Device for use in a drug delivery system - Patent application

Abstract

1. A medical device for fluidly connecting to a medical spike, the device comprising: a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the medical device; and a spike lock mechanism configured to resist withdrawal of the medical spike from the spike port.

Description

[Technical field]

[0001] The subject matter of the present disclosure is in the medical field and relates to devices for use in drug delivery or transport systems. In particular, the subject matter of the present disclosure relates to adapters and devices for connecting between different parts of a drug delivery system to enable drug transport therethrough. [Background technology]

[0002] Drug delivery systems, such as infusion systems, should transport drugs, particularly hazardous drugs, in a safe manner while preventing or at least minimizing exposure of the drug to the environment and people, such as staff or patients.

[0003] Therefore, various devices used with or within a drug delivery system, such as adapters and drug transfer devices, should provide a complete seal to eliminate the possibility of leakage of the drug being transported along the pathway.

[0004] Additionally, the device should provide a tight, preferably airtight connection to other parts of the system to prevent accidental, or sometimes intentional, disconnection between them during use.

[0005] Drug delivery systems are typically designed for single use only, and therefore it is desirable to make them from disposable, lightweight, and drug-compatible materials while ensuring their rigidity and contamination-free qualities. Summary of the Invention

[0006] The subject matter of the present disclosure provides a device for use in a drug delivery or drug transport system. The disclosed device is configured for easy handling and is extremely safe for users (staff and patients) at least in that it provides a reliable, tight connection throughout the system and a completely effective seal during use.

[0007] Typically, the medical spike is inserted into and withdrawn from the spike port under frictional forces exerted on the spike by the spike port, specifically the inner walls of the spike port. The insertion and withdrawal actions are referred to as twist-off actions, in which the spike is rotated and twisted during the insertion and withdrawal actions. It should be noted that typically, once the medical spike is inserted and safely located within the spike port, it is intended to be retained therein and completely discarded after a single use. The frictional forces exerted on the medical spike by the spike port are intended to connect and keep the medical spike securely located inside the spike port and prevent the spike from exiting therefrom.

[0008] The above technique has several drawbacks. First, a certain, but not small, amount of insertion force must be applied by the medical staff to the spike to overcome the frictional forces during the insertion action. It is understood that the greater the friction, the better the retention of the spike in the spike port. Thus, the applied insertion force may cause pain and, less frequently, damage to the hands of the medical staff. The chances of developing pain and causing damage increase with repetitive insertion actions performed on a regular basis. Second, the application of the insertion force to the spike may cause damage to the spike itself. In this case, a very large withdrawal force applied by the medical staff is required to pull out the damaged spike, which also involves the above-mentioned risks, and another insertion action of a new spike. Third, sometimes the spike is not tightly held inside the spike port, and accidental withdrawal of the spike from the spike port, whether intentional or unintentional, may occur, with undesirable exposure to the drug environment.

[0009] The subject matter of the present disclosure provides technology that can securely lock a spike into a spike port while eliminating the risk of the spike being accidentally pulled out of the spike port, even when a relatively large pull-out force is applied.

[0010] Specifically, the subject matter of the present disclosure provides a medical device, and more specifically, a spike port configured to receive therein a medical spike for fluidly connecting the medical device to the medical spike. In conventional ports, friction between the inner surface of the spike port and the outer surface of the spike serves as a spike retention mechanism that resists the spike from accidentally falling off the medical device. However, such friction also contributes to the insertion of the spike into the spike port, and thus the connection. The spike port as described herein largely eliminates friction between the port and the spike, thereby resulting in much easier insertion (with much less insertion force) of the spike into the spike port. Friction between the spike and the portion of the spike port that contacts the spike can be further reduced by using a low friction material such as Teflon® applied to the top of the inner surface of the spike port and / or a lubricant such as silicone oil on the medical spike itself. At the same time, the spike port is configured to resist withdrawal of the spike from the spike port even with reduced friction, since the force required to withdraw the spike from the port is at least three times the force required to insert the spike to connect to the spike port. In one embodiment, the spike port includes a spike lock mechanism for locking the spike inside the spike port, thereby providing the aforementioned resistance to withdrawal of the spike from the spike port. The spike lock mechanism also provides stabilization to the medical spike when the medical spike is received inside the spike port.

[0011] Furthermore, the spike port can have a spike seal element, while the spike includes or does not include a spike lock mechanism configured to seal the interior of the spike port from its exterior when the spike is received in the spike port. The spike seal element is configured primarily to seal fluid flow and is not specifically configured to contribute to either stabilizing or locking the medical spike in the spike port. For example, the spike seal element can be configured to provide very low friction for the spike when it is inserted / withdrawn into / from the spike port. In one implementation, especially if the spike port does not include a spike lock mechanism, the spike port can have a port entrance with a narrower cross section compared to its adjacent regions configured to support and stabilize the spike when it is received inside the port.

[0012] It is therefore to be understood herein that, according to the subject matter of the present disclosure, the spike port provides easy insertion of the spike and difficult withdrawal of the spike without friction between the port and the spike while providing the necessary seal. The spike port can also stabilize the spike within the port by a locking mechanism and / or a narrowed port entrance. The spike port can also have a spike seal element that seals against fluid flow from the spike port, and the spike seal element does not necessarily contribute to locking and / or stabilizing the spike. It is therefore to be understood that the spike port described according to the various aspects and embodiments below can have features related to one or more of easy insertion of the spike, difficult withdrawal of the spike, sealing against fluid flow from the port, and stabilization of the spike in various combinations of the aspects and embodiments detailed in this application.

[0013] According to a first aspect, the presently disclosed subject matter discloses a medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the medical device, and a spike lock mechanism configured to resist withdrawal of the medical spike from the spike port.

[0014] Medical spike, or simply spike, as used herein in this application, refers to a commonly known spike used in medical applications at the end of one part of a drug delivery / transport system to allow for the serial connection of that part to another part of the drug delivery / transport system. Specifically, medical spikes are constructed according to known accepted standards such as ISO 18250-7:2018 and ISO 8536-4:2019, and are sometimes referred to as closed piercing devices. The physical properties of the spike, such as dimensions, tensile strength, insertion force into and withdrawal force from the corresponding spike port, are defined and known.

[0015] The sealing element of the presently disclosed subject matter may be configured to seal the interior of the spike port from the exterior of the spike port such that no leakage occurs when a test spike according to ISO 8536-4 remains inserted in the spike port for 5 hours and then the interior of the spike port distal to the sealing element is exposed to a gauge pressure of 20 kPa for 15 seconds.

[0016] It should be noted that the pull-out force / action of the spike from the spike port, as referred to herein, includes both intentional (e.g., by pulling), unintentional pull-out force / action, such as dropping the device, and natural forces, such as gravity. Additionally, the pull-out force can be an axial and / or rotational (twisting) force. It should also be noted that the spike port has a port longitudinal axis along which the spike is inserted. The spike also has a spike longitudinal axis, such that the spike is inserted into the port such that both the port and spike longitudinal axes are coincident.

[0017] The spike port according to the first aspect may include one or more of the features described below relating to the operation of the locking mechanism. The spike lock mechanism can be located inside the spike port; the spike lock mechanism may be configured to operate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port to resist withdrawal of the medical spike; the spike lock mechanism may be configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port; the spike lock mechanism may be switchable between an unlocked state, which allows insertion of a medical spike into the spike port, and a locked state, which resists withdrawal of the medical spike from the spike port; the spike lock mechanism may be switchable from the unlocked state to the locked state in response to initiation of withdrawal of the medical spike from the spike port; The spike port may comprise a proximal port inlet, a distal port end, and a port longitudinal axis extending between the port inlet and the distal port end, and the spike lock mechanism comprises a spike lock element positioned between the proximal port inlet and the distal port end.

[0018] According to a second aspect of the subject matter of the present disclosure, there is provided a spike lock mechanism configured to be received within a spike port of a medical device and to resist withdrawal of the medical spike when the medical spike is received within the spike port, the spike lock mechanism being switchable between an unlocked state in which insertion of the medical spike into the spike port is permitted and a locked state in which the medical spike resists withdrawal from the spike port, the locked state being automatically activated upon initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port.

[0019] The spike lock mechanism may comprise a spike lock element configured to be positioned within the spike port between a proximal port inlet and a distal port end of the spike port.

[0020] The spike lock element according to the first and / or second aspect may include one or more of the features listed below. the spike lock element may comprise an outer rigid portion and a movable portion which, when positioned within the spike port, extends inwardly from the rigid portion towards the port longitudinal axis and away from the proximal port inlet, and is configured to, upon initiation of withdrawal of the medical spike from the spike port, contact the spike and move further towards the port longitudinal axis and the proximal port inlet, thereby resisting said withdrawal of the spike from the spike port; the movable part is movable at least radially towards the longitudinal axis of the spike port; - said movable portion of the spike locking element may comprise at least one first inwardly protruding element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is located within the spike port, the first protruding elements being configured to actuate by increasing the at least one first element angle upon application of a withdrawal force initiating withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port; The at least one first protruding element may include a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion. - said movable portion of the spike lock element may comprise at least one second protruding element, each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis and greater than said at least one first element angle, and each having at least one second element distal edge, wherein the at least one second protruding element is operatively connected to said at least one first protruding element such that upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port; - upon further application of the withdrawal force, at least the second element distal edge may be configured to cut into an outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port; the at least one second protruding element may include a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge; the spike lock element is configured to be positioned within a seating portion in the spike port and may be configured to freely rotate within the seating portion about the port longitudinal axis; Said intimate contact between the at least one first element distal portion and an outer surface of the medical spike may cause the locking element to rotate as the spike rotates.

[0021] The medical device according to the first aspect may further comprise a port cover member configured to selectively open and close the port entrance.

[0022] According to a third aspect of the subject matter of the present disclosure, there is provided a medical device configured to fluidly connect to a medical spike, the medical device comprising a spike port configured to receive the medical spike therein, the medical device configured to fluidly connect to the medical spike upon insertion of the medical spike into the spike port with a first minimum force, and the spike port configured to resist withdrawal of the medical spike from the spike port with a minimum second force that is at least three times greater than the first force.

[0023] Optionally, the second minimum force may define the minimum force required to withdraw the medical spike from the spike port when the medical spike is connected to the medical device.

[0024] Optionally, the second minimum force may be at least four times greater than the first minimum force.

[0025] Optionally, the second minimum force is at least five times greater than the first force.

[0026] Optionally, the first minimum force is 500 mm min when tested with a test spike according to ISO 8536-4. -1 The insertion speed is up to 40N.

[0027] According to some embodiments, the first minimum force is 500 mm min when tested with a test spike according to ISO 8536-4. -1 or 500 mm min when tested with a test spike according to ISO 8536-4. -1 or 500 mm min when tested with a test spike according to ISO 8536-4. -1 The insertion speed can be up to 25N.

[0028] Optionally, the second minimum force is 100 mm min -1is at least 120 N when measured with the same test spike as used for the first minimum force measurement at a removal rate of 100 rpm.

