Peripheral intravenous catheter sets
By introducing a diaphragm design with a slot or channel in the catheter assembly, combined with lubricants and retainers, the problems of high resistance and blood leakage during PIVC insertion and removal are solved, improving patient comfort and the effectiveness of catheter use.
Patent Information
- Application Number
- CN202211126264.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-08-23
- Filing Date
- 2019-08-23
- Publication Date
- 2025-09-05
- Estimated Expiration
- 2039-08-23
AI Technical Summary
Existing over-the-needle peripheral intravenous catheters (PIVCs) have high resistance during the insertion and removal of the introducer needle, causing patient discomfort and potential blood leakage.
A catheter assembly is designed, comprising a septum with a narrow groove or channel, reducing the contact area and friction between an introducer needle and the septum, reducing resistance through lubricant, and fixing the septum with a septum housing and a retainer to ensure sealing.
The resistance during the withdrawal of the guide needle is reduced, the patient's comfort is improved, the risk of blood leakage is reduced, and the sealing and ease of use of the catheter are enhanced.
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Figure CN115400324B_ABST
Abstract
Description
[0001] This application is a divisional application of the Chinese patent application with Chinese application number 201910781056.8, application date August 23, 2019, and name “Peripheral Intravenous Catheter Assembly”. Technical Field
[0002] The present disclosure relates to the field of medical devices, and in particular, to a peripheral intravenous catheter assembly. Background Art
[0003] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids (such as saline solution, various medications, and total parenteral nutrition) into a patient. Catheters can also be used to withdraw blood from a patient.
[0004] A common type of catheter is an over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC can be mounted on an introducer needle with a sharp distal tip. The PIVC and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the introducer needle facing upward, away from the patient's skin. The PIVC and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.
[0005] To verify that the introducer needle and / or PIVC is properly placed in the vein, the user typically confirms the presence of a "flashback" of blood in the flashback chamber of the PIVC assembly. Once needle placement has been confirmed, the user can temporarily occlude blood flow in the vein and remove the introducer needle, leaving the PIVC in the proper position within the vein. The user can also attach a device to the PIVC assembly to perform fluid infusions and / or draw blood. This process is somewhat difficult in practice because many PIVC placement locations do not allow for easy occlusion of the vein at all. In addition, even when such occlusion is achieved, it may be imperfect, resulting in blood leaking from the PIVC assembly that houses the PIVC and endangering medical personnel.
[0006] Therefore, the art provides PIVC assemblies that provide various seals or "septa" for preventing fluid from escaping during and after the introducer needle is removed from the vein. The septum can be fixed within the PIVC assembly by friction between the septum and the wall of the catheter assembly and / or an adhesive.
[0007] In some cases, after the PIVC has been placed in the vein, the introducer needle can be withdrawn from the PIVC assembly through the septum. The septum can significantly increase the force that the user needs to apply to the introducer needle in order to withdraw the introducer needle from the PIVC assembly. The force applied by the user can cause pain to the patient and / or dislodgement of the PIVC from the vein.
[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided merely to illustrate one exemplary technology area where some embodiments described herein may be practiced. Summary of the Invention
[0009] The present disclosure generally relates to septa for use in catheter assemblies, and related systems and methods. In some embodiments, the septum can reduce the resistance of an introducer needle moving relative to the septum. In some embodiments, reducing resistance can improve patient comfort and facilitate first-time needle insertion success or facilitate placement of a catheter within a vein on the first attempt. In some embodiments, resistance can be reduced by reducing the surface area of the septum in contact with the introducer needle.
[0010] In certain embodiments, the septum of catheter assembly can comprise a main body with a distal end and a proximal end. In certain embodiments, the distal end of main body and the proximal end of main body can be sealing. In certain embodiments, septum can comprise a slit arranged in the outer surface of main body and oriented along the longitudinal axis of main body. In certain embodiments, slit can comprise a distal end spaced apart from the distal end of main body and a proximal end spaced apart from the proximal end of main body. In certain embodiments, an introducer pin can extend through the slit. In certain embodiments, an introducer pin can be spaced apart from the bottom of the slit.
