# US 2014/0155862 A1 · Devices and methods for perfusion therapy

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- Number: US 2014/0155862 A1
- Document ID: US20140155862A1
- Status: Published application
- Kind: A1
- Application number: 14/094,758
- Filed: 2013-12-02
- Published: 2014-06-05
- Earliest claimed: 2009-02-08
- Assignees: Neuronal Protection System, LLC
- Applicants: Neuronal Protection System, LLC
- Inventors: Blaise Baxter; Thomas Devlin; Christian Devlin; Paul J. Fitzpatrick; Dirk V. Hoyns; Charles Rex Teeslink
- Web page: https://patentgrep.com/patent/US20140155862A1

## CPC

- A61M 25/0054: {with regions for increasing flexibility}
- 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
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61M 2025/0079: {Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter}
- 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

Devices, methods, and assemblies for perfusion therapy including cerebral perfusion therapy such as those for use in the treatment of acute ischemic stroke. The treatment includes delivery of blood to or about the vicinity of a thrombus site.

## Claims

### Claim 1

An assembly for cerebral perfusion therapy, including:
an outer catheter configured for cerebral perfusion therapy and including
a single lumen first elongate member having a proximal portion with a proximal end, a distally tapered distal portion having a distally tapered distal end and an open distal tip, the tapered distal end configured to facilitate navigating the outer catheter into the cerebral circulation and traversing clots within vessels within the brain, an inner lumen extending along at least the distal portion, a plurality of oblong apertures disposed along the distal end and extending from an outer surface of the first elongate member to the first elongate member inner lumen, the apertures having a first transverse dimension and a second transverse dimension which is substantially perpendicular to the first transverse dimension and substantially less than the first transverse dimension; the outer catheter being further configured for perfusion of fluids including any one or more of blood, therapeutic agents, diagnostic agents, lytic solutions, and the like; through or in the vicinity of an obstructing cerebral thrombus; and
An inner catheter configured for use in cerebral perfusion therapy and including
a second elongate member having a proximal portion with a proximal end, a distal portion with a distal end and an open distal tip, a lumen extending along at least the distal portion, the inner catheter configured for slidable coaxial advancement within the inner lumen of the outer catheter and slidable disposal at any one or more locations, proximal, adjacent, or distal; to at least a portion of the apertures; the inner catheter further being configured for extending distally from the open distal tip of the outer catheter.

### Claim 2 (depends on 1)

An assembly according to claim 1, wherein the outer catheter has a variable stiffness along a length thereof.

### Claim 3 (depends on 2)

An assembly according to claim 2, wherein the stiffness of a relatively distal portion of the outer catheter is less than the stiffness of a portion relatively proximal thereto.

### Claim 4 (depends on 1)

An assembly according to claim 1, wherein the outer catheter is configured to bend over a range up to 180 degrees relative to the catheter in an unbent and straight configuration

### Claim 5 (depends on 4)

An assembly according to claim 4, wherein the outer catheter is configured to provide the bend angle over a distance of at least 10 mm.

### Claim 6 (depends on 1)

An assembly according to claim 1, wherein the inner catheter has a variable stiffness along a length thereof.

### Claim 7 (depends on 6)

An assembly according to claim 6, wherein the stiffness of a relatively distal portion of the inner catheter is less than the stiffness of a portion relatively proximal thereto.

### Claim 8 (depends on 1)

An assembly according to claim 1, wherein the sum of the areas of the apertures is at least the same as an inner diameter of the outer catheter at a location proximal to a proximal end of the distal tapered portion of the outer catheter.

### Claim 9 (depends on 1)

An assembly according to claim 1, wherein the sum of the areas of the apertures is greater than an inner diameter of the outer catheter at a location proximal to a proximal end of the distal tapered portion of the outer catheter.

### Claim 10 (depends on 1)

An assembly according to claim 1, wherein, the apertures are configured to provide for a fluid flow direction having an acute angle as measured from the surface of the outer catheter distal end.

