# US 2019/0167331 A1 · Compensation assembly for fluid injection line of intravascular catheter system

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- Number: US 2019/0167331 A1
- Document ID: US20190167331A1
- Status: Published application
- Kind: A1
- Application number: 16/206,308
- Filed: 2018-11-30
- Published: 2019-06-06
- Earliest claimed: 2017-11-30
- Assignees: Cryterion Medical, Inc.
- Applicants: Cryterion Medical, Inc.
- Inventors: Eric A. Schultheis; Eugene J. Jung; Xiaoyu Yu
- Web page: https://patentgrep.com/patent/US20190167331A1

## CPC

- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/0022: {Balloons}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0262: {using a circulating cryogenic fluid}
- A61B 2018/0287: {the fluid flowing through a long thin tube with spiral shape}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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 fluid injection line compensation assembly for an intravascular catheter system including a balloon catheter having a guidewire lumen and a cryoballoon, includes a fluid injection line, a proximal fluid injection line stop, and a distal fluid injection line stop. The fluid injection line has a fluid discharge region positioned within the cryoballoon. The fluid discharge region includes a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon. The fluid discharge region is not affixed to the guidewire lumen. The proximal fluid injection line stop is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon. The distal fluid injection line stop is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

## Claims

### Claim 1

A cryoablation catheter comprising:
a catheter shaft;
a guidewire lumen disposed within and slidable relative to the shaft;
a cryoballoon having a first end portion secured to a distal end of the shaft, and a second end portion attached to the guidewire lumen distal to the distal end of the shaft;
a fluid injection line having a fluid discharge region positioned within the cryoballoon, the fluid discharge region including a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon, the fluid discharge region being movable relative to the guidewire lumen;
a proximal fluid injection line stop that is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon; and
a distal fluid injection line stop that is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

### Claim 2 (depends on 1)

The cryoablation catheter of claim 1, wherein the fluid discharge region is movable in a longitudinal direction along the guidewire lumen.

### Claim 3 (depends on 2)

The cryoablation catheter of claim 2, wherein when the guidewire lumen moves in either a distal or proximal direction, the fluid injection line moves substantially with the guidewire lumen.

### Claim 4 (depends on 1)

The cryoablation catheter of claim 1, wherein the fluid discharge region is rotatably movable about the guidewire lumen.

### Claim 5 (depends on 1)

The cryoablation catheter of claim 1, wherein at least one of the proximal fluid injection line stop and the distal fluid injection line stop encircles the guidewire lumen.

### Claim 6 (depends on 1)

The cryoablation catheter of claim 1, further including a frictional element that frictionally maintains the positioning of the fluid injection line absent movement of the guidewire lumen.

### Claim 7

A cryoablation catheter comprising:
a catheter shaft;
a guidewire lumen disposed within and slidable relative to the shaft;
a cryoballoon having a first end portion secured to a distal end of the shaft, and a second end portion attached to the guidewire lumen distal to the distal end of the shaft;
a fluid injection line having a fluid discharge region positioned within the cryoballoon, the fluid discharge region including a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon, the fluid discharge region being movable relative to the guidewire lumen; and
a handle assembly coupled to a proximal end of the shaft and including a handle manifold through which the guidewire lumen and the fluid injection line slidably extend, and further including a guidewire lumen sealer that forms a seal around the guidewire lumen.

### Claim 8 (depends on 7)

The cryoablation catheter of claim 7, wherein the guidewire lumen sealer does not bias the guidewire lumen in either a proximal or a distal direction relative to the cryoballoon.

### Claim 9 (depends on 7)

The cryoablation catheter of claim 7 wherein the guidewire lumen sealer includes one or more O-rings disposed within the handle manifold and around the guidewire lumen.

### Claim 10 (depends on 7)

The cryoablation catheter of claim 7, wherein the guidewire lumen sealer includes at least one of an electronic actuator, a solenoid, and a set screw.

### Claim 11 (depends on 7)

The cryoablation catheter of claim 7, wherein the guidewire lumen sealer can be tuned to vary an amount of friction between the guidewire lumen sealer and the fluid injection line.

### Claim 12 (depends on 7)

The cryoablation catheter of claim 7, further comprising a coupler that holds a portion of the fluid injection line adjacent to a portion of the guidewire lumen.

### Claim 13 (depends on 12)

The cryoablation catheter of claim 12, wherein the coupler at least partially encircles the fluid injection line and the guidewire lumen.

### Claim 14

A cryoablation catheter comprising:
a catheter shaft;
a guidewire lumen disposed within and slidable relative to the shaft;
a cryoballoon having a first end portion secured to a distal end of the shaft, and a second end portion attached to the guidewire lumen distal to the distal end of the shaft;
a fluid injection line having a fluid discharge region positioned within the cryoballoon, the fluid discharge region including a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon, the fluid discharge region being movable relative to the guidewire lumen;
a fluid injection line stop that is positioned within the cryoballoon;
a distal bias stop that is secured to the fluid injection line; and
a fluid injection line bias that imparts a bias force upon the distal bias stop to bias the fluid injection line in a direction toward the fluid injection line stop.

### Claim 15 (depends on 14)

The cryoablation catheter of claim 14, wherein the distal region is biased by the fluid injection line bias to remain in substantially the same position relative to the guidewire lumen whether the cryoballoon is in an inflated state or a deflated state.

### Claim 16 (depends on 15)

The cryoablation catheter of claim 15, further comprising a handle assembly coupled to a proximal end of the shaft and including a handle manifold through which the guidewire lumen and the fluid injection line slidably extend, and wherein the distal bias stop and the fluid injection line bias are disposed within the handle manifold.

### Claim 17 (depends on 16)

The cryoablation catheter of claim 16, further comprising a proximal bias stop disposed within the handle manifold, wherein the fluid injection line bias is positioned against the proximal bias stop.

### Claim 18 (depends on 17)

The cryoablation catheter of claim 17, wherein the fluid injection line further comprises a proximal region disposed within the handle manifold, the proximal region of the fluid injection line being configured to form a compression spring that defines the fluid injection line bias.

### Claim 19 (depends on 14)

The cryoablation catheter of claim 14, further comprising:
a proximal fluid injection line stop that is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon; and
a distal fluid injection line stop that is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

### Claim 20 (depends on 19)

The cryoablation catheter of claim 19, wherein one or both of the proximal fluid injection line stop and the distal fluid injection line stop is secured to the guidewire lumen.
