# US 6,569,147 B1 · Systems and methods of use for delivering beneficial agents for revascularizing stenotic bypass grafts and other occluded blood vessels and for other purposes

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- Number: US 6,569,147 B1
- Document ID: US6569147B1
- Status: Granted
- Kind: B1
- Application number: 09/667,744
- Filed: 2000-09-22
- Granted: 2003-05-27
- Earliest claimed: 1996-07-26
- Assignees: Kensey Nash Corporation
- Inventors: Douglas G. Evans; John E. Nash
- Web page: https://patentgrep.com/patent/US6569147B1

## CPC

- 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 17/22: 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
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61L 2300/22: Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/622: Microcapsules
- A61L 2300/624: Nanocapsules
- A61L 2300/626: Liposomes, micelles, vesicles
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A system and method for opening a lumen in an occluded blood vessel, e.g., a coronary bypass graft, of a living being. The system comprises an atherectomy catheter having a working head, e.g., a rotary impacting impeller, and a debris extraction sub-system. The atherectomy catheter is located within a guide catheter. The working head is arranged to operate on, e.g., impact, the occlusive material in the occluded vessel to open a lumen therein, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, through the guide catheter to create a differential flow adjacent the working head, whereupon the debris is withdrawn in the infusate liquid and blood for collection outside the being's body. A guide wire having an inflatable balloon on its distal end may be used with the atherectomy catheter to block the flow of debris distally, while enabling distal tissues to be perfused with an oxygenating liquid.

## Claims

### Claim 1

An intra-luminal system for locally delivering an infusate liquid comprising at least one beneficial agent to the wall of a lumen in the body of a living being, said system comprising:
an infusation means for delivering said infusate liquid, said delivery done at an infusate liquid flow rate, said infusate liquid comprising a beneficial agent;
an extraction means for removing an extraction liquid, said removing done at an extraction liquid flow rate, said extraction liquid comprising the beneficial agent, the concentration of the beneficial agent in the extraction liquid either the same or different from the concentration of the beneficial agent in the infusate liquid;
wherein the extraction liquid flow rate exceeds the infusion liquid flow rate.

### Claim 2 (depends on 1)

The intra-luminal system of claim 1 wherein said at least one beneficial agent comprises at least one lipid.

### Claim 3 (depends on 2)

The intra-luminal system of claim 2 wherein said at least one lipid is ceramide.

### Claim 4 (depends on 2)

The intra-luminal system of claim 2 wherein said at least one lipid is sphingolipid or derivitized sphingolipid.

### Claim 5 (depends on 2)

The intra-luminal system of claim 2 wherein said at least one lipid is cell-permeable (C6-ceramide).

### Claim 6 (depends on 1)

The intraluminal system of claim 1 wherein said beneficial agent is an antineoplastic agent.

### Claim 7 (depends on 6)

The intra-luminal system of claim 6 wherein said beneficial agent is an antineoplastic agent selected from the group consisting of alkylating agents, antimetabolites, antimitotic agents, antibiotics, hormones, enzymes, cytoprotective agents, biological response modifiers and monoclonal antibodies.

### Claim 8 (depends on 1)

The intra-luminal system of claim 1, wherein the infusation means comprises an outlet port and additionally a blocking member arranged to be located distally of said outlet port to block the lumen.

### Claim 9 (depends on 8)

The intra-luminal system of claim 8 wherein said blocking member comprises a balloon.

### Claim 10

A method for locally delivering at least one beneficial agent to the wall of a lumen in the body of a living being comprising the steps of:
A. providing an intra-luminal system comprising an infusate liquid, an infusation means for delivering said at least one beneficial agent, an extraction means for removing an extraction liquid, said infusation means comprising an outlet port, said infusation liquid comprising at least one beneficial agent,
B. positioning said intra-luminal system within the body of the being so that said outlet port is within the lumen adjacent a portion of the wall thereof, and
C. delivering, at an infusate liquid flow rate, said infusation liquid through said infusation means and out of said outlet port for localized delivery into the adjacent lumen wall portion; and
D. removing via the extraction means, at an extraction liquid flow rate, at least a portion of said infusation liquid;
wherein the extraction liquid flow rate exceeds the infusion liquid flow rate.

### Claim 11 (depends on 10)

The method of claim 10 wherein said at least one beneficial agent comprises at least one lipid.

### Claim 12 (depends on 11)

The method of claim 11 wherein said at least one lipid is ceramide.

### Claim 13 (depends on 11)

The method of claim 11 wherein said at least one lipid is sphingolipid or derivitized sphingolipid.

### Claim 14 (depends on 11)

The method of claim 11 wherein said at least one lipid is cell-permeable (C6-ceramide).

### Claim 15 (depends on 10)

The method of claim 10 wherein said beneficial agent is an antineoplastic agent.

### Claim 16 (depends on 15)

The method of claim 15 wherein said beneficial agent is an antineoplastic agent selected from the group consisting of alkylating agents, antimetabolites, antimitotic agents, antibiotics, hormones, enzymes, cytoprotective agents, biological response modifiers and monoclonal antibodies.

### Claim 17 (depends on 10)

The method of claim 10 wherein the infusation means comprises an outlet port and additionally a blocking member arranged to be located distally of said outlet port to block the lumen.

### Claim 18 (depends on 17)

The method of claim 17 wherein said blocking member comprises a balloon.

### Claim 19

An intra-luminal system for locally delivering an infusate liquid comprising at least one beneficial agent to the wall of a lumen in the body of a living being, said system comprising:
a working head to open the lumen;
an infusation means for delivering said infusate liquid, said delivering done at an infusate liquid flow rate, said infusate liquid comprising a beneficial agent;
an extraction means for removing an extraction liquid, said removing done at an extraction liquid flow rate, said extraction liquid comprising the beneficial agent, the concentration of the beneficial agent in the extraction liquid either the same or different from the concentration of the beneficial agent in the infusate liquid;
wherein the extraction liquid flow rate exceeds the infusion liquid flow rate.

### Claim 20 (depends on 19)

The intra-luminal system of claim 19 wherein said at least one beneficial agent comprises at least one lipid.

### Claim 21 (depends on 20)

The intra-luminal system of claim 20 wherein said at least one lipid is ceramide.

### Claim 22 (depends on 20)

The intra-luminal system of claim 20 wherein said at least one lipid is sphingolipid or derivitized sphingolipid.

### Claim 23 (depends on 20)

The intra-luminal system of claim 20 wherein said at least one lipid is cell-permeable (C6-ceramide).

### Claim 24 (depends on 19)

The intraluminal system of claim 19 wherein said beneficial agent is an antineoplastic agent.

### Claim 25

The intra-luminal system of claim wherein said beneficial agent is an antineoplastic agent selected from the group consisting of alkylating agents, antimetabolites, antimitotic agents, antibiotics, hormones, enzymes, cytoprotective agents, biological response modifiers and monoclonal antibodies.

### Claim 26 (depends on 19)

The intra-luminal system of claim 19 wherein the infusation means comprises an outlet port and additionally a blocking member arranged to be located distally of said outlet port to block the lumen.

### Claim 27 (depends on 26)

The intra-luminal system of claim 26 wherein said blocking member comprises a balloon.

### Claim 28 (depends on 19)

A system of claim 19 wherein the working head creates debris and the extraction liquid comprises at least a portion of said debris.

### Claim 29

A method for locally delivering at least one beneficial agent to the wall of a lumen in the body of a living being comprising the steps of:
A. providing an intra-luminal system comprising a working head, infusate liquid, an infusation means for delivering said drug, an extraction means for removing an extraction liquid, said infusation means comprising an outlet port, said infusation liquid comprising at least one beneficial agent,
B. positioning said intra-luminal system within the body of the being so that that the working head and said outlet port is within the lumen adjacent a portion of the wall thereof, and
C. delivering, at an infusate liquid flow rate, said infusation liquid through said infusation means and out of said outlet port for localized delivery into the adjacent lumen wall portion; and
D. removing via the extraction means, at an extraction liquid flow rate, at least a portion of said infusation liquid;
wherein the extraction liquid flow rate exceeds the infusion liquid flow rate.

### Claim 30 (depends on 29)

The method of claim 29 wherein said at least one beneficial agent comprises at least one lipid.

### Claim 31 (depends on 30)

The method of claim 30 wherein said at least one lipid is ceramide.

### Claim 32 (depends on 30)

The method of claim 30 wherein said at least one lipid is sphingolipid or derivitized sphingolipid.

### Claim 33 (depends on 30)

The method of claim 30 wherein said at least one lipid is cell-permeable (C6-ceramide).

### Claim 34 (depends on 29)

The method of claim 29, wherein said beneficial agent is an antineoplastic agent.

### Claim 35 (depends on 34)

The method of claim 34 wherein said beneficial agent is an antineoplastic agent selected from the group consisting of alkylating agents, antimetabolites, antimitotic agents, antibiotics, hormones, enzymes, cytoprotective agents, biological response modifiers and monoclonal antibodies.

### Claim 36 (depends on 29)

The method of claim 29 wherein the infusation means comprises an outlet port and additionally a blocking member arranged to be located distally of said outlet port to block the lumen.

### Claim 37 (depends on 36)

The method of claim 36 wherein said blocking member comprises a balloon.

### Claim 38 (depends on 29)

A system of claim 29 wherein the working head creates debris and the extraction liquid comprises at least a portion of said debris.