# US 10,478,201 B2 · Insertable medical device system with plaque treatment portion and methods of using

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- Number: US 10,478,201 B2
- Document ID: US10478201B2
- Status: Granted
- Kind: B2
- Application number: 15/053,526
- Filed: 2016-02-25
- Published: 2016-09-01
- Granted: 2019-11-19
- Earliest claimed: 2015-02-26
- Assignees: SurModics, Inc.
- Applicants: SurModics, Inc.
- Inventors: Charlie Olson
- Web page: https://patentgrep.com/patent/US10478201B2

## 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 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- A61M 25/104: {used for angioplasty}
- A61B 2017/00685: {Archimedes screw}
- A61B 2017/22001: {Angioplasty, e.g. PCTA}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22061: {for spreading elements apart}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61B 2017/320004: {abrasive}
- A61B 2017/320008: {Scrapers}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- 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 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- 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

The disclosure provides plaque treatment catheter assemblies for the treatment of arterial plaques and removal of clots. One assembly includes a second catheter tube movable within a first catheter tube, and an expansion member movable within the second tube. The second catheter tube has one or more distally-disposed and outwardly-expandable plaque treatment portion(s). Another assembly includes a catheter tube and at least one channel(s) within the catheter. The channel includes an elongate member with a distally-disposed plaque scoring or clot retrieval member. Optionally, the assembly includes an expandable member that can cause movement of the scoring member.

## Claims

### Claim 1

A plaque treatment catheter assembly comprising:
a first catheter tube having inner and outer diameters and capable of being inserted within vasculature;
a second catheter tube having inner and outer diameters, the outer diameter of the second catheter tube being smaller than the inner diameter of the first catheter tube and capable of moving within and out of the first catheter tube, the second catheter tube having a distal portion comprising one or more plaque treatment portion(s) on an outer surface of the second catheter tube, wherein all or a portion of the second catheter tube including the one or more plaque treatment portion(s) is capable of outward expansion in response to force of an outer surface of an expansion member; and
wherein the expansion member is movable within and out of the inner diameter of the second catheter tube when in a contracted state.

### Claim 2 (depends on 1)

The plaque treatment catheter assembly of claim 1 wherein the expansion member comprises a balloon member of a balloon catheter, wherein the balloon catheter is movable within and out of the inner diameter of the second catheter tube in an uninflated state.

### Claim 3 (depends on 1)

The plaque treatment catheter assembly of claim 1 wherein the one or more plaque treatment portions comprises a mechanical feature, a bioactive agent feature, or both, that can affect an arterial plaque.

### Claim 4 (depends on 1)

The plaque treatment catheter assembly of claim 1 wherein the one or more plaque treatment portions comprises a plaque scoring member.

### Claim 5 (depends on 4)

The plaque treatment catheter assembly of claim 4 wherein the plaque scoring member is configured on the outer surface of the second catheter tube in a helical arrangement.

### Claim 6 (depends on 4)

The plaque treatment catheter assembly of claim 4 wherein the plaque scoring member comprises a metal.

### Claim 7 (depends on 1)

The plaque treatment catheter assembly of claim 1 comprising a bioactive agent releasable from the one or more plaque treatment portion(s).

### Claim 8 (depends on 7)

The plaque treatment catheter assembly of claim 7 comprising first and second plaque treatment portions each comprising bioactive agent, and a third plaque treatment portion comprising plaque scoring member, wherein the third plaque treatment portion is positioned between the first and second plaque treatment portions.

### Claim 9 (depends on 7)

The plaque treatment catheter assembly of claim 7 wherein the bioactive agent is rapamycin.

### Claim 10 (depends on 7)

The plaque treatment catheter assembly of claim 7 wherein the bioactive agent is present in a polymeric coating.

### Claim 11 (depends on 1)

The plaque treatment catheter assembly of claim 1 wherein the second catheter tube has a proximal portion, and the distal portion has greater expandability than the proximal portion.

### Claim 12 (depends on 11)

The plaque treatment catheter assembly of claim 11 wherein the distal portion is made of a material that has a lower melting point, or has greater elastomericity, than material of the proximal portion.

### Claim 13 (depends on 1)

The plaque treatment catheter assembly of claim 1 comprising a first and a second plaque treatment portions, wherein the first and second plaque treatment portions differ in regards to type of bioactive agent associated with the portions, amount of bioactive agent associated with the portions, or type or configuration of the plaque scoring member, or combinations thereof.

### Claim 14 (depends on 1)

A method for treating an arterial plaque, comprising a step of:
treating one or more arterial plaque(s) with the plaque treatment portion of the second catheter tube of the plaque treatment catheter assembly of claim 1.

### Claim 15

A plaque treatment catheter assembly comprising:
a first catheter tube having inner and outer diameters and capable of being inserted within vasculature;
a second catheter tube having inner and outer diameters, the outer diameter of the second catheter tube being smaller than the inner diameter of the first catheter tube and capable of moving within and out of the first catheter tube, the second catheter tube having a distal portion comprising one or more plaque treatment portion(s) on an outer surface of the second catheter tube, wherein all or a portion of the plaque treatment portion is attached to the outer surface of the second catheter tube, and wherein all or a portion of the second catheter tube including the one or more plaque treatment portion(s) is capable of outward expansion in response to force of an outer surface of an expansion member so as to push the plaque treatment portion up against a plaque during use, and wherein the second catheter tube does not include a balloon; and
wherein the expansion member is movable within and out of the inner diameter of the second catheter tube when in a contracted state.

### Claim 16 (depends on 15)

The plaque treatment catheter assembly of claim 15 wherein the second catheter tube has constant inner and outer diameters from its proximal to distal end.

### Claim 17 (depends on 15)

The plaque treatment catheter assembly of claim 15, wherein the plaque treatment portion is not capable of moving independently of the second catheter tube.

### Claim 18 (depends on 15)

The plaque treatment catheter assembly of claim 15 comprising first and second plaque treatment portions,
wherein the first plaque treatment portion comprises a plaque scoring member and all or a portion of the plaque treatment portion is attached to the outer surface of the second catheter tube, and
wherein the second plaque treatment portion comprises a bioactive agent associated the outer surface of the second catheter tube and releasable from the second plaque treatment portion,
wherein the first and second plaque treatment portions are located at different positions along the length of the second catheter tube.

### Claim 19 (depends on 15)

The plaque treatment catheter assembly of claim 15 wherein the bioactive agent is selected from the group consisting of antibiotics, anti-inflammatory agents, anti-proliferative agents, immunomodulatory agents, anti-mitotics and anesthetics, and the bioactive agent is associated with a polymeric coating on the outer surface of the second catheter tube.