[0029] According to another embodiment, the second minimum force is 100 mm min 2 with the same test spike as that used for measuring the first minimum force. -1 be at least 105 N when measured at a removal speed of 100 mm min (if the first minimum force is 35 N) or 100 mm min with the same test spike as used for the first minimum force measurement. -1 be at least 90 N (if the first minimum force is 30 N) when measured at a removal speed of 100 mm min -1 be at least 75 N (if the first minimum force is 25 N) when measured at a removal speed of 100 mm min -1 When measured at a removal speed of 100 N, the force may be at least 140 N, 150 N, or 175 N (wherein the first minimum force is a maximum of 40 N).

[0030] According to a fourth aspect of the subject matter of the present disclosure, there is provided a medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising a port distal portion provided in a closed state and configured to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port, a port proximal portion configured to stabilize the medical spike when the medical spike is received in the spike port, and at least one spike seal element located between the port distal portion and the port proximal portion.

[0031] According to a fifth aspect of the subject matter of the present disclosure, there is provided a medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising: a port distal portion provided in a closed state and configured to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port; a port proximal portion; a port longitudinal axis extending between the port distal portion and the port proximal portion; and at least one spike seal element located between the port distal portion and the port proximal portion, the port proximal portion comprising a seating portion configured to accommodate at least one spike lock mechanism.

[0032] The spike seal element can define a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, and the proximal inner surface portion defines a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than the seal minimum diameter.

[0033] The distal inner surface portion may define a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0034] According to a sixth aspect of the subject matter of the present disclosure, there is provided a medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising: a port distal portion configured to be provided in a closed state and to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port; a port proximal portion comprising a port inlet, the port inlet defining an inlet minimum diameter in a cross section taken perpendicular to a port longitudinal axis; and at least one spike seal element located between the port distal portion and the port proximal portion and defining a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, the port proximal portion defining a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than both the inlet minimum diameter and the seal minimum diameter.

[0035] The seal minimum diameter may be greater than the inlet minimum diameter.

[0036] The port distal portion may define a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0037] The port inlet may be stiffer than the spike seal element.

[0038] The medical device according to the fourth, fifth, and / or sixth aspects may include one or more of the features listed below. at least when the medical spike is fully inserted into the spike port, the at least one spike seal element completely circumferentially engages an outer surface of the medical spike, thereby sealing the spike port and preventing fluid leakage from the spike port through the port proximal portion to the exterior of the device; the spike port may have a port inner surface facing an interior of the spike port, the port inner surface comprising a proximal inner surface portion corresponding to a port proximal portion and a distal inner surface portion corresponding to a distal port portion; the at least one spike seal element may be formed as a protrusion extending from an inner port surface toward a port longitudinal axis extending between a port distal portion and a port proximal portion; At least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion may be configured to not contact the medical spike when the medical spike is received within the spike port; the at least one spike seal element may form an integral part of the port inner surface; At least the port distal portion, the at least one spike seal element, and the port interior surface may be formed as a unibody member; the at least one spike seal element may be made from an elastic material; The unibody member may be made of a resilient material; the elastic material may be a thermosetting resin; the port distal portion may comprise a closed region; the closure region may comprise a weakened region configured to be pierced by a distal end of a medical spike during insertion of the medical spike into the spike port, thereby opening a distal portion of the port; The weakened area may have a thickness that is less than the nominal thickness of the distal portion of the port.

[0039] A medical device according to any of the fourth, fifth and / or sixth aspects may include a locking mechanism according to any of the first and second aspects having one or more features with respect to the locking mechanism described for those aspects.

[0040] Furthermore, according to any of the fourth, fifth and sixth aspects, the locking element may be stiffer than the spike seal element.

[0041] The medical device according to any of the first, third, fourth, fifth and sixth aspects may further comprise a fluid inlet port and a first fluid duct connecting between the fluid inlet port and the spike port, thereby enabling fluid communication between a fluid containing device connected to the fluid inlet port and the medical spike located inside the spike port. Optionally, the fluid inlet port may be formed as a second medical spike configured to be inserted into a matching port of a fluid containing device to enable the fluid communication. Optionally, the medical device may further comprise an injection inlet port configured to receive a fluid transfer device therein and a second fluid duct connecting between the injection inlet port and the fluid inlet port, thereby enabling fluid communication between the fluid transfer device and the fluid containing device.

[0042] According to a seventh aspect of the subject matter of the present disclosure, there is provided a medical device for transporting a drug therethrough, the device comprising: a housing having at least two housing portions connected to each other by a snap-fit ​​connection, wherein at least a first housing portion of the at least two housing portions is made from at least one first thermoplastic material; and at least one element at least partially disposed within the housing and configured to pass a drug to the device and be retained by the snap-fit ​​connection of the at least two housing portions, the at least one element being made from at least one second thermoplastic material that is drug compatible and has at least one of the following properties: having a lower stiffness than the at least one first thermoplastic material; and being chemically inert.

[0043] Optionally, the at least one second thermoplastic material may have a lower physical property than the at least one first thermoplastic material, the physical property being at least one of tensile strength, flexural strength, and hardness.

[0044] Optionally, at least a first housing portion may include a protruding arm of the snap-fit ​​connection, which grips a corresponding snap-in portion formed in another housing portion of the at least two housing portions.

[0045] Optionally, the at least two housing portions may be made from at least one first thermoplastic material.

[0046] Optionally, the at least one first thermoplastic material may be a drug incompatible material.

[0047] Optionally, the at least one first thermoplastic material may include acetal.

[0048] Optionally, the at least one second thermoplastic material may include one or more of a non-PVC containing material and polypropylene.

[0049] Optionally, the first housing portion may define an injection inlet port configured to connect to a fluid transfer device and receive a medication from the fluid transfer device.

[0050] Embodiment While a more specific description is provided in the Detailed Description, below are non-limiting examples of different embodiments of the subject matter of the present disclosure. 1. A medical device for fluidly connecting to a medical spike, the device comprising: a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the medical device; a spike lock mechanism configured to resist withdrawal of the medical spike from the spike port.

[0051] 2. A medical device as described in embodiment 1, wherein the spike lock mechanism is located inside the spike port.

[0052] 3. A medical device as described in embodiment 1 or 2, wherein the spike lock mechanism is configured to activate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting withdrawal of the medical spike.

[0053] 4. A medical device as described in embodiment 3, wherein the spike lock mechanism is configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port.

[0054] 5. A medical device as described in any one of embodiments 1 to 4, wherein the spike lock mechanism is switchable between an unlocked state that allows insertion of a medical spike into the spike port, and a locked state that resists withdrawal of the medical spike from the spike port.

[0055] 6. A medical device as described in embodiment 5, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to initiation of withdrawal of the medical spike from the spike port.

[0056] 7. A medical device as described in any one of embodiments 1 to 6, wherein the spike port comprises a proximal port inlet, a distal port end, and a port longitudinal axis extending between the port inlet and the distal port end, and the spike lock mechanism comprises a spike lock element positioned between the proximal port inlet and the distal port end.

[0057] 8. The medical device of embodiment 7, wherein the spike lock element comprises an outer rigid portion and a movable portion extending inwardly from the rigid portion toward the port longitudinal axis and away from the proximal port inlet and configured to contact the spike upon initiation of withdrawal of the medical spike from the spike port and move further toward the port longitudinal axis and the proximal port inlet, thereby resisting withdrawal of the spike from the spike port.

[0058] 9. The medical device of embodiment 8, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0059] 10. A medical device described in any one of embodiments 7 to 9, wherein the spike lock element is positioned along the port longitudinal axis closer to the proximal port inlet than to the distal port end.

[0060] 11. A medical device described in any one of embodiments 7 to 10, wherein the proximal port inlet comprises an inlet edge that extends symmetrically around the port longitudinal axis.

[0061] 12. The medical device of embodiment 8 or any one of embodiments 9 to 11 when dependent on embodiment 8, wherein the movable portion of the spike lock element comprises at least one first inwardly protruding element each inclined at at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is located within the spike port, and the first protruding elements are configured to actuate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port.

[0062] 13. A medical device as described in embodiment 12, wherein the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0063] 14. The medical device of embodiment 12 or 13, wherein the movable portion of the spike lock element comprises at least one second protruding element, each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis and greater than the at least one first element angle, and each having at least one second element distal edge, and the at least one second protruding element is operably connected to the at least one first protruding element such that upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port.

[0064] 15. The medical device of embodiment 14, wherein upon further application of a withdrawal force, at least the second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port.

[0065] 16. A medical device as described in embodiment 14 or 15, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.

[0066] 17. A medical device described in any one of embodiments 7 to 16, wherein the spike port comprises a seating portion configured to accommodate the spike lock element within the spike port and allow free rotation of the spike lock element within the seating portion about the port longitudinal axis.

[0067] 18. A medical device as described in embodiment 17 when dependent on embodiment 12, wherein the intimate contact between at least one first element distal portion and an outer surface of the medical spike rotates the locking element as the spike rotates.

[0068] 19. A medical device according to any one of embodiments 7 to 18, further comprising a port cover member configured to selectively open and close the port entrance.

[0069] 20. A medical device according to any one of embodiments 7 to 19, wherein the spike port comprises a spike seal element located between the proximal port inlet and the distal port end.

[0070] 21. The medical device of embodiment 20, wherein the spike seal element is located between the locking element and the distal port end.

[0071] 22. A medical device as described in embodiment 20 or 21, wherein at least one spike sealing element completely surrounds and engages an outer surface of the medical spike when the medical spike is fully inserted into the spike port, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the device via the proximal port inlet.

[0072] 23. A medical device as described in any one of embodiments 20 to 22, wherein the spike port has a port inner surface facing the port longitudinal axis, the port inner surface comprising a proximal inner surface portion extending between the proximal port inlet and the at least one spike seal element, and a distal inner surface portion extending between the at least one spike seal element and the port distal end.

[0073] 24. A medical device as described in embodiment 23, wherein the spike seal element is formed as a protrusion extending from the inner surface of the port toward the longitudinal axis of the port.

[0074] 25. A medical device as described in embodiment 23 or 24, wherein at least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion is configured not to come into contact with the medical spike when the medical spike is received within the spike port.

[0075] 26. A medical device as described in any one of embodiments 23 to 25, wherein the port inlet defines an inlet minimum diameter in a cross section taken perpendicular to the port longitudinal axis, the spike seal element defines a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, and the proximal inner surface portion defines a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than both the inlet minimum diameter and the seal minimum diameter.

[0076] 27. A medical device as described in embodiment 26 when dependent on embodiment 17, wherein the proximal maximum diameter is the diameter of a cross section taken at the seating portion.

[0077] 28. The medical device of embodiment 27, wherein the seating portion is formed as a groove in the proximal inner surface portion.

[0078] 29. A medical device described in any one of embodiments 26 to 28, wherein the distal inner surface portion defines a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0079] 30. A medical device according to any one of embodiments 20 to 29, wherein the spike seal element is made from an elastic material.

[0080] 31. A medical device as described in embodiment 30, wherein the elastic material is a thermosetting resin.

[0081] 32. A medical device as described in embodiment 30 or 31, wherein the proximal port inlet is stiffer than the spike seal element.

[0082] 33. A medical device according to any one of embodiments 7 to 32, wherein the locking element is stiffer than the proximal port inlet.

[0083] 34. The medical device of any one of claims 1-33, wherein a spike lock mechanism stabilizes the medical spike inside the spike port.

[0084] 35. A medical device configured to fluidly connect to a medical spike, the medical device comprising: 1. A medical device comprising: a spike port configured to receive a medical spike therein, the medical device being configured to fluidly connect to the medical spike upon insertion of the medical spike into the spike port with a first minimum force, and the spike port being configured to resist withdrawal of the medical spike from the spike port with a second minimum force that is at least three times greater than the first force.

[0085] 36. The medical device of embodiment 35, wherein the second minimum force defines the minimum force required to withdraw the medical spike from the spike port when the medical spike is connected to the medical device.

[0086] 37. A medical device as described in embodiment 35 or 36, wherein the second minimum force is at least four times greater than the first minimum force.

[0087] 38. A medical device according to any one of embodiments 35 to 37, wherein the second minimum force is at least 5 times greater than the first force.

[0088] 39. The first minimum force is 500 mm min when tested with a test spike according to ISO 8536-4. -1 The medical device according to any one of embodiments 35 to 38, wherein the insertion force is up to 40 N at an insertion speed of 100 rpm.

[0089] 40. The second smallest force is 100 mm min -140. The medical device of embodiment 39, wherein the force of the first minimum force is at least 120 N when measured with the same test spike used for the first minimum force measurement at a detachment rate of 100 rpm.

[0090] 41. A spike lock mechanism configured to be received within a spike port of a medical device and to resist withdrawal of the medical spike when the medical spike is received within the spike port, the spike lock mechanism being switchable between an unlocked state, which allows insertion of the medical spike into the spike port, and a locked state, which resists withdrawal of the medical spike from the spike port, the locked state being automatically activated upon initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port.

[0091] 42. A spike lock mechanism as described in embodiment 41, wherein the spike lock mechanism comprises a spike lock element configured to be positioned within the spike port between a proximal port inlet and a distal port end of the spike port.

[0092] 43. A spike lock mechanism as described in embodiment 42, wherein the spike lock element comprises an outer rigid portion and a movable portion which, when positioned within the spike port, extends inwardly from the rigid portion toward the port longitudinal axis and away from the proximal port inlet, and is configured to contact the spike upon initiation of withdrawal of the medical spike from the spike port and move further toward the port longitudinal axis and the proximal port inlet, thereby resisting withdrawal of the spike from the spike port.

[0093] 44. A spike lock mechanism as described in embodiment 43, wherein the movable part moves at least radially toward the port longitudinal axis of the spike port.

[0094] 45. A spike lock mechanism as described in embodiment 43 or 44, wherein the movable portion of the spike lock element comprises at least one first inwardly protruding element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is located within the spike port, and the first protruding elements are configured to actuate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port.

[0095] 46. ​​A spike lock mechanism as described in embodiment 45, wherein the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0096] 47. A spike lock mechanism as described in embodiment 45 or 46, wherein the movable portion of the spike lock element comprises at least one second protruding element each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis and greater than the at least one first element angle and each having at least one second element distal edge, and the at least one second protruding element is operably connected to the at least one first protruding element such that upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port.

[0097] 48. A spike lock mechanism as described in embodiment 47, wherein upon further application of a withdrawal force, at least the second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port.

[0098] 49. A spike lock mechanism as described in embodiment 47 or 48, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.

[0099] 50. A spike lock mechanism described in any one of embodiments 41 to 49, wherein the spike lock element is configured to be positioned within a seating portion in the spike port and configured to rotate freely within the seating portion about the port longitudinal axis.

[0100] 51. A medical device as described in embodiment 50 when dependent on embodiment 45, wherein the intimate contact between at least one first element distal portion and an outer surface of the medical spike rotates the locking element as the spike rotates.

[0101] 52. A medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising: a port distal portion provided in a closed state and configured to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port; a port proximal portion configured to stabilize the medical spike when the medical spike is received within the spike port; at least one spike seal element located between the port distal portion and the port proximal portion.

[0102] 53. A medical device as described in embodiment 52, wherein at least one spike sealing element completely surrounds and engages an outer surface of the medical spike when the medical spike is fully inserted into the spike port, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the device via the port proximal portion.

[0103] 54. A medical device as described in embodiment 52 or 53, wherein the spike port has a port inner surface facing the inside of the spike port, the port inner surface comprising a proximal inner surface portion corresponding to the port proximal portion and a distal inner surface portion corresponding to the distal port portion.

[0104] 55. A medical device as described in embodiment 54, wherein the at least one spike seal element is formed as a protrusion extending from an inner surface of the port toward a port longitudinal axis extending between the port distal portion and the port proximal portion.

[0105] 56. A medical device as described in embodiment 54 or 55, wherein at least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion is configured not to come into contact with the medical spike when the medical spike is received within the spike port.

[0106] 57. A medical device as described in any one of embodiments 54 to 56, wherein the spike seal element defines a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, and the proximal inner surface portion defines a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than the seal minimum diameter.

[0107] 58. A medical device as described in embodiment 57, wherein the distal inner surface portion defines a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0108] 59. A medical device according to any one of embodiments 54 to 58, wherein the spike port comprises a spike lock mechanism positioned on the proximal inner surface portion.

[0109] 60. A medical device as described in embodiment 59, wherein the spike lock mechanism is configured to provide stabilization to the medical spike when the medical spike is received within the spike port.

[0110] 61. A medical device as described in embodiment 59 or 60, wherein the spike lock mechanism is configured to resist withdrawal of the medical spike from the spike port.

[0111] 62. A medical device described in any one of embodiments 59 to 61, wherein the spike lock mechanism is configured to activate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting withdrawal of the medical spike.

[0112] 63. A medical device as described in embodiment 62, wherein the spike lock mechanism is configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port.

[0113] 64. A medical device described in any one of embodiments 61 to 63, wherein the spike lock mechanism is switchable between an unlocked state that allows insertion of a medical spike into the spike port and a locked state that resists withdrawal of the medical spike from the spike port.

[0114] 65. A medical device as described in embodiment 64, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to initiation of withdrawal of the medical spike from the spike port.

[0115] 66. A medical device described in any one of embodiments 59 to 65, wherein the proximal inner surface portion comprises a seating portion and the spike lock mechanism comprises a spike lock element positioned within the seating portion.

[0116] 67. The spike lock element has an outer rigid portion and extends inwardly from the rigid portion toward the port longitudinal axis and the port distal portion; 67. The medical device of embodiment 66, comprising: a movable part configured to contact the spike and move further toward the port longitudinal axis and away from the port distal portion upon initiation of withdrawal of the medical spike from the spike port, thereby resisting withdrawal of the spike from the spike port.

[0117] 68. A medical device as described in embodiment 67, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0118] 69. A medical device as described in embodiment 67 or 68, wherein the movable portion of the spike lock element comprises at least one first inwardly protruding element each inclined at at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is positioned within the spike port, and the first protruding elements are configured to actuate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port.

[0119] 70. The medical device of embodiment 69, wherein the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0120] 71. The medical device of embodiment 69 or 70, wherein the movable portion of the spike lock element comprises at least one second protruding element defined relative to a proximal portion of the port longitudinal axis, each having at least one second element angle greater than the at least one first element angle, and each having at least one second element distal edge, and the at least one second protruding element is operably connected to the at least one first protruding element such that, upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port.

[0121] 72. The medical device of embodiment 71, wherein upon further application of a withdrawal force, at least the second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port.

[0122] 73. A medical device as described in embodiment 71 or 72, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.

[0123] 74. A medical device described in any one of embodiments 66 to 73, wherein the seating portion is configured to allow free rotation of the spike lock element within the seating portion about the port longitudinal axis.

[0124] 75. A medical device as described in embodiment 74 when dependent on embodiment 69, wherein the intimate contact between at least one first element distal portion and an outer surface of the medical spike rotates the locking element as the spike rotates.

[0125] 76. A medical device as described in any one of embodiments 54 to 75, wherein the at least one spike seal element forms an integral part of the inner surface of the port.

[0126] 77. A medical device as described in any one of embodiments 54 to 76, wherein at least the port distal portion, the at least one spike seal element, and the port inner surface are formed as a unibody member.

[0127] 78. A medical device as described in any one of embodiments 52 to 77, wherein the at least one spike seal element is made of an elastic material.

[0128] 79. A medical device as described in embodiment 77, wherein the unibody member is made of an elastic material.

[0129] 80. A medical device as described in embodiment 78 or 79, wherein the elastic material is a thermosetting resin.

[0130] 81. A medical device according to any one of embodiments 78 to 80 when dependent on embodiment 66, wherein the spike lock element is stiffer than at least one spike seal element.

[0131] 82. A medical device as described in any one of embodiments 52 to 81, wherein the port distal portion comprises a closed region.

[0132] 83. A medical device as described in embodiment 82, wherein the closure region comprises a weakened region configured to be punctured by a distal end of a medical spike during insertion of the medical spike into the spike port, thereby opening a distal portion of the port.

[0133] 84. A medical device as described in embodiment 83, wherein the weakened area has a thickness less than the nominal thickness of the port distal portion.

[0134] 85. A medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising: a port distal portion provided in a closed state and configured to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port; 1. A medical device comprising: a port proximal portion having a port inlet, the port inlet defining an inlet minimum diameter in a cross section taken perpendicular to a port longitudinal axis; and at least one spike seal element located between the port distal portion and the port proximal portion and defining a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, the port proximal portion defining a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than both the inlet minimum diameter and the seal minimum diameter.

[0135] 86. The medical device of embodiment 85, wherein the seal minimum diameter is greater than the inlet minimum diameter.

[0136] 87. A medical device as described in embodiment 85 or 86, wherein the port distal portion defines a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0137] 88. The medical device of embodiment 87, wherein the proximal maximum diameter is greater than the distal maximum diameter.

[0138] 89. A medical device as described in any one of embodiments 85 to 88, wherein the spike port has a port inner surface facing the inside of the spike port, the port inner surface comprising a proximal inner surface portion corresponding to the port proximal portion and extending between the port inlet and the spike seal element, and a distal inner surface portion corresponding to the distal port portion and extending between the spike seal element and the port distal end.

[0139] 90. A medical device as described in embodiment 89, wherein the at least one spike seal element is formed as a protrusion extending from an inner surface of the port toward a port longitudinal axis extending between the port distal portion and the port proximal portion.

[0140] 91. A medical device as described in embodiment 89 or 90, wherein at least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion is configured not to come into contact with the medical spike when the medical spike is received within the spike port.

[0141] 92. A medical device according to any one of embodiments 89 to 91, wherein the spike port comprises a spike lock mechanism positioned on the proximal inner surface portion between the spike seal element and the port inlet.

[0142] 93. A medical device as described in embodiment 92, wherein the spike lock mechanism is configured to at least stabilize the medical spike when the medical spike is received within the spike port.

[0143] 94. A medical device as described in embodiment 92 or 93, wherein the spike lock mechanism is configured to resist withdrawal of the medical spike from the spike port.

[0144] 95. A medical device described in any one of embodiments 92 to 94, wherein the spike lock mechanism is configured to activate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting withdrawal of the medical spike.

