Devices for use in drug delivery systems

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

[0002] Drug delivery systems, such as infusion systems, should transport drugs, specifically hazardous drugs, in a safe manner while preventing or at least minimizing exposure of drugs to the environment and to 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 and eliminate the possibility of leakage of drugs being transported along the route.

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

[0005] Drug delivery systems are typically configured for single use only, and therefore, it is desirable to construct them from disposable, lightweight, and drug-compatible materials while ensuring their rigidity and contamination-free quality. [Overview of the project]

[0006] The subject matter of this disclosure provides devices for use in drug delivery or drug transport systems. The disclosed devices are configured for easy handling and are extremely safe for users (staff and patients) in that they provide reliable, tight connections throughout the system and a fully effective seal during use.

[0007] Typically, medical spikes are inserted into and withdrawn from a spike port under frictional force applied to the spike by the spike port, specifically the inner wall of the spike port. The insertion and withdrawal actions are called twist-off actions, during which the spike is rotated and twisted. It should be noted that typically, once a medical spike is inserted and securely positioned within the spike port, it is intended to be retained inside and completely discarded after a single use. The frictional force applied to the medical spike by the spike port is intended to keep the medical spike firmly connected and positioned inside the spike port, preventing it from coming out.

[0008] The above technique has several drawbacks. Firstly, a certain amount of insertion force must be applied to the spike by the medical staff to overcome the frictional force during insertion. It is understood that the greater the friction, the better the spike is retained within the spike port. Therefore, the applied insertion force can cause pain and, less frequently, injury to the medical staff's hands. The chances of developing pain and causing injury increase with repetitive insertion movements, which are usually performed on a basic basis. Secondly, applying insertion force to the spike can damage the spike itself. In this case, a very large withdrawal force applied by the medical staff is required to withdraw the damaged spike, and another insertion movement of a new spike is needed, which carries the aforementioned risks. Thirdly, sometimes the spike is not firmly retained inside the spike port, and accidental withdrawal of the spike from the spike port, whether intentional or unintentional, can occur, resulting in undesirable exposure of the drug to the environment.

[0009] The subject matter of this disclosure provides a technology that can securely lock a spike within a spike port and eliminate the risk of the spike being accidentally pulled out of the spike port, even when a relatively large pulling force is applied.

[0010] Specifically, the subject matter of this disclosure provides a medical device, and more specifically, a spike port configured to receive a medical spike internally for fluid connection of the medical device to a medical spike. In conventional ports, friction between the inner surface of the spike port and the outer surface of the spike acts as a spike-retaining mechanism that resists the spike from accidentally falling out of the medical device. However, such friction also contributes to the insertion, and therefore connection, of the spike into the spike port. Spike ports as described herein greatly eliminate friction between the port and the spike, thereby resulting in much easier (with much less insertion force) insertion of the spike into the spike port. Friction between the portion of the spike port in contact with the spike and the spike can be further reduced by using a low-friction material such as Teflon® applied to the upper 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 the withdrawal of the spike from the spike port, even with reduced friction, such that the force required to pull the spike out of the port is at least three times the force required to insert the spike into the spike port. In one embodiment, the spike port includes a spike lock mechanism to lock the spike inside the spike port, thereby providing the aforementioned resistance to the withdrawal of the spike from the spike port. The spike lock mechanism also provides stabilization of the medical spike when the medical spike is received inside the spike port.

[0011] Furthermore, the spike port may have a spike seal element, while the spike may or may not include a spike lock mechanism configured to seal the inside of the spike port from the outside when the spike is received inside the spike port. The spike seal element is primarily configured to seal fluid flow and is not specifically configured to contribute to either stabilizing or locking the medical spike within the spike port. For example, the spike seal element may be configured to provide very low friction to the spike when it is inserted into / out of the spike port. In one implementation, particularly when the spike port does not include a spike lock mechanism, the spike port may have a port inlet having a narrower cross-section compared to its adjacent regions configured to support and stabilize the spike when the spike is received inside the port.

[0012] Therefore, it should be understood that, according to the subject matter of this disclosure, a spike port provides easy insertion into a spike while providing the necessary seal, and difficult withdrawal of the spike without friction between the port and the spike. Furthermore, a spike port can stabilize a spike within the port by a locking mechanism and / or a narrowed port inlet. A spike port may also have a spike sealing element that seals the fluid flow from the spike port, and such spike sealing element does not necessarily contribute to locking and / or stabilizing the spike. Therefore, it should be understood that the spike ports described according to the various embodiments and examples below may have features relating to one or more of the embodiments and examples detailed in this application, including easy insertion of a spike, difficult withdrawal of a spike, sealing of the fluid flow from the port, and stabilization of the spike.

[0013] According to a first aspect, the subject matter of the present disclosure discloses a medical device for fluid connection to a medical spike, the device comprising: a spike port configured to receive a medical spike internally and to 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] As used herein, medical spikes, or simply spikes, refer to commonly known spikes used in medical applications to enable a series connection of one part of a drug delivery / transfer system to another part of the drug delivery / transfer system at the end of that part. Specifically, medical spikes are constructed in accordance with known and approved standards such as ISO 18250-7:2018 and ISO 8536-4:2019 and are sometimes referred to as closed puncture devices. The physical properties of the spikes, such as dimensions, tensile strength, insertion force into the corresponding spike port, and withdrawal force from the spike port, are defined and known.

[0015] The sealing element of the subject of this disclosure may be configured to seal the inside of a spike port from the outside such that no leakage occurs when a test spike in accordance with ISO 8536-4 is left inserted into the spike port for 5 hours, and then the inside 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 a spike from a spike port includes both intentional (e.g., by pulling) and unintentional pull-out forces / actions, such as dropping the device, and natural forces such as gravity, as referred to herein. Furthermore, the pull-out force may be axial and / or rotational (torsional) force. It should also be noted that a spike port has a port longitudinal axis along which the spike is inserted. Since the spike also has a spike longitudinal axis, the spike is inserted into the port such that both the port and the spike longitudinal axis coincide.

[0017] A spike port according to the first embodiment 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 act in response to the 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. - The spike lock mechanism may be configured to operate automatically in response to the initiation of the withdrawal of the medical spike from the spike port. - The spike lock mechanism may be 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. - The spike lock mechanism may be switchable from the unlocked state to the locked state in response to the 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 longitudinal port 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, a spike lock mechanism is provided which is received in a spike port of a medical device and configured to resist withdrawal of a medical spike when the medical spike is received in the spike port, the spike lock mechanism being 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 locked state which is activated automatically when withdrawal of the medical spike from the spike port is initiated, thereby locking the medical spike in the spike port.

[0019] The spike lock mechanism can include 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 can include one or more of the features listed below. - The spike lock element can include an outer rigid portion and a movable portion that, when positioned within the spike port, extends inwardly away from the proximal port inlet toward the port longitudinal axis and contacts the spike upon initiation of withdrawal of a medical spike from the spike port and further moves toward the port longitudinal axis and the proximal port inlet, thereby being configured to resist the withdrawal of the spike from the spike port. - The movable portion can move at least radially along the port longitudinal axis of the spike port. - The movable portion of the spike lock element can include at least one first inwardly projecting element that is inclined at at least one respective first element angle defined with respect to a proximal portion of the port longitudinal axis and has at least one respective first element distal portion that contacts an outer surface of the medical spike when the medical spike is positioned within the spike port, the first projecting element being configured to operate 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 at least one 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 projecting element can include a plurality of first projecting teeth having corresponding plurality of first tooth angles that define the at least one first element angle and corresponding plurality of first tooth distal portions that define the at least one first element distal portion. - The movable portion of the spike lock element may comprise at least one second protruding element, each having at least one second element angle greater than the angle of the at least one first element, and each having at least one distal edge of the second element, wherein at the start of withdrawal of the medical spike from the spike port, at least one first element moves toward the longitudinal axis of the port and the port inlet, moving at least one second protruding element toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, thereby providing further resistance to withdrawal of the spike from the spike port. -When further pulling force is applied, at least the distal edge of the second element may be configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port. - The at least one second protruding element may include a plurality of protruding legs, each having a plurality of corresponding leg angles defining the angle of the at least one second element, and a plurality of corresponding distal leg edges defining the distal edge of the at least one second element. - The spike lock element is configured to be positioned within a seating portion within a spike port and may be configured to rotate freely within the seating portion around the longitudinal axis of the port. - The close contact between at least one distal portion of the first element and the outer surface of the medical spike may cause the locking element to rotate as the spike rotates.

[0021] A medical device according to the first embodiment may further include a port cover member configured to selectively open and close the port inlet.

[0022] A third aspect of the subject matter of the present disclosure provides a medical device configured to fluidly connect to a medical spike, the medical device comprising a spike port configured to receive a medical spike internally, the medical device being configured to fluidly connect to a 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 by a second minimum force at least three times greater than the first force.

