Medical introducer sheath including an ultrasonic imaging probe

Abstract

The present specification relates to a medical introducer sheath extending in an axial direction between a distal end and a proximal end, and having an axial lumen and a bendable portion extending to the distal end, the bendable portion comprising: an ultrasound imaging probe comprising a number of ultrasound transducers distributed in a matrix form on a transverse face of the medical introducer sheath at the distal end around the axial lumen; a directional coupling adapted to apply a certain curvature to the bendable portion; a sleeve disposed around the directional coupling and comprising a tubular portion and a protruding peripheral portion, the peripheral portion being wrapped in the axial direction around the tubular portion with a number of protruding turns; and, a connecting strip extending in the axial direction from the ultrasound transducers towards the proximal end and distributed around the sleeve; and an elastic structure wrapped in a number of turns around the sleeve and the connecting strip, the elastic structure travelling between the protruding turns.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to French patent application FR2413507, filed on December 5, 2024, entitled “Gaine d’ introduction médicalemunie d’ une sonde d’ imagerie ultrasoniore (medical introductory sheath including an ultrasound imaging probe),” which is incorporated herein by reference to the fullest extent permitted by law. Technical Field

[0003] This specification generally relates to in vivo detection and intervention devices that will be introduced at least partially into the anatomical region of a patient and include an ultrasound imaging probe capable of pointing towards the anatomical region of the patient.

[0004] This specification specifically relates to a medical infeeding device sheath, such as a cannula or catheter, which includes a mid-ultrasound imaging probe integrated into the distal end of the medical infeeding device sheath.

[0005] Medical inlet sheaths may include, for example, an inner lumen suitable for receiving catheters or any other slender medical devices. Background Technology

[0006] Some techniques used for detection and intervention in anatomical regions (such as the heart region) use imaging, such as fluoroscopy or fluorescence fluoroscopy (i.e., X-ray imaging), to help locate and guide medical devices to reach the patient's target area, generally through the patient's vascular system.

[0007] Medical devices that can be guided into a patient's body typically include access devices or medical delivery sheaths, such as cannulas or catheters, diagnostic catheters, and / or therapeutic catheters, such as ablation or replacement catheters.

[0008] Catheters and ultrasound imaging probes have been developed to directly visualize target areas. For example, catheters with integrated ultrasound imaging probes or imaging catheters can be used to image target areas and then guide access devices and treatment catheters into those target areas.

[0009] However, imaging catheters differ significantly from access and treatment catheters. On one hand, they require multiple introduction / removal procedures for various devices, and may even necessitate multiple entry points into the patient, posing risks and discomfort and potentially prolonging intervention time. On the other hand, they require location tracking to monitor the position of each device within the patient, typically performed via fluoroscopy, which can increase X-ray exposure for both patients and healthcare professionals. Cross-checking the positioning of different devices may also be necessary, potentially adding to the time wastage.

[0010] It is desirable to have a detection and intervention device that at least partially overcomes some of the shortcomings of known in vivo detection and intervention devices.

[0011] In particular, there is a need for a medical infeeding sheath suitable for receiving catheters or any other slender medical devices and incorporating imaging capabilities. It would be advantageous if the medical infeeding sheath could be easily oriented and guided to the target anatomical region. Summary of the Invention

[0012] One embodiment overcomes all or part of the disadvantages of known detection and intervention devices.

[0013] One embodiment provides a medical infeeder sheath extending axially between a distal end and a proximal end opposite to the distal end. The medical infeeder sheath has an internal axial lumen located between the distal end and the proximal end, and a bendable portion extending to the distal end, the bendable portion comprising:

[0014] - An ultrasound imaging probe comprising several ultrasound transducers arranged in a matrix on a transverse surface surrounding the distal end of an axial lumen medical delivery device sheath.

[0015] - A directional connector adapted to apply a certain curvature to a bendable portion;

[0016] - A sleeve, disposed around a directional connector, the sleeve comprising a tubular portion and a protruding peripheral portion, the peripheral portion having a plurality of protruding turns wound around the tubular portion in an axial direction, the tubular portion being included between the peripheral portion and the directional connector; and

[0017] - A connecting strip extending axially from the ultrasonic transducer toward the proximal end and distributed around the sleeve; and

[0018] - An elastic structure that is wound into multiple turns around the sleeve and connecting strip, the elastic structure traveling between the protruding turns.

[0019] According to one embodiment, the peripheral portion has a helical shape, the protruding turns correspond to the turns of the helix, and the elastic structure also has a helical shape that travels between the protruding turns.

[0020] According to one embodiment, the protruding turns of the outer portion are protruding rings that are separated from each other along the axial direction and distributed (e.g., regularly distributed) on several circumferences of the tubular portion, and the turns of the elastic structure are also separated from each other and positioned between the protruding rings.

[0021] According to one embodiment, the pitch between the turns of the elastic structure is substantially equal to the pitch between the protruding turns of the peripheral portion, and the turns of the elastic structure are regularly distributed along the axial direction.

[0022] According to one embodiment, the pitch between the turns of the elastic structure is substantially equal to the pitch between the protruding turns of the peripheral portion, and the turns of the elastic structure are irregularly distributed along the axial direction, for example, having a high density around the center of the bendable portion.

[0023] According to one embodiment, the axial lumen is sized to receive the catheter in a sliding and / or rotating manner.

[0024] According to one embodiment, the directional connector includes links, such as ball joints, with two adjacent links engaging to enable pivoting about at least one axis of rotation.

[0025] According to one embodiment, the directional connector includes a link cable that is connected to the link to keep the link abutting against each other and to control the pivoting movement of the link, and thus control the bending of the bendable portion.

[0026] According to one embodiment, the ultrasonic transducers of the ultrasonic probe are distributed in several concentric coronals surrounding an axial lumen, each coronal including several transducers distributed in radial sectors along the coronal portion, for example, the number of coronals is greater than 3, and the number of transducers in each coronal portion is greater than 30.

