Insertion system and method for inserting a medical device - Patent Application 20070122997

Abstract

An insertion tool for inserting at least a portion of a medical device into a subject, an insertion device including the insertion tool and an insertion mechanism, and a method for manufacturing the insertion tool, wherein the insertion tool includes an entry portion including a composite material, the composite material including at least one first material and at least one second material, the first material being an amorphous material or an amorphous composite, and the second material being a fibrillar material or a fibrillar composite or a crystalline material or a crystalline composite, wherein the fluid absorbency of the first material of the composite material is higher than the fluid absorbency of the second material of the composite material, and the insertion device is adapted to soften upon contact with bodily fluids due to the fluid absorbency of at least the amorphous material or the amorphous composite.

Description

[Technical Field]

[0001] Technical Field The present application refers to an insertion tool for inserting at least a portion of a medical device into a subject. [Background technology]

[0002] background For proper management of long-term health conditions, it may be important for a subject to regularly monitor the levels of one or more analytes in their bloodstream and / or their interstitial fluid. In the case of diabetes, subjects, i.e., patients, routinely monitor their glucose levels to avoid hypoglycemic and hyperglycemic episodes. For other situations where health monitoring is important, other analytes, such as lactate, cholesterol, oxygen, or other types of analytes and metabolites, may be measured.

[0003] Monitoring systems have been developed that allow a sensor to be implanted in a subject to directly monitor analyte concentrations in the bloodstream or interstitial fluid. An assembly for inserting such a sensor is known from WO 2011 / 041449 A1. The insertion assembly includes a sharp, rigid introducer as an insertion tool for piercing the subject's skin and positioning the sensor within the subject's connective tissue. After insertion of the sensor, the insertion tool is removed by a retraction mechanism of the insertion assembly.

[0004] Other medical devices are known that are partially or completely implanted in a subject.

[0005] US Patent Publication No. 2012 / 0276221 discloses an insertable medical device in which at least a portion of the medical device softens or completely dissolves upon implantation or insertion into a subject. In one embodiment, a stent with a tapered tip is described to aid insertion, where the stent is at least partially formed from a biodegradable polymer blended with a fully biodegradable or biostable polymer. Examples of biostable polymers include biopolymers such as polypeptides, proteins, and polysaccharides, including glycosaminoglycans such as fibrin, fibrinogen, collagen, elastin, chitosan, gelatin, starch, and hyaluronic acid.

[0006] Another example of a medical device that changes its properties after insertion is shown in US 2018 / 0207356, which discloses a subcutaneous infusion catheter. The catheter has a flexible cannula whose outer wall changes from a smooth shape to an accordion-like shape, thereby moving or retracting the needle tip from its end position, i.e., most likely the area of ​​trauma, and also preventing the cannula from being pulled out of the skin and providing more surface area for insulin delivery.

[0007] U.S. Patent No. 7,513,891 describes a cannula containing a temperature-sensitive medium that makes the cannula rigid before insertion and flexible after insertion due to body heat. The entire cannula, including the tip, can be formed of a temperature-sensitive material, or the temperature-sensitive medium can be received in the porous material that forms the cannula or within the gaps between different soft tubular portions of the cannula. Examples of suitable materials are PTFE, PUR, or SR.

[0008] Another example of an injection needle that changes from a rigid pre-insertion state to a flexible state after insertion is known from U.S. Pat. No. 7,435,240. The transition can be based, inter alia, on a change in temperature or pH, or on a chemical reaction of the material with the surrounding medium, or on some combination of these factors. The named materials are thermoplastic polymers or polymers with a glass transition.

[0009] Another example of a needle that dissolves after insertion can be found in US Pat. No. 9,675,545, which includes a needle comprising a biopolymer selected from chitosan derivatives, i.e., chitosan succinamide, carboxymethylchitosan, trimethylchitosan, and combinations thereof.

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

[0011] Quick Overview This problem is addressed by the insertion tool of the independent claim. Advantageous embodiments which may be implemented alone or in any arbitrary combination are listed in the dependent claims as well as in the specification as a whole.

