# US 10,946,170 B2 · Catheter and method of engaging catheter

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- Number: US 10,946,170 B2
- Document ID: US10946170B2
- Status: Granted
- Kind: B2
- Application number: 16/357,626
- Filed: 2019-03-19
- Published: 2020-09-24
- Granted: 2021-03-16
- Earliest claimed: 2019-03-19
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Marcelo Guimaraes; Ryo Okamura; Mitsuteru Yasunaga
- Web page: https://patentgrep.com/patent/US10946170B2

## CPC

- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0141: {having flexible regions as a result of using materials with different mechanical properties}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/008: {Strength or flexibility characteristics of the catheter tip}
- A61M 2210/1071: Liver; Hepar
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A catheter for a hepatic artery introduced from an arm of a patient includes a first bent portion, a second bent portion distal of the first bent portion and bent to the same side as the first bent portion, a third bent portion disposed on a distal side of the second bent portion and bent to an opposite side from the second bent portion, and a most distal end portion disposed distal of the third bent portion, in which a minimum radius of curvature of the first bent portion is larger than a minimum radius of curvature of the second bent portion. The most distal end portion is directed to a common hepatic artery and the first bent portion comes into contact with an aorta wall on an opposite side from a celiac artery when the second bent portion contacts a blood vessel wall of the celiac artery.

## Claims

### Claim 1

A catheter configured to be introduced into an arm of a patient and advanced to a hepatic artery of the patient, the catheter comprising
a tubular body that includes a lumen extending from a proximal end of the tubular body to a distal end of the tubular body;
the tubular body being comprised of a substantially linear main body portion and a shape portion that is bent so that an entirety of the shape portion is positioned in substantially the same plane;
the shape portion comprising:
a first bent portion disposed on a distal side of the main body portion, the first bent portion being bent toward one side and defining a first angle;
a second bent portion disposed on a distal side of the first bent portion, the second bent portion being bent toward a side that is the same as the side to which the first bent portion is bent, the second bent portion defining a second angle;
a third bent portion disposed on a distal side of the second bent portion, the third bent portion being bent toward a side that is opposite the side to which the first and second bent portions are bent, the third bent portion defining a third angle; a most distal end portion disposed on a distal side of the third bent portion;
the first bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the first bent portion, the second bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the second bent portion, the radius of curvature of the smallest radius of curvature portion of the first bent portion being larger than the radius of curvature of the smallest radius of curvature portion of the second bent portion;
the most distal end portion being configured to be positioned in the common hepatic artery while the first bent portion is in contact with an aorta wall on an opposite side from a celiac artery and while the second bent portion is in contact with a blood vessel wall of the celiac artery;
an axis passing through a center line of the main body portion is referred to as a first axis;
the portion of the second bent portion having the smallest radius of curvature includes opposite ends and a second bending point representing a center point between the opposite ends;
an axis passing through the second bending point and a first intermediate point positioned at a distal end of the main body portion is a fifth axis;
a first inclination angle between the fifth axis and the first axis is 34° to 63°; and
a second inclination angle constituting an angular range of the portion of the second bent portion having the smallest radius of curvature is 38° to 73°.

### Claim 2 (depends on 1)

The catheter according to claim 1, wherein the smallest radius of curvature of the first bent portion is 10 mm to 80 mm, and the smallest radius of curvature of the second bent portion is 3 mm to 9 mm.

### Claim 3 (depends on 1)

The catheter according to claim 1, wherein the smallest radius of curvature of the first bent portion is 10 mm to 80 mm, the smallest radius of curvature of the second bent portion is 3 mm to 9 mm, and a smallest radius of curvature of the third bent portion is 1 mm to 9 mm.

### Claim 4 (depends on 1)

The catheter according to claim 1, wherein the third angle is more than 0° and 90° or less.

### Claim 5 (depends on 1)

The catheter according to claim 1, wherein
the first inclination angle is 46°, and
the second inclination angle is 73°.

### Claim 6 (depends on 1)

The catheter according to claim 1, wherein a length of the most distal end portion is 0.1 mm to 50 mm.

