Iv catheter system

Abstract

An IV catheter system can have a catheter component having a catheter hub, a cannula extending distally from a distal end of the catheter hub, and a push feature extending outwardly from the catheter hub. The IV catheter system can also have a needle component having a needle hub, a needle extending distally from the needle hub along an axis, and a grip extending generally parallel to the axis from the needle hub, the grip having a pull feature. In an insertion configuration, the needle can be positioned within the cannula and a distal end of the needle hub can seat in a needle port of the catheter hub. In a fluid delivery configuration, the needle can be positioned outside of the catheter hub. The push feature and the pull feature can be positioned to facilitate manipulation with a single hand to move the IV catheter system from the insertion configuration to the fluid delivery configuration.

Description

[0001] This application is a divisional application of Chinese Invention Patent Application No. 201610958946.8, entitled "IV Catheter System," filed on October 28, 2016.

[0002] Related applications

[0003] This application claims U.S. Provisional Patent Application No. 62 / 247,596, filed October 28, 2015; U.S. Provisional Patent Application No. 62 / 296,383, filed February 17, 2016; U.S. Provisional Patent Application No. 62 / 247,599, filed October 28, 2015; U.S. Provisional Patent Application No. 62 / 247,617, filed October 28, 2015; and U.S. Provisional Patent Application Serial No. 62 / 247,617, filed October 28, 2015. The benefits of U.S. Provisional Patent Application Serial No. 62 / 247,621, filed October 28, 2015; U.S. Provisional Patent Application Serial No. 62 / 247,624, filed October 28, 2015; U.S. Provisional Patent Application Serial No. 62 / 247,626, filed October 28, 2015; and U.S. Provisional Patent Application Serial No. 62 / 296,385, filed February 17, 2016, the entire contents of each of the above patent applications are incorporated herein by reference. Technical Field

[0004] This invention relates generally to a system and method for intravenous (IV) delivery, by which fluid can be directly delivered to a patient's vascular system. More particularly, the invention relates to IV catheter systems and methods that facilitate insertion into and / or movement from an insertion configuration to a fluid delivery configuration, in which fluid can be delivered to the patient via the IV catheter system. Throughout this document, the IV catheter system according to the invention is used extensively to describe components for delivering fluid to a patient for arterial, venous, intravascular, peritoneal, and / or non-vascular delivery of fluid. Of course, those skilled in the art can use the IV catheter system to deliver fluid to other locations within the patient's body. Background Technology

[0005] Known IV catheter systems and methods have several drawbacks. Many of these systems require the physician to use both hands to position the IV catheter system and / or insert the needle into the patient's fluid delivery location (e.g., a vein to which fluid will be delivered). Furthermore, many of these systems require the physician to use both hands to move the IV catheter system from the insertion configuration to the fluid delivery configuration, in which the needle is removed from the cannula to allow fluid to be delivered through the cannula to the vein. Therefore, the physician needs to stabilize the patient's arm or other body part with the fluid delivery location before inserting the IV catheter system. As a result, the physician needs additional time to initiate the infusion. Moreover, the physician cannot perform any other work, such as stabilizing or reassuring the patient, during insertion and / or movement to the fluid delivery configuration.

[0006] Therefore, there is a need for IV catheter systems and methods that facilitate the placement, insertion, and / or preparation of IV catheter systems for fluid delivery. There is also a need for such IV catheter systems to be inexpensive, easy to manufacture, and versatile. Summary of the Invention

[0007] Embodiments of the present invention generally relate to IV catheter systems with enhanced ergonomics. In some embodiments, the IV catheter system can be inserted and moved to a fluid delivery configuration using only one hand. The IV catheter system may have a catheter component having a catheter part and a needle part. The catheter part may have a catheter seat having a distal end and a proximal end. The catheter seat may be shaped to define a chamber extending at the distal and proximal ends of the catheter seat and a needle port at the proximal end of the catheter, the needle port providing an inlet to the chamber. The catheter component may also have a cannula extending distally from the distal end of the catheter seat and a push feature extending outwardly from the catheter seat. The needle part may have a needle seat having a distal end, a proximal end, a needle extending distally along an axis from the distal end of the needle seat, and a gripping portion extending generally parallel to the axis from the needle seat. The gripping portion may have a pull feature. In the insertion configuration, the needle can be positioned within the cannula, and the distal end of the needle seat can be seated within the needle port. In the fluid delivery configuration, the needle can be positioned outside the catheter seat. The push feature can be positioned to receive a first contact from a first finger of the user's hand to push the catheter seat distally. Furthermore, the pull feature can be positioned to receive a second contact from a second finger of the hand simultaneously with the first contact, such that the first and second contacts cooperate to move the IV catheter system from the insertion configuration to the fluid delivery configuration.

[0008] The catheter seat may have a middle portion located between the proximal and distal ends of the catheter seat. The catheter assembly may also have an extension tube connection extending outward from the middle portion of the catheter seat to connect the catheter seat to an extension tube. The actuation feature may have an actuation surface extending between the middle portion of the catheter seat and the extension tube connection. The actuation surface may be oriented substantially perpendicular to the axis.

[0009] The gripping portion may have a recess shaped to receive the extension tube engagement in the insertion configuration. Moving the IV catheter system from the insertion configuration to the fluid delivery configuration may include rotating the needle assembly about an axis relative to the catheter assembly to retract the extension tube engagement from the recess.

[0010] The catheter assembly may also have a partition located within the chamber through which the needle passes in the insertion configuration. The partition may be configured to provide sufficiently low resistance to the retraction of the needle through the partition, enabling the IV catheter system to be moved from the insertion configuration to the fluid delivery configuration with one hand.

[0011] The catheter assembly may also have a fixation platform having a first wing extending generally parallel to the axis from the catheter seat. In a fluid delivery configuration, the first wing can rest on the skin of a patient receiving fluid through an IV catheter system.

[0012] The fixed platform may also have a second wing that extends from the conduit seat and is substantially coplanar with the first wing. In fluid delivery configurations, the second wing may also rest on the skin.

[0013] In the insertion configuration, the first wing and the gripping portion can be substantially parallel to each other and positioned in an abutting relationship. During the movement of the IV catheter system from the insertion configuration to the fluid delivery configuration, the gripping portion can slide along the first wing.

[0014] At least one of the first wing and the gripping portion may have one or more alignment features. The alignment features enable the first wing and the gripping portion to remain positioned in an abutting relationship with each other as the IV catheter system moves from the insertion configuration toward the fluid delivery configuration.

[0015] At least one of the first wing and the gripping portion may have one or more locking features. The locking features may keep the IV catheter system in the insertion configuration until the first and second contacts cooperate to provide a disengagement force sufficient to release the one or more locking features.

[0016] The pull feature can be the leading edge of the grip. The shape and size of the leading edge can be designed to comfortably receive a second contact.

[0017] According to an exemplary method for preparing an IV catheter system to deliver fluid to a patient, the IV catheter system may also have an insertion configuration and a fluid delivery configuration. The method includes positioning the IV catheter system near the patient's fluid delivery location. The IV catheter system may have a catheter component and a needle component. The catheter component may have a catheter seat portion having a distal end and a proximal end. The catheter seat portion may be shaped to define a chamber extending between the distal and proximal ends of the catheter seat portion and a needle port at the proximal end of the catheter seat portion, the needle port providing an inlet to the chamber. The catheter component may also have a cannula extending distally from the distal end of the catheter seat portion and a push feature extending outwardly from the catheter seat portion. The needle component may have a needle seat portion having a distal end and a proximal end. The needle component may also have a needle extending distally along an axis from the distal end of the needle seat portion and a grip portion extending generally parallel to the axis, the grip portion having a pull feature. The method may further include, with the IV catheter in the insertion configuration, inserting the needle and cannula into a fluid delivery position using one hand, in which the needle is positioned within the cannula and the distal end of the needle seat is seated in the needle port. Furthermore, the method may also include, with the needle and cannula in the fluid delivery position, using one hand to push and pull the push feature simultaneously to move the IV catheter system from the insertion configuration to the fluid delivery configuration, in which the needle is positioned outside the catheter seat.

[0018] The catheter seat may have a middle portion located between a proximal end and a distal end of the catheter seat. The catheter assembly may also have an extension tube connection extending outward from the middle portion of the catheter seat to connect the catheter seat to an extension tube. A pushing feature may be a pushing surface extending between the middle portion of the catheter seat and the extension tube connection. The pushing surface may be oriented substantially perpendicular to the axis. Pushing the pushing feature may include pressing against the pushing surface.

[0019] The catheter assembly may also have a fixation platform having a first wing extending generally parallel to the axis from the catheter seat. Moving the IV catheter system from the insertion configuration to the fluid delivery configuration may include positioning the first wing to rest on the patient's skin.

[0020] In the insertion configuration, the first wing and the gripping portion can be substantially parallel to each other and can be positioned in an abutting relationship. Propelling the IV catheter system from the insertion configuration to the fluid delivery configuration may include sliding the gripping portion along the first wing.

[0021] At least one of the first wing and the gripping portion may have one or more alignment features. Promoting the movement of the IV catheter system from the insertion configuration to the fluid delivery configuration may include using the one or more alignment features to keep the first wing and the gripping portion positioned in an abutting relationship with each other during the movement of the IV catheter system from the insertion configuration to the fluid delivery configuration.

[0022] At least one of the first wing and the gripping portion may have one or more locking features. Prompting the IV catheter system to move from the insertion configuration to the fluid delivery configuration may include providing a disengagement force sufficient to unlock the one or more locking features.

[0023] The pull feature may be the leading edge of the grip. Pulling the pull feature may include pulling on the leading edge with one hand.

[0024] In some embodiments, the IV catheter system may have an insertion configuration and a fluid delivery configuration. The IV catheter system may have a catheter component and a needle component. The catheter component may have a catheter seat portion having a distal end, a proximal end, and a middle portion between the proximal and distal ends. The catheter seat portion may be shaped to define a chamber extending between the distal and proximal ends and a needle port at the proximal end, the needle port providing an inlet to the chamber. The catheter seat portion may also have a cannula extending distally from the distal end, an extension tube junction extending outwardly from the middle portion to connect the catheter seat portion to an extension tube, a diaphragm located within the chamber, and a push feature extending outwardly from the catheter seat portion. The needle component may have a needle seat portion having a distal end, a proximal end, a needle extending distally along an axis from the distal end, and a grip portion extending generally parallel to the axis. The grip may have a pull feature defined by its leading edge. In the insertion configuration, the needle may be positioned within the cannula, the needle may pass through a septum, and the distal end of the needle seat may be seated in the needle port. In the fluid delivery configuration, the needle may be positioned outside the catheter seat. The push feature may be positioned to receive a first contact from a first finger of the user's hand to push the catheter seat distally. Furthermore, the pull feature may be positioned to receive a second contact from a second finger of the hand simultaneously with the first contact, such that the first and second contacts cooperate to move the IV catheter system from the insertion configuration to the fluid delivery configuration. The shape and size of the leading edge may be designed to comfortably receive the second contact. The septum may be configured to provide sufficiently low resistance to needle retraction through the septum to allow the IV catheter system to be moved from the insertion configuration to the fluid delivery configuration with one hand.

[0025] The actuating feature may have an actuating surface that extends between the middle portion of the guide tube seat and the extension tube junction. The actuating surface may be oriented substantially perpendicular to the axis.

[0026] The catheter component may also have a fixing platform having a first wing extending generally parallel to the axis from the catheter seat, such that in the fluid delivery configuration, the first wing can rest on the skin of a patient receiving fluid via the IV catheter system. Furthermore, the catheter component may have a second wing extending from the catheter seat and generally coplanar with the first wing, such that in the fluid delivery configuration, the second wing also rests on the skin. In the insertion configuration, the first wing and the grip may be generally parallel to each other and positioned in an abutting relationship. During movement of the IV catheter system from the insertion configuration to the fluid delivery configuration, the grip may slide along the first wing.

