# US 12,594,400 B2 · Delivery system with a torqueable catheter shaft

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- Number: US 12,594,400 B2
- Document ID: US12594400B2
- Status: Granted
- Kind: B2
- Application number: 18/253,988
- Filed: 2021-12-20
- Published: 2023-12-21
- Granted: 2026-04-07
- Earliest claimed: 2020-12-22
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Alan McGuinn; Niall Duffy
- Web page: https://patentgrep.com/patent/US12594400B2

## CPC

- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61F 2/2433: {using balloon catheter}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/0051: {made from fenestrated or weakened tubing layer}
- A61M 25/0136: {Handles therefor}
- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 2025/1061: {having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube}
- A61M 2205/583: by visual feedback
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A catheter shaft includes a proximal portion with a first polymer having a first stiffness and a first portion of a tubular braid component extending within the first polymer, an intermediate portion with a second polymer having a second stiffness and a second portion of the tubular braid component extending within the second polymer, and a distal portion with a third polymer having a third stiffness, a third portion of the tubular braid component extending within the third polymer, and a hypotube extending within the third polymer. The hypotube is configured for elastic deformation and includes a sidewall cut with a pattern. Along an overlap segment of the distal portion, the third portion of the tubular braid component and the hypotube overlap each other. The outer shaft is configured for improved torque transmission.

## Claims

### Claim 1

A balloon catheter comprising:
an outer shaft having an elongate tubular body extending from a proximal end to a distal end and defining a central lumen therethrough, the elongate tubular body having a proximal portion, a distal portion, and an intermediate portion extending between the proximal portion and the distal portion;
a balloon attached to the distal end of the elongate tubular body, the balloon being expandable from a first diameter to a second diameter greater than the first diameter; and
an inflation lumen, the inflation lumen being in fluid communication with an interior of the balloon,
wherein the proximal portion includes a first polymer having a first stiffness and a first portion of a tubular braid component extending within the first polymer, and
wherein the intermediate portion includes a second polymer having a second stiffness and a second portion of the tubular braid component extending within the second polymer, and
wherein the distal portion includes a third polymer having a third stiffness, a third portion of the tubular braid component extending within the third polymer, and a hypotube extending within the third polymer, the hypotube being configured for elastic deformation and having a proximal end, a distal end, a length between the proximal end and the distal end, and a sidewall cut with a pattern, and
wherein along an overlap segment of the distal portion, the third portion of the tubular braid component overlaps the length of the hypotube or the length of the hypotube overlaps the third portion of the tubular braid component, and
wherein the second stiffness is less than the first stiffness and the third stiffness is less than the second stiffness, and
wherein the balloon is disposed distal to the hypotube.

### Claim 2 (depends on 1)

The balloon catheter of claim 1, further comprising a handle coupled to the proximal end of the elongate tubular body, wherein a pull wire lumen is defined in a sidewall of the elongate tubular body, the pull wire lumen terminating proximal to the distal end of the elongate tubular body, and further comprising a pull wire slidingly disposed through the pull wire lumen, wherein a distal end of the pull wire is coupled to the sidewall of the elongate tubular body and a proximal end of the pull wire is coupled to an actuator of the handle, and wherein the pull wire is operable to bend the elongate tubular body for steering the balloon catheter in situ.

### Claim 3 (depends on 2)

The balloon catheter of claim 2, wherein the sidewall of the elongate tubular body has a non-uniform cross-sectional thickness, the pull wire lumen extending within a thicker wall section of the sidewall.

### Claim 4 (depends on 2)

The balloon catheter of claim 2, wherein the pull wire lumen is formed via an elongated radial protrusion that extends along an inner surface of the elongate tubular body and protrudes into the central lumen of the elongate tubular body.

### Claim 5 (depends on 2)

The balloon catheter of claim 2,
wherein the sidewall of the elongate tubular body has a substantially uniform cross-sectional thickness, the pull wire lumen having a flattened oval cross-section and the pull wire having a flattened longitudinal profile.

### Claim 6 (depends on 2)

The balloon catheter of claim 2, wherein the sidewall of the elongate tubular body has a non-uniform cross-sectional thickness such that the sidewall includes a thicker wall section and a thinner wall section that is diametrically opposed to the thicker wall section, the pull wire lumen extending within the thicker wall section of the sidewall and the thinner wall section of the sidewall including a fourth polymer having a fourth stiffness, the fourth stiffness being greater than the first stiffness.

