# US 8,784,414 B2 · Preshaped localization catheter, system, and method for graphically reconstructing pulmonary vein ostia

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- Number: US 8,784,414 B2
- Document ID: US8784414B2
- Status: Granted
- Kind: B2
- Application number: 14/029,438
- Filed: 2013-09-17
- Published: 2014-01-16
- Granted: 2014-07-22
- Earliest claimed: 2005-05-05
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Boaz Avitall; Josef V. Koblish
- Web page: https://patentgrep.com/patent/US8784414B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0144: {having flexible regions as a result of inner reinforcement means, e.g. struts or rods}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/0152: {with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes}
- A61B 6/06: Diaphragms
- A61B 2017/003: {Steerable}
- A61B 2018/00375: {Ostium, e.g. ostium of pulmonary vein or artery}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61M 2025/0161: {wherein the distal tips have two or more deflection regions}
- 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

Catheters, systems, and methods are provided for performing medical procedures, such as tissue ablation, adjacent the ostia of anatomical vessels, such as pulmonary veins. The catheter comprises an elongated flexible catheter body, which includes a proximal shaft portion and a distal shaft portion, and a tracking element carried by the distal shaft portion. The proximal section is pre-shaped to form a curve having an apex sized to be inserted into the vessel ostium, and a distal section configured to contact the adjacent tissue when the curve apex is inserted within the vessel ostium. The method may comprise inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium, and determining a location of the tracking element(s) within a coordinate system while the distal section is in contact with the first tissue site.

## Claims

### Claim 1

A method of performing a medical procedure on tissue adjacent an ostium of an anatomical vessel, comprising:
providing a catheter having an elongated flexible catheter body including a proximal shaft portion and a distal shaft portion having a proximal section pre-shaped to form a simple curve having an apex sized to be inserted into the vessel ostium, a medial section pre-shaped to form a complex curve, and a distal section configured to contact the adjacent tissue when the curve apex is inserted within the vessel ostium, the catheter including at least one tracking element carried by the distal shaft portion;
inserting the catheter into the vessel with the simple curve inserted into the ostium and the distal section in contact with a first tissue site; and
rotating the simple curve within the vessel about the curve apex to place the distal section in contact with a second tissue site.

### Claim 2 (depends on 1)

The method of claim 1, wherein after the step of inserting the catheter into the vessel, the method further comprises performing a first medical procedure with the catheter.

### Claim 3 (depends on 2)

The method of claim 2, wherein after the step of rotating the simple curve, the method further comprises performing a second medical procedure with the catheter.

### Claim 4 (depends on 3)

The method of claim 3, wherein the first and second medical procedures include determining a location of the at least one tracking element.

### Claim 5 (depends on 3)

The method of claim 3, wherein the catheter comprises a therapeutic element carried by the distal section, and at least one of the first and second medical procedures includes performing therapy with the therapeutic element at the first or second tissue site.

### Claim 6 (depends on 5)

The method of claim 5, wherein the therapeutic element comprises a tissue ablative element, and the step of performing therapy comprises delivering ablation energy to the ablative element to create a lesion at the first or second tissue site.

### Claim 7 (depends on 3)

The method of claim 3, wherein the catheter comprises a tissue mapping element, and the method further comprises receiving mapping signals from the mapping element to create a mapping data point at the first or second tissue site.

### Claim 8 (depends on 1)

The method of claim 1, wherein the vessel is a pulmonary vein.

### Claim 9

A method of performing a medical procedure adjacent an anatomical vessel using a catheter having a proximal section and a distal section, comprising:
forming the proximal section into a simple curve having an apex;
inserting the simple curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium:
rotating the simple curve within the vessel about the curve apex while the curve apex is in the vessel ostium to place the distal section in contact with a second tissue site adjacent the vessel ostium.

### Claim 10 (depends on 9)

The method of claim 9, wherein the distal section is placed into a non-radial relationship with the vessel ostium when the curve apex is inserted into the vessel ostium.

### Claim 11 (depends on 9)

The method of claim 9, wherein the distal section further has a medial section, the method further comprising forming the medial section into a complex curve that bends in a direction opposite the simple curve.

### Claim 12 (depends on 11)

The method of claim 11, wherein the complex curve bends in a direction opposite to and out-of-plane with the simple curve.

### Claim 13 (depends on 9)

The method of claim 9, wherein after the step of inserting the simple curve apex into the vessel ostium, the method further comprises performing a first medical procedure with the catheter.

### Claim 14 (depends on 13)

The method of claim 13, wherein after the step of rotating the simple curve, the method further comprises performing a second medical procedure with the catheter.

### Claim 15 (depends on 14)

The method of claim 14, wherein the catheter further comprises at least one tracking element carried by the distal section, wherein the first and second medical procedures include determining a location of the at least one tracking element.

### Claim 16 (depends on 14)

The method of claim 14, wherein the catheter comprises a therapeutic element carried by the distal section, and at least one of the first and second medical procedures includes performing therapy with the therapeutic element at the first or second tissue site.

### Claim 17 (depends on 16)

The method of claim 16, wherein the therapeutic element comprises a tissue ablative element, and the step of performing therapy comprises delivering ablation energy to the ablative element to create a lesion at the first or second tissue site.

### Claim 18 (depends on 14)

The method of claim 14, wherein the catheter comprises a tissue mapping element, and the method further comprises receiving mapping signals from the mapping element to create a mapping data point at the first or second tissue site.

### Claim 19 (depends on 9)

The method of claim 9, wherein the vessel is a pulmonary vein.