[0027] In a first embodiment of the invention, an IV catheter system including an insertion configuration and a fluid delivery configuration is provided. The IV catheter system includes a catheter component comprising: a catheter seat including a distal end and a proximal end, wherein the catheter seat is shaped to define a chamber extending between the distal end and the proximal end and a needle port at the proximal end of the catheter seat, the needle port providing an inlet to the chamber; a cannula extending distally from the distal end of the catheter seat; and a push feature extending outwardly from the catheter seat. The IV catheter system may also include a needle component comprising: a needle seat portion including a distal end and a proximal end; a needle extending distally along an axis from the distal end of the needle seat portion; and a grip portion extending generally parallel to the axis from the needle seat portion, the grip portion including a pull feature, wherein, in an insertion configuration, the needle is positioned within a cannula and the distal end of the needle seat portion is seated in a needle port, and wherein, in a fluid delivery configuration, the needle is positioned outside the catheter seat portion, and wherein, a push feature is positioned to receive a first contact from a first finger of a user's hand to push the catheter seat portion distally, and a pull feature is positioned to receive a second contact from a second finger of the hand simultaneously with the first contact, such that the first and second contacts cooperate to move the IV catheter system from the insertion configuration to the fluid delivery configuration.

[0028] In some cases, the IV catheter system also includes a catheter seat portion located between the proximal and distal ends of the catheter seat portion, wherein the catheter component further includes an extension tube junction extending outward from the intermediate portion of the catheter seat portion to connect the catheter seat portion to the extension tube, wherein the push feature includes a push surface extending between the intermediate portion of the catheter seat portion and the extension tube junction, wherein the push surface is oriented substantially perpendicular to the axis.

[0029] In some cases, the grip portion of the IV catheter system also includes a recess shaped to receive an extension tube junction in the insertion configuration. Movement of the IV catheter system from the insertion configuration to the fluid delivery configuration includes rotating the needle component about an axis relative to the catheter component to retract the extension tube junction from the recess.

[0030] In some cases, the IV catheter assembly also includes a partition located within the chamber through which the needle passes in the insertion configuration. The partition is configured to provide sufficiently low resistance to needle retraction, allowing the IV catheter system to be moved from the insertion configuration to the fluid delivery configuration with one hand. In some cases, the catheter assembly may also include a retaining platform comprising a first wing extending generally parallel to the axis from the catheter seat, such that in the fluid delivery configuration, the first wing rests on the skin of the patient receiving fluid through the IV catheter system.

[0031] In some cases, the fixation platform of an IV catheter system also includes a second wing that extends from the catheter seat and is substantially coplanar with the first wing, such that in a fluid delivery configuration, the second wing also rests on the skin.

[0032] In some cases, in the insertion configuration of an IV catheter system, the first wing and the grip are generally parallel to each other and positioned in an abutting relationship, wherein the grip slides along the first wing as the IV catheter system moves from the insertion configuration to the fluid delivery configuration.

[0033] In some cases, at least one of the first wing and the gripping portion of the IV catheter system includes one or more alignment features that maintain the first wing and the gripping portion in an abutting relationship during movement of the IV catheter system from the insertion configuration toward the fluid delivery configuration. In some cases, at least one of the first wing and the gripping portion includes one or more locking features that retain the IV catheter system in the insertion configuration until the first and second contacts cooperate to provide a disengagement force sufficient to release the one or more locking features.

[0034] In some cases, the pull feature of an IV catheter system includes a leading edge of a gripping portion, wherein the shape and size of the leading edge are designed to comfortably receive a second contact.

[0035] In a second embodiment of the invention, a method is provided for preparing an IV catheter system to deliver fluid to a patient, the IV catheter system including an insertion configuration and a fluid delivery configuration, the method comprising: 1) positioning the IV catheter system near a fluid delivery location on the patient, wherein the IV catheter system includes a catheter component and a needle component, the catheter component including: a catheter seat having a distal end and a proximal end, wherein the catheter seat is shaped to define a chamber extending between the distal end and the proximal end of the catheter seat and a needle port at the proximal end of the catheter seat, the needle port providing an inlet to the chamber; a cannula extending distally from the distal end of the catheter seat; and a push feature extending outwardly from the catheter seat. The needle assembly includes: a needle seat portion, the needle seat portion including a proximal end of the needle seat portion and a distal end of the needle seat portion; a needle extending distally along an axis from the distal end of the needle seat portion; and a grip portion extending generally parallel to the axis from the needle seat portion, the grip portion including a pull feature; 2) with the IV catheter system in the insertion configuration, inserting the needle and cannula into the fluid delivery position with one hand, in the insertion configuration, the needle being positioned within the cannula and the distal end of the needle seat portion being seated in the needle port; and 3) with the needle and cannula in the fluid delivery position, pushing the push feature with one hand while simultaneously pulling the pull feature to cause the IV catheter system to move from the insertion configuration to the fluid delivery configuration, in the fluid delivery configuration, the needle being positioned outside the catheter seat portion.

[0036] In some cases, the IV catheter system of this method includes a catheter seat portion located between a proximal end and a distal end of the catheter seat portion, wherein the catheter component further includes an extension tube junction extending outward from the intermediate portion of the catheter seat portion to connect the catheter seat portion to an extension tube, wherein the push feature includes a push surface extending between the intermediate portion of the catheter seat portion and the extension tube junction, wherein the push surface is oriented substantially perpendicular to the axis, and wherein pushing the push feature includes pressing against the push surface.

[0037] In some cases, the catheter component of the IV catheter system of this method also includes a fixation platform comprising a first wing extending generally parallel to the axis from the catheter seat portion, wherein moving the IV catheter system from the insertion configuration to the fluid delivery configuration includes positioning the first wing to rest on the patient's skin.

[0038] In some cases, in the insertion configuration of the IV catheter system of this method, the first wing and the grip are generally parallel to each other and positioned in an abutting relationship, wherein moving the IV catheter system from the insertion configuration to the fluid delivery configuration includes sliding the grip along the first wing. In some cases, at least one of the first wing and the grip includes one or more alignment features, wherein moving the IV catheter system from the insertion configuration to the fluid delivery configuration includes using the one or more alignment features to keep the first wing and the grip positioned in an abutting relationship during the movement of the IV catheter system from the insertion configuration to the fluid delivery configuration.

[0039] In some cases, at least one of the first wing and the gripping portion of the IV catheter system of the method includes one or more locking features, wherein moving the IV catheter system from the insertion configuration to the fluid delivery configuration includes providing a separation force sufficient to unlock the one or more locking features.

[0040] In some cases, the pull feature of the IV catheter system of this method also includes the leading edge of the gripping portion, wherein pulling the pull feature includes pulling on the leading edge with one hand.

[0041] In a third embodiment of the invention, an IV catheter system including an insertion configuration and a fluid delivery configuration is provided. The IV catheter system includes a catheter component comprising a catheter seat and a needle component. The catheter seat includes a distal end, a proximal end, and a middle portion of the catheter seat located between the proximal and distal ends. The catheter seat is shaped to define a chamber extending between the distal and proximal ends and a needle port at the proximal end, the needle port providing an inlet to the chamber; a cannula extending distally from the distal end of the catheter seat; an extension tube junction extending outwardly from the middle portion of the catheter seat to connect the catheter seat to an extension tube; a diaphragm located within the chamber; and a push feature extending outwardly from the catheter seat. The needle component includes a needle seat including a proximal and distal end; and a needle extending distally along an axis from the distal end of the needle seat. The device comprises: a needle; and a grip portion extending generally parallel to the axis from the needle seat portion, the grip portion including a pull feature defined by a leading edge of the grip portion, wherein, in the insertion configuration, the needle is positioned within the cannula, the needle passes through a septum, and the distal end of the needle seat portion is seated in the needle port, wherein, in the fluid delivery configuration, the needle is positioned outside the catheter seat portion, wherein the push feature is positioned to receive a first contact from a first finger of the user's hand to push the catheter seat portion distally, and the pull feature is positioned to receive a second contact from a second finger of the hand simultaneously with the first contact, such that the first and second contacts cooperate to move the IV catheter system from the insertion configuration to the fluid delivery configuration, wherein the shape and size of the leading edge can be designed to comfortably receive the second contact, and wherein the septum is configured to provide sufficiently low resistance to the retraction of the needle through the septum to enable the IV catheter system to be moved from the insertion configuration to the fluid delivery configuration with one hand.

[0042] In some cases, the actuation feature of the IV catheter system further includes an actuation surface extending between the intermediate portion of the catheter seat and the extension tube junction, wherein the actuation surface is oriented substantially perpendicular to the axis. In some cases, the catheter assembly also includes a fixation platform comprising: a first wing extending substantially parallel to the axis from the catheter seat, such that in a fluid delivery configuration, the first wing rests on the skin of a patient receiving fluid via the IV catheter system; and a second wing extending from the catheter seat and substantially coplanar with the first wing, such that in a fluid delivery configuration, the second wing also rests on the skin, wherein in an insertion configuration, the first wing and the grip are substantially parallel to each other and positioned in an abutting relationship, wherein the grip slides along the first wing during movement of the IV catheter system from the insertion configuration to the fluid delivery configuration.

[0043] In some cases, the IV catheter system also includes a catheter seat portion located between the proximal end and the distal end of the catheter seat portion, wherein the catheter component also includes an extension tube junction extending outward from the catheter seat portion to connect the catheter seat portion to an extension tube, and wherein a first wing extends between the catheter seat portion and the extension tube junction, but does not extend outward beyond the extension tube junction.

[0044] In some cases, the needle component of the IV catheter system also includes a flash unit having a proximal ventilation and at least one lateral ventilation. In some cases, the catheter component includes a visual indicator. In some cases, the visual indicator is covered by the distal end of the catheter seat when the needle tip extends distally beyond the cannula, and is exposed when the needle tip is retracted into the cannula.

[0045] In some cases, the needle component of the IV catheter system includes a side grip, and the catheter component includes a push tab. In some cases, the needle component includes a flash chamber, on which the side grip is formed. In some cases, the catheter component further includes: a fixation platform including a first wing extending generally parallel to the axis from the catheter seat, such that in a fluid delivery configuration, the first wing rests on the skin of a patient receiving fluid through the IV catheter system; and an extension tube junction extending outward from a central portion of the catheter seat to connect the catheter seat to an extension tube, wherein the extension tube junction extends in the opposite direction to the first wing.

[0046] In some cases, the IV catheter system's catheter components also include a second wing extending in the opposite direction to the first wing, the second wing joining but not extending beyond the extension tube junction. In some cases, the second wing is formed of a rigid material, and the first wing is formed of a flexible material. In some cases, the first wing is configured to pivot about an axis relative to the catheter seat. In some cases, the first wing includes a hinge to enable pivoting. In some cases, the first wing is formed of a flexible material to enable pivoting.

[0047] In a fourth embodiment of the invention, an IV catheter system is provided, the IV catheter system including a catheter component and a needle component. The catheter component includes: a catheter seat portion including a distal end and a proximal end, wherein the catheter seat portion is shaped to define a chamber extending between the distal end and the proximal end and a needle port at the proximal end of the catheter seat portion, the needle port providing an inlet to the chamber; a cannula extending distally from the distal end of the catheter seat portion; and a push tab positioned at the proximal end of the catheter seat portion. The needle component includes: a needle seat portion including a distal end and a proximal end, the distal end of the needle seat portion including a notch aligned with the push tab formed at the proximal end of the catheter seat portion; and a needle extending distally along an axis from the distal end of the needle seat portion.

