INSERTION SYSTEM AND METHOD FOR INSERTING A MEDICAL DEVICE

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

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

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

8. 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.

9. 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.

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

11. 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.

12. 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 %.

13. 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 %.

14. 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 %.

15. 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 %.

16. 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.

17. A medical device comprising the insertion tool of claim 1.

18. 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the figure number in which that element is first introduced.

[0053] FIG. 1 illustrates a composite material in accordance with one embodiment.

[0054] FIG. 2 illustrates a medical device with an insertion tool in accordance with another embodiment.

[0055] FIG. 3 illustrates a part of a penetrating portion in accordance with a further embodiment.

[0056] FIG. 4 illustrates another medical device with an insertion tool in accordance with a further embodiment.

[0057] FIG. 5 illustrates a further medical device with an insertion tool in accordance with another embodiment.

[0058] Although the exemplification set out herein illustrates embodiments of the invention, in several forms, the embodiments disclosed below are not intended to be exhaustive or to be construed as limiting the scope of the invention to the precise forms disclosed.

DETAILED DESCRIPTION

[0059] FIG. 1 schematically shows a penetrating portion 102 of an insertion tool for inserting at least a part of a medical device into a subject. In the depicted embodiment, the penetrating portion 102 is formed as a tip portion of a needle like structure and substantially consists of a composite material that comprises a first material and a second material. The first material is an amorphous material or amorphous composite 104 having a first fluid absorption ability. The second material is a fibrillary or crystalline material or crystalline composite 106 and has a second fluid absorption ability, wherein the first fluid absorption ability is greater than the second, i.e., the fluid absorption of the first material of the composite material is higher than a fluid absorption of the second material of the composite material. Due to the fluid absorption the insertion device is adapted to soften when in contact with a body fluid.

[0060] As schematically depicted in the FIG. 1 the first and second material do not form bonds but remain separate and distinct within the composite material, so that the first and second material each keep their notably different chemical and/or physical properties. While in a dry state, e.g., surrounded by air with an average humidity, temperature, pressure, etc., the fibrillary or crystalline material or crystalline composite 106 portion of the penetrating portion 102 ensure a rigidity of the penetrating portion 102 sufficient to pierce into a subject's skin, while the amorphous material or amorphous composite 104 portion of the penetrating portion 102 ensures an amount fluid absorption to soften the structure of penetrating portion 102 when surrounded by a fluid such as interstitial fluid and/or the subject's tissue, e.g., subcutaneous tissue.

[0061] FIG. 2 shows a medical device with an interstitial analyte sensor, e.g., a glucose sensor assembly, with an upper non-insertable portion 204 and a lower penetrating portions 206. While the penetrating portion 206 is inserted into a subject's skin, the upper non-insertable portion 204 is fixed to the subject's skin via a plaster 208. The penetrating portion 206 comprises the composite material comprising of an amorphous material or amorphous composite portion and a crystalline or fibrillary material or fibrillary composite portion and an insertable part of the analyte sensor, e.g., two or three electrodes. The electrodes may be printed on a surface of the composite material or on another material covering the composite material or the like. In the dry state the penetrating portion 206 is rigid and capable of pricking a subject's skin, therewith enabling the insertion of the penetrating portion 206 either manually or using a tool such as an inserter comprising an insertion mechanism. After insertion, i.e., in contact with body tissue and bodily fluid, the composite material of the penetrating portion 206 softens due to absorption of body fluid, e.g., interstitial fluid, and remains with the insertable part of the analyte sensor in the subject's tissue.

[0062] FIG. 3 shows a distal part of a penetrating portion 302 of an insertion tool according to another embodiment. The penetrating portion 302 is formed as a hollow needle with a longitudinal cut 304, e.g., for insertion of a drug 306 that is positioned within the hollow needle and may slowly dissolve through the cut. At least the distal part of the penetrating portion 302 comprises the composite material so that the distal portion is rigid in the dry state enabling insertion into a subject's skin and softens after insertion due to absorption of body fluid. Such a hollow or at least partly hollow insertion tool may also be used to insert a sensor or the like by positioning the sensor within the void in penetrating portion 302 of the insertion tool.

[0063] FIG. 4 shows a medical device in accordance with a further embodiment. The medical device comprises a penetrating portion formed as a cannula 402 for subcutaneous drug delivery, e.g., for insulin delivery, that consist of the composite material and therefore, is soft due to fluid absorption in the depicted inserted state. Before the insertion in a dry state, e.g., surrounded by ambient conditions and/or surrounded by air with a controlled reduced humidity, the cannula 402 is rigid and therefore may be inserted without the help of an additional insertion tool. The medical device further comprises a not-insertable upper part 404 with a drug reservoir 406, which is in fluid connection with the cannula 402.

[0064] FIG. 5 shows a medical device in accordance with a further embodiment. The medical device comprises an external ventricular drainage catheter 504 with a tubular penetrating portion 502 with a tip adapted to be placed in a cerebral ventricle to relieve elevated intracranial pressure by diverting fluid from the ventricle via an outer upper part 404 of the catheter. The penetrating portion 502 comprises the composite material so that the penetrating portion 502 and in particular its tip are rigid in a dry state, e.g. in ambient conditions, to facilitate the insertion into the brain. The penetrating portion 502 and its tip then soften due to fluid absorption.

[0065] While this invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles.