# US 10,946,177 B2 · Guide extension catheter

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- Number: US 10,946,177 B2
- Document ID: US10946177B2
- Status: Granted
- Kind: B2
- Application number: 16/643,759
- Filed: 2019-10-30
- Published: 2021-01-14
- Granted: 2021-03-16
- Earliest claimed: 2018-12-19
- Assignees: Teleflex Life Sciences Limited
- Applicants: Teleflex Life Sciences Limited
- Inventors: Dean Peterson; Joshua Brenizer
- Web page: https://patentgrep.com/patent/US10946177B2

## CPC

- A61M 25/0043: {characterised by structural features}
- A61M 25/1025: {Connections between catheter tubes and inflation tubes}
- A61M 25/0052: {Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 25/0662: {Guide tubes}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/104: {used for angioplasty}
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M 25/10181: {Means for forcing inflation fluid into the balloon}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1061: {having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube}
- A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding}
- A61M 2039/062: {used with a catheter}
- 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

This patent document discloses guide extension catheters for use with a predefined length guide catheter and related methods for treating blood vessel lesions and abnormalities. A guide extension catheter can include a push member, an elongate tube member, and a balloon radially surrounding a portion of the elongate tube member. The balloon can include an inflatable tube coupled to an elongate shaft having a lumen for receiving inflation fluid, and the inflatable tube can be coiled in a helical manner around the elongate tube member. A bioactive layer can coat an outer surface portion of the balloon and, when the balloon is inflated, one or more drugs of the bioactive layer can be received by the blood vessel. Inflation of the balloon can engage the elongate tube member with an inner surface of the blood vessel and/or an inner surface of the guide catheter.

## Claims

### Claim 1

A guide extension catheter for use with a predefined length guide catheter, the guide extension catheter comprising:
an elongate tube member having a circular cross-section with an outer diameter sized to be insertable through a cross-sectional inner diameter of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which an interventional cardiology device is insertable;
a push member configured to advance the elongate tube member through the guide catheter, the push member being proximal of and operably connected to the elongate tube member, the push member having a maximal cross-sectional dimension at a proximal portion that is smaller than the outer diameter of the elongate tube member and having a length that when combined with a length of the elongate tube member forms a device length that is longer than the guide catheter, such that when at least a distal portion of the elongate tube member is extended distally of a distal end of the guide catheter, at least a portion of the proximal portion of the push member extends proximally through a hemostatic valve in common with the interventional cardiology device; and
a balloon radially surrounding a portion of the elongate tube member, the balloon comprising an inflatable tube in fluid communication with an elongate lumen configured to provide inflation fluid to, or withdraw inflation fluid from, the balloon, wherein the inflatable tube is coiled in a helical manner around a central axis into a series of windings.

### Claim 2 (depends on 1)

The guide extension catheter of claim 1, wherein adjacent windings of the inflatable tube are stacked against and bonded to each other, and an inner surface of the series of windings are bonded to an outer surface of the elongate tube member.

### Claim 3 (depends on 1)

The guide extension catheter of claim 1, wherein adjacent windings of the inflatable tube are spaced apart such that a lateral space is defined between them, and an inner surface of the series of windings are bonded to an outer surface of the elongate tube member.

### Claim 4 (depends on 1)

The guide extension catheter of claim 1, wherein the inflatable tube comprises two different polymer tubes.

### Claim 5 (depends on 4)

The guide extension catheter of claim 4, wherein the two different polymer tubes include an inner tube and an outer tube, and the polymer of the inner tube has a higher melting temperature than the polymer of the outer tube.

### Claim 6 (depends on 1)

The guide extension catheter of claim 1, further comprising a bioactive layer coating an outer surface of the balloon.

### Claim 7 (depends on 6)

The guide extension catheter of claim 6, wherein the bioactive layer includes one or more drugs, therapeutic agents, diagnostic agents, or combinations thereof.

### Claim 8 (depends on 6)

The guide extension catheter of claim 6, wherein the bioactive layer includes one or more drugs and one or more excipients.

### Claim 9 (depends on 1)

The guide extension catheter of claim 1, wherein the elongate tube member includes a flexible cylindrical distal tip portion and a flexible cylindrical portion with a reinforcement member that is proximal to the flexible cylindrical distal tip portion.

