Catheter tip with integrated electronics package and catheter incorporating the same

Abstract

To provide an intravascular catheter that includes an integrated electronics package in a tip or the like.SOLUTION: An intravascular catheter includes a catheter shaft having a distal portion 190, a plurality of magnetic localization elements disposed within the distal portion, and an integrated electronics package 210 disposed within the distal portion of the catheter shaft. The integrated electronics package can be a system on a chip such as an application-specific integrated circuit, and can include a power supply, a pre-amplifier, a multiplexor, and an imaging element driver. It can also include imaging elements. The magnetic localization elements can include magnetic coils and / or solid-state magnetic localization elements, such as anisotropic magnetoresistive sensors, and can also be incorporated into the integrated electronics package.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 987,574, filed March 10, 2020, which is incorporated by reference in its entirety as if fully set forth herein. [Background technology]

[0002] The present disclosure relates generally to catheters for use in the human body, and more particularly to intravascular catheters that include an integrated electronics package in their distal region, such as in their tip.

[0003] Catheters are being used for an increasing number of procedures. For example, catheters are used for diagnostic, therapeutic, and ablation procedures, to name just a few. Typically, catheters are navigated through a patient's vasculature to an intended site, such as a site within the patient's heart. Summary of the Invention [Means for solving the problem]

[0004] Disclosed herein is an intravascular catheter including a catheter shaft having a distal portion, a plurality of magnetic localization elements disposed within the distal portion of the catheter shaft, and an integrated electronics package disposed within the distal portion of the catheter shaft, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver.

[0005] The integrated electronic package may be a system on a chip, for example an application specific integrated circuit.

[0006] The magnetic location elements can include magnetic coils, which can be operably connected to the integrated electronics package. Alternatively or additionally, the magnetic location elements can include solid-state magnetic location elements, such as anisotropic magnetoresistive sensors, which can be mounted in or on the integrated electronics package.

[0007] Also disclosed herein is a tip assembly including a shell, a plurality of magnetic localization elements disposed within the shell, and an integrated electronics package disposed within the shell, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver.

[0008] The electronic package may include a system on a chip, for example an application specific integrated circuit.

[0009] The plurality of magnetic localization elements can include a plurality of magnetic coils, which can be operably connected to an integrated electronic package. Alternatively or additionally, the plurality of magnetic localization elements can include a plurality of solid-state magnetic localization elements, such as a plurality of anisotropic magnetoresistive sensors, which can be mounted within the integrated electronic package.

[0010] The present disclosure also provides a method of manufacturing a tip assembly for an intravascular catheter, the method including forming a shell, positioning an integrated electronics package within the shell, positioning a plurality of magnetic localization elements within the shell, and operably connecting the plurality of magnetic localization elements to the integrated electronics package, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver.

[0011] It is contemplated that multiple magnetic location elements may be incorporated into an integrated electronic package. For example, multiple solid-state magnetic location elements may be incorporated into an integrated electronic package.

[0012] The integrated electronic package may include an application specific integrated circuit.

[0013] The foregoing and other aspects, features, details, utilities, and advantages of the present invention will become apparent from reading the following description and claims, and from studying the accompanying drawings. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a perspective view of an exemplary catheter according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 illustrates a first embodiment of a tip assembly for an intravascular catheter as disclosed herein. [Diagram 3] FIG. 3 illustrates a second embodiment of a tip assembly for an intravascular catheter as disclosed herein.

[0015] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Aspects of the present disclosure relate to a catheter having an electronics package integrated at its distal end (e.g., positioned within its distal tip assembly). Those skilled in the art will appreciate that the teachings herein may be applied to good advantage in connection with various types of catheters, including, but not limited to, intracardiac echocardiography (ICE) catheters. For example, the teachings herein may be applied in connection with intravascular catheters such as those disclosed in U.S. Patent Application Serial No. 15 / 948,818 (the "'818 Application"). As another example, the teachings herein may be applied in connection with catheters such as those disclosed in U.S. Patent Application Publication No. 2014 / 0275957 (the "'957 Publication"). The '818 Application and the '957 Publication are incorporated herein by reference as if fully set forth herein.

[0017] For purposes of explanation, Figure 1 illustrates a perspective view of a representative catheter 100 including a shaft 105 having a proximal portion 110 and a distal portion 190 terminating in a tip 195. Insofar as the basic structure of catheter 100 is familiar to those of ordinary skill in the art, details thereof will be omitted herein, except to the extent relevant to an understanding of the present disclosure.

[0018] 2 is a close-up view of the distal portion 190 including the tip 195 according to a first embodiment of the present disclosure. A plurality of magnetic localization elements (e.g., magnetic coils 200) are disposed within the distal portion 190 (which may be described as a "shell" for purposes of illustration). FIG. 2 shows three orthogonal coils 200. As one skilled in the art will appreciate, these three orthogonal coils 200 allow the tip 195 to be localized in six degrees of freedom within a magnetic localization field generated by an electroanatomical mapping system, such as the EnSite Precision™ cardiac mapping system from Abbott Laboratories, Inc. (Chicago, Ill.).

[0019] Also shown within distal portion 190 is an integrated electronics package 210. In an embodiment of the present 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).

[0020] The integrated electronics package 210 includes a power supply, a preamplifier, a multiplexer, and electronics for driving the imaging elements, e.g., a transmitter and / or a receiver. The imaging elements themselves (e.g., ultrasound transducer arrays, optical fibers, etc.) can also be included within the integrated electronics package 210, or alternatively, the integrated electronics package 210 can include connections to imaging elements that are external to the integrated electronics package 210.

