Intravenous catheter system

Abstract

An intravenous catheter system may include a catheter adapter having a proximal end and a distal end. The intravenous catheter system may also include a cannula extending through the catheter adapter. The proximal end of the cannula may include a notch. The intravenous catheter system may further include a needle hub that can be coupled to the proximal end of the catheter adapter. The needle hub may include a flashback chamber that is in fluid communication with the notch when the intravenous catheter system is in an insertion configuration.

Description

[0001] This application is a divisional application of Chinese Invention Patent Application No. 201810418651.0, entitled "Intravenous Catheter System", filed on May 4, 2018.

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 501,670, entitled “INTRAVENOUS CATHETER SYSTEMS ANDMETHODS”, filed May 4, 2017, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure relates to an intravenous catheter system. Background Technology

[0005] Infusion therapy (a common medical procedure) can be facilitated through vascular access devices. Hospitalized, home-care, and other patients receive fluids, medications, and blood products via vascular access devices inserted into the vascular system. Blood collection is another common medical procedure that can be facilitated through vascular access devices.

[0006] Vascular access devices can enter and exit a patient's peripheral or central vascular system. Vascular access devices can be left in place for short (days), medium (weeks), or long (months to years). In some cases, prolonged placement of a vascular access device in the appropriate position may cause skin irritation. Vascular access devices can be used for continuous or intermittent infusion therapy.

[0007] A common type of vascular access device is the needle-type peripheral intravenous catheter (“PIVC”). As its name suggests, a “needle-type” PIVC is mounted on a guide needle with a sharp distal tip. The sharp distal tip is used to puncture the patient’s skin and vascular system. Insertion of the PIVC into the vascular system can occur after the needle has punctured the vascular system. Typically, the needle and PIVC are inserted into the patient’s vascular system through the skin at a small angle, with the bevel of the needle facing away from the patient’s skin.

[0008] To verify proper placement of the guide needle and / or PIVC within the vascular system, the user typically confirms the presence of a visible flashback of blood. In some cases, the guide needle may include a notch positioned distal to the guide needle and positioned within the vascular system in response to the distal tip of the guide needle, allowing blood to flow proximally through the needle lumen, exit the lumen through the notch, and then travel proximally between the outer surface of the guide needle and the inner surface of the PIVC.

[0009] Therefore, with the PIVC at least partially transparent, the user can visualize a small amount of blood "flashback" to confirm the PIVC's location within the vascular system. The presence of vascular system ingress indicators (e.g., flashback) facilitates successful PIVC placement. Once the guide needle's placement within the vascular system is confirmed, the user can temporarily occlude flow in the vascular system and withdraw the guide needle, leaving the PIVC in place for future blood aspiration and / or fluid infusion.

[0010] Users can also attach a device to the PIVC for fluid infusion and / or blood collection. This process is somewhat difficult in practice because many catheter placement sites simply do not allow for easy venous obstruction. Furthermore, even if such obstruction is achieved, it may be imperfect, leading to blood leakage from the catheter assembly housing the PIVC and endangering medical personnel. Therefore, catheter assemblies have been provided in the art that offer various seals or “septa” to prevent fluid leakage during and after removal of the guide needle from the vessel.

[0011] The diaphragm can be secured within the catheter assembly by friction and / or adhesive between the diaphragm and the walls of the catheter assembly. However, in some cases, diaphragm displacement may occur in response to pressure applied to the catheter assembly, such as venous pressure, high or low pressure fluid injection, catheter assembly flushing, blood collection, etc. Diaphragm displacement poses a risk of exposing healthcare personnel to blood or other fluids. Therefore, using vascular access devices for infusions and / or blood draws remains challenging.

[0012] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely as an exemplary technical field to illustrate some of the embodiments described herein that may be practiced therein. Summary of the Invention

[0013] In some embodiments, an intravenous (IV) catheter system may include a catheter adapter having a proximal and a distal end. In some embodiments, the IV catheter system may also include a cannula extending through the catheter adapter. In some embodiments, the proximal end of the cannula may include a notch. In some embodiments, the IV catheter system may also include a needle hub that can be coupled to the proximal end of the catheter adapter. In some embodiments, the needle hub may include an elongated visualization channel that is in fluid communication with the notch when the IV catheter system is in an insertion configuration. In some embodiments, the visualization channel and other elements described in more detail later may facilitate visualization of blood flashbacks by the user of the IV catheter system.

[0014] In some embodiments, a portion of the catheter adapter may be made of a first material and another portion of the catheter adapter may be made of a second material. In some embodiments, the second material may have a lower stiffness than the first material and may be softer or more flexible. In some embodiments, the second material may improve the contact between the IV catheter system and the patient's skin and provide other advantages, which will be explained in more detail later.

[0015] In some embodiments, the catheter adapter may include one or more stabilizing features, such as ribs or other types of protrusions, that can reduce the distance between the diaphragm tubes housing the IV catheter system. In some embodiments, stabilizing ribs can increase the fixation of the diaphragm tubes and diaphragm within the catheter adapter, as will be explained in further detail later.

[0016] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and mechanisms shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention unless specifically stated otherwise. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0017] Exemplary embodiments will be described and explained with more features and details using the accompanying drawings, in which:

[0018] Figure 1A This is a top view of an exemplary catheter system according to some embodiments;

[0019] Figure 1B According to some embodiments Figure 1A Top perspective view of the catheter system;

[0020] Figure 1C According to some embodiments Figure 1A A cross-sectional view of the conduit system;

[0021] Figure 1D According to some embodiments Figure 1A A top view of the catheter system, which is held in the first gripper;

[0022] Figure 1E According to some embodiments Figure 1A A top view of the catheter system, which is held in the second gripper;

[0023] Figure 2 This is a cross-sectional view of another exemplary catheter system according to some embodiments, showing a subflashback chamber;

[0024] Figure 3A This is a top perspective view of another exemplary catheter system according to some embodiments, which shows an exemplary sleeve;

[0025] Figure 3B According to some embodiments, the sleeve was removed. Figure 3A Top perspective view of the catheter system;

[0026] Figure 3C This is a cross-sectional view of another exemplary catheter system according to some embodiments, which shows an exemplary subflashback chamber;

[0027] Figure 4A This is a top perspective view of an exemplary retaining feature of an exemplary pin holder according to some embodiments;

[0028] Figure 4B This is a top perspective view of an example of a retaining feature corresponding to an exemplary sleeve according to some embodiments;

[0029] Figure 4C This is a cross-sectional view of an exemplary potting ring according to some embodiments;

[0030] Figure 5A This is a top view, according to some embodiments, showing an exemplary needle hub retracted from an exemplary catheter adapter portion and an exemplary sleeve removed from the needle hub;

[0031] Figure 5B According to some embodiments, it is shown that the portion is withdrawn from the catheter adapter section. Figure 5A A perspective view of the needle hub and the upper part of the sleeve connected to the needle hub;

[0032] Figure 6A This is a top view, according to some embodiments, showing an exemplary needle hub retracted from an exemplary catheter adapter portion and an exemplary sleeve removed from the catheter adapter;

[0033] Figure 6B According to some embodiments, it is shown that the portion is withdrawn from the catheter adapter section. Figure 6A A perspective view of the needle hub and the upper part of the sleeve connected to the needle hub;

[0034] Figure 7A This is a cross-sectional view of an exemplary pin header and a visual channel according to some embodiments;

[0035] Figure 7B According to some embodiments Figure 7A The upper perspective view of the needle holder shows an exemplary reservoir;

[0036] Figure 7C According to some embodiments, it can be arranged in Figure 7AA cross-sectional view of an exemplary tunnel in the needle holder;

[0037] Figure 7D According to some embodiments Figure 7B The needle hub along Figure 7B The cross-sectional view of line 7D-7D shows the needle seat disposed within an exemplary sleeve;

[0038] Figure 8A This is a top perspective view of an exemplary lens according to some embodiments;

[0039] Figure 8B According to some embodiments Figure 8A A cross-sectional view of the lens;

[0040] Figure 8C This is a top perspective view of another exemplary lens according to some embodiments;

[0041] Figure 8D This is a top perspective view of another exemplary lens according to some embodiments;

[0042] Figure 9A This is a cross-sectional view of a portion of an exemplary visualization channel according to some embodiments;

[0043] Figure 9B This is a cross-sectional view of a portion of another exemplary visualization channel according to some embodiments;

[0044] Figure 9C This is a top view of another exemplary visualization channel according to some embodiments;

[0045] Figure 9D This is a top perspective view of an exemplary needle hub partially removed from an exemplary sleeve and an exemplary cap removed from the sleeve, according to some embodiments;

[0046] Figure 9E It is fixed within a cannula for inserting a catheter system into a patient, according to some embodiments. Figure 9D Cross-sectional view of the needle hub and cap;

[0047] Figure 10A This is an exemplary upper perspective view of a raised section according to some embodiments;

[0048] Figure 10B This is a top perspective view of an exemplary notch according to some embodiments;

[0049] Figure 10C This is a top perspective view of an exemplary nozzle according to some embodiments;

[0050] Figure 10D This is a top perspective view of an example vent according to some embodiments;

[0051] Figure 10E This is a cross-sectional view of an example vent plug according to some embodiments;

[0052] Figure 10F This is a top perspective view of an exemplary porous material according to some embodiments;

[0053] Figure 11A This is a top view of an exemplary catheter system with a shortened sleeve according to some embodiments;

[0054] Figure 11B This is a top view of an example conduit system in a non-integral configuration and without extension tubes, according to some embodiments;

[0055] Figure 11C This is a top perspective view of an exemplary sleeve with an external groove according to some embodiments;

[0056] Figure 11D This is a top perspective view of another catheter system having a non-clamping configuration according to some embodiments;

