CN-121971775-A - Microfabricated catheter device with high axial strength

CN121971775ACN 121971775 ACN121971775 ACN 121971775ACN-121971775-A

Abstract

The present disclosure describes a microfabricated intravascular device that is configured for high axial strength while also maintaining effective bending flexibility. A tubular member includes a series of circumferentially extending rings interconnected by a series of axially extending beams. The transverse cuts separate and define loops. A series of axial cuts are aligned with the beams and extend partially from the beams into the adjoining rings such that the beam lengths partially nest within the axial lengths of the adjoining rings. This increases the functional length of the beam to provide bending flexibility while still providing sufficient ring structure to provide effective axial stiffness.

Inventors

C.C. DAVIS

Assignees

血管科学公司

Dates

Publication Date: 20260505
Application Date: 20211005
Priority Date: 20211004

Claims (15)

1. A microfabricated elongate tube member for an intravascular device, the elongate tube member extending along a longitudinal axis and comprising: A plurality of circumferentially extending rings, each ring having an axial length; a plurality of transverse cuts, each transverse cut being positioned between adjacent rings, each transverse cut extending in a direction transverse to the longitudinal axis of the tube member; a plurality of axially extending beams, each beam extending from one ring to another ring to connect adjacent rings, and A plurality of axial slits aligned with the beams, each axial slit extending partially into an adjoining ring in a substantially axial direction such that a respective beam is at least partially nested within a length of one or both of the adjoining rings connected by the respective beam; Wherein at least a portion of the transverse cuts are wedge-shaped, at least a portion of the transverse cuts being narrower near the respective beam and widening when extending circumferentially away from the respective beam; The wedge angle of the transverse cut increases or decreases gradually along the longitudinal axis in successive sections of the tube member.
2. The tubular member of claim 1, wherein at least a portion of the axial cutout is wedge-shaped.
3. The tubular member of claim 2, wherein at least a portion of the axial slit is wider at an edge of the adjoining ring and narrows as it extends into the adjoining ring along the axial direction.
4. The tubular member of claim 1, wherein the tubular member has a double beam configuration such that there are pairs of beams between each pair of adjacent rings, and the pairs of beams between each pair of adjacent rings are circumferentially spaced 180 degrees apart.
5. The tubular member of claim 4, wherein the dual beam configuration comprises a rotational offset such that the beams between a given pair of adjacent rings are rotationally offset from beams of a previous and/or subsequent pair of adjacent rings.
6. The tubular member of claim 5, wherein the rotational offset is 5 degrees to 90 degrees.
7. The tube member of claim 1, wherein the ring axial length gradually decreases toward the distal end of the tube member.
8. The tube member of claim 1, wherein a beam thickness gradually decreases toward a distal end of the tube member.
9. The tube member of claim 1, wherein at the distal section of the tube member, the ring has a ratio of ring length to ring diameter of 0.25 to 0.8.
10. The tubular member of claim 1, wherein at least a section of the tubular member has a micromachining to homogeneity ratio of at least 3.
11. The tube member of claim 1, wherein the tube member is formed from one or more of polyetheretherketone PEEK, stainless steel, or nitinol.
12. The tubular member of claim 1, further comprising a polymer applied to the tubular member to fill the transverse and axial cuts.
13. The tubular member of claim 1, further comprising one or both of an inner liner or an outer liner.
14. The tubular member of claim 13, wherein the inner liner and the outer liner do not fill the transverse cut or the axial cut.
15. A microfabricated elongate tube member for an intravascular device, the elongate tube member extending along a longitudinal axis and comprising: A plurality of circumferentially extending rings, each ring having an axial length; a plurality of axially extending beams, each beam extending from one ring to another ring to connect adjacent rings, and A plurality of transverse cuts, each transverse cut being positioned between adjacent rings, each transverse cut extending in a direction transverse to the longitudinal axis of the tube member, wherein each transverse cut is narrower near a respective beam and widens as it extends circumferentially away from the respective beam; Wherein at least a portion of the transverse cuts are wedge-shaped, at least a portion of the transverse cuts being narrower near the respective beam and widening when extending circumferentially away from the respective beam; The wedge angle of the transverse cut increases or decreases gradually along the longitudinal axis in successive sections of the tube member.

