# US 5,702,413 A · Curved bristle atherectomy device and method

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- Number: US 5,702,413 A
- Document ID: US5702413A
- Status: Granted
- Kind: A
- Application number: 08/584,474
- Filed: 1996-01-11
- Granted: 1997-12-30
- Earliest claimed: 1996-01-11
- Assignees: SciMed Life Systems, Inc.
- Inventors: Daniel M. Lafontaine
- Web page: https://patentgrep.com/patent/US5702413A

## CPC

- A61M 25/0043: {characterised by structural features}
- 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 17/22031: {Gripping instruments, e.g. forceps, for removing or smashing calculi (A61B17/221 takes precedence)}
- A61B 2017/320012: {Brushes}
- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61M 25/104: {used for angioplasty}
- A61M 2025/109: {having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow}
- 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)

## Abstract

An medical device with hook like bristles suitable for capturing occlusive material. The device is inserted to a patient's vasculature and moved through an area of occlusion in such a way as to dislodge and capture the material causing the occlusion.

## Claims

### Claim 1

A medical device for removing occlusive material and the like from a patient's vasculature or body cavities, the device comprising:
an elongate flexible shaft having a proximal end and a distal end, the
distal end being insertable into the vasculature; and
a plurality of flexible bristles disposed on the distal end of the elongate shaft, wherein the bristles comprise a shape memory material that reversibly changes shape when subjected to a change in temperature beyond a transition temperature and the bristles are adapted to capture occlusive material.

### Claim 2 (depends on 1)

The medical device of claim 1, further comprising:
a retractable sheath disposed about the bristles.

### Claim 3 (depends on 1)

The medical device of claim 1, further comprising:
an atraumatic tip attached to the distal end of the elongate shaft.

### Claim 4

A method of removing occlusive material from a patient's vasculature, comprising the steps of:
providing an elongate shaft having a distal end and a plurality of shape memory bristles disposed about the distal end;
inserting the elongate shaft into the patient's vasculature;
capturing occlusive material in the bristles by moving the shaft through the occlusive material;
removing the elongate shaft and captured occlusive material from the patient's vasculature;
washing the occlusive material filled bristles in a liquid having a temperature suitable for changing the bristles from a memorized curved shape to a memorized straight shape; and
cooling the straightened bristles to a temperature suitable for changing the shape memory material from the memorized straight shape to the memorized curved shape.

### Claim 5 (depends on 4)

The method of claim 4 wherein the shaft includes a retractable sheath thereon, further comprising the step of:
retracting the sheath after inserting the elongate shaft into the patient's vasculature thereby allowing occlusive material to be captured in the bristles.

### Claim 6 (depends on 5)

The method of claim 5 further comprising the steps of:
moving the sheath to its distal-most position following occlusive material capture, thereby further trapped occlusive material between the sheath and the bristles.

### Claim 7 (depends on 5)

The method of claim 5, further comprising the step of:
moving the sheath distally so that the sheath acts as a cutter.

### Claim 8 (depends on 4)

The method of claim 4 further comprising the steps of:
washing the occlusive material filled bristles in a liquid having a temperature suitable for changing a shape memory material from a memorized curved shape to a memorized straight shape; and
bending the bristles back into a curved shape without cooling the straightened bristles.

### Claim 9

A medical device comprising:
an elongate tube having
a proximal end and a distal end,
a first inflation lumen and a second flushing lumen extending therethrough, and
a retractable sheath movably disposed about the elongate tube, the sheath having an interior;
an inflatable balloon attached to the distal end of the elongate tube and in fluid communication with the proximal end of the elongate tube via the first inflation lumen, the inflatable balloon having a smooth exterior suitable for sealing engagement with the distal end of the retractable sheath when the retractable sheath is moved over the balloon and the balloon is inflated;
a plurality of bristles disposed about the distal end of the elongate tube proximal of the balloon; and
an at least one orifice in fluid communication with the second lumen and disposed adjacent the bristles.

### Claim 10 (depends on 9)

The medical device of claim 9 further comprising:
a restriction vent disposed about the interior of the sheath.

### Claim 11 (depends on 9)

The medical device of claim 9 wherein the elongate shaft has a guide wire lumen.

### Claim 12 (depends on 9)

The medical device of claim 9 further comprising:
a stiffening wire disposed within the elongate tube.

### Claim 13

A method of removing thrombus from a patient's vasculature comprising the steps of:
providing a catheter having a distal end, a balloon attached to the distal end, a plurality of bristles disposed about the catheter proximal of the balloon, and a retractable sheath disposed about the catheter;
inserting the catheter, into a patient's vasculature;
capturing occlusive material in the bristles;
moving the sheath over the curved bristles;
inflating the balloon, thereby sealing the bristles between the sheath and the catheter;
flushing a lysing fluid from within the catheter, over the bristles, and back out between the catheter and the sheath;
retracting the sheath;
capturing additional occlusive material; and
removing the catheter from the patient's body.
