CN-114554971-B - Intraluminal ultrasound assemblies with multiple material support members and related devices, systems, and methods

Abstract

The present invention provides an intravascular imaging probe that includes a multi-material support member or base and related devices, systems, and methods. According to one embodiment, an intraluminal ultrasound imaging catheter includes a flexible elongate member configured to be positioned within a body lumen of a patient, a support member coupled to a distal portion of the flexible elongate member, and an ultrasound scanner assembly positioned about the support member. The support member includes a hollow inner member comprising a first material, and a first annular member positioned around a perimeter of the hollow inner member at a proximal portion of the hollow inner member. The first annular member extends radially outwardly from the hollow inner member and includes a second material different from the first material.

Inventors

• D. K. Frostad
• M. Minas
• N. A. WILLIAMS

Assignees

• 皇家飞利浦有限公司

Dates

Publication Date

20260512

Application Date

20200930

Priority Date

20191008

Claims (19)

1. 1. An intraluminal ultrasound imaging catheter, comprising: a flexible elongate member configured to be positioned within a body lumen of a patient, A support member coupled to a distal portion of the flexible elongate member, wherein the support member comprises: a hollow inner member comprising a first material, and A first annular member positioned around a perimeter of the hollow inner member at a proximal portion of the hollow inner member, wherein the first annular member extends radially outward from the hollow inner member and the first annular member comprises a second material different from the first material, and An ultrasound scanner assembly positioned about the first annular member of the support member, wherein the ultrasound scanner assembly is configured to obtain ultrasound imaging data of the body lumen; Wherein the support member further comprises a sleeve member positioned around the perimeter of the hollow inner member at an intermediate portion of the hollow inner member, Wherein the sleeve member is positioned distal to the first annular member, and Wherein the sleeve member comprises a third material.
2. 2. The intraluminal ultrasound imaging catheter of claim 1, wherein the hollow inner member comprises a cylindrical shape.
3. 3. The intraluminal ultrasound imaging catheter of claim 2, wherein the hollow inner member comprises a constant outer surface and a constant inner surface.
4. 4. The intraluminal ultrasound imaging catheter of claim 2, Wherein the hollow inner member comprises an outer surface having a first groove, Wherein the first groove is formed at the proximal portion of the hollow inner member such that the second material of the first annular member is positioned within the first groove.
5. 5. The intraluminal ultrasound imaging catheter of claim 1, wherein the first material of the hollow inner member comprises a metal and the second material of the first annular member comprises a polymer.
6. 6. The intraluminal ultrasound imaging catheter of claim 5, wherein the second material is overmolded onto the hollow inner member.
7. 7. The intraluminal ultrasound imaging catheter of claim 1, wherein the first annular member comprises an annular shape.
8. 8. The intraluminal ultrasound imaging catheter of claim 1, wherein the first annular member comprises a polygonal shape.
9. 9. The intraluminal ultrasound imaging catheter of claim 1, wherein the hollow inner member and the first annular member are coupled at the proximal portion of the hollow inner member by an adhesive.
10. 10. The intraluminal ultrasound imaging catheter of claim 9, wherein the adhesive comprises a polymeric material.
11. 11. The intraluminal ultrasound imaging catheter of claim 1, Wherein the hollow inner member comprises an outer surface having a second groove, Wherein the second groove is formed at the intermediate portion of the hollow inner member such that a sleeve member is positioned within the second groove to form a continuous outer profile with the hollow inner member.
12. 12. The intraluminal ultrasound imaging catheter of claim 1, wherein the third material of the sleeve member comprises a polymer.
13. 13. The intraluminal ultrasound imaging catheter of claim 1, Wherein the support member further comprises a second annular member positioned around the perimeter of the hollow inner member at a distal portion of the hollow inner member, Wherein the second annular member extends radially outwardly from the hollow inner member, Wherein the ultrasound scanner assembly is positioned about the second annular member.
14. 14. The intraluminal ultrasound imaging catheter of claim 13, Wherein the second annular member comprises the second material, and Wherein the second annular member comprises an annular shape.
15. 15. The intraluminal ultrasound imaging catheter of claim 13, Wherein the support member further comprises a distal tubular member extending distally of the hollow inner member, and Wherein the second annular member and the distal tubular member comprise a flexible third material.
16. 16. The intraluminal ultrasound imaging catheter of claim 13, wherein the first annular member, the sleeve member, and the second annular member form an integral component positioned around the perimeter of the hollow inner member.
17. 17. The intraluminal ultrasound imaging catheter of claim 1, wherein the side wall of the hollow inner member comprises at least one of a groove or a through hole.
18. 18. The intraluminal ultrasound imaging catheter of claim 1, wherein the intraluminal ultrasound imaging catheter further comprises: A proximal tubular member coupled to the proximal portion of the hollow inner member and extending proximally of the hollow inner member, and A distal tip member coupled to a distal portion end of the hollow interior member and extending distally of the hollow interior member, wherein the distal tip member comprises: An annular portion positioned about the perimeter of the hollow inner member at a distal portion of the hollow inner member, wherein the annular portion extends radially outward from the hollow inner member, and A tapered portion extending distally of the annular portion, Wherein the proximal tubular member and the distal tip member comprise a polymeric material.
19. 19. An intraluminal ultrasound imaging system comprising: The intraluminal ultrasound imaging catheter of any one of claims 1 to 18, and A processor circuit in communication with the intraluminal ultrasound imaging catheter, wherein the processor circuit is configured to generate an intraluminal ultrasound image using the ultrasound imaging data and output the intraluminal ultrasound image to a display.