[0011] In some embodiments, the catheter assembly may include a catheter adapter and a catheter. In some embodiments, the catheter assembly may include a PIVC catheter assembly with a PIVC. In some embodiments, the catheter assembly may include an integrated catheter system with an integrated extension tube. In these and other embodiments, the septum that may be provided in the catheter adapter may be configured for single use. In more detail, in some embodiments, the septum may be penetrated by an introducer needle when the catheter assembly is in the insertion position, but the septum may remain closed after the catheter is placed and the introducer needle is withdrawn through the septum.
[0012] In some embodiments, the inner surface of the catheter adapter can seal the slot. In some embodiments, the catheter assembly can include a septum housing. In some embodiments, the septum can be at least partially disposed within the septum housing. In some embodiments, the inner surface of the septum housing can seal the slot.
[0013] In some embodiments, the length of the slot can correspond to a majority of the length of the body. In some embodiments, the depth of the slot can be greater than half the width of the body. In some embodiments, the bevel of the introducer needle can face upward while the slot can face downward. In some embodiments, the slot can face downward so that blood droplets in the slot and from the introducer needle are not visible to the patient. In some embodiments, the slot can be filled with a lubricant that can reduce the visibility of blood droplets to the patient and reduce drag.
[0014] In some embodiments, the septum can include a semi-annular groove disposed within the body. In some embodiments, the semi-annular groove can help secure the septum within the catheter adapter. In some embodiments, the semi-annular groove can extend around a portion of the circumference of the body. In some embodiments, the slot can extend between a first end of the semi-annular groove and a second end of the semi-annular groove.
[0015] In some embodiments, the septum can include a channel that can be disposed within the septum and oriented along the longitudinal axis of the body. In these and other embodiments, the septum can be integrally formed as a single unit. In some embodiments, the channel can be formed by the inner surface of the body. In some embodiments, the introducer needle can extend through the channel. In some embodiments, the introducer needle can be spaced apart from the inner surface of the body. In some embodiments, at least a portion of the channel can be generally cylindrical. In some embodiments, the length of the channel can correspond to a substantial portion of the length of the body.
[0016] In some embodiments, the septum can include a slit extending from an outer surface of the body to the passageway. In some embodiments, the slit can be oriented along the longitudinal axis of the body. In some embodiments, the slit can be closed when the septum is disposed within the lumen of the catheter adapter. In some embodiments, the slit can extend through the entire length of the body. In some embodiments, the slit can extend partially through the length of the body.
[0017] In some embodiments, the septum can include a semi-annular groove or annular groove that can help secure the septum within the catheter adapter. In some embodiments, a slit can extend through the semi-annular groove or annular groove. In some embodiments, the septum can be formed by injection molding. In some embodiments, the septum can be an elastomer. In some embodiments, the septum can be molded in a bulged position, wherein the slit is open to allow insertion of the mold and formation of the channel.
