Medical device with forward and sideward ablation monitoring ultrasound transducers

Abstract

The invention relates to ultrasound imaging method and apparatus suitable for minimally invasive ultrasound diagnostic devices in cardiac ablation monitoring and in tumor ablation monitoring. The present invention proposes an assembly of forward and side-facing transducers and a system of embedded forward and side-facing transducers in apertures on surfaces of the assembly. This provides control of the acoustic properties of the transducer and improved ablation monitoring when the assembly is incorporated in a medical device.

Claims

1. A combined ablation and ultrasound imaging catheter for insertion within a body, the catheter comprising: a catheter tip comprising: an ablation cap configured to provide ablation to the body during an ablation procedure, the ablation cap comprising a distal-facing aperture and a plurality of lateral- facing apertures formed through the ablation cap, wherein the plurality of lateral-facing apertures are located proximal of the distal facing aperture and are arrayed around a circumference of the ablation cap; and an ultrasound transducer system fixed within the ablation cap and comprising: a first ultrasound transducer element configured to follow the ablation procedure in a first direction through the distal-facing aperture of the ablation cap, the first direction orientated primarily distally away from the catheter tip; and a plurality of second ultrasound transducer elements located proximal to the first ultrasound transducer element, the plurality of second ultrasound transducer elements arrayed about the circumference of the ablation cap and configured to follow the ablation procedure through the plurality of lateral-facing apertures of the ablation cap in a plurality of second directions, respectively, the plurality of second directions orientated laterally away from the catheter tip and different from the first direction.

2. The catheter of claim 1, wherein the ablation cap comprises a radio frequency (RF) ablation cap.

3. The catheter of claim 1, wherein the first ultrasound transducer element and the plurality of second ultrasound transducer elements are mounted on a base structure and are entirely within the ablation cap.

4. The catheter of claim 1, wherein the plurality of lateral-facing apertures are evenly spaced about the circumference of the ablation cap.

5. The catheter of claim 1, wherein each of the plurality of second ultrasound transducer elements are located along a curved portion of the ablation cap.

6. The catheter of claim 1, wherein the plurality of second ultrasound transducer elements are four ultrasound elements evenly arrayed at angles of 90° about the circumference of the ablation cap.

7. The catheter of claim 1, wherein the ablation cap is a platinum ablation cap.

8. The catheter of claim 1, wherein the ablation cap is a cylindrical shell.

9. The catheter of claim 1, wherein the ultrasound transducer system comprises: a flexible foil comprising openings extending from the top to the bottom surface of said flexible foil; the first ultrasound transducer element contained into a first opening of said openings and fastened to an internal rim of said first opening; the plurality of second ultrasound transducer elements contained into remaining openings of said openings and fastened to an internal rim of said remaining openings; a base structure comprising cavities, wherein said cavities are filled with backing material.

10. An ablation catheter comprising: an ultrasound transducer assembly placed in a base structure and comprising ultrasound transducers, and a catheter tip comprising an ablation cap configured to provide ablation and surrounding the base structure, wherein the base structure comprises two or more openings containing the ultrasound transducers, wherein an ultrasound transducer of at least a first of the two or more openings faces outward from an end of the base structure and an ultrasound transducer of at least a second of the two or more openings faces outward from a length of the base structure, and wherein the ultrasound transducer assembly is connected and fixed in the catheter tip.

11. The ablation catheter of claim 10, wherein the ablation cap comprises a material transparent to ultrasound.

12. The ablation catheter of claim 10, wherein the ablation cap comprises platinum.

13. The ablation catheter of claim 10, wherein the ablation cap comprises apertures aligned with the ultrasound transducers.

14. The ablation catheter of claim 10, wherein the catheter tip comprises a material that is transparent to ultrasound.

15. The ablation catheter of claim 10, wherein the ultrasound transducers comprise piezoelectric elements.

16. A catheter tip comprising: an ultrasound transducer assembly placed in a base structure and comprising ultrasound transducers, an ablation cap configured to provide ablation and surrounding the base structure, wherein the base structure comprises two or more openings containing the ultrasound transducers, wherein an ultrasound transducer of at least a first of the two or more openings faces outward from an end of the base structure and an ultrasound transducer of at least a second of the two or more openings faces outward from a length of the base structure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Embodiments of the invention will be described, by way of example only, with reference to the drawings.

(2) FIG. 1 shows a perspective view of a flexible foil with patterned openings according to embodiments of the invention.

