Search

EP-4577280-B1 - A MICROCATHETER FOR INTERVENTIONAL CARDIOVASCULAR AND/OR NEUROVASCULAR APPLICATIONS

EP4577280B1EP 4577280 B1EP4577280 B1EP 4577280B1EP-4577280-B1

Inventors

  • Abbring, Drewes Pieter
  • ELEVELD, Rolf
  • VAN DE WEG, Joachim
  • LAMERS, Edwin Adriaan Derk
  • Schulting, Edwin Alexander

Dates

Publication Date
20260506
Application Date
20231005

Claims (14)

  1. A catheter (1), being a microcatheter for interventional cardiovascular and/or interventional neurovascular applications, wherein the catheter comprises a tubular catheter wall (2), which is surrounding a lumen structure (3) of the catheter, the catheter wall having a proximal end (4), a distal end (5) and a longitudinal direction (10) extending from the proximal end to the distal end, wherein the catheter wall has a length of at least 1000 mm from the proximal end to the distal end along the longitudinal direction; and wherein the catheter wall (2) comprises: - a proximal section (6), being defined as extending distally along the longitudinal direction from the proximal end (4) to a first position (21) at 160 mm proximal from the distal end (5), - a first distal section (31), being defined as extending distally along the longitudinal direction from said first position to the distal end, - a second distal section (32), being defined as extending distally along the longitudinal direction from a second position (22) to the distal end (5), said second position (22) being at 80 mm proximal from the distal end (5), and - a third distal section (33), being defined as extending distally along the longitudinal direction from a third position (23) to the distal end (5), said third position (23) being at 40 mm proximal from the distal end (5); and wherein the catheter wall (2) comprises: - a skeleton (7), which is an interrupted tubular reinforcement wall obtained by microfabricating a cut pattern (7A) in a fully uninterrupted tubular reinforcement wall made of a reinforcement material, and - an inner liner (8), which is co-axially surrounded by said skeleton (7) relative to a center line (12) of the catheter wall (2); and wherein said skeleton (7) provides reinforcement of the catheter wall (2) in the longitudinal direction (10), as well in a circumferential direction (11) around the longitudinal direction (10); and wherein said skeleton (7) and said inner liner (8) are extending at least in the first distal section (31), the second distal section (32) and the third distal section (33); characterized in that : an overall skeleton cut-away ratio of a longitudinal section of the catheter wall (2) in a longitudinal range along the longitudinal direction (10) is defined as the percentage of: - the volume of all parts, within said longitudinal range, of said reinforcement material being cut-away from said fully uninterrupted tubular reinforcement wall according to said microfabricated cut pattern (7A), relative to - the volume of all parts, within said longitudinal range, of said reinforcement material of said fully uninterrupted tubular reinforcement wall; and wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 40%, the overall skeleton cut-away ratio of the second distal section (32) is at least 50%, and the overall skeleton cut-away ratio of the third distal section (33) is at least 60%.
  2. The catheter (1) according to claim 1, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 50%, the overall skeleton cut-away ratio of the second distal section (32) is at least 60%, and the overall skeleton cut-away ratio of the third distal section (33) is at least 70%.
  3. The catheter (1) according to claim 2, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 60%, the overall skeleton cut-away ratio of the second distal section (32) is at least 70%, and the overall skeleton cut-away ratio of the third distal section (33) is at least 80%.
  4. The catheter (1) according to claim 1, wherein the catheter wall (2) further comprises: - a fourth distal section (34), being defined as extending distally along the longitudinal direction from a fourth position (24) to the distal end (5), said fourth position (24) being at 20 mm proximal from the distal end (5), and wherein said skeleton (7) and said inner liner (8) are furthermore extending in the fourth distal section (34), and wherein the overall skeleton cut-away ratio of the fourth distal section (34) is at least 70%.
  5. The catheter (1) according to claim 4, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 50%, the overall skeleton cut-away ratio of the second distal section (32) is at least 60%, the overall skeleton cut-away ratio of the third distal section (33) is at least 70%, and the overall skeleton cut-away ratio of the fourth distal section (34) is at least 80%.
  6. The catheter (1) according to claim 5, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 60%, the overall skeleton cut-away ratio of the second distal section (32) is at least 70%, the overall skeleton cut-away ratio of the third distal section (33) is at least 80%, and the overall skeleton cut-away ratio of the fourth distal section (34) is at least 85%.
  7. The catheter (1) according to claim 1, wherein the catheter wall (2) further comprises: - a fourth distal section (34), being defined as extending distally along the longitudinal direction from a fourth position (24) to the distal end (5), said fourth position (24) being at 20 mm proximal from the distal end (5), and - a fifth distal section (35), being defined as extending distally along the longitudinal direction (10) from a fifth position (25) to the distal end (5), said fifth position (25) being at 10 mm proximal from the distal end (5); wherein said skeleton (7) and said inner liner (8) are furthermore extending in the fourth distal section (34) and the fifth distal section (35); and wherein the overall skeleton cut-away ratio of the fourth distal section (34) is at least 70%, and the overall skeleton cut-away ratio of the fifth distal section (35) is at least 80%.
  8. The catheter (1) according to claim 7, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 50%, the overall skeleton cut-away ratio of the second distal section (32) is at least 60%, the overall skeleton cut-away ratio of the third distal section (33) is at least 70%, the overall skeleton cut-away ratio of the fourth distal section (34) is at least 80%, and the overall skeleton cut-away ratio of the fifth distal section (35) is at least 85%.
  9. The catheter (1) according to claim 8, wherein the overall skeleton cut-away ratio of the first distal section (31) is at least 60%, the overall skeleton cut-away ratio of the second distal section (32) is at least 70%, the overall skeleton cut-away ratio of the third distal section (33) is at least 80%, the overall skeleton cut-away ratio of the fourth distal section (34) is at least 85%, and the overall skeleton cut-away ratio of the fifth distal section (35) is at least 90%.
  10. The catheter (1) according to any one of the preceding claims, wherein the inner liner (8) is extending distally beyond the skeleton (7) to form an atraumatic distal tip of the catheter.
  11. The catheter (1) according to any one of the preceding claims, wherein at least the first distal section (31) of the catheter wall (2) further comprises an outer laminate (9) which is co-axially surrounding said skeleton (7) relative to the center line (12) of the catheter wall.
  12. The catheter (1) according to claim 11, wherein the outer laminate is extending distally beyond the skeleton to form an atraumatic distal tip of the catheter.
  13. The catheter (1) according to claim 11, wherein the inner liner (8) and the outer laminate (9) are extending distally beyond the skeleton (7) to form an atraumatic distal tip of the catheter.
  14. The catheter (1) according to any one of the preceding claims, wherein the skeleton (81), being said interrupted tubular reinforcement wall, comprises at least one elongated reinforcement portion (14, 15), which is longitudinally extending along at least one corresponding longitudinal reinforcement path (16, 17) along said interrupted tubular reinforcement wall, respectively, wherein a distribution of thickness of at least one of the at least one elongated reinforcement portion (14, 15) progressively decreases as seen distally along the longitudinal direction (10) of the catheter wall (2), wherein said thickness of the at least one elongated reinforcement portion (14, 15) is defined as occurring within said interrupted tubular reinforcement wall and as occurring perpendicular to the corresponding longitudinal reinforcement path (16, 17).

