JP2010531718A - Improved catheter - Google Patents

Abstract

  An improved catheter is provided. The catheter can have a deflecting member located at the distal end of the catheter. The deflection member may comprise an ultrasonic transducer array. The catheter can include a lumen extending from the proximal end of the catheter to the distal end. The lumen may be used to deliver the interventional device to a point more distal to the catheter distal end. The deflection member may be selectively deflected in a pivot-like manner over an arc of at least 90 degrees. In embodiments where the deflecting member comprises an ultrasonic transducer array, the ultrasonic transducer array is operable to image both when aligned with the catheter and when rotated relative to the catheter. When rotated with respect to the catheter, the ultrasound transducer array can have a field of view distal to the distal end of the catheter.

Description

  This application claims priority from US Provisional Application No. 60 / 946,807, filed June 28, 2007, entitled “Ultrasound Catheter”, which is hereby incorporated by reference in its entirety, Claimed priority of US patent application Ser. No. 12 / 163,325, filed Jun. 27, 2008, entitled “Improved Catheter”, which is hereby incorporated by reference in its entirety.

  The present invention relates to an improved catheter, and more particularly to imaging and interfacing that can be used to obtain a target image such that an interventional device is located at a desired location in a patient's body and / or a delivery target location. It relates to catheters for the delivery of conventional devices (eg, diagnostic or therapeutic devices, ultrasound catheters with drug or energy delivery capabilities).

  A catheter is a tubular medical device that is inserted into a body vessel, body cavity, or duct and can be manipulated using a portion that extends outside the body. Typically, the catheter is relatively thin and flexible, facilitating advancement / retraction along a non-linear path. The catheter can be used for a variety of purposes, including internal body positioning of diagnostic and / or therapeutic devices. For example, the catheter can be used to position internal imaging devices, deploy implantable devices (eg, stents, stent grafts, vena cava filters, etc.), and / or energy delivery (eg, ablation catheters).

  In this regard, the use of ultrasound imaging techniques to acquire visual images of structures is becoming increasingly common, especially in the medical field. Roughly speaking, an ultrasonic transducer usually consists of a number of individually actuated piezo elements, which are provided with appropriate drive signals so that a pulse of ultrasonic energy moves through the patient's body. The ultrasonic energy is reflected at the interface between the structures of varying acoustic impedance. The same or different transducers detect return energy reception and provide a corresponding output signal. This signal is processed in a known manner to produce an image of the interface between the structures, but also an image of the structure itself as a visible image on the display screen.

  In order to perform very accurate surgery, many prior patents discuss the use of ultrasound imaging in combination with its own surgical instruments. For example, many patents use ultrasound technology to guide a “biopsy gun”, a device that takes a tissue sample from a specific area as a pathology test, to determine whether a specific tissue is a malignant tumor, etc. It shows that Similarly, other prior art patents discuss the use of ultrasound imaging techniques for other sensitive tasks such as assisting in the removal of viable egg cells from in vitro fertilization and related purposes. .

  Along with the development of internal diagnosis and therapy, there is a need to improve the imaging of treatment procedures using a compact and easy to operate catheter. In particular, current inventors have facilitated the selective positioning and control of components located at the distal end of the catheter while maintaining a relatively small profile, thus providing enhanced functionality for various clinical applications. Recognizing the desirability of providing such a catheter feature.

  The present invention relates to improved catheter design. For this purpose, a catheter is defined as a device that can be inserted into a body vessel, body cavity, or duct, at least a portion of the catheter extending out of the body, manipulating that portion of the catheter extending out of the body, and The catheter can be manipulated and / or removed from the body by pulling. In various designs, the catheter has an outer tubular body with a wall, a proximal end, and a distal end. The catheter may further comprise a deflection member located at the distal end of the outer tubular body. The deflection member may comprise one or more therapeutic devices and / or diagnostic devices. For example, the deflection member can include an imaging device such as an ultrasonic transducer array. The deflecting member can be selectively deflected with respect to the outer tubular body, and the operation of the component having the deflecting member can be facilitated.

  In a further aspect, at least a portion of the deflecting member can be permanently disposed outside the outer tubular body. In this regard, the deflection member may be selectively deflected away from the central axis of the outer tubular body. In certain embodiments, such deflectability may be at least partially or completely peripheral to the distal end of the outer tubular body.

  In one aspect, the catheter may also include a lumen that carries the interventional device to extend through the outer tubular body from the proximal end of the outer tubular body toward a distal point thereof. it can. For this purpose, an “interventional device” is an unlimited number of diagnostic devices [eg pressure transducer, conductivity measuring device, temperature measuring device, flow measuring device, electronic neurophysiological mapping device, material detecting device, imaging device, center Venous pressure (CVP) monitoring device, intracardiac echocardiography (ICE) catheter, balloon sizing catheter, needle, biopsy tool], treatment device [eg, ablation catheter (eg, radio frequency, ultrasound, and optics) , Patent foramen ovale (PFO) closure device, cryotherapy catheter, vena cava filter, stent, stent implantation, nasal septum tool], and drug delivery device (eg, needle, cannula, catheter, long member). For this purpose, “medicament” includes, without limitation, therapeutic agents, pharmaceuticals, compounds, biological compounds, genetic material, dyes, saline, and contrast agents. The drug may be a liquid, gel, solid, or other suitable form. Further, the lumen itself may be used for drug delivery without using an interventional device. By providing a lumen as an interventional device in combination with a deflecting member, the multifunctionality of the catheter is promoted. This is advantageous because it reduces the number of catheters and administration sites required during the procedure, offers the potential to reduce interventional processing times, and further improves ease of use.

  In this regard, the lumen may be formed by the inner surface of the wall of the outer tubular body in some embodiments. In other embodiments, it may be formed by the inner surface of the inner tubular body placed in the outer tubular body and extending from its proximal end to its distal end.

  In a further aspect, the deflecting member may be selectively deflectable over an arc of at least 45 degrees, and in various embodiments at least 90 degrees. For example, the deflection member may be deflectable in a pivot-like manner around a pivot or hinge axis over an arc of at least 90 degrees. Furthermore, the deflection member can be selectively deflected or held at a plurality of positions over a range of different tilt positions. Such an embodiment is particularly suitable when implementing a deflection member having an imaging device.

In some embodiments, the deflection imaging device is exposed from a first position for lateral monitoring in an exposed state (eg, where at least a portion of the opening of the deflection imaging device does not interfere with the outer tubular body). Can be selectively deflected to a second position for forward monitoring. As used herein, “lateral monitoring” is defined as the position of a deflection imaging device as described above, oriented so that the field of view of the deflection imaging device is substantially perpendicular to the distal end of the outer tubular body. Is done. “Forward monitoring” includes the above-described state in which the imaging field of view of the deflecting imaging device is at least partially deflected, thereby enabling imaging of a volume portion far from the distal end of the catheter. For example, the deflection imaging apparatus (for example, an ultrasonic transducer array) may be aligned with the central axis of the outer tubular body at the first position (for example, an arrangement parallel to or coaxial with the central axis). Such access methods are adapted to imaging anatomical landmarks during catheter positioning (eg, during insertion and advancement of the catheter into a vessel tract or body cavity), and the resulting anatomical landmarks obtained. The mark image can be used for accurate positioning of the exit port of the lumen with the catheter. Similarly, the ultrasound transducer array may move from a first position for lateral monitoring to a second position for forward monitoring (e.g., at least 45 degrees or 90 degrees depending on the application) relative to the central axis of the catheter. Can be deflected. Then, the interventional device passes through the lumen of the catheter and advances to a work area in the vicinity of the lumen outlet port and within the imaging field of the ultrasound transducer array, and only imaging from the ultrasound transducer array, or The internal imaging process can be completed using an interventional device in combination with other imaging means (fluoroscopy). The deflecting imaging device can be deflected so that any part thereof does not occupy a volume that has the same cross-sectional area as the exit port and extends from the exit port to the distal end. As such, the imaging field of view of the deflection imaging device is fixed relative to the outer tubular body as the interventional device passes through the outer tubular body, through the exit port, and into the imaging field of the deflection imaging device. May be held in the aligned position.

  In a related aspect, the deflection member may include an ultrasonic transducer having an opening length that is at least as large as the largest transverse dimension of the outer tubular body. Correspondingly, the ultrasonic transducer array is selectively deflected from a first position adapted to the progression of the catheter through the vascular tract to a second position angled with respect to the first position. May be provided. In some embodiments, the second position may be selectively set by the user.

  In a related aspect, it may be deflectable from a first position aligned with (eg parallel to) the central axis of the catheter toward a second position angled with respect to the central axis, When in position 2, the deflection member will be located outside the working area adjacent to the lumen exit port. In such cases, the interventional device may be able to travel through an exit port that does not interfere with the deflection member.

  In some embodiments, the deflecting member can be provided such that its cross-sectional shape matches the cross-sectional shape at the distal end of the outer tubular body. For example, when using a cylindrical outer tubular body, the deflecting member is placed beyond the distal end of the outer tubular body, adjacent to such distal end, and the fictitious formed Formed to conform to the cylindrical volume (eg, slightly exceeding, occupying, or shaped to fit within the volume) and the deflecting member selectively deflects out of such volume You may be able to do it. This approach facilitates the initial progression and positioning of the catheter through the vascular tract.

  In some embodiments, the deflecting member may be deflected along an arcuate track extending away from the central axis of the outer tubular body. As an example, in various implementations, the deflection member deflects from a first position remote from the lumen outlet port to a second position that is lateral to the outer tubular body (eg, one side of the outer tubular body). Can be arranged.

  In another aspect, the deflection member may be provided to deflect from the longitudinal axis of the catheter, and this deflection may form a displacement arc. In a catheter having a tip fixed relative to the outer tubular body, the arc of displacement is the minimum curvature of the catheter. In the case of a catheter having a deflecting member movable with respect to the outer tubular body, the arc of displacement is the smallest arc that is the tangent to the catheter surface or the tangent to the central axis of the catheter. Currently, the deflection member may be provided such that the ratio of the maximum transverse dimension of the distal end of the outer tubular body to the arc radius of this displacement is at least about 1. As an example, for a cylindrical outer tubular body, this ratio is defined by the outer diameter of the distal end of the outer tubular body that exceeds the arc radius of displacement, and such ratio is set to at least about 1. It is preferable.

  In another aspect, the deflection member can be interconnected to the body of the catheter at the distal end of the outer tubular body. As will be further described, such interconnections can provide support functions and / or selective deflection functions. With respect to the latter, the deflection member may be able to deflect about a deflection axis that is offset from the central axis of the outer tubular body. For example, the deflection axis may be included in a plane transverse to the central axis of the outer tubular body and / or in a plane extending parallel to the central axis. As for the former, in one embodiment, the deflection axis may be included in a plane extending perpendicular to the central axis. In certain implementations, the deflection axis may be included in a plane that extends tangentially to the exit port of the lumen that extends through the outer tubular body of the catheter.

  In yet another aspect, the catheter has a lumen for interventional device delivery extending from a proximal end to an outlet port located at a distal end of the outer tubular body, the outlet port comprising the outer It may have a central axis that is coaxially aligned with the central axis of the tubular body. Such an arrangement facilitates the realization of relatively small catheter cross-dimensions, thereby improving the positioning of the catheter (eg, within a small and / or intricate vessel tract). The deflection member is positioned to deflect away from the coaxial central axis, thereby facilitating angled lateral positioning away from the initial catheter introduction (eg, 0 degree) position of the deflection member. Also good. In some embodiments, the deflection member may be able to deflect over an arc of at least 90 degrees.

  In a further aspect, the catheter may comprise a drive device extending from the proximal end to the distal end of the outer tubular body and interconnect the drive device to the deflection member. The drive device and the outer tubular body are arranged for relative movement so that the deflection member can deflect over an arc of at least 45 degrees, corresponding to the relative movement between the drive device / outer tubular body of 5 mm or less. You may do it. As an example, in some embodiments, the deflection member may be deflectable over an arc of at least 90 degrees to accommodate relative movement between the drive device / outer tubular body of 1.0 mm or less.

  In a further aspect, the deflection member can be interconnected to the outer tubular body. As one approach, the deflection member may be supportably interconnected to the distal end of the outer tubular body. Similarly, a drive device having one or more elongated members (eg, wire-like structures) is positioned along the outer tubular body and interconnected to the distal end of the deflecting member and pulled to the proximal end of the elongated member The deflection member may be deflected by the distal end of the elongated member by imposing a force (eg, traction force). In this approach, the outer tubular body may be formed with a lumen therethrough for the conveyance of an interventional device extending from the proximal end of the outer tubular body to an outlet port located far from the proximal end. .

  In another approach, the deflecting member is supportably interconnected to one of the outer tubular body and the drive device and can be constrained to the other of the outer tubular body and the drive device by a restraining member (eg, ligature). The restraining member may restrain the movement of the deflecting member by the relative movement between the outer tubular body / driving device and influence the deflection.

  For example, the deflection member may be supportably interconnected to the drive device and constrainably interconnected to the distal end of the outer tubular body. In this approach, the drive device has an inner tubular body that forms a lumen therein for the delivery of an interventional device that extends from the proximal end of the catheter body to an outlet port located far from the proximal end. Yes.

  More particularly, as a further feature, the catheter has an inner tubular body that is disposed within the outer tubular body and relative movement between the inner tubular body / outer tubular body (eg, relative sliding movement). ) May be possible. A deflection member located at the distal end may be supportably interconnected to the inner tubular body. In some embodiments, the deflection member is arranged so that selective deflection of the outer tubular body and the inner tubular body allows the deflection member to be selectively deflected and held in a desired angular direction. Can be done.

  For example, in one implementation, the inner tubular body is slidably advanced and retracted relative to the outer tubular body, and the face-to-face engagement of the two parts is selected relative to the two parts, and It is possible to provide a mechanical joint sufficient to hold the deflection position of the deflection member corresponding to the. Proximity handles may also be provided to facilitate maintaining a selected relative position between these two parts.

  In another aspect, the catheter may comprise a drive device that extends from the proximal end to the distal end of the outer tubular body and is movable relative to the outer tubular body to impose a deflection force on the deflection member. In this regard, the drive device may be provided such that the drive device transmits the deflection force from the proximal end to the distal end in a balanced distribution around the central axis of the outer tubular body. As can be appreciated, such balanced distribution of force facilitates unbiased catheter bending control and improved positioning characteristics.

  In combination with one or more of the aspects described above, the catheter is supportably interconnected to the outer tubular body or the included drive device (eg, inner tubular body) in certain embodiments. A hinge may be provided. The hinge is structurally separate from the catheter body (eg, outer tubular body or inner tubular body) and can be securely interconnected thereto. The hinge may further be securely interconnected to the deflecting member so that the deflecting member can deflect in a pivot-like manner. By imposing a predetermined driving force, the hinge is at least partially elastically deformable from the first configuration to the second configuration, and releasing the predetermined driving force causes at least a second operation. You may make it return from a form to a 1st form. Such a function allows the drive device to move from an initial first position to a desired second position by applying a predetermined drive force (e.g., a pulling force, a traction force, or a compression pressing force applied thereto). And a deflection member that is selectively actuable via the selective release of the driving force so that it can be automatically and at least partially retracted to the initial first position. However, the continuously deflectable positioning / withdrawing of the deflecting member can be performed during a given processing procedure to improve functionality in various clinical applications.

  In some embodiments, the hinge member is provided with sufficient column strength to reduce unintentional deflection of the deflection member during catheter positioning (eg, due to mechanical resistance associated with the course of the catheter). sell. As an example, the hinge member may exhibit a column strength at least equal to that of the outer tubular body.

  In some implementations, the hinge may be part of a one-piece unitary member. For example, the hinge may be formed from a shape memory material (eg, nitinol). In one approach, the hinge member comprises a curved first portion and a second portion interconnected thereto, the second portion being around a deflection axis defined by the curved first portion. It may be possible to deflect by. As an example, the curved first portion may have a cylindrical surface. In one embodiment, the curved first portion has two cylindrical surfaces each having a central axis that is included in a common plane and obliquely intersecting each other, and the two cylindrical surfaces can form a narrow saddle-type structure. .

  In yet another aspect, the outer tubular body can be configured to easily include an electrical component at its distal end. More specifically, the outer tubular body can have a plurality of interconnected conductors extending from its proximal end to its distal end. For example, in one embodiment, the outer conductor is interconnected by interconnecting the conductors in a ribbon-like member that is helically disposed about coaxially along the entire catheter central axis, or at least a portion of the central axis. It is possible to improve the quality of the structure with respect to the wall surface of the body and avoid applying excessive stress to the conductor when the outer tubular body is curved. For example, in one embodiment, the conductor quality may be knitted along at least a portion of the central axis of the catheter to improve the structural quality of the outer tubular wall surface. The outer tubular body further includes a first layer extending from the proximal end to the distal end inside the plurality of first conductors, and from the proximal end to the distal end outside the plurality of first conductors. And a second layer extending. The first tubular layer and the second tubular layer are each provided with a dielectric constant of about 2.1 or less, so that a body fluid outside the catheter and inside the lumen through the outer tubular body can be provided. The electrostatic coupling between the plurality of conductors may be advantageously reduced.

  In another aspect, the outer tubular body includes a plurality of conductors extending from a proximal end to a distal end thereof, and a set of tubular layers located on the inside and / or outside of the first plurality of conductors. Can be included. This set of tubular layers can have a low dielectric constant layer (eg, closest to the conductor) and a high voltage endurance layer. In this regard, the low dielectric constant layer may have a dielectric constant of 2.1 or lower, and the high withstand voltage layer may be provided to withstand a voltage of at least about 2500 volts AC. Depending on the embodiment, a low dielectric constant and high withstand voltage layer set may be provided on both the inside and the outside of the plurality of conductors along the length direction of the outer tubular body.

  In some embodiments, the tie layer may be sandwiched between a conductor and one or more inner and / or outer layers. As an example, such a tie layer is made of a film material that can have a lower melting temperature than other parts of the outer tubular body, and the tie layer is selected to assemble the above component layers to form an interconnected structure. Alternatively, it may be melted. The tie layer thus selectively melted allows other layers of the tubular body to move relative to each other during manipulation of the outer tubular body (eg, during insertion into a patient).

  For some arrangements, the outer tubular body can further include a shield layer on the outside of the conductor. For example, the shield layer can be provided to reduce electromagnetic noise (EMI) radiation from the catheter itself, as well as to shield the catheter from external electromagnetic noise (EMI).

  In some embodiments, lubricants and / or coatings may also be included in and out of the layer. That is, the inner layer may be disposed inside the first tubular layer, and the outer layer may be disposed outside the second tubular layer.

  In yet another aspect, a first conductor portion extending from the proximal end to the distal end of the catheter and a second conductive portion electrically interconnected to the first conductor portion at the distal end. You may comprise the said catheter with a body part. The first conductor portion may be composed of a plurality of interconnected conductors disposed adjacent to each other with a non-conductive material interposed therebetween. In some implementations, the first conductor portion can be spirally disposed about the central axis of the catheter from its proximal end to its distal end. In combination with such an implementation, the second conductor portion is interconnected to a plurality of interconnected conductors that make up the first conductor portion and at its distal end the center of the outer tubular body It can have a plurality of conductors extending parallel to the axis. In some embodiments, the first conductor portion may be formed of a ribbon-like member contained within the wall of the outer tubular body, thereby contributing to its structural integrity.

  In combination with the above aspect, the first conductor portion defines a first width across the interconnected plurality of conductors, and the second conductor portion corresponds to the corresponding plurality of conductors. A second width that traverses may be defined. In this regard, the second conductor portion may be formed by conductive traces disposed on the substrate. As an example, the substrate may extend between the end of the first conductor portion and electrical components provided at the distal end of the catheter, including, for example, an ultrasound transducer array.

  In various embodiments, the second conductor portion may be interconnected to a deflecting member, and at least a portion of the second conductor portion may be a bendable structure that bends corresponding to the deflection of the deflecting member. More specifically, the second conductor portion can be formed by a conductive trace on the substrate that can be bent in cooperation with the deflection member over an arc of at least 90 degrees.

  In a further aspect, the catheter has a deflection member that includes an ultrasound transducer array such that at least a portion of the deflectable ultrasound transducer array is disposed within the outer tubular body at the distal end. May be. Further, the catheter can include a lumen for delivery of an interventional device that extends from the proximal end to a point farther away.

  In a further aspect, the catheter can have a “steerable” or pre-curved catheter portion near the distal end of the outer tubular body, and the deflection member can have an ultrasonic transducer array. Further, the catheter can include a lumen for delivery of an interventional device that extends from the proximal end to a point farther away.

  In another aspect, the catheter can have an outer tubular body having a wall, a proximal end, and a distal end. The catheter may further comprise a lumen for conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end. The catheter can further include a first conductor portion comprising a plurality of conductors disposed adjacent to each other with a non-conductive material therebetween. The first conductor portion can extend from the proximal end to the distal end. The catheter may further comprise a second conductor portion that is electrically interconnected to the first conductor portion at the distal end. The second conductor portion may have a plurality of conductors. The catheter can further comprise a deflection member located at the distal end. The second conductor portion is electrically interconnected to the deflection member and can bend in response to deflection of the deflection member.

  In another aspect, the catheter can have an outer tubular body having a wall, a proximal end, and a distal end. The catheter may further comprise a lumen for delivering an interventional device extending through the outer tubular body from a proximal end to an outlet port located farther from the proximal end. The catheter further includes a deflecting member, at least a portion of which is permanently located outside the outer tubular body at its distal end and is selectively deflectable relative to the outer tubular body farther than the outlet port. Can be provided. In one embodiment, the catheter further includes a hinge located at a distal end thereof, and the deflection member can be interconnected so as to be supportable by the hinge. In such an embodiment, the deflecting member may be selectively deflectable relative to the outer tubular body about a hinge axis defined by the hinge.

  Many aspects described above have a selectively deflectable imaging device located at the distal end of the outer tubular body of the catheter. An additional feature of the present invention is that a deflection member can be provided instead of such a deflection imaging apparatus. Such a deflection member can comprise an imaging device, a diagnostic device, a therapeutic device, or any combination of these devices.

  In another aspect, a method of operating a catheter is provided that places a deflection imaging device at a distal end thereof. The method can include moving the distal end of the catheter from an initial position to a desired position and acquiring image data from the deflection imaging device during at least a portion of the moving step. Note that the deflection imaging apparatus can be arranged at the first position during the moving step. The method further uses the image data to determine when the catheter is located at the desired position, and after the moving step, deflects the deflection imaging device from a first position to a second position; Advancing the interventional device through the exit port at the distal end of the catheter and into the imaging field of view of the deflection imaging device in the second position.

  In one arrangement, the deflection step further comprises translating the proximal end of the outer tubular body of the catheter and at least one of the drive device relative to the proximal end of the outer tubular body and the other of the drive device. May be included.

  A deflection force may be applied to the hinge according to the translation step. The deflection imaging device can be supportably interconnected to one of the outer tubular body and the drive device by a hinge. The deflection force may be initiated in response to the translation step. The deflection force can be transmitted in a balanced manner around the central axis of the outer tubular body.

  In one arrangement, the position of the deflection imaging device can be held relative to the distal end of the catheter during the moving and acquiring steps. In one embodiment, the deflection imaging device can be in a lateral monitoring state at a first position and in a forward monitoring state at a second position. In one embodiment, the imaging field is maintained in an aligned position that is substantially fixed relative to the distal end of the catheter during the progression step.

  The various features described above in connection with each of the aspects described above can be exploited by any of the aspects described above. Additional aspects and corresponding advantages will become apparent to those skilled in the art from the further description that follows.

