can be applied at the effective region 1466 of SMP 1462.

[0130] Figure 14C Another embodiment of a transducer 1460c having two transducer arrays 1404a and 1404b is depicted. In this embodiment, only one ASIC 1468b is provided, which receives acoustic signals from both transducer arrays 1404a and 1404b. In the depicted cross-sectional portion, the conductive trace 1470c shown is configured to conduct analog signals from acoustic transducer element 1412' to ASIC 1468b. Each transducer element 1412 may be provided with a separate conductive trace 1470 that transmits acoustic information to a single ASIC 1468b positioned below the second transducer array 1404b. Thus, the trace 1470c carrying the analog signal from the first transducer array 1404a must travel through the effective region 1466 of the SMP 1462. In the depicted example, trace 1470c is applied to the top surface of SMP 1462, but in other embodiments, it may be embedded within SMP 1462 or may extend to the bottom surface of SMP.

[0131] Figure 14D An implementation scheme of transducer 1460d is depicted, wherein SMP 1462 is connected only between ASICs 1468a and 1468b and does not provide any connection with... Figures 14A-14C The same backing layer as in the implementation. Here, ASICs 1468a and 1468b are used as backing layers for the corresponding transducer arrays 1404a and 1404b. This implementation can be advantageous because it can be made thinner by eliminating multiple backing layers and providing the backing function using only ASICs 1468a and 1468b.

[0132] In this embodiment, traces 1470 are disposed on the top and bottom surfaces of the SMP 1462. Specifically, in this cross-sectional view, a first trace 1470d' is disposed on the top surface of the SMP 1462, and a second trace 1470d″ is disposed on the bottom surface of the SMP 1462. Both the top and bottom surfaces of the SMP 1462 are used to provide conductive traces, thereby doubling the available surface area of ​​the conductive traces.

[0133] Figures 15A-15C An implementation of a transducer is depicted, wherein each effective region 1566 of the SMP 1562 includes one or more ridges 1580 configured to facilitate movement of the SMP 1562, particularly the effective region 1566, between two or more shapes or transducer configurations. For example, the ridges 1580 may be formed by etching, tilting, cutting, or otherwise creating thinned regions or portions within the effective region 1566 of the SMP 1562. In these examples, transducers 1560a-1560c each include three transducer arrays 1504, each transducer array having an associated ASIC 1568. The ASIC 1568 is mounted to the top surface of the SMP 1562, wherein the SMP 1562 spans the entire region of the transducers 1560a-1560c and forms a backing layer for each of the plurality of ASICs 1568 and the transducer array 1504. In other embodiments, the same textured 1580 structure can be applied to the external arrangement of the SMP described above. Similarly, the textured 1580 embodiment can be... Figures 14A-14D The transducers 1560a-1560c depicted are used together, such as in which ASIC 1568 is embedded in SMP 1562 or in which ASIC 1568 forms a backing layer and in which SMP only spans between ASICs providing the effective area 1566.

[0134] exist Figure 15A In this configuration, transducer 1560a includes ridges 1580 in each effective region 1566 of SMP 1562. The ridges 1560 are valleys 1582 in the SMP, extending in a direction orthogonal to the curvature direction 1586 of the effective region 1566. Therefore, each valley 1582 extends longitudinally between transducer arrays 1504. Each valley 1582 has a depth d less than that of SMP 1562. 2 depth d 1 Therefore, valley 1582 is a recess in the effective region 1566 that does not extend entirely through SMP 1562, but only narrows, thins, or otherwise reduces the amount of SMP material in the effective region 1566. This facilitates a change in the shape of the effective region 1566.

[0135] Various configurations of Valley 1582 are available, and Figure 15C Another valley configuration is illustrated below. In some embodiments, a plurality of valleys 1582 may extend orthogonally to the curvature direction 1586 in the effective region 1566, wherein a plurality of parallel and adjacent valleys extend longitudinally between each adjacent pair of transducer arrays 1504. In other embodiments, valleys or other ribbed structures may extend in different directions or may span only a portion of the length or width of the transducer region.

[0136] Conductive trace 1570 extends through the active region 1566 to conduct signals to each ASIC in ASIC 1568 as described above. Conductive trace 1570 may be constructed differently relative to the ridge 1580. For example... Figure 15A As shown, conductive trace 1570 extends along the top surface 1561 of SMP 1562, following the contour of valley 1582. In other embodiments, as described below... Figure 15C As shown, the conductive trace 1570 may be embedded in the SMP 1562 below the valley 1582, or may otherwise be configured to accommodate the curvature of the effective region 1566. Alternatively or additionally, the conductive trace 1570 may be configured to accommodate the contraction or stretching of the SMP in the curvature direction 1586. For example, the conductive trace 1570 may have a serpentine shape that is orthogonally wound with respect to the curvature direction 1586 and is thus configured to accommodate lateral movement—e.g., the contraction and stretching of the effective region 1566.