[0012] When used below, the terms "having," "comprising," or "including," or any grammatical variants thereof, are used in a non-exclusive manner. These terms can therefore refer both to a situation in which, besides the features introduced by these terms, no further features are present in the entity described in this context, and to a situation in which one or more further features are present. As an example, the expressions "A has B," "A comprises B," and "A includes B" can both refer to a situation in which, besides B, no other elements are present in A (i.e., a situation in which A consists solely and exclusively of B), and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D, or further 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 more than once are typically used only once when introducing each feature or element. In most cases below, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, regardless of the fact that each feature or element may be present more than once.

[0014] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms may be used in conjunction with any feature without limiting its alternative possibilities. Therefore, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The present invention may be implemented by using alternative features, as recognized by those skilled in the art. Similarly, features introduced by "in an embodiment of the present invention" or similar expressions are intended to be optional features without any limitations regarding alternative embodiments of the present invention, without any limitations regarding the scope of the present invention, and without any limitations regarding the possibility of combining the feature introduced in this manner with other optional or non-optional features of the present 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 an insertion portion of the insertion tool softens upon contact with bodily fluids due to at least fluid absorbency.

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

[0017] For example, the medical device may include at least one of a device for delivering at least one therapeutic fluid, e.g., insulin, to a user's body tissue, specifically at least one infusion set including 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 bodily analyte in at least one bodily fluid, more specifically at least one electrochemical analyte sensor including at least one sensor electrode for detecting at least one analyte.

[0018] An "insertion tool" refers to a member suitable for entering the skin of a subject to be inserted. An "insertion tool" may refer, for example, to a needle-like or tubular structure having a sharp or hard 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 a distal portion of a cannula for drug administration. In another embodiment, the insertion tool may form a substrate or base 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 inserting the medical device. The insertion tool may insert the entire medical device or a portion (portion) of the medical device. Inserting a portion of the medical device may include placing a non-insertable portion of the medical device on the skin of the subject.

[0019] "Entry portion" refers to the tip portion of the insertion tool, i.e., the distal portion of the insertion tool adapted to enter the subject's skin during the insertion process.

[0020] The insertion tool may be inserted manually or using an insertion device, which refers to a device configured to fully or partially insert the insertion tool, and thus the medical device, into body tissue, i.e., include 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 puncture in the skin and forcing the insertion portion of the insertion tool into the user's body tissue.

[0021] "Fluid absorption" refers to a physical and / or chemical or reactive phenomenon or process by which fluid, i.e., fluid molecules, atoms, and ions, are taken up or retained by another material, i.e., enters the bulk phase of another material, e.g., a solid material.

[0022] In one embodiment of the invention, the ingress portion comprises a composite material including 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 fibrillar material or fibrillar composite or a crystalline material or crystalline composite, and the fluid absorbency of the first material of the composite is higher than the fluid absorbency of the second material of the composite. 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 fibrillar materials or fibrillar composites and / or crystalline materials or crystalline composites. By combining a fibril or crystalline material or crystalline composite, or a group of fibrils and / or crystalline material or crystalline composite, with an amorphous material or amorphous composite, or a group of amorphous material or amorphous composite, a composite is created that exhibits high stiffness in the ambient, i.e., dry, state due to that portion of the fibril and / or crystalline material, and softens when exposed to fluid due to the increased fluid absorbency due to that portion of the amorphous material or amorphous composite or material.

[0023] "Composite material" or "composite material" or "composite material" refers to a material containing at least a first and a second material as constituent materials, where the two or more constituent materials have significantly different chemical or physical properties and are combined to form a finished structure while remaining separate and distinct. In other words, the starting materials are bonded together, but fusion of the individual starting materials with each other does not occur, or occurs 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 composite materials, the fibers may extend in one or more specific directions or may have a preferred direction. Fiber composite materials can also be manufactured in layers.

[0024] The ingress portion comprises the composite material, and in particular the ingress portion consists entirely or substantially of the composite material, where "substantially" refers to the entire portion of the composite material within the ingress portion that governs the behavior of the ingress portion with respect to fluid absorption and softening.