It is a figure which shows embodiment of a catheter which arrange | positions the ultrasonic transducer | vibrator array which can be deflected in the edge part. FIG. 2 is a cross-sectional view of the catheter embodiment of FIG. FIG. 3 is a view showing a catheter embodiment in which a deflectable ultrasonic transducer array is arranged at a distal end of a catheter. FIG. 2C shows the embodiment of the catheter of FIGS. 2A and 2B, wherein the catheter further comprises an optional steerable portion. FIG. 2C shows the embodiment of the catheter of FIGS. 2A and 2B, wherein the catheter further comprises an optional steerable portion. It is a figure which shows the catheter another embodiment which arrange | positions the ultrasonic transducer | vibrator array which can be deflected to the distal end of a catheter. It is a figure which shows the catheter another embodiment which arrange | positions the ultrasonic transducer | vibrator array which can be deflected to the distal end of a catheter. Embodiment of a catheter having a conductive wire attached to an ultrasound transducer array located near the distal end of the catheter, the conductive wire extending helically toward the proximal end of the catheter and the catheter FIG. 3 shows a catheter embodiment that is implanted in a wall. FIG. 6 illustrates an exemplary lead assembly. It is a figure which shows embodiment of the catheter which has a deflection | deviation member. FIG. 10 shows a catheter embodiment having a deflecting member that allows the deflecting member to deflect by moving the inner tubular body relative to the outer tubular body. FIG. 10 shows a catheter embodiment having a deflecting member that allows the deflecting member to deflect by moving the inner tubular body relative to the outer tubular body. FIG. 10 shows a catheter embodiment having a deflecting member that allows the deflecting member to deflect by moving the inner tubular body relative to the outer tubular body. FIG. 10 shows a catheter embodiment having a deflecting member that allows the deflecting member to deflect by moving the inner tubular body relative to the outer tubular body. FIG. 3 illustrates an embodiment of electrical interconnection between a helically arranged electrical interconnection member and a flexible electrical member. FIG. 9 shows a catheter embodiment having a deflection member that allows the deflection member to deflect by moving the elongate member relative to the catheter body. FIG. 9 shows a catheter embodiment having a deflection member that allows the deflection member to deflect by moving the elongate member relative to the catheter body. FIG. 9 shows a catheter embodiment having a deflection member that allows the deflection member to deflect by moving the elongate member relative to the catheter body. FIG. 9 shows a catheter embodiment having a deflection member that allows the deflection member to deflect by moving the elongate member relative to the catheter body. FIG. 6 shows another feature where the ultrasound transducer array is located near the distal end of the catheter. By using a drive device attached to the array and extending to the proximal end of the catheter, the array is operable between lateral and forward monitoring. FIG. 6 shows another feature where the ultrasound transducer array is located near the distal end of the catheter. By using a drive device attached to the array and extending to the proximal end of the catheter, the array is operable between lateral and forward monitoring. FIGS. 7A and 7B show various exemplary variations of the catheter of FIGS. 7A and 7B. FIGS. FIGS. 7A and 7B show various exemplary variations of the catheter of FIGS. 7A and 7B. FIGS. FIGS. 7A and 7B show various exemplary variations of the catheter of FIGS. 7A and 7B. FIGS. FIGS. 7A and 7B show various exemplary variations of the catheter of FIGS. 7A and 7B. FIGS. FIG. 5 shows a further embodiment in which the ultrasound array can be deflected. FIG. 5 shows a further embodiment in which the ultrasound array can be deflected. FIG. 5 shows a further embodiment in which the ultrasound array can be deflected. FIG. 6 shows a further alternative embodiment. FIG. 6 shows a further alternative embodiment. FIG. 6 shows a further embodiment. FIG. 6 shows a further embodiment. FIG. 6 shows a further embodiment. It is a figure which shows further embodiment. 6 is a flowchart for an embodiment of a catheter actuation method.

  The following detailed description is directed to various catheter embodiments comprising a deflection member having an ultrasound transducer array and a lumen for carrying an interventional device. Such embodiments are merely exemplary and are not intended to limit the scope of the invention. In this regard, the deflecting member may have a component other than the ultrasonic transducer array or a component added thereto. Further, additional embodiments may employ inventive features that are described herein and that do not require the inclusion of a lumen.

  Ultrasonic transducer arrays assembled on catheters present unique design challenges. Two points of critical significance include the resolution of the video plane and the ability to match the video plane to the interventional device.

  The resolution of the image plane by the ultrasonic array can be approximated by the following equation.

Azimuth Resolution = Constant x Wavelength x Image Depth / Aperture Length For the catheter described here, the wavelength is typically in the range of 0.2 mm (at 7.5 MHz). The constant is in the range of 2.0. The ratio of (image depth / opening length) is a critical parameter. For ultrasound imaging in the 5-10 MHz range for catheters presented here, acceptable resolution can be achieved in the image plane when this ratio is in the range of 10 or less.

  For imaging using catheters in the main blood vessels and the heart, it is desirable to image at a depth of 70-100 mm. Catheters used in the heart and major blood vessels usually have a diameter of 3-4 mm or less. That is, conceptually, the transducer array can be made in any size and placed anywhere in the catheter body, but a transducer array that fits easily in the catheter structure is acceptable for imaging. This model shows that there is not enough width.

  The ultrasound image plane produced by the array placed on the catheter generally has such a narrow width that it is usually referred to as “out-of-plane image width”. For an object to be imaged with an ultrasound image, it is important that the object enters the image plane. When a flexible / bendable catheter is placed in the main vessel or heart, the image plane can be aligned to some extent. While it is desirable to guide a second device placed in the body with an ultrasound image, it is necessary to place the second device in the ultrasound image plane. If both the imaging array and the interventional device are on a flexible / bendable catheter that is inserted into the body, it is extremely difficult to point one interventional device into the ultrasound image plane of the imaging catheter. It is difficult.

  In some embodiments of the invention, ultrasound images are used to guide the interventional device. To achieve this, the device can be placed at a known position that is more stable than the imaging array and / or the interventional device can be matched to the ultrasound image plane and / or can be aligned to the ultrasound image plane. On the other hand, a sufficiently large opening is required to generate an image having an allowable resolution.

  Depending on the implementation, the aperture length of the ultrasound array may be greater than the maximum transverse dimension of the catheter. Depending on the implementation, the opening length of the ultrasound array may be much larger (2 to 3 times) than the diameter of the catheter. However, this large transducer may be sized to fit within the 3-4 mm maximum diameter of the catheter inserted into the body. Once inside the body, the imaging array is placed out of the catheter body with spacing through the interventional device through the catheter, which is then placed in a known position relative to the imaging array. It will be. In one arrangement, the imaging array can be arranged so that the interventional device can be easily held in the ultrasound image plane.

  The catheter can be configured for delivery via skin puncture at a remote vascular access site (eg, a leg vessel). Through this vascular access site, catheters can be introduced into cardiovascular areas such as the inferior vena cava, heart chambers, abdominal aorta and thoracic aorta.

  Positioning the catheter within these anatomical locations is subject to device delivery and treatment conduits for specific target tissues and structures. One example of this is bedside transport of the inferior vena cava filter into a patient where transporting the patient to the catheterization laboratory is at high risk or otherwise undesirable. By using a catheter with an ultrasound transducer array, clinicians can not only identify the correct anatomical site for placement of the inferior vena cava filter, but also under direct ultrasound visualization the vena cava filter It is possible to provide a lumen that enables conveyance of That is, both position recognition and apparatus conveyance can be achieved without withdrawal or replacement of the catheter and / or imaging apparatus. Furthermore, visualization after device delivery allows the clinician to confirm placement and function prior to catheter removal.

  Another use for such catheters is as a conduit that allows delivery of an ablation catheter within the atrium. Although ultrasound imaging catheters are used today in many of these cardiac ablation procedures, it is quite difficult to properly orient the ablation catheter and ultrasound catheter to achieve proper visualization of the ablation site. That is. The catheter described herein provides a lumen through which the ablation catheter can be directed and the positioning of the ablation catheter tip monitored under direct ultrasound visualization. As explained, the coaxial alignment of this catheter, other interventional devices, and the treatment delivery system will provide a means that allows direct visualization and control to be achieved.

  Turning to the drawings, FIG. 1 shows an embodiment of a catheter having an ultrasonic transducer array 7 located at the deflectable distal end of the catheter 1. Strictly speaking, the catheter 1 has a proximal end 3 and a distal end 2. Located at the distal end 2 is an ultrasonic transducer array 7. Attached to the ultrasonic transducer array 7 is at least one conductive wire 4 (such as an ultra-small flat cable) that extends from the array 7 to the proximal end 3 of the catheter 1. At least one conductive wire 4 exits the proximal end of the catheter through the mouth of the catheter wall, or other opening, and provides a transducer driver and a visual image through the device 6 5 is connected.

  FIG. 2A is a cross-sectional view taken along line AA of FIG. As can be seen from FIG. 2A, the catheter 1 has a catheter wall portion 12 that extends at least to the length of the proximal end 3 and forms a lumen 10 that extends at least to the length of the proximal end 3. The catheter wall 12 can be formed from any suitable material, such as an extruded polymer, and can have one or more layers of material. This further shows that at least one conductive wire 4 is located at the bottom of the wall 12.

  The operation of the catheter 1 can be understood with reference to FIGS. 1 and 2B. Specifically, the catheter distal end 2 can be introduced into the desired body lumen and advanced toward the desired treatment site with the ultrasound transducer array 7 in the “side-monitoring” state (shown in FIG. 1). it can. Once the target area is reached, the interventional device 11 is advanced through the lumen 10 of the catheter 1 and exits the distal port 13 and proceeds in the distal direction. As shown, the catheter 1 has an interventional device 11 that travels in the distal direction out of the distal port 13 deflects the distal end 2, resulting in the ultrasonic transducer array 7 being replaced by the “ It can be configured to convert from “side monitoring” to “forward monitoring”. As a result, the doctor can advance the interventional device 11 into the field of view of the ultrasonic transducer array 7.

  The expression “deflectable” here is defined as the ability to move an ultrasonic transducer array, or part of a catheter containing the array, from the longitudinal axis of the catheter body, thereby 1) vibration This means that the face of the child can be fully or partially forward monitored, and 2) the distal outlet port of the delivery lumen and the catheter body can be opened. For “deflectable”, 1) the array and the catheter part including the array can be remotely applied or pulled by force (eg, electrical (wired or wireless) force, mechanical force, oil pressure, air pressure, magnetic force, etc.) "Active deflection", which means moving by force transmission by various means including wires, hydraulic pipes, air pipes, conductors, and 2) including arrays and arrays when in a stationary relaxed state There is “passive deflection” which means that the catheter portion tends to be aligned with the longitudinal axis of the catheter and can be moved by local forces imposed by the introduction of the interventional device 11.

  As shown in FIG. 2B, in some embodiments, the ultrasound transducer array can be deflected up to 90 degrees from the longitudinal axis of the catheter. Further, as shown in FIG. 2C, the deflectable ultrasonic transducer array 7 can be attached to the catheter by a hinge 9. In an embodiment, the hinge 9 can also be a spring-loaded hinge device. Such a spring-loaded hinge can be actuated from the proximal end of the catheter by any suitable means. In an embodiment, the spring-loaded hinge is made of a shape memory alloy that is actuated by removing the outer sheath.

  With reference to FIGS. 2C and 2D, the catheter 1 can further include a steerable portion 8. “Stiable” is defined as the ability to direct a portion of the catheter 1 and lumen 10 farther away than the steerable portion 8 at an angle relative to the catheter near the steerable portion 8 and direct its direction. FIG. 2D shows the steerable portion 8 deflected at an angle relative to the catheter near the steerable portion.

  In a further embodiment, FIGS. 3A and 3B show a catheter 1 comprising an ultrasonic transducer array 7 on the deflection distal end 17 of the catheter 1. The catheter 1 has a proximal end (not shown) and a deflectable distal end 17. The ultrasonic transducer array 7 is disposed at the deflected distal end 17. The conducting wire 4 is attached to the ultrasonic transducer array 7 and extends in the proximal direction toward the proximal end of the catheter 1. The catheter 1 also includes a generally centered lumen 10 that extends from the proximal end to the distal end of the catheter. At the distal end 17, the lumen 10 disposed substantially in the center is basically blocked or blocked by the ultrasonic transducer array 7. Finally, the catheter 1 comprises at least one longitudinal slit 18 that extends through a region close to the ultrasound transducer array 7.

  As can be seen from FIG. 3B, once the interventional device 11 has been advanced through the lumen 10 to the end, the interventional device 11 moves the deflectable distal end 17 and the ultrasound transducer array 7 down. The lumen 10 is opened so that the interventional device 11 travels far beyond the ultrasonic transducer array 7 by being deflected to move.

  In various embodiments described herein, the catheter can be provided in such a manner as to place an ultrasound transducer array near its distal end. The catheter body may be composed of a tube having a proximal end and a distal end. Further, the catheter may have at least one lumen extending from the proximal end to at least near the ultrasound transducer array. A catheter is a conductive wire (eg, a miniature flat cable) attached to an ultrasound transducer array, embedded in a catheter wall, and spirally extending from the ultrasound transducer array toward the proximal end of the catheter. It can have a conductive wire.

  For example, such a catheter is shown in FIGS. 4 and 4A. Specifically, FIGS. 4 and 4A show a catheter 20 having a proximal end (not shown) and a distal end 22 with an ultrasonic transducer array 27 disposed at the distal end 22. Is shown. As can be seen, the lumen 28 is formed by the inner surface of the polymer tube 26, which is a suitably smooth polymer (eg, PEBAX 72D®, PEBAX 63D®, PEBAX 55D®, High-density polyethylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, and combinations of these materials, etc.) and extends from the proximal end to the distal end 22 near the ultrasound transducer array 27. A conductive wire (eg, micro flat cable) 24 is spirally wound around the polymer tube 26 and extends from near the ultrasonic transducer array 27 to near the proximal end. An example of a suitable microminiature flat cable is shown in FIG. 4A, where the microminiature flat cable 24 includes a conductive wire 21 and a suitable ground, such as copper 23, for example. A conductive circuit element 43 (flexboard or the like) is attached to the ultrasonic transducer array 27 and the conductive wire 24. A suitable polymer film layer 40 (smooth polymer, shrink wrap polymer, etc.) can be disposed on the conductive wire 24 to act as an insulating layer between the conductive wire 24 and the shield layer 41. The shield layer 41 may have any suitable conductor as long as it can be spirally wound on the polymer film 40 in a direction opposite to the conductive line 21, for example. Finally, an outer jacket 42 made of any suitable material, such as a smooth polymer, can be provided on the shield layer 41. Suitable polymers include, for example, PEBAX 70D (registered trademark), PEBAX 55D (registered trademark), PEBAX 40D (registered trademark), and PEBAX 23D film. The catheter shown in FIGS. 4 and 4A can include a deflected distal end and a steerable portion as described above.

  The catheter provides a working lumen that facilitates delivery of the interventional device to the imaging region, while providing a means of electrically interlocking with the ultrasound probe at the distal end of the catheter. In addition to providing mechanical properties that enhance kink resistance and torque performance, the catheter structure utilizes conductors to power the array. The novel structure presented here provides a means for packaging conductors and essential shielding in a thin wall. This provides a sheath shape suitable for interventional procedures with an outer diameter targeted at 14 French (Fr) or less and an inner diameter targeted at 8 Fr or greater, typical ablation catheters and filter delivery It facilitates transport of systems, needles, and other common interventional devices designed for blood vessels and other procedures.

  FIG. 5A shows an embodiment of a catheter 50 that includes a deflection member 52 and a catheter body 54. The catheter body 54 may be flexible and bendable following the contour of the body vessel into which it is inserted. The deflection member 52 may be located at the distal end 53 of the catheter 50. Catheter 50 has a handle 56 that may be disposed at the proximal end 55 of catheter 50. During the procedure in which the deflection member 52 is inserted into the patient's body, the handle 56 and a portion of the catheter body 54 remain outside the body. A user of the catheter 50 (e.g., a physician, technician, intervention person) can control the position of the catheter 50 and various functions. For example, the user may operate the slide 58 while holding the handle 56 in order to control the degree of deflection of the deflection member 52. In this regard, the deflection member 52 may be selectively deflectable. With respect to the handle 56 and slide 58, both can be configured such that the position of the slide 58 relative to the handle 56 is maintained, thereby maintaining the selected deflection of the deflection member 52. Such maintenance of position is achieved at least in part by, for example, friction (eg, friction between the slide 58 and the fixed portion of the handle 56), detents, and / or any other suitable means. be able to. The catheter 50 can be removed from the body by pulling (eg, pulling the handle 56).

  In addition, a user can insert an interventional device (eg, a diagnostic device and / or a treatment device) through the interventional device inlet 62. Further, the user can feed the interventional device through the catheter 50 and move the device to the distal end 53 of the catheter 50. The electrical interconnection between the image processor and the deflection member can be routed through the electronic port 60 and the catheter body 54 as described below.

  FIGS. 5B-5E illustrate an embodiment of a catheter with a deflection member 52 where the deflection member 52 is deflected by moving the inner tubular body 80 relative to the outer tubular body 79 of the catheter body 54. It is possible. As shown in FIG. 5B, the illustrated deflection member 52 includes a distal end portion 64. The tip portion 64 can wrap various parts and members.

  The tip 64 may have a cross section corresponding to the cross section of the outer tubular body 79. For example, as shown in FIG. 5B, the tip 64 may have a rounded distal end 66 corresponding to the outer surface of the outer tubular body 79. The portion of the distal end portion 64 that accommodates the ultrasonic transducer array 68 corresponds to at least a part of the outer surface of the outer tubular body 79 (for example, along the lower outer surface of the distal end portion 64 as shown in FIG. 5B). You may form in. At least a portion of the tip 64 may be configured to facilitate transport through the patient's internal structure, such as the vasculature. In this regard, the rounded distal end 66 may help move the deflecting member 52 through the vasculature. Other suitable end shapes can be used as the shape of the distal end of the tip 64.

  For example, in the embodiment as shown in FIGS. 5B-5D, the tip 64 can hold the ultrasonic transducer array 68. As can be seen from FIG. 5B, when the deflection member 52 is aligned with the outer tubular body 79, the ultrasonic transducer array 68 may be in a side monitoring state. The field of view of the ultrasonic transducer array 68 can be arranged to be perpendicular to the flat top surface (in the direction of FIG. 5B) of the ultrasonic transducer array 68. As shown in FIG. 5B, when the ultrasonic transducer array 68 is in the side monitoring state, the field of view may not be blocked by the outer tubular body 79. In this regard, the ultrasound transducer array 68 can be imaged during the positioning of the catheter body 54, thereby enabling imaging of anatomical landmarks that help in positioning the distal end of the lumen 82. The ultrasonic transducer array 68 may have the entire length of the opening. The total length of the opening may be larger than the maximum transverse dimension of the outer tubular body 79. At least a portion of the deflection member 52 can be permanently positioned farther than the distal end of the outer tubular body 79. In some embodiments, the entire deflection member 52 may be permanently positioned beyond the distal end of the outer tubular body 79. In such embodiments, the deflection member may not be positionable within the outer tubular body 79.

  The tip 64 may further have features that allow the catheter to follow the guide wire. For example, as shown in FIG. 5B, the tip 64 can include a distal guidewire hole 70 operatively connected to the proximal guidewire hole 72. In this regard, the catheter can be moved along the guidewire length through the distal and proximal guidewire holes 70,72, respectively.

  As will be appreciated, the deflection member 52 may be deflectable relative to the outer tubular body 79. In this regard, the deflection member 52 may be interconnected to one or more members to control the operation when the deflection member 52 is deflected. The deflection member 52 may be interconnected to the catheter body 54 by a mooring rope 78. One end of the mooring rope 78 may be anchored to the deflecting member 52, and the other end may be anchored to the catheter body 54. The mooring rope 78 can also be configured as a tension member that operates such that each anchor point does not separate from each other at a distance greater than the total length of the mooring rope 78. In this regard, the deflection member 52 may be constrainably interconnected to the outer tubular body 79 through the mooring rope 78.

  The inner tubular body 80 may be disposed in the outer tubular body 79. The inner tubular body 80 can include a lumen 82 that passes through the entire length of the inner tubular body 80. The inner tubular body 80 may be movable with respect to the outer tubular body 79. This movement may be activated by moving the slide 58 of FIG. 5A. A support 74 can interconnect the deflection member 52 to the inner tubular body 80. The support 74 may be structurally separated from the inner tubular body 80 and the outer tubular body 79. The flex board 76 may be provided with an electrical interconnect that electrically connects the ultrasonic transducer array 68 to an electrical interconnect member 104 (shown in FIG. 5E) disposed within the outer tubular body 79. It is. When the deflecting member 52 is in the patient, the exposed portion of the flex board 76 between the tip 64 and the outer tubular body 79 may be encapsulated and isolated from contact with fluid (eg, blood). Good. In this regard, the flex board 76 may be sealed with an adhesive, film wrap, or other suitable component that can isolate the conductor from the surrounding environment. In an embodiment, a mooring rope 78 may be wrapped around the portion of the flex board 76 that is between the tip 64 and the outer tubular body 79.

  The deflection of the deflection member 52 will be described with reference to FIGS. 5C and 5D. 5C and 5D show the deflecting member 52 in a state where a part of the tip end portion 64 surrounds the ultrasonic transducer array 68 and the support 74 is moved. As shown in FIG. 5C, the support 74 can include a tubular body joining portion 84 that can secure the support 74 itself to the inner tubular body 80. Tubular body joining portion 84 can be secured to inner tubular body 80 in any suitable manner. For example, the tubular body joining portion 84 may be fixed to the inner tubular body 80 by an outer shrink wrap. In such a configuration, the tubular body joint portion 84 may first be placed on the inner tubular body 80 and then the shrink wrap member may be placed on the tubular body joint portion 84. Then, the shrink wrap member is contracted by applying heat, and the tubular body joint portion 84 is fixed to the inner tubular body 80. Thereafter, an additional wrapping material may be applied onto the shrink wrap, and the tubular joint portion 84 may be further fixed to the inner tubular body 80. As another example, the tubular body joining portion 84 may be secured to the inner tubular body 80 by an adhesive, a weld, a fastener, or a combination thereof.

  The support 74 may be made of, for example, a shape memory material (for example, a shape memory alloy such as nitinol). The support 74 may further include a hinge portion 86. The hinge portion 86 may be comprised of one or more members that interconnect the tubular body joining portion 84 to the receiving portion 88. As shown in FIGS. 5-5C, the hinge portion 86 may have two members. The receiving portion 88 can support the ultrasonic transducer array 68. The hinge portion 86 as well as the support 74 is sufficient to maintain the deflection member 52 substantially in line with the outer tubular body 79 without the inner tubular body 80 being advanced relative to the outer tubular body 79. Can have strong column strength. In this regard, the deflecting member 52 can remain substantially aligned with the outer tubular body 79 when the outer tubular body 79 is inserted and guided into the patient.

  The hinge portion 86 can be formed so as to be elastically deformed along a predetermined trajectory around the deflection shaft 92 with an actuation force applied thereto. The predetermined trajectory may refer to a trajectory in which the tip portion 64 and the hinge portion 86 are moved toward positions where they do not interfere with the interventional device emerging from the distal end of the lumen 82, respectively. As the interventional device travels through the exit port 81 at the distal end of the lumen 82 and into the field of view, the imaging field of the ultrasound transducer array 68 is substantially maintained in position relative to the outer tubular body 79. sell. As shown in FIGS. 5B to 5D, the hinge portion 2 has two substantially parallel portions 86a and 86b, and ends of the substantially parallel portions 86a and 86b (for example, the hinge portion 86 contacts the receiving portion 88). And where the hinge portion 86 contacts the tubular body joint portion 84) can be formed to substantially coincide with a cylinder oriented along the central axis 91 of the inner tubular body 80. The central portions of the substantially parallel portions 86 a and 86 b can be twisted toward the central axis 91 of the outer tubular body 79 so that the central portions are substantially aligned with the deflection shaft 92. The hinge portion 86 is arranged around a portion smaller than the entire circumference of the inner tubular body 80.