[0137] Figure 15B An exemplary transducer 1560B is shown, wherein the ridge 1580 includes an aperture or slot 1584 in the SMP 1562 at the effective region 1566. The aperture or slot 1584 extends through a depth d of the SMP 1562. 2 For example, the aperture or slot 1584 may be formed as a mesh pattern or grid extending at least a portion of the longitudinal length between the transducer array 1504 and / or the ASIC 1568. In other embodiments, the aperture or slot 1584 may be formed at one or more locations along the longitudinal length of the effective region 1566 to facilitate bending or shape change in that region.

[0138] Conductive traces 1570 are formed on the SMP 1562 to extend over holes or slots, such as at holes or slots, where wires or thin film laminations are applied to the top surface 1561 of the SMP 1562. Alternatively, multiple conductive traces 1570 may be printed on or otherwise applied to the SMP 1562 in a manner that avoids multiple holes or slots 1584. For example, conductive traces 1570 may be printed or otherwise applied to the top surface 1561 of the SMP 1562 in a continuous region of effective area 1566 between the SMP and the ASIC 1568.

[0139] Figure 15C Another embodiment of the transducer 1560c is depicted, wherein the SMP 1562 has longitudinally extending, orthogonal to the bending direction 1586, valley-shaped ridges 1580 (see [link]). Figure 15A ). Figure 15C Valley 1582' is a triangular cutout or notch in the effective region 1566 configured to facilitate folding or other shape changes. For example, valley 1582 can be formed by etching, tilting, cutting, or by other means for providing a thinned region or portion within the effective region 1566 of SMP 1562. The depth d1' of valley 1582' is less than the depth d2 of SMP 1562. However, the depth d1' of the triangular valley 1582' is greater than... Figure 15A The valley 1582 has a depth d1. However, two valley embodiments with different depth ratios between d1 and d2 are possible and within the scope of this disclosure. In some embodiments, it may be preferred that the depth d1 of valleys 1582, 1582' is at least half or more of the depth d2 of SMP 1562.

[0140] exist Figure 15C In this embodiment, conductive trace 1570 is embedded in SMP 1562 and extends below valley 1582'. In this embodiment, conductive trace 1570 is embedded within SMP 1562 such that it lies below depth d1' within the active region 1566. In some embodiments, SMP 1562 has the conductive trace 1570 embedded therein, and then valley 1582' is cut or etched into the top surface 1561 of SMP 1562.

[0141] Figures 16A-16B Embodiments of transducers 1660a and 1660b are depicted, wherein the effective region 1664 of the SMP contains freely movable layers confined at or near the edges of the transducer array 1604 ASIC 1668. An exemplary embodiment shows three layers, but in other embodiments, any number of two or more layers may be provided. These layers are configured to facilitate shape changes, enabling increased movement of the array 1604 relative to each other. When transducer 1660a is in an unfolded configuration, layer 1663 may have a curved shape, as shown in FIG16a, wherein layers 1663a-1663c have an upwardly curved convex shape. Alternatively, layers 1663a-1663c may be arranged such that they have a downwardly curved concave shape when transducer 1660a is in an unfolded configuration. Figure 16B Another embodiment is shown, wherein layers 1663d-1663f are flat when transducer 1660a is in the deployed configuration.

[0142] The planar region 1664 can be a continuous and uniform SMP, such as... Figure 16A As shown. Alternatively, planar region 1664 may be formed as layers bonded together only at planar region 1664. This embodiment allows conductive traces to be applied to one or more layers during manufacturing to embed the conductive traces within the SMP.

[0143] This written description uses examples to disclose the invention, including the best mode, and also enables those skilled in the art to practice the invention, including making and using any device or system and performing any included methods. The scope of patentability of the invention is defined by the claims and may include other examples that would occur to those skilled in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements that are not indistinguishable from the literal language of the claims, or if they include equivalent structural elements that have minor differences from the literal language of the claims.

Claims

1. A deployable invasive device, the deployable invasive device comprising: A transducer having a plurality of elements connected by at least one shape memory material, the at least one shape memory material being configured to move the plurality of elements relative to each other between a first configuration and a second configuration in response to a stimulus; The shape memory material includes at least one effective region configured to facilitate movement between the first configuration and the second configuration, wherein the shape memory material is arranged externally relative to the transducer, and the external arrangement of the shape memory material includes the at least one effective region; At least two integrated circuits, the integrated circuits being configured to process signals from at least one of the plurality of elements, wherein each of the at least two integrated circuits is configured to provide a mounting surface on which at least one of the plurality of elements is mounted, each of the at least two integrated circuits being spaced apart from each other and including a first end and a second end opposite to the first end, wherein the external arrangement of the shape memory material is disposed at the same first end or the same second end of the first and second integrated circuits in the at least two integrated circuits; and Multiple conductive traces are provided on or in the shape memory material and extend through the effective region. The conductive traces are configured to connect to and conduct signals to the at least one integrated circuit. The conductive traces are configured to conform as the shape memory material moves the element between a first configuration and a second configuration.

