Insertion system and method for inserting a medical device

Abstract

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

Description

Technical Field

[0001] The present application relates to an insertion tool for inserting at least a portion of a medical device into a subject. Background Art

[0002] In order to properly manage chronic health conditions, it may be crucial for a subject to regularly monitor the levels of one or more analytes in his or her bloodstream and / or his or her interstitial fluid. In the case of diabetes, subjects (i.e., patients) routinely monitor glucose levels to avoid episodes of hypoglycemia as well as episodes of hyperglycemia. For other conditions where health monitoring is important, other analytes may be measured, such as lactate, cholesterol, oxygen, or other types of analytes and metabolites.

[0003] Monitoring systems have been developed that allow sensors to be implanted in a subject to directly monitor analyte concentrations in the bloodstream or interstitial fluid. WO 2011 / 041449 A1 discloses an assembly for inserting such a sensor. The insertion assembly includes a rigid introducer tip as an insertion tool, which is used to pierce the subject's skin and position the sensor within the subject's connective tissue. After the sensor is inserted, the insertion tool is removed via a retraction mechanism within the insertion assembly.

[0004] Other medical devices are known for partial or complete implantation into a subject.

[0005] US2012 / 0276221 A1 discloses an insertable medical device, wherein at least a portion of the medical device softens or completely dissolves after implantation or insertion into a subject. As an example, a stent is described as having a tapered tip to aid insertion, wherein the stent is formed at least in part from a fully urine-disintegrable polymer or a biodisintegrable polymer blended with a biostable polymer. Many examples of biostable materials are biopolymers such as polypeptides, proteins, and polysaccharides, including fibrin, fibrinogen, collagen, elastin, chitosan, gelatin, starch, and glycosaminoglycans such as hyaluronic acid.

[0006] Another example of a medical device that changes its properties after insertion is given in US 2018 / 0207356 A1, which discloses a subcutaneous infusion catheter. The catheter includes a flexible cannula having an outer wall that changes from a smooth to an accordion-like shape, thereby moving or pulling the needle tip back from its final position (i.e., away from the area of ​​greatest trauma), helping to prevent the cannula from being pulled out of the skin, and providing more surface area for delivering insulin.

[0007] US Pat. No. 7,513,891 B2 describes a cannula containing a temperature-sensitive medium that renders the cannula rigid before insertion and flexible after insertion due to body temperature. The entire cannula, including the tip, may be formed from the temperature-sensitive material, or the temperature-sensitive medium may be contained within a porous material forming the cannula or within a clearance space between different hose-like sections of the cannula. Examples of suitable materials are PTFE, PUR, or SR.

[0008] Another example of an injection needle that changes from a rigid state before insertion to a flexible state after insertion is known from US Pat. No. 7,435,240, B2. This transition can be based in particular on a change in temperature or pH, or on a chemical reaction of the material with the surrounding medium, or on a combination of several of these factors. The material in question is a thermoplastic polymer or a polymer with a glass transition.

[0009] Another example of a needle that dissolves after insertion can be found in US 9,675,545 B2, which needle comprises a chitosan derivative, ie a biopolymer selected from the group consisting of chitosan succinamide, carboxymethyl chitosan, trimethyl chitosan and combinations thereof.

[0010] It would therefore be desirable to provide an insertion tool that at least partially addresses the above-mentioned technical challenges and provides an advantageous alternative to known solutions. Summary of the Invention

[0011] This problem is solved by the insertion tool with the independent claim. In the dependent claims and throughout the description, advantageous embodiments are listed which can be realized individually or in any combination.

[0012] As used hereinafter, the terms "have," "comprise," or "include," or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context besides the features introduced by these terms, or the presence of one or more other features. As an example, the expressions "A has B," "A includes B," and "A contains B" may refer to the absence of other elements in A besides B (i.e., the presence of A solely and exclusively consisting of B), or the presence of one or more other elements in entity A besides B (such as element C, element C and element D, or even other elements).

[0013] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may be present once or more than once are generally used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" is not used repeatedly, even though the corresponding feature or element may be present only once or more than once.

[0014] Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the possibilities of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the present invention can be carried out through the use of alternative features. Similarly, features introduced by "in one embodiment of the invention" or similar expressions are intended to be optional features without any limitation on alternative embodiments of the invention, without any limitation on the scope of the invention, and without any limitation on the possibility of combining features introduced in this manner with other optional or non-optional features of the invention.