[0023] Optionally, the second minimum force may define the minimum force required to pull a medical spike out of a spike port when it is connected to a 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 in accordance with ISO 8536-4. -1 The maximum insertion speed is 40N.

[0027] According to some embodiments, the first minimum force is 500 mm·min when tested with a test spike in accordance with ISO 8536-4. -1 The insertion speed may be up to 35N, or 500mm·min when tested with a test spike in accordance with ISO 8536-4. -1 The insertion speed may be up to 30N, or 500mm·min when tested with a test spike in accordance with ISO 8536-4. -1 The insertion speed can reach a maximum of 25N.

[0028] Optionally, the second minimum force is 100 mm·min. -1When measured with the same test spike as that used for the measurement of the first minimum force at the removal speed of, it is at least 120 N.

[0029] According to other embodiments, the second minimum force can be at least 105 N when measured with the same test spike as that used for the measurement of the first minimum force at a removal speed of 100 mm·min -1 (when the first minimum force is 35 N), or at least 90 N when measured with the same test spike as that used for the measurement of the first minimum force at a removal speed of 100 mm·min -1 (when the first minimum force is 30 N), or at least 75 N when measured with the same test spike as that used for the measurement of the first minimum force at a removal speed of 100 mm·min -1 (when the first minimum force is 25 N), or at least 140 N, 150 N, or 175 N when measured with the same test spike as that used for the measurement of the first minimum force at a removal speed of 100 mm·min -1 (when the first minimum force is at most 40 N).

[0030] According to a fourth aspect of the subject matter of the present disclosure, a medical device for fluidly connecting to a medical spike is provided. The device includes a spike port configured to receive the medical spike therein and establish fluid communication between the medical spike and the device. The spike port is provided in a closed state and includes a port distal portion configured to be opened by a spike distal end of the medical spike during an 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, and at least one spike seal element positioned between the port distal portion and the port proximal portion.

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

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

[0033] The distal inner surface portion can define the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and this maximum distal diameter is greater than the minimum seal diameter.

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

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

[0036] The distal portion of the port can define the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and this maximum distal diameter is greater than the minimum seal diameter.

[0037] The port inlet may have higher rigidity than the spike seal element.

[0038] Medical devices according to the 4th, 5th, and / or 6th may include one or more of the following features: - At least, when the medical spike is fully inserted into the spike port, at least one spike seal element completely surrounds and engages with the outer surface of the medical spike, thereby sealing the spike port and preventing fluid leakage from the spike port to the outside of the device through the proximal portion of the port. - The spike port may have an inner surface facing the inside of the spike port, and the inner surface of the port comprises a proximal inner surface portion corresponding to the proximal portion of the port and a distal inner surface portion corresponding to the distal portion of the port. - The at least one spike seal element may be formed as a projection extending from the inner surface of the port toward the longitudinal axis of the port, which extends between the distal portion of the port and the proximal portion of the port. - At least one of the proximal inner portion and at least one of the distal inner portion may be configured not to come into contact with the medical spike when the medical spike is received within the spike port. - The at least one spike seal element can form an integral part of the inner surface of the port. -At least the distal portion of the port, the at least one spike seal element, and the inner surface of the port 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 from an elastic material. - The elastic material may be a thermosetting resin. -The distal portion of the port may include a closed region. - The closure region may include a weakening region configured to be punctured by the distal end of the spike during insertion of the medical spike into the spike port, thereby opening the distal portion of the port. - The weakened region may have a thickness 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 embodiments may include a locking mechanism according to any of the first and second embodiments, having one or more features relating to the locking mechanisms described in those embodiments.

[0040] Furthermore, according to any of the fourth, fifth, and sixth embodiments, the locking element may have higher rigidity than the spike seal element.

[0041] A medical device according to any of the first, third, fourth, fifth, and sixth embodiments may further comprise a fluid inlet port and a first fluid duct connecting the fluid inlet port and the spike port, thereby enabling fluid communication between a fluid-containing device connected to the fluid inlet port and a 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 compatible 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 internally and a second fluid duct connecting 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, a medical device is provided for transporting a drug through an interior, the device comprising: a housing comprising at least two housing portions connected to each other by a snap-fit ​​connection, wherein at least the first housing portion of the at least two housing portions is made of at least one first thermoplastic material; and at least one element at least partially disposed within the housing and configured to allow a drug to pass through the device and to be held by the snap-fit ​​connection of the at least two housing portions, wherein at least one element is made of at least one second thermoplastic material having the properties of being drug-compatible and having lower rigidity than the at least one first thermoplastic material, and being chemically inert.

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

[0044] Optionally, at least one housing portion may be provided with 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.

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

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

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

[0048] Optionally, at least one second thermoplastic material may include one or more of the following: PVC-free materials 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 drug from the fluid transfer device.

[0050] Embodiment More specific descriptions are provided in "Modes for Carrying Out the Invention," but the following are non-limiting examples of different embodiments of the subject matter of this disclosure. 1. A medical device for fluid connection to a medical spike, wherein the device is A spike port configured to receive a medical spike internally and to establish fluid communication between the medical spike and the medical device, A medical device comprising a spike lock mechanism configured to resist the withdrawal of a medical spike from a spike port.

[0051] 2. The medical device according to Embodiment 1, wherein the spike lock mechanism is located inside the spike port.

[0052] 3. The medical device according to Embodiment 1 or 2, wherein the spike lock mechanism is configured to act in response to the 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. The medical device according to Embodiment 3, wherein the spike lock mechanism is configured to operate automatically in response to the initiation of withdrawal of a medical spike from the spike port.

[0054] 5. The medical device according to 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. The medical device according to Embodiment 5, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to the initiation of withdrawal of a medical spike from the spike port.

[0056] 7. The medical device according to 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 according to Embodiment 7, wherein the spike lock element comprises an outer rigid portion and a movable portion that extends inward from the rigid portion toward the longitudinal axis of the port toward the proximal port inlet, and is configured to contact the spike and move further toward the longitudinal axis of the port and toward the proximal port inlet at the start of withdrawal of the medical spike from the spike port, thereby resisting withdrawal of the spike from the spike port.

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

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

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

[0061] 12. A medical device according to Embodiment 8 or any one of Embodiments 9 to 11 dependent on Embodiment 8, wherein the movable portion of the spike lock element comprises at least one first inward projecting element, each having at least one first element distal portion that contacts the outer surface of the medical spike when the medical spike is located within the spike port, the first projecting element being configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

[0062] 13. The medical device according to Embodiment 12, wherein the at least one first protruding element includes a plurality of first protruding teeth, each having a plurality of corresponding first tooth angles defining the angle of the at least one first element and a plurality of corresponding first tooth distal portions defining the distal portion of the at least one first element.

[0063] 14. The medical device according to Embodiment 12 or 13, wherein the movable portion of the spike lock element comprises at least one second protruding element having at least one second element angle greater than the angle of the at least one first element and at least one distal edge of the second element, the at least one second protruding element being operably connected to the at least one first protruding element such that, at the start of withdrawal of a medical spike from the spike port, at least one first element moves toward the longitudinal axis of the port and the port inlet, moving at least one second protruding element toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, and thereby providing further resistance to withdrawal of the spike from the spike port.

[0064] 15. The medical device according to Embodiment 14, wherein, when further pulling force is applied, at least the distal edge of the second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port.

[0065] 16. The medical device according to Embodiment 14 or 15, wherein the at least one second protruding element includes a plurality of protruding legs, each having a plurality of corresponding leg angles defining the angle of the at least one second element and a plurality of corresponding distal leg edges defining the distal edge of the at least one second element.

[0066] 17. The medical device according to any one of embodiments 7 to 16, wherein the spike port comprises a seating portion, the seating portion is configured to house the spike lock element within the spike port and to allow free rotation of the spike lock element within the seating portion around the longitudinal axis of the port.

[0067] 18. The medical device according to Embodiment 17, in accordance with Embodiment 12, wherein the close contact between at least one distal portion of a first element and the outer surface of a medical spike causes the locking element to rotate as the spike rotates.

[0068] 19. The 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 inlet.

[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 according to Embodiment 20, wherein the spike seal element is located between the locking element and the distal port end.

[0071] 22. The medical device according to Embodiment 20 or 21, wherein at least one spike seal element completely surrounds and engages with the 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 through the proximal port inlet.

[0072] 23. The medical device according to any one of embodiments 20 to 22, wherein the spike port has an inner surface of the port facing the longitudinal axis of the port, and the inner surface of the port comprises 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 end of the port.

[0073] 24. The medical device according to Embodiment 23, wherein the spike seal element is formed as a projection extending from the inner surface of the port toward the longitudinal axis of the port.

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

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

[0076] 27. The medical device according to Embodiment 26, which is dependent on Embodiment 17, wherein the maximum proximal diameter is the diameter of the cross-section taken at the seating portion.

[0077] 28. The medical device according to Embodiment 27, wherein the seating portion is formed as a groove within the proximal inner surface portion.

[0078] 29. The distal inner surface portion defines the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and the maximum distal diameter is greater than the minimum seal diameter, according to any one of embodiments 26 to 28.

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

[0080] 31. The medical device according to Embodiment 30, wherein the elastic material is a thermosetting resin.

[0081] 32. The medical device according to embodiment 30 or 31, wherein the proximal port inlet is more rigid than the spike seal element.

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

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

[0084] 35. A medical device configured to be fluidly connected to a medical spike, wherein the medical device is A medical device comprising a spike port configured to receive a medical spike internally, wherein the medical device is configured to fluidly connect to the medical spike when the medical spike is inserted into the spike port with a first minimum force, and the spike port is configured to resist the withdrawal of the medical spike from the spike port with a second minimum force at least three times greater than the first force.

[0085] 36. The medical device according to Embodiment 35, wherein the second minimum force defines the minimum force required to pull the medical spike out of the spike port when the medical spike is connected to the medical device.

[0086] 37. The medical device according to 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 five times greater than the first force.

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

[0089] 40. The second minimum force is 100 mm·min. -1The medical device according to Embodiment 39, which is at least 120 N when measured with the same test spike used for measuring the first minimum force at the removal speed.

[0090] 41. A spike lock mechanism that is received in a spike port of a medical device and configured to resist withdrawal of a medical spike when the medical spike is received in the spike port, wherein the spike lock mechanism is switchable between an unlocked state in which insertion of a medical spike into the spike port is permitted and a locked state in which withdrawal of the medical spike from the spike port is resisted, and the locked state is activated automatically when withdrawal of the medical spike from the spike port is initiated, thereby locking the medical spike in the spike port.

[0091] 42. The spike lock mechanism according to embodiment 41, comprising a spike lock element configured to be positioned within the spike port between the proximal port inlet and the distal port end of the spike port.

[0092] 43. The spike lock mechanism according to Embodiment 42, comprising: an outer rigid portion; and a movable portion, when positioned within the spike port, extending inward from the rigid portion toward the longitudinal axis of the port toward the proximal port inlet, and configured to contact the spike and move further toward the longitudinal axis of the port and the proximal port inlet at the start of withdrawal of the medical spike from the spike port, thereby resisting withdrawal of the spike from the spike port.

[0093] 44. The spike lock mechanism according to embodiment 43, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0094] 45. The spike lock mechanism according to Embodiment 43 or 44, wherein the movable portion of the spike lock element comprises at least one first inwardly projecting element, each having at least one first element angle defined with respect to the proximal portion of the port longitudinal axis and having at least one first element distal portion that contacts the outer surface of the medical spike when the medical spike is located within the spike port, the first projecting element is configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

[0095] 46. ​​The spike lock mechanism according to Embodiment 45, wherein the at least one first protruding element includes a plurality of first protruding teeth, each having a plurality of corresponding first tooth angles defining an angle of the at least one first element and a plurality of corresponding first tooth distal portions defining a distal portion of the at least one first element.

[0096] 47. The spike lock mechanism according to Embodiment 45 or 46, wherein the movable portion of the spike lock element comprises at least one second protruding element having at least one second element angle greater than the angle of the at least one first element and at least one distal edge of the second element, the at least one second protruding element being operably connected to the at least one first protruding element such that, at the start of withdrawal of a medical spike from the spike port, the at least one first element moves toward the longitudinal axis of the port and the port inlet, moving the at least one second protruding element at least toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, and thereby providing further resistance to withdrawal of the spike from the spike port.

[0097] 48. The spike lock mechanism according to Embodiment 47, wherein, when further pulling force is applied, at least the distal edge of the second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port.

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

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

[0100] 51. The medical device according to Embodiment 50, as dependent on Embodiment 45, wherein the close contact between at least one distal portion of a first element and the outer surface of a medical spike causes the locking element to rotate as the spike rotates.

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

[0102] 53. The medical device according to Embodiment 52, wherein at least one spike seal element completely surrounds and engages with the 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 through the proximal portion of the port.

[0103] 54. The medical device according to embodiment 52 or 53, wherein the spike port has an inner surface facing the inside of the spike port, and the inner surface of the port comprises a proximal inner surface portion corresponding to the proximal portion of the port and a distal inner surface portion corresponding to the distal port portion.

[0104] 55. The medical device according to Embodiment 54, wherein the at least one spike seal element is formed as a projection extending from the inner surface of the port toward the longitudinal axis of the port, which extends between the distal portion of the port and the proximal portion of the port.

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

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

[0107] 58. The medical device according to Embodiment 57, wherein the distal inner surface portion defines the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and the maximum distal diameter is greater than the minimum seal diameter.

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

[0109] 60. The medical device according to 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. The medical device according to embodiment 59 or 60, wherein the spike lock mechanism is configured to resist the withdrawal of the medical spike from the spike port.

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

[0112] 63. The medical device according to embodiment 62, wherein the spike lock mechanism is configured to operate automatically in response to the initiation of withdrawal of a medical spike from the spike port.

[0113] 64. The medical device according to 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. The medical device according to embodiment 64, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to the initiation of withdrawal of a medical spike from the spike port.

[0115] 66. The medical device according to 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 comprises an outer rigid portion and an inward extension from the rigid portion toward the longitudinal axis of the port and toward the distal portion of the port, The medical device according to embodiment 66, further comprising a movable part configured to contact the spike and move further toward the longitudinal axis of the port toward the distal portion of the port at the start of withdrawal of the medical spike from the spike port, thereby resisting withdrawal of the spike from the spike port.

[0117] 68. The medical device according to embodiment 67, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0118] 69. The medical device according to Embodiment 67 or 68, wherein the movable portion of the spike lock element comprises at least one first inward projecting element, each having at least one first element angle defined with respect to the proximal portion of the port longitudinal axis and at least one first element distal portion that contacts the outer surface of the medical spike when the medical spike is located within the spike port, the first projecting element is configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

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

[0120] 71. The medical device according to Embodiment 69 or 70, wherein the movable portion of the spike lock element comprises at least one second protruding element having at least one second element angle greater than the angle of the at least one first element and at least one distal edge of the second element, the at least one second protruding element being operably connected to the at least one first protruding element such that, at the start of withdrawal of a medical spike from the spike port, at least one first element moves toward the longitudinal axis of the port and the port inlet, moving at least one second protruding element toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, and thereby providing further resistance to withdrawal of the spike from the spike port.

[0121] 72. The medical device according to embodiment 71, wherein, when further pulling force is applied, at least the distal edge of the second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port.

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

[0123] 74. The medical device according to 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 longitudinal axis of the port.

[0124] 75. The medical device according to Embodiment 74, as dependent on Embodiment 69, wherein the close contact between at least one distal portion of a first element and the outer surface of a medical spike causes the locking element to rotate as the spike rotates.

[0125] 76. The medical device according to any one of embodiments 54 to 75, wherein the at least one spike seal element forms an integral portion of the inner surface of the port.

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

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

[0128] 79. The medical device according to embodiment 77, wherein the unibody member is made of an elastic material.

[0129] 80. The medical device according to 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, dependent on embodiment 66, wherein the spike lock element is more rigid than at least one spike seal element.

[0131] 82. The distal portion of the port comprises a closed region, the medical device according to any one of embodiments 52 to 81.

[0132] 83. The medical device according to embodiment 82, wherein the closed area comprises a weakening area configured to be punctured by the distal end of the spike during insertion of the medical spike into the spike port, thereby opening the distal portion of the port.

[0133] 84. The medical device according to Embodiment 83, wherein the weakened region has a thickness less than the nominal thickness of the distal portion of the port.

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

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

[0136] 87. The medical device according to embodiment 85 or 86, wherein the distal portion of the port defines the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and the maximum distal diameter is greater than the minimum seal diameter.

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

[0138] 89. The medical device according to any one of embodiments 85 to 88, wherein the spike port has an inner surface facing the inside of the spike port, and the inner surface of the port comprises a proximal inner surface portion corresponding to the proximal portion of the port 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 distal end of the port.

[0139] 90. The medical device according to Embodiment 89, wherein the at least one spike seal element is formed as a projection extending from the inner surface of the port toward the longitudinal axis of the port that extends between the distal portion of the port and the proximal portion of the port.

[0140] 91. The medical device according to embodiment 89 or 90, wherein at least a large portion of the proximal inner surface and at least one of the distal inner surface are configured not to come into contact with the medical spike when the medical spike is received in 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 located in the proximal inner surface portion between the spike seal element and the port inlet.

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

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

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

[0145] 96. The medical device according to embodiment 95, wherein the spike lock mechanism is configured to operate automatically in response to the initiation of withdrawal of a medical spike from the spike port.

[0146] 97. The medical device according to 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. The medical device according to Embodiment 97, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to the initiation of withdrawal of a medical spike from the spike port.