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

[0026] "Amorphous material or amorphous composite" or "amorphous material or amorphous composite" refers to a solid that lacks the long-range order characteristic of a crystal or crystalline material or crystalline composite. An amorphous material or amorphous composite, i.e., a composite of at least two amorphous materials, has an internal structure comprising interconnected building blocks, which may resemble, for example, 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 building blocks, with solids being characterized by a high degree of connectivity, while the building blocks in fluids have low connectivity. Here, an amorphous material or amorphous composite formed by a 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 in which components such as atoms, molecules, or ions are arranged in a highly ordered microscopic structure, forming a crystalline lattice that extends in all directions. "Fibrillar material or fibril composite" or "fibril" refers to a structural biological material or composite of structural biological material composed of linear biopolymers, characterized by a rod-like structure with a high length-to-diameter ratio.

[0028] The crystalline or fibrillar material or fibrillar composite portion is characterized by a certain hardness that provides stability to the insertion tool, while the amorphous material or amorphous composite portion allows for the absorption of a greater amount of liquid or fluid, particularly bodily fluids, thus softening the insertion tool. Thus, under normal ambient conditions, i.e., average humidity, temperature, pressure, etc., the entry portion of the insertion tool is in a rigid or stiff state, thereby adapted to puncture or pierce the subject's skin for insertion of the medical device. After insertion, the entry portion softens due to absorption of surrounding bodily fluids. Thus, the insertion tool can remain inside the subject's skin without causing any discomfort or pain throughout the entire time the medical device remains on and / or in the subject's skin. It is not necessary to separate the insertion tool from the medical device and remove it while leaving the medical device inserted, thereby significantly simplifying the insertion process and the requirements for the insertion device, if used.

[0029] The fluid absorbency of a material, i.e., its 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 cross-linked monomer components within the material, such as disulfides, also known as disulfide bridges or ss bonds, and not on the degradation of the respective material. Furthermore, the softening properties due to fluid absorbency are reversible upon drying, e.g., after retraction of the insertion tool.

[0030] In an embodiment, the first material of the composite has a fluid absorbency of at least 70% of its weight in the dry state, and the second material of the composite has a fluid absorbency of at most 35% of its weight in the dry state.

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

[0032] In embodiments, the amorphous material or amorphous composite portion is adapted to absorb, i.e., wick 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, at most, an amount of water corresponding to 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 absorbency of the first material of the composite 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 absorbency of the amorphous material or amorphous composite portion of the composite allows for softening of the entry portion.

[0034] In further embodiments, the fluid absorbency of the second material of the composite 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 allows the penetration portion to be strong in ambient conditions so that it can penetrate the skin of a subject.

[0035] In an embodiment, the weight percentages (wt%) of the first and second materials in the dry composite are equal or 20 / 80 or 80 / 20, i.e., the weight portion of the first material in the dry composite is at least 20% and at most 80%, while the weight portion of the second material in the dry composite is at least 20% and at most 80%.

[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 an embodiment, the distribution of the second material within the composite material of the tool insert is oriented along the longitudinal axis of the tool insert.

[0038] The longitudinal axis typically refers to the insertion direction. Advancement of the second crystalline or fibrillar material or fibrillar composite along the longitudinal axis, i.e., the insertion direction, can increase the stability of the entry portion in the insertion direction.

[0039] In another embodiment, the first material and / or the second material is a biopolymer. "Biopolymer" refers to a natural polymer produced by cells of living organisms. For example, fibrin or keratin. Biopolymers can help increase the biocompatibility of the composite material, i.e., the access portion, where biocompatibility refers to the material's ability to provide an appropriate host response, for example, to reduce the immune response in a subject when implanted. In other words, biocompatibility refers to the property of not having toxic or harmful effects on biological systems.

[0040] In a further 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, which is not present in many synthetic polymers, and enhances its ability to absorb fluids.Keratin is a fibrous protein that is an important structural material for, for example, hair, nails, horns, claws, and hooves.

[0041] In another embodiment, the first material is keratin, and the first material in its 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, which is typically present in large amounts in keratin, forming so-called disulfide bridges, thereby providing additional strength and rigidity through permanent, thermally stable crosslinks. "Disulfide bridge" refers to a covalent bond between the sulfur atoms of two cysteine ​​amino acids, and their formation stabilizes the tertiary and higher-order structure of proteins. Disulfides in proteins are formed between the thiol groups of cysteine ​​residues by the process of oxidative folding. The prototype of a protein disulfide bond is the two-amino acid peptide cystine, composed of two cysteine ​​amino acids linked by a disulfide bond. The structure of the disulfide bond is typically close to ±90° C. β -S γ -S γ -C β The chi between atoms ss It can be described by a dihedral angle. In another embodiment, the first material contains at least 15 wt% cysteine ​​or at least 20 wt% cysteine ​​on a dry basis.

[0042] In a further embodiment, 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 contains a second amount of a second cross-linking monomer component or a different type of cross-linking monomer component, the first amount being less than the second amount. Each amount may be between 0 wt% and 100 wt% based on the dry state. The first and second cross-linking monomer components may be the same, for example, disulfide bridges. Through the amount of cross-linking monomer component, the water absorption capacity and the associated softening properties can be controlled, for example, pre-selected when manufacturing the entry portion of the medical device.

[0043] In embodiments, 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 disulfides and the second material comprises a second amount of disulfides, the first amount being less than the second amount. For example, the amount of disulfide bridges is controlled by the amount of cross-linking monomer components, such as cysteine, because cross-linking monomer components such as cysteine ​​are required to form disulfide bridges.

[0045] In an embodiment, the entry portion is adapted to have a rigid state and a flexible state, wherein in the rigid state the total fluid content of the composite material of the entry portion is at most 10 wt% or at most 20 wt%, and in the flexible state the total fluid content of the composite material of the entry portion is 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 advancing the insertion tool into a subject, thereby inserting the medical device or a portion of a medical device into the subject.

[0047] "Insertion device" refers to a device configured to fully or partially insert an insertion tool, and thus a medical device, into body tissue, i.e., to include 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 puncture in the skin and forcing the insertion portion of the insertion tool into the body tissue of a user.

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

[0049] In a further aspect, a method for manufacturing the above-described insertion tool includes 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 by an additive manufacturing process, such as, for example, three-dimensional printing, e.g., extrusion.

[0050] Other technical features may be readily apparent to those skilled in the art from the following drawings, specifications, and claims. [Brief explanation of the drawings]

[0051] To easily identify the description of any particular element or act, the most significant digit(s) of a reference number refers to the figure number in which that element is first introduced.

[0052] [Figure 1] 1 illustrates a composite material according to one embodiment.

[0053] [Figure 2] 13 illustrates a medical device with an insertion tool according to another embodiment.

[0054] [Figure 3] 10 shows a portion of an entry section according to a further embodiment;

[0055] [Figure 4] 10 illustrates another medical device with an insertion tool according to a further embodiment.

[0056] [Figure 5] 10 illustrates a further medical device with an insertion tool according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0057] Detailed Description FIG. 1 schematically illustrates an entry portion 102 of an insertion tool for inserting at least a portion of a medical device into a subject. In the depicted embodiment, the entry portion 102 is formed as a tip portion of a needle-like structure and consists essentially of a composite material including 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 fibrillar or crystalline material or crystalline composite 106 having a second fluid absorption capacity, the first fluid absorption capacity being greater than the second fluid absorption capacity, i.e., the fluid absorption capacity of the first material of the composite is greater than the fluid absorption capacity of the second material of the composite. Due to the fluid absorption capacity, the insertion device is adapted to soften upon contact with bodily fluids.

[0058] 1, the first and second materials do not form bonds but remain separate and distinct within the composite, such that the first and second materials each maintain significantly different chemical and / or physical properties. While surrounded by air under dry conditions, e.g., average humidity, temperature, pressure, etc., the fibrillar or crystalline material or crystalline composite 106 portion of penetration portion 102 ensures sufficient rigidity of penetration portion 102 to pierce the skin of a subject, and the amorphous material or amorphous composite 104 portion of penetration portion 102 ensures an amount of fluid absorbency that softens the structure of penetration portion 102 when surrounded by fluids, such as interstitial fluid and / or tissue of a subject, e.g., subcutaneous tissue.

