Catheter

Patent metadata

Field	Value
Publication number	US-10874828-B2
Application number	US-201615265042-A
Country	US
Kind code	B2
Filing date	Sep 14, 2016
Priority date	Mar 18, 2014
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

Abstract

A catheter that includes an inner layer forming the inner surface of a tubular catheter main body having a lumen, an outer layer forming the outer surface of the catheter main body, and multiple reinforcements embedded between the inner surface and the outer surface. The inner diameter of the catheter main body is D 1 , the outer diameter is D 2 , the wall thickness is T 1 , a thickness of each reinforcement is T 2 , an effective width of each reinforcement is W, and a total number of the multiple reinforcements is N. The catheter satisfies Expressions (1), (2), and (3):

0.050 mm≤ T 1≤0.100 mm  Expression (1)

T 2/ T 1≥0.25  Expression (2)

60,000≤( D 1× D 2× W×N )/( T 1 2 ×T 2)<1,000,000  Expression (3).

First claim

What is claimed is:

1. A catheter comprising:
an inner layer forming an inner surface of a tubular catheter main body having a lumen, the lumen of the catheter being configured such that a medical instrument is insertable through the lumen of the catheter to perform treatment at a target site of a living body while the catheter is positioned in the living body;
an outer layer forming an outer surface of the catheter main body, the catheter main body possessing an inner diameter, an outer diameter and a wall thickness;
multiple reinforcements embedded between the inner surface and the outer surface of the catheter main body; and
the catheter satisfying Expressions (1), (2), (3), (4), (5), and (6) below:
0.050 mm≤ T 1≤0.100 mm  Expression (1)

T 2 /T 1≥0.25  Expression (2)

60,000≤( D 1 ×D 2 ×W×N )/( T 1 2 ×T 2)<1,000,000  Expression (3)

B 1=( D 1/ T 1)×( D 2/ T 1)  Expression (4)

B 2=( W×N )/ T 2  Expression (5)

B=B 1× B 2  Expression (6)

wherein the inner diameter of the catheter main body is D 1 , the outer diameter of the catheter main body is D 2 , the wall thickness of the catheter main body is T 1 , a thickness of each reinforcement along a radial direction of the catheter main body is T 2 , an effective width of each reinforcement along the circumferential direction of the catheter main body in a cross section orthogonal to an axial direction of the catheter main body is W, and a total number of the multiple reinforcements is N,
the catheter being configured to be introduced into a living body through a radial artery of an arm and is configured to be then advanced into a blood vessel of a lower limb of the living body,
the outer diameter of the catheter main body being 2.32 mm to 3 mm, and
the value B being 80,000 to less than 500,000.

2. The catheter according to claim 1 , wherein the effective width W of each reinforcement ranges from 0.200 mm to less than 0.600 mm.

3. The catheter according to claim 1 , wherein when the catheter main body is bent 180° and a portion of the catheter main body becomes a kinked portion, in a cross-sectional shape of the kinked portion of the catheter main body when an angle formed by the kinked portion returns to 90°, spaces formed at a left radial outer end and a right radial outer end of the lumen of the catheter main body are greater than a space formed at a center of the lumen, the center of the lumen being between the left radial outer end and the right radial outer end of the lumen of the catheter main body in the radial direction.

4. The catheter according to claim 1 , wherein when the catheter main body is bent 180° and a portion of the catheter main body becomes a kinked portion, the lumen of the catheter main body at the kinked portion when an angle formed by the kinked portion returns to 90° allows a guide wire having an outer diameter of 0.89 mm to be inserted therethrough.

5. The catheter according to claim 1 , wherein a distance between a turned-back end of a loop and a plate is equal to or less than 45 mm when the loop is made by causing the catheter main body to pass through two penetration holes that are parallel to each other, have diameters of 2.8 mm, the center-to-center distance between the two penetration holes is 10 mm in the plate having a thickness of 10 mm in water of 37° C. and a kink occurs by pulling one end of the catheter main body.