[0027] According to one embodiment, the ultrasonic transducer is a piezoelectric transducer and is formed by a plurality of annular layers extending around an axial lumen one over another, said annular layers comprising:

[0028] - A piezoelectric layer, which is metallized on each of its inner and outer surfaces and divided into several piezoelectric sectors, such as annular and radial sectors;

[0029] - An impedance matching layer, located within the piezoelectric layer and divided into several impedance matching sectors, each positioned relative to a piezoelectric sector; and

[0030] - An acoustic attenuation layer, which is located below the piezoelectric layer.

[0031] According to one embodiment, the medical implant sheath further includes an interconnect structure comprising a connecting strip, the interconnect structure further including an annular portion disposed between an acoustic attenuation layer and a piezoelectric layer, the annular portion including a metal track connected to an ultrasonic transducer and extending into the connecting strip.

[0032] According to one embodiment, the medical implant sheath further includes an annular end located at a distal end, the end being connected to a directional connector, such as a distal link connected to the directional connector, and the ultrasonic transducer being disposed integrally in a circumferential groove around the axial lumen of the end.

[0033] According to one embodiment, the medical implant sheath also includes an outer sheath surrounding the connecting strip, sleeve, and elastic structure, the outer sheath being made, for example, of a biocompatible material.

[0034] One embodiment provides an in vivo detection and intervention device that includes a medical delivery device sheath as described above.

[0035] According to one embodiment, the device further includes a catheter configured to be introduced into the axial lumen of a medical implant sheath.

[0036] According to one embodiment, the device further includes a control handle at the proximal end suitable for controlling the bending of the bendable portion.

[0037] According to one embodiment, the medical delivery device sheath is a cannula.

[0038] One embodiment provides a method of using an injector sheath.

[0039] According to one embodiment, the method of use includes using the delivery sheath for the treatment of a cardiac condition, such as for implanting a pacemaker, for performing radiofrequency ablation, or for replacing or implanting a heart valve. Attached Figure Description

[0040] The above-described features and advantages, as well as other features and advantages, will be described in detail below with reference to the accompanying drawings of specific embodiments, which are given by way of illustration rather than limitation, wherein:

[0041] Figure 1 This is a schematic diagram of an in vivo detection and intervention device according to one embodiment;

[0042] Figure 2A , Figure 2B and Figure 2C This is a longitudinal sectional view showing an example of a medical implant sheath according to one embodiment;

[0043] Figure 3A and Figure 3B yes Figures 2A to 2C A 3D view of the medical infusion device sheath;

[0044] Figure 3C and Figure 3D It shows Figure 3A and Figure 3B A view of the interconnection structure of the medical implant sheath; and

[0045] Figure 4 This is a schematic diagram illustrating an example of an ultrasound imaging probe of a medical implant sheath according to one embodiment. Detailed Implementation

[0046] In the different figures, the same elements are represented by the same reference numerals. In particular, common structural and / or functional elements in various embodiments may have the same reference numerals and may be arranged with the same structure, dimensions, and material properties.

[0047] For clarity, only steps and elements that aid in understanding the embodiments are shown and described in detail. Specifically, since the embodiments are compatible with all or most known ultrasonic transducer structures, the ultrasonic transducer of the ultrasonic probe is not described in detail.

[0048] Unless otherwise expressly stated, when referring to two elements connected together, it means that there is no direct connection between them except for the conductor, and when referring to two elements joined together, it means that the two elements may be connected or joined via one or more other elements.

[0049] Unless otherwise stated, when referring to two elements that are mounted or positioned on top of each other, it does not necessarily mean that one element is directly mounted or positioned on top of the other, as one or more other elements may be positioned between the two elements.

[0050] In the following description, unless otherwise expressly stated, when referring to absolute positional qualifiers, such as the terms “front,” “back,” “top,” “bottom,” “left,” “right,” etc., or relative positional qualifiers, such as the terms “above,” “below,” “higher,” “lower,” etc., or directional qualifiers, such as the terms “horizontal,” “vertical,” etc., refer to the orientation in the attached figures.

[0051] Unless otherwise specified, the expressions “approximately,” “about,” “substantially,” and “approximately” indicate within 10% or 10°, preferably within 5% or 5°.

[0052] In the following description, unless otherwise stated, when referring to a transducer, it means an ultrasound transducer; when referring to a probe, it means an ultrasound imaging probe; and when referring to a sheath or intubator sheath, it means a medical intubator sheath. A medical intubator sheath can be, for example, a cannula or catheter, or any other medical device used to create access to an anatomical region.

[0053] In the following description, when referring to a catheter, it is broadly defined as a thin, hollow or solid rod-shaped device that generally includes at least one bendable portion and is to be introduced into a region (e.g., cavity, lumen or tube) of a human or animal body.

[0054] Figure 1 This is a schematic diagram of an in vivo detection and intervention device 10 according to one embodiment.

[0055] The device 10 includes a medical delivery sheath 100 and a control handle 12 connected to the proximal end 100B of the sheath 100. The sheath 100 will be introduced into an anatomical region of a human or animal body, for example, for exploration and / or intervention in that anatomical region.

[0056] The sheath 100 has the shape of a tubular rod 102 along its length, within which an axial lumen 104 is defined. The axial lumen 104 is adapted to receive a catheter or any other elongated medical device (not shown). For example, the internal axial lumen 104 is sized to receive a catheter in a sliding and / or rotating manner. The length of the catheter may be substantially equal to the length of the sheath 100 and the length of the tubular rod 102.

[0057] The sheath 100 includes a bendable portion 110 or an orientable portion, i.e., a portion that can be bent to accommodate the anatomical structure of the area into which it is introduced, for example, at an angle between 90° and 180° relative to the axial direction X. The bendable portion 110 extends over a portion of the sheath 100 to the distal end 100A of the sheath 100. The bendable portion 110 has a length of, for example, a few centimeters (cm), such as approximately 4 cm.