[0059] FIG. 2 illustrates a medical device having an interstitial analyte sensor, e.g., a glucose sensor assembly, with an upper non-insertable portion 204 and a lower penetration portion 206. While penetration portion 206 is inserted into the subject's skin, upper non-insertable portion 204 is secured to the subject's skin via a patch 208. Penetration portion 206 comprises a composite material including an amorphous material or amorphous composite portion, a crystalline or fibrillar material or fibrillar composite portion, and an insertable portion of the analyte sensor, e.g., two or three electrodes. The electrodes may be printed on the surface of the composite material or on another material that covers the composite material. In a dry state, penetration portion 206 is rigid and can pierce the subject's skin, thereby allowing insertion of penetration portion 206 manually or using a tool, such as an inserter that includes an insertion mechanism. After insertion, ie, upon contact with body tissue and fluids, the composite material of the penetration portion 206 softens due to absorption of body fluids, eg, interstitial fluid, and remains with the insertable portion of the analyte sensor in the tissue of interest.

[0060] 3 shows a distal portion of an entry portion 302 of an insertion tool according to another embodiment. The entry portion 302 is formed as a hollow needle with a longitudinal cut 304 to insert, for example, a slowly dissolving drug 306 disposed within the hollow needle through the cut. At least the distal portion of the entry portion 302 comprises a composite material such that the distal portion is rigid in a dry state to allow insertion into a subject's skin and softens upon absorption of bodily fluids after insertion. Such hollow or at least partially hollow insertion tools can also be used to insert sensors, etc., by placing the sensor within the void of the entry portion 302 of the insertion tool.

[0061] 4 illustrates a medical device according to a further embodiment. The medical device includes an access portion formed as a cannula 402 made of a composite material for subcutaneous drug delivery, such as for insulin delivery, and is therefore soft due to its fluid absorbency in the depicted insertion state. Prior to insertion in a dry state, for example, surrounded by ambient conditions and / or 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 includes a non-insertable upper portion 404 with a drug reservoir 406 in fluid communication with the cannula 402.

[0062] 5 illustrates a medical device according to a further embodiment. The medical device includes an external ventricular drainage catheter 504 having a tubular access portion 502 with a tip adapted to be placed in a ventricle to relieve elevated intracranial pressure by diverting fluid from the ventricle through the catheter's outer upper portion 404. The access portion 502 includes a composite material such that the access portion 502, particularly its tip, is rigid in a dry state, e.g., ambient conditions, facilitating insertion into the brain. The access portion 502 and its tip then soften to absorb fluid.

Claims

1. 1. An insertion tool for inserting at least a portion of a medical device into a subject, comprising: - said insertion tool comprises an entry portion comprising a composite material, said composite material comprising a first material and a second material; - said first material is an amorphous material or an amorphous composite; - said second material is a fibrillar material or fibrillar composite or a crystalline material or crystalline composite, the fluid absorbency of the first material of the composite material is higher than the fluid absorbency of the second material of the composite material; - an insertion tool, wherein said insertion device is adapted to soften when in contact with bodily fluids due to said fluid absorbency of at least said amorphous material or said amorphous composite.

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

3. 3. The insertion tool of claim 1 or 2, wherein the weight percentages (wt%) of the first material and the second material relative to the composite material in a dry state are equal, or 20 / 80 or 80 / 20.

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

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

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

8. 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. 9. The insertion tool of claim 1, wherein the first material comprises a first amount of a first cross-linking monomer component or a different type of cross-linking monomer component, and the second material comprises a second amount of a second cross-linking monomer component or a different type of cross-linking monomer component, the first amount being less than the second amount.

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

11. 11. The insertion tool of claim 1, wherein the first material comprises a first amount of disulfide and the second material comprises a second amount of disulfide, the first amount being less than the second amount.

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

13. 1. An insertion device comprising: - an insertion tool according to any one of claims 1 to 12, an insertion mechanism for advancing the insertion tool into an object, thereby inserting the medical device or a part of the medical device into the object; An insertion device comprising:

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

15. 13. The method of claim 1, wherein the first material is prepared with a first amount of one or more cross-linking monomer components and the second material is prepared with a second amount of one or more cross-linking monomer components.

Images