[0057] Figure 12A This is a top perspective view of an exemplary conduit adapter having an exemplary ridge made of a second material, according to some embodiments;

[0058] Figure 12B This is a lower perspective view of another exemplary conduit adapter having an exemplary flexible region according to some embodiments;

[0059] Figure 12C This is a top perspective view of another exemplary conduit adapter having an exemplary strain relief feature according to some embodiments;

[0060] Figure 12D This is a front view of a portion of an exemplary fixed platform according to some embodiments;

[0061] Figure 12E This is a lower perspective view of another exemplary conduit adapter having another exemplary strain relief feature according to some embodiments;

[0062] Figure 12F This is a top perspective view of another exemplary conduit adapter having another exemplary flexible region according to some embodiments;

[0063] Figure 12G This is a lower perspective view of another exemplary conduit adapter having another exemplary strain relief feature according to some embodiments;

[0064] Figure 12HThis is a rear view of another conduit adapter having an exemplary notch made of a second material, according to some embodiments;

[0065] Figure 12I This is a partial cross-sectional view of another conduit adapter according to some embodiments, showing the first material arranged close to the second material within the fixing platform 26;

[0066] Figure 12J This is a lower perspective view of an exemplary friction reducer according to some embodiments;

[0067] Figure 12K This is an upper perspective view of an exemplary extraction indicator feature according to some embodiments;

[0068] Figure 13 This is a cross-sectional view of an exemplary strain relief feature according to some embodiments;

[0069] Figure 14 This is a top perspective view of another conduit adapter having a distal end made of a second material, according to some embodiments;

[0070] Figure 15A This is a front view of an exemplary boundary surface according to some embodiments;

[0071] Figure 15B This is a lower perspective view of an exemplary protrusion arranged on an exemplary interface surface according to some embodiments.

[0072] Figure 15C This is a lower perspective view of an exemplary geometric feature according to some embodiments;

[0073] Figure 15D This is an upper perspective view of an exemplary wing prior to separation, according to some embodiments;

[0074] Figure 15E It is according to some embodiments after separation Figure 15D An exemplary upper perspective view of a wing;

[0075] Figure 15F This is a rear view of a portion of another exemplary catheter adapter, showing a rotating exemplary gripper.

[0076] Figure 16A This is a top perspective view of an exemplary conduit adapter without stabilizing ribs according to some embodiments;

[0077] Figure 16B According to some embodiments Figure 16A Rear view of the conduit adapter.

[0078] Figure 17AThis is a top perspective view of an exemplary conduit adapter with an exemplary stabilizing rib according to some embodiments;

[0079] Figure 17B According to some embodiments Figure 17A Rear view of the conduit adapter;

[0080] Figure 17C According to some embodiments Figure 17A The upper perspective view of the catheter adapter shows an exemplary diaphragm tube and an exemplary diaphragm removed from the catheter adapter;

[0081] Figure 17D According to some embodiments Figure 17A The upper perspective view of the catheter adapter shows the diaphragm tube and diaphragm fixed inside the catheter adapter;

[0082] Figure 18A According to some embodiments Figure 16A Cross-sectional view of the conduit adapter;

[0083] Figure 18B According to some embodiments Figure 17A Cross-sectional view of the conduit adapter;

[0084] Figure 19A This is a cross-sectional view of an exemplary diaphragm tube according to some embodiments;

[0085] Figure 19B This is a cross-sectional view of another exemplary diaphragm tube coupled to an exemplary diaphragm according to some embodiments; and

[0086] Figure 19C This is a cross-sectional view of another exemplary diaphragm tube disposed within an exemplary conduit adapter according to some embodiments. Detailed Implementation

[0087] According to some embodiments, Figure 1A-19C Various catheter systems 10 can be described. In some embodiments, the catheter system 10 may include an IV catheter system or a PIVC system. In some embodiments, a particular catheter system 10 may include those from... Figure 1A-19C One or more components or features in one or more of the drawings.

[0088] Now for reference Figure 1A-1CIn some embodiments, the catheter system 10 may include a needle hub 12 and a gripper 14. In some embodiments, the needle hub 12 and the gripper 14 may be a single component and integrally formed. In some embodiments, the needle hub 12 and the gripper 14 may be integrally formed as a single unit. In some embodiments, the gripper 14 may extend outward from the needle hub 12. In some embodiments, the gripper 14 may include a paddle-shaped gripper.

[0089] In some embodiments, the cannula 16 of the catheter system 10 may include a notch toward the distal end of the cannula 16 (not in Figure 1A-1C (As shown in the figure), the notch provides guidance for the catheter 20 of the catheter system 10 to have a master flashback properly placed within a patient's vein. In some embodiments, the cannula 16 may include a guide needle with a sharp distal tip. In some embodiments, the proximal end of the cannula 16 may be secured to and / or secured within the needle hub 12.

[0090] In some embodiments, the needle hub 12 and / or the grip portion 14 may be transparent. In some embodiments, the needle hub 12 and / or the grip portion 14 may be opaque. In some embodiments, the catheter adapter 18 of the catheter system 10 may be transparent to allow the user to observe the master flashback. In some embodiments, it is preferable that the needle hub 12 and / or the grip portion 14 are white, which can provide a color contrast with blood to facilitate the user's observation of the master flashback. In some embodiments, the grip portion may include wings 22 extending outward from the needle hub 12.

[0091] like Figure 1C As shown, in some embodiments, the longitudinal or central axis 24 of the catheter 20 extending distally from the catheter adapter 18 may be angled relative to the bottom surface of the gripper 14 and / or the bottom surface of the fixation platform 26. This minimizes the transition between the distal nasal portion of the catheter adapter 18 and the vein once the catheter system 10 is inserted into the vein. In some embodiments, the central axis 24 of the catheter 20 may be angled relative to the bottom surface of the gripper 14 and / or the bottom surface of the fixation platform 26 at an angle θ between approximately 0 and 15 degrees. In some embodiments, the angle θ may be approximately 6 degrees.

[0092] In some embodiments, the proximal end of the cannula 16 of the catheter system 10 may be accessible during assembly of the catheter system 10, which may allow for adjustment of the lay-down distance. In some embodiments, the proximal end of the cannula 16 may be coiled and / or glued into a well-shaped portion near the rear of the needle hub 12, which may provide additional mechanical retention of the cannula 16.

[0093] In some embodiments, the catheter adapter 18 may include one or more push tab features 28. In some embodiments, the push tab features 28 may be attached to the fixation platform 26 on one or more sides of the catheter adapter 18, which may improve molding filling. In some embodiments, the distal portion of a wing 22, which may be disposed below the fixation platform 26 of the catheter system 10, may include an edge 30, which may be rounded and / or tapered to facilitate adhesion of dressings to the patient's skin and / or reduce trapped air. In some embodiments, the edge 30 may include a transitional profile that guides the user's thumb to facilitate grasping. In some embodiments, the distal portion of the wing 22 may include the edge 30, for example as... Figure 1A As shown. In some embodiments, wing 22 may include ridge 29, which may abut against fixed platform 26.

[0094] Now for reference Figure 1D-1E In some embodiments, I, T, and M refer to the user's index finger, thumb, and middle finger, respectively, and represent the approximate positions of I, T, and M. For example, the thumb may be placed near the proximal end of the needle seat 12. Figure 1D-1E A modified end-grip technique is illustrated. In some embodiments, the edge 30, which may have an angled or tapered upper surface, can assist the user in using these modified end-grip techniques.

[0095] Now for reference Figure 2 The catheter system 10 is illustrated according to some embodiments. In some embodiments, the gripper 14 and the needle hub 12 may be a single component and integrally formed. In some embodiments, the gripper 14 and the needle hub 12 may be integrally formed as a single unit. In some embodiments, the sleeve 36 of the needle hub 12 may be removable from the gripper 14 and / or the needle hub 12. In some embodiments, one or more of the sleeve 36, the needle hub 12, and the gripper 14 may be a single component and integrally formed. In some embodiments, one or more of the sleeve 36, the needle hub 12, and the gripper 14 may be integrally formed as a single unit.

[0096] In some embodiments, the flashback chamber 32 may be disposed within or near the needle hub 12 of the catheter system 10. In some embodiments, the flashback chamber 32 may be disposed between the sleeve 36 and the needle hub 12. In some embodiments, the cannula 16 may include a notch disposed toward the proximal end of the cannula 16, which may allow blood to flow into the flashback chamber 32. In some embodiments, the flashback chamber 32 may be a secondary flashback chamber in fluid communication with a notch disposed toward the proximal end of the cannula 16 and / or an opening at the proximal end of the cannula 16.

[0097] In some embodiments, needle hub 12 may include or correspond to a vent plug. In some embodiments, needle hub 12 and / or sleeve 36 may include a filter or vent that is permeable to air rather than blood. In some embodiments, plug 27 may be placed in the proximal end of sleeve 36 to form an interface with flashback chamber 32. In some embodiments, flashback chamber 32 may include a visualization channel, as will be explained in further detail later. In some embodiments, plug 27 may be white or another opaque color, which may enhance the contrast of blood in the visualization channel for better visibility. In some embodiments, sleeve 36 may be transparent.

[0098] Now for reference Figures 3A-3C In some embodiments, the catheter system 10 may include a sleeve 36, which may include an additional gripping surface 33. In some embodiments, the sleeve 36 may be coupled to the needle hub 12 and provide a flow-tight seal around the flashback chamber 32. In some embodiments, the sleeve 36 may be transparent or clear, which may allow a user to observe the blood 35 that may be disposed within the flashback chamber 32 between the sleeve 36 and the needle hub 12. In some embodiments, the needle hub 12 and / or the gripping portion 14 may be white, which is likely the most familiar color used for catheter components on the market. In some embodiments, the needle hub 12 may include a visualization channel, and the sleeve 36 may tightly cover the visualization channel to provide a flow-tight seal and prevent blood received from the cannula 16 in the visualization channel from leaving the visualization channel.

