# US 2019/0167305 A1 · Transseptal guide wire puncture system

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- Number: US 2019/0167305 A1
- Document ID: US20190167305A1
- Status: Published application
- Kind: A1
- Application number: 16/209,426
- Filed: 2018-12-04
- Published: 2019-06-06
- Earliest claimed: 2017-12-05
- Assignees: Baylis Medical Company Inc.
- Inventors: Wesley Robert Pedersen; Paul Sorajja
- Web page: https://patentgrep.com/patent/US20190167305A1

## CPC

- A61M 25/09: Guide wires
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00278: {Transorgan operations, e.g. transgastric}
- A61B 2017/00853: {low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/22042: {Details of the tip of the guide wire}
- A61M 2025/09141: {made of shape memory alloys which take a particular shape at a certain temperature}
- A61M 2025/09175: {having specific characteristics at the distal tip}
- A61M 2210/122: Pericardium
- 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

A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium. This transseptal system is uniquely forward looking and permits cautious and iterative delivery of the dilator into the fossa ovalis for “tenting” by way of a proximal sheath activator that interacts with the dilator. The proximal externalized GW is then advanced to permit puncture of the fossa ovalis. After puncturing a precise location of the fossa ovalis, the needle and coiled guide wire loops are further advanced into the left atrium. With the proximal activator, the dilator is advanced across the fossa ovalis into the left atrium using single-handed maneuvering for separate dilator advancement and steering of the sheath by way of turning or actuating the sheath handle.

## Claims

### Claim 1

A transseptal guide wire, comprising a proximal end, a distal end and a middle segment,
a. wherein the distal end comprises a transseptal needle attached to the guide wire distal end and positioned in continuity with the distal end of the guide wire;
b. wherein the middle segment is formed of a shape memory material to form at least one looped segment; and
c. wherein the proximal end is in continuity with the middle segment.

### Claim 2 (depends on 1)

The transseptal guide wire of claim 1, wherein the length of the transseptal needle is between about 0.75 and 2.0 cm.

### Claim 3 (depends on 1)

The transseptal guide wire of claim 1, wherein the transseptal needle and at least one looped segment have a lubricious coating.

### Claim 4 (depends on 1)

The transseptal guide wire of claim 1, wherein the transseptal needle has shape memory at the point of attachment to the guide wire wherein the shape memory is sufficient to have the transseptal needle retain a pre-specified angle with respect to the guide wire to maintain central atraumatic stability.

### Claim 5 (depends on 4)

The transseptal guide wire of claim 4, wherein the pre-specified angle is between about 45° to 140° with respect to the guide wire.

### Claim 6 (depends on 1)

The transseptal guide wire of claim 1 wherein the middle segment is formed of a shape memory material to form at least two looped segments.

### Claim 7 (depends on 1)

The transseptal guide wire of claim 1 wherein the looped segment is between about 2.5 cm and 4.0 cm in diameter.

### Claim 8 (depends on 6)

The transseptal guide wire of claim 6 wherein the looped segments are between about 2.5 cm and 4.0 cm in diameter.

### Claim 9 (depends on 1)

The transseptal guide wire of claim 1 wherein the middle segment is formed of a shape memory material.

### Claim 10 (depends on 9)

The transseptal guide wire of claim 9 wherein the shape memory material is nitinol.

### Claim 11 (depends on 6)

The transseptal guide wire of claim 6 forming an inner loop and an outer loop wherein the inner loop has a diameter between about 1.5 cm and 3.0 cm and the outer loop has a diameter between about 3.0 cm and 4.0 cm.

### Claim 12 (depends on 6)

The transseptal guide wire of claim 6 wherein the inner loop is offset from the outer loop by a distance of about 0.75 cm to about 2.0 cm.

### Claim 13 (depends on 1)

The transseptal guide wire of claim 1 wherein the proximal end has a diameter between about 0.021 inches and 0.035 inches.

### Claim 14 (depends on 1)

The transseptal guide wire of claim 1 wherein the proximal end has a length between about 240 cm to 300 cm,

### Claim 15 (depends on 1)

The guide wire of claim 1 further comprising a transseptal dilator for placement of the transseptal needle on the fossa ovalis.

### Claim 16 (depends on 15)

The transseptal guide wire of claim 15 wherein the transseptal dilator has a lumen having a diameter between about 0.021 and 0.035 inches.

### Claim 17 (depends on 1)

The transseptal guide wire of claim 1 wherein the transseptal dilator comprises a radiopaque marker.

### Claim 18 (depends on 1)

The transseptal guide wire of claim 1 further comprising a sheath.

### Claim 19 (depends on 18)

The transseptal guide wire of claim 18 wherein the sheath has a unipolar or bipolar deflectable distal segment and a proximal handle for steering and positioning the distal segment.

### Claim 20

A transseptal guide wire puncture system through the fossa ovalis, comprising a proximal end, a distal end, a middle segment, a transseptal dilator, and a sheath,
a. wherein the distal end comprises a transseptal needle attached to the guide wire distal end and positioned in continuity with the distal end of the guide wire, wherein the transseptal needle has shape memory at the point of attachment to the guide wire wherein the shape memory is sufficient to have the transseptal needle retain a pre-specified angle with respect to the guide wire to maintain atraumatic central positioning;
b. wherein the middle segment is formed of a shape memory material to form at least two looped segments;
c. wherein the proximal end is in continuity with the middle segment;
d. wherein the transseptal dilator has a proximal end and a distal end wherein the distal end comprises a low profile tip for placement on the fossa ovalis; and
e. wherein the sheath is a unipolar deflectable sheath having a proximal end and distal end wherein the proximal end comprises a handle for proximally actuating the sheath.

### Claim 21 (depends on 20)

The transseptal guide wire puncture system of claim 20, wherein the length of the transseptal needle is between about 0.75 and 2.0 cm.

### Claim 22 (depends on 20)

The transseptal guide wire puncture system of claim 20, wherein the transseptal guide wire has a lubricious coating.

### Claim 23 (depends on 20)

The transseptal guide wire puncture system of claim 20, wherein the pre-specified angle is between about 45° to 140° with respect to the guide wire.

### Claim 24 (depends on 20)

The transseptal guide wire puncture system of claim 20 forming an inner loop and an outer loop wherein the inner loop has a diameter between about 1.5 cm and 3.0 cm and the outer loop has a diameter between about 3.0 cm and 4.0 cm.

### Claim 25 (depends on 20)

The transseptal guide wire of puncture system claim 20 wherein the inner loop is offset from the outer loop by a distance of about 0.75 cm to about 2.0 cm.

### Claim 26 (depends on 20)

The transseptal guide wire puncture system of claim 20 wherein the proximal end has a diameter between about 0.025 inches and 0.035 inches.

### Claim 27 (depends on 20)

The transseptal guide wire puncture system of claim 20 wherein the proximal end has a length between about 240 cm to 300 cm,

### Claim 28 (depends on 20)

The transseptal guide wire puncture system of claim 20 wherein the transseptal dilator has a lumen having a diameter between about 0.021 and 0.035 inches.

### Claim 29 (depends on 20)

The transseptal guide wire puncture system of claim 20 wherein the transseptal dilator has a radiopaque marker on the distal end and the sheath has a corresponding radiopaque marker on the sheath distal end.

### Claim 30 (depends on 20)

The transseptal guide wire puncture system of claim 20 wherein the sheath comprises an actuator proximate to the handle and wherein the dilator distal end includes frictional elements, wherein the actuator interacts with frictional elements to initiate movement of the dilator within the sheath.