[0058] The control handle 12 is adapted to control the forward movement and positioning of the sheath 100, as well as the bending or curvature of the bendable portion 110 of the sheath 100.

[0059] The sheath 100 includes an ultrasound imaging probe 120 at its distal end 100A (which is also the distal end of the bendable portion 110). For example, the probe 120 extends integrally around the axial lumen 104 at the distal end 100A.

[0060] Throughout this instruction manual, the term "proximal" (or "rear") is considered relative to the device as a whole, i.e., in the direction of the control handle, while the term "distal" (or "anterior") refers to the relative direction toward the detection and / or intervention area (target area). The distal end of the medical delivery device sheath corresponds to the end through which the sheath is introduced into the target area, while the proximal end corresponds to the end opposite the distal end.

[0061] Throughout this specification, the term "axial" refers to the axis of device 10 in the X direction, i.e., its maximum dimension (length), which also corresponds to the maximum dimension (length) of sheath 100, while "radial" refers to a direction located in a plane perpendicular to the axial direction X. The term "longitudinal" refers to a direction parallel to the axial direction X, and the term "transverse" refers to a plane or direction perpendicular to the axial direction X. A longitudinal section refers to a section taken in a plane including the X direction, while a transverse section refers to a section taken in a plane perpendicular to the X direction including the radial direction.

[0062] The probe 120 is oriented in a forward-looking manner, that is, oriented from the distal end 100A of the sheath 100 in the forward direction of the sheath 100. In other words, the sheath 100, including the probe 120 at its distal end 100A, is capable of transmitting and receiving ultrasound signals in a generally forward-oriented direction. The probe 120 allows visualization of anatomical regions located relative to the distal end 100A of the sheath 100. In particular, the probe 120 allows visualization of target anatomical regions during or even before and / or after intervention without the need to introduce another catheter including an imaging probe.

[0063] For example, probe 120 can provide real-time ultrasound images of the anatomical region in the direction of the sheath 100's movement through the patient's body. For instance, the ultrasound images generated from probe 120 can be used to guide the sheath 100 to the target area to confirm tissue contact of the catheter within the target area, thereby determining the orientation of the sheath 100 and / or the catheter within the patient, thus monitoring the progression of damage formed in the tissue, or even monitoring adjacent anatomical structures, for example, to avoid undesirable side effects on these structures, thereby monitoring the progress and effectiveness of treatment, etc.

[0064] Advantageously, the sheath 100, including the probe 120, can be used to deploy a catheter in a targeted anatomical region. Advantageously, the sheath 100, including the probe 120, can significantly reduce or even eliminate the use of fluoroscopy (as a means of visualizing the sheath 100 and the catheter) during intervention. In other words, the ultrasound guidance provided by the sheath 100 allows for the limitation or even elimination of fluoroscopic guidance used to introduce the sheath into the targeted region.

[0065] In specific, non-limiting embodiments of the examples, the sheath 100 may be used in conjunction with a catheter positioned in the axial lumen 104 to implant a pacemaker, perform tissue ablation via radiofrequency (RF) ablation or cryoablation, or replace or implant a heart valve, such as performing transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR). However, the examples are not limited to these uses or any particular clinical application.

[0066] The probe 120 includes, for example, an array of ultrasonic transducers, preferably in the form of a matrix of ultrasonic transducers.

[0067] An ultrasonic transducer is a transducer suitable for converting electrical signals into ultrasonic waves and vice versa. Depending on the type of transducer, the electrical signal can correspond to voltage, current, or electric charge.

[0068] The transducer array can include any type of ultrasonic transducer, or even several types of ultrasonic transducers.

[0069] Ultrasonic transducers can be composed of single-crystal or polycrystalline piezoelectric material layers, such as PZT (lead titanate-zirconium oxide), or of composite structures including at least one piezoelectric material layer, such as a PZT layer including a polymer-filled groove.

[0070] Ultrasonic transducers can be microelectromechanical systems (MEMS) or MEMS that implement microelectronic manufacturing techniques. MEMS-type transducers typically include one or more acoustic elements, each comprising one (or more) deformable membranes suspended above a cavity and connected by a common electrode. According to one embodiment, each deformable membrane moves or deforms via a capacitive effect, wherein electrodes are attached to the membrane and separated from the cavity. This type of ultrasonic transducer is known to be abbreviated as CMUT, which stands for capacitive micromechanical ultrasonic transducer or membrane capacitive transducer. According to another embodiment, each deformable membrane moves or deforms via a piezoelectric effect, wherein a piezoelectric material layer includes two electrodes attached to the membrane. This type of ultrasonic transducer is known to be abbreviated as PMUT, which stands for piezoelectric micromechanical ultrasonic transducer or membrane piezoelectric transducer.

[0071] The problem lies in establishing a connection between the ultrasonic transducer of the ultrasonic imaging probe 120 located at the distal end 100A of the sheath and the proximal end 100B where the control handle 12 of the sheath 100 is located, particularly an electrical or even optical connection.

[0072] The ultrasonic transducer is generally connected to the interconnect structure at probe 120, particularly to the conductive rails (generally metallic) connected to the interconnect structure. The interconnect structure extends via connecting (conductive) strips, such as cables, layers, blades, or strips connecting to the conductive rails of the interconnect structure. The connecting strips extend in the axial direction X toward the proximal end 100B of the sheath 100.

[0073] The main difficulty in achieving the connection relates to the bending of the sheath 100, at least the bendable portion 110 of the sheath 100 undergoes significant and relative deformation between the inner and outer sides of the bend. Ideally, the connecting strip should pass through the center of the sheath 100, i.e., within the internal axial lumen 104 of the sheath 100, preferably as close as possible to the axis of the sheath 100, so as to minimize stress / deformation related to the distance from the neutral line when the sheath 100 bends. However, because the axial lumen 104 is used for the passage of catheters or any other slender medical devices, the connecting strip cannot pass through the axial lumen 104, but instead goes around the periphery of the sheath 100. Therefore, the connecting strip moves away from the axis of the sheath 100 and away from the neutral line, especially when the diameter of the sheath 100 is large.