[0015] In a first aspect of the present invention, an insertion tool for inserting at least a portion of a medical device into a subject is disclosed, wherein at least one penetrating portion of the insertion tool softens upon contact with body fluids due to at least fluid absorption.

[0016] "Medical device" refers to any element or object configured for use in the field of medical technology, specifically in the field of medical analysis or medical diagnosis. A medical device can be configured to perform at least one medical function and / or be used for at least one medical procedure, such as one or more of a therapeutic procedure, a diagnostic procedure, or another medical procedure.

[0017] For example, the medical device may include at least one of the following: a device for delivering at least one therapeutic fluid (e.g., insulin) into a user's body tissue, specifically at least one infusion device comprising at least one infusion cannula; at least one analyte sensor for detecting at least one analyte (e.g., blood glucose or pH value); specifically at least one analyte sensor for detecting at least one body analyte in at least one body fluid, more specifically at least one electrochemical analyte sensor comprising at least one sensor electrode for detecting at least one analyte.

[0018] "Insertion tool" refers to a component that is suitable for entering the skin of a subject to be inserted. "Insertion tool" may, for example, refer to a needle-like or tubular structure having a sharp point or solid tip when inserted. The insertion tool or at least a portion of the insertion tool may be a part of a medical device, for example, the insertion tool may be a cannula or the distal portion of a cannula for drug administration. In another embodiment, the insertion tool may form a base or a pedestal for a medical device or a portion of a medical device, or the insertion tool may receive a medical device or a portion of a medical device for insertion into the medical device. The insertion tool may insert an entire medical device or a portion or part of a medical device. Inserting a portion of a medical device may include positioning a non-insertable portion of the medical device onto the skin of the subject.

[0019] "Penetrating portion" refers to the tip portion of the insertion tool, ie, the distal portion of the insertion tool adapted to enter the skin of a subject during the insertion procedure.

[0020] The insertion tool can be inserted manually or using an insertion device, wherein "insertion device" refers to a device configured to fully or partially insert the insertion tool and, with it, the medical device, into body tissue, i.e., includes an insertion mechanism for inserting the insertion tool. The insertion device can be configured to insert the insertion tool percutaneously or subcutaneously, such as by making an incision or penetration in the skin and pushing the penetrating portion of the insertion tool into the user's body tissue.

[0021] "Fluid absorption" refers to a physical and / or chemical or reaction phenomenon or process in which a fluid (ie, fluid molecules, atoms, and ions) is absorbed or retained by another material, ie, enters the bulk of another material (eg, a solid material).

[0022] In one aspect of the invention, the penetrating portion 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 an amorphous composite and the second material is a fibril material or a fibril composite or a crystalline material or a crystalline composite, and wherein the fluid absorption of the first material of the composite material is higher than the fluid absorption of the second material of the composite material. In other words, the composite material comprises a first portion consisting of one or more amorphous materials or amorphous composites and a second portion consisting of one or more fibril materials or fibril composites and / or crystalline materials or crystalline composites. By combining a fibril or crystalline material or a crystalline composite or a group of fibrils and / or crystalline materials or crystalline composites with an amorphous material or an amorphous composite or a group of amorphous materials or amorphous composites, a composite is formed that exhibits high rigidity under ambient (i.e., dry) conditions due to its fibril and / or crystalline material portion and softens when exposed to a fluid due to fluid absorption, the fluid absorption being enhanced by the amorphous material or amorphous composite or material portion of the composite.

[0023] A "composite material," "composite material," or "composite" refers to a material comprising at least a first material and a second material as constituent materials, wherein the two or more constituent materials have significantly different chemical or physical properties and are combined to form a finished structure, wherein the constituent materials remain separate and distinct. In other words, the starting materials are connected to each other, but the individual starting materials do not dissolve in each other, or dissolve only superficially. For example, particles or fibers of a first component are embedded in another component of the composite material, forming a matrix structure. In fiber composites, the fibers may extend along one or more specific directions or have a preferred orientation. Fiber composites can also be produced in layers.

[0024] The through-portion comprises the composite material, in particular the through-portion consists entirely or substantially of the composite material, wherein "substantially" here means that the entire portion of the composite material within the through-portion dominates the behavior of the through-portion with respect to fluid absorption and softening.

