# US 11,998,727 B2 · Subcutaneous insertion systems; devices and related methods

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- Number: US 11,998,727 B2
- Document ID: US11998727B2
- Status: Granted
- Kind: B2
- Application number: 17/549,373
- Filed: 2021-12-13
- Published: 2022-03-31
- Granted: 2024-06-04
- Earliest claimed: 2016-04-29
- Assignees: Smiths Medical ASD, Inc.
- Applicants: Smiths Medical ASD, Inc.
- Inventors: Steven Albert Cote; Mark Henry Faust; David Andrae Justmann
- Web page: https://patentgrep.com/patent/US11998727B2

## CPC

- A61M 5/3287: {Accessories for bringing the needle into the body; Automatic needle insertion (A61M5/20, A61M5/31525 take precedence)}
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/6848: {Needles}
- A61B 5/6861: {Capsules, e.g. for swallowing or implanting}
- A61M 5/14248: {of the skin patch type}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 25/06: Body-piercing guide needles or the like
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/6865: {Access ports}
- A61B 17/3403: {Needle locating or guiding means}
- A61B 2562/162: Capsule shaped sensor housings, e.g. for swallowing or implantation
- A61M 5/46: having means for controlling depth of insertion
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- 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)

## Abstract

Embodiments relate to subcutaneous insertion systems comprising a surface device to be applied to a patient's skin and an insertion system for applying the surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The surface device comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, wire, filament or other device, extending from the skin's surface at an angle greater than 0 degrees and less than 90 degrees.

## Claims

### Claim 1

An insertion site, comprising:
a patient-side surface;
a central hub having a side aperture formed therein;
a subcutaneous element coupled to the site at an acute angle with respect to the patient-side surface; and
a septum having a longitudinal axis that is coaxial with a longitudinal septum axis of the central hub extending substantially orthogonally from the patient side surface,
wherein the side aperture of the central hub configured to enable an insertion needle to pass through the septum at an oblique angle relative to the longitudinal septum axis, to enter the subcutaneous element at the oblique angle.

### Claim 2 (depends on 1)

The insertion site of claim 1, wherein the acute angle is between about 20 degrees and about 50 degrees.

### Claim 3 (depends on 1)

The insertion site of claim 1, when the patient-side surface comprises an adhesive layer configured to removably couple the insertion site to tissue.

### Claim 4 (depends on 1)

The insertion site of claim 1, wherein a perimeter of the patient side surface is one of round, elliptical, oblong, rectangular, semi-rectangular, rounded rectangular, square, rounded square, or a combination thereof.

### Claim 5 (depends on 1)

The insertion site of claim 1, further comprising a finger tab configured to enable a user to easily grasp and remove the insertion site from the tissue.

### Claim 6 (depends on 1)

The insertion site of claim 1, wherein the septum and the subcutaneous element are in fluid communication with one another.

### Claim 7 (depends on 1)

The insertion site of claim 1, further comprising a site cap configured to secure the septum within the central hub.

### Claim 8 (depends on 1)

The insertion site of claim 1, wherein the subcutaneous element comprises a cannula.

### Claim 9 (depends on 1)

The insertion site of claim 1, wherein the central hub of the insertion site is configured to selectively couple to an infusion set.

### Claim 10 (depends on 1)

The insertion site of claim 1, wherein the subcutaneous element comprises an analyte sensor.

### Claim 11 (depends on 1)

The insertion site of claim 1, wherein the insertion site is configured to wirelessly communicate with an external device.

### Claim 12 (depends on 1)

The insertion site of claim 1, wherein the site comprises a patch pump.

### Claim 13

A method of deploying a subcutaneous element at an acute angle relative to a surface of a skin of a patient to improve a likelihood of landing the subcutaneous element in a subcutaneous layer of the patient, the method comprising:
providing a insertion site to be applied to a skin of a patient, the site comprising a patient-side surface, a central hub having a side aperture formed therein, a subcutaneous element coupled to the site at an acute angle with respect to the patient-side surface, and a septum having a longitudinal axis that is coaxial with a longitudinal septum axis of the central hub extending substantially orthogonally from the patient side surface,
passing an insertion needle through the septum at an oblique angle relative to the longitudinal septum axis, to enter the subcutaneous element at the oblique angle.

### Claim 14 (depends on 13)

The method of claim 13, when the patient-side surface comprises an adhesive layer configured to removably couple the insertion site to tissue.

### Claim 15 (depends on 13)

The method of claim 13, wherein a perimeter of the patient side surface is one of round, elliptical, oblong, rectangular, semi-rectangular, rounded rectangular, square, rounded square, or a combination thereof.

### Claim 16 (depends on 13)

The method of claim 13, wherein the subcutaneous element comprises a cannula.

### Claim 17 (depends on 13)

The method of claim 13, wherein the central hub of the insertion site is configured to selectively couple to an infusion set.

### Claim 18 (depends on 13)

The method of claim 13, wherein the subcutaneous element comprises an analyte sensor.

### Claim 19 (depends on 13)

The method of claim 13, wherein the insertion site is configured to wirelessly communicate with an external device.

### Claim 20 (depends on 13)

The method of claim 13, wherein the site comprises a patch pump.