[0099] In some embodiments, the sleeve 36 may be universal for all catheter sizes. In some embodiments, all features related to the catheter size may be arranged in the needle hub 12 and / or the gripper 14, while the sleeve 36 may remain standard across all catheter sizes. Figure 3C The diagram illustrates a possible configuration of a catheter system 10 having a sleeve 36 according to some embodiments.

[0100] like Figure 3C As shown, in some embodiments, the proximal end of the cannula 16 may be secured in the needle hub 12 via an adhesive or other suitable mechanism. In some embodiments, the cannula 16 may include a notch 37 facing the proximal end of the cannula 16, and the notch 37 may be in fluid communication with the flashback chamber 32. In some embodiments, the flashback chamber 32 may be disposed between the sleeve 36 and the needle hub 12. In some embodiments, in response to insertion of the cannula 16 into a patient's vein, blood may flow into the cannula 16 and out through the notch 37 into the flashback chamber 32. In some embodiments, a ventilation passage 39 may be disposed near the flashback chamber 32 and may be permeable to air rather than blood.

[0101] Now for reference Figures 4A-4CIn some embodiments, the needle hub 12 may be secured to the sleeve 36 to prevent separation of the needle hub 12 and the sleeve 36 when the sleeve 36 is gripped by a user. In some embodiments, one or more mechanisms may be used to join the needle hub 12 and the sleeve 36 together. For example, the needle hub 12 and the sleeve 36 may be joined together by an interference fit. As another example, a mechanical lock and / or snap-fit ​​feature may be used to join the needle hub 12 and the sleeve 36 together. As yet another example, an adhesive may be provided in the cavity at the junction of the needle hub 12 and the sleeve 36 to join the needle hub 12 and the sleeve 36 together. Figure 4A and 4B Exemplary retaining features of the needle hub 12 and sleeve 36 are shown respectively. More specifically, in some embodiments, the retaining feature 34A of the needle hub 12 may be configured to engage with a corresponding retaining feature 34B of the sleeve 36. In some embodiments, the retaining feature 34A may be disposed on the outer surface of the needle hub, and the corresponding retaining feature 34B may be disposed on the inner surface of the sleeve 36. Figure 4C An example potting ring 38 is shown, which may include an adhesive to bond the needle hub 12 and the sleeve 36 together.

[0102] Now for reference Figures 5A-5B In some embodiments, the sleeve 36 and the gripper 14 may be a single component and integrally formed. In some embodiments, the sleeve 36 may be generally cylindrical. In some embodiments, the sleeve 36 may surround and / or enclose the needle hub 12. In some embodiments, the needle hub 12 may be coupled to the sleeve 36 and the gripper 14 via one or more mechanisms discussed with reference to FIG4. In some embodiments, a portion of the needle hub 12 may be directly coupled to the proximal end of the catheter adapter 18. In some embodiments, coupling the sleeve 36 to the proximal end of the catheter adapter 18 may include an interference fit or other types of coupling.

[0103] Now for reference Figures 6A-6B In some embodiments, the needle hub 12 may be white. In some embodiments, the gripper 14 and / or sleeve 36 may be transparent or clear. In some embodiments, the sleeve 36 may be directly coupled to the proximal end of the catheter adapter 18. In some embodiments, the coupling of the sleeve 36 to the proximal end of the catheter adapter 18 may include an interference fit or other types of coupling.

[0104] In some embodiments, catheter system 10 can enhance venous confirmation in vascular access systems characterized by blood flashback. In some embodiments, catheter system 10 can provide improved visualization timing, optical magnification, continuous motion optimization, and fluid management. In some embodiments, catheter system 10 can provide a reduction in the time it takes for blood to appear in flashback chamber 32 to accommodate pre-perfusion that might otherwise flood another flashback chamber, and measure flow rate in the visualization channel.

[0105] In some embodiments, the catheter system 10 may provide fluid restriction to guide inflow through a flashback chamber 32, which may have a high surface area-to-volume ratio. In some embodiments, the catheter system 10 may provide overflow patterns to compensate for various excess fluid conditions. In some embodiments, the catheter system may provide unobstructed, high-contrast, real-time visualization of blood flashbacks throughout the entire duration of venous access. In some embodiments, the catheter system 10 may provide immediate signal transmission and amplification in the presence of low blood abundance.

[0106] Now for reference Figures 7A-7B In some embodiments, the flashback chamber 32 may include a pouch 40 that accommodates the proximal end of the cannula 16. In some embodiments, the pouch 40 may be adjacent to and / or in fluid communication with the visualization channel 42. In some embodiments, the visualization channel 42 may be located outside and / or above the needle hub 12, allowing the user unobstructed observation of secondary flashbacks. In some embodiments, a secondary flashback may refer to a flashback near the needle hub 12, while a primary flashback may refer to a flashback near the catheter 20 and / or catheter adapter 18. In some embodiments, the pouch 40 may include an inverted cone shape. In some embodiments, the top of the pouch 40 is widened to better visualize blood drops emerging from the proximal end of the cannula 16 and / or from a notch positioned towards the proximal end of the cannula 16.

[0107] In some embodiments, the walls of the bag 40 may include an outward traction force that can convert a portion of the bag filling motion into in-plane liquid movement that is perceptible to the user. In some embodiments, the volume of the bag 40 may be reduced for smaller sizes and / or a sleeve receiving port may be introduced into the bag 40, for example, as... Figure 7A As shown, this can shorten the time it takes for blood to flow out of the notch and / or proximal end of the cannula 16 and begin to flow through the flashback chamber 32.

[0108] In some embodiments, the visualization channel 42 may include a high surface area-to-volume aspect ratio, which can create an enhanced visualization signal with a small amount of blood. The aspect ratio of the visualization channel 42 can convert the volumetric flow rate into a stable meniscus velocity that can be easily captured by the human eye. In some embodiments, the continuous longitudinal movement of blood flowing through the visualization channel 42 can provide a clear, thermometer-like signal of the venous access. In some embodiments, the visualization channel 42 may include a length that can be specified for the duration of continuous movement according to a typical catheter insertion procedure. Thus, in some embodiments, confirmation of the extended vein can be provided throughout the insertion.

[0109] like Figure 7B As shown, in some embodiments, the flashback chamber 32 may include a cavity or a reservoir 44. In some embodiments, the reservoir 44 may be disposed below the visualization channel 42 when the needle hub 12 is assembled with the sleeve 36. In some embodiments, the reservoir 44 may be molded in the needle hub 12 and / or connected to the visualization channel 42 via a discharge channel 46 disposed at the proximal end of the visualization channel 42. In some embodiments, the volume of the reservoir 44 may be greater than or equal to about 20 microliters to contain excess fluid before blood flows through the visualization channel 42.

[0110] In some embodiments, the catheter system 10 may include a vent 48 that may be disposed on the needle hub 12. In some embodiments, the vent 48 may be formed by one or more microgrooves on the needle hub 12. In some embodiments, the vent 48 may be located at the end of the entire fluid path through the flashback chamber 32. For example, a reservoir 44 may be disposed near the front flange of the needle hub 12 and / or above the reservoir 44. In some embodiments, the vent 48 may throttle fluid flow during pre-infusion (where saline may be infused into the catheter system to purge air) and during flashback (where blood may be driven into the flashback chamber) to reduce excess saline volume without significantly impairing visualization of blood in the large-format visualization channel 42 over time. In some embodiments, the vent 48 may serve as a barrier to prevent fluid leakage to the outside of the catheter system 10.

[0111] In some embodiments, the catheter system 10 may include one or more ribs 50, which may be disposed on the needle hub 12. In some embodiments, the ribs 50 may be molded together with the visualization channel 42. In some embodiments, the ribs 50 may facilitate fluid path restriction. In some embodiments, the ribs 50 may be disposed at the distal and proximal ends or flanges of the needle hub 12. In some embodiments, the ribs 50 may be disposed along the longitudinal edge of the visualization channel 42. In some embodiments, the ribs 50 may interfere with and / or contact the interior of the sleeve 36 of the catheter system 10.

[0112] Now for reference Figure 7C In some embodiments, the bag-like member 40 may include a tunnel portion 41, which may include and / or the proximal end of the protective sleeve 16. Referring now to... Figure 7D In some embodiments, the reservoir 44 may be disposed on one or both sides of the needle holder 12. Figure 7C The reservoirs 44 are shown on both sides of the needle holder 12.

[0113] In some embodiments, the depth of the visualization channel 42 may depend on the specifications of the sleeve 16. For example, when the specification size is small, the depth of the visualization channel 42 may be small, while when the specification size is large, the depth of the visualization channel 42 may be large. Therefore, in some embodiments, the visualization channel 42 may be formed in a specific specification manner so as to have a consistent duration of continuous movement and to ensure that the meniscus velocity is well within the human recognition range.

[0114] Now refer to Figures 8A-8B In some embodiments, lens 52 may be disposed within sleeve 36 or other components of catheter system 10. In some embodiments, lens 52 may include a unilateral convex lens. In some embodiments, lens 52 may be constructed into sleeve 36 to minimize the impact on manufacturing. In some embodiments, lens 52 may be disposed above pouch 40 and / or above the proximal end of cannula 16 to immediately capture the presence of blood in flashback chamber 32. In some embodiments, lens 52 may be positioned above pouch 40 and / or visualization channel 42. In some embodiments, lens 52 may extend across the top of sleeve 36, which may provide sufficient field of view. In some embodiments, the shape of lens 52 relative to the outer surface of sleeve 36 may reduce the impact of lens 52 on the technique of use.