[0025] The constituent materials of the composite material of the penetrating portion of the insertion tool are amorphous material or amorphous composite and fibrils or crystalline material or composite. This does not exclude the composite material from containing other materials, as long as the amount of other materials does not substantially change the behavior of the composite material with respect to fluid absorption, rigidity and softening.

[0026] "Amorphous material or amorphous composite" or "amorphous material or composite" refers to a solid that lacks the long-range order that is characteristic of a crystalline or crystalline material or composite. An amorphous material or composite (i.e., a composite of at least two amorphous materials) has an internal structure comprising interconnected structural units, wherein the structural units may, for example, be similar to the basic structural units found in the corresponding crystalline phase of the same compound. Whether a material is a liquid or a solid depends primarily on the connectivity between its basic structural units; solids are characterized by a high degree of connectivity, while structural units in fluids have lower connectivity. Here, the amorphous material or composite included in the composite material is in a solid state.

[0027] "Crystalline material or crystalline composite" or "crystal" refers to a solid material or composite of solid materials whose constituents, such as atoms, molecules, or ions, are arranged in a highly ordered microstructure, forming a lattice extending in all directions. "Fibrillar material or fibrillar composite" or "fibril" refers to a structured biomaterial or composite of structured biomaterials composed of linear biopolymers and characterized by a rod-like structure with a high aspect ratio.

[0028] While the crystalline or fibril material or fibril composite portion is characterized by a certain hardness that imparts stability to the insertion tool, the amorphous material or amorphous composite portion allows for the absorption of larger amounts of liquid or fluid (specifically, body fluids), and thereby softens the insertion tool. Thus, under normal environmental conditions (i.e., average humidity, temperature, pressure, etc.), the penetration portion of the insertion tool is in a rigid or hard state and is adapted therewith to penetrate or puncture the skin of the subject to insert the medical device. After insertion, the penetration portion softens due to absorption of surrounding body fluids. The insertion tool can remain within the subject's skin for the entire time the medical device remains on and / or within the subject's skin without causing any discomfort or pain. It is unnecessary for the insertion tool to retract while being removed from the medical device and keeping the medical device inserted, and therefore, if used, the insertion process and the requirements for the insertion device will be significantly simplified.

[0029] The fluid absorption of a material (i.e., the ability to absorb a certain amount of fluid) depends, for example, on the internal structure of the material. For example, the water absorption of a material, and therefore its softening properties, may depend primarily on the amount of crosslinking monomer components (such as disulfides, also known as disulfide bridges or ss-bonds) within the material and not on the degradation of the corresponding material. Furthermore, the softening properties caused by fluid absorption are reversible after drying, for example, after retraction of the insertion tool.

[0030] In an embodiment, the fluid absorption of the first material of the composite material is at least 70% of its weight in the 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.

[0031] "Dry state" refers to a first state of the first and second materials when the first and second materials are surrounded by air or another gas having at least a non-condensing relative humidity and / or a humidity below a threshold. For example, the dry state can be achieved under ambient dry conditions (i.e., with air having average humidity, temperature, pressure, etc. and not in direct contact with fluids or tissue, etc.). In another embodiment, the dry state can be achieved with air having lower humidity (e.g., with humidity reduced and / or controlled by, for example, a desiccant added to the packaging of the insertion tool). The dry state of the first and second materials can each be defined by the total water content of the material, such as a total water content of 10 wt%, i.e., in the dry state, 10% of the total mass or entire mass of the material is water.

[0032] In this embodiment, the amorphous material or amorphous composite portion is adapted to absorb (i.e., take up) an amount of water corresponding to at least 70% of its weight in the dry state (i.e., the weight of the amorphous material or amorphous composite portion in the dry state). Correspondingly, the crystalline or fibrillar material or fibrillar composite portion is adapted to absorb an amount of water corresponding to at most 35% of its weight in the dry state (i.e., the weight of the crystalline or fibrillar material or fibrillar composite portion in the dry state).

[0033] In another embodiment, the fluid absorption of the first material of the composite material is at least 60% or at least 65% or at least 75% or at least 80% of its weight in the dry state.The fluid absorption of the amorphous material or amorphous composite part of the composite material allows softening of the penetrating portion.

