# US 10,307,580 B2 · Devices, systems and methods for enhancing intraluminal drug delivery and uptake

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- Number: US 10,307,580 B2
- Document ID: US10307580B2
- Status: Granted
- Kind: B2
- Application number: 15/190,730
- Filed: 2016-06-23
- Published: 2016-12-29
- Granted: 2019-06-04
- Earliest claimed: 2015-06-25
- Assignees: Cardiovascular Systems, Inc.
- Applicants: Cardiovascular Systems, Inc.
- Inventors: Victor L. Schoenle; Matthew D. Cambronne; Brittany N. Pusey; Jeffrey A. McBroom
- Web page: https://patentgrep.com/patent/US10307580B2

## CPC

- A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis}
- 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)}
- A61K 41/0023: {Aggression treatment or altering}
- A61B 2017/22065: {Functions of balloons}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61B 2017/22088: {ultrasound absorbing, drug activated by ultrasound}
- A61B 2017/320004: {abrasive}
- A61B 2017/320766: {eccentric}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present disclosure generally relates to methods, devices and systems relating to applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, the present invention comprises enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing.

## Claims

### Claim 1

A system for enhancing the efficiency of administering therapeutic agents and delivering a therapeutically effective amount of the therapeutic agent to the wall of a biological conduit in a treatment region of interest of a patient, the biological conduit having a diameter, comprising:
a catheter inserted at least partially within the biological conduit and comprising a lumen;
an inflatable balloon attached proximate a distal end of the catheter and comprising
an inflatable portion, and
an intermediate section in the inflatable portion and comprising a plurality of apertures therethrough;
a therapeutic agent infusion lumen in fluid communication with the plurality of apertures;
a therapeutic agent reservoir located outside the patient's body, comprising therapeutic agent therein, the therapeutic agent within the therapeutic agent reservoir in fluid communication with the therapeutic agent infusion lumen;
a balloon infusion lumen in fluid communication with the inflatable balloon, wherein the balloon infusion lumen and therapeutic agent infusion lumen are not in fluid communication with each other;
a therapeutic agent pumping mechanism located outside the patient's body and in fluid communication with the therapeutic agent reservoir, the therapeutic agent infusion lumen and the apertures, but not in fluid communication with the balloon infusion lumen; and
a pulse generator located outside the patient's body and in operative communication with the therapeutic agent pumping mechanism and further adapted to generate a range of therapeutically effective frequencies to the therapeutic agent to drive the therapeutic agent through the therapeutic agent infusion lumen and out of the plurality of apertures of the inflatable balloon in response to pulses generated by the therapeutic agent pulse generator that correspond with the generated therapeutically effective frequencies.

### Claim 2 (depends on 1)

The system of claim 1, further comprising an occlusion balloon in fluid communication with the balloon infusion lumen and located distally to the inflatable portion.

### Claim 3 (depends on 2)

The system of claim 2, further comprising an occlusion portion in fluid communication with the balloon infusion lumen and located proximally to the inflatable portion.

### Claim 4 (depends on 1)

The system of claim 1, further comprising:
an EKG monitor in operative communication with the patient and with the pulse generator and capable of measuring the blood pulse of the patient.

### Claim 5 (depends on 3)

The system of claim 3, further comprising:
an EKG monitor in operative communication with the patient and with the pulse generator.

### Claim 6 (depends on 1)

The system of claim 1, wherein the range of therapeutically effective frequencies generated match a blood pulse frequency of the patient.

### Claim 7 (depends on 5)

The system of claim 5, wherein the range of therapeutically effective frequencies generated match the blood pulse frequency measured by the EKG monitor.
