Insertion system and method for inserting a medical device

Abstract

The present application relates to an insertion device for inserting at least a portion of a medical device into the body of a subject, the insertion device comprising: a chamber for receiving the medical device; an insertion tool for inserting an insertable portion of the medical device; an insertion mechanism; a retraction mechanism for retracting the insertion tool from the subject after insertion; a holding mechanism for holding the insertion tool in an end position after retraction; an inner housing comprising said retaining mechanism and a retracted insertion tool in said end position; an inserter housing comprising the insertion mechanism and a chamber for receiving the inner housing wherein the inserter housing is formed from a recyclable or biodegradable or compostable material, the insertion device comprising an ejection mechanism, the ejection mechanism is to remove the inner housing from the chamber when the insertion tool is held within the inner housing by the holding mechanism, and the ejection mechanism is activatable by a user.

Description

Technical Field

[0001] The present application relates to an insertion device for inserting at least a part of a medical device into a subject, the insertion device comprising: a chamber for receiving the medical device; an insertion tool for inserting the medical device or an insertable part of the medical device; an insertion mechanism for piercing the insertion tool into the subject and inserting it at the medical device or the insertable part of the medical device; a retraction mechanism for retracting the insertion tool from the subject after insertion; a holding mechanism for holding the insertion tool in an end position after retraction; an inner housing comprising the holding mechanism and the retracted insertion tool in the end position; and an inserter housing comprising the insertion mechanism and a chamber for receiving the inner housing Background Art

[0002] For the proper management of chronic health conditions, it may be crucial for a subject to regularly monitor the level of one or more analytes in his or her bloodstream. In the case of diabetes, the subject routinely monitors glucose levels to avoid hypoglycemic and hyperglycemic episodes. For other conditions important for health monitoring, other analytes can be measured, such as lactate or oxygen.

[0003] Systems have been developed that allow sensors to be implanted into a subject to directly monitor the concentration of analytes in the bloodstream or interstitial fluid. For example, an electrochemical sensor can be inserted into the subcutaneous area of the subject, where the analyte concentration is continuously monitored and / or recorded.

[0004] For example, US10653445B2 discloses a sensor insertion assembly for inserting a sensor, the sensor insertion assembly having an inserter with a chamber for removably receiving a sensor cartridge, wherein the sensor cartridge includes an insertion needle having a sensor therein, the needle being disposed within a sealed sterile capsule. The inserter further includes an actuator for actuating the insertion. After insertion, the cartridge can be removed and the inserter can be reused with a new cartridge unit. The used cartridge covers the needle after removal, thus preventing anyone removing and handling the cartridge from coming into contact with the used needle. Another insertion assembly with a reusable inserter is described in US9883888B2, which discloses a sensor cartridge having a sterile capsule including a needle and a retraction mechanism.

[0005] Patent US10945649B2 discloses a reusable insertion assembly, wherein the insertion assembly is configured to receive a needle hub and a sensor hub, the needle hub and the sensor hub being transferred to the inserter by means of a carrier. The carrier can also be used to remove the needle hub from the inserter after inserting the sensor, but the carrier neither holds the needle in a sterile environment before transferring the needle to the inserter nor seals it when used to remove the needle.

[0006] Additional insertion assemblies with reusable insertion guns are known from US6579690B1.

[0007] US10737021B2 discloses an inserter for inserting a part of a medical system, such as a cannula of an insulin pump, where the needle is encapsulated within an inner housing before insertion into the inserter.

[0008] The reusable design of the insertion device does have the advantage of reducing the amount of waste per application. The cost of this advantage is that more effort is required in production and during use, as the user must prepare the inserter assembly before use.

[0009] US20210052302A1 discloses a disposable biosensor inserter assembly having a carrier for a biosensor, an insertion device, and a retraction mechanism positioned within a housing assembly. After insertion, the retraction mechanism prevents the insertion device from being re-inserted, thereby fixedly positioning the insertion device within the housing. The housing may be formed from recyclable or biodegradable or compostable materials.

[0010] The advantage of a fully disposable design is more labor-saving and more convenient to handle for the user, but the amount of waste generated and the effort involved in disposing of the inserter device is generally more. SUMMARY OF THE INVENTION

[0011] The disadvantages of the prior art are solved by providing a mechanism for separating the recyclable or biodegradable part of the insertion device from the encapsulated sharp and / or contaminated part after use of the insertion device. The disadvantages are solved by a device, a kit, and a method for inserting at least a part of a medical device into a subject having the features of the independent claims. Advantageous embodiments that can be implemented in isolation or in any arbitrary combination are listed in the dependent claims, the list of embodiments, and throughout the specification.

[0012] As used hereinafter, the terms "having", "including", or "comprising" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms can refer both to the case where no other features exist in the entity described in this context except for the features introduced by these terms, and to the case where one or more additional features exist. As an example, the statements "A has B", "A includes B", and "A comprises B" can refer both to the case where no other elements exist in A except for B (i.e., the case where A consists of B alone and uniquely); and to the case where one or more other elements (such as element C, elements C and D, or even other elements) also exist in entity A in addition to B.

[0013] Further, 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 only used once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, although the corresponding feature or element may be present only once or multiple times, the expressions "at least one" or "one or more" are not repeated.

[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 restricting the possibility of alternatives. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As those skilled in the art will recognize, the present invention can be practiced by using alternative features. Similarly, features introduced by "in an embodiment of the present invention" or similar expressions are intended to be optional features, without any limitation on alternative embodiments of the present invention, without any limitation on the scope of the present invention, and without any limitation on the possibility of combining the features introduced in this way with other optional or non-optional features of the present invention.

[0015] In a first aspect of the present invention, an insertion device for inserting at least a portion of a medical device into a subject's body is disclosed. The insertion device includes a chamber for receiving the medical device; an insertion tool for inserting the medical device or an insertable portion of the medical device; a retraction mechanism for piercing the insertion tool into the subject's body and using it to insert the medical device or an insertable portion of the medical device into the subject's body; a retraction mechanism for retracting the insertion tool from the subject to an end position after insertion; a holding mechanism for holding the insertion tool in the end position after retraction; an inner housing including the holding mechanism and the retracted insertion tool in the end position; and an inserter housing including an insertion mechanism and the inner housing. The inserter housing is formed of a recyclable or biodegradable or compostable material. In addition, the insertion device includes a ejection mechanism for removing the inner housing from the inserter housing when the insertion tool is restricted within the inner housing by the holding mechanism, and the ejection mechanism can be activated by a user.

[0016] The term "insertion device" refers to a device configured to insert a medical device fully or partially into body tissue. The insertion device can be configured to insert a medical device or a portion of a medical device percutaneously or subcutaneously into body tissue, such as by making an incision or puncture in the user's skin and transferring the medical device fully or partially into the body tissue.

[0017] The term "insertion" refers to the act or process of implanting and / or positioning a medical device into and / or within one or more of a user's body tissues, either percutaneously or subcutaneously. A medical device (such as an analyte sensor or a drug delivery device) can be inserted fully or partially into the body tissue. The insertion of the medical device can be performed by using an insertion device. After insertion, the medical device or at least a portion of the medical device can be maintained within the user's body tissue for a predetermined period of time, such as several hours, or several days, or several weeks.

[0018] The term "medical device" refers to any element or object configured for use in the field of medical technology, specifically in the fields of medical analysis or medical diagnosis. A medical device can 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 treatment process, a diagnostic process, or another medical process.

[0019] For example, a medical device can include at least one of the following: a device for delivering at least one therapeutic fluid (such as 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, such as blood glucose or pH value; specifically, at least one analyte sensor for detecting at least one body analyte in at least one body fluid, and more specifically, at least one electrochemical analyte sensor including at least one sensor electrode for detecting at least one analyte.

[0020] A "chamber" for receiving a medical device refers to a void or cavity within an insertion device, in which the medical device can be positioned prior to the insertion step. For example, the chamber can be a void within an inner housing or a void adjacent to the inner housing within an inserter housing. In some embodiments, the chamber includes a retention device that holds or fixes the medical device within the chamber prior to insertion and releases the medical device during or after the insertion step.

[0021] An "insertion tool" refers to a sharp or at least rigid member suitable for entering the skin for inserting a medical device, such as a needle or cannula having a hollow tube and a sharp tip. The insertion tool is considered to be part of the insertion device. However, especially during the manufacture of the insertion device, the insertion tool can also be considered to be part of the medical device. For example, the insertable portion of the medical device (such as a sensor and / or sensor electrode) can be positioned within the insertion tool, such as a needle having a longitudinal slit.

[0022] "Insertion mechanism" refers to the mechanism and / or components for inserting a medical device completely or partially into body tissue. In other words, the insertion mechanism is arranged to move the medical device from a first position, a proximal position, to a second position, a distal position, where in the first position, the medical device is entirely within the insertion device, e.g., at the proximal end of the insertion device, and in the second position, at least a portion of the medical device is outside the insertion device, e.g., protruding from the distal opening of the insertion device. This movement can be caused by a force applied by the user and / or a spring, etc.

[0023] In some embodiments, the medical device includes a conforming unit and a sensor protruding from the lower surface of the conforming unit, where in the second position, the conforming unit is positioned at the distal end of the insertion device such that the lower surface of the conforming unit is within the distal opening of the insertion device and the sensor protrudes from the insertion device.

[0024] The inserter housing can consist of one or two or more parts. For example, the inserter housing includes an insertion cap and a contact sleeve, where the insertion cap can be part of the insertion mechanism. For example, the insertion cap is movable relative to the contact sleeve to move or push the medical device from a proximal position within the contact sleeve to a distal position where the medical device at least partially protrudes from the distal opening of the contact sleeve.

[0025] "Retraction mechanism" refers to the mechanism and / or one or more components for retracting the insertion tool from the user's body tissue after inserting the medical device, i.e., moving the insertion tool from a distal position where it at least partially protrudes from the insertion device to a proximal position within the insertion device, i.e., the end position. The insertion tool can be retracted deeply into the needle housing of the insertion device to minimize the risk of infection as much as possible. After the insertion movement of the insertion tool into the skin, the retraction of the insertion tool can be initiated by the user or automatically.

[0026] "End position" refers to the position where the insertion tool arrives after retraction, at which the insertion tool is completely enclosed within the inner housing.

[0027] "Retention mechanism" refers to the mechanism and / or one or more components for retaining the insertion tool within the insertion device after the insertion tool has been retracted by the retraction mechanism. In some embodiments, the retention mechanism includes a locking device to fix the insertion tool in the position it reaches after being retracted by the retraction mechanism.

[0028] "Inner housing" refers to a housing that at least includes the retention mechanism and the insertion tool at the end position reached after retraction, and the housing prevents any additional contact with the insertion tool. The inner housing encapsulates the insertion tool, thereby encapsulating the sharp and contaminated parts, thus ensuring safe operation of the insertion tool when disassembling the insertion device.

[0029] "Recyclable or biodegradable or compostable material" means any material that, after use, can be converted into new materials, or can be biodegraded and thus decomposed by microorganisms such as bacteria and fungi, or can be composted.

[0030] "Ejection mechanism" means a mechanism (i.e., one or more components) that is configured to disassemble the insertion device and, in particular, to separate the inner housing from the rest of the inserter medical device, in particular from the inserter housing. In this way, the insertion tool can be safely disposed of, and the rest of the insertion device, in particular the inserter housing, can be recycled or composted, thus significantly reducing the environmental burden of the entire system.

[0031] "Capable of being activated" means being configured to activate and / or trigger a function, such as triggering a mechanism such as an ejection mechanism to operate. In the case where the ejection mechanism can be activated by a user, the user can determine the time point at which the insertion device is disassembled.

[0032] An advantage of the insertion device of the present invention is that the sustainability is improved due to the use of recyclable materials as much as possible. Another advantage is that the safety and ease of operation are maintained due to the inventive concept of encapsulating any sharp and / or contaminated parts and providing a mechanism for easily and safely disassembling different parts of the insertion device of the present invention. No additional tools are required, and there is no risk of contacting sharp objects.

[0033] The insertion device may also include a case where the ejection mechanism is configured to retract at least one fastener from a stop position.