[0148] 99. The medical device according to any one of embodiments 94 to 98, wherein the proximal inner 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 according to Embodiment 99, wherein the spike lock element comprises an outer rigid portion and a movable portion that extends inward from the rigid portion toward the longitudinal axis of the port and toward the distal portion of the port, and is configured to contact the spike when withdrawal of the medical spike from the spike port begins, and to move further toward the longitudinal axis of the port toward the distal portion of the port, thereby resisting withdrawal of the spike from the spike port.

[0150] 101. The medical device according to Embodiment 100, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0151] 102. The medical device according to Embodiment 100 or 101, wherein the movable portion of the spike lock element comprises at least one first inward projecting element, each having at least one first element distal portion that contacts the outer surface of the medical spike when the medical spike is located within the spike port, the first projecting element being configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

[0152] 103. The medical device according to Embodiment 102, wherein the at least one first protruding element includes a plurality of first protruding teeth, each having a plurality of corresponding first tooth angles defining the angle of the at least one first element and a plurality of corresponding first tooth distal portions defining the distal portion of the at least one first element.

[0153] 104. The medical device according to Embodiment 102 or 103, wherein the movable portion of the spike lock element comprises at least one second protruding element having at least one second element angle greater than the angle of the at least one first element and at least one distal edge of the second element, the at least one second protruding element being operably connected to the at least one first protruding element such that, at the start of withdrawal of a medical spike from the spike port, at least one first element moves toward the longitudinal axis of the port and the port inlet, moving at least one second protruding element toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, and thereby providing further resistance to withdrawal of the spike from the spike port.

[0154] 105. The medical device according to Embodiment 104, wherein, when further pulling force is applied, at least the distal edge of the second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port.

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

[0156] 107. The medical device according to 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 longitudinal axis of the port.

[0157] 108. The medical device according to Embodiment 107, in accordance with Embodiment 102, wherein the close contact between at least one distal portion of a first element and the outer surface of a medical spike causes the locking element to rotate as the spike rotates.

[0158] 109. The medical device according to any one of embodiments 85 to 108, wherein the at least one spike seal element forms an integral portion of the inner surface of the port.

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

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

[0161] 112. The medical device according to embodiment 110, wherein the unibody member is made of an elastic material.

[0162] 113. The medical device according to embodiment 111 or 112, wherein the elastic material is a thermosetting resin.

[0163] 114. The medical device according to Embodiment 92 or any one of Embodiments 93 to 113, if dependent on Embodiment 92, wherein the spike lock element is more rigid than at least one spike seal element.

[0164] 115. The medical device according to Embodiment 92 or any one of Embodiments 93 to 114, wherein the spike lock element is more rigid than the port inlet.

[0165] 116. The 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. The distal portion of the port comprises a closed region, the medical device according to any one of embodiments 85 to 116.

[0167] 118. The medical device according to Embodiment 117, wherein the closure region comprises a weakening region configured to be punctured by the distal end of the spike during insertion of a medical spike into the spike port, thereby opening the distal portion of the port.

[0168] 119. The medical device according to Embodiment 118, wherein the weakened region has a thickness less than the nominal thickness of the distal portion of the port.

[0169] 120. A medical device according to any one of embodiments 85 to 119, wherein at least one spike seal element completely surrounds and engages with the 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 through the proximal portion of the port.

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

[0171] 122. The medical device according to Embodiment 121, wherein at least one spike sealing element completely surrounds and engages with the 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 through the proximal portion of the port.

[0172] 123. The medical device according to embodiment 121 or 122, wherein the spike port has an inner surface facing the inside of the spike port, and the inner surface of the port comprises a proximal inner surface portion corresponding to the proximal portion of the port and a distal inner surface portion corresponding to the distal port portion.

[0173] 124. The medical device according to Embodiment 123, wherein the at least one spike seal element is formed as a projection extending from the inner surface of the port toward the longitudinal axis of the port, which extends between the distal portion of the port and the proximal portion of the port.

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

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

[0176] 127. The medical device according to Embodiment 126, wherein the distal inner surface portion defines the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and the maximum distal diameter is greater than the minimum seal diameter.

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

[0178] 129. The medical device according to Embodiment 128, wherein the spike lock mechanism is configured to at least stabilize the medical spike when the medical spike is received in the spike port.

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

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

[0181] 132. The medical device according to embodiment 131, wherein the spike lock mechanism is configured to operate automatically in response to the initiation of withdrawal of a medical spike from the spike port.

[0182] 133. The medical device according to 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. The medical device according to Embodiment 133, wherein the spike lock mechanism is switchable from an unlocked state to a locked state in response to the initiation of withdrawal of a medical spike from a spike port.

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

[0185] 136. The medical device according to Embodiment 135, wherein the spike lock element comprises an outer rigid portion and a movable portion that extends inward from the rigid portion toward the longitudinal axis of the port and toward the distal portion of the port, and is configured to contact the spike when withdrawal of the medical spike from the spike port begins, and to move further toward the longitudinal axis of the port toward the distal portion of the port, thereby resisting withdrawal of the spike from the spike port.

[0186] 137. The medical device according to embodiment 136, wherein the movable part moves at least radially toward the longitudinal axis of the spike port.

[0187] 138. The medical device according to Embodiment 136 or 137, wherein the movable portion of the spike lock element comprises at least one first inward projecting element, each having at least one first element angle defined with respect to the proximal portion of the port longitudinal axis and at least one first element distal portion that contacts the outer surface of the medical spike when the medical spike is located within the spike port, the first projecting element being configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

[0188] 139. The medical device according to Embodiment 138, wherein the at least one first protruding element includes a plurality of first protruding teeth, each having a plurality of corresponding first tooth angles defining the angle of the at least one first element and a plurality of corresponding first tooth distal portions defining the distal portion of the at least one first element.

[0189] 140. The medical device according to Embodiment 138 or 139, wherein the movable portion of the spike lock element comprises at least one second protruding element having at least one second element angle greater than the angle of the at least one first element and at least one distal edge of the second element, the at least one second protruding element being operably connected to the at least one first protruding element such that, at the start of withdrawal of a medical spike from the spike port, at least one first element moves toward the longitudinal axis of the port and the port inlet, moving at least one second protruding element toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, and thereby providing further resistance to withdrawal of the spike from the spike port.

[0190] 141. The medical device according to Embodiment 140, wherein, when further pulling force is applied, at least the distal edge of the second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pulling of the spike out of the spike port.

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

[0192] 143. The medical device according to 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 longitudinal axis of the port.

[0193] 144. The medical device according to Embodiment 143, in accordance with Embodiment 138, wherein the close contact between at least one distal portion of a first element and the outer surface of a medical spike causes the locking element to rotate as the spike rotates.

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

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

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

[0197] 148. The medical device according to embodiment 146, wherein the unibody component is made of an elastic material.

[0198] 149. The medical device according to 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, dependent on Embodiment 135, wherein the spike lock element is more rigid than at least one spike seal element.

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

[0201] 152. The medical device according to Embodiment 151, wherein the closed region comprises a weakening region configured to be punctured by the distal end of a spike during insertion of a medical spike into the spike port, thereby opening the distal portion of the port.

[0202] 153. The medical device according to Embodiment 152, wherein the weakened region has a thickness less than the nominal thickness of the distal portion of the port.

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

[0204] 155. The medical device according to Embodiment 154, wherein the fluid inlet port is formed as a second medical spike configured to be inserted into a suitable port of a fluid-containing device to enable fluid communication.

[0205] 156. A medical device according to embodiment 154 or 155, further comprising: an injection inlet port configured to receive a fluid transfer device internally; and a second fluid duct connecting 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 through its interior, the device comprising a housing comprising at least two housing portions connected to each other by a snap-fit ​​connection, wherein at least the first housing portion of the at least two housing portions is made of at least one first thermoplastic material, A medical device comprising: at least one element at least partially disposed within a housing, configured to allow a drug to pass through the device and to be held by the snap-fit ​​connection of at least two housing portions, wherein at least one element is made of at least one second thermoplastic material having at least one of the properties of being drug-compatible and having lower rigidity than at least one first thermoplastic material, and being chemically inert.

[0207] 158. The medical device according to 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. The medical device according to embodiment 157 or 158, wherein at least one housing portion comprises 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. The medical device according to 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 according to 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 according to any one of embodiments 157 to 161, wherein the at least one first thermoplastic material comprises acetal.