2. The apparatus of claim 1, wherein the plurality of elements are arranged in at least one transducer array.

3. The apparatus of claim 2, wherein the plurality of elements are arranged in a plurality of transducer arrays, and the at least one shape memory material is configured to allow the plurality of transducer arrays to move relative to each other.

4. The apparatus of claim 1, wherein each integrated circuit is configured to receive the signal from a different element among the plurality of elements; and At least a portion of the said plurality of traces are configured to conduct signals between the at least two integrated circuits.

5. The apparatus of claim 1, wherein at least a portion of the plurality of traces is configured to conduct analog signals from the at least one element to the at least one integrated circuit.

6. The apparatus of claim 1, wherein the effective region is located between at least one subset of the plurality of elements.

7. The apparatus of claim 1, wherein the shape memory material is configured to fold in response to the stimulus, and wherein the plurality of conductive traces are configured to bend as the shape memory material folds.

8. The apparatus of claim 1, wherein the shape memory material is configured to connect the plurality of elements by attaching to an edge of each element or forming a backing layer of each of the plurality of elements.

9. The apparatus of claim 1, further comprising at least one ridge in the at least one effective region of the shape memory material, wherein the ridge is configured to facilitate movement of the shape memory material between the first configuration and the second configuration.

10. The apparatus of claim 9, wherein the at least one ridge comprises a valley in the shape memory material.

11. The apparatus of claim 10, wherein the valley extends in a direction orthogonal to the curvature direction of the effective region.

12. The apparatus of claim 9, further comprising a plurality of ridges, wherein the ridges are holes or slots extending through a depth of the shape memory material.

13. The apparatus of claim 1, wherein the shape memory material further comprises a plurality of planar regions, each planar region being configured to remain substantially coplanar with at least one of the plurality of elements, wherein each effective region in the at least one effective region is positioned between two planar regions; and The at least one integrated circuit is mounted to at least one planar region of the planar region of the shape memory material.

14. The apparatus of claim 13, wherein each of the at least one integrated circuit is positioned between the shape memory material and one of the plurality of elements.

15. The apparatus of claim 1, wherein the conductive traces and the integrated circuit are applied to the top surface of the shape memory material.

16. The apparatus of claim 15, wherein the plurality of conductive traces are applied to the top surface of the shape memory material by one of: printing the plurality of conductive traces on the top surface, cryogenically depositing the plurality of conductive traces on the top surface, and laminating a wire containing the plurality of conductive traces onto the top surface.

17. The apparatus of claim 1, wherein the conductive traces and / or the integrated circuit are embedded in the shape memory material.

18. The apparatus of claim 1, wherein the shape memory material comprises at least a first layer containing a first effective region and a second layer containing a second effective region, wherein at least a portion of the first effective region is disconnected from the second effective region; and The device further includes a first plurality of conductive traces extending across the first effective region on the first layer and a second plurality of conductive traces extending across the second effective region on the second layer.

19. A transducer for an imaging catheter, the transducer comprising: Multiple elements, the multiple elements being connected by at least one shape memory material, the at least one shape memory material being configured to allow the multiple elements to move relative to each other between a first configuration and a second configuration, wherein the first configuration has a larger footprint than the second configuration; The shape memory material includes at least one effective region, which is configured to change shape to facilitate movement between a first configuration and a second configuration, wherein the shape memory material is arranged externally relative to the transducer, and the external arrangement of the shape memory material includes the at least one effective region; A plurality of integrated circuits connected by the at least one shape memory material, each integrated circuit being configured to process signals from at least one of the plurality of elements, wherein each of the plurality of integrated circuits is configured to provide a mounting surface on which at least one of the plurality of elements is mounted, each of the plurality of integrated circuits being spaced apart from each other and including a first end and a second end opposite to the first end, wherein the external arrangement of the shape memory material is disposed at the same first end or the same second end of at least the first integrated circuit and the second integrated circuit in the plurality of integrated circuits; and Multiple conductive traces on or in the shape memory material, the multiple conductive traces extending through the effective region, each of the conductive traces being connected to at least one of the multiple integrated circuits.

20. The transducer of claim 19, wherein the plurality of elements are arranged in at least one transducer array, and wherein at least a portion of the plurality of conductive traces are configured to conduct signals between the plurality of integrated circuits, and / or at least a portion of the plurality of conductive traces are configured to conduct the signals from at least one of the plurality of elements to one of the plurality of integrated circuits.

21. The transducer of claim 19, further comprising at least one ridge in each effective region of the at least one effective region of the shape memory material.

22. The transducer of claim 21, wherein the at least one ridge comprises a valley in the shape memory material, and wherein the plurality of conductive traces are located on the top surface of the shape memory material, including the top surface of the valley.

23. The transducer of claim 21, further comprising a plurality of ridges in each of the at least one effective region.

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