Description

Microfabricated catheter device with high axial strength The present application is a divisional application of application number 202180077110.6, titled "microfabricated catheter device with high axial strength", with application number 2021, 10/05. Cross Reference to Related Applications The present application claims priority from U.S. patent application Ser. No. 17/493,265, entitled "microfabricated catheter device with high Axial Strength" (Microfabricated CATHETER DEVICES WITH HIGH Axial Strength) filed on 4 th 2021, while this application claims priority and benefit from U.S. provisional patent application Ser. No. 63/087,410, entitled "microfabricated catheter device with high Axial Strength" (Microfabricated CATHETER DEVICES WITH HIGH Axial Strength) filed on 5 th 2020, each of which is incorporated herein by reference in its entirety. Background Guidewires and catheters are often utilized in the medical field to perform delicate procedures deep within the vasculature of the body. Typically, a catheter is inserted into a patient's femoral, radial, carotid, or jugular vein vessel and passed through the patient's vasculature to the heart, brain, or other target anatomy. Typically, a guidewire is first directed to the target anatomy, and then one or more catheters are passed through the guidewire (pass) and directed to the desired location. Once in place, the catheter can be used to aspirate clots or other obstructions, or to deliver drugs, stents, embolic devices, radiopaque dyes (dye), or other devices or substances for treating patients. In many applications, such catheters must be guided through the curved bends and folds of the vasculature path to reach the target anatomy. Desirably, these catheters include design feature(s) that enable efficient navigation of such curved paths. For example, the catheter should be flexible enough to navigate the bends of the vasculature, but should also be able to provide sufficient pushability (pushability) (i.e., the ability to transfer axial forces from the proximal portion to the distal portion) and torqueability (i.e., the ability to transfer torque from the proximal portion to the distal portion). For example, if the catheter lacks sufficient axial stiffness, it would be difficult for the operator to push the catheter forward through the vasculature. That is, the axial force applied by the operator at the proximal end may cause the catheter to axially compress and "collapse (accordion)", rather than being effectively transmitted to the distal end of the catheter. Designing the catheter with a higher axial stiffness can alleviate this problem. However, increasing the axial stiffness of the catheter can lead to other problems (interfering with the effectiveness of the catheter). For example, increasing the axial stiffness of the catheter generally also increases the bending stiffness of the catheter, which can be detrimental if the bending flexibility remaining in the device is insufficient. Accordingly, there is a continuing need for catheter devices having features designed to allow effective axial stiffness without unduly compromising desired characteristics such as flexibility and torqueability of the device. Disclosure of Invention The present disclosure describes a microfabricated intravascular device that is configured for high axial strength while also maintaining effective bending flexibility. In one embodiment, the tubular member comprises a series of circumferentially extending rings interconnected by a series of axially extending beams. A plurality of transverse cuts separate and define the loops. The transverse cuts are disposed between adjacent rings and extend in a direction transverse to the longitudinal axis of the tubular member, but do not cut completely through the tubular member, thereby positioning the beams between the rings. In some embodiments, at least a portion of the transverse cuts are wedge-shaped. For example, one or more transverse cuts may be narrower near the respective beam and then wider as it extends circumferentially away from the respective beam. In some embodiments, a series of axial cuts are aligned with the beam and extend partially from the beam into the adjoining (joining) ring such that the beam length is partially nested within the axial length of the adjoining ring. This increases the functional length of the beam to provide bending flexibility while still providing sufficient ring structure to provide effective axial stiffness. In some embodiments, at least a portion of the axial slit is wedge-shaped. For example, one or more axial cuts may be wider at the edge of the adjoining ring and then become wider as they extend into the adjoining ring in the axial direction. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter