# US 2014/0155679 A1 · Method And Device For Drug Delivery

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- Number: US 2014/0155679 A1
- Document ID: US20140155679A1
- Status: Published application
- Kind: A1
- Application number: 14/066,140
- Filed: 2013-10-29
- Published: 2014-06-05
- Earliest claimed: 2007-03-19
- Assignees: Insuline Medical Ltd.
- Applicants: Insuline Medical Ltd.
- Inventors: Benny Pesach; Gabriel Bitton; Ron Nagar; Ram Weiss
- Web page: https://patentgrep.com/patent/US20140155679A1

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61H 9/0057: {Suction (suction kneading A61H7/008)}
- A61H 23/00: Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms {(apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B)}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)}
- A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis}
- A61N 1/406: {using implantable thermoseeds or injected particles for localized hyperthermia (preparations of seeds and particles A61K41/0052)}
- A61N 2/002: {in combination with another treatment}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61F 7/007: {characterised by electric heating}
- A61F 7/10: Cooling bags, e.g. ice-bags
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/05: combined with other kinds of therapy
- A61M 2205/051: with radiation therapy
- A61M 2205/052: infrared
- A61M 2205/058: with ultrasound therapy
- A61N 1/30: Apparatus for iontophoresis, {i.e. transfer of media in ionic state by an electromotoric force into the body}, or cataphoresis
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61N 2005/0645: {Applicators worn by the patient}
- 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)}
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Systems, devices and methods for delivery of a chemical substance to the body of the patient are provided. Such embodiments may include an infusion catheter configured to be inserted into tissue, a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin, a drug delivery pump configured to infuse a drug into the infusion catheter for delivery to a drug infused region on the body of the patient, and a treatment element configured to apply a treatment to the drug infused region to improve pharmacodynamics of the drug during a period of delivery of the drug to the patient.

## Claims

### Claim at position 1

1-346. (canceled)

### Claim 347

A system for delivering a therapeutic substance into the body of a patient, comprising:
a drug delivery device including
a drug delivery pump coupled to a drug reservoir containing the therapeutic substance; and
a detection unit coupled to the drug delivery pump, the detection unit including a sensor for detecting delivery of the therapeutic substance;
an infusion set including
an infusion catheter for insertion into the body of the patient;
a tube connecting the infusion catheter with the drug delivery device and configured to allow delivery of the therapeutic substance from the drug delivery device to the infusion catheter;
a treatment element for applying treatment to a region on the body of the patient in which the therapeutic substance is infused; and
a control unit for initiating a predetermined treatment profile using the treatment element when the drug delivery device starts drug infusion;
at least one power source for powering at least one of the drug delivery device and the infusion set;
wherein the detection unit is configured to transmit a wireless communication signal to the control unit upon detection of the delivery of the therapeutic substance, the wireless communication signal is indicative of at least a rate at which the therapeutic substance is being delivered to the body of the patient;
wherein the control unit is configured to initiate the predetermined treatment profile based on at least the rate at which the therapeutic substance is being delivered to the body of the patient.

### Claim 348 (depends on 347)

The system according to claim 347, wherein the therapeutic substance is selected from a group consisting of: insulin, insulin analogues and insulin mimetics.

### Claim 349 (depends on 347)

The system according to claim 347, wherein the treatment is applied short time before, during and/or after an infusion of the therapeutic substance.

### Claim 350 (depends on 347)

The system according to claim 347, wherein the treatment is configured to modify pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance;
wherein the pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance is modified to perform at least one of the following actions: enable a faster onset of action of the substance infused into the infused region; enable a faster peak of action of the substance infused into the infused region; enable a faster clearance of the therapeutic substance from the infused region to the circulatory system of the patient; improve the repeatability of the pharmacokinetic and/or pharmacodynamics profile in response to the infusion of the therapeutic substance; to reduce a variability of absorption of the therapeutic substance into the blood system and/or lymphatic system of the patient; to reduce a variability of onset of action of the therapeutic substance; to reduce a variability of time to peak of action of the therapeutic substance; and to reduce a variability of the clearance of the therapeutic substance from the infused region to the circulatory system of the patient.