[0115] In some embodiments, lens 52 may include various shapes, sizes, and curvatures depending on the specific conduit system 10. For example, lens 52 may include a biconvex lens or an asymmetrical shape with directional distortion. In some embodiments, lens 52 may be of any size that can be integrated onto the outer contour of a component in conduit system 10. In some embodiments, lens 52 may be conformal or non-conformal to the outer contour. In some embodiments, a particular non-conformal lens 52 may be disposed on a protruding platform on the outer contour. In some embodiments, lens 52 may be integrated into the interior of a component. In some embodiments, lens 52 may be translucent or partially transparent. In a preferred embodiment, lens 52 may be transparent. In some embodiments, lens 52 may be integrated into or molded into sleeve 36.

[0116] In some embodiments, lens 52 may be integrated at various locations in the fluid path for optical magnification. For example, lens 52 may be located on top of catheter adapter 18 to better observe blood entering catheter adapter 18 after the main flashback.

[0117] Now for reference Figure 8C In some embodiments, the lens 52 may extend longitudinally along all or part of the visualization channel 42, which allows for better observation of the blood flowing through the visualization channel 42. In some embodiments, multiple lenses 52 may be arranged along the visualization channel 42.

[0118] Now for reference Figure 8D In some embodiments, the sleeve 36 may be molded to include a cavity or hole 54 in the inner wall of the sleeve 36. In some embodiments, the lens 52 may be inserted into the cavity during assembly, such as... Figure 8D As shown. In this way, in some embodiments, inconsistent wall thickness at the location of lens 52 can be resolved, and lens 52 can be independent of the limitations of molding material and geometry.

[0119] The conduit system 10 is compatible with a wide variety of fluid conditions, including overflow conditions. In some embodiments, fluid enters from the sleeve 16 and flows into the visualization channel 42. The fluid can then be discharged into the reservoir 44 before being ultimately kept closed by the vent 48.

[0120] The catheter system 10 can provide various advantages. In some embodiments, the catheter system 10 can provide immediate visualization of blood as it exits from the proximal end of the cannula 16 or through a notch positioned towards the proximal end of the cannula 16. In some embodiments, the catheter system 10 can provide continuous motion of blood flowing axially through the visualization channel 42 at a stable meniscus velocity greater than or equal to approximately 0.25 mm / s. In some embodiments, the meniscus can flow across the entire length of the flashback chamber 32 between approximately 5 and 20 seconds. Continuous motion provides real-time venous confirmation, rather than a more static signal, throughout the duration of the catheter insertion procedure.

[0121] In some embodiments, the catheter system 10 can provide enhanced visualization of blood flashbacks. In some embodiments, blood entering the flashback chamber 32 can be pushed to the top of the flashback chamber 32, for example, to the visualization channel 42 on the top of the needle hub 12, which provides an unobstructed view for the user. In some embodiments, the visualization channel 42 provides a large, substantially flat visualization area that provides a stronger signal than in prior art devices where blood falls to the bottom of the chamber and accumulates in the chamber before generating a perceptible signal. In some embodiments, the needle hub 12 is white, which can provide strong background contrast when blood is present in the flashback chamber 32, which may be formed by the needle hub 12 and / or the sleeve 36. In some embodiments, a notch is provided towards the proximal end of the cannula 16 and / or the proximal end of the cannula 16 may be visible within the pouch 40.

[0122] In some embodiments, the top portion of the pouch 40 may have a larger diameter than the bottom portion of the pouch 40 and / or the pouch 40 may include a traction wall to facilitate rapid signaling in the presence of blood. In some embodiments, the lens 52 may provide optical magnification of blood disposed within the flashback chamber 32 (including the pouch 40 and / or visualization channel 42). This may be particularly useful for small-gauge cannulas and / or catheters. In some embodiments, the catheter system 10 may allow the generation of a valid signal for venous confirmation with less than 10 microliters of blood. Prior art devices may require 50–500 microliters to generate a valid signal.

[0123] In some embodiments, the catheter system 10 may provide extended venous confirmation facilities that can cover the lengthy period corresponding to the insertion of the catheter 20 within the vein. In some embodiments, the flashback chamber 32 may be used in conjunction with the main flashback feature to facilitate venous confirmation during various stages of the catheter insertion process. In some embodiments, each stage may include a cannula penetration “shroud” in which the cannula can be retracted by approximately 2 mm to reduce the risk of venous puncture, catheter advancement, and cannula retraction.

[0124] In some embodiments, the enhanced flashback visualization feature outlined in this disclosure can be used with any vascular access device that includes a flashback chamber. For example, the enhanced flashback visualization feature outlined in this disclosure can be used with standard or modified plugs without requiring additional components or manufacturing steps.

[0125] In some embodiments, the visualization channel 42 may be arranged at various locations within a particular catheter system 10. For example, the visualization channel 42 may be arranged inside the sleeve 36 and / or the needle hub 12 may be used to seal the visualization channel 42. As another example and now referenced Figure 9AThe visualization channel 42 can be coaxial with the sleeve 16, which can reduce the volume of the bag 40.

[0126] Now for reference Figure 9B In some embodiments, the central axis of the visualization channel 42 may transition between the top of the sleeve 16 and the needle hub 12. In these and other embodiments, the visualization channel 42 may be inclined toward the top of the needle hub 12. Referring now to... Figure 9C In some embodiments, the visualization channel 42 may be tapered. Figure 9C The visualization channel 42 can correspond to any visualization channel 42 discussed in this disclosure. For example... Figure 9D As further shown, in some embodiments, the flashback chamber 32 can be lower and closer to the central axis of the sleeve 16, which can produce a stable meniscus velocity. In some embodiments, at least a portion of the sleeve 36 positioned above the visualization channel 42 can be transparent.

[0127] Reference Figure 9D-9E In some embodiments, the top of the sleeve 36 may include a separate component, such as a cap 56. In some embodiments, the cap 56 may be transparent or clear. In these and other embodiments, the portion of the sleeve 36 that differs from the cap 56 may not be limited to any particular material. In some embodiments, the outer diameter of the needle hub 12 and the inner diameter of the sleeve 36 are arranged with tight geometric tolerances. In some embodiments, the cap 56 may be attached to the sleeve 36 in many ways, including, for example, by gluing, mechanical snap-fitting, etc. Therefore, in some embodiments, the attachment of the cap to the sleeve 36 may not depend on a tight geometric tolerance fit between the needle hub 12 and the sleeve 36.

[0128] In some embodiments, the visualization channel 42 may include various geometries and locations. In some embodiments, the visualization channel 42 may be straight. In some embodiments, the visualization channel 42 may include serpentine, curved, or serrated portions to increase the length of the visualization channel 42. In some embodiments, multiple visualization channels 42 may be used in combination. In some embodiments, the multiple visualization channels 42 may be parallel. In some embodiments, the visualization channel 42 may be integrated into the side of the needle hub 12 to accommodate gripping techniques (e.g., central grip or conventional end-hold grip) that may partially obstruct a top view of the catheter system 10. In some embodiments, instead of including the visualization channel 42, the catheter system 10 may include a visualization area that is an open space for a large volume of blood to flow through a larger cannula size. In some embodiments, the open space may include an annular space between the needle hub 12 and the sleeve 36 or a cavity separate from the needle hub 12.

[0129] Now for reference Figure 10AIn some embodiments, the height of the visualization channel 42 or the distance between the bottom and top of the visualization channel 42 can be in the sub-millimeter range to trigger a capillary effect and / or accelerate blood flow through the visualization channel when the visualization channel 42 is pre-wetted. In some embodiments, the needle hub 12 may include a ridge 57 that, when the needle hub 12 is assembled with the sleeve 36, forms a micro-gap corresponding to the visualization channel 42.

[0130] Now for reference Figure 10B In some embodiments, one or more markers or notches 58 may be integrated along the longitudinal edge of the visualization channel 42 to provide a better indication of the distance traveled by blood flow within the visualization channel 42. In some embodiments, the markers 58 may be spaced apart. In some embodiments, blood may sequentially color the markers 58 as it flows through the visualization channel 42. In some embodiments, the markers 58 may be molded into the needle hub 12.

[0131] Now for reference Figure 10C In some embodiments, one or more functional structures may be integrated into the needle hub 12 to provide localized fluid manipulation. For example, a divergent diffuser or nozzle 60 may be molded into the needle hub 12 at the distal end of the visualization channel 42 to buffer transient pressure spikes. In some embodiments, the shape of the nozzle 60 may increase the diameter of the fluid path as blood flows proximally.

[0132] Now for reference Figure 10D-10F In some embodiments, one or more vents may be integrated into the duct system 10 at multiple locations. In some embodiments, the vent may include a reference vent. Figure 7B Vent 48 is discussed. In some embodiments, a specific vent 51 may be integrated near the outlet of the visualization channel 42 for additional fluid restriction and / or throttling for larger sizes.

[0133] In some embodiments, the vent may be configured to allow air, rather than fluid, to pass through. The vent can be created in various ways, including, for example, one or more of the following: a groove molded in the needle seat 12, a small cutout at the rib 50 (see example...). Figure 10D ), a separate porous vent plug 62 near the proximal end of the visualization channel 42 (see example) Figure 10E ), and porous material 64 deposited in at least a portion of the visualized channel 42 (see, for example) Figure 10FIn some embodiments, a small cutout at the sealing rib 50 may be provided on the parting line to intentionally compensate for molding mismatch. In some embodiments, the porous material 64 may be deposited by overmolding, spin coating, stamping, etc. In some embodiments, the vent 48 may have a mechanical geometry that allows air to pass through but prevents fluid from passing through. In some embodiments, the vent 48 may be formed of paper, fiber, membrane, or other materials with porosity that allows air to escape while restricting fluid escape.

[0134] In some embodiments, the catheter system 10 may include various types of catheter adapters 18, regardless of the type of gripping technology or fixation platform 26 (if any). In some embodiments, the catheter system 10 may include straight, integrated, or end-hold catheter adapters. In some embodiments, the catheter system 10 may include a Luer-accessible vascular access device with a flow control plug.