[0048] In some cases, the IV catheter system includes a retaining platform. In some cases, the push tab and the retaining platform are connected via one or more connecting channels. In some cases, the catheter component includes a stress relief portion positioned distal to the catheter seat around the cannula, connected to the retaining platform via a connecting channel. In some cases, both the catheter component and the needle component include protrusions that intersect to restrict rotation of the needle component relative to the catheter component. In some cases, the needle component includes wings, wherein the protrusions prevent the wings from rotating downward below the retaining platform. In some instances, the IV catheter system also includes a flash flow component that includes path-defining structures for controlling blood flow within the flash flow component.

[0049] These or other advantages of the invention may be incorporated into certain embodiments of the invention and will become more apparent from the following description and appended claims, or may be learned by practicing the invention as set forth below. It is not necessary to incorporate all the advantageous features and advantages described herein into every embodiment of the invention. Attached Figure Description

[0050] To facilitate understanding of the above and other features and advantages of the present invention, a more detailed description of the invention, briefly described above, will be provided with reference to specific embodiments of the invention shown in the accompanying drawings. These drawings depict only exemplary embodiments of the invention and are therefore not intended to limit the scope of the invention.

[0051] Figure 1 This is a perspective view of an IV catheter system according to one embodiment;

[0052] Figure 2 This is a perspective view of a portion of an IV catheter system according to an alternative embodiment;

[0053] Figure 3A and 3B These are perspective views and plan views of a portion of an IV catheter system according to another alternative embodiment;

[0054] Figure 4 This is a plan view of an IV catheter system according to another alternative embodiment;

[0055] Figure 5 This is a perspective view of an IV catheter system according to another alternative embodiment;

[0056] Figure 6 This is a perspective view of an IV catheter system according to another alternative embodiment;

[0057] Figure 7This is a perspective view of an IV catheter system according to another alternative embodiment;

[0058] Figure 8 This is a plan view of an IV catheter system according to another alternative embodiment;

[0059] Figure 9A and 9B These are, respectively, a perspective cross-sectional view and a side cross-sectional view of an IV catheter system according to yet another alternative embodiment;

[0060] Figure 10A , 10B 10C is a perspective view of an IV catheter system according to yet another alternative embodiment, wherein the catheter component and the needle component are partially separated, in an insertion configuration, and wherein the catheter component and the needle component are partially separated.

[0061] Figure 11 This is a flowchart illustrating a method for preparing an IV catheter system to deliver fluid to a patient, according to one embodiment.

[0062] Figure 12A and 12B These are perspective views of an IV catheter system according to another alternative embodiment, in both fully assembled and disassembled states.

[0063] Figure 13A and 13B This is a perspective view of an IV catheter system according to another alternative embodiment, with the catheter in the open and closed states respectively.

[0064] Figure 14A , 14B 14C and 14D are perspective views of an IV catheter system according to yet another alternative embodiment, respectively, in the compact state in the insertion configuration, in the open state in the insertion configuration, and in the disassembled state of the flash flow component.

[0065] Figure 15A , 15B 15C and 15D are perspective views of an IV catheter system according to yet another alternative embodiment, with the individual catheter and needle components respectively in the insertion configuration in the compact state, in the insertion configuration in the open state, and the flash flow component in the disassembled state.

[0066] Figure 16 This is a perspective view of an IV catheter system according to various embodiments, wherein the fixing platform includes a wing extending only between the catheter component and the extension tube junction;

[0067] Figure 17This is a perspective view of an IV catheter system according to yet another alternative embodiment, wherein the flashover component incorporated into the needle assembly includes a side ventilation section;

[0068] Figure 18A and 18B These are perspective and side views of IV catheter systems according to various embodiments, wherein catheter components include visual indicators to provide indication when the needle reaches the cover position;

[0069] Figure 19A and 19B These are perspective and side views of IV catheter systems according to various embodiments, wherein the elongated flash flow component includes a side grip and the catheter component includes a push tab.

[0070] Figure 20 This is a perspective view of an IV catheter system according to various embodiments, which provides several additional features;

[0071] Figure 21 An example of an anti-rotation feature that can be used with one or more embodiments of an IV catheter system is shown.

[0072] Figure 22A and 22B This illustrates how many exposed features can be provided on an open IV catheter system;

[0073] Figure 23 This illustrates a path-defining structure that can be used in the flash chamber of an embodiment of an IV conduit system;

[0074] Figures 24A-24E All show including Figure 23 A cross-sectional view of the flash chamber of the path-defined structure;

[0075] Figure 25A and 25B Another path-defined structure that can be used in the flash chamber of an embodiment of an IV conduit system is shown;

[0076] Figure 25C It shows including Figure 25A and 25B A cross-sectional view of the flash chamber of the path-defined structure.

[0077] Figure 26 This demonstrates how the vent plug can be used in conjunction with a path-limiting structure;

[0078] Figures 27A-27C All of these demonstrate different ways to fix the path-limiting structure within the flash chamber;

[0079] Figure 28A and 28B The path-defined structure is shown to include porous materials;

[0080] Figure 29 It is shown that the path-defining structure can be altered to delay the time required to provide visual confirmation of proper catheter placement;

[0081] Figure 30 This demonstrates how a sealing cap can be used on a flash chamber to prevent saline from flowing into the flash chamber during pre-priming of an IV catheter system. Detailed Implementation

[0082] The presently preferred embodiments of the invention can be understood with reference to the accompanying drawings, wherein the same reference numerals denote the same or functionally similar elements. It will be readily understood that the components of the invention, which are generally described herein and illustrated in the drawings, can be arranged and designed in a wide variety of different configurations. Therefore, the following more detailed description represented in the drawings is not intended to limit the scope of the claimed invention, but is merely representative of the presently preferred embodiments of the invention.

[0083] Furthermore, the accompanying drawings may show simplified or partial views, and for clarity, the dimensions of elements in the drawings may be exaggerated or otherwise drawn out of scale. Additionally, the singular forms “a,” “an,” “the,” etc., include a plural of the objects referred to, unless the context explicitly indicates otherwise. Thus, for example, referring to a terminal includes referring to one or more terminals. Furthermore, when referring to a list of elements (e.g., elements a, b, c), such a reference is intended to include any one of the listed elements themselves, any combination of not all of the listed elements, and / or a combination of all the listed elements.

[0084] The term “substantially” means that the described features, parameters or values ​​are not necessarily to be exactly realized, but may vary in quantity (e.g., including tolerances, measurement errors, measurement accuracy limitations and other factors known to those skilled in the art), but such deviations or variations will not prevent the effects that the features are intended to provide.

[0085] In this article, the terms “proximal,” “top,” “up,” or “upward” refer to the location on the device that is closest to the physician using the device and furthest from the patient to whom the device is being applied, when the device is used in normal operation. Conversely, the terms “distal,” “bottom,” “lower,” or “downward” refer to the location on the device that is furthest from the physician using the device and closest to the patient to whom the device is being applied, when the device is used in normal operation.

[0086] In this document, the terms "inside" and "towards" refer to the position of the device facing inwards during normal use. Conversely, the terms "outside" and "towards" refer to the position of the device facing outwards during normal use.

[0087] Figure 1 This is a perspective view of an IV catheter system 100 according to one embodiment. The IV catheter system 100 can be connected to a fluid supply unit to be infused. The fluid supply unit (not shown) may include a blood or drug bag to be delivered to the patient, an infusion chamber for regulating the flow of fluid to the IV catheter system 100, and / or other components involved in supplying fluid to the IV catheter system 100. Figure 1 As shown in the exemplary embodiments, the IV catheter system 100 may have multiple components. These components may include a catheter component 102, a needle component 104, an extension tube 106, a clamp 108, and / or a Luer lock adapter 110.

[0088] The catheter component 102 can be inserted into a fluid delivery location within a patient to deliver fluid to the patient. The needle component 104 can facilitate insertion of the catheter component 102 into the fluid delivery location. The extension tube 106 can deliver fluid to the catheter component 102. The clamp 108 can be used to manually block fluid flow to the catheter component 102 when it is desired to stop or pause fluid delivery. The Luer lock adapter 110 can be easily connected to the fluid supply unit, for example, via a complementary Luer lock (not shown) connected to the fluid supply unit.

[0089] like Figure 1 As illustrated, the IV catheter system 100 can be an integrated IV catheter system, in which case the extension tube 106 is pre-attached to the catheter component 102. In other embodiments, IV catheter systems with various open, integrated, and / or safety integrated configurations can be used.

[0090] The catheter assembly 102 may have various components, including a catheter seat 120, a fixation platform 122, an extension tube junction 124, and a cannula 126. The catheter seat 120 may have a generally tubular and / or hollow conical construction and may have a proximal end 130 and a distal end 132. The catheter seat 120 may be shaped to define a chamber 134 through which fluid flows to reach a fluid delivery location. The catheter seat 120 may have a needle port 136 at the proximal end 130. The chamber 134 may accommodate a septum 138 designed to block the flow of blood and / or fluid from the chamber 134 through the needle port 136. The cannula 126 may be secured to the distal end 132 of the catheter seat 120.

[0091] The fixation platform 122 may have a generally planar construction designed to allow the fixation platform 122 to be secured to the patient's skin close to the fluid delivery location, thereby firmly holding the catheter assembly 102 in place during fluid delivery. Figure 1As illustrated, the fixing platform 122 may have a first wing 140 and a second wing 142, the first wing having a generally planar shape, and the second wing also having a generally planar shape generally coplanar with the first wing 140. The second wing 142 may be positioned on the side of the guide tube seat 120 opposite to the first wing 140. Thus, relative to the guide tube seat 120, the first wing 140 and the second wing 142 may extend outward from the guide tube seat 120 in opposite directions. Both the first wing 140 and the second wing 142 may be securely fixed to the guide tube seat 120, and both may have a generally triangular shape when viewed from a direction perpendicular to the fixing platform 122. Alternatively, the first wing 140 and / or the second wing 142 may have any shape, including but not limited to polygonal shapes (e.g., triangular and rectangular shapes) and non-polygonal shapes (e.g., circular, semi-circular, oval, oblong, and irregular shapes). Some examples of these alternative shapes will be shown in subsequent embodiments. Both the first wing 140 and the second wing 142 may have a trailing edge 144 oriented toward the proximal end 130 of the guide seat portion 120.

[0092] The needle assembly 104 may have a needle hub 150, a grip 152, and a needle 154. The needle hub 150 may be detachably coupled to the catheter hub 120 of the catheter assembly 102. The grip 152 may extend outward from the needle hub 150. The needle 154 may be removably positioned within the cannula 126 such that the needle 154 facilitates access to a fluid delivery location (e.g., a vein) and proper positioning of the cannula 126 to deliver fluid to the fluid delivery location.

[0093] The needle seat portion 150 may have a generally tubular shape with a proximal end 160 and a distal end 162. The needle seat portion 150 may have a boss 164 positioned at the distal end 162; the boss 164 may be able to be inserted into the needle port 136 of the catheter seat portion 120 of the catheter component 102.

[0094] The grip portion 152 may have a generally planar shape extending outward from the needle seat portion 150. When viewed from a direction perpendicular to the grip portion 152, the grip portion 152 may have an oblong and / or partially elliptical shape. The grip portion 152, the first wing portion 140, and / or the second wing portion 142 may have one or more grip features 170, as shown on the grip portion 252, which help provide a secure interface that facilitates hand gripping and / or movement of the grip portion 152. The grip portion 152 may have a leading edge 172.

[0095] The IV catheter system 100 may have an insertion configuration and a fluid delivery configuration. In the insertion configuration, the IV catheter system 100 can be easily inserted to position the cannula 126 in the fluid delivery position. In the fluid delivery configuration, the fluid flow through the cannula 126 is relatively unobstructed. Figure 1 In this configuration, the IV catheter system 100 is in the insertion configuration. A needle 154 is positioned within a cannula 126 to provide a sharp tip for tissue insertion and a relatively rigid body to support the cannula 126 during insertion. A boss 164 of the needle seat portion 150 is positioned within the needle port 136 of the catheter seat portion 120. The needle 154 passes through a septum 138 of the catheter component 102.

[0096] The IV catheter system 100 can be inserted into the appropriate position by positioning the tip of the cannula 126 near the fluid delivery site (e.g., a patient's vein). The fixation platform 122 can be placed on the patient's skin, close to the fluid delivery site, and / or held in the physician's hand. The catheter component 102 and needle component 104 can be advanced to push the cannula 126 until the tip of the cannula 126 pierces the surrounding tissue and reaches the fluid delivery site. If necessary, the catheter component 102 can be advanced by pushing the pushing surface of the catheter component 102. The "pushing surface" is a generally proximal oriented surface that can receive contact from the physician's hand to push the catheter component 102 and needle component 104 distally together.

[0097] Once the end of the cannula 126 has reached the fluid delivery position, the IV catheter system 100 can move to the fluid delivery configuration. This can be accomplished by retracting the needle assembly 104 proximally from the catheter assembly 102. This may first involve retracting the boss 164 proximally from the needle port 136. The needle 154 can also be retracted proximally from the cannula 126, then through the chamber 134, including the diaphragm 138. The needle 154 can then exit the chamber 134 through the needle port 136, thus completing the movement of the IV catheter system 100 to the fluid delivery configuration. Fluid flow to the delivery position can now be achieved by facilitating fluid flow through the extension tube 106, into the chamber 134, and through the cannula 126 to the fluid delivery position.

[0098] The IV catheter system 100 can be advantageously designed to facilitate easy insertion to the fluid delivery position with one hand. For example, during insertion, a physician can hold the catheter component 102 and needle component 104 with one hand, for example, by grasping the fixation platform 122 and the grip 152. Subsequently, the physician can apply slight pressure with the same hand to one or more push surfaces of the catheter component 102 (e.g., the trailing edge 144 of the first wing 140 and / or the second wing 142) to induce the tip of the cannula 126 to pierce the patient's skin and ultimately reach the fluid delivery position. If desired, one or more locking features (not shown) can be used to hold the catheter component 102 and needle component 104 together until the physician applies a threshold force to move the IV catheter system 100 from the insertion position to the fluid delivery position. Such locking features can take the form of an interlocking feature (not shown) between the boss 164 and the needle port 136, etc.

[0099] The IV catheter system 100 can be designed to provide visual confirmation of proper placement in a blood vessel. For example, at least a portion of the catheter seat 120 can be translucent to provide visibility within the chamber 134. Thus, the resulting blood flow, or "flash flow," as the distal end of the cannula 126 enters the vein can be seen through the outer wall of the catheter seat 120 as blood enters the chamber 134. Optionally, the extension tube junction 124 and the extension tube 106 can also be translucent. In some embodiments, the flash flow can extend through the extension tube 106 to the Luer lock adapter 110. The Luer lock adapter 110 can be coupled to the fluid supply in a manner that substantially prevents blood leakage.

[0100] Furthermore, the IV catheter system 100 can be advantageously designed to facilitate movement from the insertion configuration to the fluid delivery configuration using only one hand. For example, a physician can grasp the catheter component 102 and the needle component 104 with one hand (which can be the same hand used to insert the IV catheter system 100 into the fluid delivery position) and retract the needle component 104 proximally from the catheter component 102. The catheter component 102 can be substantially held in place such that only the needle component 104 moves significantly to move the IV catheter system 100 from the insertion configuration to the fluid delivery configuration.

[0101] This can be accomplished by positioning the fingers of the hand in contact with one or more pull surfaces of the needle component 104 and one or more push surfaces of the catheter component 102, and then using these fingers to pull the needle component 104 proximally while simultaneously pushing the catheter component 102 distally to prevent the catheter component from moving proximally with the needle component 104. For example, the rear edge 144 of the fixation platform 122 can be used as the push surface, while the leading edge 172 of the grip 152 can be used as the pull surface. The physician can place one or more fingers on the leading edge 172 of the grip 152 and pull proximally while pushing with the thumb and / or one or more other fingers on the rear edge 144 of the fixation platform 122. Thus, the catheter component 102 can be held in the appropriate position with the end of the cannula 126 in the fluid delivery position, while the needle component 104 retracts proximally from the catheter component 102 to unlock the fluid delivery path leading to the fluid delivery position.

[0102] The relative positions of the pulling and pushing surfaces facilitate one-handed operation as described above. If needed, the connection between the needle hub 150 and the catheter seat 120 allows the needle hub 150 to rotate relative to the catheter seat 120 when the IV catheter system 100 is in the insertion configuration. Therefore, the physician can use this hand to rotate the grip 152 to the most comfortable orientation for pulling on the leading edge 172 before pulling on the leading edge 172 and pushing on the trailing edge 144.

[0103] The septum 138 may have a "low-friction" or "low-drag" design configured to provide low resistance to the proximal retraction of the needle 154 through the septum 138 as the IV catheter system 100 transitions from an insertion configuration to a fluid delivery configuration. The resistance to needle retraction through the septum 138 can be low enough that a physician can easily move the IV catheter system 100 from the insertion configuration to the fluid delivery configuration using only one hand. In some embodiments, the resistance to retraction can be less than about 50 gf on average.

[0104] Figure 2 This is a perspective view of an IV catheter system 200 according to an alternative embodiment. The IV catheter system 200 may have the same... Figure 1 The components of the IV catheter system 100 are roughly corresponding to the components. Figure 2 Only the catheter component 202, the needle component 204, and the distal end of the extension tube 206 connected to the catheter component 202 are shown. The IV catheter system 200 can be constructed similarly to... Figure 1 The IV catheter system 100 is constructed as follows; however, some components may be shaped differently to provide alternative ergonomics.

[0105] The conduit assembly 202 may have a conduit seat 220, a fixing platform 222, an extension tube junction 224, and a sleeve 226. The conduit seat 220 may have a generally tubular and / or hollow conical shape, having a proximal end 230 and a distal end 232. The conduit seat 220 may have a generally translucent outer wall shaped to define a chamber 234 through which fluid flows to reach the fluid delivery location via the sleeve 226. The conduit seat 220 may have a needle port 236 located near the proximal end 230 of the conduit seat 220 and connected to the needle assembly 204. The conduit seat 220 may also have a septum 238 located within the chamber 234. The septum 238 may be a "low-drag" septum as described above.

[0106] The fixation platform 222 can be attached to the patient's skin during fluid delivery to hold the cannula 226 in place at the fluid delivery location. The fixation platform 222 may have a first wing 240 and a second wing 242, both of which may be generally planar in shape and may extend in opposite directions relative to the catheter seat 220. When viewed perpendicularly to the fixation platform 222, each of the first wing 240 and the second wing 242 may have a generally rectangular shape, with its trailing edge 244 serving as a push surface.

[0107] The needle component 204 may have a needle seat portion 250, a grip portion 252, and a needle 254. The needle seat portion 250 may be generally cylindrical in shape, having a proximal end 260 and a distal end 262. The needle seat portion 250 may also have a boss 264 that extends from the distal end 262 to intersect with the needle port 236 of the guide tube seat portion 220.

[0108] The grip portion 252 may have a generally planar shape, and when viewed perpendicularly to the grip portion 252, it has a generally rectangular shape. However, the grip portion 252 may have any other suitable shape. The grip portion 252 may have a leading edge (not shown) that can serve as a pulling surface. The grip portion 252, the first wing 240, and / or the second wing 242 may have one or more grip features 270 that can help provide a secure interface that facilitates hand gripping and / or movement of the grip portion 152.

[0109] To move the IV catheter system 200 from the insertion configuration to the fluid delivery configuration, the physician can place one finger (e.g., a non-thumb) on the leading edge of the grip 252 and another finger (e.g., a non-thumb, or a thumb) on the trailing edge 244 of the first wing 240 and / or the second wing 242. The physician can then pull the leading edge proximally as indicated by arrow 290 and push the trailing edge 244 of the first wing 240 and / or the second wing 242 distally as indicated by arrow 292. This allows the catheter assembly 202 to be held in place while simultaneously retracting the needle assembly 204 proximally from the catheter assembly 202.

[0110] The grip portion 252 and the first wing portion 240 can be positioned parallel to each other and adjacent to each other, such that the grip portion and the first wing portion are in abutting relationship with each other during the insertion configuration and during the initial stage of movement from the insertion configuration to the fluid delivery configuration. In order to maintain the required relative positioning between the grip portion 252 and the first wing portion 240, the grip portion 252 and / or the first wing portion 240 may have one or more alignment features that maintain the relative positioning and / or orientation between the first wing portion 240 and the grip portion 252.

[0111] Specifically, the grip 252 may have an alignment feature in the form of an alignment ridge 280, which may extend toward the first wing 240 and may be received in a complementary alignment feature (not shown), such as a groove or other feature on the surface of the first wing 240 facing the grip 252. The alignment ridge 280 and the complementary alignment feature can help maintain the parallelism of the needle 254 with the cannula 226 during movement of the IV catheter system 200 to the fluid delivery configuration. This helps ensure that the needle component 204 can be smoothly retracted from the catheter component 202. More specifically, the application of an unbalanced force on the catheter component 202 and / or the needle component 204 can cause the needle component 204 to rotate relative to the catheter component 202. For example, if a physician pulls on the leading edge of the grip 252 while pushing on the trailing edge 244 of the first wing 240, this can cause the needle component 204 to rotate clockwise relative to the catheter component 202 (about...). Figure 2 (view).

[0112] The complementary alignment features of the alignment ridge 280 and the first wing 240 help ensure that no relative rotation occurs before the needle component 204 has been fully retracted from the conduit component 202 so that the alignment ridge 280 separates from the complementary alignment features of the first wing 240. Therefore, constraints and / or other undesirable interactions between the conduit component 202 and the needle component 204 can be avoided during the movement from the insertion configuration to the fluid delivery configuration.

[0113] Figure 3A and 3B These are perspective views and plan views, respectively, of a portion of an IV catheter system 300 according to another alternative embodiment. The IV catheter system 300 may have... Figure 1 and Figure 2 The components roughly correspond to the components. Figure 3A and 3B Only the catheter component 302, the needle component 304, and the distal end of the extension tube 306 connected to the catheter component 302 are shown. The IV catheter system 300 may be constructed similarly to the construction of the foregoing embodiments; however, some components may be shaped differently to provide alternative ergonomics.

[0114] As described in the foregoing embodiments, the conduit component 302 may have a conduit seat 320, a fixing platform 322, an extension tube junction 324, and a sleeve 326. The conduit seat 320 may have a generally tubular and / or hollow conical shape, having a proximal end 330 and a distal end 332. The conduit seat 320 may have a generally translucent outer wall shaped to define a chamber 334 through which fluid flows to reach a fluid delivery location via the sleeve 326. The conduit seat 320 may have a needle port 336 connected to a needle component 304 near the proximal end 330 of the conduit seat 320. The conduit seat 320 may also have a septum 338 located within the chamber 334. The septum 338 may be a "low-drag" septum as described above.

[0115] The fixation platform 322 can be attached to the patient's skin during fluid delivery to keep the cannula 326 in place at the fluid delivery location. The fixation platform 322 may have only a single wing in the form of a first wing 340, the trailing edge of which 344 can serve as a push surface. The first wing may be generally planar in shape and generally trapezoidal in shape when viewed perpendicularly to the fixation platform 322.

[0116] The first wing 340 can be integral with the extension tube junction 324, such that the extension tube junction 324 defines the leading edge of the first wing 340. The extension tube junction 324 can provide an enlargement at its leading edge for the width of the first wing 340; this enlargement allows the extension tube junction 324 to function as a pushing surface. More specifically, when the extension tube junction 324 is integral with the first wing 340, a physician can push on the rear portion of the extension tube junction 324 to advance the catheter component 302 forward.

