# US 12,599,406 B2 · Methods and devices for puncturing tissue

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- Number: US 12,599,406 B2
- Document ID: US12599406B2
- Status: Granted
- Kind: B2
- Application number: 19/270,234
- Filed: 2025-07-15
- Published: 2025-11-06
- Granted: 2026-04-14
- Earliest claimed: 2013-08-07
- Assignees: Boston Scientific Medical Device Limited
- Applicants: Boston Scientific Medical Device Limited
- Inventors: Gareth Davies; John Paul Urbanski; Ferryl Alley; Bogdan Beca
- Web page: https://patentgrep.com/patent/US12599406B2

## CPC

- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/003: {Steerable}
- A61B 2017/22042: {Details of the tip of the guide wire}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2018/00351: {Heart}
- A61B 2018/00363: {Epicardium}
- A61B 2018/00601: {Cutting}
- A61B 2018/144: {Wire}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/09: Guide wires
- 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

Novel and unique medical devices and associated methods are disclosed, for a medical device for puncturing tissue at a tissue site. The medical device includes an elongate member having a distal section defining a distal section curved portion and a distal section straight portion. The distal section straight portion is distal to the distal section curved portion. An active tip is located at a distal end of the distal section. The active tip is operable to deliver energy to create a puncture through the tissue. The medical device includes a constant diameter layer. The distal section straight portion includes a minimum diameter portion located proximal to a constant diameter portion, and the constant diameter layer surrounds the minimum diameter portion.

## Claims

### Claim 1

A medical device for creating a transseptal puncture within a patient's heart, the medical device comprising:
a multi-function guidewire having a proximal section, a distal section including an electrode, and a rail section between the proximal and distal sections;
the electrode operable to deliver energy to aid the creation of a puncture through a septum of the patient's heart; and
the rail section being configured to both act as a rail for supporting installation of one or more treatment tools thereupon as well as to be maneuverable for enabling access to the heart septum by the guidewire;
wherein the distal section comprises a curved portion and a straight portion, the straight portion being distal to the curved portion;
wherein a stiffness of the guidewire at a region in the straight portion is greater than a stiffness of the guidewire at a region in the curved portion;
wherein the distal section is configured to automatically form a coil or a J-shape in a deployed state for anchoring the distal section.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein a stiffness of the guidewire at a region in the rail section is greater than the stiffness of the guidewire at the region in the distal section curved portion.

### Claim 3 (depends on 2)

The medical device of claim 2, wherein a stiffness of the guidewire at a region in the proximal section is less than the stiffness of the guidewire at the region in the rail section.

### Claim 4 (depends on 1)

The medical device of claim 1, further comprising a radiofrequency (RF) generator for supplying the energy to the electrode.

### Claim 5 (depends on 4)

The medical device of claim 4, wherein the supply of the energy is controlled through the use of a push button in communication with the generator.

### Claim 6 (depends on 1)

The medical device of claim 1, further comprising a radiopaque marker positioned on the distal section of the guidewire.

### Claim 7 (depends on 6)

The medical device of claim 6, wherein the radiopaque marker is a helical coil surrounding the guidewire at the distal section.

### Claim 8

A medical device for creating a transseptal puncture within a patient's heart, the medical device comprising:
a multi-function guidewire having at least a rail section and a distal section, wherein the rail section is proximal of the distal section, and wherein the distal section includes an electrode having an atraumatic tip;
the electrode operable to deliver energy to aid the creation of a puncture through a septum of the patient's heart; and
the rail section being configured to both act as a rail for supporting installation of one or more treatment tools thereupon as well as to be maneuverable for enabling access to the heart septum by the guidewire;
wherein the distal section comprises a curved portion and a straight portion, the straight portion being distal to the curved portion;
wherein at least part of the straight portion has a first stiffness and at least part of the curved portion has a second stiffness, and the first stiffness is greater than the second stiffness.

### Claim 9 (depends on 8)

The medical device of claim 8, wherein at least part of the rail section of the guidewire has a third stiffness greater than the second stiffness.

### Claim 10 (depends on 8)

The medical device of claim 8, wherein at least part of the rail section of the guidewire has a fourth stiffness greater than the first stiffness.

### Claim 11 (depends on 8)

The medical device of claim 8, wherein the rail section of the guidewire is sufficiently stiff to enable puncturing the septum of the patient's heart from a superior approach.

### Claim 12 (depends on 8)

The medical device of claim 8, wherein the rail section of the guidewire is sufficiently stiff to enable puncturing the septum of the patient's heart from an inferior approach.

### Claim 13 (depends on 8)

The medical device of claim 8, wherein the guidewire is configured for electrical communication with a radiofrequency (RF) generator for supplying the energy to the electrode.