[0018] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative and are not intended to limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentation shown in the accompanying drawings. It should also be understood that the embodiments may be combined, or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be construed in a limiting sense. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Through use of the accompanying drawings, example embodiments will be described and explained with additional specificity and detail, in which:
[0020] Figure 1A is an upper perspective view of an exemplary catheter assembly of the prior art;
[0021] Figure 1B It can be used with Figure 1A An upper perspective view of a prior art septum for use with a catheter assembly;
[0022] Figure 1C yes Figure 1A a cross-sectional view of a catheter assembly;
[0023] Figure 2A is an upper perspective view of an exemplary diaphragm having a slot according to some embodiments;
[0024] Figure 2B According to some embodiments, the image is taken along line 2B-2B. Figure 2A a cross-sectional view of the diaphragm;
[0025] Figure 2C is an upper perspective view of an exemplary catheter assembly according to some embodiments, showing the catheter assembly oriented in a first position. Figure 2A diaphragm;
[0026] Figure 2D is an upper perspective view of a catheter assembly according to some embodiments showing the catheter assembly oriented in a second position. Figure 2A diaphragm;
[0027] Figure 2E According to some embodiments Figure 2D a cross-sectional view of a catheter assembly;
[0028] Figure 3A is an upper perspective view of another exemplary diaphragm having a slot according to some embodiments;
[0029] Figure 3B According to some embodiments, the image is taken along line 3B-3B. Figure 3A a cross-sectional view of the diaphragm;
[0030] Figure 3C is provided in an exemplary diaphragm housing according to some embodiments. Figure 3A An upper perspective view of the diaphragm;
[0031] Figure 3D According to some embodiments Figure 3C Exploded view of the diaphragm and diaphragm housing;
[0032] Figure 3E According to some embodiments Figure 3C A partial cross-sectional view of the diaphragm and the diaphragm housing;
[0033] Figure 3F is located in an exemplary catheter assembly according to some embodiments Figure 3C A cross-sectional view of the diaphragm and diaphragm housing;
[0034] Figure 4A is an upper perspective view of an exemplary diaphragm having a channel according to some embodiments;
[0035] Figure 4B According to some embodiments, the image is taken along line 4B-4B. Figure 4A a cross-sectional view of the diaphragm;
[0036] Figure 4C According to some embodiments, Figure 4A an upper perspective view of an exemplary catheter assembly having a septum;
[0037] Figure 4D According to some embodiments, the image is taken along line 4D-4D. Figure 4C a cross-sectional view of a catheter assembly;
[0038] Figure 5A is a cross-sectional view of another catheter assembly according to some embodiments, showing an exemplary introducer needle partially withdrawn;
[0039] Figure 5B According to some embodiments Figure 5A an enlarged view of a portion of a catheter assembly;
[0040] Figure 5C is an upper perspective view of another exemplary diaphragm according to some embodiments;
[0041] Figure 5D According to some embodiments Figure 5C a cross-sectional view of the diaphragm;
[0042] Figure 5E is an upper perspective view of an exemplary diaphragm holder according to some embodiments; and
[0043] Figure 5FAccording to some embodiments Figure 5E Cross-sectional view of the diaphragm retainer. DETAILED DESCRIPTION
[0044] Now refer to Figure 1A FIG1C shows a prior art catheter assembly 10. The catheter assembly 10 may include a septum 12 disposed within a lumen of a catheter adapter 14 of the catheter assembly 10. A catheter 16 may extend distally from the catheter adapter 14. The septum 12 may correspond to, for example, a BD INTIMA II TM After the user confirms that the catheter 16 of the catheter assembly 10 is positioned within the patient's vein, the introducer needle 18 of the catheter assembly 10 can be withdrawn from the patient and the catheter assembly 10, leaving only the catheter 16 in place in the vein. Figure 1C As shown, the entire portion of introducer needle 18 positioned within septum 12 may contact septum 12, thereby creating a high resistance when introducer needle 18 is withdrawn proximally from the patient and catheter assembly 10. The high friction between introducer needle 18 and septum 12 may cause discomfort to the patient when withdrawing and / or removing catheter 16 of catheter assembly 10 from the patient's vein.
[0045] Now refer to Figure 2A -2C. In some embodiments, septum 20 can reduce the resistance of introducer needle 22 to movement relative to septum 20 during proximal withdrawal of introducer needle 22 from the patient and catheter assembly 24. In some embodiments, reducing this resistance can improve patient comfort and facilitate successful first-time needle insertion or placement of catheter 26 within a vein on the first attempt. In some embodiments, this resistance can be reduced by reducing the surface area of septum 20 in contact with introducer needle 22. In some embodiments, the proximal end of introducer needle 22 can be secured in needle hub 27.
[0046] In some embodiments, the septum 20 of the catheter assembly 24 can include a body 28 having a distal end 30 and a proximal end 32. In some embodiments, the distal end 30 of the body 28 and the proximal end 32 of the body 28 can be sealed. In some embodiments, the septum 20 can provide a seal around the introducer needle 18 during storage and use of the introducer needle 22, and can then seal the catheter assembly 24 to prevent fluid from escaping when the introducer needle 22 is withdrawn. In some embodiments, the septum 20 can be pre-slit along the longitudinal axis 36 before the introducer needle 22 is inserted through the septum 20. In some embodiments, the septum 20 can be pre-slit along the longitudinal axis 36.
[0047] In some embodiments, the distal end 30 of the main body 28 can be arranged at a position farthest from the user of the catheter assembly 24 but closest to the patient, to act as a primary seal and prevent blood from escaping from the catheter assembly 24. In some embodiments, the proximal end 32 of the main body 28 can be used as an auxiliary seal to prevent blood from escaping from the catheter assembly 24. In some embodiments, the distal end 30 and / or the proximal end 32 can wipe the introducer needle 22 when the introducer needle 22 is withdrawn. In some embodiments, the septum 20 can be made of an elastomer or a resilient material. In some embodiments, the septum 20 can be made of silicone and / or rubber. In some embodiments, the septum 20 can cause the use of less material and save costs. In some embodiments, the septum 20 can be integrally formed as a single unit. In some embodiments, the septum 20 can comprise a single-piece or multi-piece septum.
[0048] In some embodiments, the septum 20 may include a slot 34 disposed in an outer surface of the body 28 and oriented along the longitudinal axis 36 of the body. In some embodiments, the slot 34 may include a distal end 38 spaced from the distal end 30 of the body 28 and a proximal end 40 spaced from the proximal end 32 of the body 28. In some embodiments, the introducer needle 22 may extend through the slot 34. In some embodiments, the introducer needle 22 may be spaced from the bottom 42 of the slot 34. In some embodiments, the slot 34 may reduce friction acting on the introducer needle 22. In some embodiments, only the distal end 30 and the proximal end 32 of the body 28 of the septum may contact the introducer needle. In some embodiments, the slot 34 may have various shapes. In some embodiments, the slot 34 may be generally rectangular. In some embodiments, the sides of the slot 34 disposed between the distal end 38 and the proximal end 40 may be straight (e.g., as Figure 2A as shown) or have other shapes.
[0049] In some embodiments, the catheter assembly 24 may include a catheter adapter 44 and a catheter 26. In some embodiments, the catheter assembly 24 may include a PIVC catheter assembly and the catheter 26 may include a PIVC. In some embodiments, the catheter assembly 24 may include an integrated catheter system having an integrated extension tube 46 extending from a side port of the catheter adapter 44. In these and other embodiments, the septum 20 that may be provided in the catheter adapter 44 may be configured for single use. In more detail, in some embodiments, when the catheter assembly 24 is in the insertion position for insertion into a patient, the introducer needle 22 may penetrate the septum 20, but after the catheter 26 is placed in the vein and the introducer needle 22 is withdrawn proximally through the septum, the septum 20 may remain closed.
[0050] In some embodiments, the length 48 of the slot 34 can correspond to a majority of the length 50 of the body 28. In some embodiments, the depth 52 of the slot 34 can be greater than half the width 54 of the body 28, which can prevent a portion of the introducer needle 22 extending through the slot 34 from contacting the slot 34. In some embodiments, the septum 20 can be disposed within the catheter adapter 44 in a variety of orientations. Figure 2C The septum 20 is shown with the slot 34 facing one side of the catheter adapter 44 when the catheter assembly 24 is in the inserted position. In other embodiments, the slot 34 can face the top or bottom of the catheter adapter 44 when the catheter assembly 24 is in the inserted position. In some embodiments, the inner surface of the catheter adapter 44 can seal against the slot 34.
[0051] In some embodiments, the septum 20 can include a groove 56, which can be semi-annular and disposed in the outer surface of the body 28. In some embodiments, the groove 56 can help secure the septum 20 within the catheter adapter 44. For example, the catheter adapter 44 can include a protrusion or similar element that fits within the groove 56. In some embodiments, the groove 56 can extend around a portion of the circumference of the body 28. In some embodiments, the slot 34 can extend between a first end 58 of the groove 56 and a second end 60 of the groove 56. In some embodiments, the septum 20 can be at least partially disposed in the septum housing.
[0052] Now refer to Figure 2D -2E. In some embodiments, in the inserted position, the bevel of the introducer needle 22 can face upward, while the slot 34 can face downward or toward the bottom of the catheter adapter 44. In some embodiments, the slot 34 can face downward so that blood droplets from the introducer needle 22 in the slot 34 are not visible to the patient, for example, Figure 2D In some embodiments, slot 34 may be filled with a lubricant, which may reduce the visibility of blood droplets to the patient and reduce drag.
[0053] Now refer to Figure 3A -3B, In some embodiments, catheter assembly 62 may include septum 64. In some embodiments, catheter assembly 62 may include or correspond to catheter assembly 24 of FIG. 2 . In some embodiments, catheter assembly 62 may include one or more features or elements of catheter assembly 24. In some embodiments, catheter assembly 24 may include one or more features or elements of catheter assembly 62. In some embodiments, septum 64 may include or correspond to septum 20 of FIG. 2 . In some embodiments, septum 64 may include one or more features of septum 20. In some embodiments, septum 20 may include one or more features of septum 64.
[0054] Now refer to Figure 3C-3F, In some embodiments, the septum 62 can be at least partially disposed within a septum housing 66. In some embodiments, the inner surface of the septum housing 66 can seal the slot 34 of the septum 62. In some embodiments, the septum housing 66 can provide compression to the septum 62. In some embodiments, the septum housing 66 can be a separate component or can alternatively be a region of the catheter adapter 44. In some embodiments, the septum housing 66 can include a canister that provides radial compression. In some embodiments, the radial compression from the canister helps ensure compliance of the septum 62 to the shape of the introducer needle 22 inserted therein and a tight seal when the introducer needle 22 is withdrawn. In some embodiments, the septum 62 can be held in place solely by compression, by mechanical attachment or interlocking, and / or by adhesives known to those of ordinary skill in the art. Figure 3E The needle 22 is shown partially withdrawn, according to some embodiments.
[0055] Now refer to Figure 4A -4D, In some embodiments, the septum 70 of the catheter assembly 72 may include a channel 74, which may be disposed within the septum 70 and oriented along the longitudinal axis 36 of the body 28. In some embodiments, the catheter assembly 72 may include or correspond to the catheter assembly 24 of Figure 2 and / or the catheter assembly 62 of Figure 3. In some embodiments, the catheter assembly 72 may include one or more features or elements of the catheter assembly 24 and / or the catheter assembly 62. In some embodiments, the catheter assembly 24 and / or the catheter assembly 62 may include one or more features or elements of the catheter assembly 72. In some embodiments, the septum 70 may include or correspond to the septum 20 of Figure 2 and / or the septum 64 of Figure 3. In some embodiments, the septum 20 and / or the septum 64 may include one or more features of the septum 70. In some embodiments, the septum 70 may include one or more features of the septum 20 and / or the septum 64.
[0056] In some embodiments, the septum 70 can be integrally formed as a single unit. In some embodiments, the channel 74 can be formed by the inner surface of the body 28. In some embodiments, the introducer needle 22 can extend through the channel. In some embodiments, the introducer needle 22 can be spaced apart from the inner surface of the body 28. In some embodiments, at least a portion of the channel 74 can be generally cylindrical. In some embodiments, the distal end and / or proximal end of the channel 74 can be tapered. In some embodiments, the length of the channel 74 can correspond to the majority of the length of the body 28.