[0145] 96. A medical device as described in embodiment 95, wherein the spike lock mechanism is configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port.

[0146] 97. A medical device described in any one of embodiments 94 to 96, wherein the spike lock mechanism is switchable between an unlocked state that allows insertion of a medical spike into the spike port and a locked state that resists withdrawal of the medical spike from the spike port.

[0147] 98. A medical device as described in embodiment 97, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to initiation of withdrawal of the medical spike from the spike port.

[0148] 99. A medical device as described in any one of embodiments 94 to 98, wherein the proximal inner surface portion comprises a seating portion and the spike lock mechanism comprises a spike lock element positioned within the seating portion.

[0149] 100. The medical device of embodiment 99, wherein the spike lock element comprises an outer rigid portion and a movable portion extending inwardly from the rigid portion toward the port longitudinal axis and the port distal portion and configured to contact the spike upon initiation of withdrawal of the medical spike from the spike port and move further toward the port longitudinal axis and away from the port distal portion, thereby resisting withdrawal of the spike from the spike port.

[0150] 101. A medical device as described in embodiment 100, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0151] 102. A medical device as described in embodiment 100 or 101, wherein the movable portion of the spike lock element comprises at least one first inwardly protruding element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is positioned within the spike port, and the first protruding elements are configured to actuate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port.

[0152] 103. A medical device as described in embodiment 102, wherein the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0153] 104. The medical device of embodiment 102 or 103, wherein the movable portion of the spike lock element comprises at least one second protruding element, each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis and greater than the at least one first element angle, and each having at least one second element distal edge, and the at least one second protruding element is operably connected to the at least one first protruding element such that, upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port.

[0154] 105. A medical device as described in embodiment 104, wherein upon further application of a withdrawal force, at least the second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port.

[0155] 106. A medical device as described in embodiment 104 or 105, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.

[0156] 107. A medical device described in any one of embodiments 99 to 106, wherein the seating portion is configured to allow free rotation of the spike lock element within the seating portion about the port longitudinal axis.

[0157] 108. A medical device as described in embodiment 107 when dependent on embodiment 102, wherein the intimate contact between at least one first element distal portion and an outer surface of the medical spike rotates the locking element as the spike rotates.

[0158] 109. A medical device as described in any one of embodiments 85 to 108, wherein the at least one spike seal element forms an integral part of the port inner surface.

[0159] 110. A medical device as described in any one of embodiments 89 to 109, wherein at least the port distal portion, the at least one spike seal element, and the port inner surface are formed as a unibody member.

[0160] 111. A medical device according to any one of embodiments 85 to 110, wherein the at least one spike seal element is made from an elastic material.

[0161] 112. A medical device as described in embodiment 110, wherein the unibody member is made of an elastic material.

[0162] 113. A medical device as described in embodiment 111 or 112, wherein the elastic material is a thermosetting resin.

[0163] 114. A medical device described in embodiment 92 or any one of embodiments 93 to 113 when dependent on embodiment 92, wherein the spike lock element is stiffer than at least one spike seal element.

[0164] 115. A medical device described in embodiment 92 or any one of embodiments 93 to 114 when dependent on embodiment 92, wherein the spike lock element is more rigid than the port inlet.

[0165] 116. A medical device according to any one of embodiments 85 to 115, wherein the port inlet is more rigid than the spike seal element.

[0166] 117. A medical device according to any one of embodiments 85 to 116, wherein the port distal portion comprises a closed region.

[0167] 118. A medical device as described in embodiment 117, wherein the closure region comprises a weakened region configured to be punctured by a distal end of a medical spike during insertion of the medical spike into the spike port, thereby opening a distal portion of the port.

[0168] 119. A medical device as described in embodiment 118, wherein the weakened area has a thickness less than the nominal thickness of the port distal portion.

[0169] 120. A medical device as described in any one of embodiments 85 to 119, wherein at least one spike sealing element completely surrounds and engages an outer surface of the medical spike when the medical spike is fully inserted into the spike port, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the device via the port proximal portion.

[0170] 121. A medical device for fluidly connecting to a medical spike, the device comprising a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device, the spike port comprising: a port distal portion provided in a closed state and configured to be opened by a spike distal end of the medical spike during initial insertion of the medical spike into the spike port; a proximal portion of the port; a port longitudinal axis extending between a port distal portion and a port proximal portion; at least one spike seal element located between the port distal portion and the port proximal portion, the port proximal portion comprising a seating portion configured to accommodate at least one spike lock mechanism.

[0171] 122. A medical device as described in embodiment 121, wherein at least one spike sealing element completely surrounds and engages an outer surface of the medical spike when the medical spike is fully inserted into the spike port, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the device via the port proximal portion.

[0172] 123. A medical device as described in embodiment 121 or 122, wherein the spike port has a port inner surface facing the inside of the spike port, the port inner surface comprising a proximal inner surface portion corresponding to the port proximal portion and a distal inner surface portion corresponding to the distal port portion.

[0173] 124. A medical device as described in embodiment 123, wherein the at least one spike seal element is formed as a protrusion extending from an inner surface of the port toward a port longitudinal axis extending between the port distal portion and the port proximal portion.

[0174] 125. A medical device as described in embodiment 123 or 124, wherein at least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion is configured not to come into contact with the medical spike when the medical spike is received within the spike port.

[0175] 126. A medical device as described in any one of embodiments 123 to 125, wherein the spike seal element defines a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, and the proximal inner surface portion defines a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than the seal minimum diameter.

[0176] 127. A medical device as described in embodiment 126, wherein the distal inner surface portion defines a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

[0177] 128. A medical device according to any one of embodiments 123 to 127, wherein the spike port comprises a spike lock mechanism positioned on the proximal inner surface portion.

[0178] 129. A medical device as described in embodiment 128, wherein the spike lock mechanism is configured to at least stabilize the medical spike when the medical spike is received within the spike port.

[0179] 130. A medical device as described in embodiment 128 or 129, wherein the spike lock mechanism is configured to resist withdrawal of the medical spike from the spike port.

[0180] 131. A medical device described in any one of embodiments 128 to 130, wherein the spike lock mechanism is configured to activate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting withdrawal of the medical spike.

[0181] 132. A medical device as described in embodiment 131, wherein the spike lock mechanism is configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port.

[0182] 133. A medical device described in any one of embodiments 130 to 132, wherein the spike lock mechanism is switchable between an unlocked state that allows insertion of a medical spike into the spike port and a locked state that resists withdrawal of the medical spike from the spike port.

[0183] 134. A medical device as described in embodiment 133, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to initiation of withdrawal of the medical spike from the spike port.

[0184] 135. A medical device as described in any one of embodiments 128 to 134, wherein the spike lock mechanism comprises a spike lock element positioned within the seating portion.

[0185] 136. A medical device as described in embodiment 135, wherein the spike lock element comprises an outer rigid portion and a movable portion extending inwardly from the rigid portion toward the port longitudinal axis and the port distal portion and configured to contact the spike upon initiation of withdrawal of the medical spike from the spike port and move further toward the port longitudinal axis and away from the port distal portion, thereby resisting withdrawal of the spike from the spike port.

[0186] 137. A medical device as described in embodiment 136, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0187] 138. A medical device as described in embodiment 136 or 137, wherein the movable portion of the spike lock element comprises at least one first inwardly protruding element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts an outer surface of the medical spike when the medical spike is positioned within the spike port, and the first protruding elements are configured to actuate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port.

[0188] 139. A medical device as described in embodiment 138, wherein the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0189] 140. The medical device of embodiment 138 or 139, wherein the movable portion of the spike lock element comprises at least one second protruding element, each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis and greater than the at least one first element angle, and each having at least one second element distal edge, and the at least one second protruding element is operably connected to the at least one first protruding element such that, upon initiation of withdrawal of the medical spike from the spike port, the at least one first element moves toward the port longitudinal axis and the port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact an outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port.

[0190] 141. A medical device as described in embodiment 140, wherein upon further application of a withdrawal force, at least the second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting withdrawal of the spike from the spike port.

[0191] 142. A medical device as described in embodiment 140 or 141, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.

[0192] 143. A medical device described in any one of embodiments 135 to 142, wherein the seating portion is configured to allow free rotation of the spike lock element within the seating portion about the port longitudinal axis.

[0193] 144. A medical device as described in embodiment 143 when dependent on embodiment 138, wherein the intimate contact between at least one first element distal portion and an outer surface of the medical spike rotates the locking element as the spike rotates.

[0194] 145. A medical device according to any one of embodiments 121 to 144, wherein the at least one spike seal element forms an integral part of the inner surface of the port.

[0195] 146. A medical device as described in any one of embodiments 121 to 144, wherein at least the port distal portion, the at least one spike seal element, and the port inner surface are formed as a unibody member.

[0196] 147. A medical device according to any one of embodiments 121 to 146, wherein the at least one spike seal element is made of an elastic material.

[0197] 148. A medical device as described in embodiment 146, wherein the unibody member is made of an elastic material.

[0198] 149. A medical device as described in embodiment 147 or 148, wherein the elastic material is a thermosetting resin.

[0199] 150. A medical device according to any one of embodiments 147 to 149 when dependent on embodiment 135, wherein the spike lock element is stiffer than at least one spike seal element.

[0200] 151. A medical device according to any one of embodiments 121 to 150, wherein the port distal portion comprises a closed region.

[0201] 152. A medical device as described in embodiment 151, wherein the closure region comprises a weakened region configured to be punctured by a distal end of a medical spike during insertion of the medical spike into the spike port, thereby opening a distal portion of the port.

[0202] 153. A medical device as described in embodiment 152, wherein the weakened area has a thickness less than the nominal thickness of the port distal portion.

[0203] 154. A medical device described in any one of embodiments 1 to 40 and embodiments 52 to 153, further comprising a fluid inlet port and a first fluid duct connecting between the fluid inlet port and the spike port, thereby enabling fluid communication between a fluid-containing device connected to the fluid inlet port and the medical spike located inside the spike port.

[0204] 155. A medical device as described in embodiment 154, wherein the fluid inlet port is formed as a second medical spike configured to be inserted into a matching port of a fluid-containing device to enable the fluid communication.

[0205] 156. A medical device as described in embodiment 154 or 155, further comprising an injection inlet port configured to receive a fluid transfer device therein, and a second fluid duct connecting between the injection inlet port and the fluid inlet port, thereby enabling fluid communication between the fluid transfer device and the fluid containing device.

[0206] 157. A medical device for transporting a drug therethrough, the device comprising at least two housing parts connected to each other by a snap-fit ​​connection, the housing comprising at least a first housing part of the at least two housing parts being made from at least one first thermoplastic material; and at least one element at least partially disposed within the housing and configured to pass a drug through the device and be retained by said snap-fit ​​connection of the at least two housing portions, wherein the at least one element is made from at least one second thermoplastic material that is drug compatible and has at least one of the following properties: lower stiffness than the at least one first thermoplastic material; and chemically inert.

[0207] 158. A medical device as described in embodiment 157, wherein the at least one second thermoplastic material has lower physical properties than the at least one first thermoplastic material, the physical properties being at least one of tensile strength, flexural strength, and hardness.

[0208] 159. A medical device as described in embodiment 157 or 158, wherein the at least a first housing portion has a protruding arm of the snap-fit ​​connection, the protruding arm gripping a corresponding snap-in portion formed in another housing portion of the at least two housing portions.

[0209] 160. A medical device as described in any one of embodiments 157 to 159, wherein the at least two housing portions are made from at least one first thermoplastic material.

[0210] 161. A medical device as described in any one of embodiments 157 to 159, wherein the at least one first thermoplastic material is a drug-incompatible material.

[0211] 162. The medical device of any one of embodiments 157-161, wherein the at least one first thermoplastic material comprises acetal.

[0212] 163. The medical device of any one of embodiments 157-162, wherein the at least one second thermoplastic material comprises one or more of a non-PVC-containing material and polypropylene.

[0213] 164. A medical device described in any one of embodiments 157 to 163, wherein the first housing portion defines an injection inlet port configured to connect to a fluid transfer device and receive a medication from the fluid transfer device. [Brief description of the drawings]

[0214] For a better understanding of the subject matter disclosed herein, and to illustrate how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: [Figure 1A] 1 is a perspective view of a non-limiting example of a medical device incorporating the subject matter of the present disclosure. [Figure 1B] FIG. 1B is a cross-sectional view of the medical device of FIG. 1A taken along line AA. [Figure 2A] FIG. 1C is an expanded view of the cross-sectional view of FIG. 1B showing a non-limiting example of a spike lock element according to a first aspect of the presently disclosed subject matter. [Figure 2B] FIG. 1B is an exploded close-up view of the spike-receiving portion of the medical device of FIG. 1A showing the spike lock element. [Figure 2C] 2A-2F are different close-up views of the spike lock element, FIG. 2C being a perspective view, FIG. 2D being a side view, FIG. 2E being a front view, and FIG. 2F being a rear view. [Figure 2D] 2A-2F are different close-up views of the spike lock element, FIG. 2C being a perspective view, FIG. 2D being a side view, FIG. 2E being a front view, and FIG. 2F being a rear view. [Figure 2E] 2A-2F are different close-up views of the spike lock element, FIG. 2C being a perspective view, FIG. 2D being a side view, FIG. 2E being a front view, and FIG. 2F being a rear view. [Figure 2F]2A-2F are different enlarged views of the spike lock element, FIG. 2C being a perspective view, FIG. 2D being a side view, FIG. 2E being a front view, and FIG. 2F being a rear view. [Figure 3A] 1C is an enlarged view of the cross-sectional view of FIG. 1B showing a non-limiting example of a spike port including a port seal and a spike stabilizing element according to a second aspect of the presently disclosed subject matter. [Figure 3B] 1B is an exploded perspective view of the medical device of FIG. 1A showing a non-limiting example of a spike port according to the subject matter of the present disclosure. [Figure 3C] FIG. 1 is an enlarged view of a spike port. [Figure 3D] FIG. 3D is a cross-sectional view of the spike port taken along line BB of FIG. 3C. [Figure 4A] 4A is a perspective view of a spike approaching the medical device of FIG. 1A, illustrating the insertion and locking of a spike into a spike port constructed in accordance with the subject matter of the present disclosure. [Figure 4B] 4A and 4B are perspective views showing the insertion and locking of a spike into a spike port constructed in accordance with the subject matter of the present disclosure. [Figure 4C] 4A-4C are enlarged cross-sectional views illustrating the insertion and locking of a spike into a spike port constructed in accordance with the subject matter of the present disclosure, and the interaction between the spike and a sealing element of the spike port. [Figure 4D] 4D is a perspective view of a spike lock element showing the insertion and locking of a spike into a spike port constructed in accordance with the presently disclosed subject matter; [Figure 5A] 5A is an enlarged view of the drug injection portion of the medical device of FIG. 1A showing a third embodiment of the presently disclosed subject matter, and FIG. 5A shows a snap-fit ​​connection between the two housing portions in a closed state. [Figure 5B] 5A shows a third embodiment of the presently disclosed subject matter; FIG. 5B shows an enlarged view of the drug injection portion of the medical device of FIG. 1A, with FIG. 5B showing the two housing portions separated. [Figure 5C]5A is an enlarged view of a drug injection portion of the medical device of FIG. 1A, showing a third embodiment of the presently disclosed subject matter, and FIG. 5C is an exploded view of the device of FIG. 4A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0215] Reference is made to FIGS. 1A-1B, which show a medical device 10 according to a non-limiting embodiment of the presently disclosed subject matter. FIG. 1A is a perspective view of the medical device 10, and FIG. 1B is a cross-sectional view of the medical device 10 along line AA as shown in FIG. 1A. The medical device 10, in this non-limiting example, is a spike adapter configured to be connected between at least two other devices at once to establish a fluid connection between them when the medical device 10 is an intermediate device. It is noted that spike adapters and their basic functionality are generally known in the art and are described briefly herein for clarity and completeness. The medical device 10 illustrated herein incorporates aspects of the presently disclosed subject matter as described in detail herein below. However, it is noted that describing different aspects, particularly with respect to spike ports, with reference to the medical device 10, which in this particular example is a spike adapter, should not be specifically mentioned herein and should not limit the broad aspects of the presently disclosed subject matter, which may be utilized and practiced in various other medical devices, examples of which may be IV bags, adapters, etc.

[0216] While all embodiments of the medical devices illustrated herein are configured to be used for connection with any standard spike, regardless of its shape and / or size, via their spike ports, it should be understood herein that any such standard spike is constructed in accordance with known accepted standards, such as ISO 18250-7:2018 and / or ISO 8536-4:2019.

[0217] As shown in the figures, the medical device 10 includes a body having three body portions 100, 200, and 300, each terminating in at least one fluid inlet and / or outlet. The body portion 100 includes a spike port 102 configured to receive a medical spike therein and establish fluid communication between the medical spike and the medical device 10 through a port inlet 104, as further shown below. Thus, the body portion 100 is referred to as the spike receiving portion. The medical spike essentially forms an inlet and / or outlet to a second medical device, such as an infusion set, configured to be connected to a patient's body to deliver a medication thereto.

[0218] In some embodiments, the port inlet can act not only as an opening through which the spike is introduced into the spike port, but also as a spike stabilizer. In such a case, the port inlet includes an inlet edge extending symmetrically around the port longitudinal axis, which contacts a proximal portion of the spike's outer surface when the spike is received inside the spike port, thereby stabilizing the spike and concentrating the spike along the port longitudinal axis inside the spike port. The inlet edge contacts a proximal portion of the spike's outer surface when the spike is fully inserted into the port. It should be understood that, for the purposes of this description, fully inserted spike is intended to mean that the spike is inserted into the port to the extent necessary and sufficient for effective connection of the spike with the port to establish the desired fluid communication between the medical device and the medical spike.

[0219] In other embodiments, the port inlet may not be stabilized, or may not even actually contact the medical spike when the spike is connected to the medical device, in which case stabilization is provided by other means / elements as described in further detail below.

[0220] The body portion 200 is configured as a second medical spike 202 terminating in at least one fluid inlet / outlet 204. The body portion 200 is therefore referred to as a spike terminal portion. The medical spike 202 is configured to be connected to a spike port of a third medical device and establish fluid communication with the spike port via at least one fluid inlet / outlet 204 such that fluid communication is established between the third medical device and the medical device 10. For example, the third medical device may be a drug bag having a spike port (which may be configured according to the subject matter of the present disclosure) that receives the spike 202, such that fluid communication is established through the medical device 10 between the drug bag connected to the spike 202 and the patient connected to the spike received in the spike port 102. This exemplary fluid connection is indicated by arrow D1 in FIG. 1B, where the fluid path begins at the fluid inlet 2041, forms at least one fluid inlet / outlet at the end of the spike 202, and progresses through dedicated ducts / channels inside the medical device 10 until it enters the medical spike received within the spike port 102.

[0221] The body portion 300 is configured as a fluid transfer device 302 utilizing contamination-free fluid transfer, such as the techniques and devices described in WO 08 / 129550, assigned to the assignee of the present application. The contamination-free fluid transfer device 302, referred to as the drug injection portion of the device 10, terminates in a fluid inlet 304 configured to connect to an external second fluid transfer device, such as a syringe, from which it receives fluid and transports the fluid through the medical device 10 via a dedicated internal duct / channel to another external device, such as a drug bag, connected to the spike 202 via a fluid outlet 2042. The fluid inlet 304 may be configured as an injection fluid inlet configured to receive fluid by injection from an injection device, such as a syringe. The fluid path between the inlet 304 and the outlet 2042 is illustrated by the arrow D2. This fluid transfer controlled by the fluid transfer device 302 may be used to transfer a drug into a bag drug, possibly including another drug, where different drugs mix, before connecting an infusion set to the spike port 102 to administer the mixed drug to the patient.

[0222] Reference is now made to Figures 2A and 2B, which show a first embodiment of the subject matter of the present disclosure. Figure 2A is an enlarged view of a cross section of the body portion 100 and the spike port 102 as shown in Figure 1B. Figure 2B is an exploded perspective view of some of the elements of the body portion 100. As shown, the spike port 102 includes a spike lock mechanism 110 on its proximal side (i.e., the side closer to the port inlet 104), which allows a spike inserted into the spike port 102 along the port's longitudinal axis PA to be securely locked inside the spike port 102, thereby eliminating the risk of the spike being accidentally pulled out of the spike port 102, even when a relatively large pull-out force is applied. Thus, the spike port 102 provides resistance to the withdrawal of the spike from the spike port 102.

[0223] Generally, according to one embodiment, the spike port is configured to allow the medical spike to be easily inserted into the spike port in order to fluidly connect the medical spike to the medical device. The spike port provides a resistance to the insertion of the spike therein that can be overcome by a first minimum force, due to friction between the inner surface of the spike port and the outer surface of the spike, and / or due to a pierceable closed area in the spike port. In other words, the spike can be connected to the medical device when inserted into the spike port with a first minimum force. For the purposes of understanding this description, the term connected in relation to the fluid connection between the spike and the medical device is intended to mean that the spike is effectively connected to the medical device and ready for use in the transfer of a drug. Thus, the first minimum force defines the minimum force required to insert the spike into the spike port in order to be connected to the medical device.

[0224] In this specification, the first minimum force, in other words the force required to insert the spike into the spike port for connection, is 500 mm min when tested with a standard plastic test spike, e.g., one manufactured according to ISO 8536-4. -1 It should be understood that the insertion speed is measured at 100 rpm.

[0225] The first minimum force mentioned above is much less than the minimum force required for insertion of a medical spike (similar to that mentioned herein) in a conventional spike port known in the art. The spike port according to the present description provides much less friction to the spike during insertion than is provided by a conventional spike port. For example, the spike port 102 (described later in this specification according to a non-limiting example) is configured such that a majority of the inner surface of the spike port remains free of (not in contact with) the spike when the spike is inserted into the spike port.

[0226] Meanwhile, at the same time, the spike port is configured such that the spike cannot be easily pulled out of the spike port. In other words, the spike port is configured to make it more difficult to pull out the spike therefrom, compared to conventional spike ports. For example, the spike port resists the withdrawal of the spike from the spike port with a second minimum force that is at least three times greater than the first minimum force. The second minimum force defines the minimum force required to pull out the spike from the spike port by overcoming the resistance provided by the spike port to the withdrawal when the medical spike is connected to the medical device, by friction and / or by locking as described according to the non-limiting examples described later in this specification.