[0135] In some embodiments, catheter system 10 may not include a main flashback. However, in some embodiments, catheter system 10 is compatible with various main flashback features, such as BD INSTAFLASH. TM The technology is characterized by a notch on the bevel facing the sleeve 16; a separate fluid path, characterized by a groove on the outside of the sleeve 16; a double notch on the sleeve 16; a vented extension tube; or other main flashback features.

[0136] Now for reference Figure 11A In some embodiments, the catheter adapter 18 may not include a central gripping area, such as the push tab feature 28. In these and other embodiments, the needle hub 12 and / or sleeve 36 may be significantly shortened, such as... Figure 11A As shown. In some embodiments, the catheter adapter 18 may be a dual-tube or single-tube catheter adapter 18. In some embodiments, the catheter adapter 18 may be made of a flexible material, such as one or more of the following: polypropylene, high-density polyethylene, low-density polyethylene, copolyester, polycarbonate, and other polymeric materials. In some embodiments, the flexible material may allow for a fixed platform 26 with a foldable hinge.

[0137] It is understood that the conduit 20 of the conduit system 10 may include one or more diffuser orifices near the distal tip of the conduit 20 to improve flow rate. It should also be understood that one or more components of the conduit system 10 may include antimicrobial agents or antipathogenic agents. In some embodiments, the antimicrobial agent or antipathogenic agent may include a coating or component in the fluid path of the conduit system 10. In some embodiments, the antimicrobial agent or antipathogenic agent may include an elution coating or additive.

[0138] It should be understood that the catheter system 10 may include a single-purpose or multi-purpose blood control valve system. In some embodiments, the blood control valve system may be disposed in one or more Luer ports at the end of the extension tube. Referring now to... Figure 11B In some embodiments, the blood control valve system can be arranged in a non-integrated configuration without an extension tube. Now refer to Figure 11C In some embodiments, the catheter system 10 may include an external recess in the cannula 16 for blood visualization. More specifically, in some embodiments, the external recess may allow a master flashback between the cannula 16 and the catheter 20, and may be transparent.

[0139] Now for reference Figure 11D In some embodiments, the catheter system 10 may have a non-grip or non-paddle grip configuration, allowing the user to hold the catheter system 10 without using the grip portion 14. In these and other embodiments, the sleeve 36 may be adapted to various gripping methods, including, for example, a "straight grip" or an "end grip". Figure 11D The “straight grip” configuration is shown, with the thumb and middle finger positioned on either side of the device and the index finger used to advance the catheter adapter.

[0140] Now for reference Figure 12A-12K For reasons of simplicity and cost, catheter adapters 18 are typically manufactured using a single material. Due to the functional limitations imposed on the chosen material, catheter adapters 18 made of a single material often exhibit trade-offs in one or more areas. Take high-pressure performance as an example. Catheter adapters 18 designed to support high-pressure performance typically reflect a high level of structural stiffness. This stiffness characteristic contrasts directly with product attributes such as patient comfort, ease of use, efficient assembly processes, and component tolerance adjustments.

[0141] In some embodiments described in this disclosure, a second material is introduced into the catheter adapter 18 via an integrated manufacturing process such as secondary injection molding, which allows for improvements to a wider range of product properties. In some embodiments, critical, specific catheter fluid path geometry can be produced using a suitable first material, while properties such as product stability, patient comfort, user grip, and the integrity of the flexible product can be improved using a second material. In some embodiments, the addition of a second material may not result in a significant increase in cost or assembly complexity due to the integrated nature of the assembly process.

[0142] Figure 12A-12KThe portion of the catheter system shown that optionally includes a second material is shown in a speckled shaded area. In some embodiments, the second material may be disposed in a location of the catheter system 10 other than the area shown in the speckled shaded area. The portion of the catheter system 10 that may include a first material is shown in a cross-hatched shaded area. In some embodiments, the first material may be disposed in a location of the catheter system 10 other than the area shown in the cross-hatched shaded area. In some embodiments, the area including the second material may be composed only partially of the second material. Figure 12A-12F Various catheter adapters 18 according to some embodiments are shown. It should be understood that... Figure 12A-12F The embodiments shown can be combined, and a particular catheter adapter 18 may include those from Figure 12A-12F One or more feature parts of a figure.

[0143] In some embodiments, the second material is a softer material designed to optimize patient comfort, product stability, user grip compatibility, catheter kinking resistance, fixation compatibility, and component assembly flexibility. In some embodiments, the second material may be flexible or semi-flexible. These improvements are achieved by using a multi-material catheter adapter 18 manufactured using a highly integrated manufacturing method. In some embodiments, the second material may be useful in terms of skin sensitivity and biocompatibility.

[0144] In some embodiments, the second material is softer and less hard than the first material. In some embodiments, the introduction of the second material improves patient comfort by providing a softer and larger contact area 72 that comes into contact with the patient's skin. According to some embodiments, Figure 12B An example contact area 72 made of a second material is shown. In some embodiments, the specific contact area 72 may extend to or beyond the proximal end of the catheter adapter 18, which may further enhance patient comfort and safety and provide support for the stability of the adapter 18.

[0145] In some embodiments, the fixing platform 26 may include a first material and / or a second material. In some embodiments, the perimeter of the second material may be independent of the perimeter of the first material. For example, the perimeter of the second material may extend beyond the surface area of ​​the first material, or the perimeter 70 of the first material may extend beyond the surface area of ​​the second material.

[0146] like Figure 12A As shown, in some embodiments, the proximal end of the catheter adapter 18 may include a ridge 71, which may be configured to contact the patient's skin when the catheter system 10 is inserted into the patient's vascular system.

[0147] like Figure 12BAs shown, in some embodiments, the introduction of a second material can also contribute to a softer and larger contact area 72 in contact with the skin, and in some embodiments, proximity to a diaphragm 66 designed to flex under pressure applied by the dressing (e.g., Figure 1C The flexible region 74 shown in the figure (see, for example, Figure 12B-12C This improves the stability of post-dressing products. Figure 12B An example of a flexible region 74 and a contact region 72 made of a second material is shown. Figure 12C As shown, in some embodiments, the proximal end of the conduit adapter 18 may include another flexible region 75 at least partially disposed on the upper portion of the conduit adapter 18. In some embodiments, part tolerances may be slightly relaxed due to the suitability of a second material.

[0148] In some embodiments, the introduction of a second material also provides improved dressing stability through specific features located at the perimeter of the product. For example, the edge 30 of the fixing platform 26 may include a tapered upper surface, such as... Figure 12D As shown. In some embodiments, the tapered circular profile can reduce the air gap between the fixation strap and the catheter adapter 18 used to secure the catheter system 10 to the patient.

[0149] In some embodiments, the benefits of a particular feature may not be associated with material stiffness. In some embodiments, the introduction of a second material can also provide user grip compatibility by introducing a flexible central push tab feature 28 and / or a flexible fixing platform 26 to accommodate conventional winged insert styles. Figure 12A An example of a flexible central gripping area or pushing lug feature 28 and a flexible fixing platform 26 made of a second material is shown.

[0150] like Figure 12E As shown, in some embodiments, the introduction of a second material provides improved kink resistance of the catheter 20 by introducing a strain-relieving feature 78 at the distal end of the catheter adapter 18. An exemplary strain-relieving feature 78 made of the second material is shown below. Figure 12E As shown. In some embodiments, the strain relief feature 78 can be designed to be as short as possible to avoid negatively impacting system stiffness. In some embodiments, the effectiveness of this shortened design is a byproduct of a second material flow path via a wide channel, which also flexes under duct load.

[0151] In some embodiments, the introduction of a second material can provide improved kink resistance of the extension tube by introducing a strain relief feature 78 at the engagement location where the extension tube is coupled to the conduit adapter. Figure 12FAn example of a strain-relieving feature 78 made of a second material at the joint location is shown. In some embodiments, the strain-relieving feature 78 may be further described by U.S. Patent Application Serial No. 15 / 286,212, filed October 5, 2016, entitled "Extension Tubing Strain Relief," which is incorporated herein by reference. In some embodiments, a fixation feature, for example added to the extension tube port, may visually and / or improve dressing placement by providing a strain-relieving feature. As an example, Figure 12F The side port including the strain relief feature 79 is shown.

[0152] like Figure 12G As shown, in some embodiments, a second material with lower hardness may be formed to mimic a semi-circular shape 81 to reduce stress in the off-axis region, thereby potentially accommodating a wider range of loading conditions. In some embodiments, the second material may include a surface layer of the conduit adapter 18. In some embodiments, the second material may extend all the way through the wall of the conduit adapter 18.

[0153] In some embodiments, the second material may allow for reduced assembly complexity, for example, of safety mechanism components. In some embodiments, under the action of assembly forces, the second material flexes at a location near the safety mechanism component (e.g., a notch 80 that may be configured as a contact pin safety clip). Figure 12H An example gap is shown in the figure.

[0154] In some embodiments, the second material may be attached to the first material in a highly integrated manufacturing sequence, such as secondary injection molding. In some embodiments, the first and second materials may be formulated to enable chemical bonding rather than purely mechanical bonding via geometric features. In some embodiments, depending on the product and application, the second material is a material with a lower hardness in the range of approximately 50A to 95A. In some embodiments, the second material may include a material with a lower hardness in the range of approximately 10A to 95A. In some embodiments, certain additives may be incorporated into the base material of the second material to improve properties such as skin comfort and improved lubricity. In some embodiments, the catheter adapter 18 utilizes the second material to improve many aspects of the product, including but not limited to patient comfort, user grip comfort and compatibility, catheter kinking resistance, improved fixation and stability, and reduced cost burden due to ease of assembly and looser part tolerances.

