# US 2019/0167955 A1 · Method and Devices for Passing a Chronic Total Occlusion and Re-entry into a True Lumen

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- Number: US 2019/0167955 A1
- Document ID: US20190167955A1
- Status: Published application
- Kind: A1
- Application number: 16/019,005
- Filed: 2018-06-26
- Published: 2019-06-06
- Earliest claimed: 2017-12-05
- Inventors: Justin Panian
- Web page: https://patentgrep.com/patent/US20190167955A1

## CPC

- A61M 25/104: {used for angioplasty}
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- A61M 25/0194: {Tunnelling catheters}
- C02F 1/008: {Control or steering systems not provided for elsewhere in subclass C02F}
- C02F 1/78: with ozone {(C02F1/4672 takes precedence)}
- A61B 2017/22001: {Angioplasty, e.g. PCTA}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22061: {for spreading elements apart}
- A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space}
- A61M 2025/018: {Catheters having a lateral opening for guiding elongated means lateral to the catheter}
- A61M 2025/0183: {Rapid exchange or monorail catheters}
- A61M 2025/0197: {for creating an artificial passage within the body, e.g. in order to go around occlusions}
- C02F 2103/04: for obtaining ultra-pure water
- C02F 2209/02: Temperature
- C02F 2209/03: Pressure
- C02F 2209/40: Liquid flow rate
- 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)
- C02F: TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE (separation in general B01D; special arrangements on waterborne vessels of installations for treating water, waste water or sewage, e.g. for producing fresh water, B63J; adding materials to water to prevent corrosion C23F; treating radioactively-contaminated liquids G21F9/04; regeneration of reactants for recirculation into processes, see the relevant places for the processes)

## Abstract

Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

## Claims

### Claim 1

A dual guidewire lumen balloon catheter system, comprising:
a first guidewire and a second guidewire; and
an elongated catheter shaft having a distal portion with a distal end, a proximal portion with a proximal end, and a plurality of lumens that include a first lumen, a second lumen and a third lumen, with a balloon positioned adjacent the distal end of the elongated catheter shaft, wherein the first lumen of the elongated catheter shaft is fluidly coupled to the balloon, the first guidewire extends through the second lumen, and the second guidewire extends through the third lumen, and wherein the third lumen has a guidewire an exit port located distal to the balloon.

### Claim 2 (depends on 1)

The dual guidewire balloon catheter system of claim 1, wherein the second lumen has a guidewire entry port at the proximal portion of the catheter shaft and an exit port proximal to the balloon

### Claim 3 (depends on 1)

The dual guidewire balloon catheter system of claim 1, wherein the catheter shaft comprises one of the following: a shaft with multi-lumen extrusion, a shaft with separate tubes bundled together or a combination of all.

### Claim 4 (depends on 1)

A dual guidewire balloon catheter system of claim 1, wherein the second guidewire extends along the balloon and provides a cutting feature during the balloon inflation.

### Claim 5

A dual guidewire lumen balloon catheter system, comprising:
a first guidewire and a second guidewire; and
an elongated catheter shaft having a distal portion with a distal end, a proximal portion with a proximal end, a balloon positioned adjacent the distal end of the elongated catheter shaft, an inflation lumen extending through the elongated catheter shaft and fluidly coupled to the balloon, a first guidewire lumen segment that extends through the proximal portion of the catheter shaft, and a second guidewire lumen segment that extends through the distal portion of the catheter shaft, wherein the first guidewire extends through the first guidewire lumen segment, the second guidewire extends through the second guidewire lumen segment; and wherein the first and second guidewire lumens are located coaxially within the inner lumen of the catheter shaft.

### Claim 6

A dual guidewire lumen balloon catheter system, comprising:
a first guidewire and a second guidewire; and
an elongated catheter shaft having a distal portion with a distal end, a proximal portion with a proximal end, and a plurality of lumens that include a first lumen, a second lumen and a third lumen, with a balloon positioned adjacent the distal end of the elongated catheter shaft, wherein a first lumen of the elongated catheter shaft is fluidly coupled to the balloon, the first guidewire extends through the second lumen, and the second guidewire extends through the third lumen, and wherein the second and third lumens are at least partially positioned in a parallel and overlapping relationship within the catheter shaft.

### Claim 7 (depends on 6)

The dual guidewire balloon catheter system of claim 6, wherein the second lumen has a guidewire entry port on the proximal end of the catheter shaft.

### Claim 8

A dual guidewire lumen balloon catheter system, comprising:
a first guidewire and a second guidewire; and
an elongated catheter shaft having a distal portion with a distal end, a proximal portion with a proximal end, and a plurality of lumens that include a first lumen, a second lumen and a third lumen;
a distal balloon and a proximal balloon, both balloons positioned adjacent the distal end of the catheter shaft, wherein a first lumen of the catheter shaft is fluidly coupled to both balloons, the first guidewire extends through the second lumen, and the second guidewire extends through the third lumen, and wherein the second guidewire lumen has an entry port on the proximal end of the catheter shaft and an exit port located between the distal and proximal balloons.

### Claim 9 (depends on 8)

The dual balloon catheter system of claim 8, wherein the third lumen has an entry port on the distal end of the catheter shaft and an exit port proximal to the proximal balloon.

### Claim 10 (depends on 9)

The dual balloon catheter system of claim 9, wherein the second and third lumens are at least partially positioned in parallel within the catheter shaft.

### Claim 11

A dual guidewire lumen balloon catheter system, comprising:
a first guidewire and a second guidewire; and
an elongated catheter shaft having a distal portion with a distal end, a proximal portion with a proximal end, a plurality of lumens that include a first lumen, a second lumen and third lumen, and a balloon positioned adjacent the distal end of the catheter shaft, wherein a first lumen of the catheter shaft is fluidly coupled to the balloon, the first guidewire extends through the second lumen, and the second guidewire extends through the third lumen, and wherein the second guidewire lumen has an entry port on the proximal end of the catheter shaft and an exit port located inside the balloon.

### Claim 12 (depends on 11)

The dual balloon catheter system of claim 11, wherein the exit port of the second guidewire lumen is attached to the balloon wall.