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

[0213] 164. A medical device according to 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 drug from the fluid transfer device. [Brief explanation of the drawing]

[0214] Embodiments are described herein, only as non-limiting examples, with reference to the accompanying drawings, in order to better understand the subject matter disclosed herein and to illustrate how it can actually be carried out. [Figure 1A] This is a perspective view of a non-limiting embodiment of a medical device incorporating the subject matter of this disclosure. [Figure 1B] This is a cross-sectional view of the medical device shown in Figure 1A along line AA. [Figure 2A] This is an enlarged view of the cross-sectional view of Figure 1B, showing a non-limiting embodiment of a spike lock element according to a first aspect of the subject matter of this disclosure. [Figure 2B] Figure 1A is an exploded view of the spike-receiving portion of the medical device, showing the spike lock element. [Figure 2C] Figure 2C is a perspective view, Figure 2D is a side view, Figure 2E is a front view, and Figure 2F is a rear view. [Figure 2D] Figure 2C is a perspective view, Figure 2D is a side view, Figure 2E is a front view, and Figure 2F is a rear view. [Figure 2E] Figure 2C is a perspective view, Figure 2D is a side view, Figure 2E is a front view, and Figure 2F is a rear view. [Figure 2F]Figure 2C is a perspective view, Figure 2D is a side view, Figure 2E is a front view, and Figure 2F is a rear view. [Figure 3A] This is an enlarged view of the cross-sectional view of Figure 1B, showing a non-limiting embodiment of a spike port, including a port seal and a spike stabilization element, according to a second aspect of the subject matter of the present disclosure. [Figure 3B] Figure 1A is an exploded perspective view of a medical device illustrating a non-limiting embodiment of a spike port according to the subject matter of this disclosure. [Figure 3C] This is a magnified view of the spike port. [Figure 3D] Figure 3C is a cross-sectional view of the spike port along line BB. [Figure 4A] This shows the insertion and locking of a spike into a spike port configured in accordance with the subject matter of this disclosure. Figure 4A is a perspective view showing the spike approaching the medical device of Figure 1A. [Figure 4B] This shows the insertion and locking of a spike into a spike port configured in accordance with the subject matter of this disclosure. Figure 4B is a perspective view showing a spike located inside the spike port of a medical device. [Figure 4C] The insertion and locking of a spike into a spike port configured in accordance with the subject matter of this disclosure is shown. Figure 4C is an enlarged cross-sectional view showing the interaction between the spike and the sealing element of the spike port. [Figure 4D] This shows the insertion and locking of a spike into a spike port configured in accordance with the subject matter of this disclosure. Figure 4D is a perspective view showing the spike lock state of a spike lock element. [Figure 5A] Figure 5A shows a close-up view of the drug injection portion of the medical device of Figure 1A, illustrating a third aspect of the subject matter of this disclosure, and the snap-fit ​​connection between the two housing portions in a closed state. [Figure 5B] Figure 1A is a magnified view of the drug injection portion of the medical device shown in Figure 1A, illustrating a third aspect of the subject matter of this disclosure, and Figure 5B shows the two separated housing portions. [Figure 5C]Figure 1A is an enlarged view of the drug injection portion of the medical device shown in Figure 4A, illustrating a third aspect of the subject matter of this disclosure, and Figure 5C is an exploded view of the device shown in Figure 4A. [Modes for carrying out the invention]

[0215] Refer to Figures 1A and 1B showing a medical device 10 according to a non-limiting embodiment of the subject matter of this disclosure. Figure 1A is a perspective view of the medical device 10, and Figure 1B is a cross-sectional view of the medical device 10 along line AA as shown in Figure 1A. In this non-limiting embodiment, the medical device 10 is a spike adapter configured to connect 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 should be noted that spike adapters and their basic functionality are generally known in the art and are described concisely herein for clarity and completeness. The medical device 10 illustrated herein incorporates aspects of the subject matter of this disclosure as described in detail below herein. However, it should be noted that describing different embodiments, particularly with respect to the spike port, with reference to the medical device 10 which is a spike adapter in this particular embodiment, is not specifically mentioned herein and should not limit the broader aspects of the subject matter of this disclosure, as such examples may be available and practiced in a variety of other medical devices, such as IV bags, adapters, etc.

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

[0217] As shown in the figure, the medical device 10 includes a body having three body sections 100, 200, and 300, each terminating with at least one fluid inlet and / or outlet. Body section 100 includes a spike port 102 configured to receive a medical spike internally through a port inlet 104 and to establish fluid communication between the medical spike and the medical device 10, as further shown below. Thus, body section 100 is referred to as the spike receiving section. 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 and to deliver a drug thereto.

[0218] In some embodiments, the port inlet can function not only as an opening through which a spike is introduced into the spike port, but also as a spike stabilizer. In such cases, the port inlet includes an inlet rim extending symmetrically around the port's longitudinal axis, which contacts the proximal portion of the spike's outer surface when the spike is received inside the spike port, thereby stabilizing the spike and concentrating it along the port's longitudinal axis inside the spike port. The inlet rim contacts the proximal portion of the spike's outer surface when the spike is fully inserted into the port. For the purposes of this description, it should be understood that, in this specification, "fully inserted" means that the spike is inserted into the port to a degree necessary and sufficient for effective connection of the spike with the port in order 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 when the spike is connected to the medical device, or in fact, may not even be in contact with the medical spike. In such cases, stabilization is provided by other means / elements, as further detailed below.

[0220] The main body portion 200 is configured as a second medical spike 202, terminating at least one fluid inlet / outlet 204. Thus, the main body portion 200 is referred to as the spike terminal portion. The medical spike 202 is connected to a spike port of a third medical device and is configured to establish fluid communication with the spike port via at least one fluid inlet / outlet 204, so as to establish fluid communication 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 this disclosure) that receives the spike 202, so that fluid communication is established through the medical device 10 between the drug bag connected to the spike 202 and a patient connected to the spike received in the spike port 102. This exemplary fluid connection is indicated by arrow D1 in Figure 1B, and the fluid path proceeds through a dedicated duct / channel inside the medical device 10, starting from a fluid inlet 2041, forming at least one fluid inlet / outlet at the end of the spike 202, and entering the medical spike received within the spike port 102.

[0221] The main body portion 300 is configured as a fluid transfer device 302 that utilizes contamination-free fluid transfer, such as the technology and devices described in International Publication No. 08 / 129550, which has been assigned to the assignee of this application. The contamination-free fluid transfer device 302, called the drug injection portion of device 10, terminates at 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 it through a dedicated internal duct / channel through the medical device 10 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 arrow D2. This fluid transfer controlled by the fluid transfer device 302 may be used to transfer drugs into a drug bag containing different drugs, possibly including another drug, before connecting the infusion set to the spike port 102 for administering the mixed drugs to a patient.

[0222] Herein, we refer to Figures 2A and 2B illustrating a first aspect of the subject matter of this disclosure. Figure 2A is an enlarged cross-sectional view of the body portion 100 and the spike port 102 as shown in Figure 1B. Figure 2B is an exploded perspective view of some 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 longitudinal axis PA of the port 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 pull-out of the spike from the spike port 102.

[0223] In general, according to one embodiment, a spike port is configured to allow easy insertion of a medical spike into the spike port for fluid connection of the medical spike to a medical device. The spike port provides resistance to the insertion of the spike therein, which can be overcome by a first minimum force, by friction between the inner surface of the spike port and the outer surface of the spike, and / or by a perforable closure area within the spike port. In other words, the spike can be connected to a medical device when inserted into the spike port with a first minimum force. To understand this explanation, the term "connected" in relation to 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 drug delivery. Thus, the first minimum force defines the minimum force required to insert the spike into the spike port in order to connect 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 using a standard plastic test spike, e.g., one manufactured according to ISO 8536-4. -1 Please understand that this is measured by the insertion speed.

[0225] The first minimum force described above is far less than the minimum force required for the insertion of a medical spike (similar to those referred to herein) in a conventional spike port known in the art. The spike port according to this description provides far less friction to the spike during insertion than is provided by conventional spike ports. For example, the spike port 102 (described later herein according to a non-limiting embodiment) is configured such that when the spike is inserted into the spike port, a large portion of the inner surface of the spike port remains in no contact with the spike (not in contact with the spike).

[0226] On the other hand, the spike port is also configured to prevent the spike from being easily pulled out of it. In other words, the spike port is configured to make it more difficult to pull a spike out of it compared to conventional spike ports. For example, the spike port resists pulling a spike out of it with a second minimum force that is at least three times greater than a first minimum force. The second minimum force defines the minimum force required to pull a spike out of the spike port by overcoming resistance through friction and / or by locking, as described in the non-limiting embodiments described later herein, which are provided to pull the medical spike out when it is connected to a medical device.

[0227] In certain embodiments, the second minimum force can be at least four times, at least five times, or even more than six times greater than the first minimum force. In certain embodiments, the second minimum force may be large enough to resist pull-out so as to effectively prevent the pull-out of the spike from the spike port. The term “prevent” is intended to mean resisting pull-out to such an extent that the spike cannot be pulled out of the spike port without likely destroying or damaging at least one of the spike or spike port. Locking mechanisms may exist that lock the spike and are as effective as those described herein, but resist the pull-out of the spike without damaging the spike or port upon pull-out, 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 in accordance with ISO 8536-4. -1 The insertion speed may be up to 40N, or 500mm·min when tested with a test spike in accordance with ISO 8536-4. -1 The insertion speed may be up to 35N, or 500mm·min when tested with a test spike in accordance with ISO 8536-4. -1The insertion speed may be up to 30N, or 500mm·min when tested with a test spike in accordance with ISO 8536-4. -1 The insertion speed can reach a maximum of 25N.