[0034] "Fastener" means a device and / or means for fixing a component in a defined position. A fastener such as a pin can be a simple way to fix the inner housing in a fixed position within the inserter housing during use. Then, the ejection mechanism may include at least one tool, part, and / or mechanism to move the fastener from a first position (also referred to as a stop position) so as to fix the inner housing to a second position, where the inner housing can move freely relative to the inserter housing when the fastener is in the second position. Then, the inner housing can be released from the inserter housing, for example, by shear force.

[0035] The insertion device may also include a case where, in order to activate the ejection mechanism, the inserter housing includes at least one button.

[0036] In another embodiment, the ejection mechanism further includes a securing device that must be removed and / or activated in order to push the button to prevent unintentional activation of the ejection mechanism. In an alternative embodiment, the ejection mechanism includes two buttons that must be pressed simultaneously to activate the ejection mechanism. Other safety measures may be included by the ejection mechanism to prevent unintentional activation of the ejection mechanism and / or to prevent activation of the ejection mechanism before the insertion process has occurred (i.e., before the insertion tool has been inserted, retracted, and held in the end position by the corresponding mechanism).

[0037] The insertion device may also include at least one opening to at least partially insert an activation tool into the inserter housing for activating the ejection mechanism. An "activation tool" refers to any part or component configured to trigger the ejection mechanism. For example, the activation tool may include a rod-shaped portion that can be inserted through the opening to activate the ejection mechanism.

[0038] Thereby, the ejection mechanism can be fully retracted into the housing, thereby reducing or avoiding the risk of unintentional actuation.

[0039] The insertion device may also include a case where the insertion device includes a removable component that forms an activation tool when removed from the insertion device.

[0040] For example, a portion of the inserter housing may include an elongated portion, such as a rod or a finger, etc., which can be easily removed from the insertion device, i.e., forms a removable component, and serves as an activation tool.

[0041] The insertion device may also include a case where the removable component of the insertion device is a sealing cap or a part of a sealing cap.

[0042] A "sealing cap" or a safety cap refers to a cap that covers the distal opening of the insertion device as long as the insertion device is not in use. The sealing cap may include an elongated portion that protrudes from the sealing cap after the sealing cap is removed from the insertion device, for example, by pulling or rotating the cap relative to the rest of the insertion device.

[0043] The insertion device may also include a case where at least one opening of the inserter housing is sealed by a removable or breakable lid.

[0044] For example, the opening may be sealed with a sticker label that can be removed or pierced by the activation tool. The lid can help improve hygiene, thereby preventing any contaminants from entering through the opening.

[0045] The insertion device may also include a case where the chamber for receiving the medical device is included by an inner housing.

[0046] Another alternative is to position the medical device in a chamber within the inserter housing that is not included by the inner housing.

[0047] In one aspect, the kit includes the insertion device according to any one of the foregoing claims and a medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The above aspects of the exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments in conjunction with the accompanying drawings, in which:

[0049] Figure 1 The insertion device according to the first embodiment is schematically shown.

[0050] Figure 2 The insertion device according to the second embodiment is schematically shown.

[0051] Figure 3 A sectional view of the insertion device according to a further embodiment is shown.

[0052] Figure 4 An activation tool according to one embodiment is shown.

[0053] Figure 5 The appearance of the insertion device according to one embodiment before use is shown.

[0054] Figure 6 A sectional view of the insertion device according to one embodiment during the insertion process is shown.

[0055] Figure 7 A sectional view of the insertion device according to one embodiment after the insertion process is shown.

[0056] Figure 8 A sectional view of the inner housing according to one embodiment after the ejection process is shown. DETAILED DESCRIPTION

[0057] To facilitate identification of the discussion of any particular element or act, one or more of the most significant digits in the reference numerals refer to the figure number in which the element is first introduced.

[0058] The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Instead, the embodiments are selected and described so that others skilled in the art can understand and appreciate the principles and practices of the present disclosure

[0059] In Figure 1Schematic illustration of certain aspects of an insertion device 102 for inserting at least a portion of a medical device into a subject, according to a first embodiment. The insertion device 102 includes an inner housing 104 that at least encapsulates an insertion tool (not shown) and a holding mechanism for holding the insertion tool within the inner housing 104 after the insertion process. For the insertion process, the inner housing 104 is positioned within an inserter housing 106 made of a recyclable or biodegradable or compostable material. An activation tool (not shown) is inserted via an ejection mechanism, such as through an opening 108 at the distal end of the inserter housing 106, and the inner housing 104 is separable from the inserter housing 106 so that sharp and / or contaminated parts can be safely disposed of separately from the recyclable or biodegradable parts. The ejection mechanism is configured to be activated by a user. The insertion device 102 further includes a chamber 110 within the inserter housing 106, between a proximal opening 112 and the inner housing 104, to receive the medical device.

[0060] Alternatively, as Figure 2 shown, the chamber 206 is included in the inner housing 204 of the insertion device 202 such that the medical device can be received by the inner housing 204 prior to the insertion process.

[0061] Figure 3 Cross-sectional view showing aspects of a kit including an insertion device 302 and a medical device 310, according to an embodiment. The insertion device 302 is shown prior to use, where the inserter housing 304 is combined with a sealing cap 306 to enclose the proximal opening of the inserter housing 304. Preferably, the sealing cap 306 is also made of a recyclable or biodegradable or compostable material. The inner housing 308 is positioned within the inserter housing 304, and the medical device 310 is positioned within the proximal opening of the inner housing 308, where the insertable portion (e.g., sensor electrode) of the medical device 310 is positioned within an insertion tool 312 (such as a longitudinal slit needle) that projects through an opening of the medical device 310 and into the sealing cap 306. The distal end of the insertion tool 312 is fixed in a needle hub 314 within the inner housing 308.

[0062] A retraction mechanism 316 for retracting the insertion tool 312 after insertion is implemented by a retractor that holds the needle hub 314 and a prestressed retraction spring. Together with a locking structure 320 that locks the retractor in the retracted position, the retraction mechanism 316 also forms part of a holding mechanism that holds the insertion tool in an end position within the inner housing 308 after retraction.

[0063] The ejection mechanism 318 is achieved through an opening in the proximal wall of the inserter housing 304 and two flexible arms included in the inserter housing 304. The two flexible arms can reach through the opening, for example, by activating a tool (not shown) and releasing the inner housing 308 from the inserter housing 304 when pressed.

[0064] Figure 4 An embodiment of the seal cap 402 is shown as a removable component having an elongated arm protruding from the side wall. The arm can be used as an activation tool 404, which can activate the ejection mechanism 318 by being inserted through the proximal wall opening by pressing down on the flexible arm.

[0065] Figure 5 The appearance of the insertion device 502 is shown, where the seal cap 504 is attached to the inserter housing 506 such that the protruding arm-shaped activation tool 508 reaches above a part of the inserter housing 506.

[0066] Figure 6 The insertion device 602 during the insertion process is shown. The seal cap is removed, and the inner part of the inserter housing 604 is positioned at the insertion site. The outer cover part of the inserter housing 604 is pushed downward in the proximal direction while moving the medical device 606 and the insertion tool 608 downward, such that the insertion tool 608 protrudes from the inserter housing 604 and is inserted into the subject's body at the insertion site.

[0067] Figure 7 The insertion device 702 after the insertion process is shown. The insertion tool 704 is retracted from the insertion site by a retraction mechanism, i.e., by moving the retractor 708 in the distal direction through a retraction spring 706, and is held by a holding mechanism 722, i.e., the retractor 708 is locked in the retracted position to fix or hold the insertion tool 704 in the end position. Now, the inner housing 710 can be released from the inserter housing 712 by inserting the arm-shaped activation tool 714 of the seal cap 716 through the opening to push down the two lever arms 720 of the ejection mechanism while releasing the lateral holding hook 718. The lateral holding hook 718 serves as a fastener that fixes the inner housing 710 within the inserter housing 712 in the first position (i.e., the so-called stop position), and releases the inner housing 710 when retracting from the stop position to the second laterally expanded position after activating the ejection mechanism.

[0068] Figure 8 The inner housing 802 after being released from the inserter housing by the ejection mechanism is shown. The ejected inner housing 802 includes an insertion tool 804 held within the inner housing 802 by a holding mechanism 806.