[0227] In certain embodiments, the second minimum force can be at least 4 times, at least 5 times, or even at least 6 times greater than the first minimum force. In certain embodiments, the second minimum force can be of a magnitude that resists withdrawal so as to effectively prevent withdrawal of the spike from the spike port. The term "prevent" is intended to mean resisting withdrawal to the extent that the spike cannot be withdrawn from the spike port without likely destroying or damaging at least one of the spike or the spike port. There may be locking mechanisms that lock the spike and resist withdrawal of the spike similarly effective as those described herein, but without damaging the spike or the port upon withdrawal, and all such locking mechanisms are considered to be within the scope of this application.

[0228] According to some embodiments, the first minimum force is 500 mm min when tested with a test spike according to ISO 8536-4. -1 or 500 mm min when tested with a test spike according to ISO 8536-4. -1 or 500 mm min when tested with a test spike according to ISO 8536-4. -1or 500 mm min when tested with a test spike according to ISO 8536-4. -1 The insertion speed can be up to 25N.

[0229] According to the above example of the first minimum force, the second minimum force is 100 mm min -1 may be at least 120 N (if the first minimum force is 40 N) when measured at a removal speed of 100 mm min -1 may be at least 105 N (if the first minimum force is 35 N) when measured at a removal speed of 100 mm min -1 may be at least 90 N (if the first minimum force is 30 N) when measured at a removal speed of 100 mm min -1 may be at least 75 N (if the first minimum force is 25 N) when measured at a removal speed of 100 mm min -1 When measured at a removal speed of 100 N, the force may be at least 140 N, 150 N, or 175 N (wherein the first minimum force is a maximum of 40 N).

[0230] Thus, the spike port is configured to provide very low resistance to the insertion of the spike into the spike port and at the same time provide very high resistance to the withdrawal of the spike. In fact, the spike port according to the subject matter of the present disclosure eliminates the need for friction between the inner surface of the spike port and the spike to resist withdrawal of the spike. To reduce the resistance provided by the spike port to the spike during insertion of the spike, a lubricant such as silicone oil and / or a low resistance material such as Teflon can be used on the inner portion of the spike port that contacts the spike, thereby reducing friction. Thus, resistance to withdrawal is achieved by a locking mechanism (described in detail herein below) instead of friction as in conventional spike ports. Such a lock provides improved resistance to withdrawal of the spike, which is highly desirable and necessary in drug delivery systems, especially those dealing with hazardous drugs.

[0231] It should be understood that in this specification, resistance to insertion is intended to mean the resistance offered by the spike port to the insertion of the spike into the spike port when the spike is almost completely inserted therein, and resistance to withdrawal is intended to mean the resistance offered by the port to the withdrawal of the spike from the port at the beginning of the withdrawal, i.e. as soon as a withdrawal force (manual or natural, axial and / or rotational) is applied. In other words, even when the spike is almost completely inserted in the port, the resistance to insertion is significantly less than the resistance to withdrawal even at the beginning (start) of the withdrawal.

[0232] The term "at least resist" is also intended to include within its scope the above meaning of the term prevent.

[0233] It should be understood that, in this specification, the pull-out force / action of the spike from the spike port 102 includes intentional (e.g., by pulling), unintentional pull-out force / action such as a jerk, and natural forces such as gravity, and the forces include axial and rotational forces instead of or in addition to the axial force. Next, the operation of the spike port 102 described above will be described in detail with reference to Figures 2A-4D. To resist the pull-out of the spike from the spike port 102, according to the illustrated embodiment, the spike port 102 includes a locking mechanism 110. The spike locking mechanism 110 is configured to resist the pull-out of the spike from the spike port 102 at least to the extent that the outer surface of the spike contacts the spike locking mechanism 110 when the spike is at least partially received in the spike port 102.

[0234] The spike lock mechanism 110 is configured to be actuated in response to the initiation of withdrawal of the medical spike from the spike port 102, thereby locking the spike inside the spike port 102. It should be understood that, for the purposes of this description, herein, the term actuated with respect to the lock mechanism is intended to mean a state in which the lock mechanism grips the spike strongly enough to at least resist withdrawal of the spike from the port, and the term locking is intended to mean gripping the spike strongly enough to at least resist withdrawal of the spike from the port. Although the lock mechanism is in contact with the spike even prior to its actuation, the lock mechanism grips the spike strongly enough to resist withdrawal of the spike only upon actuation, i.e., when the lock mechanism locks the spike. The spike lock mechanism 110 is configured to automatically actuate upon application of a withdrawal force, i.e., in response to application of a withdrawal force. The only action required to actuate the spike lock mechanism is the initial application of a withdrawal force.

[0235] The spike lock mechanism 110 is mostly transparent with respect to the insertion of the spike, only minimally interacts with or contacts the spike when the spike is inserted into the spike port 102 so as not to stiffen the insertion of the spike into the spike port or while disposed therein, and only operates or activates when a withdrawal action is engaged, as further exemplified herein below. Thus, the spike lock mechanism 110 is configured to have two states, an unlocked state in which the insertion of the medical spike into the spike port 102 is permitted, and a locked state that at least resists withdrawal of the medical spike from the spike port 102. Thus, the spike lock mechanism 110 may switch from the unlocked state to the locked state when a withdrawal force is initiated. It should be understood that, herein, activation of the spike lock mechanism is intended to have the same meaning as the spike lock mechanism switching to its locked state.

[0236] 2A and 2B, the medical device includes a port cover member 130 that selectively covers the port inlet 104 when a spike is not inserted into the spike port 102 and exposes the port inlet 104 to allow for insertion of a spike. It will be appreciated that the port inlet 104 can be attached to the body portion 100 in a variety of ways. For example, it can form an integral part of the body portion 100. In another embodiment, it can be releasably attached to the body portion 100. In the described embodiment, the port inlet 104 includes a plurality of pockets 132 (generally at least two) that form part of a snap-fit ​​connection and are connected to a compliant arm 134 that extends proximally from the body portion 100.

[0237] In some embodiments, the spike lock mechanism 110 includes at least one spike lock element positioned between the port inlet 104 and the distal end 1021 of the spike port 102. In the described example, the spike lock mechanism 110 includes a spike lock element 1101. In general, the spike lock element can be positioned at any point along the port longitudinal axis between the port inlet and the distal port end. In the described non-limiting example, the spike lock element 1101 is positioned closer to the port inlet 104 than the distal port end 1021. This configuration can be advantageous for integrating the spike lock mechanism 110, and specifically the spike lock element 1101, into any spike port in general. Additionally, this positioning helps prevent debris potentially resulting from the spike locking action from being released into the medication and transported through the spike to the patient when the spike lock element 1101 is locked to the outer surface of the spike, as described further below.

[0238] In some embodiments, as described further below, the spike port includes a seating portion configured to receive the spike lock element within the spike port and allow free rotation of the spike lock element within the seating portion. Allowing free rotation of the spike lock element enhances spike locking and resists withdrawal of the spike, as it negates the option of withdrawing the spike by rotating it within the spike port.

[0239] Please refer to Figures 2C-2F, which show different views of the spike lock element 1101. Figure 2C is a perspective view, Figure 2D is a side view, Figure 2E is a front view (seen from the distal side of the spike port) and Figure 2F is a rear view (seen from the proximal side of the spike port). The spike lock element 1101 includes an outer rigid part 1102, which allows the element to be positioned within the spike port 102 and typically contacts the inner surface of the spike port 102, and a movable part 1104, which extends radially inward from the rigid part 1102, i.e., towards the longitudinal axis PA and towards the distal side of the port, and is configured to move further towards the longitudinal axis PA and away from the distal side of the port (i.e., towards the port inlet 104) upon initiation of withdrawal of the medical spike from the spike port 102. The rigid part has a profile that allows the spike lock element to rotate inside the spike port. In some non-limiting examples, the rigid portion has an annular shape that traces the circular cross section of the lumen of the spike port. In this example, the rigid portion 1102 has a semicircular symmetrical outer shape to reduce contact with the surroundings, thus allowing for smoother rotation with the locked spike when the spike is located inside the spike port. The movable portion 1104 moves along at least the radial direction R of the spike port 102 toward the port longitudinal axis PA of the spike port 102. In some embodiments, the movable portion of the spike lock element includes at least one first inwardly protruding element each inclined at at least one first element angle defined relative to a proximal portion of the port longitudinal axis and each having at least one first element distal portion that contacts the outer surface of the spike when the medical spike is received in the spike port 102. In the described embodiment, the spike lock element 1101 includes a plurality of first inwardly protruding elements 1106, i.e., six first protruding elements, each of which is inclined at at least one first element angle α defined relative to a proximal portion of the port longitudinal axis PA, and each of which has at least one first element distal portion 1106P.At least one first protruding element 1106 is configured to actuate by increasing at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port, such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists withdrawal of the medical spike from the spike port. For example, when the spike is inserted into the spike port 102, the outer surface of the spike contacts the first element distal portion 1106P. At the start of withdrawal of the spike, the spike tends to move (or move slightly) out of the spike port 102, thereby moving the first element distal portion 1106P in a direction toward the port longitudinal axis as well as in a direction away from the distal side of the spike port 102 by pivoting the first element distal portion 1106P at their respective connection points with the outer rigid portion to increase the first element angle α. Such movement causes the first element distal portions 1106P to tighten their contact with the outer surface of the spike, thereby gripping the spike more tightly and locking it inside the spike port. In some embodiments, the at least one first protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

[0240] In some embodiments, the movable portion of the spike lock element includes at least one second protruding element, each having at least one second element angle defined relative to a proximal portion of the port longitudinal axis PA that is greater than the at least one first element angle of the at least one first protruding element, and each having at least one second element distal edge. In the illustrated example, the movable portion 1104 of the spike lock element 1101 includes six second protruding elements 1108, each having at least one second element angle β defined relative to a proximal portion of the port longitudinal axis PA that is greater than α, and each having at least one second element distal edge 1108E that contacts the outer surface of the medical spike upon actuation. The second protruding element 1108 is operably connected to the first protruding element 1106 such that, in response to initiation of withdrawal of the medical spike from the spike port, the at least one first element 1106 moves as described above to move the at least one second protruding element 1108 at least toward the port longitudinal axis and increase the at least one second element angle, thereby causing the at least one second element distal edge to contact the outer surface of the medical spike, thereby further resisting withdrawal of the spike from the spike port. For example, the second protruding element 1108 is operably connected to the first protruding element 1106 via an outer rigid portion. Thus, the above-mentioned movement of the first protruding element in response to initiation of withdrawal, the second protruding element 1108 also moves at least in a direction toward the longitudinal axis PA and increases the second element angle β, thereby causing the second element distal edge 1108E to contact the outer surface of the spike, thereby further restricting withdrawal of the spike. Further application of the pull-out force causes the second element 1108 to move further, further increasing the second element angle β, thereby causing the second element distal edge 1108E to cut into the outer surface of the spike, thereby more tightly resisting pull-out of the spike from the spike port. In some embodiments, the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles defining the at least one second element angle and a corresponding plurality of leg distal edges defining the at least one second element distal edge.Further, in the illustrated embodiment, each of the second protruding elements 1108 is surrounded by two adjacent protruding elements 1106 (one on either side). In some embodiments, the number of protruding elements 1106 can be different from the number of second protruding elements 1108. The first protruding element acts as a primary locking point and the second protruding element acts as a secondary locking point and is a more aggressive locker than the first protruding element. In some embodiments, the locking element, or at least the second protruding element, is made of a material, such as a metal, that is hard / rigid enough to cut into the surface of the spike.