  The inner tubular body 80 may be moved relative to the outer tubular body 79 in order to deflect the deflection member 52 relative to the outer tubular body 79. Such relative motion is shown in FIG. 5D. As shown in FIG. 5D, movement of the inner tubular body 80 in the driving direction 90 (eg, the orientation of the ultrasound transducer array 68 when the deflecting member 52 is aligned with the outer tubular body 79). The force is applied to the support 74 in the driving direction 90. However, since the receiving portion 88 is connected to the outer tubular body 79 while being constrained by the mooring rope 78, the receiving portion 88 is substantially prevented from moving in the driving direction 90. At this point, movement of the inner tubular body 80 in the drive direction 90 results in the receiving portion 88 pivoting about the point of contact with the mooring rope 78, and the hinge portion 86 bends as shown in FIG. 5D. become. That is, by moving the inner tubular body 80 in the driving direction 90, as shown in FIG. 5D, the receiving portion 88 (and the ultrasonic transducer array 68 attached to the receiving portion 88) also rotates 90 degrees. It will be. Therefore, the degree of deflection of the deflection member 52 can be controlled by the movement of the inner tubular body 80. As shown, the deflecting member 52 can be selectively deflected away from the central axis 91 of the outer tubular body 79.

  In the exemplary embodiment, moving the inner tubular body 80 by about 0.1 cm allows the deflecting member 52 to deflect over an arc of about 9 degrees. In this regard, moving the inner tubular body 80 about 1 cm allows the deflection member 52 to deflect over about 90 degrees. In this way, the deflection member 52 can be selectively deflected from the side monitoring state to the front monitoring state. The intermediate position of the deflecting member 52 can be achieved by moving the inner tubular body 80 by a predetermined distance. For example, in the current exemplary embodiment, the deflection member 52 deflects 45 degrees from the lateral monitoring position by moving the inner tubular body 80 about 0.5 cm in the driving direction 90 relative to the outer tubular body 79. Can do. Other suitable member geometries may be incorporated to create other relationships between the inner tubular body 80 and the deflecting member 52 that deflects. Furthermore, a deflection exceeding 90 degrees can be obtained. Moreover, embodiments of the catheter 50 can be configured with respect to the deflection member 52 such that a maximum predetermined deflection is achieved. For example, the handle 56 may be configured to limit the movement of the slide 58 so that the full range of movement of the slide 58 corresponds to 45 degrees of deflection of the deflection member 52 (or other suitable deflection). .

  Slide 58 and handle 56 may be configured such that any relative movement of slide 58 relative to handle 56 results in deflection of deflection member 52. In this regard, a so-called dead zone of the slide 58 that does not cause deflection of the deflection member 52 even if the slide 58 moves may be substantially eliminated. Furthermore, the relationship between the movement of the slide 58 (for example, movement with respect to the handle 56) and the corresponding deflection amount of the deflection member 52 can be substantially linear.

  When the deflecting member 52 is deflected from the position of FIG. 5C so that any portion of the tip 64 does not occupy a cylindrical portion that is the same diameter as the exit port and extends further away, the interventional device will It can travel through the outlet port 81 without contact. As such, while the interventional device travels through the catheter body 54 and enters the imaging field of the ultrasound transducer array 68 through the exit port 81, imaging of the ultrasound transducer array 68 is performed. The field of view can be maintained in a fixed alignment position relative to the catheter body 54.

  When in the forward monitoring position, the field of view of the ultrasonic transducer array 68 can include an area through which an interventional device can be inserted through the lumen 82. In this regard, the ultrasonic transducer array 68 may be useful for positioning and operating the interventional device.

  The deflection member 52 can be deflected about a deflection axis 92 (the deflection axis 92 is shown here as a dot since it extends in the viewing direction of FIG. 5D). The deflection axis 92 can be defined as a point that is fixed relative to the tubular body joining portion 84 and around which the receiving portion 88 rotates. As shown in FIG. 5D, the deflection axis 92 can be offset from the central axis 91 of the outer tubular body 79. For any deflection of the deflection member 52, the displacement arc 93 can be defined as the smallest arc that touches the surface of the deflection member 52 and the center axis 91 of the catheter. In an embodiment of the catheter 50, the ratio of the maximum transverse dimension of the distal end of the outer tubular body 79 to the radius of the displacement arc 93 can be at least about 1.

  The deflecting member 52 can deflect the periphery of the deflection shaft 92 so that the ultrasonic transducer array 68 is close to the outlet port 81. In conjunction with the small displacement arc 93, such positioning reduces the distance traveled by the interventional device from the exit port 81 and into the field of view of the ultrasonic transducer array 68. For example, due to the 90 degree deflection as shown in FIG. 5D, the acoustic surface of the ultrasonic transducer array 68 is smaller than the maximum transverse dimension of the distal end of the outer tubular body 79 (measured along the central axis 91). The ultrasonic transducer array 68 may be positioned so as to be separated from the outlet port 81 with the

  As shown in FIGS. 5C and 5D, the flex board 76 may remain interconnected to the catheter body 54 and the deflection member 52 regardless of the deflection of the deflection member 52.

  FIG. 5E illustrates one embodiment of the catheter body 54. The illustrated catheter body 54 has an inner tubular body 80 and an outer tubular body 79. In the illustrated embodiment, the outer tubular body 79 has all of the parts illustrated in FIG. 5E except for the inner tubular body 80. For illustration of FIG. 5E, portions of various layers have been removed to reveal the structure of the catheter body 54. The outer tubular body 79 can include an outer cover 94. For example, the outer cover 94 may be a high voltage breakdown material. An exemplary structure may have a substantially non-porous laminated film comprising expanded polytetrafluoroethylene (ePTFE) with an ethylene, fluoroethylene, and perfluoride heat seal layer on one side. An exemplary structure may have a width of about 25 mm, a thickness of about 0.0025 mm, an isopropyl alcohol with a boiling point of about 0.6 MPa or more, and a tensile strength in the length direction (eg, the strongest direction) of about 309 MPa. The outer cover 94 may be smooth to assist the passage of the outer tubular body 79 through the patient. The outer cover 94 can provide high voltage breakdown. An outer low dielectric constant layer 96 can be disposed inside the outer cover 94. This outer low dielectric constant layer 96 can reduce the electrical capacitance between the electrical interconnect member 104 and the material (eg, blood) outside the outer cover 94. The outer low dielectric constant layer 96 may have a dielectric constant less than about 2.2. In an embodiment, the thickness of the outer low dielectric constant layer 96 may be about 0.07 mm to 0.15 mm. In embodiments, the outer low dielectric constant layer 96 may be made of a porous material such as ePTFE. The pores of the porous material may be filled with a low dielectric material such as air.

  The next layer toward the center of the outer tubular body 79 is the first tie layer 97. The first tie layer 97 may be made of a film material having a lower melting temperature than the other parts constituting the outer tubular body 79. During manufacture of the outer tubular body 79, the first tie layer 97 can be selectively melted to create an interconnected structure. For example, by selectively melting the first tie layer 97, it can be useful for mutual adhesion between the outer low dielectric constant layer 96, the first tie layer 97, and a shield layer 98 (described later).

  The next layer toward the center of the outer tubular body 79 is a shield layer 98. The shield layer 98 can be used to reduce electrical emissions from the outer tubular body 79. The shield layer 98 can be used to protect components (eg, the electrical interconnect member 104) inside the shield layer 98 from external electrical noise. The shield layer 98 can be in the form of a double side wound shield wire or braid. In the exemplary embodiment, shield layer 98 may have a thickness of about 0.05 to 0.08 mm. The next layer toward the center of the outer tubular body 79 is the second tie layer 100. The second tie layer 100 may be made of a film material having a lower melting temperature than the other components that make up the outer tubular body 79. During manufacture of the outer tubular body 79, the second tie layer 100 can be selectively melted to create an interconnected structure.

  Inside the second tie layer 100 is an electrical interconnect member 104. The electrical interconnect member 104 may have a plurality of conductors arranged in parallel and an insulating (eg, non-conductive) material between each conductor. The electrical interconnect member 104 may include one or more microminiature flat cables. The electrical interconnect member 104 may include any suitable number of conductors arranged in parallel. As an example, the electrical interconnect member 104 may include 32 or 64 conductors arranged in parallel. The electrical interconnection member 104 may be arranged in a spiral within the outer tubular body 79. In this regard, the electrical interconnect member 104 may be helically disposed within the wall of the outer tubular body 79. Also, the electrical interconnection member 104 may be arranged in a spiral so that no part of the electrical interconnection member 104 overlaps. The electrical interconnect member 104 can extend from the proximal end 55 of the catheter 50 to the distal end 53 of the outer tubular body 79. In an embodiment, the electrical interconnect member 104 may be disposed along and parallel to the central axis of the outer tubular body 79.

  As shown in FIG. 5E, a gap having a width Y may be provided between the coils formed of the electrical interconnection members 104 wound in a spiral. Further, the electrical interconnect member 104 may have a width of X as shown in FIG. 5E. The electrical interconnection member 104 can be arranged in a spiral so that the ratio of the width X to the width Y is 1 or more. In such an arrangement, the helically arranged electrical interconnect member 104 can provide greater mechanical strength to the outer tubular body 79. This may obviate or reduce the need to provide a separate reinforcing layer within the outer tubular body 79 in some embodiments. Further, the gap Y may be changed along the length of the outer tubular body 79 (for example, continuously or by a plurality of discontinuous steps). For example, it may be beneficial for the outer tubular body 79 to be more rigid toward the proximal end of the outer tubular body 79. That is, the gap Y may be made smaller toward the proximal end of the outer tubular body 79.

  The inner tie layer 102 can be disposed inside the electrical interconnect member 104. The inner tie layer 102 is configured similarly to the second tie layer 100 and can perform the same function. The inner tie layer 102 may have a melting point of, for example, 160 degrees Celsius. The layer next to the center of the outer tubular body 79 may be the inner low dielectric constant layer 106. The inner low dielectric constant layer 106 is configured similarly to the outer low dielectric constant layer 96 and can perform the same function. The inner low dielectric constant layer 106 may be able to reduce the capacitance between the electrical interconnect member 104 and the material in the outer tubular body 79 (eg, blood, interventional device). The next layer toward the center of the outer tubular body 79 may be the inner cover 108. The inner cover 108 is configured similarly to the outer cover 94 and can perform the same function.

  Each of the tie layers (the first tie layer 97, the second tie layer 100, and the inner tie layer 102) may have substantially the same melting point. In this regard, during manufacture, the catheter body 54 can be exposed to temperatures that are high enough to melt each tie layer simultaneously and secure the various layers of the catheter body 54 together. Alternatively, the melting point of each tie layer may be different, and one or more of these tie layers may be selected and melted without melting the other tie layer or the plurality of tie layers. Thus, in some embodiments of the catheter body 54, the number of tie layers that have been fused to secure the various layers of the catheter body 54 to other layers of the catheter body 54 are 0, 1, 2, 3 Or more.

  Each of the layers described above (from the outer cover 94 to the inner cover 108) can be secured to one another. Together with these layers an outer tubular body 79 can be formed. It is the inner tubular body 80 that is located inside these layers and may be movable relative to these layers. The inner tubular body 80 can be arranged such that a certain amount of gap is formed between the outer surface of the inner tubular body 80 and the inner surface of the inner cover 108. The inner tubular body 80 is a braided reinforced polyether block amide (eg, the polyether block amide may be made of REAX® material available from Arkema, Philadelphia PA). May be. The inner tubular body 80 may be reinforced by a mesh reinforcing member or a coil reinforcing member. The inner tubular body 80 translates the lateral movement of the slide 58 along the length of the inner tubular body 80 so that the deflection member 52 can be actuated by relative movement of the inner tubular body 80 in contact with the support 74. Can have enough column strength. The inner tubular body 80 is also able to maintain the shape of the lumen 82 passing through the length of the inner tubular body 80 while the deflecting member 52 is deflected. Thus, the user of the catheter 50 can select and adjust the deflection amount of the deflection member 52 by operating the handle 56. The lumen 82 can have a central axis that is aligned with the central axis 91 of the outer tubular body 79.

  As a modification of the embodiment shown in FIG. 5E, the inner tubular body 80 can be replaced with an external tubular body located outside the outer cover 94. In such an embodiment, the parts of the outer tubular body 79 (parts from the outer cover 94 to the inner cover 108) can be left substantially unchanged (as shown in FIG. 5E). In terms of the diameter of each part, it can be slightly reduced to maintain a similar overall inner and outer diameter of the catheter body 54). The outer tubular body may fit outside the outer cover 94 and be movable relative to the outer cover 94. Such relative movement can facilitate deflection of the deflection member 52 in a manner similar to that described with reference to FIGS. 5A-5D. In such embodiments, the electrical interconnect member 104 will be part of the outer tubular body 79 that will be placed inside the outer tubular body. The outer tubular body may be configured in the same manner as the inner tubular body 80 described above.

  In the exemplary embodiment, the catheter body 54 can have a capacitance of less than 2,000 picofarads. In one embodiment, the catheter body 54 may have a capacitance of about 1,600 picofarads. In the above embodiment of FIG. 5E, the outer cover 94 and the outer low dielectric constant layer 96 can be combined to have a breakdown voltage of at least about 2500 volts AC. Similarly, the combination of outer cover 108 and inner low dielectric constant layer 106 can have a breakdown voltage of at least about 2500 volts AC. In other embodiments, different withstand voltages can be achieved, for example, by changing the thickness of the cover and / or the low dielectric constant layer. In the exemplary embodiment, the outer diameter of the outer tubular body 79 can be, for example, about 12.25 Fr. The inner diameter of the inner tubular body can be, for example, about 8.4 Fr.

  The catheter body 5 may have a kink diameter that is less than 10 times the diameter of the catheter body 54 (below the bending diameter of the catheter body 54 that causes the catheter body 54 to twist). Such a structure is suitable for the anatomical placement of the catheter body 54.

  As used herein, the term “outer tubular body” refers to the outermost layer of the catheter body and all layers of the catheter body that are arranged to move with the outermost layer. For example, in the catheter body 54 shown in FIG. 5E, the outer tubular body 79 includes all illustrated layers of the catheter body 54 except for the inner tubular body 80. In general, in embodiments where there is no inner tubular body, the outer tubular body may coincide with the catheter body.

  FIG. 5F illustrates an embodiment of the electrical interconnection between the spirally arranged electrical interconnect member 104 and the flex board 76 (flexible / bendable electrical member). For convenience of illustration, FIG. 5F does not show all parts of the catheter body 54 except for the electrical interconnect member 104 and the flex board 76. The flex board 76 can have a curved portion 109. The bending portion 109 may be bent corresponding to the curvature of the outer tubular body 79. The bending portion 109 of the flex board 76 is disposed at the end of the outer tubular body 79 close to the deflecting member 52 and inside the same position as the electrical interconnection member 104 for each layer of the outer tubular body 79. can do. As a result, the bending portion 109 of the flex board 76 can come into contact with the electrical interconnection member 104. In this regard, the distal end of the electrical interconnect member 104 can be interconnected to the flexboard 76 within the interconnect region 110.

  Within the interconnect region 110, conductive portions (eg, wires) of the electrical interconnect member 104 can be interconnected to conductive portions (eg, traces, conductive paths) of the flex board 76. This electrical interconnection can be accomplished by stripping or removing a portion of the insulation of the electrical interconnect member 104 and connecting the exposed conductive portion to the corresponding exposed conductive portion of the flex board 7. The ends of the electrical interconnection member 104 and the exposed conductive portions of the electrical interconnection member 104 may be disposed obliquely with respect to the width direction of the electrical interconnection member 104. In this regard, the pitch between the exposed conductive portions of the flex board 76 (eg, exposed) while maintaining the electrical interconnection between the conductors of both the electrical interconnect member 104 and the flex board 76. The distance between the conductive portions that are present) may be greater than the pitch of the electrical interconnect members 104 (measured across the width).

  As shown in FIG. 5F, the flexboard 76 can have a flexure or curved region 112 that is narrower than the width of the electrical interconnect member 104. As can be seen, the width of the individual conductive paths through the flexure region 112 may be smaller than the width of each conductive member in the electrical interconnect member 104. Further, the pitch between the conductive members within the flexure region 112 may be smaller than the pitch of the electrical interconnect members 104.

  The flexure region 112 can be interconnected to the array contact region 114 of the flex board 76 through which the electrical interconnection members 104 and the respective conductive paths of the flex board 76 are electrically connected to the transducers of the ultrasonic transducer array 68. Will be interconnected.

  As shown in FIGS. 5C and 5D, the deflection region 112 of the flex board 76 may be able to be deflected by the deflection member 52 in accordance with the deflection. Also in this regard, the bending region 112 can be bent corresponding to the deflection of the deflecting member 52. Each conductor of the electrical interconnection member 104 can maintain an electrical communication state with each transducer of the ultrasonic transducer array 68 even while the deflection member 52 is deflected.

  In an embodiment, the electrical interconnect member 104 may have two or more separate sets of conductors (eg, two or more microminiature flat cables). In such an embodiment, each other set of conductors may be interconnected to the flex board 76 in a manner similar to that shown in FIG. 5F. In addition, the electrical interconnect member 104 (a single electrical interconnect member 104 shown in FIG. 5F or an electrical interconnect member 104 comprised of a plurality of individual cables substantially parallel) is a distal end 53 of the catheter body. Or an electrical interconnection member 104 that extends collectively from the distal end 53 to the proximal end 55 of the catheter body 54 and is continuously interconnected. Alternatively, it may be composed of a plurality of discrete members. In an embodiment, the flex board 76 may include an electrical interconnect member 104. In such an embodiment, the flexboard 76 may have a helically wrapped portion that extends from the distal end 53 to the proximal end 55 of the catheter body 54. In such embodiments, conductor-to-conductor interconnections (eg, between the flex board 76 and the microflat cable) may not be required between the array contact region 114 and the proximal end of the catheter body 54. .

  6A-6D show an embodiment of a catheter with a deflection member 116 where the deflection member 116 can be deflected by moving the elongate member relative to the outer tubular body 118. . It will be appreciated that this embodiment shown in FIGS. 6A-6D does not include an inner tubular body, and the outer tubular body 118 is also characterized as a catheter body.

  The deflecting member 116 may be selectively deflectable. As shown in FIG. 6A, the illustrated deflection member 116 includes a tip 120. The tip 120 can include an ultrasonic transducer array 68 and can include a rounded distal end 66 and a guidewire opening 70 similar to the tip 64 described with reference to FIG. 5B. . Similar to the tip 64 of FIG. 5B, when the deflection member 116 is aligned with the outer tubular body 118, the ultrasonic transducer array 68 can be in a lateral monitoring state. In this regard, the ultrasound transducer array 68 may be able to image anatomical landmarks during catheter insertion to help guide and / or position the outer tubular body 118.

  Outer tubular body 118 can include a lumen 128 through which an interventional device can be passed. In some cases, at least a portion of the deflection member 116 may be permanently disposed at a location remote from the distal end of the outer tubular body 118. In some embodiments, the entire deflection member 116 may be permanently disposed at a position farther from the distal end of the outer tubular body 118.

  The deflecting member 116 can be deflected with respect to the outer tubular body 118. In this regard, the deflection member 116 can be interconnected to one or more elongated members to control the movement of the deflection member 116 during deflection. The elongated member can take the form of a puller wire 130. The puller wire 130 may be a circular wire. As another example, the cross section of the pulling wire 130 may be formed in a shape, for example. For example, the puller wire can have a rectangular cross section with a width to thickness ratio of about 5: 1.

  Similar to the catheter embodiment described in FIGS. 5B-5E, the catheter of FIGS. 6A-6D can include a support 126 that can support the ultrasound transducer array 68. Support 126 can interconnect deflection member 116 to outer tubular body 118. The flex board 122 may include an electrical interconnect that can electrically connect the ultrasonic transducer array 68 to the electrical interconnect member 104 (shown in FIG. 6D) located within the outer tubular body 118. The exposed portion of the flex board 122 can be sealed similarly to the flex board 76 described above.

  Outer tubular body 118 can include a distal portion 124. The distal portion 124 can be comprised of a plurality of wrap layers disposed around the anchoring portion 133 (shown in FIGS. 6B and 6C) of the support 126. As will be described below with reference to FIG. 6D, the wrapping layer may help to secure the anchor portion 133 to the inner portion of the outer tubular body 118.

  The deflection of the deflection member 116 will be described below with reference to FIGS. 6B and 6C. FIGS. 6B and 6C show the deflecting member 116 with the tip 120 surrounding the ultrasound imaging array 68 and support 126 removed. Also, the distal portion 124 of the outer tubular body wound around the fixing portion 133 is omitted here. The support 126 can be formed in the same manner as the support 74 described above. The support 126 can further include a hinge portion 131 similar to the hinge portion 86.

  To deflect the deflecting member 116 relative to the outer tubular body 118, the puller wire 130 can be moved relative to the outer tubular body 118. As shown in FIG. 6C, pulling the puller wire 130 (eg, toward the handle 56) applies a force to the support 126 at the puller wire anchor point 132 facing the puller wire outlet 134 along the puller wire 130. become. The puller wire outlet 134 is the point where the puller wire 130 exits the puller wire housing 136. The puller wire housing 136 can be secured to the outer tubular body 118. Such a force results in bending of the deflecting member 116 towards the puller wire outlet 134. As in the embodiment shown in FIGS. 5C and 5D, the deflection of the deflection member will be suppressed by the hinge portion 131 of the support 126. As shown in FIG. 6C, the resulting deflection of the deflection member 116 will cause the ultrasound transducer array 68 to rotate to the forward monitoring position. It will be appreciated that changing the amount of deflection of the deflection member 116 can be accomplished by adjusting the movement of the puller wire 130. In this regard, a deflection angle between 0 and 90 degrees can be achieved by displacing the puller wire 130 by a smaller amount than shown in FIG. 6C. In addition, a deflection of 90 degrees or more can be achieved by displacing the puller wire 130 to a greater extent than the state shown in FIG. 6C. As shown in FIGS. 6B and 6C, the flex board 122 can still be interconnected to the outer tubular body 118 and the deflection member 116 regardless of the deflection of the deflection member 116.

  FIG. 6D shows an embodiment of the outer tubular body 118. To illustrate the structure of the outer tubular body 118 in describing FIG. 6D, some of the various layers have been removed. Layers similar to those of the embodiment of FIG. 5E are labeled with the same reference numbers as in FIG. 5E and will not be described in detail here. A puller wire housing 136 that houses the puller wire 130 may be disposed closest to the outer cover 94. Next, the outer package 138 may be disposed on the outer cover 94 and the pulling wire housing 136, and the pulling wire housing 136 may be fixed to the outer cover 94. Alternatively, for example, the pulling wire housing 136 and the pulling wire 130 may be disposed between the outer cover 94 and the outer low dielectric constant layer 96. In such embodiments, the outer wrap 138 may not be necessary. Other suitable locations for the puller wire housing 136 and the puller wire 130 may be used.

  In some cases, the shield layer 98 is disposed on the inner side of the outer low dielectric constant layer 96. A first tie layer (not shown in FIG. 6D) similar to the first tie layer 97 may be disposed between the outer low dielectric constant layer 96 and the shield layer 98. The second tie layer 100 is disposed inside the shield layer. Also, an electrical interconnection member 104 is disposed inside the second tie layer 100. Disposed inside the electrical interconnect member 104 is an inner low dielectric constant layer 142. In this regard, the electrical interconnect member 104 can be helically disposed within the wall of the outer tubular body 118.

  The layer that moves toward the center of the outer tubular body 118 and that comes next may be the coil reinforcement layer 144. For example, the coil reinforcement layer 144 can be comprised of a stainless steel coil. In an exemplary embodiment, the thickness of the coil reinforcement layer 144 can be about 0.05 to 0.08 mm. The next layer that moves toward the center of the outer tubular body 118 and can be the inner cover 146. The inner cover 146 is configured in the same manner as the outer cover 94 and can perform the same function. The lumen 128 may have a central axis that is aligned with the central axis of the outer tubular body 118.

  As described above, the winding layer of the distal portion 124 of the outer tubular body 118 can help secure the anchoring portion 133 of the support 126 within the outer tubular body 118. For example, each layer outside the electrical interconnect member 104 may be removed at the distal portion 124. Moreover, the electrical interconnect member 104 can be electrically interconnected to the flexboard 122 near the distal portion 124 in a manner similar to that described with reference to FIG. 5F. Accordingly, the anchor portion 133 of the support 126 is positioned over the remaining inner layer (eg, the inner low dielectric constant layer 142, the coil reinforcement layer 144, and the inner cover 146), and a plurality of material layers are disposed on the distal portion 124. It is possible to wrap around and fix the fixing portion 133 to the outer tubular body 118.