### Claim 10

A guide extension catheter for use with a predefined length guide catheter, the guide extension catheter comprising:
an elongate tube member having a circular cross-section with an outer diameter sized to be insertable through a cross-sectional inner diameter of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which an interventional cardiology device is insertable, wherein a proximal portion of the elongate tube member comprises structure defining a proximal side opening extending for a distance along a longitudinal axis, and accessible from a longitudinal side defined transverse to the longitudinal axis, to receive the interventional cardiology device into the coaxial lumen while the proximal portion remains within a lumen of the guide catheter;
a push member configured to advance the elongate tube member through the guide catheter, the push member being proximal of and operably connected to the elongate tube member, the push member having a maximal cross-sectional dimension at a proximal portion that is smaller than the outer diameter of the elongate tube member and having a length that when combined with a length of the elongate tube member forms a device length that is longer than the guide catheter, such that when at least a distal portion of the elongate tube member is extended distally of a distal end of the guide catheter, at least a portion of the proximal portion of the push member extends proximally through a hemostatic valve in common with the interventional cardiology device; and
a balloon radially surrounding a portion of the elongate tube member, the balloon comprising an inflatable tube in fluid communication with an elongate lumen configured to provide inflation fluid to, or withdraw inflation fluid from, the balloon.

### Claim 11 (depends on 10)

The guide extension catheter of claim 10, wherein the proximal side opening defines a concave track configured to guide the interventional cardiology device along a length of the concave track.

### Claim 12 (depends on 10)

The guide extension catheter of claim 10, wherein the inflatable tube comprises two different polymer tubes.

### Claim 13 (depends on 10)

The guide extension catheter of claim 10, further comprising a bioactive layer coating an outer surface of the balloon.

### Claim 14 (depends on 10)

The guide extension catheter of claim 10, wherein the elongate tube member includes a flexible cylindrical distal tip portion and a flexible cylindrical portion with a reinforcement member that is proximal to the flexible cylindrical distal tip portion.

### Claim 15

A method, comprising:
advancing a distal end of a predefined length guide catheter having a continuous lumen through a blood vessel to an ostium of a coronary artery;
advancing a distal end of a guide extension catheter through, and beyond the distal end of, the guide catheter, including advancing a push member of the guide extension catheter that is proximal of, operably connected to, and more rigid along a longitudinal axis than an elongate tube member of the guide extension catheter, into the continuous lumen of the guide catheter, the push member having a maximal cross-sectional dimension at a proximal portion that is smaller than a cross-sectional outer diameter of the elongate tube member and having a length such that, when combined with the length of the elongate tube member, a distal end portion of the elongate tube member is extendable through the continuous lumen of the guide catheter and beyond the distal end of the guide catheter while a proximal end of the push member is extendable through a hemostatic valve positioned at a proximal end of the guide catheter,
the advancement of the push member causing advancement of the distal end portion of the elongate tube member beyond the distal end of the guide catheter while a side opening of the guide extension catheter remains within the continuous lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the guide extension catheter and accessible from a longitudinal side defined transverse to the longitudinal axis, the elongate tube member defining a lumen coaxial with the continuous lumen of the guide catheter and having a cross-sectional inner diameter through which an interventional cardiology device is insertable; and
inflating a balloon, which radially surrounds a portion of the elongate tube member, to engage the elongate tube member with an inner surface of the guide catheter, including urging fluid into the balloon to inflate a series of helical windings of the balloon.

### Claim 16 (depends on 15)

The method, of claim 15, wherein urging fluid into the balloon to inflate the series of helical windings of the balloon includes urging fluid through a lumen of an elongate shaft, which is defined within the elongate tube member and the push member.

### Claim 17 (depends on 16)

The method of claim 16, wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes sealing around the push member and the elongate shaft with the hemostatic valve positioned at the proximal end of the guide catheter.

### Claim 18 (depends on 15)

The method of claim 15, further comprising maintaining the balloon in an inflated configuration and releasing a bioactive layer, which is coated on an outer surface of the balloon, into an inner surface of the coronary artery.

### Claim 19 (depends on 18)

The method of claim 18, wherein maintaining the balloon in the inflated configuration includes maintaining the balloon in the inflated configuration for more than 60 seconds.

### Claim 20 (depends on 15)

The method of claim 15, further comprising:
maintaining the distal end portion of the elongate tube member in position beyond the distal end of the guide catheter; and
while maintaining the distal end portion of the elongate tube member is positioned beyond the distal end of the guide catheter, advancing a balloon catheter or stent at least partially through the continuous lumen of the guide catheter, into the side opening and through the coaxial lumen of the elongate tube member, and into the coronary artery.