### Claim 11 (depends on 1)

An assembly according to claim 1, wherein the inner catheter is further configured for delivery of either or both fluids including blood, therapeutic agents, diagnostic agents, lytic solutions and the like; and delivery of treatment devices including thrombectomy devices; to or in the vicinity of the obstructing thrombus.

### Claim 12

A method for cerebral perfusion therapy of a patient, including:
Providing a cerebral perfusion device including
An outer catheter configured for cerebral perfusion therapy and including a single lumen first elongate member having a proximal portion with a proximal end, a distally tapered distal portion having a distally tapered distal end and an open distal tip, the tapered distal end configured to facilitate navigating the outer catheter into the cerebral circulation and traversing clots within vessels within the brain, an inner lumen extending along at least the distal portion, a plurality of oblong apertures disposed along the distal portion and extending from an outer surface of the first elongate member to the first elongate member inner lumen, the apertures having a first transverse dimension and a second transverse dimension which is substantially perpendicular to the first transverse dimension and substantially less than the first transverse dimension; the outer catheter being further configured for perfusion of fluids including any one or more of blood, therapeutic agents, diagnostic agents, lytic solutions, and the like; through or in the vicinity of an obstructing cerebral thrombus; and
An inner catheter configured for use in cerebral perfusion therapy and including a second elongate member having a proximal portion with a proximal end, a distal portion with a distal end and an open distal tip, a lumen extending along at least the distal portion, the inner catheter configured for slidable coaxial advancement within the inner lumen of the outer catheter and slidable disposal at any one or more locations, proximal, adjacent, or distal; to at least a portion of the apertures; the inner catheter further being configured for extending distally from the open distal tip of the outer catheter;
Providing a perfusion pump fluidically connectable to the cerebral perfusion device and configured to actively supply blood to a treatment site through the outer catheter or the inner catheter;
Advancing intracorporeally the outer catheter and the inner catheter through a patient's artery to a treatment site distal to a distal edge of the thrombus site;
Retracting the inner catheter proximally to expose at least a portion of the apertures which are distal to the distal edge of the thrombus site; and
Pumping blood from the perfusion pump through either the outer catheter or the inner catheter to the treatment site distal to the thrombus site, through any one or more of the open distal tip of the outer catheter, the open distal tip of the inner catheter, and any unobstructed apertures.

### Claim 13 (depends on 12)

A method according to claim 12, wherein the advancing step comprises advancing intracorporeally the outer catheter and the inner catheter through an cavernous section of an internal carotid artery.

### Claim 14 (depends on 13)

A method according to claim 13, wherein the cerebral perfusion device is configured to bend over a range up to 180 degrees relative to the device in an unbent and straight configuration.

### Claim 15 (depends on 14)

A method according to claim 14, wherein the cerebral perfusion device is configured to provide the bend angle over a distance of at least 10 mm.

### Claim 16 (depends on 12)

A method according to claim 12, wherein the cerebral perfusion device is bent up to 180 degrees relative to the device in an unbent and straight configuration over a distance of at least or about 10 mm as the device navigates through an cavernous section of an internal carotid artery.

### Claim 17 (depends on 12)

A method according to claim 12, wherein the sum of the areas of the apertures is at least the same as an inner diameter of the outer catheter at a location proximal to a proximal end of the distal tapered portion of the outer catheter.

### Claim 18 (depends on 12)

A method according to claim 12, further including advancing a revascularizing device including an endovascular thrombectomy device through the inner lumen of the inner catheter and revascularizing the thrombus site.

### Claim 19 (depends on 18)

A method according to claim 18, wherein the revascularization step includes advancing an endovascular thrombectomy device through the inner catheter and performing a thrombectomy procedure.

### Claim 20 (depends on 19)

A method according to claim 19, wherein the method is to directly treat ischemic stroke.