[0074] When the sheath 100 is bent, one half of the semi-cylindrical structure experiences elongation (stretching) on ​​the side opposite to the curvature, while the other half experiences contraction (compression) of the same magnitude. The elongation and contraction caused by the curvature are greater the further away from the axis of the sheath 100 and the closer to the plane of curvature. On the plane of curvature, the connecting strips passing around the periphery of the sheath 100 also experience elongation and contraction caused by the curvature. One existing solution to prevent the connecting strips from experiencing these stresses, or at least to limit them, is to wind them around the sheath 100, for example, in a basically helical manner, so as to evenly distribute the areas experiencing elongation and contraction. However, in addition to the potential technical difficulties in implementing this type of solution within the constrained dimensions of the inlet sheath, which ranges from a few millimeters to tens of millimeters in outer diameter, winding inevitably leads to elongation of the connecting strips, which in turn leads to a proportional increase in electrical losses.

[0075] Furthermore, in the case of transducer arrays with high-density transducers, the interconnection of the transducers is typically high-density within a small and constrained size, which can amplify electrical losses and generally increase costs.

[0076] The following Figures 2A to 3D A solution is shown for establishing a connection between the ultrasonic transducer of the ultrasonic imaging probe 120 and the control handle 12, which allows for the management of elongation and contraction caused by the curvature of the sheath 100 while limiting the length of the connection strip, thereby reducing associated electrical losses.

[0077] Furthermore, a solution is sought to address the elongation and contraction issues caused by the curvature of the sheath, even for transducer arrays with high-density transducers and high-density interconnects, allowing for individual or RCA-type addressing of these transducers.

[0078] Figure 2A , Figure 2B and Figure 2C This is a longitudinal sectional view of an example of a medical implant sheath 200 according to one embodiment. Figures 2A to 2C More specifically, the bendable portion 210 or distal portion 210 of the infeeder sheath 200 is shown. Figure 2A This is a view of the far part 210 of the straight-line structure. Figure 2B This is a view of the structure of the distal portion 210, which is bent at approximately 90°. Figure 2C It is taken from Figure 2B A detailed view of the far side portion 210 of the circle shown.

[0079] When the sheath is bent, it can be referred to as a curved sheath in the technical field of this specification.

[0080] exist Figure 2A In the middle, the axial direction X is straight, while in... Figure 2B and Figure 2C In the middle, the axial direction X is bent.

[0081] Figures 2A to 2C The infuser sheath 200 shown can correspond to Figure 1 The sheath 100, wherein the distal portion 210 corresponds to Figure 1 The bendable part 110 in the middle.

[0082] The sheath 200 is hollow and has an internal axial cavity 204 extending along the axial direction X between the distal end 200A and the proximal end 200B of the sheath 200.

[0083] The distal portion 210 of the medical implant sheath 200 includes a directional connector 211 adapted to apply a certain curvature to the distal portion 210.

[0084] The directional connector 211 includes a plurality of links 212, with two adjacent links engaging to allow pivoting about at least one axis of rotation. For example, the links 212 form a joint.

[0085] The multiple links 212 specifically include:

[0086] - The distal link 212A at the distal end 211A of the connector 211;

[0087] - The proximal link 212B at the proximal end 211B of the connector 211; and

[0088] - Intermediate link 212C between distal link 212A and proximal link 212B.

[0089] Link 212 is made of, for example, a material that may form a sliding bearing between the links, such as:

[0090] - Metals: such as steel, aluminum, tungsten, titanium, etc.;

[0091] - Rigid polymer materials: such as polycarbonate (PC), polymethyl methacrylate (PMMA), etc.; - Ceramic materials: such as alumina (Al2O3), zirconium oxide (ZrO2), silicon carbide (SiC), etc.

[0092] Link 212 is, for example, a ball joint. Those skilled in the art will be able to identify other types of links that can pivot relative to each other about at least one axis of rotation, thereby applying a certain curvature to the bendable portion 210 of the sheath 200.

[0093] Distal link 212A is connected to distal ring 201. Proximal link 212B is connected to proximal ring 202, for example, fitted into proximal ring 202. Rings 201 and 202 may form a reinforcement. Distal ring 201 may be referred to as a "bent head".

[0094] The distal loop 201 is assembled into the end 203 that engages with the distal link 212A, thereby forming an integral distal loop / end / distal link assembly. The end 203 is, for example, an annular end.

[0095] In the example shown, the distal ring 201 has a tapered diameter toward the distal end 200A of the sheath 200. Therefore, the distal ring 201 includes a cylindrical proximal portion 201B with a diameter D1, a cylindrical distal portion 201A with a diameter D2 smaller than the diameter D1, and a truncated tapered portion 201C connecting the portions 201A and 201B.

[0096] In the example shown, the diameter of the end 203 increases toward the distal end 200A of the sheath 200. Therefore, the end 203 includes a cylindrical proximal portion 203B with a diameter D3 (which engages with the distal link 212A), a cylindrical distal portion 203A with a diameter D4 greater than the diameter D3, and a truncated tapered portion connecting portions 203A and 203B.

[0097] Rings 201, 202 and end 203 are hollow, for example annular, and link 212 is annular, or at least shaped to define a hollow central portion, such that sheath 200 retains axial lumen 204, included in distal portion 210.

[0098] The links 212 are held abutting against each other by cables 205, 206 or by connecting cables (e.g., metal cables) passing through grooves 213, 214 formed on the periphery of the links 212.