[0057] In some embodiments, the septum 70 can include a slit 76 extending from an outer surface of the body 28 to the passage 74. In some embodiments, the slit 76 can be aligned with the longitudinal axis 36 of the body 28. In some embodiments, the slit 76 can close in response to the septum 70 being positioned within the lumen of the catheter adapter 44, which can compress the septum 70. In some embodiments, the slit 76 can extend through the entire length of the body 28. In some embodiments, the slit 76 can extend partially through the length of the body 28. In some embodiments, the slit 76 can be disposed in the middle of the body 28. In some embodiments, the septum 70 may or may not include the groove 56.
[0058] In some embodiments, the septum 70 may include a groove 56, which may be annular or semi-annular, which may help secure the septum 70 within the catheter adapter. In some embodiments, a slit 76 may extend through the groove 56. In some embodiments, the septum 70 may be formed by injection molding. In some embodiments, the septum 70 may be molded in a bulged position, with the slit open to allow an undercut feature of the mold to be inserted into the slit 76 and form the channel 74. In some embodiments, the elastomeric material of the septum 70 may allow the undercut feature to be removed from the channel 74 through the slit 76 after injection molding.
[0059] Now refer to Figure 5A -5F, another catheter assembly 78 is shown, according to some embodiments. In some embodiments, the catheter assembly 78 may include a septum retainer 80, which may include a head 82 and a body 84. In some embodiments, the outer diameter of the head 82 may be smaller than the outer diameter of the body 84, such that an annular flange 86 is disposed between the head 82 and the body 84. In some embodiments, when the septum retainer 80 is disposed within the lumen 88 of the catheter adapter 44, the head 82 may be disposed distally of the body 84. In some embodiments, the head 82 may be generally cylindrical. In some embodiments, the body 84 may be generally conical and have a tapered outer surface. In some embodiments, the outer surface of the body 84 may taper outwardly in a proximal direction.
[0060] In some embodiments, the head 82 can be sized and configured to fit snugly within the cavity 90 or pocket of the septum 92. In some embodiments, the cavity 90 can be cylindrical. In some embodiments, the outer diameter of the septum 92 can be slightly smaller than the diameter of the cavity 90. In some embodiments, the outer diameter of the septum 92 can be equal to or slightly larger than the diameter of the cavity 90, and the septum retainer 80 can have an interference fit with the septum 92. In some embodiments, the proximal end 94 of the septum 92 can contact the annular flange 86 of the septum retainer 80. In some embodiments, the septum retainer 80 and / or the catheter adapter 44 can be constructed of a plastic material or another suitable material.
[0061] In some embodiments, the septum retainer 80 can help secure the septum 92 within the lumen 88 of the catheter adapter 44. In more detail, in some embodiments, the inner wall of the catheter adapter 44 that forms the lumen 88 can include one or more protrusions 96 that can contact the outer surface of the body 84 to clamp the body 84 and hold the body 84 in place, thereby also securing the septum 92. In some embodiments, the protrusions 96 can be annular. In some embodiments, one or more sides of the protrusions 96 can include undercuts. In some embodiments, the protrusions 96 can include two opposing protrusions. In some embodiments, the protrusions 96 can be equally or unequally spaced around the circumference of the inner wall that forms the lumen 88. In some embodiments, the outer diameter of the body 84 that is aligned with the protrusions 96 can be greater than the distance between the protrusions 96 to facilitate the clamping action.
[0062] In some embodiments, the septum 92 and septum retainer 80 can reduce the resistance acting on the introducer needle 22 when the introducer needle 22 is withdrawn in the proximal direction. More specifically, the septum retainer 80 can allow the area of the septum 92 through which the introducer needle 22 passes and contacts to be reduced. In some embodiments, the septum retainer 80 can include a passage 98 extending through the septum retainer 80. In some embodiments, when the catheter assembly 78 is in the inserted position and / or the introducer needle 22 is withdrawn, the introducer needle 22 can extend through the passage 98 and / or be separated from the wall of the passage 98 along all or a portion of the length of the passage 98. In some embodiments, a portion of the introducer needle 22 disposed within the passage 98 can be surrounded by an annular space. In some embodiments, the outer diameter of the introducer needle 22 can be smaller than the diameter of the passage 98. In some embodiments, there can be no contact between the wall forming the passage 98 and the introducer needle 22.
