Catheter tip with integrated electronics package and catheter so that

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of United States provisional application no. 62 / 987,574, filed 10 March 2020.BACKGROUND

[0002] The present disclosure relates generally to catheters that are used in the human body. In particular, the present disclosure relates to an intravascular catheter that includes an integrated electronics package in its distal region, such as within its tip.

[0003] Catheters are used for an ever-growing number of procedures. For example, catheters are used for diagnostic, therapeutic, and ablative procedures, to name just a few examples. Typically, the catheter is manipulated through the patient's vasculature and to the intended site, for example, a site within the patient's heart.

[0004] For example, an ultrasound catheter is known from US 2008 / 0009745 A1. A catheter with merged optical tissue evaluation is known from US 2019 / 0380589 A1. A catheter handle with compliant circuit is known from WO 2019 / 232256 A1. US2007 / 293721 describes a small gauge steerable catheter including a locatable guide with a sheath, used as an enhancement to a bronchoscope.BRIEF SUMMARY

[0005] Disclosed herein is an intravascular catheter with the features according to claim 1 and a method of manufacturing a tip assembly for an intravascular catheter with the features according to claim 8. Preferred embodiments are given in the dependent claims.

[0006] The integrated electronics package can be a system on a chip, such as an application specific integrated circuit.

[0007] The plurality of magnetic localization elements can include a plurality of magnetic coils, which can be operably connected to the integrated electronics package. According to the invention, the plurality of magnetic localization elements include a plurality of solid-state magnetic localization elements, such as a plurality of anisotropic magnetoresistive sensors, and are mounted within the integrated electronics package.

[0008] The intravascular catheter further includes a shell.

[0009] It is contemplated that the plurality of magnetic localization elements can be incorporated into the integrated electronics package. For instance, a plurality of solid state magnetic localization elements can be incorporated into the integrated electronics package.

[0010] The integrated electronics package can include an application specific integrated circuit.

[0011] The foregoing and other aspects, features, details, utilities, and advantages of the present invention will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of a representative catheter according to aspects of the instant disclosure. Figure 2 illustrates a first embodiment of a tip assembly for an intravascular catheter as disclosed herein. Figure 3 illustrates a second embodiment of a tip assembly according to the invention for an intravascular catheter as disclosed herein. DETAILED DESCRIPTION

[0013] Aspects of the instant disclosure relate to catheters with electronics packages integrated into their distal ends (e.g., positioned within their distal tip assemblies). Those of ordinary skill in the art will appreciate that the teachings herein can be applied to good advantage in connection with various types of catheters, including, but not limited to, intracardiac echocardiography (ICE) catheters. For instance, the teachings herein can be applied in connection with intravascular catheters as disclosed in United States application no. 15 / 948,818 ("the '818 application"). As another example, the teachings herein can be applied in connection with catheters such as those disclosed in United States patent application publication no. 2014 / 0275957 ("the '957 publication").

[0014] For purposes of illustration, Figure 1 depicts a perspective view of a representative catheter 100, including a shaft 105 having a proximal portion 110 and a distal portion 190, which terminates in a tip 195. Insofar as the basic construction of catheter 100 will be familiar to those of ordinary skill in the art, the details thereof will be omitted herein, except to the extent relevant to an understanding of the instant disclosure.

[0015] Figure 2 is a close-up view of distal portion 190, including tip 195, according to a first embodiment. A plurality of magnetic localization elements (e.g., magnetic coils 200) are disposed within distal portion 190 (which, for purposes of explanation, can also be referred to as a "shell"). Figure 2 depicts three orthogonal coils 200. As those of ordinary skill in the art will appreciate, these three orthogonal coils 200 allow tip 195 to be localized with six degrees of freedom within a magnetic localization field generated by an electroanatomical mapping system such as the EnSite Precision ™< cardiac mapping system of Abbott Laboratories (Chicago, IL).

[0016] Also shown within distal portion 190 is an integrated electronics package 210. In embodiments of the disclosure, integrated electronics package 210 is implemented as a system-on-a-chip (SoC), such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA).

[0017] Integrated electronics package 210 includes a power supply, a pre-amplifier, a multiplexor, and electronics to drive imaging elements, such as transmitters and / or receivers. The imaging elements themselves are an ultrasonic transducer array and are included within integrated electronics package 210; alternatively, integrated electronics package 210 can include connections to imaging elements that are external to integrated electronics package 210 (embodiment not covered by the claimed invention).