[0099] Two cables 205 constitute a Figures 2A to 2C The first pair of cables are parallel to each other in the plane, while the other two cables 206 are arranged perpendicular to each other. Figures 2A to 2C A second pair of cables parallel to each other in the plane of the plane. For example, cable 205 allows the distal portion 210 to be in a direction perpendicular to the X direction and parallel to the plane of the plane. Figures 2A to 2C The cable 206 bends on the plane of the plane, while the distal portion 210 allows the cable to be perpendicular to the X direction and perpendicular to the plane of the X direction. Figures 2A to 2C It bends in the direction of the plane.

[0100] For example, cables 205 and 206 each have a distal end held in a distal link 212A, loop 201, or end 203.

[0101] Cables 205 and 206 preferably extend to the proximal end 200B of the sheath 200, for example, extending to... Figure 1 The control handle 12 is visible in the middle. Therefore, cables 205 and 206 can be controlled to control the pivoting movement of link 212, and thus control the bending of the distal portion 210.

[0102] The distal portion 210 of the medical implant sheath 200 further includes a sleeve 215 disposed around the directional connector 211, i.e., around the link 212.

[0103] Sleeve 215 can engage with proximal ring 202 while surrounding directional connector 211. Sleeve 215 can extend around end 203, for example, around proximal portion 203B of end 203.

[0104] The sleeve 215 is made of a flexible material, allowing it to conform to the curvature of the distal portion 210. For example, the sleeve 215 can be made of an elastic material, such as a thermoplastic elastomer (TPE), a polyether block amide (PEBA), or silicone. The sleeve 215 can be made of a biocompatible material, but this is not mandatory, as the sleeve does not come into contact with the external environment of the sheath 200, i.e., it does not come into contact with the environment surrounding the sheath 200 or the environment inside the sheath 200 (in the lumen 204).

[0105] Sleeve 215 includes a generally cylindrical tubular portion 216 and a peripheral portion 217 projecting from the outer wall of the tubular portion 216. The peripheral portion 217 includes a plurality of projecting turns 219 or protrusions. The protrusions 219 project outward in a radial direction, i.e., away from the axis, such that the tubular portion 216 is contained between the protrusions 219 and the link 212.

[0106] In the example shown, the outer portion 217 has a helical, protruding shape that surrounds and winds around the tubular portion 216 in the axial direction X. The protrusions 219 correspond to turns of the helix and are thus connected to each other. The pitch of the helix can be regular or irregular.

[0107] As a variation, the peripheral portion may include a plurality of protruding rings that are separate from each other and wound around the tubular portion 216. The protruding rings are distributed along the axial direction X, for example, regularly distributed over a plurality of circumferences of the tubular portion 216, wherein the protruding rings form protrusions. In this case, the protruding loops forming the protrusions are separate from each other.

[0108] The sheath 200 includes an ultrasound imaging probe 220, referred to as a forward-looking ultrasound imaging probe, at its distal end 200A (which is also the distal end of the distal portion 210), oriented in the forward direction of the sheath 200 from the distal end 200A, as described above. The probe 220 extends integrally around the axial lumen 204 on a transverse surface 200C at the distal end 200A of the sheath 200. The transverse surface 200C is a surface perpendicular to the axial direction X. In this example, the transverse surface 200C is coronal in shape and integrally surrounds the axial lumen 204.

[0109] The probe 220 includes an array of several ultrasonic transducers 225 (in Figure 3A (marked in the middle), these transducer arrays are at least partially positioned in circumferential grooves 203C formed in the end portion 203 of the axial cavity 204.

[0110] The transducer array is preferably a transducer matrix.

[0111] The transducer array can include any number of ultrasonic transducers, for example, between 128 and 1024. The transducer array can, for example, include several concentric coronals, each including several ultrasonic transducers. As described below... Figure 4 As shown in the example, ultrasonic transducers in the same coronary region can be distributed in the radial sector of that coronary region.

[0112] For example, the number of crowns is greater than 3, and the number of transducers (radial sectors) in each crown is greater than 30.

[0113] The transducer is typically connected to the interconnect structure 230 at probe 220 (see below). Figures 3A to 3D (As described herein), specifically, the transducer is connected to the conductive tracks of the interconnect structure. The interconnect structure extends via a connecting strip (conductive) 231, for example via a connecting cable, layer, blade, or strip cable connected to the conductive tracks of the interconnect structure. In the remainder of the description, the connecting strip 231 is referred to as strip cable 231.

[0114] Each of the ribbon cables 231 is made of, for example, a flexible printed circuit. The flexible printed circuit consists of conductive tracks, for example, made of copper, arranged on or inside a flexible insulating substrate made of a dielectric material, typically a polymer, such as polyimide.

[0115] The ribbon cable 231 extends in the axial direction X from the probe 220 toward the proximal end 200B of the sheath 200. For example, in Figure 2A In the configuration shown, the ribbon cable 231 is essentially straight (without a curved sheath).

[0116] 231 ribbon cable Bypass The periphery of the sheath 200, particularly surrounding and along the sleeve 215. For example, a ribbon cable 231 is regularly distributed around the sleeve 215.

[0117] The ribbon cable 231 may extend to the proximal end 200B of the sheath 200. As a variation, the ribbon cable 231 may terminate before the proximal end 200B of the sheath 200 and may be connected, for example, to a flexible conductive layer that extends to or even beyond the proximal end 200B.

[0118] The distal portion 210 of the medical implant sheath 200 further includes an elastic structure 218 wound around the sleeve 215 and the ribbon cable 231. The elastic structure 218 travels along several circumferences between the protrusions 219.

[0119] When the distal portion 210 bends, the elastic structure 218 is adapted to absorb the elongation (extension) of one side E of the sheath 200 (the side opposite to the curvature, or the side with a larger radius of curvature) and the contraction (compression) of the other side F of the sheath 200 (the side with the curvature, or the side with a smaller radius of curvature), while the ribbon cable 231 remains extended in the axial direction X, i.e., it is not necessary to wind the ribbon cable 231 around the sheath 200, thus limiting the length of the ribbon cable and thereby proportionally limiting electrical losses.

[0120] from Figure 2C It can be seen from this:

[0121] - On the side E opposite to the curvature, the ribbon cable 231 extends substantially between the protrusions 219, and the elastic structure 218 extends on this side E; and

[0122] - On one side of the curvature F, the elastic structure 218 in a compressed state presses the ribbon cable 231 against the sleeve 215, and in particular against the protrusion 219 and the tubular portion 216 between the protrusions 219.

[0123] Therefore, the protrusions 219, through their contours formed with the tubular portion 216 and the elastic structure 218, allow the ribbon cable 231 to have a substantially uniform length overall. Those skilled in the art will be able to determine the thickness of the protrusions 219, and possibly the width of the protrusions in the X direction, to achieve this effect.

[0124] The elastic structure 218 is made of a sufficiently soft material to be wound around the ribbon cable 231, for example, made of rubber, elastomer or polymer.

[0125] The cross-section of the elastic structure 218 is, for example, circular, elliptical, rectangular, or polygonal. The elastic structure 218 may also be constructed from a rigid wire in the form of a spring.

[0126] It should be noted that when constructing from a straight line ( Figure 2A Move to the curved structure ( Figure 2B When the elastic structure 218 undergoes deformation, it maintains a relatively low degree of deformation. In fact, the elastic structure 218 moves away from the center of curvature without significant deformation. The elasticity of the structure 218 and its cross-section should preferably be adjusted by those skilled in the art to absorb the deformation of the ribbon cable 231.

[0127] In the example shown, the elastic structure 218 and the peripheral portion 217 are in the form of a helix with several turns, surrounding and traveling along the sleeve 215 in the axial direction X. The turns of the elastic structure 218 travel between the protrusions 219 of the peripheral portion 217.

[0128] As a variation, the elastic structure, and in this case, the peripheral portion, can take the form of several rings that are separate from each other. In this case, the turns of the elastic structure are separate from each other. The rings of the elastic structure are positioned between the protruding rings of the peripheral portion.

[0129] The turns of the elastic structure 218 and the turns of the peripheral portion 217, whether they are connected or separated in the form of rings, can be distributed at regular intervals in the X direction.

[0130] As a variation, the turns of the elastic structure 218 and the turns of the peripheral portion 217, whether they are connected or separated in the form of rings, can be irregularly distributed, for example, with an increased density around the center C of the distal portion 210, where the curvature reaches its maximum value.

[0131] The number of turns of the elastic structure 218 is, for example, between 5 and 150. More generally, those skilled in the art will be able to determine the number of turns based on the buckling angle of the distal portion 210, the outer diameter of the sheath 200, the radius of curvature of the protrusion 219, and the absorption capacity. Those skilled in the art may choose to distribute the elastic structure 218 along essentially the entire length of the sheath 200, rather than just around the bendable portion 210, which can increase the number of turns.

[0132] The outer sheath 207 encloses all the above components, particularly the ribbon cable 231, the elastic structure 218, the sleeve 215, the rings 201 and 202, the end 203, and the cables 205 and 206.

[0133] The outer cover 207 may include a distal end 207A positioned on the probe 220, in which case the outer cover 207 is preferably transparent to ultrasound, for example made of silicone.

[0134] The outer cover 207 is preferably biocompatible, for example made of silicone resin, such as PEBA, or coated with a biocompatible material, such as parylene.

[0135] An inner sheath can be provided around the distal portion 201A of the distal ring 201 (in Figures 2A to 2C (Not visible in the middle), and then the distal portion 203A of the end 203 surrounds the inner sleeve. The inner sleeve is made of, for example, silicone resin.

[0136] As a non-limiting example, the maximum diameter of the axial lumen 204 (i.e., the inner diameter of the distal portion 210 of the sheath 200) is between 2.5 and 25 mm, and the total diameter of the distal portion 210 of the sheath 200 (i.e., the outer diameter of the outer sleeve 207) is between 7 and 30 mm.

[0137] Figure 3A and Figure 3B yes Figures 2A to 2C A three-dimensional view of the medical infusion device sheath 200. Figure 3C and Figure 3D It shows Figure 3A and Figure 3B A view of the interconnection structure 230 of the medical implant sheath. Figure 3A The bendable portion 210 without an outer sheath is shown in a three-dimensional view, while Figure 3B The bendable portion 210 with an outer cover 207 is shown in a three-dimensional view. Figure 3C The details of the interconnect structure 230 deployed perpendicular to the X direction are shown in a 3D view. Figure 3D Another detail of the interconnect structure 230 in a direction parallel to the X direction is shown.

[0138] Figure 3A and Figure 3B The infuser sheath shown corresponds to Figures 2A to 2C The sheath 200 in the middle, wherein the bendable portion corresponds to Figures 2A to 2C The distal portion 210.

[0139] exist Figure 3A In the example, the ultrasonic transducer 225 of the ultrasonic imaging probe 220 is a piezoelectric transducer and is formed by a plurality of annular layers extending one over the other around the axial lumen 204:

[0140] - A piezoelectric material layer 221 (or piezoelectric layer 221) is cut along its entire thickness to form a plurality of sectors of the piezoelectric layer; or piezoelectric sectors: the piezoelectric layer may be metallized on each of its inner and outer surfaces to form an outer metal layer and an inner metal layer, cutting the piezoelectric layer includes cutting the outer metal layer and the inner metal layer, so that each piezoelectric sector includes an outer electrode corresponding to the sector of the cut outer metal layer and an inner electrode corresponding to the sector of the cut inner metal layer; and

[0141] - Impedance matching layer 222 on the piezoelectric layer: The impedance matching layer is usually cut at the same time as the piezoelectric layer to form several sectors of the impedance matching layer, or impedance matching sectors, each impedance matching sector being positioned opposite to the piezoelectric sector and, for example, in contact with the piezoelectric sector to form a stack.