[0034] In yet another embodiment, the fluid absorption of the second material of the composite material is at most 40% or at most 30% or at most 25% of its weight in a dry state. The second material portion of the composite material allows the rigidity of the penetrating portion under ambient conditions to penetrate the skin of the subject. Low capacity

[0035] In one embodiment, in a dry state, the weight percentage (wt %) of the first material and the second material relative to the composite material is equal or 20 / 80 or 80 / 20, that is, the first material accounts for at least 20% and at most 80% of the weight of the composite material in a dry state, and the second material accounts for at most 80% and at least 20% of the weight of the composite material in a dry state.

[0036] In another embodiment, the first material and the second material are uniformly distributed within the composite material or are at least partially structured.

[0037] In one embodiment, the distribution of the second material within the composite material of the insertion tool is oriented along the longitudinal axis of the insertion tool.

[0038] The longitudinal axis generally points in the direction of insertion.As the second crystalline or fibrillar material or fibrillar composite travels along the longitudinal axis (ie the direction of insertion), the stability of the penetrating portion in the direction of insertion may be increased.

[0039] In another embodiment, the first material and / or the second material is a biopolymer. "Biopolymer" refers to a natural polymer produced by the cells of a living organism. For example, fibrin or keratin. Biopolymers can help increase the biocompatibility of the composite material (i.e., the penetrating portion), where biocompatibility refers to the ability of a material to undergo an appropriate host response, for example, to reduce an immune response in a subject upon implantation. In other words, biocompatibility refers to the quality of not having toxic or deleterious effects on biological systems.

[0040] In yet another embodiment, the first material and / or the second material is keratin. Keratin is an example of a biopolymer and has the properties of biocompatibility, biodegradability, and bioactivity. It also has a hydrophilic surface that is not found in many synthetic polymers, enhancing their ability to absorb fluids. Keratin is a fibrous protein that is a key structural material in, for example, hair, nails, horns, claws, and hooves.

[0041] In another embodiment, the first material is keratin and the first material in the dry state contains at least 10 wt% cysteine. "Cysteine" refers to a sulfur-containing proteinogenic amino acid with the formula HOOC-CH(-NH2)-CH2-SH and is usually present in large quantities in keratin, forming so-called disulfide bridges and conferring additional strength and rigidity with them through permanent, heat-stable cross-linking. "Disulfide bridge" refers to a covalent connection between the sulfur atoms of two cysteines and their formation stabilizes the tertiary and higher order structures of proteins. Disulfides in proteins are formed between the thiol groups of cysteine ​​residues by an oxidative folding process. The prototype of protein disulfide bonds is the diamino acid cystine peptide, which consists of two cysteine ​​amino acids joined by a disulfide bond. The structure of the disulfide bond can be seen by its C β -S γ -S γ -C β χ between atoms ss The first material can be described by a dihedral angle, which is typically close to ±90°. In another embodiment, the first material contains at least 15 wt% cysteine ​​or at least 20 wt% cysteine ​​in a dry state.

[0042] In yet another embodiment, the first material contains a first amount of a first crosslinking monomer component or a different type of crosslinking monomer component, and the second material contains a second amount of a second crosslinking monomer component or a different type of crosslinking monomer component, wherein the first amount is less than the second amount. Each amount can range from 0 wt% to 100 wt% relative to the dry state. The first and second crosslinking monomer components can be identical, such as disulfide bridges. The amounts of the crosslinking monomer components can be used to control water absorption capacity and, consequently, softening properties, such as when preselecting the amount of the crosslinking monomer component when manufacturing a penetrating portion of a medical device.

[0043] In one embodiment, the first cross-linking monomer component and / or the second cross-linking monomer component is cysteine.

[0044] In another embodiment, the first material comprises a first amount of disulfide and the second material comprises a second amount of disulfide, wherein the first amount is less than the second amount. The amount of disulfide bridges can be controlled, for example, by the amount of cross-linking monomer components (e.g., cysteine), since cross-linking monomer components (such as cysteine) are required to form disulfide bridges.

[0045] In one embodiment, the penetrating portion is adapted to have a rigid state and a soft state, wherein the rigid state has a total fluid content of the composite material of the penetrating portion of at most 10 wt% or at most 20 wt%, and in the soft state the total fluid content of the composite material of the penetrating portion of at least 50 wt% or at least 60 wt%.

[0046] In another aspect, an insertion device comprises an insertion tool as described above and an insertion mechanism for penetrating the insertion tool into a subject and inserting the medical device or portion of the medical device therewith into the subject.

[0047] An "insertion device" is a device configured to fully or partially insert an insertion tool and, with it, a medical device, into body tissue, i.e., includes an insertion mechanism for inserting the insertion tool. The insertion device may be configured to insert the insertion tool percutaneously or subcutaneously, such as by making an incision or penetration in the skin and advancing the penetrating portion of the insertion tool into the user's body tissue.

[0048] In another aspect, a medical device comprises an insertion tool as described above.

[0049] In yet another aspect, a method for manufacturing an insertion tool as described above includes the steps of: preparing a first material having a first amount of one or more cross-linking monomer components; and preparing a second material having a second amount of one or more cross-linking monomer components. One or more of the cross-linking monomer components can be, for example, cysteine. The composite material is manufactured, for example, by an additive manufacturing process such as 3D printing (e.g., extrusion).

[0050] Other technical features will be apparent to those skilled in the art from the following drawings, description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] To facilitate identification of the discussion of any particular element or activity, the most significant digit(s) in a reference number refers to the figure number in which the element is first introduced.

[0052] Figure 1 A composite material according to one embodiment is shown.

[0053] Figure 2 A medical device with an insertion tool according to another embodiment is shown.

[0054] Figure 3 A portion of a penetration portion according to yet another embodiment is shown.

[0055] Figure 4 Another medical device having an insertion tool according to yet another embodiment is shown.

[0056] Figure 5 Yet another medical device having an insertion tool according to another embodiment is shown. DETAILED DESCRIPTION

[0057] Figure 1 A penetrating portion 102 of an insertion tool for inserting at least a portion of a medical device into a subject is schematically illustrated. In the depicted embodiment, the penetrating portion 102 is formed as a tip portion of a needle-like structure and consists essentially of a composite material comprising a first material and a second material. The first material is an amorphous material or amorphous composite 104 having a first fluid absorption capacity. The second material is a fibril or crystalline material or a crystalline composite 106 and has a second fluid absorption capacity, wherein the first fluid absorption capacity is greater than the second fluid absorption capacity, i.e., the fluid absorption of the first material of the composite material is higher than the fluid absorption of the second material of the composite material. Due to the fluid absorption, the insertion device is adapted to soften upon contact with bodily fluids.

[0058] like Figure 1As schematically depicted in , the first and second materials do not form a bond, but rather remain separate and distinct within the composite material, such that the first and second materials each retain their significantly different chemical and / or physical properties. In a dry state, e.g., surrounded by air having average humidity, temperature, pressure, etc., the fibrils or crystalline material or crystalline composite 106 portion of the penetrating portion 102 ensures that the penetrating portion 102 is rigid enough to penetrate into the skin of a subject, while the amorphous material or amorphous composite 104 portion of the penetrating portion 102 ensures a certain amount of fluid absorption to soften the structure of the penetrating portion 102 when surrounded by fluid, such as interstitial fluid and / or tissue (e.g., subcutaneous tissue) of the subject.

[0059] Figure 2 Shown is a medical device with an interstitial analyte sensor (e.g., a glucose sensor assembly) having an upper non-insertable portion 204 and a lower penetrating portion 206. When the penetrating portion 206 is inserted into the skin of a subject, the upper non-insertable portion 204 is fixed to the skin of the subject via a paste 208. The penetrating portion 206 comprises a composite material and an insertable portion (e.g., two or three electrodes) of the analyte sensor, the composite material comprising an amorphous material or an amorphous composite portion and a crystalline or fibril material or a fibril composite portion. The electrodes may be printed on the surface of the composite material or on another material covering the composite material, etc. In a dry state, the penetrating portion 206 is rigid and can pierce the skin of the subject, thereby allowing the penetrating portion 206 to be inserted manually or using a tool (such as an inserter comprising an insertion mechanism). After insertion, i.e., when in contact with body tissue and body fluids, the composite material of the penetrating portion 206 softens due to absorption of body fluids (e.g., interstitial fluid) and remains in the tissue of the subject together with the insertable portion of the analyte sensor.