[0229] According to the above example of the first minimum force, the second minimum force is 100 mm·min using the same test spike used for measuring the first minimum force. -1 When measured at the removal speed, it can be at least 120N (if the first minimum force is 40N), or 100mm·min with the same test spike used for measuring the first minimum force. -1 When measured at the removal speed, it can be at least 105N (if the first minimum force is 35N), or 100mm·min with the same test spike used for measuring the first minimum force. -1 When measured at the removal speed, it can be at least 90N (if the first minimum force is 30N), or 100mm·min with the same test spike used for measuring the first minimum force. -1 When measured at the removal speed, it can be at least 75N (if the first minimum force is 25N), or with the same test spike used for measuring the first minimum force, at 100mm·min -1 When measured at the removal speed, it can be at least 140N, 150N, or 175N (if the first minimum force is a maximum of 40N).

[0230] Therefore, the spike port is configured to provide very low resistance to the insertion of a spike into the spike port, and at the same time, very high resistance to the withdrawal of the spike. In fact, the spike port according to the subject matter of this disclosure eliminates the need for friction between the inner surface of the spike port and the spike to resist its withdrawal. To reduce the resistance provided to the spike by the spike port during spike insertion, 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 below herein) instead of friction as in conventional spike ports. Such a lock provides improved resistance to the withdrawal of the spike, which is highly desirable and necessary in drug transfer systems, especially in systems handling hazardous drugs.

[0231] In this specification, resistance to insertion is intended to mean the resistance provided by the spike port to the insertion of a spike into the spike port when the spike is almost completely inserted into the spike port, and resistance to withdrawal is intended to mean the resistance provided by the port to the withdrawal of the spike from the port at the start of 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 into the port, the resistance to insertion is significantly less than the resistance to withdrawal, even at the beginning of withdrawal.

[0232] Furthermore, the term "at least resist" is intended to include, within its scope, the aforementioned meaning of the term "prevent."

[0233] In this specification, the forces / actions that pull out a spike from the spike port 102 include intentional (e.g., by pulling), unintentional pulling forces / actions such as jerks, and natural forces such as gravity, and it should be understood that the forces include axial forces and rotational forces, in place of or in addition to axial forces. Next, the operation of the spike port 102 described above will be explained in detail with reference to Figures 2A to 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 lock mechanism 110 is configured to resist the pull out of the spike from the spike port 102 to the extent that at least the outer surface of the spike is in contact with the spike lock mechanism 110 when the spike is at least partially received within the spike port 102.

[0234] The spike lock mechanism 110 is configured to act 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. For the purposes of this description, the term "actually actualized" with respect to the lock mechanism is intended to mean that the lock mechanism grips the spike sufficiently to resist withdrawal from the port, and the term "locked" is intended to mean that it grips the spike sufficiently to resist withdrawal from the port. The lock mechanism is in contact with the spike even before its actuation, but the lock mechanism grips the spike sufficiently to resist withdrawal only when it is actualized, i.e., when the lock mechanism locks the spike. The spike lock mechanism 110 is configured to act automatically when an extraction force is applied, i.e., in response to the application of an extraction force. The only action required for the spike lock mechanism to actualize is the initial application of the extraction force.

[0235] The spike lock mechanism 110 is almost transparent with respect to the insertion of the spike, and when the spike is inserted into the spike port 102, it interacts with the spike minimally, i.e., only makes contact with the spike, so as not to harden the insertion of the spike into the spike port, or while positioned inside it, and operates only when an extraction operation is involved, i.e., it operates, as further illustrated below herein. Thus, the spike lock mechanism 110 is configured to have two states: an unlocked state in which insertion of a medical spike into the spike port 102 is permitted, and a locked state in which it at least resists the extraction 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 an extraction force is initiated. It should be understood herein that the operation of the spike lock mechanism is intended to have the same meaning as the spike lock mechanism switching to its locked state.

[0236] As shown in Figures 2A and 2B, the medical device includes a port cover member 130 that selectively covers the port inlet 104 when the spike is not inserted into the spike port 102 and exposes the port inlet 104 to allow the spike to be inserted. It is understood 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 may be possible to attach it to the body portion 100 in a detachable manner. In the embodiment described, the port inlet 104 includes a plurality of pockets 132 (generally at least two) that form part of a snap-fit ​​connection and connect to a fitting arm 134 that extends proximal to 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 embodiment described, the spike lock mechanism 110 includes a spike lock element 1101. Generally, the spike lock element can be positioned at any point along the longitudinal axis of the port between the port inlet and the distal port end. In the non-limiting embodiment described, the spike lock element 1101 is positioned closer to the port inlet 104 than to the distal port end 1021. This configuration may be advantageous for integrating the spike lock mechanism 110, specifically the spike lock element 1101, into any spike port in general. Furthermore, this positioning helps prevent potentially generated debris from the spike lock action from being released into the drug and transported to the patient through the spike when the spike lock element 1101 locks onto the outer surface of the spike, as will be further described below.

[0238] In some embodiments, as further described below, the spike port includes a seating portion, which houses the spike lock element within the spike port and is configured to allow free rotation of the spike lock element within the seating portion. Allowing free rotation of the spike lock element enhances the lock on the spike and resists extraction by eliminating the option of pulling the spike out by rotating it within the spike port.

[0239] Refer to Figures 2C to 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 (viewed distal to the spike port), and Figure 2F is a rear view (viewed proximal to the spike port). The spike lock element 1101 includes an outer rigid portion 1102 that 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 portion 1104 that extends radially inward from the rigid portion 1102, i.e., toward the longitudinal axis PA and toward the distal side of the port, and is configured to move further toward the longitudinal axis PA and toward the distal side of the port (i.e., toward the port inlet 104) when the withdrawal of the medical spike from the spike port 102 is initiated. The rigid portion has an external shape that allows the spike lock element to rotate inside the spike port. In some non-limiting embodiments, the rigid portion has an annular shape that traces the circular cross-section of the lumen of the spike port. In this embodiment, the rigid portion 1102 has a semicircular symmetrical shape to reduce contact with the surroundings and thus allows for smoother rotation with the locked spike when the spike is positioned inside the spike port. The movable portion 1104 moves along at least the radial 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 projecting element, each inclined at at least one first element angle defined with respect to the 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 inside the spike port 102. In the embodiment described, the spike lock element 1101 includes a plurality of first inward projecting elements 1106, i.e., six first projecting elements, each of which is inclined at at least one first element angle α defined with respect to the proximal portion of the port longitudinal axis PA, and each has at least one first element distal portion 1106P.At least one first protruding element 1106 is configured to act by increasing the angle of at least one first element when an extraction force is applied that initiates the extraction of a medical spike from the spike port, so that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port. For example, when a spike is inserted into the spike port 102, the outer surface of the spike contacts the distal portion 1106P of the first element. At the initiation of the extraction of the spike, the spike tends to move out of (or slightly out of) the spike port 102, thereby causing the distal portion 1106P of the first element to move in the direction toward the longitudinal axis of the port and away from the distal side of the spike port 102, by the pivoting of the distal portion 1006P of the first element at their respective connection points with the outer rigid portion to increase the first element angle α. Such movement causes the distal portion 1106P of the first element to tighten their contact with the outer surface of the spike, thereby gripping the spike more tightly and locking the spike inside the spike port. In some embodiments, at least one first projection element includes a plurality of first projection teeth having a plurality of corresponding first tooth angles defining at least one element angle and a plurality of corresponding first tooth distal portions defining 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 with respect to the proximal portion of the port longitudinal axis and greater than at least one first element angle of at least one first protruding element, and each having at least one second element distal edge. In the embodiments described, 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 with respect to the proximal portion of the port longitudinal axis PA, greater than α, and having at least one second element distal edge 1108E that contacts the outer surface of the medical spike when in operation. The second protruding element 1108 is operably connected to the first protruding element 1106 such that, in response to the initiation of withdrawal of the medical spike from the spike port, at least one of the first elements 1106 moves as described above, causing at least one of the second protruding elements 1108 to move at least toward the longitudinal axis of the port, increasing the angle of at least one of the second elements, thereby bringing the distal edge of at least one of the second elements into contact with the outer surface of the medical spike, and thereby further resisting the 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, in response to the initiation of withdrawal, the above-described movement of the first protruding element causes the second protruding element 1108 to also move at least toward the longitudinal axis PA, increasing the angle β of the second element, thereby bringing the distal edge 1108E of the second element into contact with the outer surface of the spike, further restricting the withdrawal of the spike. Further application of tensile force causes the second element 1108 to move further, further increasing the second element angle β, thereby causing the distal edge 1108E of the second element to cut into the outer surface of the spike, thereby providing more tight resistance to the pull of the spike out of the spike port. In some embodiments, at least one second protruding element includes a plurality of protruding legs, each having a plurality of corresponding leg angles defining the angle of the at least one second element, and a plurality of corresponding distal leg edges defining the distal edge of the at least one second element.Furthermore, in the embodiments described, 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 may differ from the number of second protruding elements 1108. The first protruding elements act as primary locking points, and the second protruding elements act as auxiliary locking points and are more aggressive rockers than the first protruding elements. In some embodiments, the locking elements, or at least the second protruding elements, are made of a material, such as metal, that is hard / rigid enough to cut into the surface of the spike.