[0241] Typically, the spike lock mechanism contacts the spike during the insertion phase and locks the spike in the spike port in response to the initiation of withdrawal. Specifically, the spike lock mechanism can apply a first and a second resistance force to the medical spike during insertion and withdrawal of the medical spike into and from the spike port, respectively, where the first resistance force is negligible (or at least three times smaller) than the second resistance force as described above. In the described embodiment, the diameter D defined by an imaginary circle inscribed by the first protruding element is smaller than the diameter D' of a similar imaginary circle inscribed by the second protruding element, thereby causing the first protruding element to initially engage the spike, and the second protruding element to engage the spike only upon activation of the lock mechanism. In other embodiments, both of these diameters may be equal. This contact between the first protruding elements during insertion of the spike also stabilizes the spike inside the spike port, in which case the spike lock element serves as a spike stabilizer.

[0242] As described above with reference to FIG. 2A, the spike port 102 includes a seating portion 106 that houses the spike locking element 1101, specifically the rigid portion 1102. Specifically, the seating portion 106 is formed as a groove on the inner surface of the spike port that houses the rigid portion of the spike locking element while keeping it rotatable inside the port, thereby enhancing the locking of the spike as it rotates with the spike when it is subjected to a rotational pull-out force, and thus resisting the spike being pulled out of the spike port by rotating the spike. In the illustrated embodiment, one wall of the groove 106 is formed by the port inlet 104, however, in some embodiments where the port inlet need not be structured as described herein and where the proximal most opening of the spike port functions as the port inlet without a reduced diameter as shown herein, the groove may still be formed on the inner surface of the spike port.

[0243] While the locking mechanism, and more specifically the locking element, is illustrated herein as a continuous annular structure, it is understood herein that in some embodiments the locking mechanism can have separate protruding elements distributed about the longitudinal axis within the seating portion and configured to operate in the same manner as the locking elements described above, while in other embodiments the locking mechanism can have a structure that differs from that described above while still being configured to serve the purposes described above.

[0244] 3A-3D, the above-mentioned features relating to easy insertion of a spike into the spike port 102 will now be described in detail. As described above, the medical device 10 includes a spike port configured to receive a medical spike therein and establish fluid communication therewith. It should be noted that the medical device 10 can incorporate both the above-mentioned aspects relating to the spike lock mechanism as well as the aspects described herein below relating to easy insertion, stabilization, and sealing of a spike into the spike port, but can also incorporate either independently. The examples described herein should not be construed as limiting different and separate but combinable aspects of the disclosed subject matter.

[0245] According to the following description, a solution to the large and difficult spike insertion force required and the spike safety retention requirement mentioned above is provided. As shown in FIG. 3A, which shows a close-up of a perspective cross section along line AA in FIG. 1A, the medical device 10 includes a spike port 102 including a port distal portion 1022 provided in a closed state in a closed region constituted by a port distal end 1021 and configured to be opened by the distal end of the spike during insertion of the medical spike into the spike port 102. The closed region may be in other regions of the spike port in other embodiments. The spike port 102 also includes a port proximal portion 1023 including a port inlet 104 and configured to stabilize the medical spike when the medical spike is received in the spike port 102, and at least one sealing element 1024 located between the port distal portion 1022 and the port proximal portion 1023. In some embodiments, the spike port may not include a port inlet (i.e., with a reduced diameter compared to its adjacent portions) as described herein, and the open proximal end (without a reduced diameter) may act as the port inlet. In such embodiments, stabilization may be achieved by a locking mechanism positioned in a seating portion formed in the form of a groove in the proximal portion of the spike port.

[0246] The sealing element 1024 is configured to seal the spike port 102 and prevent leakage therefrom through the port inlet 104. It should be understood that, as used herein, the sealing element 1024 functions solely as a sealing element without substantially contributing to the stabilization provided by either the port inlet and / or the locking mechanism.

[0247] The sealing element 1024 is configured to seal the interior of the spike port from the exterior of the spike port such that no leakage occurs when a test spike according to ISO 8536-4 remains inserted in the spike port for 5 hours and then the interior of the spike port distal to the sealing element is exposed to a gauge pressure of 20 kPa for 15 seconds. As mentioned above, the separation between the stabilizing function and the sealing function, which in common practice is generally assigned to the port inlet, makes it possible to reduce the insertion force required to overcome the large frictional forces into the spike port by reducing the contact surface between the spike port and the spike on one side and by allowing the use of different materials with different stiffness and flexibility properties on the other side. Thus, friction can be further reduced by using low-friction materials such as Teflon and / or by using lubricants such as silicone oil in the sealing element, thereby largely eliminating friction between the spike port and the spike while achieving resistance to withdrawal by the locking mechanism as described above.

[0248] As shown, the spike port 102 has a port inner surface / lumen 1025 including a proximal port inner surface 1025A corresponding to the port proximal portion 1023 and extending between the port inlet and at least one sealing element 1024, and a distal port inner surface 1025B corresponding to the port distal portion 1022 and extending between the at least one sealing element 1024 and the port distal end. The port lumen is essentially circular and symmetrical. In this case, the port inlet 104 and each one of the at least one sealing element 1024 respectively define an inlet minimum diameter A4 in a cross section taken at the proximal port inlet perpendicular to the longitudinal axis and a seal minimum diameter A2 in a cross section taken at the sealing element 1024 perpendicular to the longitudinal axis. The seal minimum diameter A2 is smaller than the inlet minimum diameter A4. Each one of the proximal port inner surface portion 1025A and the distal port inner surface portion 1025B defines a proximal maximum diameter A1 in a cross section taken at the proximal portion (specifically the seating portion) perpendicular to the longitudinal axis, and a distal maximum diameter A3 in a cross section taken at the distal portion (specifically adjacent the sealing element) perpendicular to the longitudinal axis. The proximal maximum diameter A1 is larger than the distal maximum diameter A3. The proximal maximum diameter A1 is also larger than both the inlet minimum diameter A4 and the seal minimum diameter A2. The seal minimum diameter A2 is smaller than the distal maximum diameter A3. In this way, the contact surface between the spike and the lumen 1025 of the spike port is absent or at least reduced, resulting in reduced frictional forces and therefore reduced spike insertion forces.

[0249] When the spike is fully received within the spike port, the spike seal element completely surrounds the medical spike, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the medical device through the port proximal portion. For example, the spike seal element is a ring having an annular shape as in the described embodiment, which contacts the entire circumference of the ring portion of the outer surface of the spike. In other words, the spike seal element circumferentially envelops a portion of the medical spike, i.e., completely covers and tightly engages the circular portion of the outer surface of the spike when the spike is received inside the spike port.

[0250] In the illustrated embodiment, at least one spike seal element 1024 is formed as a protrusion extending radially inward from the port inner surface 1025 toward the port longitudinal axis PA.

[0251] In some embodiments, the at least one spike seal element forms an integral part of the port inner surface, as in the illustrated examples, hi some embodiments, the at least one spike seal element is a separate element, such as a ring, that is inserted into and attached to the inner surface of the port transversely to the longitudinal axis of the port.

[0252] In some embodiments, at least one sealing element is made from an elastic material, thereby further reducing frictional forces, while the stabilizing element forming at least a part of the port proximal portion is made from a harder, more rigid material to hold the spike firmly in place. In the described example, the stabilizing element is essentially a spike lock mechanism 110.

[0253] In some embodiments, the port distal portion, at least one sealing element, and the port inner surface are formed as a single body / unibody member. This can be advantageous in manufacturing processes using, for example, molding techniques. In one example, the unibody member is made of an elastic material. In some embodiments, the elastic material is a thermosetting resin. As shown in Figures 3B-3D, where Figure 3B shows a partially exploded perspective view of the body portion 100, Figure 3C shows one form of a spike port, and Figure 3D is a cross-sectional view of Figure 3C along line BB, in the illustrated example, the spike port has a unibody shape 1026, a port distal portion 1022 (including a port distal end 1021), a sealing element 1024, and a port inner surface 1025, apart from a port proximal portion at least partially constituted by a port cover member 130. The unibody 1026 is securely received inside the body portion 100 (spike receiving portion). In the illustrated embodiment, the unibody 1026 includes an integral ridge portion 1026R in the form of a ring that is received in a matching recess 107 in the body portion 100. This securely fixes the port unibody 1026 in place without the need for adhesive materials and allows the port unibody to be manufactured from a thermosetting material, particularly a drug compatible soft elastic material such as silicone. As can be seen, the port unibody 1026 is held securely in place by attaching the port inlet 104 to the body portion 100 (using a snap-fit ​​connection) from the proximal side (right side of the illustrated figure). Thus, the port inlet 104 includes a circular rim 136 that presses against the proximal side of the ridge 1026, and the distal side of the ridge 1026R presses against a circular rim 108 formed on the body portion 100. This configuration allows all associated parts to be attached without the use of adhesive materials.

[0254] As mentioned above, the port distal portion / end is provided in a closed state to prevent leakage of the drug from the medical device into the spike port prior to connecting the medical spike. Indeed, in most cases, connecting the medical spike is the last step to establish a fluid connection through the fluid transfer system. In some embodiments, the port distal portion includes a plug configured to be pushed by the spike distal end during insertion of the medical spike into the spike port, thereby opening the port distal portion. In some embodiments, the port distal portion includes a weakened region configured to be punctured by the spike distal end during insertion of the medical spike into the spike port, thereby opening the port distal portion. In one example, the weakened region has a thickness less than the nominal thickness of the port distal portion to facilitate its puncture by the spike distal end. In the illustrated embodiment, as shown in Figures 3C and 3D, the port distal end 1021 is provided in a closed state and includes a weakened region 1021W in the form of a depression having a cross shape such that the wall is thinner than other regions of the port distal end and can be weaker and more easily peeled off by the sharp distal end of an inserted spike.

[0255] Reference is made to Figures 4A-4D, which show the interaction between the spikes 20 when inserted into the spike port 102 of the medical device 10. Figure 4A shows the spike 20 approaching the medical device 10. The spike 20 has a spike distal end 22 configured to pierce or puncture the port distal end of the spike port, and an outer surface 24 where the spike interacts with a sealing element and a spike locking element disposed within the spike port. Figure 4B shows the situation when the spike 20 is fully inserted inside the single body 1026 of the spike port, such that the distal portion of the spike 20 protrudes in the distal direction (towards the inside of the device 10). 4C, a close-up cross-sectional view of the spike 20 located inside the spike port of the device 10, shows how the elastic sealing element 1024 is pressed by the outer surface 24 of the spike 20 towards the circumference of the spike port such that sealing of the port is achieved and fluid cannot pass at least from the distal (inner) side of the spike port towards the proximal (outer) side of the spike port. Also shown in the figure are spaces S1 and S2 between the outer surface 24 of the spike 20 and the front and rear inner surfaces (1025A and 1205B) of the sealing element 1024, respectively. Spaces S1 and S2 do not exist in all circumstances and their appearance or value depends on several factors such as the size of the spike, the value of the protrusion of the sealing element from the inner surface of the port, among others.