Description

The invention relates to a catheter, being a microcatheter for interventional cardiovascular and/or neurovascular applications, wherein the catheter comprises a tubular catheter wall, which is surrounding a lumen structure of the catheter, the catheter wall having a proximal end, a distal end and a longitudinal direction extending from the proximal end to the distal end, wherein the catheter wall has a length of at least 1000 mm from the proximal end to the distal end along the longitudinal direction;and wherein the catheter wall comprises a proximal section, being defined as extending distally along the longitudinal direction from the proximal end to a first position at 160 mm proximal from the distal end, and at least a first distal section, being defined as extending distally along the longitudinal direction from said first position to the distal end,and wherein at least the first distal section of the catheter wall comprises a skeleton, which is an interrupted tubular reinforcement wall obtained by microfabricating a cut pattern in a fully uninterrupted tubular reinforcement wall made of a reinforcement material, and an inner liner, which is co-axially surrounded by said skeleton relative to a center line of the catheter wall,and wherein said skeleton provides reinforcement of the catheter wall in the longitudinal direction, as well in a circumferential direction around the longitudinal direction. In said cardiovascular and neurovascular applications, such a catheter must be angled through the tortuous bends and curves of a vasculature passageway to arrive at the targeted anatomy. Such a catheter requires sufficient flexibility, particularly closer to its distal end, to navigate such tortuous pathways. However, other design aspects must also be considered. For example, the catheter must also be able to provide sufficient torquability (i.e., the ability to transmit torque applied at the proximal end all the way to the distal end), pushability (i.e., the ability to transmit axial push to the distal end), and structural integrity for performing intended medical functions. US 2019/0255290 A1 discloses in Fig. 3 an example of an interventional cardiovascular catheter specifically designed for being positioned near the aortic root. Figs. 4A-4D and Fig. 5 of US 2019/0255290 A1 show some examples of skeletons that can be applied in the various longitudinal sections of the catheter of Fig. 3 of US 2019/0255290 A1, wherein such a skeleton is an interrupted tubular reinforcement wall obtained by microfabricating a cut pattern in a fully uninterrupted tubular reinforcement wall made of a reinforcement material. The catheter of Fig. 3 of US 2019/0255290 A1 has been particularly designed for providing a relatively sharp bend 54 (see Fig. 2 of US 2019/0255290 A1) to extend across the aortic root 16 and reach into the artery 24 (see Fig. 2 of US 2019/0255290 A1). Especially the proximal-intermediate section 106 of Fig. 3 of US 2019/0255290 A1), which includes the one-beam configuration of the skeleton of Fig. 4D of US 2019/0255290 A1) has been designed for providing said relatively sharp bend 54. US 2011/077620 A1 discloses high performance guide catheters suitable for neurovascular access. They are constructed using a machined core, in which the core includes transition features from a proximal to distal-most section of the device. US 2008/097398 A1 discloses a component for use as or incorporation within a medical instrument navigable through body vessels of a human subject. The component includes a tubular portion with an interrupted spiral defined by alternating cut and uncut sections. EP 1 475 120 A1 discloses a tubular medical catheter having a least one region of selectively varied lamination. US 2006/004346 A1 discloses a bend relief for supporting a cannula wherein said bend relief includes a tubular body having a region near a first end that is substantially flexible and a region near a second end that is substantially rigid. Said tubular body has a series of weakened zones disposed therealong, wherein said weakened zones provide said tubular body with regions of differential flexibility. It is an object of the present invention to provide a solution for optimizing the flexibility of the catheter when navigating deep into the very fine cardiovascular and neurovascular tortuous pathways, while still maintaining torquability, pushability, and structural integrity of the catheter. For that purpose the invention provides a catheter according to the appended independent claim 1. Preferable embodiments of the invention are provided by the appended dependent claims 2-14. Accordingly, the invention provides a catheter, being a microcatheter for interventional cardiovascular and/or interventional neurovascular applications, wherein the catheter comprises a tubular catheter wall, which is surrounding a lumen structure of the catheter, the catheter wall having a proximal end, a distal end and a longitudinal direction ex