  For example, the outer diameter of the outer tubular body 118 can be about 12.25 Fr. Further, the inner diameter of the outer tubular body 118 can be set to about 8.4 Fr, for example.

  7A and 7B show a further embodiment. As shown, the catheter 30 has a deflectable distal end 32. Located at the deflection distal end 32 is an ultrasonic transducer array 37. The catheter also includes a wire 33 attached to the ultrasound transducer array 37 and extending to the proximal end of the catheter 30, with the catheter 30 exiting through a port or other opening at the proximal end. . As shown in FIG. 7A, the ultrasonic transducer array 37 here is in the “side monitoring” state. The catheter can be delivered to the treatment site with an ultrasound transducer array 37 in a “lateral monitoring” state, as shown in FIG. 7A. Once the treatment site has been reached, the wire 33 is pulled proximally and the deflectable distal end 32 is deflected to place the ultrasound transducer array 37 in a “forward monitoring” state as shown in FIG. 7B. Can bring. As shown in FIG. 7B, once the ultrasound transducer array 37 has been placed in the “forward monitoring” position and the deflecting distal end 32 has been deflected as shown, a generally centered lumen 38 is used. The appropriate interventional device will then be delivered to a point far from the catheter distal end 32. Alternatively, a deflectable distal end 32 can be deflected to the “forward monitoring” state using a tube that includes a lumen 38 and is movable relative to the outer surface of the catheter 30.

  FIG. 8A is a front view of the single lobe structure of the apparatus shown in FIGS. 7A and 7B. FIG. 8B shows the two-lobe structure of the catheter shown in FIGS. 7A and 7B. FIG. 8C shows a three-lobe structure, and FIG. 8D shows a four-lobe structure. As is apparent from the figure, a desired number of lobe configurations are possible. Furthermore, in the multiple lobe configuration, the ultrasonic transducer array 37 may be arranged on one or more lobes.

  A further embodiment is shown in FIGS. 9, 9A, and 9B. FIG. 9 shows a catheter 1 having an ultrasonic transducer array 7 near its distal end. The ultrasonic transducer array 7 is attached to the catheter 1 by a hinge 9. The conductive wire 4 is connected to the ultrasonic transducer array 7 and extends to the vicinity of the proximal end of the catheter 1. The catheter 1 includes a distal outlet port 13. The hinge 9 can be arranged at the distal end of the ultrasonic transducer array 7 as shown in FIG. 9A, or can be arranged at the proximal end of the ultrasonic transducer array 7 as shown in FIG. 9B. In any case, the ultrasonic transducer array 7 can be passively or actively deflectable as described above. The ultrasonic transducer array 7 can be deflected to a forward monitoring state (as shown in FIGS. 9A and 9B), and the interventional device can be advanced to at least partly exit the distal outlet port 13, which As a result, at least a part of the interventional device falls within the field of view of the ultrasonic transducer array 7.

  10A and 10B show a further embodiment in which the catheter comprises an ultrasonic transducer array 7 near its distal end 2. The catheter further comprises a steerable portion 8 and a lumen 10. Lumen 10 is an interventional device that can be inserted at the proximal end of the catheter and is sized to receive a suitable interventional device that can travel through lumen 10 and outlet port 13. be able to. The catheter can further comprise a guide wire receiving lumen 16. The guidewire receiving lumen 16 can include a proximal port 15 and a distal port 14 to allow for “quick exchange” of a well-known appropriate guidewire.

  Further, as shown in FIGS. 11, 11A and 11B, the catheter steerable portion 8 can be bent in any suitable direction. For example, the steerable portion is bent away from the port 13 in FIG. 11A and the steerable portion is bent so as to approach the port 13 in FIG. 11B.

  FIG. 12 shows yet another embodiment. Specifically, the catheter 1 can include an ultrasound transducer array 7 that is disposed at the distal end 2 of the catheter 1. The conductive wire 4 is attached to the ultrasonic transducer array 7 and extends to the proximal end of the catheter 1. The lumen 19 is disposed near the ultrasonic transducer array 7 and includes a proximal port 46 and a distal port 45. Lumen 19 can be sized to receive a suitable guidewire and / or interventional device. Lumen 19 can be constructed from a suitable polymer tubing such as ePTFE. The conductive wire 4 can be arranged at the center of the catheter 1 or in the vicinity thereof.

  FIG. 13 is a flowchart for an embodiment of a method of operating a catheter having a deflection imaging device at its distal end. In a first step 150 of the method, the distal end of the catheter is moved from the initial position to the desired position, and the deflection imaging device is placed in the first position during this movement step. Here, when in the first position, the deflection imaging device can monitor sideways. The moving step may include introducing a catheter into the body through an entry site that is smaller than the opening of the deflection imaging device. The moving step can include rotating the catheter about its circumference.

  In the next step 152, imaging data is acquired from the deflection imaging device during at least a portion of the moving step. This acquisition step can be performed with the deflection imaging device in the first position. During this movement and acquisition step, the position of the deflection imaging device relative to the distal end of the catheter can be maintained. That is, the deflection imaging apparatus can be moved without moving the deflection imaging apparatus with respect to the distal end of the catheter, and an image can also be acquired. During this moving step, the catheter and the deflection imaging device can be rotated relative to their surroundings. Such rotation may allow the deflection imaging device to acquire multi-directional images that traverse the path traveled by the catheter during the movement steps.

  In the next step 154, the imaging data is used to determine when the catheter is positioned at the desired location. For example, the imaging data can refer to the position of the deflection imaging device relative to a landmark (eg, an anatomical landmark) or the position of the distal end of the catheter.

  In the next step 156, the deflection imaging apparatus is deflected from the first position toward the second position. This deflection step can follow the moving step. The deflection imaging apparatus can be monitored forward at the second position. When in the second position, the deflection imaging device can be tilted at least 45 degrees relative to the central axis of the catheter. Optionally, after this deflection step, the deflection imaging device may be returned to the first position and the catheter may be repositioned (eg, repeating the move step 150, the acquisition step 152, and the use step 154). Once rearranged, the deflection step 156 is repeated and the method can continue.

  In embodiments, the catheters can each have an outer tubular body and a drive device that extend from the proximal end to the distal end of the catheter. In such embodiments, the deflection step may include translating the proximal end of at least one of the outer tubular body and the drive device relative to the other proximal end of the outer tubular body and the drive device. The deflection imaging device is supportably interconnected to the outer tubular body and one of the drive devices by a hinge, and the deflection step may further include applying a deflection force to the hinge corresponding to the translation step. Moreover, the deflection step can further include initiating application of a deflection force to the hinge in response to the translation step. The deflection force can be applied and maintained by manipulating a handle interconnected to the proximal end of the catheter. Further, the applying step may include transmitting the deflection force by the drive device from the proximal end to the distal end of the catheter in a balanced distributed manner about the central axis of the outer tubular body.

  In the next step 158, the interventional device is advanced through the exit port at the distal end of the catheter and enters the imaging field of view of the deflection imaging device in the second position. During this progression step, the imaging field can be maintained in an alignment position that is substantially fixed relative to the distal end of the catheter.

  After the interventional device is advanced and used (e.g., for performing a procedure, attaching / retrieving the device, measuring, etc.), the interventional device can be retrieved through the exit port. Then, the deflection imaging apparatus is returned to the first position. The return to the first position can be facilitated by the elastic deformation characteristics of the hinge itself. For example, the hinge may be biased to place the deflection imaging device in the first position. Similarly, when the deflection imaging apparatus is in the second position and the deflection force is removed, the deflection imaging apparatus may return to the first position. After retrieving the interventional device through the exit port (optionally from the entire catheter) and returning the deflecting imaging device to the first position, the catheter may then be repositioned and / or Can be removed.

  Further modifications and extensions to the above-described embodiments will be apparent to those skilled in the art. Such modifications and extensions are intended to be included within the scope of the invention as defined by the following claims.

Claims (84)