[0069] List of drawing elements

[0070] 102 Insertion device

[0071] 104 Inner housing

[0072] 106 Insertor housing

[0073] 108 Opening

[0074] 110 Chamber

[0075] 112 Proximal opening

[0076] 202 Insertion device

[0077] 204 Inner housing

[0078] 206 Chamber

[0079] 302 Insertion device

[0080] 304 Insertor housing

[0081] 306 Sealing cap

[0082] 308 Inner housing

[0083] 310 Medical device

[0084] 312 Insertion tool

[0085] 314 Needle hub

[0086] 316 Retraction mechanism

[0087] 318 Ejection mechanism

[0088] 320 Locking structure

[0089] 402 Sealing cap

[0090] 404 Activation tool

[0091] 502 Insertion device

[0092] 504 Sealing cap

[0093] 506 Insertor housing

[0094] 508 Activation tool

[0095] 602 Insertion device

[0096] 604 Insertor housing

[0097] 606 Medical device

[0098] 608 Insertion tool

[0099] 702 Insertion device

[0100] 704 Insertion tool

[0101] 706 Retraction Spring

[0102] 708 Retractor

[0103] 710 Inner Housing

[0104] 712 Insertion Tool Housing

[0105] 714 Activation Tool

[0106] 716 Sealing Cap

[0107] 718 Lateral Retaining Hook

[0108] 720 Lever Arm

[0109] 722 Retaining Mechanism

[0110] 802 Inner Housing

[0111] 804 Insertion Tool

[0112] 806 Retaining Mechanism

Claims

1. An insertion device (102, 202, 302, 502, 602) for inserting at least a portion of a medical device (310, 606) into a subject, the insertion device comprising: - a chamber (110, 206) for receiving the medical device (310, 606), - an insertion tool (312, 608, 704, 804) for inserting the medical device (310, 606) or an insertable portion of the medical device (310, 606), - an insertion mechanism for piercing the insertion tool (312, 608, 704, 804) into the subject and using it to insert the medical device (310, 606) or the insertable portion of the medical device (310, 606) into the subject, - a retraction mechanism (316) for retracting the insertion tool (312, 608, 704, 804) from the subject to an end position after insertion, - a holding mechanism (722, 806) for holding the insertion tool (312, 608, 704, 804) in the end position after retraction, - an inner housing (104, 204, 308, 710, 802) including the holding mechanism (722, 806) and the retracted insertion tool (312, 608, 704, 804) in the end position, - an inserter housing (106, 304, 506, 604, 712) including the insertion mechanism and the inner housing (104, 204, 308, 710, 802), wherein, - the inserter housing (106, 304, 506, 604, 712) is formed of a recyclable or biodegradable or compostable material, - the insertion device (102, 202, 302, 502, 602) includes an ejection mechanism (318) for removing the inner housing (104, 204, 308, 710, 802) from the inserter housing (106, 304, 506, 604, 712) when the insertion tool (312, 608, 704, 804) is held in the inner housing (104, 204, 308, 710, 802) by the holding mechanism (722, 806), and - the ejection mechanism (318) is activatable by a user.

2. The insertion device according to claim 1, wherein the ejection mechanism (318) is configured to withdraw at least one fastener (718) from a stop position.

3. The insertion device according to claim 2, wherein the inserter housing (106, 304, 506, 604, 712) includes at least one button for activating the ejection mechanism (318).

4. The insertion device according to claim 2, at least one opening for at least partially inserting an activation tool into the inserter housing (106, 304, 506, 604, 712) for activating the ejection mechanism (318).

5. The insertion device according to claim 4, wherein the insertion device (102, 202, 302, 502, 602) comprises a removable part which forms the activation tool when removed from the insertion device (102, 202, 302, 502, 602).

6. The insertion device according to claim 5, wherein the removable part of the insertion device (102, 202, 302, 502, 602) is a sealing cap (306, 402, 504) or a part of the sealing cap.

7. The insertion device according to any one of claims 4 to 6, wherein the at least one opening of the inserter housing (106, 304, 506, 604, 712) is sealed by a removable or breakable lid.

8. The insertion device according to any one of claims 1 to 6, wherein the chamber for receiving the medical device (310, 606) is included by the inner housing (104, 204, 308, 710, 802).

9. A kit comprising the insertion device according to any one of the preceding claims and a medical device (310, 606).

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