# US 12,214,156 B2 · Systems, methods, apparatuses and devices for drug or substance delivery

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- Number: US 12,214,156 B2
- Document ID: US12214156B2
- Status: Granted
- Kind: B2
- Application number: 16/643,218
- Filed: 2018-08-28
- Published: 2020-11-05
- Granted: 2025-02-04
- Earliest claimed: 2017-08-28
- Assignees: Triple Jump Israel Ltd.
- Applicants: Triple Jump Israel Ltd.
- Inventors: Yishai Ben-David; Kfir Solomon; Ofer Yodfat; Guy Shinar
- Web page: https://patentgrep.com/patent/US12214156B2

## CPC

- A61M 5/14248: {of the skin patch type}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/1456: {with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/1585: {Needle inserters}
- A61M 2202/0486: Glucose
- A61M 2205/18: with alarm
- A61M 2205/273: preventing reuse, e.g. of disposables
- A61M 2205/3546: Range
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2209/06: Packaging for specific medical equipment
- 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

Embodiments of the present disclosure are directed to miniature insulin patch pump, assistance devices (e.g., for reservoir filling and/or cannula insertion), and methods related thereto. For example, in some embodiments, a substance/drug-delivery patch pump is provided and includes a reusable part (RP) including a power source, a driving mechanism, and an electronic module, and a disposable part (DP), where the disposable part can include at least a plurality of an adhesive base, a reservoir, a dosing mechanism, and a cannula.

## Claims

### Claim 1

A patch pump assisting system comprising:
an assisting device including a soft cannula insertion mechanism configured to at least insert a soft cannula in tissue, the device including:
a housing;
a first exit port septum configured within a cup opening;
an exit port well; and
a second exit port septum;
and
a soft cannula having a lumen, and a rigid cannula having a lumen,
wherein:
the soft cannula and rigid cannula each include at least one lateral opening along a length thereof;
the housing is configured for placement on skin of a user for cannula insertion;
prior to insertion, the rigid cannula is positioned within the soft cannula with both cannulas initially traversing a cup septum, and distal ends of the soft cannula and rigid cannula are positioned within the exit port well;
immediately after insertion, the distal ends of the rigid cannula and soft cannula are positioned within and/or below the skin of the user, and corresponding lateral openings thereof are positioned within the exit port well,
and
the rigid cannula is configured for removal from the soft cannula by retraction of the assistance device from the skin of the user.

### Claim 2 (depends on 1)

The system of claims 1, wherein the lateral opening of the soft cannula is aligned with the at least one lateral opening of the rigid cannula.

### Claim 3 (depends on 1)

The system of claim 1, wherein the cup opening is integral with the housing.

### Claim 4 (depends on 1)

The system of claim 1, wherein a sharp end of the rigid cannula protrudes beyond an end of the soft cannula.

### Claim 5 (depends on 1)

The system of claim 1, wherein the device further comprises:
a trigger, an inserter spring, an inserter hammer, a cup, and a cup septum, wherein the cup is configured to fit within the cup opening.

### Claim 6 (depends on 5)

The system of claim 5, wherein a first end of the soft cannula includes a stopper configured to prevent the soft cannula from moving out of an end of the cup.

### Claim 7 (depends on 1)

The system of claim 1, wherein the assisting device includes a cannula bending spring.

### Claim 8 (depends on 7)

The system of claim 7, wherein energy stored in the cannula bending spring is released upon separation of the assisting device from a drug delivery system.

### Claim 9 (depends on 7)

The system of claim 7, wherein the at least one lateral opening of the soft cannula 1 s aligned with the lateral opening of the rigid cannula.

### Claim 10 (depends on 7)

The system of claim 7, wherein a sharp end of the rigid cannula protrudes beyond an end of the soft cannula.

### Claim 11 (depends on 7)

The system of claim 7, wherein the energy released by the cannula bending spring moves the rigid cannula from a first position to a second position.

### Claim 12 (depends on 11)

The system of claim 11, wherein in the first position is approximately orthogonal relative to a side or portion of the housing, and the second position is approximately parallel to the side or portion of the housing.

### Claim 13 (depends on 1)

The system of claim 1, wherein the device further comprises at least one of the following: a trigger, an inserter spring, an inserter hammer, a cup, and a cup septum, wherein the cup is configured to fit within the cup opening.

### Claim 14 (depends on 13)

The system of claim 13, wherein a first end of the rigid cannula is rigidly connected to the inserter hammer.

### Claim 15 (depends on 13)

The system of claim 13, wherein the cup septum is configured to seal the interior of the cup.

### Claim 16 (depends on 13)

The system of claim 13, wherein the cup septum is configured to seal the interior of the cup.

### Claim 17 (depends on 13)

The system of claim 13, wherein a first end of the soft cannula includes a stopper configured to prevent the soft cannula from moving out of an end of the cup.

### Claim 18 (depends on 17)

The system of claim 17, wherein the stopper is integral with the soft cannula.

### Claim 19 (depends on 1)

A drug delivery patch-pump system comprising: a drug-delivery patch pump including a reservoir; a doser device; and the assisting device according to claim 1, wherein: upon filing the reservoir, the pump is configured for priming via the doser, such that, fluid is pumped through an exit port conduit into a filling port well, through the lumen of the rigid cannula, and out the at least one lateral opening of each cannula.

### Claim 20

A method for inserting a soft cannula for a drug delivery system into tissue of a user, comprising:
triggering a trigger of a cannula insertion mechanism such that one or more safety catches release energy stored in an inserter spring of an inserter mechanism such that:
an inserter hammer of the inserter mechanism is driven in a first direction,
a cup, a cup opening, a cup septum, a rigid cannula and a soft cannula of the inserter mechanism move towards a patient's skin; and
a tip of a rigid cannula punctures the skin establishing a path for a soft cannula;
upon an end of the cup residing on an end of cup septum, the cup placed in the cup opening, and lateral openings of the rigid and the soft cannulas being in fluid communication with an exit port well, and corresponding ends of the rigid cannula and the soft cannula are under the patient's skin, the assisting device is removed while removing the rigid cannula from the lumen of the soft cannula.

### Claim 21

A patch pump assisting system comprising:
an assisting device including a soft cannula insertion mechanism configured to at least insert a soft cannula in tissue, the device including:
a housing;
a first exit port septum;
an exit port well; and
a second exit port septum;
and
a soft cannula having a lumen, and a rigid cannula having a lumen,
wherein:
the soft cannula and rigid cannula each include at least one lateral opening along a length thereof;
the housing is configured for placement on skin of a user for cannula insertion;
prior to insertion, the rigid cannula is positioned within the soft cannula with distal ends of the soft cannula and rigid cannula positioned within the exit port well;
immediately after insertion, the distal ends of the rigid cannula and soft cannula are positioned within and/or below the skin of the user, and corresponding lateral openings thereof are positioned within the exit port well,
and
the rigid cannula is configured for removal from the soft cannula by retraction of the assistance device from the skin of the user.