[0060] Figure 3 The distal portion of a penetrating portion 302 of an insertion tool according to another embodiment is shown. The penetrating portion 302 is formed as a hollow needle having a longitudinal incision 304, for example, for inserting a drug 306 positioned within the hollow needle and capable of slowly dissolving through the incision. At least the distal portion of the penetrating portion 302 comprises a composite material, such that the distal portion is rigid in a dry state, enabling insertion into the skin of a subject, and softens after insertion by absorbing bodily fluids. Such hollow or at least partially hollow insertion tools can also be used to insert sensors, etc., by positioning the sensor within the void in the penetrating portion 302 of the insertion tool.

[0061] Figure 4A medical device according to yet another embodiment is shown. The medical device comprises a penetrating portion formed as a cannula 402 for subcutaneous drug delivery (e.g., for insulin delivery), the penetrating portion being composed of a composite material and being soft due to fluid absorption in the depicted insertion state. Prior to insertion in a dry state, e.g., surrounded by ambient conditions and / or surrounded by air with controlled reduced humidity, the cannula 402 is rigid and therefore can be inserted without the aid of an additional insertion tool. The medical device further comprises a non-insertable upper component 404 having a drug reservoir 406, which is fluidically connected to the cannula 402.

[0062] Figure 5 A medical device according to yet another embodiment is shown. The medical device includes an extracorporeal drainage catheter 504 having a tubular penetrating portion 502 having a tip adapted to be placed within a cerebral ventricle to divert fluid from the ventricle via the outer upper member 404 of the catheter to relieve elevated intracranial pressure. The penetrating portion 502 comprises a composite material such that the penetrating portion 502, and in particular its tip, is rigid in a dry state (e.g., under ambient conditions) to facilitate insertion into the brain. The penetrating portion 502 and its tip then soften due to fluid absorption.

Claims

1. An insertion tool for inserting at least a portion of a medical device into a subject, wherein - the insertion tool comprises a penetrating portion, the penetrating portion comprises a composite material, the composite material comprises a first material and a second material, wherein - the first material is an amorphous material or an amorphous composite, - the second material is a fibrillar material or a fibrillar composite or a crystalline material or a crystalline composite, - the fluid absorption of the first material of the composite material is higher than the fluid absorption of the second material of the composite material, and - The insertion device is adapted to soften upon contact with body fluids at least due to fluid absorption by said amorphous material or amorphous composite.

2. The insertion tool of claim 1 , wherein the 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 according to claim 1 or 2, wherein in a dry state, the weight percentage (wt%) of the first material and the second material relative to the composite material is equal or 20 / 80 or 80 / 20. 4 . The insertion tool according to claim 1 , wherein the first material and the second material are uniformly distributed within the composite material or are at least partially structured.

5. The insertion tool according to any one of claims 1 to 4, wherein the 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 according to any one of claims 1 to 5, wherein the first material and / or the second material is a biopolymer.

7. The insertion tool according to any one of claims 1 to 6, wherein the first material and / or the second material is keratin.

8. The insertion tool according to any one of claims 1 to 7, the first material being keratin and containing at least 10 wt% cysteine ​​in a dry state.

9. The insertion tool according to any one of claims 1 to 8, wherein the first material contains a first amount of a first cross-linking monomer component or a different type of cross-linking monomer component, and the second material includes a second amount of a second cross-linking monomer component or a different type of cross-linking monomer component, wherein the first amount is less than the second amount. 10 . The insertion tool according to claim 9 , wherein the first cross-linking monomer component and / or the second cross-linking monomer component is cysteine.

11. The insertion tool of any one of claims 1 to 10, wherein the first material comprises a first amount of disulfide, the second material comprises a second amount of disulfide, and the first amount is less than the second amount.

12. An insertion tool according to any one of claims 1 to 11, wherein the penetrating portion is adapted to have a rigid state and a soft state, wherein in the rigid state the total fluid content of the composite material of the penetrating portion is at most 10 wt% or at most 20 wt%, and in the soft state the total fluid content of the composite material of the penetrating portion is at least 50 wt% or at least 60 wt%.

13. An insertion device comprising: - An insertion tool according to any one of the preceding claims, - an insertion mechanism for penetrating the insertion tool into the subject and inserting therewith the medical device or a portion of the medical device into the subject.

14. A medical device comprising an insertion tool according to any one of claims 1 to 12.

15. A method for making an insertion tool according to any one of claims 1 to 12, wherein the first material is prepared in a first amount of one or more cross-linking monomer components and the second material is prepared in a second amount of one or more cross-linking monomer components.

Images