# US 11,076,808 B2 · Flexible medical device with marker band and sensor

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- Number: US 11,076,808 B2
- Document ID: US11076808B2
- Status: Granted
- Kind: B2
- Application number: 15/456,480
- Filed: 2017-03-11
- Published: 2017-10-12
- Granted: 2021-08-03
- Earliest claimed: 2016-03-26
- Assignees: Makaha Medical, LLC.
- Applicants: Makaha Medical, LLC.
- Inventors: Marc-Alan Levine
- Web page: https://patentgrep.com/patent/US11076808B2

## CPC

- A61B 5/6852: {Catheters}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14539: {for measuring pH}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/6851: {Guide wires}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 8/0833: {involving detecting or locating foreign bodies or organic structures}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/445: {Details of catheter construction}
- A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/09: Guide wires
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 8/4494: {characterised by the arrangement of the transducer elements}
- A61B 8/461: {Displaying means of special interest}
- A61B 8/467: {characterised by special input means}
- A61B 2017/00106: {ultrasonic}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system and method for determining a pH level of blood in a vessel of a patient including a flexible elongated device configured and dimensioned for insertion in the vessel of the patient. The elongated device has a tubular portion, a marker band positioned distally of the tubular portion and a pH sensor positioned within the marker band to measure the pH level of blood downstream of the blood clot and an indicator to indicate the measured pH.

## Claims

### Claim 1

A system for determining a pH level of blood in a vessel of a patient, the system comprising:
a flexible elongated device configured and dimensioned for insertion in the vessel of the patient, the elongated device having a proximal portion, a distal portion and a tubular portion having a lumen formed therein, the elongated device configured for insertion so the distal portion extends past a blood clot for positioning of the distal portion distal of the blood clot;
a marker band, at least a portion of the marker band positioned distally of a distalmost edge of the tubular portion, and exposed from the tubular portion, wherein the marker band has an internal diameter larger than an internal diameter of the tubular portion from which it distally extends;
a sensor for positioning distal of the blood clot, the sensor positioned within the marker band and positioned distally of the distalmost edge of the tubular portion; and
a connector operably connecting the tubular portion to an indicator, the sensor is configured to measure the pH level of blood downstream of the blood clot to thereby determine pH of the vessel downstream of the blood clot to determine the condition of the vessel to assess subsequent treatment of the blood clot, the indicator providing an indication of the pH measured by the sensor.

### Claim 2 (depends on 1)

The system of claim 1, wherein the tubular portion comprises a hypotube.

### Claim 3 (depends on 2)

The system of claim 2, wherein the hypotube has a martensitic distal region and an austenitic proximal region.

### Claim 4 (depends on 1)

The system of claim 1, wherein the tubular portion has a first wall thickness and the marker band has a second wall thickness, the second wall thickness being less than the first wall thickness at a distal portion of the tubular portion so the marker band has the larger internal diameter.

### Claim 5 (depends on 4)

The system of claim 4, wherein the first wall thickness is between about 0.002 inches and about 0.004 inches and the second wall thickness is between about 0.001 inches and about 0.002 inches.

### Claim 6 (depends on 4)

The system of claim 4, wherein the tubular portion has a first outer diameter and the marker band has a second outer diameter substantially equal to the first outer diameter.

### Claim 7 (depends on 1)

The system of claim 1, wherein the marker band has a window to enable communication of the sensor with the blood in the vessel.

### Claim 8 (depends on 1)

The system of claim 1, wherein the tubular portion has a first reduced diameter region at a distal region, and a radiopaque coil is positioned on the first reduced diameter region.

### Claim 9 (depends on 8)

The system of claim 8, wherein the tubular portion has a second reduced diameter region formed proximal of the first reduced diameter region to support a vascular implant.

### Claim 10 (depends on 8)

The system of claim 8, further comprising a second radiopaque coil positioned on the tubular portion proximal of the first radiopaque coil, and a gap is formed between the first and second coils providing an exposed region having a window, the sensor positioned within the tubular portion and aligned with the window.

### Claim 11 (depends on 1)

The system of claim 1, further comprising a second marker band positioned proximal of the first marker band which has the sensor therein.

### Claim 12 (depends on 1)

The system of claim 1, wherein the sensor is contained in a microchip and a wire extends through the lumen of the tubular portion.

### Claim 13 (depends on 1)

The system of claim 1, further comprising a second sensor for sensing a parameter of the blood clot and a second indicator to indicate the sensed parameter, the second sensor connected to the second indicator and configured to sense a density of the blood clot.

### Claim 14 (depends on 13)

The system of claim 13, wherein the second sensor is positioned within the marker band.

### Claim 15 (depends on 1)

The system of claim 1, wherein the sensor includes fiber optics transmission.

### Claim 16 (depends on 1)

The system of claim 1, wherein the indicator communicating with the sensor is configured to be positioned outside the patient, the indicator indicating the pH level of the blood.

### Claim 17

A method for determining a pH level of blood downstream of a cerebral blood clot in a cerebral vessel of a patient comprising the steps of:
providing an elongated flexible device having a) a tubular portion, b) a radiopaque marker band exposed from the tubular portion and extending distally from a distalmost edge of the tubular portion, an internal diameter of the marker band is larger than an internal diameter of a distal portion of the tubular portion, and c) a sensor positioned within the internal space of the marker band;
inserting the flexible device through vasculature of the patient and past the cerebral blood clot to a position downstream of the blood clot in the vessel, the marker band indicating to the user the position of the sensor;
sensing a pH level of the blood downstream of the blood clot;
indicating to the user the pH level of the blood to enable the user to determine a pH level of the vessel downstream of the blood clot for subsequent selection of a clot treatment method; and
indicating to the user the position of the sensor due to its placement within the internal space of the marker band.

### Claim 18 (depends on 17)

The method of claim 17, further comprising the step of determining a density of the blood clot to determine the clot treatment method.

### Claim 19 (depends on 17)

The method of claim 17, further comprising a connector connecting the flexible device to an indicator to indicate the pH level.

### Claim 20 (depends on 17)

The method claim 17, wherein the tubular portion has a first wall thickness and the marker band has a second wall thickness, the second wall thickness being less than the first wall thickness at a distal portion of the tubular portion so the marker band has a larger internal diameter than an internal diameter at the distal portion of the tubular portion.