# US 11,027,102 B2 · Perfusion catheters and related methods

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- Number: US 11,027,102 B2
- Document ID: US11027102B2
- Status: Granted
- Kind: B2
- Application number: 16/414,921
- Filed: 2019-05-17
- Published: 2020-01-23
- Granted: 2021-06-08
- Earliest claimed: 2018-07-20
- Assignees: Teleflex Life Sciences Limited
- Applicants: Teleflex Life Sciences Limited
- Inventors: Dean Peterson; Loic Van Horne; Danny Jester
- Web page: https://patentgrep.com/patent/US11027102B2

## CPC

- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61M 25/10184: {Means for controlling or monitoring inflation or deflation}
- A61M 25/104: {used for angioplasty}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril}
- A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon}
- A61M 2025/1097: {with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include an inflatable balloon coiled in a helical manner around a central axis into a series of windings. An inner surface of the series of windings, when inflated, can define a passage through the inflatable balloon. A catheter can also include an elongate shaft extending from a proximal portion to a distal portion, having an inner surface that defines a lumen for providing inflation fluid to, or withdrawing inflation fluid from, a distal end of the inflatable balloon. A catheter can further include a guidewire support tube including a lumen, separate from the lumen from the elongate shaft and the passage through the inflatable balloon, for receiving a guidewire.

## Claims

### Claim 1

A perfusion catheter, comprising:
an inflatable balloon coiled in a helical manner around a central axis into a series of windings, wherein an inner surface of the series of windings, when inflated, defines a passage through the inflatable balloon;
an elongate shaft extending from a proximal portion to a distal portion, having an inner surface that defines a lumen for providing inflation fluid to, or withdrawing inflation fluid from, a distal end of the inflatable balloon; and
a guidewire support tube including a lumen for receiving a guidewire, the lumen of the guidewire support tube separate from the lumen of the elongate shaft and the passage through the inflatable balloon, wherein the guidewire support tube is inset in the inner surface of the series of windings.

### Claim 2 (depends on 1)

The perfusion catheter of claim 1, wherein an outer surface of the elongate shaft and the distal end of the inflatable balloon are affixed by a heat treatment process such that the shaft's lumen is in fluid communication with an interior of the balloon.

### Claim 3 (depends on 1)

The perfusion catheter of claim 1, wherein the passage has a diameter ranging from 2 mm-6 mm and a length ranging from 10 mm-50 mm.

### Claim 4 (depends on 1)

The perfusion catheter of claim 1, wherein the elongate shaft is eccentrically positioned relative to the inflatable balloon such that the elongate shaft does not protrude radially into the passage.

### Claim 5 (depends on 1)

The perfusion catheter of claim 1, wherein a proximal portion of the inflatable balloon wraps around the elongate shaft, such that the proximal portion is sealed.

### Claim 6 (depends on 1)

The perfusion catheter of claim 1, wherein the inflatable balloon is configured to deflate in a distal-to-proximal direction.

### Claim 7 (depends on 1)

The perfusion catheter of claim 1, wherein the inflatable balloon includes concentric inner and outer tubes, a polymer of the inner tube is cross-lined, a polymer of the outer tube is non-cross-linked, and the polymer of the inner tube has sufficient radial stiffness to resist bursting when exposed to inflation pressure.

### Claim 8 (depends on 7)

The perfusion catheter of claim 7, wherein adjacent windings of the series of windings are stacked against and bonded to each other through adhesive properties of the polymer of the outer tube when heated.

### Claim 9 (depends on 1)

The perfusion catheter of claim 1, wherein a distal portion of the guidewire support tube protrudes distally beyond the distal end of the inflatable balloon by 2 mm-8 mm.

### Claim 10

A method, comprising:
passing a perfusion catheter, comprising a balloon and an elongate shaft that is attached to the balloon, into a blood vessel until the balloon is positioned adjacent a perforation or dissection in a wall of the blood vessel, including advancing a guidewire through a guidewire support tube, which is separate from a lumen of the elongate shaft and separate from a passage defined by a series of helical windings of the balloon;
inflating the balloon to seal the perforation or dissection in the wall of the blood vessel, including urging fluid through the lumen of the elongate shaft and into the balloon to inflate the series of helical windings of the balloon,
the balloon, upon inflation, moving from a deflated configuration to an inflated configuration at which an outer surface of the balloon engages the wall of the blood vessel and an inner surface of the balloon's series of helical windings defines the passage;
after inflating the balloon, passing a treatment device at least partially through the passage, including receiving, in a distal-to-proximal direction, or delivering, in a proximal-to-distal direction, the treatment device;
deflating the balloon by withdrawing fluid from the balloon in a distal-to-proximal direction of the balloon; and
retracting the perfusion catheter from the blood vessel.

### Claim 11 (depends on 10)

The method of claim 10, wherein the guidewire support tube is inset into the inner surface of the balloon's series of helical windings.

### Claim 12

A method, comprising:
passing a perfusion catheter, comprising a balloon and an elongate shaft that is attached to the balloon, into a blood vessel until the balloon is positioned adjacent a perforation or dissection in a wall of the blood vessel;
inflating the balloon to seal the perforation or dissection in the wall of the blood vessel, including urging fluid through a lumen of the elongate shaft and into the balloon in a distal-to-proximal direction to inflate a series of helical windings of the balloon, and
the balloon, upon inflation, moving from a deflated configuration to an inflated configuration at which an outer surface of the balloon engages the wall of the blood vessel and an inner surface of the balloon's series of helical windings defines a passage;
after inflating the balloon, passing a treatment device at least partially through the passage, including receiving, in a distal-to-proximal direction, or delivering, in a proximal-to-distal direction, the treatment device;
deflating the balloon by withdrawing fluid from the balloon in a distal-to-proximal direction of the balloon; and
retracting the perfusion catheter from the blood vessel.

### Claim 13 (depends on 12)

The method of claim 12, wherein inflating the balloon includes dilating occlusive material accumulation within the wall of the blood vessel.

### Claim 14 (depends on 13)

The method of claim 13, wherein deflating the balloon and retracting the perfusion catheter occur simultaneously.

### Claim 15 (depends on 13)

The method of claim 13, wherein inflating the balloon includes inflating the balloon to a pressure between 2 atm-20 atm, inclusive.

### Claim 16 (depends on 13)

The method of claim 13, wherein delivering the treatment device to a treatment site or distal to the perforation or dissection includes guiding the treatment device along a path offset from an axis of the elongate shaft.

### Claim 17 (depends on 13)

The method of claim 13, wherein inflating the balloon comprises urging the fluid through a fluid connection at a distal end of the balloon and a distal end of the elongate shaft.

### Claim 18 (depends on 10)

The method of claim 10, wherein inflating the balloon comprises urging the fluid into the balloon in a distal-to-proximal direction of the balloon.

### Claim 19 (depends on 10)

The method of claim 10, wherein inflating the balloon comprises urging the fluid through a fluid connection at a distal end of the balloon and a distal end of the elongate shaft.

### Claim 20 (depends on 10)

The method of claim 10, wherein deflating the balloon and retracting the perfusion catheter occur simultaneously.