[0117] The needle component 304 may have a needle seat portion 350, a grip portion 352, and a needle 354. The needle seat portion 350 may have a generally cylindrical shape, having a proximal end 360 and a distal end 362. The needle seat portion 350 may also have a boss 364 that extends from the distal end 362 to intersect with the needle port 336 of the guide tube seat portion 320.

[0118] The grip portion 352 may have a generally planar shape, and when viewed perpendicularly to the grip portion 352, it has a generally trapezoidal shape. The grip portion 352 may have a leading edge 372, which can serve as a pull surface. The grip portion 352 and / or the first wing portion 340 may have one or more grip features 370, which can help provide a firm interface that facilitates hand gripping and / or movement of the grip portion 152.

[0119] To move the IV catheter system 300 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 372 of the grip 352 and / or the leading edge of the tab 384, and one finger (e.g., a non-thumb, or thumb) on the trailing edge 344 of the first wing 340. The physician may then pull the leading edge 372 and / or the leading edge of the tab 384 proximally and push the trailing edge 344 of the first wing 340 distally. This allows the catheter assembly 302 to be held in place when the needle assembly 304 is retracted proximally from the catheter assembly 302.

[0120] The grip portion 352 and the first wing portion 340 can be positioned parallel to each other and adjacent to each other, such that the grip portion and the first wing portion are in abutting relationship with each other during the insertion structure and during the initial stage of movement from the insertion structure to the fluid delivery structure. In order to maintain the required relative positioning between the grip portion 352 and the first wing portion 340, the grip portion 352 and / or the first wing portion 340 can have one or more alignment features that maintain the relative positioning and / or orientation between the first wing portion 340 and the grip portion 352.

[0121] Specifically, the grip 352 may have alignment features in the form of a pair of alignment ridges 380, which may extend toward the first wing 340 and may be received in complementary alignment features in the form of slots 382 formed in the first wing 340. The alignment ridges 380 and slots 382 can help maintain the parallelism between the needle component 304 and the catheter component 302 during movement of the IV catheter system 300 to the fluid delivery configuration, which can facilitate movement to the fluid delivery configuration, as described in the foregoing embodiments.

[0122] If desired, the first wing 340 may be translucent to help the user see the grip 352, and more specifically, to help the user see the edge 372. In addition to the leading edge 372, the needle component 304 may have a tab 384 that extends outward from the needle seat 350 in a direction generally opposite to the direction in which the grip 352 extends. In addition to and / or replacing the leading edge 372 of the grip 352, the tab 384 may provide a pull surface that can be used by a physician. This provides the physician with additional options for inserting the IV catheter system 300 with one hand and / or for moving the IV catheter system 300 from the insertion configuration to the fluid delivery configuration with one hand.

[0123] Figure 4 This is a plan view of an IV catheter system 400 according to another alternative embodiment. The IV catheter system 400 may have the same... Figure 3A and 3B The components of the IV catheter system 300 are similar to those of other components. Figure 4 Only the catheter component 402, the needle component 404, and the distal end of the extension tube 406 connected to the catheter component 402 are shown. The IV catheter system 400 may be constructed similarly to the IV catheter system 300; however, some components may be shaped differently to provide alternative ergonomics.

[0124] As described in the foregoing embodiments, the conduit component 402 may have a conduit seat 420, a fixing platform 422, an extension tube junction 424, and a sleeve 426. The conduit seat 420 may have a generally tubular and / or hollow conical shape, having a proximal end 430 and a distal end 432. The conduit seat 420 may have a generally translucent outer wall shaped to define a chamber 434 through which fluid flows to reach the fluid delivery location via the sleeve 426. The conduit seat 420 may have a needle port 436 connected to the needle component 404 near the proximal end 430 of the conduit seat 420. The conduit seat 420 may also have a septum 438 located within the chamber 434. The septum 438 may be a "low-drag" septum as described above.

[0125] The fixation platform 422 can be attached to the patient's skin during fluid delivery to keep the cannula 426 in place at the fluid delivery location. The fixation platform 422 may have only a single wing in the form of a first wing 440, the trailing edge of which 444 can serve as a push surface. The first wing may be generally planar in shape and generally triangular in shape when viewed perpendicularly to the fixation platform 422.

[0126] The first wing 440 can be integral with the extension tube junction 424, such that the extension tube junction 424 defines the leading edge of the first wing 440. The extension tube junction 424 can provide an enlargement at its leading edge for the width of the first wing 440; this enlargement allows the extension tube junction 424 to function as a pushing surface. More specifically, when the extension tube junction 424 is integral with the first wing 440, a physician can push on the rear portion of the extension tube junction 424 to advance the catheter component 402 forward.

[0127] The needle component 404 may have a needle seat portion 450, a grip portion 452, and a needle 454. The needle seat portion 450 may have a generally cylindrical shape, having a proximal end 460 and a distal end 462. The needle seat portion 450 may also have a boss 464 that extends from the distal end 462 to intersect with the needle port 436 of the guide tube seat portion 420.

[0128] The grip portion 452 may have a generally planar shape, and when viewed perpendicularly to the grip portion 452, it has a generally triangular shape. The grip portion 452 may have a leading edge 472, which can serve as a pull surface. The grip portion 452 and / or the first wing portion 440 may have one or more grip features 470, which can help provide a firm interface that facilitates hand gripping and / or movement of the grip portion 452.

[0129] To move the IV catheter system 400 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 472 of the grip 452 and / or the leading edge of the tab 484, and one finger (e.g., a non-thumb, or thumb) on the trailing edge 444 of the first wing 440. The physician may then pull the leading edge 472 and / or the leading edge of the tab 484 proximally and push the trailing edge 444 of the first wing 440 distally. This allows the catheter assembly 402 to be held in place as the needle assembly 404 is retracted proximally from the catheter assembly 402.

[0130] The grip portion 452 and the first wing portion 440 can be positioned parallel to each other and adjacent to each other, such that the grip portion and the first wing portion are in abutting relationship with each other during the insertion structure and during the initial stage of movement from the insertion structure to the fluid delivery structure. In order to maintain the required relative positioning between the grip portion 452 and the first wing portion 440, the grip portion 452 and / or the first wing portion 440 may have one or more alignment features that maintain the relative positioning and / or orientation between the first wing portion 440 and the grip portion 452.

[0131] Specifically, the grip 452 may have alignment features in the form of a pair of alignment ridges 480, which may extend toward the first wing 440 and may be received in complementary alignment features in the form of slots 482 formed in the first wing 440. The alignment ridges 480 and slots 482 can help maintain the parallelism between the needle component 404 and the catheter component 402 during movement of the IV catheter system 400 to the fluid delivery configuration, which can facilitate movement to the fluid delivery configuration, as described in the foregoing embodiments.

[0132] If desired, the first wing 440 may be translucent to facilitate the user's view of the grip 452, and more specifically, to facilitate the user's view of the edge 472. In addition to the leading edge 472, the needle component 404 may have a tab 484 that extends outward from the needle seat 450 in a direction substantially opposite to the direction in which the grip 452 extends. In addition to and / or replacing the leading edge 472 of the grip 452, the tab 484 may provide a pull surface that can be used by a physician. This provides the physician with additional options for inserting the IV catheter system 400 with one hand and / or for moving the IV catheter system 400 from the insertion configuration to the fluid delivery configuration with one hand.

[0133] and Figure 3A and 3B Compared to the IV catheter system 300, the first wing 440 and the grip 452 can have a more triangular swept shape, as shown in the figure. This different shape allows the leading edge 472 of the grip 452 to be positioned at different angles and / or locations, which can facilitate one-handed operation for some users. Furthermore, in Figure 4 In the IV catheter system 400, the alignment ridge 480 can be relatively short, thereby providing low frictional resistance to the movement of the IV catheter system 400 from the insertion configuration to the fluid delivery configuration.

[0134] Figure 5 This is a perspective view of an IV catheter system 500 according to another alternative embodiment. The IV catheter system 500 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 5 Only the catheter component 502, the needle component 504, and the distal end of the extension tube 506 connected to the catheter component 502 are shown.

[0135] As described in the foregoing embodiments, the conduit component 502 may have a conduit seat 520, a fixing platform 522, an extension tube connection 524, and a sleeve 526. The conduit seat 520 may have a generally tubular and / or hollow conical shape, having a proximal end 530 and a distal end 532. The conduit seat 520 may have a generally translucent outer wall shaped to define a chamber 534 through which fluid flows to reach the fluid delivery location via the sleeve 526. The conduit seat 520 may have a needle port 536 connected to a needle component 504 near the proximal end 530 of the conduit seat 520. The conduit seat 520 may also have a septum 538 positioned within the chamber 534. The septum 538 may be a "low-drag" septum as described above.

[0136] The fixation platform 522 can be attached to the patient's skin during fluid delivery to hold the cannula 526 in place at the fluid delivery location. The fixation platform 522 may have a first wing 540 and a second wing 542, each of which may be generally planar. When viewed perpendicularly to the fixation platform 522, both the first wing 540 and the second wing 542 may have a generally trapezoidal shape, with their trailing edges 544 serving as a push surface.

[0137] The first wing 540 can be integral with the extension tube junction 524, such that the extension tube junction 524 defines the leading edge of the first wing 540. The extension tube junction 524 can provide an enlargement at its leading edge for the width of the first wing 540; this enlargement allows the extension tube junction 524 to function as a pushing surface. More specifically, when the extension tube junction 524 is integral with the first wing 540, a physician can push on the rear portion of the extension tube junction 524 to advance the catheter component 502 forward.

[0138] The second wing 542 can be rotatably coupled to the catheter seat 520. Therefore, the physician can position the second wing 542 in substantially any orientation about the axis defined by the cannula 526 and / or needle 554. The second wing 542 can rotate relatively freely about the catheter seat 520, such that before or during insertion of the IV catheter system 500 into the fluid delivery position and / or before or during movement of the IV catheter system 500 from the insertion position to the fluid delivery position, the physician can rotate the second wing 542 relative to the first wing 540 with one hand to obtain a desired grip.

[0139] The needle component 504 may have a needle seat portion 550, a grip portion 552, and a needle 554. The needle seat portion 550 may have a generally cylindrical shape, having a proximal end 560 and a distal end 562. The needle seat portion 550 may also have a boss 564 that extends from the distal end 562 to intersect with the needle port 536 of the guide tube seat portion 520.

[0140] The grip portion 552 may have a generally planar shape, or a generally trapezoidal shape when viewed perpendicularly to it. The grip portion 552 may have a leading edge 572, which may serve as a pull surface. The grip portion 552 and / or the first wing portion 540 may have one or more grip features 570 that help provide a secure interface that facilitates hand gripping and / or movement of the grip portion 552.

[0141] The grip portion 552 and the first wing portion 540 can be positioned parallel to each other and adjacent to each other, such that the grip portion and the first wing portion are in an abutting relationship during the insertion configuration and during the initial phase of movement from the insertion configuration to the fluid delivery configuration. In order to maintain the required relative positioning between the grip portion 552 and the first wing portion 540, the grip portion 552 and / or the first wing portion 540 may have one or more alignment features that maintain the relative positioning and / or orientation between the first wing portion 540 and the grip portion 552.

[0142] Specifically, the grip 552 may have alignment features in the form of a pair of alignment ridges 580, which may extend toward the first wing 540 and may be received in complementary alignment features in the form of slots 582 formed in the first wing 540. The alignment ridges 580 and slots 582 can help maintain the parallelism between the needle component 504 and the catheter component 502 during movement of the IV catheter system 500 to the fluid delivery configuration, which can facilitate movement to the fluid delivery configuration, as described in the foregoing embodiments.

[0143] If desired, the first wing 540 and / or the second wing 542 may be translucent to help the user see the grip 552, and more specifically, to help the user see the edge 572. In addition to the leading edge 572, the needle component 504 may have a tab 584 that extends outward from the needle seat 550 in a direction substantially opposite to the direction in which the grip 552 extends. In addition to and / or replacing the leading edge 572 of the grip 552, the tab 584 may provide a pull surface that can be used by a physician. This provides the physician with additional options for inserting the IV catheter system 500 with one hand and / or for moving the IV catheter system 500 from the insertion configuration to the fluid delivery configuration with one hand.