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

[0242] As described above with reference to Figure 2A, the spike port 102 includes a seating portion 106 that accommodates the spike lock 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 accommodates the rigid portion of the spike lock element while keeping it rotatable inside the port, thereby reinforcing the lock of the spike when it rotates with the spike when subjected to a rotational pull-out force, and thus resisting the spike being pulled out of the spike port by rotating it. In the illustrated embodiment, one wall of the groove 106 is formed by the port inlet 104, but the port inlet does not have to be structured as described herein, and in some embodiments, the groove may still be formed on the inner surface of the spike port, in which the most proximal opening of the spike port functions as the port inlet without a reduction in diameter as shown herein.

[0243] The locking mechanism, more specifically the locking element, is illustrated herein as a continuous annular structure; however, it should be understood that in some embodiments, the locking mechanism may have separate protruding elements distributed around the longitudinal axis within the seating portion and configured to operate in the same manner as the locking element described above. In other embodiments, the locking mechanism may have a structure different from the above-described structure, while still being configured to serve the above-described purpose.

[0244] The above-described features relating to the easy insertion of a spike into the spike port 102 will now be described in detail with reference to Figures 3A-3D. As described above, the medical device 10 includes a spike port configured to receive a medical spike internally and to establish fluid communication with it. The medical device 10 may incorporate both the above-described embodiments relating to the spike lock mechanism and the embodiments relating to the easy insertion, stabilization, and sealing of a spike into the spike port described below herein, but it should be noted that either can be incorporated independently. The embodiments described herein should not be construed as limiting different, distinct, but combinable embodiments of the subject matter disclosed.

[0245] Solutions to the required large and difficult spike insertion force and the spike safety retention requirements described above are provided according to the following description. As shown in Figure 3A, which shows an enlarged perspective cross section along line AA in Figure 1A, the medical device 10 includes a spike port 102, which includes a distal port portion 1022 provided in a closed state within a closed region formed by the distal port end 1021, and is configured to be opened by the distal end of the spike during insertion of a medical spike into the spike port 102. In other embodiments, the closed region may be another region of the spike port. The spike port 102 also includes a port inlet 104 and a proximal port portion 1023 configured to stabilize the medical spike when the medical spike is received into the spike port 102, and at least one sealing element 1024 located between the distal port portion 1022 and the proximal port portion 1023. In some embodiments, the spike port may not include a port inlet (i.e., with a reduced diameter compared to its adjacent portion) 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 within a seating portion formed in the form of a groove within the proximal portion of the spike port.

[0246] The sealing element 1024 is configured to seal the spike port 102 and prevent leakage from there through the port inlet 104. It should be understood herein that the sealing element 1024 functions solely as a sealing element and does not substantially contribute to any stabilization provided by either the port inlet or / or the locking mechanism.

[0247] The sealing element 1024 is configured to seal the inside of the spike port from the outside so that no leakage occurs when a test spike compliant with ISO 8536-4 is left inserted into the spike port for 5 hours, and then the inside of the spike port distal to the sealing element is subjected to a gauge pressure of 20 kPa for 15 seconds. As described above, the separation between the stabilization function and the sealing function is generally assigned to the port inlet in common implementations, and 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 rigidity and flexibility properties on the other side, the insertion force required to overcome the large frictional force into the spike port is reduced. Thus, friction can be further reduced by using a low-friction material such as Teflon and / or a lubricant such as silicone oil on the sealing element, thereby significantly 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 which includes a proximal port inner surface 1025A corresponding to the proximal portion 1023 of the port and extending between the port inlet and at least one seal element 1024, and a distal port inner surface 1025B corresponding to the distal portion 1022 of the port and extending between at least one seal element 1024 and the distal end of the port. The port lumen is basically circular and symmetrical. In this case, one of the port inlet 104 and at least one seal element 1024 defines a minimum inlet diameter A4 in a cross section taken at the proximal port inlet perpendicular to the longitudinal axis and a minimum seal diameter A2 in a cross section taken at the seal element 1024 perpendicular to the longitudinal axis, respectively. The minimum seal diameter A2 is smaller than the minimum inlet diameter A4. Each 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 to the seal element) perpendicular to the longitudinal axis. The proximal maximum diameter A1 is greater than the distal maximum diameter A3. Furthermore, the proximal maximum diameter A1 is greater 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 force and therefore reduced spike insertion force.

[0249] Once the spike is fully received within the spike port, the spike seal element completely encloses 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 proximal portion of the port. For example, the spike seal element is a ring having an annular shape, as in the described embodiment, that contacts the entire circumference of the ring portion of the outer surface of the spike. In other words, the spike seal element wraps around a portion of the medical spike circumferentially, i.e., completely covering and tightly engaging the circular portion of the outer surface of the spike when the spike is received inside the spike port.

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

[0251] In some embodiments, at least one spike seal element forms an integral portion of the inner surface of the port, as in the embodiments described. In some embodiments, 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 in a direction laterally to the longitudinal axis of the port.

[0252] In some embodiments, at least one sealing element is made of an elastic material to further reduce frictional force. On the other hand, a stabilizing element forming at least a portion of the port proximal portion is made of a harder, more rigid material to firmly hold the spike in place. In the embodiments described, the stabilizing element is essentially a spike lock mechanism 110.

[0253] In some embodiments, the distal portion of the port, at least one sealing element, and the inner surface of the port are formed as a single body / unibody member. This may be advantageous in a manufacturing process using, for example, molding techniques. In one embodiment, the unibody member is made from an elastic material. In some embodiments, the elastic material is a thermosetting resin. Figure 3B shows a partially exploded perspective view of the body portion 100, Figure 3C shows one embodiment of the spike port, and Figure 3D is a cross-sectional view of Figure 3C along line BB. As shown in Figures 3B to 3D, in the embodiment described, the spike port has a unibody shape 1026, a distal portion of the port 1022 (including the distal end of the port 1021), a sealing element 1024, and an inner surface of the port 1025, apart from the proximal portion of the port, which is at least partially formed by the port cover member 130. The unibody 1026 is firmly received inside the body portion 100 (spike receiving portion). In the embodiment described, the unibody 1026 includes a ring-shaped, integrated ridge portion 1026R that is received in a matching recess 107 within the body portion 100. This allows the port unibody 1026 to be securely fixed in place without the need for adhesive material and enables the manufacture of the port unibody from thermosetting materials, particularly pharmaceutically compatible soft elastic materials such as silicone. As can be seen from the figure, 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 in the figure shown). Thus, the port inlet 104 includes a circular rim 136 that is pressed against the proximal side of the ridge 1026, and the distal side of the ridge 1026R is pressed against a circular rim 108 formed in the body portion 100. This configuration allows all associated components to be attached without the use of adhesive material.

[0254] As described above, the distal portion / end of the port is provided in a closed state to prevent leakage of medication from the medical device into the spike port before connecting the medical spike. In fact, in most cases, connecting the medical spike is the final step in establishing a fluid connection through the fluid transfer system. In some embodiments, the distal portion of the port includes a plug configured to be pressed by the distal end of the spike during insertion of the medical spike into the spike port, thereby opening the distal portion of the port. In some embodiments, the distal portion of the port includes a weakening region configured to be punctured by the distal end of the spike during insertion of the medical spike into the spike port, thereby opening the distal portion of the port. In one embodiment, the weakening region has a thickness less than the nominal thickness of the distal portion of the port to facilitate its puncture by the distal end of the spike. In the embodiments described, as shown in Figures 3C and 3D, the distal end of the port 1021 is provided in a closed state and includes a weakened region 1021W in the form of a cross-shaped recess, such that the wall is thinner than the rest of the distal end of the port and the wall can be weakened more easily and peeled off by the sharp distal end of an inserted spike.

[0255] Refer to Figures 4A to 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 distal spike end 22 configured to perforate or puncture the distal end of the spike port, and an outer surface 24 in which the spike interacts with a sealing element and a spike lock element positioned inside the spike port. Figure 4B shows the situation when the spike 20 is fully inserted inside the single body 1026 of the spike port, with the distal portion of the spike 20 protruding distally (towards the inside of the device 10). Figure 4C, a cross-sectional enlargement of the spike 20 located inside the spike port of device 10, shows how the elastic sealing element 1024 is pressed toward the circumference of the spike port by the outer surface 24 of the spike 20 so that the port is sealed and fluid cannot pass through at least from the distal (inner) side of the spike port toward the proximal (outer) side. The figure also shows the 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 situations, and their appearance or value depends on several factors, among others, such as the size of the spike and the amount of protrusion of the sealing element from the inner surface of the port.