(3) FIG. 2a shows a cross section of the flexible foil as shown in FIG. 1.

(4) FIG. 2b shows a cross section of the flexible foil including a piezoelectric element according to embodiments of the invention.

(5) FIG. 2c shows a cross section of the flexible foil including a piezoelectric element glued into the opening of the flexible foil according to embodiments of the invention.

(6) FIG. 3a shows a cross section of the flexible foil as shown in FIG. 2c where conducting electrodes are deposited.

(7) FIG. 3b shows a cross section of the flexible foil as shown in FIG. 3a positioned on a base or supporting structure.

(8) FIG. 3c shows a cross section of the transducer assembly as shown in FIG. 3b where the cavities in the base structure are filled with backing material.

(9) FIG. 4a shows a cross section of the flexible foil as shown in FIG. 2c where a single conducting electrode is deposited on the back surface of the flexible foil and piezoelectric element.

(10) FIG. 4b shows a cross section of the flexible foil as shown in FIG. 4a positioned on a base or supporting structure.

(11) FIG. 4c shows a cross section of the transducer assembly as shown in FIG. 4b where the cavities in the base structure are filled with backing material.

(12) FIG. 4d shows a cross section of the transducer system as shown in FIG. 4c where a conducting electrode is deposited around the transducer system.

(13) FIG. 4e shows a cross section of the transducer system as shown in FIG. 4d where a matching or electrical isolation layer is deposited around the transducer system.

(14) FIG. 5 shows a top view of a patterned flexible foil including transducer elements according to embodiments of the invention.

(15) FIG. 6 shows a perspective view of a base element according to embodiments of the invention.

(16) FIG. 7 shows an ultrasound transducer system according to embodiments of the invention.

(17) FIG. 8 shows the flowchart of a method for fabricating an ultrasound transducer system according to one aspect of the invention.

(18) FIG. 9 shows a prospective view of an ultrasound transducer system according to embodiments of the invention comprising an ablation cap.

(19) FIG. 10 shows a cross section view of an ultrasound transducer system according to embodiments of the invention comprising an ablation cap.

DESCRIPTION OF EMBODIMENTS

(20) FIG. 1 shows three steps of the method for fabricating an ultrasound transducer according to one aspect of the invention. On the flexible foil 1 a desired patterned is produced, e.g. opening 2, extending from the top surface 6 to a bottom surface 7. Piezoelectric elements, e.g. piezoelectric element 3, are located in into the openings, e.g. opening 2 and fastened to the internal rim 8 of opening 2. Non-conductive glue 4 may be used to fasten the piezoelectric element 3 to the internal rim 8 of opening 2.

(21) FIG. 2a shows a cross section of the flexible foil 1 before including the piezoelectric elements. The opening 2 is filled, as shown in FIG. 2b by a piezoelectric element 3. The mounting of the piezoelectric element 3, e.g. a piezoelectric patch, is achieved by gluing the patches in the designated areas at the rim or edge of the opening 2. In some embodiments the mounting of the piezoelectric element 3 may be achieved by gluing a thin peripheral annular region of the piezoelectric patch 3 on the flexible foil 1.

(22) FIG. 2b shows the flexible foil 1 with opening 2 where the piezoelectric element 3 is located into the opening 2.

(23) FIG. 2c shows the transducer assembly of FIG. 2b where the piezoelectric element 3, i.e. the external edge of the piezoelectric element 3, is fastened to the inside edge, i.e. the internal rim of the opening 2 of the flexible foil 1 by means of glue 4. The glue may be non-conductive glue so as to provide isolation of the piezoelectric element 3, e.g. piezoelectric patch from the flexible foil 1.

(24) FIG. 3a shows the transducer assembly of FIG. 2c after conductive layers 5 are deposited on the flexible foil 1 and on the piezoelectric element 2. In particular conductive layer 5a is deposited on the top surface of the flexible foil 1 and of the piezoelectric element 2 providing the top electrode, while the conductive layer 5b is deposited on the bottom surface of the flexible foil 1 and of the piezoelectric element 2 providing the bottom electrode.

(25) In FIG. 3b the transducer assembly of FIG. 3a is then placed onto a base structure 6, characterized by cavities 11 extending from the top surface 12 to the bottom surface 13 of the base structure 6. The transducer assembly is filled with backing material 7 as shown in FIG. 3c.