[0155] In some embodiments, the first material may be rigid or semi-rigid. In some embodiments, the first material may be flexible. In some embodiments, the first material may have greater stiffness or be harder than the second material. In some embodiments, the first and / or second material may include plastics, elastomers such as silicone rubber, or other suitable materials. In some embodiments, the first material may be disposed proximal to the diaphragm 66. In some embodiments, the conduit system 10 may include the second material, but may not have the combination of the current ease of assembly and loose part tolerance characteristics.

[0156] like Figure 12I As shown, in some embodiments, the first material may extend into the second material to provide shape and / or support. In these and other embodiments, the first material may not be visible on the outside. In some embodiments, the first material may extend beyond the surface of the second material to improve product functionality. In these and other embodiments, the first material may act as one or more interface friction reducers 82, such as... Figure 12J As shown. In some embodiments, the friction reducer 82 can reduce friction between the catheter system 10 and the patient's skin and / or the wings 22. In some embodiments, one or more interface friction reducers 82 may include protrusions.

[0157] Now for reference Figure 12K In some embodiments, the second material may be used for other purposes, such as adding the withdrawal indicator feature 84. The length 85 of the withdrawal indicator feature 84 may vary. In some embodiments, the withdrawal indicator feature 84 may be approximately 2 mm.

[0158] Figure 13 An exemplary strain relief feature 86 is shown, which may include or correspond to any of the strain relief features 78 and / or 79 described with reference to FIG12. In some embodiments, the strain relief feature 86 may be integrated into the catheter system 10 via a second material and / or be as short as possible for various reasons. In some embodiments, the strain relief feature 86 may form a channel 88. In some embodiments, the underside of the distal end of the channel 88 closest to the patient's skin may include a second material that is flexible based on the load placed on the catheter 20. In some embodiments, the arrangement of the channel 88 may reduce potential stress concentration between the first and second materials in areas of significant and direct load. In some embodiments, in response to a 0.5-inch flexure applied at a single node at the distal end of the catheter, a single-material catheter adapter 18 may experience a peak stress at its distal end that is 10-50% higher than the peak stress at an equivalent location on another multi-material catheter adapter 18 including a strain relief feature 86 with a second material.

[0159] In some embodiments, when the catheter 20 is against the patient's skin, a strain relief feature 86, at least partially made of a second material, can influence the curvature profile of the catheter 20. In some embodiments, the strain relief feature 86 having a second material results in a larger curvature radius in the catheter 20 and a reduced insertion angle into the patient's vein.

[0160] In some embodiments, the strain relief feature 86 may be designed to operate within a specific angular range, for example, depending on product requirements. Figure 13 As shown, in some embodiments, the strain relief feature 86 includes both a first material and a second material extending to the distal end of the conduit adapter 18 to limit the effect of the strain relief function. Figure 13 As shown, in some embodiments, depending on, for example, desired performance characteristics, the strain relief feature 86 may include a mixture of a primary material and a second material. In some embodiments, the strain relief feature 86 may include an antimicrobial agent to improve the retention of the conduit 20. In some embodiments, the antimicrobial agent may be an additive in the first material and / or the second material. In some embodiments, the antimicrobial agent may include a coating applied to the strain relief feature 86.

[0161] like Figure 14 As shown, in some embodiments, the second material may comprise the entire diameter of the distal end of the catheter adapter 18, thereby providing strain relief. In some embodiments, the entire distal end of the catheter adapter 18 may be made of the second material.

[0162] Catheter insertion can require a high level of skill. Personnel facing the challenge of constructing and supporting insertion techniques often develop preferences and techniques based on the equipment they are using. In the case of peripheral venous catheters, several insertion grip styles have been developed. By manipulating geometry and materials, the design of catheter system 10 has been modified to better support the refinement and mastery of these grip styles.

[0163] One more widely used grip involves a pinching motion between the thumb and forefinger. In some embodiments, the seat 31 of the catheter system 10 may include a needle hub 12 and / or a sleeve 36 detachable from the catheter adapter 18. In some embodiments, the seat 31 may include a wing-like feature (which may be referred to herein as "wing 22") to serve as a contact point for catheter insertion and cannula withdrawal and removal. In some embodiments, the wing 22 may be caught between the thumb and forefinger to further describe the pinching motion. During the insertion process, the wing 22 may function as a grip stabilizer and control feature.

[0164] In some embodiments, the catheter adapter 18 may include one or more stabilizing features to benefit the patient and user. In some embodiments, the stabilizing features may extend centrally and / or laterally from the catheter adapter 18. In some embodiments, the stabilizing features may include one or more wings 33, which may be part of the fixation platform 26 and / or extend outward from the catheter adapter 18. In some embodiments, the combination of the catheter adapter 18 with the stabilizing features and the seat 31 with the wings 22 creates a more complex interface between the catheter adapter 18 and the seat 31. In some embodiments, this interface may allow the user to pinch the wings 22 in conjunction with the stabilizing features on the catheter adapter 18, rather than simply pinching the wings 22 on the needle hub 12 during insertion.

[0165] After successful initial insertion of catheter 20, the user can then separate the seat 31 from the catheter adapter 18 before securing the catheter adapter 18 to the patient. In some embodiments, the catheter system 10 described herein may facilitate the separation of the respective geometric features of the seat 31 and the catheter adapter 18.

[0166] Now for reference Figures 15A-15B In some embodiments, the interface between wing 22 and wing 33 allows for easy and efficient separation of components under a range of potential pinching forces. This ease of separation can be achieved through various technical means. For example, the material used to form the interface surface 90 on wing 22 and / or wing 33 can be modified to a substantial extent (e.g., preformed pellets) to include additives or chemical compound modifiers designed to enhance specific effects. In some embodiments, interface surface 90 may comprise the surfaces of wing 22 and / or wing 33. In some embodiments, interface surface 90a of wing 33 may contact or interface with interface surface 90b of wing 22 (interface surfaces 90a and 90b may be referred to together herein as “interface surface 90”). In some embodiments, interface surface 90a may interface with or contact interface surface 90b when the catheter system 10 is in an insertion configuration for insertion into a patient.

[0167] In some embodiments, the interface surface 90 may include the lower surface of wing 33 and the upper surface of wing 22. In some embodiments, the second material on the conduit adapter 18 may be modified to increase lubricity for the copolyester mating parts. This may be a preferred approach because it eliminates at least one additional manufacturing operation. Furthermore, functional variations between products may be reduced.

[0168] As another example, the contact surfaces on the corresponding interface surface 90 can be geometrically modified to improve certain properties, such as the effective coefficient of friction. In some embodiments, the contact surfaces of the interface surface 90 can be textured at the micrometer or nanometer scale; the interface surface 90 can contain geometric patterns of form and depth that provide the desired interface characteristics. In these and other embodiments, microscale textures can be applied to one or more interface surfaces 90. This modification represents only one of many possible modifications.

[0169] As another example, a third material may be added to one or more of the interface surfaces 90 to act as a reagent for reducing variables such as the coefficient of friction. The third material can take many forms. In some embodiments, the third material may include one or more powders, such as talc or starch. In some embodiments, the third material may include one or more lubricants that can be used in different phases. In some embodiments, the third material may include one or more additional mechanical components, such as tape or similar adhesive components. In some embodiments, the third material may include one or more insert molding components.

[0170] As yet another example, the geometry on one or both of the interface surfaces 90 may include features for receiving and facilitating force vectors in the separation direction. The interface surfaces 90 may take many forms, but they are often opposite in the assembly layout to mitigate separation difficulties.

[0171] Regarding the details of the junction between wing 22 and wing 33, any reasonable combination of materials can be used to improve or highlight certain features. In some embodiments, the junction surface 90 can be constructed using a polymer. In some embodiments, the materials used to construct the junction surface 90 may include one or more of the following: polycarbonate, copolyester, polyester, polypropylene, acrylonitrile butadiene styrene (ABS), acetal, polyethylene, nylon, any of the subclasses of thermoplastic elastomers (TPE), silicone, and other suitable materials. In some embodiments, a third material may be applied on top of the materials used to construct the junction surface 90.

[0172] In some embodiments, the sub-component may be inserted into one or both of the interface surfaces 90. In some embodiments, the sub-component may be metallic, polymeric, or ceramic, or a combination of these categories. In some embodiments, the sub-component may include intentional surface modifications, such as texturing over a specific size range. Reference now. Figure 15B In some embodiments, the sub-component may include a protrusion 91 and / or a groove. In some embodiments, the protrusion 91 may be disposed on the contact surface 90a and / or on an additional portion of the bottom of the fixing platform 26, which may contact the patient's skin or the user's hand.

[0173] In some embodiments, the material used to form the fixed platform 26 (which may include wing 33) can be modified at most levels to improve properties related to the interface (which may include the interface between winglets). Figure 15B As shown, in some embodiments, one or more of the interface surfaces 90 may include surface texture variations to reduce the coefficient of friction between the interface surfaces 90 during separation. In some embodiments, a third material may be applied to one or more interface surfaces 90.

[0174] Now for reference Figure 15C In some embodiments, one or more geometric features 92 may be disposed on a surface configured to contact the user's hand and / or the patient's skin, such as the bottom surface of wing 22. In some embodiments, the geometric feature 92 may include protrusions or notches. In some embodiments, the geometric feature 92 may facilitate a force vector in the separation direction. The geometric feature 92 may include various shapes and sizes. In some embodiments, the geometric features 92 may be positioned opposite each other to alleviate separation difficulties. Figure 15D-15E Wings 22 and 33 are shown before and after separation, according to some embodiments.

