# US 11,896,804 B2 · Insertion device for a biosensor and insertion method thereof

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- Number: US 11,896,804 B2
- Document ID: US11896804B2
- Status: Granted
- Kind: B2
- Application number: 16/945,602
- Filed: 2020-07-31
- Published: 2021-02-04
- Granted: 2024-02-13
- Earliest claimed: 2019-08-02
- Assignees: Bionime Corporation
- Applicants: Bionime Corporation
- Inventors: Chun-Mu Huang; Chieh-Hsing Chen; Chen-Hao Lee; Kuan-Lin Chang
- Web page: https://patentgrep.com/patent/US11896804B2

## CPC

- A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/150305: {Packages specially adapted for piercing devices or blood sampling devices}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/6833: {Adhesive patches}
- A61B 5/6848: {Needles}
- A61B 5/6849: {in combination with a needle set}
- A61M 5/3221: {Constructional features thereof, e.g. to improve manipulation or functioning}
- A61M 5/3234: {Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user}
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61M 5/206: {with automatic needle insertion}
- A61M 2205/3327: Measuring
- 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

An insertion device includes an upper casing, an insertion module and a lower casing. The insertion module is disposed in the upper casing, and includes a main body assembly, an insertion seat, a first elastic member, a retraction seat and a second elastic member. When the upper casing is depressed, the insertion seat is driven by the first elastic member to perform an automatic-insertion operation, such that limiting structure between the insertion seat and the retraction seat collapses upon the collapse of another limiting structure between the insertion seat and the main body assembly, and that the retraction seat is driven by the second elastic member to perform an automatic-retraction operation.

## Claims

### Claim 1

An insertion device comprising:
an upper casing including an outer shell, and a cover body that is disposed in said outer shell, said cover body having an accommodating space;
an insertion module disposed in said accommodating space, forming movement relationship with said outer shell and said cover body of said upper casing, and including a main body assembly, an insertion seat, a first elastic member, a retraction seat, a second elastic member, a base and a sensor assembly, said main body assembly including an upper portion, and a lower portion that cooperates with said upper portion to define a displacement space therebetween, said insertion seat being removably positioned in said upper portion, and being able to move in said displacement space between said lower portion and said upper portion, said first elastic member having two opposite ends that respectively abut against said insertion seat and said upper portion of said main body assembly, said retraction seat being removably positioned relative to said insertion seat, said second elastic member having two opposite ends that respectively abut against said insertion seat and said retraction seat, said base being separably positioned relative to said main body assembly, said sensor assembly being separably mounted to said base; and
a lower casing separably connected to said upper casing;
wherein the insertion device is configured such that, when said upper casing is depressed to move relative to said main body assembly, the insertion seat is driven by a restoring force of said first elastic member to perform an automatic-insertion operation and to collapse a first limiting structure between said insertion seat and said lower portion of said main body assembly,
wherein the insertion device is configured such that, after the automatic-insertion operation is completed, said upper casing is positioned relative to said main body assembly without rebounding, and a second limiting structure between said insertion seat and said retraction seat collapses upon the collapse of said first limiting structure between said insertion seat and said lower portion of said main body assembly, so that said retraction seat is driven by a restoring force of said second elastic member to move upwardly to perform an automatic-retraction operation, and
wherein said upper casing has at least one casing engaging structure, said main body assembly having at least one body engaging structure, said at least one casing engaging structure engaging said at least one body engaging structure when said first limiting structure collapses, so that said upper casing is prevented from rebounding relative to said main body assembly.

### Claim 2 (depends on 1)

The insertion device as claimed in claim 1, wherein said main body assembly includes a main body that corresponds to said lower portion, and a main cover that corresponds to said upper portion and that cooperates with said main body to define said displacement space therebetween.

### Claim 3 (depends on 2)

The insertion device as claimed in claim 2, wherein said insertion seat has at least one limiting groove, said main cover having at least one limiting member that removably engages with said at least one limiting groove of said insertion seat, said insertion seat further having at least one positioning portion that positions said retraction seat relative to said insertion seat, said at least one limiting groove cooperating with said at least one limiting member and said at least one positioning portion to form a retraction limiting structure among said insertion seat, said retraction seat and said main cover that serves as said second limiting structure.

### Claim 4 (depends on 2)

The insertion device as claimed in claim 2, wherein said upper casing has at least one urging portion on an inner surrounding surface thereof, said main body having at least one stopping portion, said insertion seat having at least one buckle portion that separably abuts against said at least one stopping portion of said main body so as to position said insertion seat relative to said main body, said at least one buckle portion being able to be pushed by said at least one urging portion of said upper casing to be separated from said at least one stopping portion of said main body, said at least one buckle portion of said insertion seat cooperating with said at least one stopping portion of said main body to form an insertion limiting structure between said insertion seat and said main body that serves as said first limiting structure.