[0144] To move the IV catheter system 500 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 572 of the grip 552 and / or the leading edge of the tab 584, and one finger (e.g., a non-thumb, or thumb) on the trailing edge 544 of the first wing 540. The physician may then pull the leading edge 572 and / or the leading edge of the tab 484 proximally and push the trailing edge 544 of the first wing 540 distally. This allows the catheter assembly 502 to be held in place when the needle assembly 504 is retracted proximally from the catheter assembly 502.

[0145] Figure 6 This is a perspective view of an IV catheter system 600 according to another alternative embodiment. The IV catheter system 600 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 6 Only the catheter component 602, the needle component 604, and the distal end of the extension tube 606 connected to the catheter component 602 are shown.

[0146] As described in the foregoing embodiments, catheter assembly 602 may have a catheter seat 620, a fixing platform 622, an extension tube junction 624, and a cannula 626. The catheter seat 620 may have a generally tubular and / or hollow conical shape, having a proximal end 630 and a distal end 632. The catheter seat 620 may have a generally translucent outer wall shaped to define a chamber (not shown) through which fluid flows to reach the fluid delivery location via the cannula 626. The catheter seat 620 may have a needle port 636 connected to a needle assembly 604 near the proximal end 630 of the catheter seat 620. The catheter seat 620 may also have a septum (not shown) located within the chamber. The septum may be a "low-drag" septum as described above. Furthermore, the catheter seat 620 may have an anti-kink feature that helps prevent the cannula 626 from kinking during insertion and / or infusion. The anti-kink feature may take the form of a proximal extension 628 on the distal end 632 of the catheter seat portion 620. The proximal extension 628 may receive the cannula 626 and may provide some resistance to bending of the cannula 626 at the junction of the cannula 626 and the proximal end 630 to reduce bending strain at that location, thereby helping to avoid kinking or other undesirable bending of the cannula 626.

[0147] The fixation platform 622 can be attached to the patient's skin during fluid delivery to hold the cannula 626 in place at the fluid delivery location. The fixation platform 622 may have a first wing 640 and a second wing 642, each of which may be generally planar. When viewed perpendicularly to the fixation platform 622, each of the first wing 640 and the second wing 642 may have a generally triangular shape, with its trailing edge 644 serving as a push surface. The first wing 640 and the second wing 642 may extend outward in opposite directions from the axis of the catheter seat portion 620.

[0148] The second wing 642 may be integral with the extension tube junction 624, such that the extension tube junction 624 extends beyond the trailing edge 644 of the second wing 642. The extension tube junction 624 may provide an enlargement to the width of the second wing 642 near the trailing edge 644; this enlargement allows the extension tube junction 624 to function as a pushing surface. Furthermore, the catheter component 602 may have a pushing feature in the form of a pushing surface 646 between its proximal end 630 and distal end 632, the pushing surface extending between the extension tube junction 624 and the intermediate portion of the catheter seat 620. The size of the pushing surface 646 may be selected to allow a physician to easily push on the pushing surface 646 with one finger to propel the catheter component 602 forward. The pushing surface 646 may be oriented substantially perpendicular to the axes of the catheter component 602 and the needle component 604.

[0149] The needle component 604 may have a needle seat portion 650, a grip portion 652, and a needle (not shown). The needle seat portion 650 may have a generally cylindrical shape, having a proximal end 660 and a distal end 662. The needle seat portion 650 may also have a boss 664 that extends from the distal end 662 to intersect with the needle port 636 of the guide tube seat portion 620.

[0150] The grip portion 652 may have a generally planar shape, but when viewed perpendicularly to it, it has a generally irregular shape. The grip portion 652 may have a narrow portion 666 extending from the needle hub portion 650 to connect to a larger portion 668, which abuts against a first wing 640 of the holding platform 622 when the IV catheter system 600 is in insertion configuration. The grip portion 652 may have a leading edge 672, which can serve as a pulling surface. The grip portion 652 and / or the first wing 640 may have one or more grip features (not shown) that help provide a secure interface facilitating hand gripping and / or movement of the grip portion 652.

[0151] To move the IV catheter system 600 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 672 of the grip 652 and another finger (e.g., a non-thumb, or thumb) on the trailing edge 644 and / or the actuating surface 646 of the first wing 640. The physician may then pull the leading edge 672 proximally and push the trailing edge 644 and / or the actuating surface 646 distally. This allows the catheter assembly 602 to be held in place as the needle assembly 604 is retracted proximally from the catheter assembly 602.

[0152] Figure 7 This is a perspective view of an IV catheter system 700 according to another alternative embodiment. The IV catheter system 700 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 7 Only the catheter component 702, the needle component 704, and the distal end of the extension tube 706 connected to the catheter component 702 are shown.

[0153] As described in the foregoing embodiments, catheter assembly 702 may have a catheter seat 720, a fixing platform 722, an extension tube connection 724, and a cannula 726. The catheter seat 720 may have a generally tubular and / or hollow conical shape, having a proximal end 730 and a distal end 732. The catheter seat 720 may have a generally translucent outer wall shaped to define a chamber (not shown) through which fluid flows to reach the fluid delivery location via the cannula 726. The catheter seat 720 may have a needle port 736 connected to a needle assembly 704 near the proximal end 730 of the catheter seat 720. The catheter seat 720 may also have a diaphragm (not shown) located within the chamber. The diaphragm may be a "low-drag" diaphragm as described above. Furthermore, the catheter seat 720 may have an anti-kink feature that helps prevent the cannula 726 from kinking during insertion and / or infusion. The anti-kink feature may take the form of a proximal extension 728 on the distal end 732 of the catheter seat portion 720. The proximal extension 728 may receive the cannula 726 and may provide some resistance to bending of the cannula 726 at the junction of the cannula 726 and the proximal end 730 to reduce bending strain at that location, thereby helping to avoid kinking or other undesirable bending of the cannula 726.

[0154] The fixation platform 722 can be attached to the patient's skin during fluid delivery to hold the cannula 726 in place at the fluid delivery location. The fixation platform 722 may have a first wing 740 and a second wing 742, each of which may be generally planar. When viewed perpendicularly to the fixation platform 722, both the first wing 740 and the second wing 742 may have a generally triangular shape, with their trailing edge 744 serving as a push surface. The first wing 740 and the second wing 742 may extend outward in opposite directions from the axis of the catheter seat portion 720.

[0155] The second wing 742 may be integral with the extension tube junction 724, such that the extension tube junction 724 extends beyond the trailing edge 744 of the second wing 742. The extension tube junction 724 may provide an enlargement in width for the second wing 742 near the trailing edge 744; this enlargement allows the extension tube junction 724 to function as a push surface. Furthermore, the catheter component 702 may have a push feature in the form of a push surface 746 between its proximal end 730 and distal end 732, the push surface extending between the extension tube junction 724 and the intermediate portion of the catheter seat 720. The size of the push surface 746 may be selected to allow a physician to easily push on the push surface 746 with one finger to propel the catheter component 702 forward. The push surface 746 may be oriented substantially perpendicular to the axes of the catheter component 702 and the needle component 704.

[0156] The needle component 704 may have a needle seat portion 750, a grip portion 752, and a needle (not shown). The needle seat portion 750 may have a generally cylindrical shape, having a proximal end 760 and a distal end 762. The needle seat portion 750 may also have a boss 764 that extends from the distal end 762 to intersect with the needle port 736 of the guide tube seat portion 720.

[0157] The grip portion 752 may have a generally planar shape, but when viewed perpendicularly to it, it has a generally irregular shape. The grip portion 752 may have a narrow portion 766 extending from the needle hub portion 750 to connect to a larger portion 768, which abuts against a first wing 740 of the holding platform 722 when the IV catheter system 700 is in insertion configuration. The grip portion 752 may have a leading edge 772 that can serve as a pulling surface. The grip portion 752 and / or the first wing 740 may have one or more grip features (not shown) that help provide a secure interface facilitating hand gripping and / or movement of the grip portion 752.

[0158] The first wing 740 and / or the grip 752 may have one or more locking features that help retain the IV catheter system 700 in the insertion configuration until a physician applies a threshold disengagement force sufficient to disengage the needle component 704 from the catheter component 702. As shown, the locking features may include a locking tab 780 on the first wing 740 and a locking tab 782 on the grip 752. In the insertion configuration, the locking tab 780 of the first wing 740 may be suspended above the locking tab 782 of the grip 752. In the insertion configuration, the locking tabs 780 and 782 may interlock such that one or both of the locking tabs 780 and 782 must be buckled to allow the locking tabs 780 and 782 to disengage from each other.

[0159] To move the IV catheter system 700 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 772 of the grip 752 and another finger (e.g., a non-thumb, or thumb) on the trailing edge 744 of the first wing 740 and / or the actuating surface 746. The physician may then pull the leading edge 772 proximally and push the trailing edge 744 and / or the actuating surface 746 distally. Applying the desired threshold separation force may disengage the locking tab 782 from the locking tab 780, thereby allowing the needle component 704 to move proximally relative to the catheter component 702. The catheter component 702 can then be held in place as the needle component 704 is retracted proximally from the catheter component 702.

[0160] Figure 8 This is a plan view of an IV catheter system 800 according to another alternative embodiment. The IV catheter system 800 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 8 Only the catheter component 802, the needle component 804, and the distal end of the extension tube 806 connected to the catheter component 802 are shown.

[0161] As described in the foregoing embodiments, catheter component 802 may have a catheter seat 820, an extension tube junction 824, and a cannula 826. However, catheter component 802 may not have a fixation platform. Therefore, the presence of a fixation platform is optional. If desired, the catheter seat 820 may alternatively be directly fixed to the patient's skin to keep the cannula 826 in place at the fluid delivery position.

[0162] The conduit seat 820 may have a generally tubular and / or hollow conical shape, having a proximal end 830 and a distal end 832. The conduit seat 820 may have a generally translucent outer wall shaped to define a chamber 834 through which fluid flows to reach a fluid delivery location via a sleeve 826. The conduit seat 820 may have a needle port 836 connected to a needle assembly 804 near the proximal end 830 of the conduit seat 820. The conduit seat 820 may also have a septum 838 located within the chamber 834. The septum 838 may be a "low-drag" septum as described above.

[0163] The catheter component 802 may have a push feature in the form of a push surface 846 between its proximal end 830 and distal end 832, the push surface extending between the intermediate portion of the extension tube junction 824 and the catheter seat 820. The size of the push surface 846 may be selected to allow a physician to easily push on the push surface 846 with one finger to advance the catheter component 802. The push surface 846 may be oriented substantially perpendicular to the axes of the catheter component 802 and the needle component 804.

[0164] The needle component 804 may have a needle seat portion 850, a grip portion 852, and a needle 854. The needle seat portion 850 may have a generally cylindrical shape, having a proximal end 860 and a distal end 862. The needle seat portion 850 may also have a boss 864 that extends from the distal end 862 to intersect with the needle port 836 of the guide tube seat portion 820.

[0165] The grip portion 852 may have a generally planar shape, but when viewed perpendicularly to it, it has a generally irregular shape. The grip portion 852 may have a narrow portion 866 extending from the needle hub portion 850 to connect to a larger portion 868, which can be coupled to the extension tube junction 824 when the IV catheter system 800 is in the insertion configuration. The grip portion 852 may have a leading edge 872, which can serve as a pulling surface. The grip portion 852 may have one or more grip features 870 that help provide a secure interface facilitating hand gripping and / or movement of the grip portion 852.