[0142] Instead of a single piezoelectric layer, piezoelectric layers can be stacked.

[0143] The stacking of impedance matching sectors on the piezoelectric sector allows for the formation of all or part of the ultrasonic transducer 225. The stacking of impedance matching sectors and piezoelectric sectors is typically separated from each other by slots or slits.

[0144] The sector can be annular or radial, such that the transducer array includes a crown, each crown including a plurality of transducers 225 distributed along the circumference of the crown.

[0145] An annular layer 223 or backing layer of acoustic damping material is positioned below the piezoelectric layer 221. For example, the backing layer 223 is not segmented.

[0146] The interconnect structure 230 includes an annular portion 232 sandwiched between the backing layer 223 and the piezoelectric layer 221 and connected to the ribbon cable 231.

[0147] The ribbon cable 231 is folded over the end 203 and the sleeve 215.

[0148] like Figure 3C and Figure 3D As shown, the annular portion 232 includes electrical contact pads 234, each of which is connected to a metal track 236. Typically, the contact pads 234 are connected to the transducer 225. The metal track 236 extends into the ribbon cable 231. The contact pads 234 and the metal track 236 are dedicated, for example, to transducer signals. The metal tracks 236 are insulated from each other and are disposed within and / or on an insulating support 237 or a dielectric support. The dielectric support 237 is, for example, in the form of a polymeric material film, preferably flexible, such as polyimide. Several other materials are also suitable for the flexible dielectric support, such as polyester, polyethylene naphthalate, or polyetherimide. The metal track 236 can advantageously be made of a stretchable material, such as gold or copper. This is because the metal track 236 is folded simultaneously with the ribbon cable 231. Furthermore, the interconnect structure 230 includes internal strips 233 or tabs 233. Each tab 233 includes an electrical contact pad 235, which is, for example, a grounding pad.

[0149] The tab 233 is folded on the side of the sheath 200, that is, in the axial cavity 204, for example, in contact with the inner wall of the distal ring 201.

[0150] The annular portion 232 is connected to the strip cable 231 and the tab 233 and is located between the strip cable 231 and the tab 233, which extend radially from the annular portion 232 in two directions opposite to each other.

[0151] For example, the number of tabs 233 is equal to the number of ribbon cables 231.

[0152] According to an embodiment, the interconnect structure 230 includes sixteen ribbon cables 231 and eighteen metal rails 236 for each ribbon cable (two for grounding and sixteen for connecting to electrodes of the transducer elements of the ultrasonic probe 220), allowing 256 transducers to be electrically connected independently.

[0153] For example, the metal tracks 236 have a width of approximately 20 μm and are spaced apart at approximately 50 μm intervals, and the ribbon cable has a width of approximately 2 mm. Thinner and denser metal tracks can be created between them. For example, the metal tracks 236 can have a width of less than 15 μm, such as approximately 5 μm, and a spacing of less than 25 μm, such as approximately 5 μm. This allows for the electrical connection of more transducers, such as more than the 256 transducers shown in the example of interconnection structure 230.

[0154] According to another solution for electrically connecting more transducers, which can be combined with the previous solution, the interconnection structure 230 can include several interconnection layers on and / or in the dielectric support 237, and each interconnection layer can be similar to the interconnection layers described above, and the metal tracks of different interconnection layers are connected to each other by vertical connections called "vias". This allows for the interconnection of a very large number of transducers, typically more than 256, such as 512 transducers similar to those described above for two interconnection layers, 768 transducers similar to those described above for three interconnection layers, 1024 transducers similar to those described above for four interconnection layers...

[0155] The interconnect structure 230 can be a flexible printed circuit board or "FPCB".

[0156] Figure 3B It is shown that the outer sheath 207 can extend over the probe 220 (part 207A), as further described below, and it can also extend inside the axial lumen 204, contacting the inner wall of the sheath 200.

[0157] Figure 4 This is a schematic diagram illustrating an example of an ultrasound imaging probe 420 of a medical implant sheath according to one embodiment.

[0158] The ultrasound imaging probe 420 can correspond to Figure 2A , Figure 2B and Figure 3A The ultrasound imaging probe 220. The medical delivery device sheath can correspond to... Figures 2A to 2C Sheath 200.

[0159] In the ultrasound imaging probe 420, the transducer array includes a plurality of concentric crowns surrounding an axial lumen 204, each crown including a plurality of transducers 425. In this example, the transducer array includes the same number of transducers for all crowns, substantially equal surface areas for all transducers, and substantially constant spacing between the transducers. In the example shown, the transducer array includes eight crowns, and each crown has 128 transducers, thus forming a transducer matrix of 1024.

[0160] In the ultrasound imaging probe 420, the first electrode of each transducer 425 is individually connected to the conductive track of the interconnect structure 230, and the second electrode is connected to a common ground together with the other second electrodes of the other transducers of the probe 420, so that each transducer can be driven individually.

[0161] As a variation, the first electrodes of transducers 425 in the same angular sector can be connected to each other, and the second electrodes of transducers in the same crown can also be connected to each other. This results in a transducer matrix that can be driven by radius-angle, with a driving principle similar to a matrix that can be addressed by row and column (RCA). The advantage of this variation is that it reduces the number of connections required for the same number of transducers, or increases the number of transducers required for the same number of connections. Figure 4 In the example, probe 420 would require 8 plus 128 or 136 connections instead of 1024.

[0162] The examples of the described embodiments demonstrate that a medical implant sheath can be adapted to receive a catheter or any other elongated medical device and include imaging capabilities. Furthermore, the medical implant sheath can be oriented while allowing electrical connection of the ultrasound transducer.

