# US 8,784,366 B2 · Intravascular cerebral catheter device and method of use

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- Number: US 8,784,366 B2
- Document ID: US8784366B2
- Status: Granted
- Kind: B2
- Application number: 12/876,786
- Filed: 2010-09-07
- Published: 2010-12-30
- Granted: 2014-07-22
- Earliest claimed: 2008-03-24
- Applicants: Joe Sam Robinson
- Inventors: Joe Sam Robinson
- Web page: https://patentgrep.com/patent/US8784366B2

## CPC

- A61M 5/16854: {by monitoring line pressure}
- A61B 5/0215: by means inserted into the body
- A61B 5/6852: {Catheters}
- A61L 33/0011: {Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- 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)}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 2210/0693: Brain, cerebrum
- 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)
- 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

Cerebral catheter devices and methods for use are provided. The catheter devices provided may include an anti-thrombotic agent coating on an exterior surface. The catheter devices may include unique tip configurations to allow improved fluid delivery capabilities. Further, the catheter devices may also or alternatively include one or more sensor devices in communication with a controller that allow automatically adjusting a delivery of a therapeutic fluid, for example a vasodilator, in response to a condition sensed by the catheter devices, such as increased pressure. Moreover, the catheter devices may also be used in conjunction with blood flow transducers to detect and timely prevent and treat vasospasms or other conditions. Methods for preventing and treating vasospasm, neoplasm, or other pathological conditions while prolonged using the catheter devices are also provided.

## Claims

### Claim 1

A catheter device, comprising:
an elongate catheter body, comprising a distal end and a proximal end;
at least one lumen extending from the proximal end to the distal end of the elongate catheter body;
a distal sensor device affixed to the elongate catheter body substantially near the distal end, wherein the distal sensor device generates a first signal that is a distal pressure or flow rate;
a proximal sensor device affixed to the elongate catheter body proximal the distal sensor device and configured to be positioned in a patient's systemic vasculature, wherein the proximal sensor device generates a second signal that is a proximal pressure or flow rate;
a controller in communication with the proximal and distal sensor devices, and
a fluid delivery device in fluid communication with the at least one lumen and in electrical communication with the controller;
wherein said catheter device is a cerebral catheter device configured to be inserted into cerebral arteries;
wherein the controller is configured to perform an analysis comprising comparing:
the first and second signals generated from the distal and proximal sensor devices, and cause an
(a) increase in fluid delivery to the at least one lumen from the fluid delivery device if the distal pressure or flow rate is at a first predefined limit greater than the proximal pressure or flow rate, or
(b) decrease in fluid delivery to the at least one lumen from the fluid delivery device if the distal pressure or flow rate is at a second predefined limit lower than the proximal pressure or flow rate.

### Claim 2 (depends on 1)

The catheter device of claim 1, wherein the analysis performed by the controller comprises determining a ratio of the distal pressure or flow rate to the proximal pressure or flow rate, and wherein if the ratio is at or exceeds a first predefined ratio limit, the fluid delivery is adjusted to be increased, and wherein if the ratio is below a second predefined ratio limit, the fluid delivery is adjusted to be decreased.

### Claim 3 (depends on 2)

The catheter device of claim 2, wherein the first predefined ratio limit and the second predefined ratio limit comprise the same value.

### Claim 4 (depends on 1)

The catheter device of claim 1, wherein the fluid delivery device delivers a fluid comprising at least a saline solution comprising a vasodilator, an anti-thrombotic agent, an antibiotic, a chemotherapeutic agent, other suitable therapeutic agent, or combination thereof.

### Claim 5 (depends on 4)

The catheter device of claim 4, wherein said anti-thrombotic agent is selected from the group consisting of heparin, warfarin, synthetic pentasaccharide inhibitors of factor Xa, and derivatives thereof.

### Claim 6 (depends on 4)

The catheter device of claim 4, wherein said vasodilator is verapamil.

### Claim 7 (depends on 1)

The catheter device of claim 1, further comprising an anti-thrombotic agent at least partially coated or deposited thereon.

### Claim 8 (depends on 7)

The catheter device of claim 7, wherein the anti-thrombotic agent comprises a coating applied to substantially an entire surface of the elongate catheter body.

### Claim 9 (depends on 7)

The catheter device of claim 7, wherein the anti-thrombotic agent is at least partially impregnated into the elongate catheter body.

### Claim 10 (depends on 7)

The catheter device of claim 7, wherein the anti-thrombotic agent is deposited at least partially in an interior surface of the catheter device comprising the at least one lumen.

### Claim 11 (depends on 7)

The catheter device of claim 7, wherein the anti-thrombotic agent is time releasable.

### Claim 12 (depends on 1)

The catheter device of claim 1, wherein the distal end of the catheter device further comprises a perforated tip affixed thereon, wherein the perforated tip comprises a rounded or substantially planar surface on a distal end of the perforated tip, and a plurality of perforated orifices on the rounded or substantially planar surface and extending through the perforated tip and in fluid communication with the at least one lumen.

### Claim 13 (depends on 12)

The catheter device of claim 12, wherein the at least one lumen comprises a first and a second lumen, wherein the plurality of perforated orifices further comprise at least one central orifice in communication with the first lumen, and wherein the plurality of perforated orifices other than the at least one central orifice are in fluid communication with the second lumen.

### Claim 14 (depends on 13)

The catheter device of claim 13, further comprising a secondary medical device passed through the first lumen and the at least one central orifice, wherein the secondary medical device comprises one of a guide wire and a balloon.

### Claim 15 (depends on 12)

The catheter device of claim 12, wherein a fluid is delivered through the at least one lumen and the plurality of perforated orifices, wherein the fluid comprises at least one of a saline solution comprising a vasodilator, an anti-thrombotic agent, an antibiotic, a chemotherapeutic agent, other suitable therapeutic agent, or combination thereof.

### Claim 16 (depends on 12)

The catheter device of claim 12, wherein the perforated tip is inserted into or is inserted over the elongate catheter body.

### Claim 17 (depends on 1)

A method for preventing and treating vasospasm using the catheter device of claim 1.

### Claim 18 (depends on 17)

The method of claim 17, wherein said catheter device is used in conjunction with a blood flow transducer operable to detect a blood flow velocity and a presence of vasospasm.

### Claim 19 (depends on 18)

The method of claim 18, wherein said blood flow transducer is an ultrasonic monitoring device.

### Claim 20 (depends on 18)

The method of claim 18, wherein said blood flow transducer is implanted, recessed into, screwed onto, or temporarily attached to the patient's skull.

### Claim 21 (depends on 18)

The method of claim 18, wherein the blood flow velocity obtained from the blood flow transducer is supplied to the controller for adjusting delivery of a therapeutic fluid comprising a desired therapeutic agent.

### Claim 22 (depends on 1)

A method for treating neoplasm using the catheter device of claim 1.

### Claim 23 (depends on 22)

The method of claim 22, wherein said neoplasm is brain glioblastomas.

### Claim 24 (depends on 1)

The catheter device of claim 1, wherein the controller includes instructions to increase a rate of the fluid delivery based on at least one of the first and second signals from at least one of the proximal and distal sensor devices.

### Claim 25 (depends on 24)

The catheter device of claim 24, wherein the rate of fluid delivery increase is proportional to a difference between the first signal from the distal sensor device and the second signal from the proximal sensor device.