6. The catheter according to claim 1 , wherein the multiple reinforcements are embedded within only the outer layer of the catheter main body.

7. The catheter according to claim 1 , wherein the catheter main body is linear throughout an axial extent of the catheter main body before being inserted into a living body.

8. The catheter according to claim 1 , wherein the value B is less than 250,000.

9. The catheter according to claim 1 , wherein the inner diameter D 1 of the catheter main body is 2.16 mm 2.26 mm.

10. The catheter according to claim 1 , wherein the inner diameter D 1 of the catheter main body is 1.85 mm 2.26 mm.

11. A catheter comprising:
a tubular catheter main body comprising a lumen, the catheter main body possessing an inner surface and an outer surface, the lumen being defined by the inner surface of the catheter main body, the lumen of the catheter being configured such that a medical instrument is insertable through the lumen of the catheter to perform treatment at a target site of a living body while the catheter is positioned in the living body;
the catheter main body possessing an inner diameter, an outer diameter and a wall thickness;
multiple reinforcements being embedded between the inner surface of the catheter main body and the outer surface of the catheter main body, the multiple reinforcements being helically-wound; and
the catheter satisfying Expressions (1), (2), (3), (4), (5), and (6) below:
0.050 mm≤ T 1≤0.100 mm  Expression (1)

T 2 /T 1≥0.25  Expression (2)

60,000≤( D 1 ×D 2 ×W×N )/( T 1 2 ×T 2)<1,000,000  Expression (3)

B 1=( D 1/ T 1)×( D 2/ T 1)  Expression (4)

B 2=( W×N )/ T 2  Expression (5)

B=B 1× B 2  Expression (6)

wherein the inner diameter of the catheter main body is D 1 , the outer diameter of the catheter main body is D 2 , the wall thickness of the catheter main body is T 1 , a thickness of each reinforcement along a radial direction of the catheter main body is T 2 , an effective width of each reinforcement along the circumferential direction of the catheter main body in a cross section orthogonal to an axial direction of the catheter main body is W, and a total number of the multiple reinforcements is N,
the catheter being configured to be introduced into the living body through a radial artery of the living body and is configured to be then maneuvered within the living body to reach a blood vessel in a lower limb of the living body,
the outer diameter of the catheter main body being 2.32 mm to 2.39 mm, and
the value B being 80,000 to less than 500,000.

12. The catheter according to claim 11 , wherein the total number of the multiple reinforcements is at least 8 and not greater than 32.

13. The catheter according to claim 11 , wherein the effective width W of each reinforcement is at least 0.200 mm and no greater than 0.600 mm.

14. The catheter according to claim 11 , wherein each of the reinforcements possess a pitch of at least 1.5 mm and no greater than 7.0 mm.

15. The catheter according to claim 11 , wherein each of the reinforcements is helically-wound an angle of at least 10° and no greater than 80° relative to the axial direction of the catheter main body.

16. The catheter according to claim 11 , wherein each of the reinforcements is stainless steel.

17. The catheter according to claim 11 , wherein the helically-wound reinforcements overlap one another.

18. The catheter according to claim 17 , wherein two of the overlapping reinforcements collectively possess a combined thickness that is at least half of the wall thickness T 1 of the catheter main body.

19. The catheter according to claim 11 , wherein the catheter main body is linear throughout an axial extent of the catheter main body before being inserted into a living body.

20. The catheter according to claim 11 , wherein the value B is less than 250,000.

21. The catheter according to claim 11 , wherein the inner diameter D 1 of the catheter main body is 2.16 mm-2.26 mm.

22. The catheter according to claim 11 , wherein the inner diameter D 1 of the catheter main body is 1.85 mm-2.

Assignees

• Terumo Corp

Inventors

• Otake Yuya
• Hamuro Kota
• Tashiro Koichiro
• Maruyama mariko
• Fukuoka Tetsuya

Classifications

• A61M2025/0025

  having a collapsible lumen · CPC title

• A61M25/005 Primary

  with embedded materials for reinforcement, e.g. wires, coils, braids · CPC title