[0021] The coil 200 is operatively connected to the integrated electronics package 210, for example, to provide power from the integrated electronics package 210 to the coil 200 and to provide electromagnetic signals (e.g., magnetic field measurements, control signals, etc.) between the coil 200 and the integrated electronics package 210.

[0022] Advantageously, the close proximity between the coil 200 and the integrated electronics package 210 allows the coil 200 to be smaller than conventional magnetic localization elements. For example, a conventional coil 200 may range in length from about 0.5 cm to about 1 cm and in diameter from about 0.3 cm to about 0.5 cm. However, the close proximity between the coil 200 and the integrated electronics package 210 according to the present disclosure allows for a reduction in these dimensions by about 50%.

[0023] An additional cable connector 220 is provided for connecting the integrated electronics package 210 (and thus the coil 200) to a control unit. Although only one connector 220 is shown in the figures, those skilled in the art will appreciate that multiple such connectors 220 can be used and / or bundled through the shaft 105.

[0024] 3, the coil 200 is replaced by one or more solid-state magnetic localization elements 300, which may be mounted on or within the integrated electronic package 210 (e.g., incorporated into an SoC or ASIC). For example, the solid-state magnetic localization elements 300 may be anisotropic magnetoresistive (AMR) sensors, such as an AFF811 sensor manufactured by Sensitec GmbH (Lahnau, Germany).

[0025] In either embodiment (i.e., whether the magnetic localization element is implemented as a coil 200 or a solid-state element 300), the close proximity of the magnetic localization element and the integrated electronics package 210 advantageously improves the quality of signal communication between them (e.g., it provides an improved signal-to-noise ratio compared to conventional catheters).

[0026] Additionally, the burden and expense associated with assembling the catheter 100 is minimized by incorporating the elements into the integrated electronics package 210 (e.g., requiring only a single bundle of connectors 220 (e.g., wires) extending along the catheter shaft 105, eliminating additional wiring between the magnetic location sensor and the integrated electronics package if solid-state elements 300 are used).

[0027] Although several embodiments have been described above with a certain degree of particularity, those skilled in the art could make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the invention.

[0028] For example, the integrated electronics package 210 may also include elements that sense the orientation of the shaft 105, such as one or more solid-state accelerometers.

[0029] All directional descriptions (e.g., top, bottom, upper, lower, left, right, left-handed, right-handed, top, bottom, upper, lower, vertical, horizontal, clockwise, and counterclockwise) are used for identification purposes only to aid the reader's understanding of the present invention, and do not create limitations, particularly with respect to the position, orientation, or use of the present invention. Joint descriptions (e.g., attached, coupled, connected, etc.) should be interpreted broadly and may include intermediate members between the connection of elements and the relative movement between the elements. Thus, a joint description does not necessarily infer that two elements are directly connected and in a fixed relationship to each other.

[0030] 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 as limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

Claims

1. 1. An intravascular catheter comprising: a catheter shaft having a distal portion; a plurality of magnetic localization elements disposed within the distal portion of the catheter shaft; an integrated electronics package disposed within the distal portion of the catheter shaft, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver; An intravascular catheter comprising:

2. The intravascular catheter of claim 1 , wherein the electronics package comprises a system on a chip.

3. The intravascular catheter of claim 2 , wherein the system-on-chip comprises an application specific integrated circuit.

4. The intravascular catheter of claim 1 , wherein the plurality of magnetic localization elements comprises a plurality of magnetic coils.

5. The intravascular catheter of claim 4 , wherein the plurality of magnetic coils are operatively connected to the integrated electronics package.

6. The intravascular catheter of claim 1 , wherein the plurality of magnetic localization elements comprises a plurality of solid state magnetic localization elements.

7. The intravascular catheter of claim 6 , wherein the plurality of solid-state magnetic localization elements comprises a plurality of anisotropic magnetoresistive sensors.

8. The intravascular catheter of claim 6 , wherein the plurality of solid state magnetic localization elements are mounted within the integrated electronics package.

9. 1. A tip assembly for an intravascular catheter, comprising: A shell, a plurality of magnetic location elements disposed within the shell; an integrated electronics package disposed within the shell, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver; A tip assembly comprising:

10. The tip assembly of claim 9 , wherein the electronic package comprises a system-on-chip.

11. The tip assembly of claim 10 , wherein the system-on-chip comprises an application specific integrated circuit.

12. The tip assembly of claim 9 , wherein the plurality of magnetic locating elements comprises a plurality of magnetic coils.

13. The tip assembly of claim 12 , wherein the plurality of magnetic coils are operatively connected to the integrated electronics package.

14. The tip assembly of claim 9 , wherein the plurality of magnetic locating elements comprises a plurality of solid state magnetic locating elements.

15. The tip assembly of claim 14 , wherein the plurality of solid state magnetic locating elements comprises a plurality of anisotropic magnetoresistive sensors.

16. The chip assembly of claim 14 , wherein the plurality of solid state magnetic locating elements are mounted within the integrated electronic package.

17. 1. A method of manufacturing a tip assembly for an intravascular catheter, comprising: forming a shell; and positioning an integrated electronics package within the shell, the integrated electronics package including a power supply, a preamplifier, a multiplexer, and an imaging element driver; positioning a plurality of magnetic locating elements within the shell; operatively connecting a plurality of magnetic location elements to the integrated electronics package; A method comprising:

18. The method of claim 17 , wherein operably connecting the plurality of magnetic location elements to the integrated electronics package comprises incorporating the plurality of magnetic location elements within the integrated electronics package.

19. 20. The method of claim 18, wherein incorporating the plurality of magnetic location elements into the integrated electronic package comprises incorporating a plurality of solid-state magnetic location elements into the integrated electronic package.

20. The method of claim 17 , wherein the integrated electronic package comprises an application specific integrated circuit.

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