[0018] Coils 200 are operably connected to integrated electronics package 210, for example to pass power from integrated electronics package 210 to coils 200 and to pass electromagnetic signals (e.g., magnetic field measurements, control signals, and the like) between coils 200 and integrated electronics package 210.

[0019] Advantageously, because of the proximity between coils 200 and integrated electronics package 210, coils 200 can be made smaller than extant magnetic localization elements. For instance, extant coils 200 may be from about 0.5 cm to about 1 cm in length with diameters ranging from about 0.3 cm to about 0.5 cm. The proximity between coils 200 and integrated electronics package 210 according to the instant disclosure, however, allows these dimensions to be reduced by about 50%.

[0020] Additional cable connectors 220 are provided to connect integrated electronics package 210 (and thus coils 200) to a control unit. Although only one connector 220 is shown in the Figures, those of ordinary skill in the art will appreciate that multiple such connectors 220 can be used and / or bundled through shaft 105.

[0021] In another embodiment according to the invention and depicted in Figure 3, coils 200 are replaced by solid-state magnetic localization elements 300, which are mounted within integrated electronics package 210 (e.g., incorporated into the SoC or ASIC). For instance, solid-state magnetic localization elements 300 may be anisotropic magnetoresistive (AMR) sensors, such as the AFF811 sensor from Sensitec GmbH (Lahnau, Germany).

[0022] In either embodiment (that is, whether the magnetic localization elements are implemented as coils 200 or as solid state elements 300), the proximity between the magnetic localization elements and integrated electronics package 210 advantageously improves the quality of signal communication therebetween (e.g., it offers an improved signal-to-noise ratio relative to extant catheters).

[0023] In addition, the burden and expense associated with assembly of catheter 100 is minimized through the incorporation of elements into integrated electronics package 210 (e.g., requiring only a single bundle of connectors 220 (e.g., wires) extending along catheter shaft 105; eliminating additional wiring between the magnetic localization sensors and the integrated electronics package when solid state elements 300 are used).

[0024] Although several embodiments have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention.

[0025] For example, integrated electronics package 210 can also include elements that sense the orientation of shaft 105, such as one or more solid state accelerometers.

[0026] All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

[0027] It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the invention as defined in the appended claims.

Claims

1. An intravascular catheter (100), comprising: a catheter shaft (105) having a distal portion (190); a plurality of magnetic localization elements disposed within the distal portion (190) of the catheter shaft (105); and an integrated electronics package (210) disposed within the distal portion (190) of the catheter shaft (105), wherein the integrated electronics package (210) comprises: a power supply; a pre-amplifier; a multiplexor; an imaging element driver; and imaging elements, wherein the imaging elements are an ultrasonic transducer array which is included within the integrated electronics package (210) and characterised in that the plurality of magnetic localization elements comprises a plurality of solid-state magnetic localization sensors (300) mounted within the integrated electronics package (210).

2. The intravascular catheter (100) according to claim 1, wherein the electronics package (210) comprises a system on a chip.

3. The intravascular catheter (100) according to claim 2, wherein the system on a chip comprises an application specific integrated circuit.

4. The intravascular catheter (100) according to claim 1, wherein the plurality of solid-state magnetic localization sensors comprises a plurality of anisotropic magnetoresistive sensors.

5. The intravascular catheter (100) according to any one of claims 1 to 4, wherein the distal portion of the catheter shaft (105) is a shell.

6. A method of manufacturing a tip assembly for an intravascular catheter (100), comprising: forming a shell (190); positioning an integrated electronics package (210) within the shell, wherein the integrated electronics package comprises: a power supply; a pre-amplifier; a multiplexor; an imaging element driver; and imaging elements, positioning a plurality of magnetic localization elements within the shell; and operably connecting the plurality of magnetic localization elements to the integrated electronics package (210), wherein the imaging elements are an ultrasonic transducer array which is included within the integrated electronics package (210), characterised in that operably connecting the plurality of magnetic localization elements to the integrated electronics package (210) comprises incorporating the plurality of magnetic localization elements into the integrated electronics package (210), wherein incorporating the plurality of magnetic localization elements into the integrated electronics package (210) comprises incorporating a plurality of solid-state magnetic localization sensors (300) into the integrated electronics package (210).

7. The method according to claim 6, wherein the integrated electronics package (210) comprises an application specific integrated circuit.