# US 10,499,934 B2 · Methods for crossing and treating an occlusion

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,499,934 B2
- Document ID: US10499934B2
- Status: Granted
- Kind: B2
- Application number: 14/682,897
- Filed: 2015-04-09
- Published: 2015-07-30
- Granted: 2019-12-10
- Earliest claimed: 2013-09-18
- Assignees: XableCath Inc.
- Applicants: XableCath Inc.
- Inventors: Johannes B. Dahm; Bart M. E. Segers
- Web page: https://patentgrep.com/patent/US10499934B2

## CPC

- 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 17/3207: Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)}
- A61B 17/320708: {Curettes, e.g. hollow scraping instruments}
- A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- A61B 17/320758: {with a rotating cutting instrument, e.g. motor driven (A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002)}
- A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)}
- A61M 25/0043: {characterised by structural features}
- A61M 25/0136: {Handles therefor}
- A61M 25/104: {used for angioplasty}
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 2017/22001: {Angioplasty, e.g. PCTA}
- A61B 2017/22002: {preventing restenosis}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22047: {Means for immobilising the guide wire in the patient}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22079: {with suction of debris}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B 2017/320004: {abrasive}
- A61B 2017/320044: {Blunt dissectors}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61B 2217/007: with irrigation system
- 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

A device and method for treating a patient with total or near total occlusion is provided. The device can be positioned in a blood vessel at a treatment site. An occlusion at the treatment site is enlarged by a catheter. The catheter can be advanced over a guidewire into the occlusion. One or more of [a] compression or torsion applied to the guidewire or [b] compression or torsion applied to the catheter body expands or creates a path through the occlusion. The expansions or creation of the access path can be by cutting or abrading the occlusion or by a shoe-horn effect.

## Claims

### Claim 1

A method of treating a patient with an occlusion, the occlusion being a total or near total occlusion, comprising:
accessing a blood vessel of a patient at a peripheral access location;
advancing a guidewire into the patient along a pathway away from the peripheral access location to reach the occlusion;
advancing a catheter having a catheter body over the guidewire to bring a distal tip of the catheter into apposition with a proximal portion of the occlusion, the catheter having a lumen therethrough and a rigid ring at a distal portion thereof, wherein the rigid ring is disposed radially outward of the distal portion;
compressing a bumper zone disposed at the distal tip of the catheter against the proximal portion of the occlusion to deform the bumper zone proximally relative to the rigid ring such that an active end of the rigid ring moves into contact with the proximal portion of the occlusion; and
after advancing the catheter to bring the active end of the rigid ring into contact with the proximal portion of the occlusion, continuing to advance the catheter body along the guidewire while rotating the catheter body about the outer surface of the guidewire in a reciprocating clockwise and counterclockwise fashion to slide over the surface of the occlusion the active end to enlarge a lumen through the occlusion by removing matter from the occlusion.

### Claim 2 (depends on 1)

The method of claim 1, further comprising, after rotating the catheter body, axially moving a distal portion of the guidewire relative to the lumen further into the occlusion.

### Claim 3 (depends on 2)

The method of claim 2, further comprising, after axially moving the distal portion of the guidewire, repeating at least one of rotating the catheter body and axially moving the guidewire until the lumen across the occlusion has been enlarged.

### Claim 4 (depends on 1)

The method of claim 1, further comprising advancing a balloon catheter through the lumen of the catheter body.

### Claim 5 (depends on 1)

The method of claim 1, further comprising exchanging the guidewire for a stiff wire and advancing the stiff wire into the occlusion.

### Claim 6 (depends on 1)

The method of claim 1, further comprising exchanging the catheter body for a second catheter body after the catheter body is loaded with matter separated from the occlusion.

### Claim 7 (depends on 1)

The method of claim 1, wherein the active end of the rigid ring comprises teeth disposed on the distal facing surface of the distal end.

### Claim 8 (depends on 1)

The method of claim 1, wherein the active end of the rigid ring comprises an abrasive portion disposed on the distal facing surface of the distal end.

### Claim 9

A method of treating a patient, comprising:
accessing a blood vessel of a patient at an access location using a catheter technique;
advancing a guidewire into the patient and to a treatment site, the treatment site having a total or near total occlusion;
advancing a catheter over the guidewire into apposition with a proximal portion of the occlusion, the catheter having an elongate body and a lumen therethrough, a rigid ring that surrounds an outer surface of a distal end of the elongate body, the rigid ring being cylindrical in shape and comprising an anchor face comprising a cutting edge disposed at a distal facing end thereof, the catheter further comprising a sleeve having an inside surface disposed radially outward of an outside surface of the rigid ring and fixedly attached to a proximal portion of the rigid ring such that there is no relative motion between the sleeve and the rigid ring, wherein the proximal portion of the rigid ring is disposed between the sleeve and the elongate body;
applying compression to a proximal portion of the guidewire to move a distal portion of the guidewire relative to the lumen further into the occlusion while supporting the guidewire against buckling with the rigid ring; and
rotating a handle at a proximal end of the elongate body in a reciprocating clockwise and counterclockwise fashion to rotate the rigid ring at the distal end of the elongate body to slide the cutting edge over the occlusion to remove matter from the occlusion.

### Claim 10 (depends on 9)

The method of claim 9, wherein supporting the guidewire against buckling comprises applying a compressive force to the catheter body to securely engage the anchor face with the proximal face of the occlusion.

### Claim 11 (depends on 9)

The method of claim 9, wherein the lumen comprises an inner size that is no more than about 10% greater than the outer diameter of the guidewire such that the guidewire is supported against buckling.

### Claim 12 (depends on 9)

The method of claim 9, further comprising exchanging the guidewire for a stiff wire and advancing the stiff wire into the occlusion.

### Claim 13 (depends on 9)

The method of claim 9, further comprising exchanging the catheter body for a second catheter body after the catheter body is loaded with matter separated from the occlusion.

### Claim 14 (depends on 9)

The method of claim 9, wherein the guidewire further comprises a helical anchor and wherein the method further comprises advancing rotationally the helical anchor into the occlusion.