[0166] Furthermore, the grip 852 may have a recess 874 that receives the extension tube coupling 824 when the IV catheter system 800 is in the insertion configuration. The recess 874 may be shaped to receive the extension tube coupling 824 and the push surface 846 to maintain alignment between the catheter component 802 and the needle component 804 during insertion. The positioning of the extension tube coupling 824 and the push surface 846 within the recess 874 may interfere with the relative axial movement between the catheter component 802 and the needle component 804. In this case, as the IV catheter system 800 is about to move from the insertion configuration to the fluid delivery configuration, the needle component 804 (and therefore the grip 852 with the recess 874) may rotate relative to the catheter component 802 to retract the extension tube coupling 824 and the push surface 846 from within the recess 874. The proximal movement of the needle component 804 relative to the catheter component 802 may then be unimpeded. However, in some embodiments, in order to retract the extension tube joint 824 and the push surface 846 from the recess 874 (e.g., due to the flexibility of the extension tube joint 824 and the push surface 846), the needle member 804 does not need to rotate relative to the conduit member 802.

[0167] In addition to the leading edge 872, the needle component 804 may also have a tab 884 that extends outward from the needle seat portion 850 in a direction substantially opposite to the direction in which the grip portion 852 extends. Besides and / or replacing the leading edge 872 of the grip portion 852, the tab 884 can provide a pull surface that can be used by a physician. This provides an additional option for the physician to insert the IV catheter system 800 with one hand and / or to move the IV catheter system 800 from the insertion configuration to the fluid delivery configuration with one hand.

[0168] To move the IV catheter system 800 from the insertion configuration to the fluid delivery configuration, the physician can first rotate the needle component 804 relative to the catheter component 802 to retract the extension tube junction 824 and the push surface 846 from the recess 874, as described above. The physician can then place one finger (e.g., a non-thumb) on the leading edge 872 of the grip 852 and / or the leading edge of the tab 884, and place another finger (e.g., a non-thumb, or thumb) on the push surface 846. The physician can then pull the leading edge 872 and / or the tab 884 proximally and push the push surface 846 distally. The catheter component 802 can then remain in the appropriate position when the needle component 804 is retracted proximally from the catheter component 802.

[0169] Figure 9A and 9B These are perspective sectional views and side sectional views of an IV catheter system 900 according to another alternative embodiment. The IV catheter system 900 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 9A and9B Only catheter component 902 and needle component 904 are shown. IV catheter system 900 may be an open system rather than an integrated system; therefore, IV catheter system may not have an integrated extension tube or extension tube junction.

[0170] As in the foregoing embodiments, catheter component 902 may have a catheter seat 920, a tab 924, and a cannula 926. However, as in the IV catheter system 800, catheter component 902 may not have a fixing platform. If desired, the catheter seat 920 may be directly fixed to the patient's skin to hold the cannula 926 in place at the fluid delivery position.

[0171] The catheter seat 920 may have a generally tubular and / or hollow conical shape, having a proximal end 930 and a distal end 932. The catheter seat 920 may have a generally translucent outer wall shaped to define a chamber 934 through which fluid flows to reach a fluid delivery location via a sleeve 926. The catheter seat 920 may have a needle port 936 connected to a needle assembly 904 near the proximal end 930 of the catheter seat 920. The catheter seat 920 may have a septum 938, which may be a "low-drag" septum as described above.

[0172] In an alternative embodiment (not shown), the catheter seat 920 may not have a septum. Instead, fluid can flow from the proximal end 930 to the distal end 932 through the body of the catheter seat 920 to reach the cannula 926. After the cannula 926 has been positioned at the fluid delivery location and the needle component 804 has been retracted from the catheter component 802, a fluid supply unit can be connected to the needle port 936 of the catheter seat 920 to supply the fluid to be infused to the proximal end 930 of the catheter seat 920.

[0173] A tab 924 may extend outward from the catheter seat 920 and may provide a ready-to-grip surface to facilitate user manipulation of the catheter seat 920. The tab 924 may have a main portion 940 and an elevated distal end 942. A plurality of gripping features 944 may be positioned on the main portion 940 and the distal end 942. The tab 924 may serve as a push feature that can be easily pushed with the fingers of the hand to facilitate insertion of the IV catheter system 900 and / or movement of the IV catheter system 900 from an insertion configuration to a fluid delivery configuration. The user may place their fingers on the main portion 940 and / or the elevated distal end 942 of the tab 924. Furthermore, the shape of the elevated distal end 942 may define a push surface 946 oriented substantially perpendicular to the axis of the cannula 926. The user may place their fingers on the main portion 940 against the push surface 946 to facilitate the application of forward (i.e., distal) pressure on the catheter component 902.

[0174] The needle component 904 may have a needle seat portion 950, a first grip portion 952, a second grip portion 953, and a needle 954. The needle seat portion 950 may have a generally cylindrical shape, having a proximal end 960 and a distal end 962. The needle seat portion 950 may also have a boss 964 that extends from the distal end 962 to intersect with the needle port 936 of the guide tube seat portion 920.

[0175] Both the first grip portion 952 and the second grip portion 953 may have a generally planar shape, but when viewed perpendicularly to the first grip portion 952 and the second grip portion 953, they have an irregular shape. Each of the first grip portion 952 and the second grip portion 953 may have a narrow portion 966 that extends from the needle seat portion 950 to connect to the larger portion 968. Both the first grip portion 952 and the second grip portion 953 may have a leading edge 972 that can serve as a pulling surface. The leading edges 972 of the first grip portion 952 and the second grip portion 952 may cooperate to define a single continuous surface that extends around the outer periphery of the distal end 932 of the catheter seat portion 920 to connect the first grip portion 952 to the second grip portion 953. The interconnection between the first grip portion 952 and the second grip portion 952 (in Figure 9B (As shown more clearly in the image) can serve as an anti-kink feature and / or provide additional support, which tends to keep the needle component 904 parallel to the catheter component 902 during insertion and / or transition from the insertion configuration to the fluid delivery configuration.

[0176] To move the IV catheter system 900 from the insertion configuration to the fluid delivery configuration, a physician can place one finger (e.g., a non-thumb) on the leading edge 972 of the first grip 952 and / or the leading edge 972 of the second grip 953, and place another finger (e.g., a non-thumb, or a thumb) on the tab 924 (e.g., on the push surface 946). The physician can then pull the leading edge 972 proximally and push the push surface 946 distally. The catheter component 902 can be held in place when the needle component 904 is retracted proximally from the catheter component 902.

[0177] Figure 10A , 10B 10C and 10C are perspective views of an IV catheter system 1000 according to yet another alternative embodiment, with the catheter component 1002 and needle component 1004 partially separated in an insertion configuration and with the catheter component 1002 and needle component 1004 partially separated. The IV catheter system 1000 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 6 Only the catheter component 1002, the needle component 1004, and the distal end of the extension tube 1006 connected to the catheter component 1002 are shown.

[0178] As described in the foregoing embodiments, the catheter component 1002 may have a catheter seat 1020, a fixing platform 1022, an extension tube junction 1024, and a sleeve 1026. The catheter seat 1020 may have a generally tubular and / or hollow conical shape, having a proximal end 1030 and a distal end 1032. The catheter seat 1020 may have a generally translucent outer wall shaped to define a chamber 1034 through which fluid flows to reach the fluid delivery location via the sleeve 1026. The catheter seat 1020 may have a needle port 1036 connected to the needle component 1004 near the proximal end 1030 of the catheter seat 1020. The catheter seat 1020 may also have a diaphragm 1038 located within the chamber 1034. The diaphragm may be a "low-drag" diaphragm as described above.

[0179] Furthermore, the catheter hub 1020 may have an anti-kink feature that helps prevent the cannula 1026 from kinking during insertion and / or infusion. The anti-kink feature may take the form of a proximal extension 1028 on the distal end 1032 of the catheter hub 1020. The proximal extension 1028 may receive the cannula 1026 and may provide some resistance to bending of the cannula 1026 at the junction of the cannula 1026 and the proximal end 1030, thereby mitigating bending strain at that location and helping to prevent kinking or other undesirable bending of the cannula 1026.

[0180] The fixation platform 1022 can be attached to the patient's skin during fluid delivery to hold the cannula 1026 in place at the fluid delivery location. The fixation platform 1022 may have a first wing 1040 and a second wing 1042, each of which may be generally planar. Both the first wing 1040 and the second wing 1042 may have a trailing edge 1044, which can serve as a push surface. The first wing 1040 and the second wing 1042 may extend outward in opposite directions from the axis of the catheter seat portion 1020. The first wing 1040 may be adjacent to the extension tube junction 1024.

[0181] The needle component 1004 may have a needle seat portion 1050, a grip portion 1052, and a needle 1054. The needle seat portion 1050 may have a generally cylindrical shape, with a proximal end 1060 and a distal end 1062. The needle seat portion 1050 may also have a boss 1064 that extends from the distal end 1062 to intersect with the needle port 1036 of the guide tube seat portion 1020. Between the proximal end 1060 and the distal end 1062, the needle seat portion 1050 may have a plurality of outwardly extending ridges 1066. The needle seat portion 1050 may be elongated, allowing the user to grip the ridges 1066 at any position along the length of the needle seat portion 1050. Ridge 1066, or more specifically, the distal surface of ridge 1066, may optionally serve as a push surface 1068, which helps to hold needle component 1004 to move IV catheter system 1000 from insertion configuration to fluid delivery configuration.

[0182] The grip portion 1052 may have a generally planar shape, and when viewed perpendicularly to the grip portion 1052, it has a generally rectangular shape. When the IV catheter system 1000 is in the insertion configuration, the grip portion 1052 may be in abutment with the first wing 1040 of the fixing platform 1022. The grip portion 1052 may have a leading edge 1072, which may serve as a pulling surface. The grip portion 1052 and / or the first wing 1040 may have one or more grip features (not shown) that help provide a secure interface that facilitates hand gripping and / or movement of the grip portion 1052.

[0183] To move the IV catheter system 1000 from the insertion configuration to the fluid delivery configuration, a physician may place one finger (e.g., a non-thumb) on the leading edge 1072 and / or the pulling surface 1068 of the first grip 1052, and another finger (e.g., a non-thumb, or a thumb) on the trailing edge 1044 of the first wing 1040 and / or the trailing edge 1044 of the second wing 1042. The physician may then pull one or both of the leading edges 1072 proximally and push the trailing edge 1044 and / or the pulling surface 1068 distally. This allows the catheter assembly 1002 to be held in place when the needle assembly 1004 is retracted proximally from the catheter assembly 1002.

[0184] Figure 11 This is a flowchart illustrating a method for preparing an IV catheter system to deliver fluid to a patient according to one embodiment. Figure 11 The method can be used Figure 1-10C This refers to any implementation of the IV catheter system disclosed herein, or implementation using other IV catheter system embodiments not explicitly shown or described herein. By way of example, it will be combined with... Figure 1 The method is described in IV catheter system 100. Furthermore, Figure 11The methods described are merely exemplary; other methods may be used in conjunction with any IV catheter system embodiment included within the scope of this disclosure.

[0185] The method can begin with step 1120, in which the catheter system is prepared. This preparation step may include placing the various components (e.g., in an illustrative manner, for example, ...) Figure 1 The catheter component 102, needle component 104, extension tube 106, clamp 108, and / or Luer lock adapter 110 are connected together. Additionally, this step may include preparing any adhesives required to secure the catheter component 102 to the patient, preparing components to be connected to the fluid source of the IV catheter system 100, and / or similar operations.

[0186] In step 1130, the IV catheter system 100 can be held with one hand. This step may include placing the fingers of the hand to contact one or more pull surfaces of the needle component 104 and one or more push surfaces of the catheter component 102, as described above. Note that the surfaces used as pull and push surfaces may vary depending on the specific embodiment used. Furthermore, catheter insertion may primarily involve pushing; therefore, the physician may choose not to contact the pull surfaces at this stage, but rather to contact them as the IV catheter system 100 is about to move toward the fluid delivery configuration.

