# US 10,864,355 B2 · Perfusion catheters and related methods

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- Number: US 10,864,355 B2
- Document ID: US10864355B2
- Status: Granted
- Kind: B2
- Application number: 16/191,833
- Filed: 2018-11-15
- Published: 2019-03-21
- Granted: 2020-12-15
- Earliest claimed: 2014-09-10
- Assignees: Teleflex Life Sciences Limited
- Applicants: Teleflex Life Sciences Limited
- Inventors: Howard C. Root; Chad Kugler; Dean Peterson; Joshua Brenizer
- Web page: https://patentgrep.com/patent/US10864355B2

## CPC

- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 17/12036: {partial occlusion}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61M 25/104: {used for angioplasty}
- A61B 2017/22001: {Angioplasty, e.g. PCTA}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- 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 a balloon formed of an inflatable tube and an elongate shaft having a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon. The inflatable tube can be coiled in a helical manner around a central axis into a series of windings. Adjacent windings can be stacked against and bonded to each other, and an inner surface of the series of windings, when inflated, can define the passage. The elongate shaft can be eccentrically attached to a proximal portion of the balloon and the shaft's lumen can be in fluid communication with the interior of the balloon, specifically the inflatable tube. The inflatable tube can include two different polymer tubes, one slightly smaller than the other.

## Claims

### Claim 1

A perfusion catheter, comprising:
a balloon including an inflatable tube coiled in a helical manner around a central axis into a
series of windings with adjacent windings stacked against and bonded to each other, an inner surface of the series of windings, when inflated, defining a passage through the center of the helix for delivery of a medical device or maintaining blood flow; an elongate shaft extending proximal of the balloon and eccentrically positioned relative to the passage; and
a guidewire support tube having a length less than a combined length of the balloon and the elongate shaft and having a guidewire lumen therethrough, the guidewire support tube extending through the passage, inset in the interior surface of the series of windings, and non-coaxial with the elongate shaft.

### Claim 2 (depends on 1)

The perfusion catheter of claim 1, wherein the inflatable tube of the balloon includes two different polymer tubes, an inner tube positioned within an outer tube, that are coextruded.

### Claim 3 (depends on 2)

The perfusion catheter of claim 2, wherein the inner tube is formed from a polymer having a radial stiffness to resist collapse or bursting when exposed to inflation pressures, and the outer tube is formed from a polymer configured to exhibit adhesive properties when heated.

### Claim 4 (depends on 2)

The perfusion catheter of claim 2, wherein the inner tube is formed from a polymer that is cross-linked, and the outer tube is formed from a polymer that is non-cross-linked.

### Claim 5 (depends on 2)

The perfusion catheter of claim 2, wherein the inner tube is formed from a polymer having a higher melting temperature than a polymer that forms the outer tube.

### Claim 6 (depends on 1)

The perfusion catheter of claim 1, wherein a proximal portion of the elongate shaft includes a hypotube.

### Claim 7 (depends on 6)

The perfusion catheter of claim 6, wherein a distal portion of the elongate shaft includes a support wire that is coupled to the hypotube.

### Claim 8 (depends on 7)

The perfusion catheter of claim 7, wherein the support wire extends to a location distal to the balloon.

### Claim 9 (depends on 1)

The perfusion catheter of claim 1, wherein a proximal end of the balloon is wrapped about a portion of the elongate shaft.

### Claim 10 (depends on 9)

The perfusion catheter of claim 9, further comprising means to affix the elongate shaft and the proximal end of the balloon, the means to affix creating a fluid tight seal between the elongate shaft and the balloon.

### Claim 11 (depends on 10)

The perfusion catheter of claim 10, wherein the means to affix includes nylon.

### Claim 12 (depends on 1)

The perfusion catheter of claim 1, wherein a polymer of the guidewire support tube and a polymer of the inflatable tube are configured to adhere to each other upon application of heat treatment.

### Claim 13 (depends on 1)

The perfusion catheter of claim 1, wherein the length of the guidewire support tube is longer than a length of the passage.

### Claim 14 (depends on 1)

The perfusion catheter of claim 1, wherein a distal tip of the guidewire support tube includes an atraumatic tip.

### Claim 15 (depends on 1)

The perfusion catheter of claim 1, further comprising a first radiopaque marker positioned proximal to the balloon and a second radiopaque marker positioned distal to the balloon.

### Claim 16 (depends on 1)

The perfusion catheter of claim 1, further comprising a first radiopaque marker positioned on the elongate shaft and a second radiopaque marker position on the guidewire support tube.

### Claim 17 (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 18 (depends on 1)

The perfusion catheter of claim 1, wherein the balloon, when inflated, impinges upon or engages a vessel wall at a treatment site at pressures of 2 atm-20 atm.

### Claim 19 (depends on 1)

The perfusion catheter of claim 1, further comprising an elastic sheath disposed around the balloon.