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

[0257] Refer to Figures 5A to 5C, which show a medical device 10 having a third aspect of the subject matter of this disclosure. Here again, the third aspect is shown with reference to medical device 10, but it should be noted that none of the aspects described in the subject matter of this disclosure should be limited to a specific configuration, and any one aspect may be implemented independently or in combination with one or more of the other aspects described in the same medical device.

[0258] As described above, the medical device 10 includes a drug injection / transfer device 302 constructed from a main body portion 300 and configured to transport drugs through its interior in a non-contamination manner.

[0259] Drug transfer devices should be drug-compatible, at least with respect to the device components that come into contact with the drug. Some common drug-compatible materials used in the manufacture of drug transfer devices include thermoplastic materials such as polypropylene and PVC-free materials. However, these drug-compatible thermoplastic materials are relatively soft and have low rigidity, making it difficult to construct the entire body of a drug transfer device from them. Additionally, drug transfer devices often include several functional elements that need to be assembled together, preferably, and sometimes necessarily, without the use of adhesive materials, and the device housing, at least, needs to be sufficiently rigid to hold multiple functional elements together. Furthermore, some drug-compatible materials are chemically inert, eliminating the possibility of them being assembled by bonding to one another. The subject matter of this disclosure provides alternative methods for assembling different elements into a single device, for example, by utilizing snap-fit ​​connections.

[0260] As shown in the figure, the device 302 includes a housing 300 that includes at least two housing parts 300A and 300B connected to each other by a snap-fit connection 300C set at the time of factory shipment. At least one of the housing parts 300A and 300B is made of at least one first thermoplastic material having high rigidity such as acetal. The first thermoplastic material forming the outermost housing part does not need to be drug-compatible and may be drug-incompatible. The second housing part may be made of at least one first thermoplastic material or at least one softer (having lower rigidity) second thermoplastic material. In some embodiments, at least one second thermoplastic material has physical properties of a smaller size than at least one first thermoplastic material, and the physical properties are 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 allow a drug to pass through the device. In the described embodiment, there are a plurality of internal elements including at least one drug channel and at least one air channel (not specifically shown) housed within an element 308 received within the housing part 300A, at least one air filter 310, and at least one one-way air valve 312 communicating with at least one air channel within the element 308. Further details about such a contamination-free drug delivery device can be found as described above in International Publication No. 08 / 129550 assigned to the assignee of the present application.

[0262] Elements that contact a drug, such as the element 308, are made of a drug-compatible thermoplastic material having at least one of the following properties: relatively low rigidity, chemically inert. In the described embodiment, the element 308 is made of polypropylene. In some embodiments, the second thermoplastic material is a material that does not include PVC.

[0263] The snap-fit ​​connector 300C holds the two housing sections 300A and 300B.

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

Claims

1. A medical device for fluid connection to a medical spike, wherein the medical device is A spike port having a proximal port inlet, wherein the proximal port inlet is configured to receive the medical spike through it and to establish fluid communication between the medical spike and the medical device, and the spike port has a longitudinal axis of the port, A spike lock mechanism configured to resist the withdrawal of the medical spike from the spike port, wherein the spike lock mechanism comprises a spike lock element having an outer rigid portion and a movable portion extending inward from the outer rigid portion toward the longitudinal axis of the port toward the proximal port inlet, and the movable portion of the spike lock element is At least one first inwardly projecting element, having each at least one distal portion of the first element that is inclined at at least one first element angle defined with respect to the proximal portion of the longitudinal axis of the port and that contacts the outer surface of the medical spike when the medical spike is located within the spike port, A medical device comprising: at least one second protruding element inclined at at least one second element angle defined with respect to the proximal portion of the longitudinal axis of the port, wherein the at least one second element angle is greater than the at least one first element angle, and each of the at least one second protruding elements has at least one distal edge of the second element configured to contact the outer surface of the medical spike.

2. The spike lock mechanism is configured to activate in response to the initiation of the withdrawal of the medical spike from the spike port, thereby locking the medical spike within the spike port and resisting its withdrawal. The medical device according to claim 1, wherein the spike lock mechanism is configured to operate automatically in response to the commencement 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. The medical device according to claim 1, wherein the spike lock mechanism is switchable from the unlocked state to the locked state in response to the commencement of the withdrawal of the medical spike from the spike port.

4. The medical device according to claim 1, wherein the spike lock mechanism is located inside the spike port, the spike port comprises 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. The medical device according to claim 1, wherein the movable portion is configured to contact the medical spike at the start of withdrawal of the medical spike from the spike port, and to move further toward the longitudinal axis of the port and toward the proximal port inlet, thereby resisting the withdrawal of the medical spike from the spike port.

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

7. The medical device according to claim 1, wherein the at least one first inwardly projecting element is configured to operate by increasing the angle of the at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

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

9. The medical device according to claim 1, wherein the at least one second protruding element is operably connected to the at least one first inward protruding element such that, at the start of the withdrawal of the medical spike from the spike port, the at least one first inward protruding element moves toward the longitudinal axis of the port and toward the proximal port inlet, moving the at least one second protruding element at least toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, thereby providing further resistance to the withdrawal of the medical spike from the spike port.

10. The medical device according to claim 9, wherein when the pull-out force is further applied, the distal edge of at least one second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pull-out of the medical spike from the spike port.

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

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

13. The medical device according to claim 1, wherein the spike port comprises at least one spike seal element located between the proximal port inlet and the distal port end of the spike port.

14. The spike port has an inner surface facing the longitudinal axis of the port, and the inner surface of the port comprises 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, The medical device according to claim 13, wherein at least one of at least a large portion of the proximal inner surface portion and at least a large portion of the distal inner surface portion is configured not to come into contact with the medical spike when the medical spike is received in the spike port.

15. The proximal port inlet defines the minimum inlet diameter of a cross section taken perpendicular to the longitudinal axis of the port, the at least one spike seal element defines the minimum seal diameter of a cross section taken perpendicular to the longitudinal axis of the port, the proximal inner surface portion defines the maximum proximal diameter of a cross section taken perpendicular to the longitudinal axis of the port, and the maximum proximal diameter is greater than both the minimum inlet diameter and the minimum seal diameter. The medical device according to claim 14, wherein the distal inner surface portion defines the maximum distal diameter of a cross-section taken perpendicular to the longitudinal axis of the port, and the maximum distal diameter is greater than the minimum seal diameter.

16. The medical device according to claim 1, wherein the spike lock element has higher rigidity than the proximal port inlet.

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

18. A spike lock mechanism is configured to be received in a spike port of a medical device and to resist withdrawal of a medical spike when the medical spike is received in the spike port, wherein the spike lock mechanism is switchable between an unlocked state in which insertion of the medical spike into the spike port is permitted and a locked state in which withdrawal of the medical spike from the spike port is resisted, wherein the locked state is activated automatically when withdrawal of the medical spike from the spike port is initiated, thereby locking the medical spike in the spike port, and the spike lock mechanism comprises a spike lock element having an outer rigid portion and a movable portion extending inward from the outer rigid portion toward the longitudinal axis of the spike port toward the proximal port inlet of the spike port, wherein the movable portion of the spike lock element is At least one first inwardly projecting element, having each at least one distal portion of the first element that is inclined at at least one first element angle defined with respect to the proximal portion of the longitudinal axis of the port and that contacts the outer surface of the medical spike when the medical spike is located within the spike port, A spike lock mechanism comprising: at least one second protruding element inclined at at least one second element angle defined with respect to the proximal portion of the longitudinal axis of the port, wherein the at least one second element angle is greater than the at least one first element angle, and each of the at least one second protruding elements has at least one distal edge of the second element configured to contact the outer surface of the medical spike.

19. The spike lock mechanism according to claim 18, wherein the at least one first inwardly projecting element is configured to act by increasing the angle of the at least one first element when an extraction force is applied that initiates the extraction of the medical spike from the spike port, such that the distal portion of the first element tightens its contact with the outer surface of the medical spike and resists the extraction of the medical spike from the spike port.

20. The at least one second protruding element is operably connected to the at least one first inward protruding element such that, at the start of the withdrawal of the medical spike from the spike port, the at least one first inward protruding element moves toward the longitudinal axis of the port and toward the proximal port inlet, and the at least one second protruding element moves at least toward the longitudinal axis of the port, thereby increasing the angle of the at least one second element, and thereby bringing the distal edge of the at least one second element into contact with the outer surface of the medical spike, thereby providing further resistance to the withdrawal of the medical spike from the spike port. The spike lock mechanism according to claim 18, wherein when the pull-out force is further applied, the distal edge of at least one second element is configured to cut into the outer surface of the medical spike, thereby providing more tight resistance to the pull-out of the medical spike from the spike port.

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