### Claim 5 (depends on 1)

The insertion device as claimed in claim 1, wherein said retraction seat is mounted with an insertion needle, and said insertion seat includes a pushing portion, after the automatic-insertion operation performed by the insertion module, said insertion needle being configured to be inserted through said base to insert a sensor underneath a skin surface of a host, and said pushing portion of said insertion seat tightly abutting against said sensor assembly so as to prevent said sensor assembly from being separated from a mounting portion of said base.

### Claim 6 (depends on 5)

The insertion device as claimed in claim 5, wherein said insertion module further includes an auxiliary insertion seat that is separably mounted to said insertion needle, said sensor assembly being separably mounted to said auxiliary insertion seat.

### Claim 7 (depends on 6)

The insertion device as claimed in claim 6, wherein said auxiliary insertion seat has at least one coupling portion, said sensor assembly having at least one coupling portion that corresponds to said at least one coupling portion of said auxiliary insertion seat and that is fittingly engaged with said at least one coupling portion of said auxiliary insertion seat.

### Claim 8 (depends on 1)

The insertion device as claimed in claim 1, wherein each of said first elastic member and said second elastic member is configured as a pre-compressed spring.

### Claim 9 (depends on 1)

The insertion device as claimed in claim 1, wherein said lower casing is air-tightly and separably coupled to said upper casing so as to form an airtight space within said insertion device, said airtight space being provided with a desiccant therein.

### Claim 10 (depends on 1)

The insertion device as claimed in claim 1, wherein said base has a mounting portion for said sensor assembly to be separably mounted thereto.

### Claim 11 (depends on 10)

The insertion device as claimed in claim 10, wherein said mounting portion of said base includes a recess that permits said sensor assembly to be press-fitted thereinto.

### Claim 12 (depends on 11)

The insertion device as claimed in claim 11, wherein said mounting portion of said base further includes an adhesive layer that is disposed in said recess for said sensor assembly to be adhered thereto.

### Claim 13 (depends on 10)

The insertion device as claimed in claim 10, wherein said mounting portion of said base includes at least one resilient hook that is for engaging with said sensor assembly.

### Claim 14 (depends on 1)

The insertion device as claimed in claim 1, wherein the insertion device is configured such that a time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 100 milliseconds.

### Claim 15 (depends on 14)

The insertion device as claimed in claim 14, wherein the insertion device is configured such that the time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 8 milliseconds.

### Claim 16 (depends on 14)

The insertion device as claimed in claim 14, wherein the insertion device is configured such that the time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 4 milliseconds.

### Claim 17 (depends on 14)

The insertion device as claimed in claim 14, wherein the insertion device is configured such that the time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 2 milliseconds.

### Claim 18 (depends on 1)

The insertion device as claimed in claim 1, further comprising a cushion wall that is disposed on an inner side of a bottom portion of said upper casing, said base being higher than a bottom edge of said cushion wall before said insertion device is operated.

### Claim 19

An insertion method of a sensor, comprising:
an upper casing including an outer shell, and a cover body that is disposed in the outer shell;
an insertion device forming movement relationship with the outer shell and the cover body of the upper casing, and including a displacement space that is cooperatively defined by a main cover and a main body;
an insertion module disposed in the displacement space, the insertion module being movable in the displacement space by pre-compressed first and second elastic members therein so as to perform an automatic-insertion operation and an automatic-retraction operation;
an insertion limiting structure disposed between the insertion module and the main body for removably positioning the insertion module at a pre-insertion position; and
a retraction limiting structure disposed between the insertion module and the cover body, a portion of the insertion module being able to move from a post-insertion position to the pre-insertion position when the retraction limiting structure is collapsed,
wherein, when the insertion device is kept being depressed after the upper casing is depressed to move relative to the main body, the insertion limiting structure is collapsed, and the insertion module is biased by a restoring force of the first elastic member to move downwardly to perform the automatic-insertion operation, the retraction limiting structure being collapsed immediately after the insertion module finishing the automatic-insertion operation, such that the insertion module is biased by a restoring force of the second elastic member to move upwardly to perform the automatic-retraction operation, the insertion module positioning a sensor assembly thereof onto a base during the automatic-insertion operation, a time needed for performing the automatic-insertion operation and the automatic-retraction operation being no more than 100 milliseconds, and
wherein said upper casing has at least one casing engaging structure, said main body having at least one body engaging structure, said at least one casing engaging structure engaging said at least one body engaging structure when said insertion limiting structure collapses, so that said upper casing is prevented from rebounding relative to said main body.