# US 10,369,277 B2 · Invisible needle

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- Number: US 10,369,277 B2
- Document ID: US10369277B2
- Status: Granted
- Kind: B2
- Application number: 11/519,137
- Filed: 2006-09-11
- Published: 2007-04-26
- Granted: 2019-08-06
- Earliest claimed: 2005-09-12
- Assignees: Unomedical A/S
- Applicants: Lasse W. Mogensen; Orla Mathiasen
- Inventors: Lasse W. Mogensen; Orla Mathiasen
- Web page: https://patentgrep.com/patent/US10369277B2

## CPC

- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 25/0612: {Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders}
- A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user}
- A61M 39/02: Access sites
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a 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)}

## Abstract

The invention relates to an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance, such as e.g. insulin. The inserter comprises a needle hub comprising an insertion needle and two spring units assuring automatic insertion and automatic retraction of the insertion needle. The inserter comprises a housing (1), a carrier body (2) carrying an infusion part (8), a needle hub (3), a first moving unit (4) bringing the carrier body (2) to a forward position and a second moving unit (5) bringing the carrier body (2) to a retracted position. The inserter is characterized in that it has means for activation which should be activated at least once in order to bring the carrier body (2) from a retracted to a forward position, and back from the forward to the retracted position.

## Claims

### Claim 1

An inserter for an infusion set comprising
a housing;
a carrier body carrying an infusion part, the infusion part adjoined to a cannula and configured to be releasable from the carrier body;
an insertion needle, the insertion needle secured to a needle hub;
the carrier body moveable between a retracted position and a forward position;
wherein when the carrier body is in the forward position, the infusion part is configured to contact a patient's skin or an adhesive pad on the patient's skin; and
wherein when the carrier body is in the retracted position, the infusion part is configured to be away from the patient's skin;
a first moving unit biasing the carrier body to the forward position when the carrier body is in the retracted position; and
a second moving unit biasing the needle hub away from the carrier body when the carrier body is in the forward position;
wherein after insertion of the insertion needle and the cannula, the second moving unit is configured to retract the insertion needle from the patient's skin and at least a portion of the insertion needle is positioned inside the housing, and wherein the first moving unit and the second moving unit are placed at least partly parallel to each other and the second moving unit does not extend beyond first and second ends of the first moving unit in all positions of the needle hub.

### Claim 2 (depends on 1)

The inserter of claim 1, wherein the first and the second moving units both are connected to a distal surface of the carrier body.

### Claim 3 (depends on 1)

The inserter of claim 1, wherein the first moving unit and the second moving unit are placed inside the housing, and the housing comprises a proximal end with a proximal opening.

### Claim 4 (depends on 1)

The inserter of claim 1, wherein
the housing comprises an internal surface and a guiding means is provided on the internal surface for guiding a movement of the carrier body,
the carrier body is provided with locking members corresponding to the guiding means of the housing,
and in the retracted position of the carrier body, the carrier body and the needle hub are locked to each other.

### Claim 5 (depends on 4)

The inserter of claim 4, wherein the adhesive pad is placed at a proximal end of the housing.

### Claim 6 (depends on 5)

The inserter of claim 5, wherein the adhesive pad covers a proximal opening of the housing through which the infusion part is conveyed.

### Claim 7 (depends on 5)

The inserter of claim 5, wherein the first moving unit and the second moving unit each comprise a compression spring.

### Claim 8 (depends on 4)

The inserter of claim 4, wherein the carrier body is provided with at least one inclined surface, wherein the at least one inclined surface is in contact with a protruding member of the needle hub, which protruding member can rotate in relation to the needle hub, and the housing is provided with locking members preventing the protruding member of the needle hub from rotating when the carrier body is in the retracted position.

### Claim 9 (depends on 1)

The inserter of claim 1, wherein the carrier body stays in the forward position after insertion of the needle.

### Claim 10 (depends on 1)

The inserter of claim 1, wherein the adhesive pad comprises an adhesive proximal surface.

### Claim 11 (depends on 1)

The inserter of claim 1, wherein the adhesive pad comprises an adhesive distal surface.

### Claim 12 (depends on 1)

The inserter of claim 1, wherein the insertion needle extends at least partially through the infusion part before insertion of the infusion part.

### Claim 13 (depends on 1)

The inserter of claim 1, wherein the carrier body stays in the forward position after the infusion part is configured to contact the patient's skin and the insertion needle is configured to be retracted from the patient's skin.

### Claim 14 (depends on 1)

The inserter of claim 1, wherein the needle hub extends distal to the carrier body within the housing.

### Claim 15 (depends on 1)

The inserter of claim 1, wherein the needle hub comprises at least one protruding member releasably lockable with the carrier body.