Description

Intraluminal ultrasound assemblies with multiple material support members and related devices, systems, and methods Technical Field The present disclosure relates generally to structural arrangements of intravascular ultrasound devices, and more particularly to intravascular ultrasound devices having support members formed of multiple materials to provide structural support and other mechanical properties to the device. Background Intravascular ultrasound (IVUS) imaging is widely used as a diagnostic tool in cardiac interventions for assessing diseased blood vessels (e.g. arteries) in the human body to determine the necessity of treatment, to guide the intervention and/or to assess its effectiveness. An IVUS device comprising one or more ultrasound transducers is advanced into a blood vessel and directed to an area to be imaged. The transducer emits ultrasonic energy to form an image of the vessel of interest. Ultrasound waves are reflected by discrete portions caused by tissue structures (e.g., layers of the vessel wall), erythrocytes, and other features of interest. Echoes of the reflected waves are received by the transducer and transferred to the IVUS imaging system. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the vessel in which the device is placed. Solid state (also known as synthetic aperture) IVUS catheters are one of the two IVUS devices commonly used today, the other being rotary IVUS catheters. The solid state IVUS catheter carries a scanner assembly comprising an ultrasound transducer array distributed around its perimeter and one or more integrated circuit controller chips mounted adjacent to the transducer array. The controller selects an individual transducer element (or group of elements) to transmit an ultrasonic pulse and receive an ultrasonic echo signal. By stepping through a series of transmit-receive pairs, a solid-state IVUS system can synthesize the effect of mechanically scanned ultrasound transducers, but without moving parts (hence the name solid-state). Because there are no rotating mechanical elements, the transducer array can be placed in direct contact with blood and vascular tissue, minimizing the risk of vascular damage. Furthermore, the electrical interface is simplified as there is no rotating element. The solid state scanner can be directly wired to the imaging system through a simple cable and standard detachable electrical connector (rather than the complex rotating electrical interface required for a rotating IVUS device). In designing an IVUS device, it is important to consider practical limitations such as manufacturability, reliability, elasticity, and mechanical properties. It is desirable for an ultrasound catheter assembly to be able to produce high quality raw image signals for signal processing systems located outside the body into which the intravascular ultrasound transducer assembly is inserted for imaging. However, there is a concern that limiting the number of components, as the increased complexity increases manufacturing costs and reduces the yield of the intravascular ultrasound catheter assembly. It is desirable that the device be sufficiently flexible and have sufficient structural support to traverse tortuous areas of the vasculature without damaging the electronic components of the IVUS device. Conventional IVUS devices include a support member, which may also be referred to as a base, or a unitary piece, formed from a metal tube. The ultrasound imaging assembly is positioned on or around the support member. The support member provides structural support, rigidity, radiopacity, and other characteristics to the scanner assembly. Conventional support members have a number of disadvantages. For example, manufacturing techniques available for metals (e.g., milling, welding, etc.) limit the geometric configurations of support members that can be produced. Similarly, steel cannot reflow with the polymer, nor effectively scatter or attenuate ultrasound. Accordingly, the structure of conventional support members may limit the mechanical and/or acoustic performance of the IVUS device. Disclosure of Invention The present application provides an improved intravascular imaging probe that includes a multi-material support member or mount that is part of an imaging assembly located at a distal portion of an IVUS catheter. The support member is formed of a plurality of (i.e., two, three, or more) materials having various structural complexities. The base may include a cylindrical hollow core or hypotube that incorporates polymer features that are overmolded, assembled, or otherwise directly coupled to the hollow core. The multiple material structures allow the features to be molded or coupled directly to the support structure, which may improve and/or simplify the manufacturing process, and may provide more varied geometric configurations that exhibit improved mechanical and/or acoustic performance. In certain