[0163] The medical delivery sheath according to the embodiment can be applied in the treatment of heart diseases, such as pacemaker implantation, radiofrequency ablation (RF ablation), or replacement or implantation of heart valves, such as transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR). The sheath is typically used in conjunction with a catheter or any other elongated medical device positioned within the axial lumen of the sheath. Other applications are envisioned that combine a catheter-type elongated medical device to realize a medical delivery sheath including an ultrasound imaging probe according to the embodiment.

[0164] Various embodiments and variations have been described. Those skilled in the art will understand that certain features of these different embodiments and variations can be combined, and other variations will be apparent to those skilled in the art.

[0165] Finally, based on the functional indications given above, the actual implementation of the described embodiments and variations is within the capabilities of those skilled in the art.

Claims

1. A medical inlet sheath (100; 200) extending in an axial direction (X) between a distal end (100A; 200A) and a proximal end (100B; 200B) opposite to the distal end, the medical inlet sheath having an internal axial lumen (104) located between the distal end and the proximal end; 204) and a bendable portion (110; 210) extending to the distal end, the bendable portion comprising: - An ultrasound imaging probe (120; 220; 420) comprising a plurality of ultrasound transducers (225; 425) arranged in a matrix around the axial lumen (104; 204) on a transverse surface (200C) of the medical delivery device sheath located at the distal end (200A). - Oriented connector (211), which is adapted to apply a certain curvature to the bendable portion (210); - A sleeve (215) disposed around the directional connector (211), the sleeve comprising a tubular portion (216) and a protruding peripheral portion (217), the peripheral portion being wound around the tubular portion (216) in the axial direction (X) into a plurality of protruding turns (219), the tubular portion (216) being included between the peripheral portion (217) and the directional connector (211); and - Connecting strip (231), which extends from the ultrasonic transducer (225; 425) in the axial direction (X) toward the proximal end (200B) and is distributed around the sleeve (215); as well as - An elastic structure (218) is wound around the sleeve (215) and the connecting strip (231) in multiple turns, the elastic structure (218) traveling between the protruding turns (219).

2. The medical implant sheath (200) according to claim 1, wherein, The outer portion (217) has a spiral shape, the protruding turns (219) correspond to the turns of the spiral, and the elastic structure (218) also has a spiral shape that travels between the protruding turns (219).

3. The medical implant sheath according to claim 1, wherein, The protruding turns of the outer portion are protruding rings, which are separated from each other along the axial direction and distributed, for example, regularly distributed on several circumferences of the tubular portion. The turns of the elastic structure are also separated from each other and positioned between the protruding rings.

4. The medical implant sheath (200) according to any one of claims 1 to 3, wherein, The pitch between the turns of the elastic structure (218) is substantially equal to the pitch between the protruding turns (219) of the peripheral portion (217), and the turns of the elastic structure are regularly distributed along the axial direction (X).

5. The medical delivery device sheath according to any one of claims 1 to 3, wherein, The pitch between the turns of the elastic structure is substantially equal to the pitch between the protruding turns of the peripheral portion. The turns of the elastic structure are irregularly distributed along the axial direction (X), for example, having a high density around the center (C) of the bendable portion (210).

6. The medical delivery device sheath according to any one of claims 1 to 5, wherein, The axial lumen is sized to receive the catheter in a sliding and / or rotating manner.

7. The medical implant sheath (200) according to any one of claims 1 to 6, wherein, The directional connector (211) includes links (212), such as ball joints, where two adjacent links engage with each other to enable pivoting about at least one axis of rotation.

8. The medical implant sheath (200) according to claim 7, wherein, The directional connector (211) includes link cables (205, 206) connected to the link (212) to keep the links abutting against each other and to control the pivoting movement of the links (212), and thus to control the bending of the bendable portion (210).

9. The medical implant sheath (200) according to any one of claims 1 to 8, wherein, The ultrasonic transducers (225; 425) of the ultrasonic probe (220; 420) are distributed in a plurality of concentric coronals surrounding the axial lumen (204), each coronal including a plurality of transducers distributed in radial sectors along the coronal portion, for example, the number of coronals is greater than 3, and the number of transducers in each coronal portion is greater than 30.

10. The medical implant sheath (200) according to any one of claims 1 to 9, wherein, The ultrasonic transducer (225) is a piezoelectric transducer and is formed by a plurality of annular layers extending one over the other around the axial lumen (204), the annular layers comprising: - A piezoelectric layer (221) is metallized on each of its inner and outer surfaces and is divided into several piezoelectric sectors, such as annular and radial sectors; - Impedance matching layer (222), which is located on the piezoelectric layer (221) and divided into several impedance matching sectors, each impedance matching sector being positioned relative to the piezoelectric sector; and - Acoustic attenuation layer (223), which is located below the piezoelectric layer (221).

11. The medical implant sheath of claim 10, further comprising an interconnect structure (230) including the connecting strip (231), the interconnect structure further comprising an annular portion (232) disposed between the acoustic attenuation layer (223) and the piezoelectric layer (221), the annular portion including a metal track (236) connected to the ultrasonic transducer (225) and extending into the connecting strip (231).

12. The medical implant sheath (200) according to any one of claims 1 to 11, further comprising an annular end (203) located at the distal end (200A), the end being connected to the directional connector (211), for example, to a distal link (212A) of the directional connector, the ultrasonic transducer (225) being disposed integrally around the axial lumen (204) in a circumferential groove (203C) of the end.

13. The medical implant sheath according to any one of claims 1 to 12, further comprising an outer sheath (207) surrounding the connecting strip (231), the sleeve (215) and the elastic structure (218), the outer sheath being made of, for example, a biocompatible material.

14. An in vivo detection and intervention device (10) comprising a medical implant sheath (100; 200) according to any one of claims 1 to 13.

15. The device (10) of claim 14 further includes a catheter configured to be introduced into the axial lumen (104; 204) of the medical implant sheath (100; 200).

16. The device (10) according to claim 14 or 15 further includes a control handle (12) at the proximal end (100B; 200B) adapted to control the bending of the bendable portion (110; 210).

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