# US 12,178,458 B1 · Guidewireless shock wave catheters

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- Number: US 12,178,458 B1
- Document ID: US12178458B1
- Status: Granted
- Kind: B1
- Application number: 18/666,301
- Filed: 2024-05-16
- Granted: 2024-12-31
- Earliest claimed: 2024-05-16
- Assignees: Shockwave Medical, Inc.
- Applicants: Shockwave Medical, Inc.
- Inventors: Rainier Betelia; Todd Weston Jenkins; Danielle Sheree Rond; John Barritt; Kevin Nunes; Huy Phan
- Web page: https://patentgrep.com/patent/US12178458B1

## CPC

- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 18/26: for producing a shock wave, e.g. laser lithotripsy
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61B 2017/22021: {electric leads passing through the catheter}
- A61B 2017/22025: {applying a shock wave (A61B2017/22091 takes precedence)}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2018/263: {the conversion of laser energy into mechanical shockwaves taking place in a liquid}
- 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

Various shock wave catheters and methods of use thereof that do not utilize a guidewire are described herein. The shock wave catheters include at least one shock wave emitter disposed within a distal portion of the shock wave catheter and configured to generate shock waves. The ends of conductive wires extending within an elongate tube can form the shock wave emitter(s). The shock wave emitter(s) can be surrounded by an enclosure fillable with a conductive fluid delivered by the lumen of the elongate tube. The elongate tube can include a coil or slits therein that enable flexibility of the shock wave catheter, which, in combination with the narrow profile of the shock wave catheters described herein, enable their use in navigating and treating small, tortuous vessels.

## Claims

### Claim 1

A shock wave catheter for treating a lesion of a body lumen, the shock wave catheter comprising:
an elongate tube;
at least one shock wave emitter disposed distal to the elongate tube and configured to generate at least one shock wave;
a core wire extending within the elongate tube and terminating proximate to a distal end of the elongate tube, wherein the core wire is configured to control deflection of at least a distal portion of the shock wave catheter, and wherein a distal end of the core wire comprises a distal tip disposed at or proximate to a distal end of the at least one shock wave emitter, the distal tip having a larger diameter than an elongate portion of the core wire extending within the elongate tube; and
an enclosure enclosing at least the at least one shock wave emitter.

### Claim 2 (depends on 1)

The shock wave catheter of claim 1, wherein at least a portion of the elongate tube comprises a coil or a plurality of slits.

### Claim 3 (depends on 1)

The shock wave catheter of claim 1, wherein at least a portion of the elongate tube comprises a braided portion.

### Claim 4 (depends on 1)

The shock wave catheter of claim 1, wherein an internal volume of the enclosure is less than 1.5 cm3.

### Claim 5 (depends on 1)

The shock wave catheter of claim 1, wherein the shock wave catheter does not include a guidewire lumen.

### Claim 6 (depends on 1)

The shock wave catheter of claim 1, comprising a pair of conductive wires, wherein the at least one shock wave emitter comprises an electrode pair and a distal end of each conductive wire of the pair of conductive wires forms an electrode of the electrode pair.

### Claim 7 (depends on 6)

The shock wave catheter of claim 6, wherein at least one of the conductive wires extends through the elongate tube to the at least one shock wave emitter and comprises a refractory metal.

### Claim 8 (depends on 1)

The shock wave catheter of claim 1, comprising an optical fiber optically coupled to the at least one shock wave emitter.

### Claim 9 (depends on 1)

The shock wave catheter of claim 1, comprising a radiopaque marker disposed proximate to the at least one shock wave emitter for viewing the at least one shock wave emitter.

### Claim 10 (depends on 1)

The shock wave catheter of claim 1, comprising a first fluid lumen configured to fill the enclosure, and a second fluid lumen configured to remove gas bubbles from the enclosure that are generated during shock wave generation.

### Claim 11 (depends on 1)

The shock wave catheter of claim 1, wherein the at least one shock wave emitter is configured to emit at least one distally directed shock wave when an energy pulse is supplied to the at least one shock wave emitter.

### Claim 12 (depends on 1)

The shock wave catheter of claim 1, wherein an outer diameter of the shock wave catheter is between 0.25-1 mm.

### Claim 13 (depends on 1)

The shock wave catheter of claim 1, wherein the distal tip is configured to maintain a position and orientation of the at least one shock wave emitter during use.

