# US 10,245,420 B2 · Medicament distribution systems and related methods of use

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- Number: US 10,245,420 B2
- Document ID: US10245420B2
- Status: Granted
- Kind: B2
- Application number: 13/649,202
- Filed: 2012-10-11
- Published: 2013-12-26
- Granted: 2019-04-02
- Earliest claimed: 2012-06-26
- Assignees: Picolife Technologies, LLC
- Applicants: PicoLife Technologies
- Inventors: Farid Amirouche
- Web page: https://patentgrep.com/patent/US10245420B2

## CPC

- A61K 9/7084: {Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches}
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/4839: {combined with drug delivery}
- A61F 13/00063: {comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic (drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00)}
- A61M 35/10: {Wearable devices, e.g. garments, glasses or masks}
- A61B 5/6828: {Leg}
- A61B 2560/0431: Portable apparatus, e.g. comprising a handle or case
- A61F 2013/00153: {coloured or with decoration pattern or printing}
- A61F 2013/0017: {possibility of applying fluid}
- A61F 2013/00272: {protection of the body or articulation}
- A61F 2013/00387: {skin protection}
- A61F 2013/00429: {for conducting tests}
- A61F 2013/00646: {Medication patches, e.g. transcutaneous}
- A61F 2013/00906: {for transcutaneous or transdermal drugs application}
- A61F 2013/0094: {for sensing physical parameters}
- A61F 2013/8494: {including pumping devices}
- A61H 2201/105: with means for delivering media, e.g. drugs or cosmetics
- A61K 9/703: {characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches}
- A61K 9/7092: {Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs}
- A61M 5/14248: {of the skin patch type}
- 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)}
- A61M 35/006: {using sponges, foams, absorbent pads or swabs as spreading means}
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- 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)
- 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)
- 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)

## Abstract

Embodiments of the disclosure may include a medical device for releasing a medicament. The device may include a multi-layer patch. The patch may include a base layer configured to secure the patch to a body of a user and a medicament array located adjacent the base layer. The array may include a plurality of wells configured to release a quantity of medicament from the array to the body of the user. The device may also include a cover layer located on a side of the medicament array opposite the base layer and a pump operably coupled to the patch and configured to deliver a quantity of fluid to the patch.

## Claims

### Claim 1

A medical device for releasing a medicament, comprising:
a multi-layer patch, including:
a base layer configured to secure the patch to a body of a user;
a medicament array located adjacent the base layer, wherein the medicament array includes a plurality of wells each configured to contain and release a quantity of medicament from the medicament array to the body of the user; a bottom surface of each of the plurality of wells being configured to allow the quantity of medicament contained in each well to pass from the well to the body of the user in response to an increase in pressure against the well, and wherein the medicament array is configured to be elevated off of the body of the user when the patch is secured to the body of the user;
a cover layer located on a side of the medicament array opposite the base layer;
a pump operably coupled to the patch and configured to deliver a quantity of fluid to the patch;
a controller operably coupled to the pump; and
one or more sensors configured to measure one or more body parameters, wherein at least one body parameter is at least partially indicative of an effectiveness of the quantity of medicament, wherein the sensors are configured to relay information about the one or more body parameters to the controller, wherein at least one sensor is located on or proximate to the multi-layer patch, wherein at least one sensor comprises one or more electrodes and at least one body parameter comprises nerve conduction velocity, and wherein one or both the controller and pump comprise programming configured to receive input feedback from the one or more sensors, wherein the input feedback is used to adjust one or more dosage and delivery rate.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the multi-layer patch further includes a membrane located between the cover layer and the medicament array, and wherein the cover layer and the membrane define a cavity configured to hold the quantity of fluid, and wherein the membrane is configured to deform into the plurality of wells in response to an increased volume of fluid in the cavity.

### Claim 3 (depends on 1)

The medical device of claim 1, wherein the cover layer further includes at least one port connecting an inner region of the cover layer with an outer region of the cover layer, wherein the port is configured to receive a catheter to operably connect the multi-layer patch to the pump.

### Claim 4 (depends on 3)

The medical device of claim 3, wherein the cover layer includes two ports and the medical device is configured to release more than one type of medicament.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein the pump is located adjacent to the multi-layer patch.

