# US 2025/0352242 A1 · Insertion system and method for inserting a medical device

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- Number: US 2025/0352242 A1
- Document ID: US20250352242A1
- Status: Published application
- Kind: A1
- Application number: 19/285,164
- Filed: 2025-07-30
- Published: 2025-11-20
- Earliest claimed: 2023-02-15
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Thomas Kuensting
- Web page: https://patentgrep.com/patent/US20250352242A1

## CPC

- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61M 25/06: Body-piercing guide needles or the like
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61L 31/125: {having a macromolecular matrix}
- A61L 31/129: {containing macromolecular fillers}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/32: Needles; Details of needles pertaining to their connection with syringe or hub (infusion needles A61M5/158); Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 27/006: {Cerebrospinal drainage; Accessories therefor, e.g. valves}
- A61M 37/0015: {by using microneedles}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2560/063: Devices specially adapted for delivering implantable medical measuring apparatus
- A61M 2005/1585: {Needle inserters}
- A61M 2025/0065: {which become stiffer or softer when becoming wet or humid, e.g. immersed within a liquid}
- A61M 2027/004: {with at least a part of the circuit outside the body}
- A61M 2037/0053: {Methods for producing microneedles}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Insertion tool for inserting at least a part of a medical device into a subject, insertion device comprising the insertion tool and an insertion mechanism, and method for manufacturing the insertion tool, wherein the insertion tool comprises a penetrating portion that comprises a composite material comprising at least one first material and at least one second material. Wherein the first material is an amorphous material or amorphous composite and the second material is a fibrillary material or fibrillary composite or a crystalline material or crystalline composite. A fluid absorption of the first material of the composite material is higher than a fluid absorption of the second material of the composite material, and the insertion device is adapted to soften when in contact with a body fluid at least due to the fluid absorption of the amorphous material or amorphous composite.

## Claims

### Claim 1

An insertion tool for inserting at least a part of a medical device into a subject, wherein the insertion tool comprises:
a penetrating portion comprising a composite material, the composite material comprising a first material and a second material, wherein:
the first material is an amorphous material or amorphous composite,
the second material is a fibrillary material or fibrillary composite or a crystalline material or crystalline composite,
a fluid absorption of the first material of the composite material is higher than a fluid absorption of the second material of the composite material, and
the insertion device is adapted to soften when in contact with a body fluid at least due to the fluid absorption of the amorphous material or amorphous composite.

### Claim 2 (depends on 1)

The insertion tool of claim 1, wherein a fluid absorption of the first material of the composite material is at least 70% of its weight in a dry state and the fluid absorption of the second material of the composite material is at most 35% of its weight in the dry state.

### Claim 3 (depends on 1)

The insertion tool of claim 1, wherein a weight percent (wt %) of first material and second material with regard to the composite material in a dry state are equal or 20/80 or 80/20.

### Claim 4 (depends on 1)

The insertion tool of claim 1, wherein the first material and the second material are homogeneously distributed within the composite material or are at least in parts structured.

### Claim 5 (depends on 1)

The insertion tool of claim 1, wherein a distribution of the second material within the composite material of the insertion tool is oriented along a longitudinal axis of the insertion tool.

### Claim 6 (depends on 1)

The insertion tool of claim 1, wherein the first material and/or the second material is a biopolymer.

### Claim 7 (depends on 1)

The insertion tool of claim 1, wherein the first material and/or second material is keratin.

### Claim 8 (depends on 1)

The insertion tool of claim 1, wherein the first material is keratin and the first material in a dry state contains at least 10 wt % cysteine.

### Claim 9 (depends on 1)

The insertion tool of claim 1, wherein the first material contains a first amount of a first cross-linking monomeric component or of different types of cross-linking monomeric components, and the second material comprises a second amount of a second cross-linking monomeric component or of different types of cross-linking monomeric components, wherein the first amount is smaller than the second amount.

### Claim 10 (depends on 9)

The insertion tool of claim 9, wherein the first cross-linking monomeric component and/or the second cross-linking monomeric component is cysteine.

### Claim 11 (depends on 1)

The insertion tool of claim 1, wherein the first material comprises a first amount of disulfide, the second material comprises a second amount of disulfide and the first amount is smaller than the second amount.

### Claim 12 (depends on 1)

The insertion tool of claim 1, wherein the penetrating portion is adapted to have a rigid state and a soft state, wherein in the rigid state an overall fluid content of the composite material of the penetrating portion is at most 20 wt % and in the soft state an overall fluid content of the composite material of the penetrating portion is at least 50 wt %.

### Claim 13 (depends on 12)

The insertion tool of claim 12, wherein the overall fluid content of the composite material of the penetrating portion in the rigid state is at most 10 wt %.

### Claim 14 (depends on 12)

The insertion tool of claim 12, wherein the overall fluid content of the composite material of the penetrating portion in the soft state is at least 60 wt %.

### Claim 15 (depends on 14)

The insertion tool of claim 14, wherein the overall fluid content of the composite material of the penetrating portion in the rigid state is at most 10 wt %.

### Claim 16 (depends on 1)

An insertion device comprising:
the insertion tool of claim 1, and
an insertion mechanism for penetrating the insertion tool into the subject and therewith inserting the medical device or the portion of the medical device into the subject.

### Claim 17 (depends on 1)

A medical device comprising the insertion tool of claim 1.

### Claim 18 (depends on 1)

A method for manufacturing the insertion tool of claim 1, wherein the first material is prepared with a first amount of one or more cross-linking monomeric components and the second material is prepared with a second amount of one or more cross-linking monomeric components.