[0063] In some embodiments, the septum 92 can include a flange 100 that can contact one or more corresponding flanges 102 of the catheter adapter 44, which can help secure the septum 92. In some embodiments, the corresponding flanges 102 of the catheter adapter 44 can prevent the septum 92 from moving distally, and the septum retainer 80 can prevent the septum 92 from moving proximally. In some embodiments, one or more of the following can help secure the septum 92 within the lumen 88, which can enhance the fluid seal of the septum 92: contact or interference between the flange 100 and the corresponding flange 102; contact or interference between the head 82 of the septum retainer 80 and the septum 92; and contact or interference between the body 84 of the septum retainer 80 and the protrusion 96.
[0064] In some embodiments, the distal end 30 of the septum 92 can be flush or nearly flush with the y-channel of the catheter adapter 44, which can help with the flushability of the blood and reduce the dead zone of the blood. In some embodiments, the distal end 30 of the septum 92 may include a slit 104. In some embodiments, the septum 92 can be pre-cut, or the slit 104 can be formed by the introducer needle 22 during assembly. In some embodiments, all or a portion of the slit 104 can be coated with a hydrophobic coating, such as parylene or other suitable hydrophobic coating. In some embodiments, the hydrophobic coating can reduce the coefficient of friction when the introducer needle 22 is withdrawn proximally from the catheter assembly 78. In some embodiments, the combination of the hydrophobic coating provided in the slit 104 and the reduced contact area between the introducer needle 22 and the septum 92 can reduce the resistance acting on the introducer needle 22 when the introducer needle 22 is withdrawn proximally from the catheter assembly 98.
[0065] In some embodiments, all or a portion of the walls of the passageway 98 may be coated with a high-viscosity lubricant 106, which may be non-migratory. In some embodiments, the high-viscosity lubricant 106 may be applied to the proximal end of the passageway 98. In some embodiments, when the introducer needle 22 is withdrawn, the high-viscosity lubricant 106 may at least partially block and cover the recess 108 of the introducer needle 22, which may prevent blood from leaking. In some embodiments, the high-viscosity lubricant 106 may reduce resistance when the introducer needle 22 is withdrawn proximally from the catheter assembly 78.
[0066] It should be understood that, in some embodiments, catheter assembly 78 may include or correspond to one or more of the following: catheter assembly 24 of FIG. 2 , catheter assembly 62 of FIG. 3 , or catheter assembly 72 of FIG. 4 . In some embodiments, catheter assembly 78 may include one or more features or elements of one or more of the following: catheter assembly 24, catheter assembly 62, and catheter assembly 72. For example, in some embodiments, septum 92 may include or correspond to one or more of the following: septum 20 of FIG. 2 , septum 64 of FIG. 3 , and septum 70 of FIG. 4 . In some embodiments, one or more of the following may include one or more features or elements of catheter assembly 78: catheter assembly 24, catheter assembly 62, and catheter assembly 72.
[0067] All examples and conditional language described herein are intended to be used for teaching purposes to help readers understand the present invention and the concepts provided by the inventors for further deepening the art, and should be interpreted as not being limited to these specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made thereto without departing from the spirit and scope of the present invention.
