# US 12,004,772 B2 · Chronic total occlusion crossing devices and methods

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- Number: US 12,004,772 B2
- Document ID: US12004772B2
- Status: Granted
- Kind: B2
- Application number: 17/139,410
- Filed: 2020-12-31
- Published: 2021-04-29
- Granted: 2024-06-11
- Earliest claimed: 2017-03-31
- Applicants: Jihad A. Mustapha
- Inventors: Jihad A. Mustapha
- Web page: https://patentgrep.com/patent/US12004772B2

## CPC

- A61B 17/320783: {through side-hole, e.g. sliding or rotating cutter inside catheter}
- 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)}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- 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 2017/00867: {shape memory effect}
- A61B 2017/22042: {Details of the tip of the guide wire}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B 2017/320791: {with cutter extending outside the cutting window}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter 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 for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

## Claims

### Claim 1

A device for crossing a lesion in a tissue lumen, comprising:
a catheter;
a crossing wire configured to pass through a lumen of the catheter, the crossing wire including a loop at a distal end of the crossing wire, the loop having a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion; and
a stationary inner catheter disposed within the catheter, the stationary inner catheter including a second lumen therein;
wherein an outer surface of the stationary inner catheter is fixed to an inner surface of the catheter.

### Claim 2 (depends on 1)

The device for crossing a lesion according to claim 1, further comprising:
a mobile inner catheter disposed within the lumen of the catheter eccentric to the stationary inner catheter, the mobile inner catheter forming a third lumen therein, the mobile inner catheter configured to move axially and radially with respect to the stationary inner catheter.

### Claim 3 (depends on 2)

The device for crossing a lesion according to claim 2, wherein a first proximal side of the loop is configured to be disposed within the second lumen, and wherein a second proximal side of the loop is configured to be disposed within the third lumen.

### Claim 4

A device for crossing a lesion in a tissue lumen, comprising:
a catheter forming a lumen; and
a crossing wire configured to pass through the lumen of the catheter, the crossing wire including a primary shaft and a loop at a distal end of the primary shaft, the loop having a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a leading portion configured to interrogate the lesion,
wherein the crossing wire has a first configuration in which opposing lateral sides of the loop are not twisted or are twisted by a first amount, and a second configuration wherein the opposing lateral sides of the loop are twisted by a second amount that is different from the first amount,
wherein the crossing wire can be changed from the first configuration to the second configuration by twisting the primary shaft at a position proximal to the catheter, and
wherein the crossing wire is configured to (i) enter the catheter in the first configuration and (ii) be twisted into the second configuration while within the catheter.

### Claim 5 (depends on 4)

The device according to claim 4, wherein a first side of the opposing lateral sides of the loop is directly connected to the primary shaft,
wherein a second side of the opposing lateral sides of the loop is directly connected to a secondary shaft of the crossing wire, and
wherein the primary shaft and the secondary shaft are disposed inside the lumen of the catheter.

### Claim 6 (depends on 4)

The device according to claim 4, wherein in the second configuration, the opposing lateral sides of the crossing wire twist about each other a plurality of times.

### Claim 7 (depends on 4)

The device according to claim 4, wherein a shape of the loop at a position distal to the catheter is configured to change when a rotational force is applied to the primary shaft at a position proximal to the catheter.
