# US 10,765,803 B2 · Moving basal engine for a fluid delivery device

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- Number: US 10,765,803 B2
- Document ID: US10765803B2
- Status: Granted
- Kind: B2
- Application number: 15/728,706
- Filed: 2017-10-10
- Published: 2018-02-15
- Granted: 2020-09-08
- Earliest claimed: 2014-01-31
- Assignees: Zealand Pharma A/S
- Applicants: Valeritas, Inc.
- Inventors: Robert R. Gonnelli
- Web page: https://patentgrep.com/patent/US10765803B2

## CPC

- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/14248: {of the skin patch type}
- A61M 5/14526: {the piston being actuated by fluid pressure}
- A61M 5/31526: {by means of stepwise axial movements, e.g. ratchet mechanisms or detents}
- A61M 5/31533: {Dosing mechanisms, i.e. setting a dose (administrating mechanisms A61M5/31565)}
- A61M 5/31578: {the piston rod being moved by the axial movement of a component directly in contact with it}
- A61M 5/3159: {Dose expelling manners}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/1454: {spring-actuated, e.g. by a clockwork}
- A61M 2005/1405: {Patient controlled analgesia [PCA]}
- A61M 2005/14204: {with gas-producing electrochemical cell}
- A61M 2005/14506: {mechanically driven, e.g. spring or clockwork}
- A61M 2005/14513: {with secondary fluid driving or regulating the infusion}
- 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)}

## Abstract

A fluid delivery device comprises a fluid reservoir for containing medicament. The fluid reservoir is sealed proximate one end with a sliding seal piston. A delivery path is configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device. A basal engine mechanism is configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate. A bolus mechanism configured to move the basal engine relative to the fluid reservoir and directly or indirectly move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time.

## Claims

### Claim 1

A fluid delivery device comprising:
a housing including a fluid reservoir for containing medicament, the fluid reservoir being sealed proximate one end with a sliding seal piston;
a delivery path configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device;
a basal actuator coupled to a proximal side of the sliding seal piston, the basal actuator including an electrochemical device configured to volumetrically expand the basal actuator in at least one dimension while being charged or discharged and configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate;
a bolus actuator coupled to a proximal end of the basal actuator and configured to move the basal actuator relative to the fluid reservoir and move the sliding seal piston in the fluid reservoir a limited discrete bolus amount at a time; and
a limiting mechanism engaged with the bolus actuator,
wherein the movement of the basal actuator relative to the fluid reservoir is limited to a distal direction.

### Claim 2 (depends on 1)

The fluid delivery device of claim 1, wherein the electrochemical device is connected to a circuit configured to control a charge or discharge rate of the electrochemical device.

### Claim 3 (depends on 1)

The fluid delivery device of claim 1, wherein the electrochemical device is connected to a circuit configured to allow for user interface and device function,
wherein the circuit is powered by the discharge of the electrochemical device.

### Claim 4 (depends on 1)

The fluid delivery device of claim 1, wherein there is a hydraulic fluid between the basal actuator and the sliding seal piston.

### Claim 5 (depends on 4)

The fluid delivery device of claim 4, wherein the basal actuator includes a sliding seal, the sliding seal being in contact with the hydraulic fluid that is in contact with the sliding seal piston.

### Claim 6 (depends on 1)

The fluid delivery device of claim 1, wherein the sliding seal piston is in direct contact with the basal actuator and the medicament.

### Claim 7 (depends on 1)

The fluid delivery device of claim 1, wherein the housing includes an adhesive patch configured to be adhered to a skin surface of the patient.

### Claim 8 (depends on 1)

The fluid delivery device of claim 1, wherein the delivery path includes a needle.

### Claim 9 (depends on 1)

The fluid delivery device of claim 1, wherein the bolus actuator includes a plunger.

### Claim 10 (depends on 9)

The fluid delivery device of claim 9, wherein the plunger is coupled to the limiting mechanism.

### Claim 11 (depends on 1)

The fluid delivery device of claim 1, wherein the controlled basal rate is a continuous basal rate.

### Claim 12 (depends on 1)

The fluid delivery device of claim 1, wherein the basal actuator is directly coupled to the proximal side of the sliding seal piston.

### Claim 13 (depends on 1)

The fluid delivery device of claim 1, wherein the limiting mechanism is a rack and pawl.

### Claim 14 (depends on 13)

The fluid delivery device of claim 13, wherein the engagement of the rack and pawl with the bolus actuator is what limits movement of the basal actuator to the distal direction.

### Claim 15 (depends on 1)

The fluid delivery device of claim 1, wherein the limiting mechanism includes a release element, the limiting t mechanism configured to limit the distance the basal actuator can travel each time the release element is actuated.

### Claim 16 (depends on 1)

The fluid delivery device of claim 1, wherein there is only one sliding seal piston.

### Claim 17 (depends on 1)

The fluid delivery device of claim 1, wherein the delivery path includes at least one bend.

### Claim 18 (depends on 17)

The fluid delivery device of claim 17, wherein the at least one bend is 90°.

### Claim 19

A fluid delivery device comprising:
a housing including a fluid reservoir configured to contain medicament;
a delivery path configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device;
a basal actuator sealing one end of the fluid reservoir and sealingly and slidingly coupled to an inside surface of the fluid reservoir, the basal actuator including an electrochemical device configured to volumetrically expand the basal actuator in at least one dimension while being charged or discharged to reduce a volume of the fluid reservoir at a controlled basal rate;
a bolus actuator coupled to a proximal end of the basal actuator and configured to move the basal actuator relative to the fluid reservoir and move the basal actuator in the fluid reservoir a limited discrete bolus amount at a time; and
a limiting mechanism engaged with the bolus actuator,
wherein the movement of the basal actuator relative to the fluid reservoir is limited to a distal direction.