[0175] In some embodiments, the catheter system 10 may combine the benefits of a robust and stable catheter adapter 18 with winged gripper insertion technology. In some embodiments, the interface surface 90 between wings 33 and 22 allows for more efficient one-handed disassembly and withdrawal. In some embodiments, moving the fingers involved in the gripping action in the opposite direction parallel or nearly parallel to the central axis of the catheter 20 while pinching the overlapping wings 33, 22 can quickly and effectively initiate cannula withdrawal.

[0176] In some embodiments, the fixing platform 26 can be added to the integrated conduit (e.g., BD NEXIVA). TM In closed IV catheter systems, this is a step toward improving the patient experience. In some embodiments, the fixation platform 26 is compatible with a “central grip” insertion method and / or a degree of “end-grip” insertion method. Current technology does not take into account a “winged grip” insertion method. In some embodiments, adding a wing 22 below the wing 33 results in an improved integrated catheter for users who prefer winged grip insertion techniques. In some embodiments, the wing 22, disposed below the wing 33 and having wings 22 and 33 that are slidable relative to each other, allows the product to have compatibility with conventional winged products (e.g., BD INTIMA II). TM The IV catheter offers a similar insertion experience and the patient benefits of a fixed platform 26.

[0177] In some embodiments, once the initial insertion is complete, the interface surfaces 90 can be disconnected and / or slid past each other in a rapid and controlled manner. Ease of disconnection is critical and can be optimized using one or more of the following techniques: altering the matrix material used to construct the interface surfaces 90 by introducing composite additives; varying the surface texture in one or more regions of one or more interface components; adding components or media (e.g., lubricants or tapes) applied to one or more regions of one or more interface surfaces 90; and creating geometries to minimize the application of finger-based pinching force vectors perpendicular to or nearly perpendicular to the principal direction of component separation.

[0178] In some embodiments, the catheter adapter 18 may include one or more specific wings 33 that may be positioned slightly symmetrically relative to the longitudinal axis of the catheter 20. In some embodiments, the wings 33 may form a seamless fixation platform 26 to abut against the patient's skin. In some embodiments, the fixation platform 26 may include a material with lower hardness than the material of the seat 31 and the material of the body of the catheter adapter 18 through which the lumen can extend. In some embodiments, the hardness of the lower-hardness material may be in the range of 50A to 95A.

[0179] In some embodiments, the seat 31 may include a wing 22 that is asymmetrically opposed to the extension tube port on the conduit adapter 18. In some embodiments, the wing 22 may be made of a harder and more rigid material relative to the fixing platform 26 of the conduit adapter 18. In some embodiments, the wing 22 includes geometry for gripping with the fingers of the right hand.

[0180] In some embodiments, in a fully assembled configuration, wing 33 fits directly over the contour of wing 22. In some embodiments, under typical gripping directions and forces, minimal deformation may occur in wing 33 due to load transfer through the more rigid wing 22. Referring now... Figure 15F In some embodiments, the seat 31 can rotate relative to the catheter adapter 18 about the catheter axis to accommodate certain insertion gripping methods. In some embodiments, the overlapping wings 22, 33 captured in the grip, when a clamping force is applied, allows for a more rigid system to be used to improve insertion. In these and other embodiments, the wing 22 may rest on top of the wing 33, rather than the wing 33 resting on top of the wing 22. In these embodiments, the user's thumb may contact or rest on top of the wing 22 and may move proximally to shield the cannula 16 and / or withdraw the needle hub 12 from the catheter adapter 18.

[0181] In some embodiments, when the user is ready to withdraw the cannula 16, the fingers of the right hand used to grip the wings 22 and 33 move in opposite directions approximately parallel to the axis of the conduit 20. Typically, the thumb will move distally with the wing 33, while the opposite finger (in some cases, the index finger) moves proximally with the wing 22. In some embodiments, the wings 22 and 33 may move relative to each other with a coefficient of friction of about 0.2 (preferably in the range of 0.1 to 0.5). In some embodiments, depending on, for example, market and target performance characteristics, the coefficient of friction may be in the range of about 0.1 to 1.0. In some embodiments, the coefficient of friction may be in the range of 0.1 to 1.5.

[0182] In some embodiments, wing 33 may rest on the top surface of wing 22. In some embodiments, a thumb may contact wing 33. In some embodiments, upon retraction, the catheter adapter 18 moves distally relative to seat 31. In some embodiments, seat 31 rotates about the catheter axis relative to catheter adapter 18 within a range of 0 to 45 degrees. In some embodiments, the stiffness of wing 33 is approximately 70A.

[0183] In some embodiments, the interface surface 90 between wing 33 and wing 22 may include a central and / or lateral position of the conduit system 10. Alternatively or additionally, in some embodiments, the interface surface 90 may include a central position. In some embodiments, the interface surface 90 may include elements of the conduit system 10 other than wing 33 and wing 22. In some embodiments, a particular interface surface 90 (e.g., wing 33) may abut against the bottom surface of wing 22.

[0184] In some embodiments, the geometry of wings 33 and 22, and the mechanism of the unique layout of the catheter system 10, can be grounded in usability studies. Separating the catheter adapter 18 from the seat 31 at the end of the initial insertion into the patient's vascular system largely operates according to the equation F = μN, where: F represents the force required to separate the components, μ represents the effective coefficient of friction between wings 33 and 22, and N represents the surface normal force generated by the clamping action.

[0185] In some embodiments, μ can be reduced, while N can be controlled and guided without introducing excessive costs in the manufacture and assembly of the conduit system 10. In some embodiments, μ can be reduced via the material used to form the interface surface 90, modification of the aggregate structure of the interface surface 90 to improve the coefficient of friction, and, for example, the addition of a third material as previously described. In some embodiments, controlling N can be accomplished by using the geometry on the interface surface 90 to facilitate the force vector in the separation direction, as previously described.

[0186] To reduce the coefficient of friction, early prototypes used transparent tape as a surface modifier. The tape was placed on the underside of wing 33, with the downward-facing, non-sticky side of the tape intersecting with wing 22. In this configuration, the coefficient of friction was effectively minimized; the tape worked very well.

[0187] An experiment was conducted where tape was added to wing 22 instead of wing 33. In this arrangement, the non-adhesive side of the tape, facing upwards, directly intersects with the underside of wing 33. This configuration did not produce any significant reduction in the coefficient of friction. This was a surprising result.

[0188] The same experiment was conducted using various lubricants instead of tape. Similar results were obtained with the lubricants. Applying the lubricant directly to the underside of wing 33 resulted in a better reduction in the coefficient of friction compared to applying it to wing 22. For these evaluations, the hardness of wing 33 was significantly lower than that of wing 22.

[0189] Methods for attaching the catheter adapter 18 to the diaphragm subassembly (which may include the diaphragm 66 and / or the diaphragm tube) may include press-fitting, snap-fitting, adhesive bonding, welding, etc. A secure attachment between the catheter adapter 18 and the diaphragm subassembly can prevent the catheter system 10 from failing under high injection pressures (e.g., 300 psi). However, processes such as bonding and welding can increase the cost and complexity of the manufacturing process, and snap-fitting is often used as an assembly method.

[0190] Now for reference Figures 16A-16B , Figure 16A A conduit adapter 18 without any stabilizing ribs is shown according to some embodiments, and Figure 16B yes Figure 16A The catheter adapter 18 is shown in a rear or close-up view. In some embodiments, the catheter adapter 18 includes a diaphragm 66, which may be placed inside a diaphragm tube 98.

[0191] Now for reference Figures 17A-17D , Figure 17A A conduit adapter 18 having one or more stabilizing features (e.g., stabilizing ribs 94) is shown according to some embodiments. Figure 17B yes Figure 17AThe image shows a rear view of the catheter adapter 18. In some embodiments, the stabilizing rib 94 can stabilize and prevent swaying of the diaphragm tube 98 housing the diaphragm 66. In some embodiments, the stabilizing rib 94 can be aligned with the central axis of the catheter adapter 18. In some embodiments, the stabilizing rib 94 can be located at the proximal and / or distal end of the catheter adapter 18. In some embodiments, the stabilizing rib 94 can extend along a portion of the inner wall of the catheter adapter 18. In some embodiments, the stabilizing rib 94 can extend from the proximal end to the distal end of the catheter seat 18. In some embodiments, the stabilizing rib 94 can be generally linear. In some embodiments, the stabilizing rib 94 can be disposed within the lumen 96 of the catheter adapter 18. In some embodiments, the stabilizing rib 94 can be replaced by other suitable protrusions.

[0192] Figure 17C An exploded view of the conduit adapter 18 and the diaphragm subassembly including the diaphragm tube 98 and the diaphragm 66 is shown. Figure 17D A top perspective view of the diaphragm subassembly in the proximal end of the insertion catheter adapter 18 is shown. In some embodiments, the diaphragm 66 may include any number of pieces. In some embodiments, the diaphragm 66 may be a single-piece diaphragm, or, for example, as... Figure 18A As shown, this is a two-piece diaphragm 66.

[0193] In some embodiments, the catheter adapter 18, including the stabilizing rib 94, can achieve a secure snap-fit ​​engagement between the catheter adapter 18 and the diaphragm tube 98. In some embodiments, in addition to the stabilizing rib 94, welding, bonding, or other fixing methods may be used to increase the stability of the diaphragm tube 98 within the catheter adapter 18.

[0194] Now for reference Figures 18A-18B A conduit adapter 18 with a stabilizing rib 94 is shown according to some embodiments (e.g., Figure 18A ) and conduit adapter 18 without rib 94 (e.g., Figure 18B A comparison between the two. In some embodiments, the stabilizing rib 94 may contribute to a reduced gap between the inner wall of the conduit adapter 18 and the diaphragm tube 98. In some cases, a larger gap between the inner wall and the diaphragm tube 98 may result in an increased radial position and an increased likelihood that the diaphragm tube 98 may become unsecured, for example, when forced off-axis due to eccentric loads.