### Claim 351 (depends on 347)

The system according to claim 347, wherein the rate at which the therapeutic substance is being delivered is selected from a group consisting of: a bolus rate and a basal rate.

### Claim 352 (depends on 347)

The system according to claim 347, wherein the treatment is selected from a group consisting of: a heating device configured to heat the infused region; an optical radiation device configured to irradiate the infused region with optical radiation; a microwave generator or emitter configured to irradiate the infused region with microwave radiation; a radio frequency electromagnetic radiation generator or emitter configured to irradiate the infused region with radio frequency electromagnetic radiation; a vibration device configured to vibrate and/or massage the infused region; a vacuum device configured to apply suction to the infused region; an electric field generator and/or emitter configured to apply an electric field to the infused region; a magnetic field generator or emitter configured to apply magnetic field to the infused region; and an acoustic signal generator and/or emitter configured to apply acoustic stimulation to the infused region.

### Claim 353 (depends on 347)

The system according to claim 347, wherein the treatment device is configured to apply one or more additional substances to the infused region wherein the one or more additional substances is configured to perform at least one of the following actions: modify the pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance; modify absorption of the therapeutic substance into the blood system and/or lymphatic system of the patient; and promote clearance of the therapeutic substance from the infusion region.

### Claim 354 (depends on 347)

The system according to claim 347, wherein the treatment element is a heater element configured to apply heat to the infused region.

### Claim 355 (depends on 354)

The system according to claim 354, further comprising a thermostat for automatically regulating a heating temperature at which heat is applied by the heater element to the infused region, the heating temperature is being detected by a temperature sensor disposed in the thermostat;
wherein the thermostat is configured to increase and/or decrease power supplied to the heater element based on the temperature detected by the temperature sensor.

### Claim 356 (depends on 354)

The system according to claim 354, wherein the infused region is heated to a temperature that does not damage the therapeutic substance.

### Claim 357 (depends on 354)

The system according to claim 354, wherein the heater does not heat the drug reservoir.

### Claim 358 (depends on 354)

The system according to claim 354, wherein the heater element is configured to heat the infused region without heating the therapeutic substance above a limiting temperature prior to infusion of the therapeutic substance into the infused region, or prior to the therapeutic substance being infused into an end of the infusion catheter.

### Claim 359 (depends on 358)

The system according to claim 358, wherein the limiting temperature is about 37 degrees C.

### Claim 360 (depends on 354)

The system according to claim 354, where the control unit is configured to regulate heating of the infused region to stabilize a temperature of the infused region at a predetermined temperature.

### Claim 361 (depends on 360)

The system according to claim 360, wherein the predetermined temperature is between about 37 degrees C. and about 42 degrees C.

### Claim 362 (depends on 360)

The system according to claim 360, wherein, wherein the predetermined temperature is between about 37 degrees C. and about 39 degrees C.

### Claim 363 (depends on 360)

The system according to claim 360, wherein, wherein the predetermined temperature is between about 32 degrees C. and about 37 degrees C.

### Claim 364 (depends on 354)

The system according to claim 354, wherein the heater element is configured to apply heat subsequent to an infusion of a bolus dose of the therapeutic substance for a period of between about 10 minutes and about 30 minutes.

### Claim 365 (depends on 354)

The system according to claim 354, wherein the heater element is configured to apply heat subsequent to an infusion of a bolus dose of the therapeutic substance for a period of between about 1 minutes and about 10 minutes.

### Claim 366 (depends on 347)

The system according to claim 347, further comprising a glucose level sensor for detecting glucose level in the body of the patient;
wherein the control unit is configured to receive the detected glucose level reading from the glucose level sensor and further configured to control by way of an algorithm an infusion rate of the therapeutic substance into the infused region and the treatment element to regulate the glucose level in the body of the patient.