### Claim 7 (depends on 1)

The catheter according to claim 1, wherein an effective length of the catheter is 1,000 mm to 1,500 mm.

### Claim 8

A catheter, comprising
a tubular body that includes a lumen extending from a proximal end of the tubular body to a distal end of the tubular body;
the tubular body being comprised of a substantially linear main body portion and a shape portion that is bent so that an entirety of the shape portion is positioned in substantially the same plane;
the shape portion comprising:
a first bent portion disposed on a distal side of the main body portion, the first bent portion being bent toward one side and defining a first angle;
a second bent portion disposed on a distal side of the first bent portion, the second bent portion being bent toward a side that is the same as the side to which the first bent portion is bent, the second bent portion defining a second angle;
a third bent portion disposed on a distal side of the second bent portion, the third bent portion being bent toward a side that is opposite the side to which the first and second bent portions are bent, the third bent portion defining a third angle;
a most distal end portion disposed on a distal side of the third bent portion;
the first bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the first bent portion, the second bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the second bent portion, the radius of curvature of the smallest radius of curvature portion of the first bent portion being larger than the radius of curvature of the smallest radius of curvature portion of the second bent portion;
an axis passing through a center line of the main body portion is referred to as a first axis;
an axis passing through the most distal end portion is referred to as a fourth axis;
the portion of the second bent portion having the smallest radius of curvature includes opposite ends and a second bending point representing a center point between the opposite ends;
an axis passing through the second bending point and a first intermediate point positioned at a distal end of the main body portion is referred to as a fifth axis;
a first inclination angle formed between the fifth axis and the first axis is 34° to 63°;
a second inclination angle constituting an angular range of the portion of the second bent portion having the smallest radius of curvature in the second bent portion is 38° to 73°;
the third angle is more than 0° and 90° or less; and
a third inclination angle formed between the fourth axis and the first axis is 80° to 150°.

### Claim 9 (depends on 8)

The catheter according to claim 8, wherein in a three-point bending test in which the tubular body is supported at two fulcrums and a center position of the tubular body positioned midway of the two fulcrums is pushed by an indenter from a side opposite the side supported by the fulcrums, a distance between fulcrums is 25.4 mm, a fulcrum width of each fulcrum is 4.0 mm, a radius of curvature of each fulcrum is 2.0 mm, an indenter width is 1.0 mm, a radius of curvature of the indenter is 0.5 mm, a push amount by the indenter is 2 mm, a temperature of 25° C. and air, and an indentation load acting on the indenter is 20 gf to 250 gf in at least a part of the tubular body.

### Claim 10 (depends on 8)

The catheter according to claim 8, wherein a flexural modulus of at least a part of the shape portion is 2 MPa to 25 MPa.

### Claim 11 (depends on 8)

The catheter according to claim 8, wherein the shape portion possesses a flexural property, the flexural property changing along a major axis of the shape portion of the tubular body.

### Claim 12 (depends on 8)

The catheter according to claim 8, wherein the main body portion possesses a flexural property, the flexural property changing along a major axis of the main body portion of the tubular body.

### Claim 13 (depends on 8)

The catheter according to claim 8, wherein the tubular body includes a flexible portion at a distal portion of the tubular body, the flexible portion having a bending characteristic in which the flexible portion is more flexible than a proximal portion of the tubular body, and a length of the flexible portion is 500 mm or less.

### Claim 14 (depends on 8)

The catheter according to claim 8, wherein an outer diameter of the tubular body is 1 mm to 2.5 mm.