### Claim 6 (depends on 1)

The medical device of claim 1, wherein the fluid released from the pump to the multi-layer patch includes one or more medicaments.

### Claim 7 (depends on 6)

The medical device of claim 6, wherein the pump includes a cartridge configured to store the one or more medicaments.

### Claim 8 (depends on 1)

The medical device of claim 1, further including a removable seal adjacent the base layer, wherein removal of the seal exposes an adhesive for securing the multi-layer patch to the body of the user.

### Claim 9 (depends on 6)

The medical device of claim 6, wherein the input feedback is further used to adjust the type of medicament delivered.

### Claim 10

A medical device for releasing a medicament, comprising:
a patch including a medicament array having a plurality of wells each configured to contain and release a quantity of medicament from a storage region of the wells to a body of a user, wherein the medicament array is configured to be elevated off of the body of the user when the patch is secured to the body of the user;
a pump operably coupled to the patch and configured to deliver a quantity of fluid from the pump to a region above the storage region of the wells, and wherein a bottom surface of each of the plurality of wells is configured to allow the quantity of medicament contained in each well to pass from the well to the body of the user in response to an increase in pressure against the well caused by an increase in the quantity of fluid delivered from the pump;
a controller operably coupled to the pump; and
one or more sensors configured to measure one or more body parameters, wherein at least one body parameter is at least partially indicative of an effectiveness of the quantity of medicament, wherein the sensors are configured to relay information about the one or more body parameters to the controller, and wherein at least one sensor is located on or proximate to the patch, wherein at least one sensor comprises one or more electrodes and at least one body parameter comprises nerve conduction velocity, and wherein the one or more sensors comprises at least two electrodes, and the one or more body parameters includes an electrical activity of one or more nerves or muscles wherein the controller is configured to adjust the quantity, timing, or type of fluid delivered from the pump to the patch based on the information received from the one or more sensors.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein the patch further includes a membrane adjacent the medicament array, wherein the membrane is configured to deform into the plurality of wells in response to the increase in the quantity of fluid delivered from the pump.

### Claim 12 (depends on 10)

The medical device of claim 10, wherein the one or more sensors are configured to continuously monitor the one or more body parameters.

### Claim 13

A medical device for releasing a medicament, comprising:
a patch including a medicament array having a plurality of wells each configured to contain and release a quantity of medicament from the medicament array to a body of a user; each of the wells having an opening located in a bottom surface that is configured to release the quantity of medicament contained in each well from the well to the body of the user in response to an increase in pressure against the well, and wherein the medicament array is configured to be elevated off of the body of the user when the patch is secured to the body of the user;
a membrane located adjacent the plurality of wells and configured to deform into the plurality of wells;
a mechanism configured to secure the patch to the body of the user;
a pump configured to deliver a quantity of fluid to the patch, wherein the delivery of fluid increases an amount of pressure on the membrane, causing the membrane to deform into the plurality of wells and causing the wells to release the quantity of medicament through the openings and to the body of the user;
wherein the medical device includes a controller configured to control the delivery of fluid from the pump to the patch; and
one or more sensors configured to measure one or more body parameters, wherein at least one body parameter is at least partially indicative of an effectiveness of the quantity of medicament, wherein the sensors are configured to relay information about the one or more body parameters to the controller, and wherein at least one sensor is located on or proximate to the patch, wherein at least one sensor comprises one or more electrodes and at least one body parameter comprises nerve conduction velocity, and wherein the one or more sensors comprises at least two electrodes, and the one or more body parameters includes an electrical activity of one or more nerves or muscles, wherein the controller is configured to adjust the quantity, timing, or type of fluid delivered from the pump to the patch based on the information received from the one or more sensors.

### Claim 14 (depends on 13)

The medical device of claim 13, wherein the controller is a programmable logic controller.

### Claim 15 (depends on 13)

The medical device of claim 13, wherein the controller is wirelessly coupled to an input device and configured to receive input from a remote user.

### Claim 16 (depends on 13)

The medical device of claim 13, wherein the medicament array is configured to contain and release a plurality of medicaments.

### Claim 17 (depends on 16)

The medical device of claim 16, wherein the medicament array is configured to release a first medicament of the plurality of medicaments at a first rate and to release a second medicament of the plurality of medicaments at a second rate, wherein the second rate is different from the first rate.