(26) In some other embodiments one layer is deposited on the bottom surface of the flexible foil and on the bottom surface of the one or more piezoelectric element. FIG. 4a shows a cross section of the flexible foil as shown in FIG. 2c where a single conducting layer 17 is deposited on the back surface of the flexible foil 1 and piezoelectric element 3. The transducer assembly of FIG. 4a is then placed onto a base structure 18, characterized by cavities 19 extending from the top surface 20 to the bottom surface 21 of the base structure 18 as shown in FIG. 4b.

(27) The transducer assembly placed on the base structure 18 is filled with backing material 22 as shown in FIG. 4c.

(28) In FIG. 4d a coating layer 23 is deposited at least partially around the transducer system as shown in FIG. 4c. The transducer system as shown in FIG. 4d can be further coated by a matching or electrical isolation layer 24 deposited around the transducer system.

(29) The embodiment shown in FIG. 4 is an alternative to the embodiments shown in FIG. 3 and provides great advantages for electrical signal isolation purposes.

(30) FIG. 5 shows a top view of a patterned flexible foil including transducer elements according to an embodiment of the invention. The flexible foil 28 is patterned so as to have a cross-shape having five openings 10 in which piezoelectric elements 16 are going to be introduced. Shape and number of openings depend on the base structure to be used and on the number of piezoelectric elements to be fasten. This is within the knowledge of the person skilled in the art. The flexible foil 28 is designed so as to be folded in a three-dimensional structure with matches, e.g. in one embodiment the shape of the base structure 9 having cavities 14 as shown in FIG. 6. By folding and gluing the ultrasound transducer assembly onto the base structure the ultrasound transducer system 15 is produced as shown in FIG. 7. The piezoelectric elements 16 fastened into the openings 10 of the flexible foil 28 are positioned so as to face the cavities 14 of the base structure 9. The cavities 14 are then filled with backing materials. The filling may be achieved through injection of backing material in fluidic state followed by hardening. Hardening may be achieved e.g. by curing in air, through exposure to high temperature, exposure to UV light or through the use of chemicals, such as chemical catalyst. In case of hardening with UV exposure, the base structure 9 is made of UV transparent material.

(31) A further coating layer is deposited on the external surface of the ultrasound transducer assembly 15 so as to provide electrical isolation from external disturbance, e.g. RF ablation.

(32) In cardiac ablation monitoring, the ultrasound transducer system can be connected and fixed in a catheter tip of a catheter allowing for forward and sideward monitoring during ablation. After the ultrasound transducer system is electrically connected and fixed in the catheter tip, the ablation cap, e.g. a platinum ablation cap 25 as shown in FIGS. 9 and 10, can be mounted on the catheter body. The ablation tip may have apertures though which the ultrasound transducer system can follow the ablation procedure. Alternatively a material, such as polymethylpentene coated with thin platinum layer, which is transparent to ultrasound may be used. This avoids the need of apertures in the ablation tip.

(33) FIG. 8 shows the flowchart of a method for fabricating an ultrasound transducer system according to one aspect of the invention.

(34) In step (S1) 101, a flexible foil having openings extending from the top to the bottom surface is provided. The flexible foil may have metallization, e.g. copper) on front and backsides or alternatively has patterned metallization tracks on one of the sides for the front and backside of the piezoelectric material, e.g. PZT.

(35) In step (S2) 102, one or more piezoelectric elements is/are mounted into the flexible foil openings. Mounting comprises inserting the one or more piezoelectric elements into the openings of the flexible foil and fastening, e.g. by gluing the one or more piezoelectric elements to the internal rim of the openings of the flexible foil.

(36) In step (S3) 103, one or more conductive layers is/are deposited on the flexible foil and on the one or more piezoelectric elements. Depositing comprises depositing one or more conductive layers on the top and/or bottom surface of the flexible foil and on the top and/or the bottom surface of the one or more piezoelectric elements.

(37) In step (S4) 104, the ultrasound transducer assembly produced in the first three steps is positioned onto a base structure which comprises cavities. Positioning the ultrasound transducer assembly on the base structure comprises folding into a 3D structure the flexible foil containing the one or more piezoelectric elements and gluing the folded flexible foil around the base structure.

(38) In step (S5) 105, the cavities of the base structure are filled with backing material. The filling comprises dispensing backing material in a fluidic state and hardening the backing material.

(39) In step (S6) 106, a coating layer is deposited on the external surface of the ultrasound transducer assembly.

(40) While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems. Any reference signs in the claims should not be construed as limiting the scope.