An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A first conductor portion having a plurality of conductors disposed adjacent to each other with a non-conductive material therebetween, the first conductor portion extending from the proximal end to the distal end;
A second conductor portion electrically interconnected to the first conductor portion at the distal end and having a plurality of conductors;
A deflection imaging device located at the distal end,
The catheter wherein the second conductor portion is electrically interconnected to the imaging device and can bend according to the deflection of the deflection imaging device.   The catheter according to claim 1, further comprising a junction point between the first conductor portion and the second conductor portion.   The catheter according to claim 1, wherein the deflection imaging apparatus includes an ultrasonic transducer array.   The catheter according to any one of claims 1 to 3, wherein the second conductor portion has a conductive wiring disposed on a flexible substrate.   The catheter according to any one of claims 1 to 4, wherein at least a portion of the first conductor portion is spirally disposed along at least a portion of the outer tubular body.   The spirally disposed portion of the first conductor portion is spirally disposed so as not to overlap, and the width of the first conductor portion is a continuous coil of the spirally disposed first conductor portion. The catheter according to claim 5, wherein the catheter is at least larger than a gap therebetween.   The catheter according to claim 6, wherein the gap has a first gap portion located farther than the second gap portion, and the first gap portion is wider than the second gap portion.   The catheter according to any one of claims 1 to 7, wherein at least a part of the first conductor portion is spirally arranged around a central axis of the outer tubular body.   The catheter according to any one of claims 1 to 8, wherein at least a part of the first conductor portion is embedded in the wall.   10. A catheter according to any one of claims 1 to 9, wherein at least a portion of the deflectable imaging device is permanently disposed outside the outer tubular body at the distal end.   The catheter according to any one of claims 1 to 10, wherein a distal end of the outer tubular body cannot be disposed in a field of view of the deflection imaging apparatus.   12. A catheter according to any one of the preceding claims, wherein when the deflection imaging device is positioned for advancement of the catheter within the body, the deflection imaging device does not have the outer tubular body in the field of view. An outer tubular body having a wall, a proximal end, and a distal end;
A lumen for conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device, at least a portion of which is permanently located outside of the outer tubular body at its distal end, is selectively deflectable relative to the outer tubular body, and is distal to the outlet port; Having a catheter.   And further comprising a hinge located at a distal end thereof, wherein the deflection imaging device is interconnected so as to be supportable by the hinge, and the deflection imaging device is arranged around the hinge axis defined by the hinge. The catheter according to any one of claims 1 to 13, which is selectively deflectable with respect to the body.   The hinge can be elastically deflected from the first shape to the second shape by applying a predetermined force, and at least a part of the hinge can be removed from the second shape by removing the predetermined force. The catheter of claim 14, wherein the catheter is operable to return to the first shape.   The catheter according to claim 14 or 15, wherein the hinge shaft is located farther from a distal end of the outer tubular body.   The catheter according to any one of claims 14 to 16, wherein the hinge has a column strength at least equivalent to a column strength of the outer tubular body.   18. A catheter according to any one of claims 14 to 17, wherein the hinge comprises a shape memory material.   The catheter according to any one of claims 14 to 18, wherein the hinge has a curved portion, and the hinge axis is defined by the curved portion.   20. The hinge according to any one of claims 14 to 19, wherein the hinge has an integral structure, and includes a support portion that is connected so as to support the ultrasonic transducer array, and a fixed portion that is fixed along a central axis of the outer tubular body. The catheter according to claim 1.   21. The catheter of claim 20, wherein the hinge has two bendable portions between the support portion and the fixed portion.   The two bendable portions are formed so as to substantially coincide with a cylinder oriented along the central axis of the outer tubular body, and the central portions of the bendable portions are substantially aligned with each other. The catheter according to claim 21, wherein the catheter is twisted toward the central axis of the cylinder.   The catheter according to claim 21 or 22, wherein each of the two bendable portions has a length equal to or less than a diameter of the outer tubular body.   24. A catheter according to any one of claims 14 to 23, wherein the hinge is biased to be in line with the distal end of the outer tubular body.   14. The catheter of claim 13, wherein the distal end of the outer tubular body is not positionable within the field of view of the deflection imaging device.   14. The catheter of claim 13, wherein the deflecting imaging device does not have the outer tubular body in the field of view of the deflecting imaging device when the deflection imaging device is positioned for advancement of the catheter within the body.   The catheter according to any one of claims 1 to 26, wherein a central axis of the outlet port is aligned with a central axis of the outer tubular body. An outer tubular body extending from the proximal end to the distal end of the catheter;
An inner tubular body extending from the proximal end to the distal end within the outer tubular body for conveying an interventional device extending from the proximal end to an outlet port located at the distal end Said inner tubular body, wherein said outer tubular body and said inner tubular body are arranged for selective relative movement,
A deflection imaging device, at least a portion of which is permanently disposed outside the outer tubular body at a distal end thereof, wherein the deflectable imaging device interconnects one of the inner tubular body and the outer tubular body in a supportable manner. A catheter having a deflection imaging device, wherein the deflection imaging device can be selectively deflected in a predetermined manner by the selective relative movement.   The inter-plane engagement of the inner tubular body and the outer tubular body maintains a selected relative position between the inner tubular body and the outer tubular body and a corresponding deflection position of the deflection imaging device. 30. The catheter of claim 28, which provides a sufficient mechanical joint.   30. A catheter according to claim 28 or 29, further comprising a hinge at a distal end thereof, wherein the deflection imaging device interconnects the hinge in a supportive manner.   31. The catheter of claim 30, wherein the hinge interconnects the inner tubular body in a supportable manner and interconnects the outer tubular body in a restrained manner.   And a restraining member interconnected to the hinge and the outer tubular body, and the deflection force is transmitted to the deflection imaging device by the restraining member by the advancement of the inner tubular body with respect to the outer tubular body. The catheter according to claim 30 or 31.   33. A catheter according to any one of claims 28 to 32, wherein any movement of the inner tubular body relative to the outer tubular body results in a corresponding deflection of the deflection imaging device.   34. The catheter according to claim 33, wherein the relationship between the movement of the inner tubular body with respect to the outer tubular body and the corresponding deflection of the deflection imaging apparatus is linear.   35. A method according to any one of claims 28 to 34, wherein the selective relative movement occurs as a result of an actuation force, the actuation force being balanced and distributed with respect to a central axis of the outer tubular body. catheter.   36. The catheter according to any one of claims 28 to 35, wherein a central axis of the outer tubular body coincides with a central axis of the inner tubular body. An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device located at the distal end, the deflection imaging device being selectively deflectable from a first position to a second position and interconnected to the outer tubular body catheter.   The catheter according to any one of claims 1 to 37, wherein the deflection imaging device is deflectable around a deflection axis that is offset from a central axis of the outer tubular body.   39. The catheter of claim 38, wherein the deflection axis is in a plane transverse to the central axis.   40. A catheter according to claim 38 or 39, wherein the deflection axis is in a plane perpendicular to the central axis.   41. A catheter according to any one of claims 38 to 40, wherein the deflection axis is in a plane parallel to the central axis.   42. The deflection imaging device is interconnected to the outer tubular body by a mooring rope, and the mooring rope interconnects the deflection imaging device to the outer tubular body in a suppressive manner. The catheter according to 1.   And a flexible electrical interconnect member partially disposed between the deflection imaging device and the outer tubular body, and partially disposed between the deflection imaging device and the outer tubular body. 43. The catheter of claim 42, wherein a portion of the flexible electrical interconnect member disposed at a position is coupled to the mooring rope.   44. The deflection imaging apparatus according to any one of claims 1 to 43, wherein the deflection imaging apparatus includes an ultrasonic transducer array, the catheter further includes a distal end portion, and the distal end portion at least partially encloses the ultrasonic transducer array. The catheter described.   45. The catheter of claim 44, wherein the tip portion has a rounded distal end that guides the catheter as it is inserted into the body.   46. A catheter according to claim 44 or 45, wherein the tip portion comprises a wire guide.   47. A catheter according to any one of claims 44 to 46, wherein the tip portion is aligned with the outer tubular body.   48. A catheter according to any one of claims 44 to 47, wherein the tip portion has a maximum transverse dimension that is greater than a maximum transverse dimension of the lumen. An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A hinge disposed at the distal end;
A deflection imaging device interconnecting the hinge at the distal end in a supportive manner and selectively deflectable with respect to the outer tubular body;
A drive device extending from the proximal end to the distal end;
The drive device and the outer tubular body are disposed so as to be relatively movable, and the deflection imaging device is imposed on the hinge in a relative movement state between the drive device and the outer tubular body. A catheter that can be deflected to a forward position according to the deflection force.   50. The catheter of claim 49, wherein the deflection imaging device is deflectable over an arc of at least 45 degrees in response to a relative movement between the drive device and outer tubular body of 0.5 cm.   51. A catheter according to claim 49 or 50, wherein the drive device is an inner tubular body disposed within the outer tubular body.   51. A catheter according to claim 49 or 50, wherein the drive device is a puller wire disposed along the outer tubular body.   53. A catheter according to any one of claims 49 to 52, wherein the deflection force is balanced and distributed with respect to the central axis of the outer tubular body. And further comprising a handle disposed at the proximal end,
The handle
The handle body,
A movable member movable with respect to the main body,
54. A catheter according to any one of claims 49 to 53, wherein the drive device is interconnected to the moving member, and the selected movement of the moving member relative to the handle body affects the deflection of the deflection imaging device. .   55. The handle further comprises a detent between the moving member and the handle body, the detent being capable of providing tactile feedback of the catheter related to deflection of the deflection imaging device to a user. The catheter described. Comprising an outer tubular body having a wall, a proximal end, and a distal end;
The wall
A plurality of conductors extending from the proximal end to the distal end;
A first layer located inside the plurality of interconnected conductors and extending from the proximal end to the distal end and having a dielectric constant of 2.2 or less;
A second layer located outside the plurality of interconnected conductors and extending from the proximal end to the distal end and having a dielectric constant of 2.2 or less;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device located at the distal end, wherein the deflection imaging device is selectively deflectable from a first position to a second position and is electrically interconnected to the plurality of interconnected conductors. A catheter further comprising a deflection imaging device.   57. The method according to claim 56, further comprising a third layer disposed outside the second layer, wherein in combination, the second layer and the third layer have a withstand voltage of at least AC 2500 volts. The catheter described.   57. Further comprising a fourth layer disposed inside the first layer, wherein the first layer and the fourth layer in combination have a withstand voltage of at least AC 2500 volts. 58. The catheter according to 57.   The outer tubular body further includes an inner tubular body extending from the proximal end to the distal end, the inner tubular body forming a lumen therethrough, wherein the outer tubular body And the inner tubular body are arranged so that selective relative movement between them is possible, and the selective relative movement affects the deflection of the deflection imaging apparatus. The catheter according to claim 1.   And a puller wire extending from the proximal end to the distal end along the outer tubular body, such that the outer tubular body and the puller wire are capable of selective relative movement therebetween. 59. The catheter of any one of claims 1-24 and 56-58, wherein the catheter is disposed and the selective relative movement affects the deflection of the deflection imaging device.   57. The catheter of claim 56, wherein the plurality of interconnected conductors are spirally wound along at least a portion of the outer tubular body.   62. A catheter according to any one of claims 56 to 61, wherein at least a portion of the deflection imaging device is permanently located outside the outer tubular body at the distal end.   63. A catheter according to claim 56 and claim 61 or 62, wherein when the deflection imaging device is positioned for advancement of the catheter within the body, the field of view of the deflection imaging device is free of the outer tubular body. Comprising an outer tubular body having a wall, a proximal end, and a distal end;
The wall
A plurality of conductors extending from the proximal end to the distal end;
A first layer having a dielectric constant of 2.2 or less and extending from the proximal end to the distal end;
A second layer disposed proximate to the first layer, wherein in combination, the first layer and the second layer have a withstand voltage of at least AC 2,500 volts;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device located at the distal end, wherein the deflection imaging device is selectively deflectable from a first position to a second position and is electrically interconnected to the plurality of interconnected conductors. A catheter having a deflection imaging device. An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device located at the distal end and selectively deflectable relative to the outer tubular body from a first position to a second position;
The deflection imaging apparatus is a catheter having a hole having a length larger than a maximum transverse dimension of the outer tubular body.   66. The deflection imaging apparatus of claim 1, wherein the deflection imaging device comprises an ultrasound transducer array, the width of the ultrasound transducer array being at least 30 percent of the maximum transverse dimension of the outer tubular body at the distal end. The catheter according to any one of the above.   A displacement arc is a minimum arc in contact with an acoustic surface of the deflection imaging apparatus and a central axis of the outer tubular body, and a radius of the displacement arc is larger than a maximum transverse dimension of the distal end of the outer tubular body. The catheter according to any one of claims 1 to 66, which is small.   66. The catheter of claim 65, wherein the deflection imaging device includes an ultrasound transducer array, the catheter further includes a tip portion, and the tip portion at least partially encloses the ultrasound transducer array.   69. The catheter of claim 68, wherein the tip portion is aligned with the outer tubular body. An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A deflection imaging device located at the distal end and selectively deflectable relative to the outer tubular body from a first position to a second position;
When the deflected imaging device is in the second position, it forms an imaging field, which is relative to the catheter body as the interventional device advances through the outlet port into the imaging field. A catheter that can be held in a substantially fixed alignment position.   71. The catheter of any one of claims 65 and 68-70, wherein the outer tubular body does not enter the field of view when the deflection imaging device is positioned for catheter advancement within the body. . An outer tubular body having a wall, a proximal end, and a distal end;
A lumen conveying an interventional device extending through the outer tubular body from the proximal end to an outlet port located farther from the proximal end;
A catheter having a deflection imaging device located at the distal end and selectively deflectable and capable of being held at a selected position between 0 degrees and at least 45 degrees relative to the outer tubular body.   The deflection imaging device is deflectable over an arc of at least 45 degrees, corresponding to a 0.5 cm relative movement between the outer tubular body and the drive device, and the drive device is 73. A catheter according to any one of claims 68 to 72, extending to the distal end.   74. The catheter of claim 73, wherein the relationship between the movement of the drive device relative to the outer tubular body and the corresponding deflection of the deflection imaging device is linear.   The deflection imager is deflectable over a 90 degree arc corresponding to relative movement between the outer tubular body and the drive device, and the drive device extends from the proximal end to the distal end. The catheter according to any one of claims 65 and 68 to 74, wherein the relative movement is 2.5 times or less of a diameter of the outer tubular body. In a method of operating a catheter in which a deflection imaging device is arranged at the distal end thereof
Moving the distal end of the catheter from an initial position to a desired position, and during the moving step, the deflection imaging device is positioned at a first position;
Acquiring image data from the deflection imaging device during at least a portion of the moving step;
Using the image data to determine when the catheter is located at the desired position;
Deflecting the deflection imaging device from the first position to a second position after the moving step;
Advancing an interventional device through an exit port at the distal end of the catheter and into the imaging field of view of the deflecting imaging device at the second position.   77. The method of claim 76, wherein the deflection imaging device monitors laterally at the first position and forwards at the second position.   78. A catheter according to claim 76 or 77, wherein the deflection imaging device is bent at least 45 degrees relative to the central axis of the catheter when in the second position.   The catheter has an outer tubular body and a drive device, each extending from the proximal end to the distal end of the catheter, and the deflection step comprises the proximal end of at least one of the outer tubular body and the drive device 79. A catheter according to any one of claims 76 to 78, including translating the outer tubular body and the other proximal end of the drive device.   The deflection imaging device is hingeably interconnected to one of the outer tubular body and the drive device by a hinge, and the deflection step further includes applying a deflection force to the hinge in response to the translation step. 80. The method of claim 79.   81. The method of claim 80, wherein the deflection step further includes initiating application of a deflection force to the hinge in response to the translation step.   The applying step includes transmitting the deflection force from a proximal end to a distal end of the catheter in a distributed manner balanced around a central axis of the outer tubular body by the drive device. The catheter according to 80 or 81.   83. A catheter according to any one of claims 76 to 82, wherein the imaging field is maintained in an alignment position substantially fixed relative to the distal end of the catheter during the advancement step.   84. A catheter according to any one of claims 76 to 83, further comprising maintaining the position of the deflection imaging device relative to the distal end of the catheter during the moving and acquiring steps.

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