[0256] FIG. 4D shows the locked state of the spike lock element 1101, which is activated when the spike 20 is received within the spike port and withdrawal of the spike is initiated.

[0257] Reference is now made to Figures 5A-5C, which illustrate a medical device 10 having a third aspect of the presently disclosed subject matter. Again, while the third aspect is illustrated with reference to medical device 10, it should be noted that this should not be construed as limiting any of the described aspects of the presently disclosed subject matter to a particular configuration, and any one of the aspects may be implemented in the same medical device, either independently or in combination with one or more of the other described aspects.

[0258] As mentioned above, the medical device 10 includes a drug injection / delivery device 302 constructed with a body portion 300 and configured to deliver a drug therethrough in a contaminating manner.

[0259] Drug delivery devices should be drug compatible, at least with respect to the parts of the device that come into contact with the drug. Some of the common drug compatible materials used in the manufacture of drug delivery devices include thermoplastic materials such as polypropylene and PVC-free materials. However, these drug compatible thermoplastic materials are relatively soft and have low stiffness, making it difficult to construct the entire body of the drug delivery device from drug compatible thermoplastic materials. Additionally, drug delivery devices often include several functional elements that preferably, but sometimes inevitably, need to be combined together without the use of adhesive materials, and it is necessary that at least the housing of the device is sufficiently rigid to hold the multiple functional elements together. Additionally, some of the drug compatible materials are chemically inert, eliminating the possibility of being combined by being glued together. The subject matter of the present disclosure provides an alternative approach to combining different elements into one device, for example, by utilizing snap-fit ​​connections.

[0260] As shown in the figure, the device 302 includes a housing 300 including at least two housing portions 300A and 300B connected to each other by a factory-set snap-fit ​​connection 300C. At least one of the housing portions 300A and 300B is made from at least one first thermoplastic material having high stiffness, such as acetal. The first thermoplastic material forming the outermost housing portion need not be drug compatible and may be drug incompatible. The second housing portion may be made from the at least one first thermoplastic material or from at least one softer (having lower stiffness) second thermoplastic material. In some embodiments, the at least one second thermoplastic material has a physical property of a lower order of magnitude than the at least one first thermoplastic material, the physical property being at least one of tensile strength, flexural strength, and hardness.

[0261] The device 302 also includes at least one element disposed at least partially inside the housing 300 and configured to pass medication through the device. In the illustrated embodiment, there are multiple internal elements including at least one medication channel and at least one air channel (not specifically shown) housed within an element 308 received within the housing portion 300A, at least one air filter 310, and at least one one-way air valve 312 in communication with the at least one air channel within element 308. Further details regarding such contamination-free medication delivery devices can be found in commonly assigned WO 08 / 129550, as discussed above.

[0262] The elements in contact with the drug, such as element 308, are made from a drug-compatible thermoplastic material having at least one of the following properties: relatively low stiffness, chemical inertness. In the illustrated example, element 308 is made from polypropylene. In some embodiments, the second thermoplastic material is a PVC-free material.

[0263] A snap-fit ​​connection 300C holds the two housing portions 300A and 300B together.

[0264] The snap-fit ​​connection can be a one-fit connection that does not require separation of the parts and does not require any relative movement between the snap-fitted parts before, during or after use. The snap-fit ​​connection can be formed by at least one snap connection element located on a first housing part and at least one matching snap connection element located on a second housing part. In some embodiments, at least the first housing part includes a protruding arm of the snap-fit ​​connection that grips a corresponding snap-in part formed on another housing part of the at least two housing parts. In the illustrated example, there are two similar protruding arms 314 on the first housing 300A and two respective matching snap-in parts 316 (one of which is not explicitly shown) on the second housing 300B. The snap-fit ​​connection 300C is intended as a permanent factory-fit connection that does not require any relative movement between the two housing parts.

Claims

1. 1. A medical device for fluidly connecting to a medical spike, said device comprising: a spike port having a proximal port inlet configured to receive the medical spike therethrough and establish fluid communication between the medical spike and the medical device, the spike port comprising a port longitudinal axis; a spike lock mechanism configured to resist withdrawal of the medical spike from the spike port, the spike lock mechanism comprising a spike lock element having an outer rigid portion and a movable portion extending inwardly from the outer rigid portion toward the port longitudinal axis and away from the proximal port inlet, the movable portion of the spike lock element being: at least one first inwardly projecting element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and having a respective at least one first element distal portion contacting an exterior surface of the medical spike when the medical spike is positioned within the spike port; at least one second protruding element inclined at a respective at least one second element angle defined relative to the proximal portion of the port longitudinal axis, the at least one second element angle being greater than the at least one first element angle, the at least one second protruding element having a respective at least one second element distal edge configured to contact the outer surface of the medical spike.

2. the spike lock mechanism is configured to operate in response to initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting withdrawal of the medical spike; 10. The medical device of claim 1, wherein the spike lock mechanism is configured to automatically activate in response to initiation of withdrawal of the medical spike from the spike port.

3. the spike lock mechanism is switchable between an unlocked state that allows insertion of the medical spike into the spike port and a locked state that resists withdrawal of the medical spike from the spike port; 10. The medical device of claim 1, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to initiation of the withdrawal of the medical spike from the spike port.

4. The medical device of claim 1, wherein the spike lock mechanism is located inside the spike port, the spike port having a distal port end and a port longitudinal axis extending between the proximal port inlet and the distal port end, and the spike lock element is positioned between the proximal port inlet and the distal port end.

5. 2. The medical device of claim 1, wherein the movable portion is configured to contact the spike upon initiation of withdrawal of the medical spike from the spike port and move further toward the port longitudinal axis and the proximal port inlet, thereby resisting the withdrawal of the spike from the spike port.

6. The medical device of claim 1 , wherein the movable portion moves at least radially toward the port longitudinal axis of the spike port.

7. 2. The medical device of claim 1, wherein the at least one first inwardly protruding element is configured to actuate by increasing the at least one first element angle upon application of a withdrawal force initiating withdrawal of the medical spike from the spike port such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists the withdrawal of the medical spike from the spike port.

8. 2. The medical device of claim 1, wherein the at least one first inwardly protruding element includes a plurality of first protruding teeth having a corresponding plurality of first tooth angles defining the at least one first element angle and a corresponding plurality of first tooth distal portions defining the at least one first element distal portion.

9. 2. The medical device of claim 1, wherein the at least one second protruding element is operatively connected to the at least one first inwardly protruding element such that upon initiation of the withdrawal of the medical spike from the spike port, the at least one first inwardly protruding element moves toward the port longitudinal axis and the proximal port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact the outer surface of the medical spike, thereby further resisting the withdrawal of the spike from the spike port.

10. 10. The medical device of claim 9, wherein upon further application of the withdrawal force, the at least second element distal edge is configured to cut into an outer surface of the medical spike, thereby more tightly resisting the withdrawal of the spike from the spike port.

11. 2. The medical device of claim 1, wherein the at least one second protruding element includes a plurality of protruding legs having a corresponding plurality of leg angles that define the at least one second element angle and a corresponding plurality of leg distal edges that define the at least one second element distal edge.

12. 2. The medical device of claim 1, wherein the spike port comprises a seating portion configured to accommodate the spike lock element within the spike port and to allow free rotation of the spike lock element within the seating portion about the port longitudinal axis.

13. 10. The medical device of claim 1, wherein the spike port comprises a spike seal element located between the proximal port inlet and a distal port end of the spike port.

14. the spike port has a port inner surface facing the port longitudinal axis, the port inner surface comprising a proximal inner surface portion extending between the proximal port inlet and the at least one spike seal element, and a distal inner surface portion extending between the at least one spike seal element and the distal port end; 14. The medical device of claim 13, wherein at least one of at least a majority of the proximal inner surface portion and at least a majority of the distal inner surface portion is configured to not contact the medical spike when the medical spike is received within the spike port.

15. the port inlet defines an inlet minimum diameter in a cross section taken perpendicular to the port longitudinal axis, the spike seal element defines a seal minimum diameter in a cross section taken perpendicular to the port longitudinal axis, and the proximal inner surface portion defines a proximal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the proximal maximum diameter being greater than both the inlet minimum diameter and the seal minimum diameter; 15. The medical device of claim 14, wherein the distal inner surface portion defines a distal maximum diameter in a cross section taken perpendicular to the port longitudinal axis, the distal maximum diameter being greater than the seal minimum diameter.

16. The medical device of claim 1 , wherein the spike lock element is stiffer than the proximal port inlet.

17. 10. The medical device of claim 1, wherein the spike lock mechanism stabilizes the medical spike inside the spike port.

18. 1. A spike lock mechanism configured to be received within a spike port of a medical device and to resist withdrawal of a medical spike when the medical spike is received within the spike port, the spike lock mechanism being switchable between an unlocked state, which allows insertion of the medical spike into the spike port, and a locked state, which resists withdrawal of the medical spike from the spike port, the locked state being automatically activated upon initiation of withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port, the spike lock mechanism comprising a spike lock element having an outer rigid portion and a movable portion extending inwardly from the outer rigid portion towards a port longitudinal axis of the spike port and away from a proximal port inlet of the spike port, the movable portion of the spike lock element comprising: at least one first inwardly projecting element inclined at a respective at least one first element angle defined relative to a proximal portion of the port longitudinal axis and having a respective at least one first element distal portion contacting an exterior surface of the medical spike when the medical spike is positioned within the spike port; and at least one second protruding element inclined at a respective at least one second element angle defined relative to the proximal portion of the port longitudinal axis, the at least one second element angle being greater than the at least one first element angle, the at least one second protruding element having a respective at least one second element distal edge configured to contact the outer surface of the medical spike.

19. 20. The spike lock mechanism of claim 18, wherein the at least one first inwardly protruding element is configured to operate by increasing the at least one first element angle upon application of a withdrawal force that initiates withdrawal of the medical spike from the spike port such that the first element distal portion tightens its contact with the outer surface of the medical spike and resists the withdrawal of the medical spike from the spike port.

20. the at least one second protruding element is operatively connected to the at least one first inwardly protruding element such that upon initiation of the withdrawal of the medical spike from the spike port, the at least one first inwardly protruding element moves toward the port longitudinal axis and the inward port inlet, causing the at least one second protruding element to move at least toward the port longitudinal axis to increase the at least one second element angle, thereby causing the at least one second element distal edge to contact the outer surface of the medical spike, thereby further resisting the withdrawal of the spike from the spike port; 20. The spike lock mechanism of claim 18, wherein upon further application of the withdrawal force, the at least second element distal edge is configured to cut into the outer surface of the medical spike, thereby more tightly resisting the withdrawal of the spike from the spike port.

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