### Claim 14 (depends on 1)

The shock wave catheter of claim 1, wherein the elongate tube comprises a variable pitch flat wire coil, a pitch of a proximal portion of the coil being greater than a pitch of a distal portion of the coil.

### Claim 15 (depends on 1)

A system for treating a lesion of a body lumen, comprising:
the shock wave catheter of claim 1; and
a pulse generator coupled to the at least one shock wave emitter and configured to generate energy pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

### Claim 16 (depends on 15)

The system of claim 15, wherein the pulse generator is configured to generate the energy pulses with a frequency between 1 Hz and 5 Hz and a voltage between 0.5 kV and 10.0 kV.

### Claim 17 (depends on 15)

The system of claim 15, wherein the pulse generator is configured to generate one or more laser pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

### Claim 18 (depends on 15)

The system of claim 15, wherein the system comprises a switch coupled to the core wire to control the deflection of the distal portion of the shock wave catheter.

### Claim 19 (depends on 15)

The system of claim 15, comprising a control hub connected to a proximal portion of the elongate tube and configured to receive the core wire, the control hub comprising:
at least one fluid port connected to a lumen of the elongate tube via at least one opening in the elongate tube to aspirate and purge the lumen; and
a port that facilitates connection of the pulse generator to the at least one shock wave emitter.

### Claim 20 (depends on 19)

The system of claim 19, wherein the control hub comprises at least one pressure seal enclosing the at least one opening of the elongate tube, and wherein the fluid port fluidly connects to a vacuum pressure source and to a conductive fluid source to (a) decrease pressure within at least one of the lumen of the elongate tube and the enclosure, and (b) subsequently draw conductive fluid into at least one of the lumen of the elongate tube and the enclosure.

### Claim 21

A shock wave catheter for treating a lesion of a body lumen, the shock wave catheter comprising:
an elongate tube;
at least one shock wave emitter disposed distal to the elongate tube and configured to generate at least one shock wave;
a distal tip disposed at or proximate to a distal end of the at least one shock wave emitter;
an enclosure enclosing at least the at least one shock wave emitter;
a first fluid lumen configured to fill the enclosure; and
a second fluid lumen configured to remove gas bubbles from the enclosure that are generated during shock wave generation.

### Claim 22 (depends on 21)

The shock wave catheter of claim 21, wherein at least a portion of the elongate tube comprises a coil, a plurality of slits, or a braided portion.

### Claim 23 (depends on 21)

The shock wave catheter of claim 21, comprising a core wire extending within the elongate tube and terminating proximate to a distal end of the elongate tube, wherein the core wire is configured to control deflection of at least a distal portion of the shock wave catheter.

### Claim 24 (depends on 21)

The shock wave catheter of claim 21, wherein the shock wave catheter does not include a guidewire lumen.

### Claim 25 (depends on 21)

The shock wave catheter of claim 21, comprising a radiopaque marker disposed proximate to the at least one shock wave emitter for viewing the at least one shock wave emitter.

### Claim 26 (depends on 21)

The shock wave catheter of claim 21, wherein the at least one shock wave emitter is configured to emit at least one distally directed shock wave when an energy pulse is supplied to the at least one shock wave emitter.

### Claim 27 (depends on 21)

A system for treating a lesion of a body lumen, comprising:
the shock wave catheter of claim 21; and
a pulse generator coupled to the at least one shock wave emitter and configured to generate energy pulses to cause the at least one shock wave emitter to generate the at least one shock wave.

### Claim 28 (depends on 27)

The system of claim 27, wherein the shock wave catheter comprises a core wire extending within the elongate tube and terminating proximate to a distal end of the elongate tube, and the system comprises a switch coupled to the core wire to control deflection of a distal portion of the shock wave catheter.

### Claim 29 (depends on 27)

The system of claim 27, comprising a control hub connected to a proximal portion of the elongate tube and configured to receive the core wire, the control hub comprising:
at least one fluid port connected to the first fluid lumen of the elongate tube via at least one opening in the elongate tube to aspirate and purge the first fluid lumen; and
a port that facilitates connection of the pulse generator to the at least one shock wave emitter.

### Claim 30 (depends on 29)

The system of claim 29, wherein the control hub comprises at least one pressure seal enclosing the at least one opening of the elongate tube, and wherein the fluid port fluidly connects to a vacuum pressure source and to a conductive fluid source to (a) decrease pressure within at least one of the first fluid lumen and the enclosure, and (b) subsequently draw conductive fluid into the first fluid lumen.