[0195] In some embodiments, the stabilizing rib 94 provides fixation for the diaphragm tube 98 while allowing easy removal from the mandrel during manufacturing. In some embodiments, the stress may be radial only for the short undercut, so the deformation due to the mandrel may take on a certain shape.

[0196] In some embodiments, the stabilizing rib 94 may be molded, for example, from a thermoplastic elastomer (“TPE”) resin in a soft second short mold. This allows for a relatively low-stress press fit between the conduit adapter 18 and the diaphragm tube 98, with a small or no gap between the inner wall of the conduit adapter 18 and the diaphragm tube 98.

[0197] Various types of diaphragm cartridges 98 can be used. In some embodiments, the diaphragm cartridge 98 may correspond to those currently used in BDNEXIVA. TM And BD PEGASUS TM The diaphragm tube used in the product is 98. Figure 19A and 19B An exemplary diaphragm tube 98 according to some embodiments is shown. Reference Figure 19A In some embodiments, the proximal end of the cylinder 98 may include a snap-fit ​​flange 99 or other snap-fit ​​features that can snap into the catheter adapter 18. In some embodiments, the snap-fit ​​flange 99 may be annular. In some embodiments, the traction force on the inner wall of the catheter adapter 18 may be compensated by a tapered portion along the length of the cylinder 98. In some embodiments, because the snap-fit ​​flange 99 may be close to the proximal end of the catheter adapter 18, the undercut in the molding may be very short, making it easier to remove the adapter core pin. In some embodiments, Figure 19A The diaphragm tube 98 shown can be molded with a simple "open and close" mold construction.

[0198] Now for reference Figure 19B In some embodiments, a snap-fit ​​flange 99 may be provided at the proximal end of the cylinder 98. In some embodiments, the snap-fit ​​flange 99 may be provided at any location along the length of the cylinder 98 and / or the catheter adapter 18. In some embodiments, one or more additional stabilizing ribs 94 may be added to fill the gap between the inner wall of the catheter adapter 18 and the diaphragm cylinder 98.

[0199] like Figure 19C As shown, in some embodiments, ribs 97 on the diaphragm tube 98 may be provided on either side or both sides of the adhesive port 95 to accommodate the adhesive and allow for annular distribution of the adhesive. In some embodiments, ribs 97 may guide the flow of the adhesive for bonding throughout the annular region in the vicinity of and / or between ribs 97.

[0200] Various embodiments of the invention may further include cannula safety mechanisms. In some embodiments, the catheter system 10 may include various types of safety mechanisms to provide cannula tip coverage. In some embodiments, a particular safety mechanism may be releasably connected to the catheter adapter 18 via external or internal interlocking or interference fit. In some embodiments, a particular safety mechanism may be releasably connected to the catheter adapter 18 using external or internal stability junctions.

[0201] In some embodiments, the catheter system 10 may include a cannula safety mechanism. In some embodiments, the safety mechanism may include any safety mechanism configured to secure the sharp distal tip (which may include a guide needle) of the cannula 16 when it is withdrawn from the catheter 20 of a particular catheter device, thereby preventing accidental needlestick injuries.

[0202] The safety mechanism can be coupled to the catheter system 10 in any manner. In some embodiments, the safety mechanism may include an internal interlock, wherein the safety mechanism is coupled to the inner surface of the catheter adapter 18. The coupling may include threading, mating, snap-fit, connection, attachment, fastening, clamping, hooking, or any other suitable connection method. Non-limiting examples of safety mechanisms including internal interlocks are provided in the following patents: U.S. Patent No. 8,496,623, filed March 2, 2009, entitled "BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM"; U.S. Patent No. 9,399,120, filed July 11, 2013, entitled "BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM"; and U.S. Patent Application No. 62 / 314,262, filed March 28, 2016, entitled "CANNULA CAPTURE MECHANISM," each of which is incorporated herein by reference in its entirety. In some embodiments, the safety mechanism may include a clip disposed within the catheter adapter, a non-limiting example of which is provided in U.S. Patent No. 6,117,108, filed June 12, 1998, entitled SPRING CLIP SAFETY IV CATHETER, which is incorporated herein by reference in its entirety.

[0203] In some embodiments, the safety mechanism may include an external interlock, wherein the safety mechanism is coupled to the outer surface of the catheter adapter 18. In some embodiments, the safety mechanism may be coupled to the outer surface of the catheter adapter 18 and the inner and / or outer surface of the needle seat 12. The coupling may include threading, mating, snapping, connection, attachment, fastening, clamping, hooking, or any other suitable coupling method. A non-limiting example of a safety mechanism including an external interlock is provided in U.S. Patent Application No. 14 / 295,953, filed June 4, 2014, entitled PORTED IV CATHETER HAVING EXTERNALNEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM, which is incorporated herein by reference in its entirety. In some embodiments, the safety mechanism may include a V-clamp or similar clamp. A non-limiting example of a V-clamp is provided in U.S. Patent Application No. 14 / 295,953, filed June 4, 2014, entitled “PORTED IVCATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM,” which is incorporated herein by reference in its entirety. The V-clamp can selectively retain a portion of the catheter adapter.

[0204] In some embodiments, a failable mechanical connection is provided between the safety mechanism and at least one other component of the catheter system 10. In some cases, the mechanical connection fails when the distal tip of the cannula 16 is secured within the safety mechanism. In some embodiments, the surface of the safety mechanism is selectively coupled to one or more of the following: catheter adapter 18, blood control valve, extension tube, and gripper 14.

[0205] In some embodiments, the safety mechanism may include a safety cylinder, which may be spring-loaded. For example, the safety cylinder may be like a BD... TM AUTOGUARD TM Like a BC-shielded protective intravenous catheter, it is spring-loaded. In some embodiments, the safety mechanism can be passively and / or actively activated. In some embodiments, the safety mechanism can be configured to interact with needle features (e.g., loops, notches, coils, or ridges on the needle). In some embodiments, the safety mechanism can include an arm or lever that can be actuated to capture the distal tip within the safety mechanism and prevent the tip from emerging before safe disposal. In some embodiments, the safety mechanism can be attached to the needle body and can be slideable along its length.

[0206] In some embodiments, in the pre-insertion assembly position, a safety mechanism may be disposed between the catheter adapter 18 and the needle hub 12. In some embodiments, the catheter adapter 18 and the needle hub 12 may be spaced apart by a portion of the safety mechanism in the pre-insertion assembly position. In some embodiments, in the pre-insertion assembly position, the proximal end of the catheter adapter 18 may be disposed between the distal end of the safety mechanism and the distal end of the gripping portion 14 (e.g., a paddle-shaped gripping portion) of the seat 31. In some embodiments, in the pre-insertion assembly position, the proximal end of the body of the catheter adapter 18 may be disposed between the distal end of the safety mechanism and the proximal end of the gripping portion 14 of the needle hub 12. In some embodiments, a portion of the safety mechanism may overlap with a portion of the gripping portion 14 of the needle hub 12. In some embodiments, at least a portion of at least one of the catheter adapter 18 and the gripping portion 14 overlaps with at least some portions of the safety mechanism. In some embodiments, no portion of the catheter adapter 18 or the gripping portion 14 overlaps with any portion of the safety mechanism.

[0207] In any of the above embodiments, the components of the fixation platform 26 may be formed from the same material by injection molding or other processes. This material may be an elastomer or other low-hardness material that is relatively mild relative to the patient's skin and / or dressings used to hold the catheter components in place during fluid delivery. For example, some embodiments of the invention include low-hardness materials having a hardness gauge hardness from about 30 Shore A to about 90 Shore D. In some embodiments, the low-hardness material may include a hardness gauge hardness from about 50 Shore A to about 90 Shore D. In some embodiments, the components of the fixation platform 26 may be formed from thermoplastic elastomers (TPEs) and the like.

[0208] All examples and conditional language described herein are intended to teach and assist the reader in understanding the invention and the concepts contributed by the inventors to advance the art, and should be construed as not being limited to these specifically described examples and conditions. While embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made therein without departing from the spirit and scope of the invention.

Claims

1. An intravenous catheter system, comprising: A catheter adapter having a proximal end, a distal end, and a lumen extending through the proximal end and the distal end. The catheter adapter comprises a first part made of a first material and a second part made of a second material, wherein the second material has a lower hardness than the first material. Wherein, both the first portion and the second portion extend to the nearest edge of the catheter adapter, and The second portion includes a notch near the first portion, the notch having a length and a width shorter than the length, the length being substantially parallel to the longitudinal axis of the catheter adapter and extending in the proximal direction to the nearest edge of the catheter adapter.

2. The intravenous catheter system according to claim 1, wherein, The notch forms the bottom portion of the outer periphery of the catheter adapter, the bottom portion being configured to be closest to the patient's skin.

3. The intravenous catheter system according to claim 1, wherein, The catheter adapter also includes a fixing platform made of the second material, the second portion extending continuously from the fixing platform to the nearest side edge of the catheter adapter.

4. The intravenous catheter system according to claim 3, wherein, The second portion forms a strip defining a bottom surface of the catheter adapter, the bottom surface being configured to contact the patient's skin, and wherein both the first portion and the second portion extend to the nearest side edge of the catheter adapter.

5. The intravenous catheter system according to claim 1, wherein, The intravenous catheter system also includes a diaphragm disposed within the lumen of the catheter adapter, wherein the notch is located proximal to the diaphragm.

6. The intravenous catheter system according to claim 3, wherein, The fixation platform includes a soft material region extending along the underside of the catheter adapter, the soft material region being configured to improve patient comfort.

7. The intravenous catheter system according to claim 1, wherein, The catheter adapter further includes an indicator feature having a T-shape disposed on the upper surface of the catheter adapter, the T-shape including a handle and a crossbar perpendicular to the handle, wherein both the handle and the crossbar directly contact the outer periphery of the catheter adapter.

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