### Claim 16 (depends on 15)

The inserter of claim 15, wherein the at least one protruding member releasably locks with at least one locking member of the carrier body.

### Claim 17 (depends on 16)

The inserter of claim 16, wherein the at least one protruding member and the at least one locking member are positioned between parallel walls of the housing.

### Claim 18 (depends on 1)

The inserter of claim 1, wherein the first moving unit and the second moving unit each comprise a compression spring.

### Claim 19 (depends on 1)

The inserter of claim 1, wherein the first moving unit is located between the carrier body and the housing, and the second moving unit is located between the carrier body and the needle hub.

### Claim 20

An inserter for an infusion set comprising
a housing,
a carrier body comprising at least one inclined surface, the carrier body carrying an infusion part, the infusion part adjoined to a cannula and configured to be releasable from the carrier body,
an insertion needle, the insertion needle secured to a needle hub; the needle hub comprising at least one protruding member;
wherein the carrier body has a forward position and a retracted position,
wherein in the carrier body's retracted position, the infusion part is configured to be away from a patient's skin and the needle hub's at least one protruding member is configured to maintain contact with the carrier body's at least one inclined surface,
wherein in the carrier body's forward position, the infusion part is configured to contact the patient's skin an adhesive on the patient's skin and the needle hub's at least one protruding member is configured to release contact with the carrier body's at least one inclined surface;
a first moving unit biasing the carrier body to the forward position when the carrier body is in the retracted position; and
a second moving unit positioned between the carrier body and at least part of the needle hub, the second moving unit biasing the needle hub away from the carrier body when the carrier body is in the forward position, wherein after insertion of the insertion needle and the cannula, the insertion needle is configured to retract from the patient's skin and at least a portion of the insertion needle is positioned inside the housing, and wherein the first moving unit and the second moving unit are at least partly parallel to each other and the second moving unit does not extend beyond first and second ends of the first moving unit in all positions of the needle hub.

### Claim 21 (depends on 20)

The inserter set of claim 20, wherein the housing comprises an inner member for maintaining contact between the needle hub's at least one protruding member and the carrier body's at least one inclined surface when the carrier body is in the retracted position.

### Claim 22 (depends on 20)

The inserter of claim 20, wherein the first moving unit is located between the carrier body and the housing, and the second moving unit is located between the carrier body and the needle hub.

### Claim 23

An inserter for an infusion set comprising
a housing comprising an internal surface;
a carrier body connected to an infusion part, the infusion part adjoined to a cannula and configured to be releasable from the carrier body;
an insertion needle secured to a needle hub;
wherein the carrier body has a forward position and a retracted position;
wherein the infusion part is configured to contact a patient's skin or an adhesive on the patient's skin in the forward position, and is configured to be away from the patient's skin in the retracted position;
a first moving unit between the carrier body and the housing, the first moving unit biasing the carrier body to the forward position when the carrier body is in the retracted position; and
a second moving unit between the carrier body and at least part of the needle hub when the carrier body is in the retracted position, the second moving unit configured to bias the needle hub and the insertion needle away from the patient's skin after insertion of the insertion needle and the cannula,
wherein the housing's internal surface is located at least partly within the first moving unit and configured to maintain the carrier body in the retracted position,
wherein after insertion of the insertion needle and the cannula, the second moving unit is configured to retract the insertion needle from the patient's skin and at least a portion of the insertion needle is positioned inside the housing, and wherein the first moving unit and the second moving unit are placed at least partly parallel to each other and the second moving unit does not extend beyond first and second ends of the first moving unit in all positions of the needle hub.

### Claim 24

An inserter for an infusion set comprising:
a housing comprising an internal member,
a needle hub comprising at least one rotating member,
a carrier body comprising at least one protruding member, the carrier body carrying an infusion part, the infusion part releasably connected to the needle hub, the needle hub releasably connected to the carrier body,
two biased spring units;
means for activating the two biased spring units,
wherein when activated, a first of the two biased spring units is capable of moving the carrier body, needle hub and infusion part from a retracted position to a forward position until a proximal surface of the infusion part contacts a patient's skin or an adhesive on the patient's skin, and a second of the two biased spring units is capable of moving the needle hub from a forward position to a retracted position away from the carrier body,
wherein when the carrier body is in the retracted position, the housing's internal member is configured to maintain the needle hub's at least one rotating member in contact with the carrier body's at least one protruding member, and
wherein when the carrier body is in the forward position, the housing's internal member is configured to release the needle hub's at least one rotating member from contact with the carrier body's at least one protruding member such that the needle hub's at least one rotating member rotates about the needle hub.

### Claim 25 (depends on 24)

The inserter of claim 24, wherein the at least one rotating member rotates inward about the needle hub.