### Claim 7 (depends on 2)

The balloon catheter of claim 2, wherein the sidewall of the elongate tubular body has a substantially uniform cross-sectional thickness and a first balancing lumen is defined in the sidewall of the elongate tubular body, the first balancing lumen being diametrically opposed to the pull wire lumen.

### Claim 8 (depends on 7)

The balloon catheter of claim 7, wherein the pull wire is a first pull wire, and the balloon catheter further comprises
a second pull wire slidingly disposed through the first balancing lumen, wherein the second pull wire is operable to bend the elongate tubular body for steering the balloon catheter in situ.

### Claim 9 (depends on 7)

The balloon catheter of claim 7, further comprising:
a second balancing lumen defined in the sidewall of the elongate tubular body, the second balancing lumen being offset by approximately ninety degrees from the pull wire lumen; and
a third balancing lumen defined in the sidewall of the elongate tubular body, wherein the third balancing lumen is diametrically opposed to the second balancing lumen.

### Claim 10 (depends on 9)

The balloon catheter of claim 9, wherein the pull wire is a first pull wire, and the balloon catheter further comprises
a second pull wire slidingly disposed through the first balancing lumen, wherein the second pull wire is operable to bend the elongate tubular body for steering the balloon catheter in situ;
a third pull wire slidingly disposed through the second balancing lumen, wherein the third pull wire is operable to bend the elongate tubular body for steering the balloon catheter in situ, and
a fourth pull wire slidingly disposed through the third balancing lumen, wherein the fourth pull wire is operable to bend the elongate tubular body for steering the balloon catheter in situ.

### Claim 11 (depends on 2)

The balloon catheter of claim 2, wherein the handle includes a steering indicator that displays to a user an amount of bending of the elongate tubular body.

### Claim 12 (depends on 11)

The balloon catheter of claim 11, wherein the steering indicator includes a transparent tube disposed over a slider rack and a longitudinal position of the slider rack with the transparent tube corresponds to the amount of bending of the elongate tubular body.

### Claim 13 (depends on 1)

The balloon catheter of claim 1, wherein the third portion of the tubular braid component extends distally beyond the distal end of the hypotube.

### Claim 14 (depends on 1)

The balloon catheter of claim 1, wherein the third portion of the tubular braid component has a distal end that longitudinally terminates distal to the distal end of the hypotube.

### Claim 15 (depends on 1)

The balloon catheter of claim 1, wherein the third polymer is disposed in and around the third portion of the tubular braid component and the length of the hypotube along the overlap segment of the distal portion of the elongate tubular body.

### Claim 16 (depends on 15)

The balloon catheter of claim 15, wherein the third polymer extends through voids of the pattern of the sidewall of the hypotube and voids of the tubular braid component.

### Claim 17 (depends on 1)

The balloon catheter of claim 1, wherein the first stiffness is constant along a length of the proximal portion and the second stiffness is constant along a length of the intermediate portion.

### Claim 18 (depends on 1)

The balloon catheter of claim 1, wherein the third stiffness varies along a length of the distal portion due to the pattern of the sidewall of the hypotube and wherein the pattern of the sidewall of the hypotube defines a plurality of successive windings having a void between each pair of adjacent successive windings and wherein the plurality of successive windings includes a first plurality of successive windings, a second plurality of successive windings, and a third plurality of successive windings, the second plurality of successive windings being disposed distal to the first plurality of successive windings and the third plurality of successive windings being disposed distal to the second plurality of successive windings, wherein each winding of the first plurality of successive windings has a first width, each winding of the second plurality of successive windings has a second width, and each winding of the third plurality of successive windings has a third width, the second width being greater than the third width and the first width being greater than the second width.

### Claim 19 (depends on 18)

The balloon catheter of claim 18, wherein each void between each pair of adjacent successive windings is the same width.

### Claim 20 (depends on 1)

The balloon catheter of claim 1, wherein the elongate tubular body has a length from the proximal end to the distal end thereof and the proximal portion extends between 75-90% of the length of the elongate tubular body, the intermediate portion extends between 5-10% of the length of the elongate tubular body, and the distal portion extends between 5-15% of the length of the elongate tubular body.