Claims
1. A peripheral intravenous catheter assembly, characterized in that The peripheral intravenous catheter assembly comprises: catheter adapters; A diaphragm, comprising: a body having a distal end and a proximal end, wherein the distal end and the proximal end of the body are sealed; a slot disposed in an outer surface of the body and oriented along a longitudinal axis of the body, wherein the slot includes a distal end spaced from the distal end of the body, a proximal end spaced from the proximal end of the body, and a bottom disposed between the distal and proximal ends of the slot such that the slot can be filled with a lubricant, wherein the diaphragm is a single piece; and a semi-annular groove disposed in the body, wherein the semi-annular groove extends around a portion of a circumference of the body, the slot extending between a first end of the semi-annular groove and a second end of the semi-annular groove; and an introducer needle extending through the slot; Wherein, the catheter adapter includes a protrusion, and the protrusion is assembled in the semi-annular groove.
2. The peripheral intravenous catheter assembly according to claim 1, characterized in that The introducer needle is spaced apart from the bottom of the slot.
3. The peripheral intravenous catheter assembly according to claim 1, characterized in that The septum is disposed within the catheter adapter, and an inner surface of the catheter adapter seals the slot.
4. The peripheral intravenous catheter assembly according to claim 1, characterized in that The PIVC assembly further includes a septum housing, wherein the septum is at least partially disposed within the septum housing, an inner surface of the septum housing sealing the slot.
5. The peripheral intravenous catheter assembly according to claim 1, characterized in that The diaphragm is an elastomeric diaphragm.
6. The peripheral intravenous catheter assembly according to claim 1, characterized in that The length of the slot corresponds to a majority of the length of the body.
7. The peripheral intravenous catheter assembly according to claim 1, characterized in that The depth of the slot is greater than half the width of the body.
8. The peripheral intravenous catheter assembly according to claim 1, characterized in that The bevel of the introducer needle faces upward and the slot faces downward.
9. The peripheral intravenous catheter assembly according to claim 1, characterized in that The catheter adapter includes a side port with an integrated extension tube.
10. The peripheral intravenous catheter assembly according to claim 1, characterized in that The distal end of the slot is opposite to the proximal end of the slot, wherein the slot further comprises a first sidewall and a second sidewall opposite the first sidewall, wherein the first sidewall and the second sidewall extend from the distal end of the slot to the proximal end of the slot, wherein the distal end, the proximal end, the first sidewall and the second sidewall of the slot are integrally formed as a single unit from an elastomeric material.
11. A peripheral intravenous catheter assembly, characterized in that: The peripheral intravenous catheter assembly comprises: catheter adapters; A diaphragm, comprising: a body having a distal end and a proximal end, wherein the distal end and the proximal end of the body are sealed; a slot disposed in an outer surface of the body and oriented along a longitudinal axis of the body, wherein the slot includes a distal end spaced from the distal end of the body, a proximal end spaced from the proximal end of the body, and a bottom disposed between the distal and proximal ends of the slot such that the slot can be filled with a lubricant and an introducer needle extended through the slot; and a semi-annular groove disposed in the body, wherein the semi-annular groove extends around a portion of a circumference of the body, the slot extending between a first end of the semi-annular groove and a second end of the semi-annular groove; and a diaphragm housing, wherein the diaphragm is disposed within the diaphragm housing, the diaphragm housing surrounding the diaphragm and sealing the slot; wherein the diaphragm housing is disposed within the catheter adapter; Wherein, the catheter adapter includes a protrusion, and the protrusion is assembled in the semi-annular groove.
12. The peripheral intravenous catheter assembly according to claim 11, characterized in that in, The introducer needle is spaced apart from the bottom of the slot.
13. The peripheral intravenous catheter assembly according to claim 11, characterized in that The bevel of the introducer needle faces upward and the slot faces downward.
14. The peripheral intravenous catheter assembly according to claim 11, characterized in that The diaphragm is an elastomeric diaphragm.
15. The peripheral intravenous catheter assembly according to claim 11, characterized in that The length of the slot corresponds to a majority of the length of the body.
16. The peripheral intravenous catheter assembly according to claim 11, characterized in that The depth of the slot is greater than half the width of the body.
17. The peripheral intravenous catheter assembly according to claim 11, wherein The catheter adapter includes a side port with an integrated extension tube.
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