### Claim 15

A method comprising:
inserting a catheter into a radial artery of a patient, the catheter including a tubular body that includes a lumen extending from a proximal end of the tubular body to a distal end of the tubular body, the tubular body being comprised of a substantially linear main body portion and a shape portion that is bent so that an entirety of the shape portion is positioned in substantially the same plane, the shape portion comprising a first bent portion disposed on a distal side of the main body portion and bent toward one side of the shape portion, a second bent portion disposed on a distal side of the first bent portion and bent toward a same side of the shape portion as the side of the shape portion to which the first bent portion is bent, a third bent portion disposed on a distal side of the second bent portion and bent to a side of the shape portion opposite the side to which the first and second bent portions are bent, and a most distal end portion disposed on a distal side of the third bent portion;
moving the shape portion of the catheter forward in the radial artery to a main artery of the patient that is accessible from the radial artery;
moving the shape portion forward in the main artery to a first blood vessel that is connected to the main artery and that intersects a major axis of the main artery; and
bringing the second bent portion into contact with a blood vessel wall in front of a second blood vessel and bringing the first bent portion into contact with a blood vessel wall of the main artery at a location opposite the first blood vessel to direct the most distal end portion of the shape portion into the second blood vessel.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the inserting of the catheter into the radial artery of the patient involves inserting the catheter into a distal radial artery of the patient, a conventional radial artery of the patient, an ulnar artery of the patient, a distal ulnar artery of the patient, a brachial artery of the patient, or a snuff box radial artery of the patient.

### Claim 17 (depends on 15)

The method according to claim 15, wherein the main artery is an aorta, the branched first blood vessel is a celiac artery, and the second blood vessel is a common hepatic artery.

### Claim 18 (depends on 15)

The method according to claim 15, wherein three blood vessel branching portions are branched toward the periphery side.

### Claim 19 (depends on 15)

The method according to claim 15, wherein the first bent portion includes a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the first bent portion, the second bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the second bent portion, the radius of curvature of the smallest radius of curvature portion of the first bent portion being larger than the radius of curvature of the smallest radius of curvature portion of the second bent portion.

### Claim 20

A catheter configured to be introduced into an arm of a patient and advanced to a hepatic artery of the patient, the catheter comprising
a tubular body that includes a lumen extending from a proximal end of the tubular body to a distal end of the tubular body;
the tubular body being comprised of a substantially linear main body portion and a shape portion that is bent so that an entirety of the shape portion is positioned in substantially the same plane;
the shape portion comprising:
a first bent portion disposed on a distal side of the main body portion, the first bent portion being bent toward one side and defining a first angle;
a second bent portion disposed on a distal side of the first bent portion, the second bent portion being bent toward a side that is the same as the side to which the first bent portion is bent, the second bent portion defining a second angle;
a third bent portion disposed on a distal side of the second bent portion, the third bent portion being bent toward a side that is opposite the side to which the first and second bent portions are bent, the third bent portion defining a third angle; a most distal end portion disposed on a distal side of the third bent portion;
the first bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the first bent portion, the second bent portion including a smallest radius of curvature portion that possesses a smallest radius of curvature relative to a remainder of the second bent portion, the radius of curvature of the smallest radius of curvature portion of the first bent portion being larger than the radius of curvature of the smallest radius of curvature portion of the second bent portion;
the most distal end portion being configured to be positioned in the common hepatic artery while the first bent portion is in contact with an aorta wall on an opposite side from a celiac artery and while the second bent portion is in contact with a blood vessel wall of the celiac artery;
an axis passing through a center line of the main body portion is referred to as a first axis;
the portion of the second bent portion having the smallest radius of curvature includes opposite ends and a second bending point representing a center point between the opposite ends;
an axis passing through the second bending point and a first intermediate point positioned at a distal end of the main body portion is referred to as a fifth axis;
a first inclination angle between the fifth axis and the first axis is 46°, and
a second inclination angle constituting an angular range of the portion of the second bent portion having the smallest radius of curvature is 73° an axis passing through a center line of the main body portion is referred to as a first axis;
the portion of the second bent portion having the smallest radius of curvature includes opposite ends and a second bending point representing a center point between the opposite ends;
an axis passing through the second bending point and a first intermediate point positioned at a distal end of the main body portion is referred to as a fifth axis;
a first inclination angle between the fifth axis and the first axis is 46°; and a second inclination angle constituting an angular range of the portion of the second bent portion having the smallest radius of curvature is 73°.