[0187] In step 1140, the IV catheter system 100 can be manipulated to insert the cannula 126 into the patient. This can optionally be done with one hand. Insertion can continue until the tip of the cannula 126 has reached the fluid delivery position. Insertion can be made by pushing on the pushing surface and / or other surfaces of the catheter component 102 and / or needle component 104.

[0188] In step 1150, the IV catheter system 100 can be moved from the insertion configuration to the fluid delivery configuration. If the physician has not yet contacted the pull surface(s) of the needle component 104, he or she can now contact the pull surface(s) with one or more fingers of his or her hand. Alternatively, the IV catheter system 100 can be moved to the fluid delivery configuration independently (i.e., without the assistance of another hand) using the same hand used to insert the IV catheter system 100. The physician can pull the pull surface(s) proximally while simultaneously pushing on the push surface(s) to hold the catheter component 102 in place. Thus, the catheter component 102 can be held in place, with the end of the cannula 126 located at the fluid delivery position, as the needle component 104 is retracted proximally from the catheter component 102 to avoid obstructing the fluid delivery path to the fluid delivery position.

[0189] This can optionally be done with one hand. Therefore, during insertion and / or as the IV catheter system 100 moves to the fluid delivery configuration, the other hand can be used for other tasks. For example, the physician can use the other hand to hold the patient's arm (or other body part where the fluid delivery location is located), prepare other components for interconnection with the IV catheter system 100, prepare any necessary blood test materials, and / or similar operations.

[0190] The method can then be terminated at 1190. With the IV catheter system 100 in a fluid delivery configuration, a fluid source can be connected to the catheter assembly 102 to deliver fluid to the patient.

[0191] Within the scope of this disclosure, IV catheter systems can have a wide variety of alternative configurations. (Refer to...) Figure 12A-15D The supplementary embodiments are briefly shown and described.

[0192] Figure 12A and 12B These are perspective views of an IV catheter system 1200 according to yet another alternative embodiment, in both a fully assembled state and a disassembled state. The IV catheter system 1200 may have components similar to those of the IV catheter system of the aforementioned embodiment. Figure 12A The diagram shows catheter assembly 1202, needle assembly 1204, extension tube 1206, clamp 1208, and Luer lock adapter 1210. Figure 12B Only the catheter component 1202, needle component 1204, and extension tube 1206 are shown. As in some of the foregoing embodiments, the IV catheter system 1200 can be an integrated system; therefore, the extension tube 1206 can be pre-attached to the catheter component 1202. Several components of the IV catheter system 1200 may be similar to those in the foregoing embodiments and will therefore not be explicitly described; rather, the construction and operation of these components can be understood by referring to the description of the foregoing drawings.

[0193] As shown in the figure, the catheter component 1202 may have a fixing platform 1222 with a first wing 1240 and a second wing 1242. The first wing 1240 may be integral with an extension tube connection 1224, which connects the extension tube 1206 to the catheter component 1202. In the insertion configuration, the second wing 1242 may cover the grip portion 1252 of the needle component 1204, such that the distal ends of the grip portion 1242 and the second wing 1242 have substantially the same, generally elliptical shape.

[0194] The fixation platform 1222 may optionally be "soft," i.e., formed of a more compliant material that readily conforms to the patient's skin. In some embodiments, the fixation platform 1222 may be formed of a soft plastic, elastomer (e.g., silicone rubber), and / or similar material. The fixation platform 1222 and the grip portion 1252 may have one or more grip features 1270 that facilitate hand gripping and / or manipulation of the fixation platform 1222 and / or the grip portion 1252.

[0195] Furthermore, the fixing platform 1222 and / or the grip 1252 may optionally have features that further facilitate the movement of the IV catheter system 1200 from the insertion configuration to the fluid delivery configuration. Specifically, the second wing 1242 may have a distal ridge 1280, which can serve as a pushing feature. The distal ridge 1280 may be positioned such that fingers can easily access the proximal side of the distal ridge 1280 to apply distal pressure on the second wing 1242. The grip 1252 may have a peripheral ridge 1282 positioned at the outer edge of the grip 1252. The peripheral ridge 1282 can serve as a pulling feature. The peripheral ridge 1282 may be positioned such that fingers can easily access the top and / or distal side of the peripheral ridge 1282 to apply proximal pressure on the grip 1252. The peripheral ridge 1282 may optionally be positioned just outside the outermost edge of the second wing 1242 when the IV catheter system 1200 is in the insertion configuration, so that the peripheral ridge 1282 can be touched by fingers even when the second wing 1242 is positioned over the grip portion 1252.

[0196] Alternatively, the fixed platform 1222 and / or the grip 1252 may have one or more friction-reducing features that facilitate movement from the insertion configuration to the fluid delivery configuration. Such friction-reducing features may optionally reduce the degree of friction between the grip 1252 and the second wing 1242, allowing the grip 1252 and the second wing 1242 to slide more easily past each other. One such friction-reducing feature may be a central ridge 1284 on the second wing 1242 that extends toward the grip 1252. In the insertion configuration, the central ridge 1284 may abut against the grip 1252 to reduce the surface area of ​​contact between the second wing 1242 and the grip 1252, thereby reducing the frictional resistance to the sliding movement between the grip 1252 and the second wing 1242. Therefore, the central ridge 1284 may reduce the force required to move the IV catheter system 1200 from the insertion configuration to the fluid delivery configuration, making this transition easier to complete with just one hand.

[0197] Figure 13A and 13BThis is a perspective view of an IV catheter system 1300 according to yet another alternative embodiment, in both the open and closed states. A physician can flexibly insert the IV catheter system in the open or closed state and / or move the IV catheter system to the fluid delivery configuration. One or both states can facilitate manipulation of the IV catheter system 1300 with the fingers of one hand. The IV catheter system 1300 may have components similar to those of the IV catheter system of the foregoing embodiments. Figure 13A and 13B The catheter component 1302, needle component 1304, and extension tube 1306 are shown. As in some of the foregoing embodiments, the IV catheter system 1300 can be an integrated system; therefore, the extension tube 1306 can be pre-attached to the catheter component 1302. Several components of the IV catheter system 1300 may be similar to those in the foregoing embodiments and will therefore not be explicitly described; rather, the construction and operation of these components can be understood by referring to the description of the foregoing drawings.

[0198] As shown in the figure, the conduit component 1302 may have a fixing platform 1322 with a first wing 1340 but no second wing. The first wing 1340 may be integral with an extension tube connection 1324, which connects the extension tube 1306 to the conduit component 1302. Figure 13B In the compact configuration shown, the first wing 1340 can cover the gripping portion 1352 of the needle component 1204, such that the distal ends of the gripping portion 1352 and the first wing 1340 have substantially the same, generally elliptical shape. Figure 13A In the open state, the first wing 1340 and the grip 1352 can extend in substantially opposite directions, thereby providing a substantially symmetrical profile.

[0199] The fixation platform 1322 may optionally be "soft," i.e., formed of a more compliant material that readily conforms to the patient's skin. In some embodiments, the fixation platform 1322 may be formed of a soft plastic, elastomer (e.g., silicone rubber), and / or similar material. The fixation platform 1322 and the grip portion 1352 may have one or more grip features 1370 that facilitate hand gripping and / or manipulation of the fixation platform 1322 and / or the grip portion 1352.

[0200] Furthermore, the fixed platform 1322 and / or the grip 1352 may have one or more friction-reducing features that facilitate movement from the insertion configuration to the fluid delivery configuration. Such friction-reducing features may optionally reduce the degree of friction between the grip 1352 and the first wing 1340, allowing them to slide more easily past each other in a compact configuration. One such friction-reducing feature may be a central ridge 1384 on the grip 1352, which, in a compact configuration, may extend toward the first wing 1340. In a compact configuration, the central ridge 1384 may abut against the first wing 1340 in the insertion configuration to reduce the surface area of ​​contact between the grip 1352 and the first wing 1340, thereby reducing frictional resistance to sliding movement between the grip 1352 and the first wing 1340. Therefore, the central ridge 1384 can reduce the force required to move the IV catheter system 1300 from the insertion configuration to the fluid delivery configuration, thereby making the transition in the closed configuration easier to be completed with just one hand.

[0201] Figure 14A , 14B 14C and 14D are perspective views of an IV catheter system 1400 according to yet another alternative embodiment, respectively, in the compact state in the insertion configuration, the individual catheter component 1402 in the open state in the insertion configuration, and the flash flow component 1412 in the disassembled state. The IV catheter system 1400 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 14A The diagram illustrates catheter component 1402, needle component 1404, extension tube 1406, and flash flow component 1412. As in some of the foregoing embodiments, the IV catheter system 1400 can be an integrated system; therefore, the extension tube 1406 can be pre-attached to catheter component 1402. Several components of the IV catheter system 1400 may be similar to those in the foregoing embodiments and will therefore not be explicitly described further; rather, the construction and operation of these components can be understood by referring to the description of the foregoing drawings.

[0202] As shown in the figure, the catheter component 1402 may have a fixing platform 1422 with a first wing 1440 and a second wing 1442. The first wing 1440 may be integral with an extension tube junction 1424, which connects the extension tube 1406 to the catheter component 1402. In the insertion configuration, the second wing 1442 may cover the grip portion 1452 of the needle component 1404, such that the distal ends of the grip portion 1442 and the second wing 1442 have substantially the same generally elliptical shape, but the grip portion 1452 may be slightly larger than the second wing 1442. Therefore, the grip portion 1452 may extend beyond the contour of the second wing 1442.

[0203] The fixation platform 1422 may optionally be "soft," i.e., formed of a more compliant material that readily conforms to the patient's skin. In some embodiments, the fixation platform 1422 may be formed of a soft plastic, elastomer (e.g., silicone rubber), and / or similar materials. The fixation platform 1422 and the grip portion 1452 may have one or more grip features 1470 that facilitate hand gripping and / or manipulation of the fixation platform 1422 and / or the grip portion 1452.

[0204] Furthermore, the fixing platform 1422 and / or the gripping portion 1452 may optionally have features that further facilitate the movement of the IV catheter system 1400 from the insertion configuration to the fluid delivery configuration. Specifically, the extension tube connection 1424 may have a recess 1480, which can serve as a pushing feature. The recess 1480 may be positioned such that fingers can easily access the extension tube connection 1424 and thus easily access the first wing 1440 to apply distal pressure on the first wing 1440. The second wing 1442 may have a stepdown 1482, where the thickness of the second wing 1442 changes from a greater thickness toward the distal end of the second wing 1442 to a smaller thickness toward the proximal end of the second wing 1442. Therefore, the stepdown 1482 can provide a proximal oriented surface, which can also serve as a pushing feature. The physician can place his fingers on the proximal-oriented surface of the second wing 1442 to help apply distal pressure on the second wing 1442.

[0205] The grip portion 1452 may have a proximal ridge 1483 located at the proximal edge of the grip portion 1452. The proximal ridge 1483 may serve as a pull feature. The proximal ridge 1483 may be positioned such that fingers can easily access the apex and / or distal side of the proximal ridge 1483 to apply proximal pressure to the grip portion 1452. The proximal ridge 1483 may optionally be positioned just near the proximal edge of the second wing 1442 when the IV catheter system 1400 is in the insertion configuration, such that the proximal ridge 1483 can be accessed by fingers even when the second wing 1442 is positioned over the grip portion 1452.

[0206] Alternatively, the fixed platform 1422 and / or the grip 1452 may have one or more friction-reducing features that facilitate movement from the insertion configuration to the fluid delivery configuration. Such friction-reducing features may optionally reduce the degree of friction between the grip 1452 and the second wing 1442, allowing the grip 1452 and the second wing 1442 to slide more easily past each other. One such friction-reducing feature may be a series of central protrusions 1484 on the grip 1452 that extend toward the second wing 1442. In the insertion configuration, the central protrusions 1484 may abut against the second wing 1442 to reduce the surface area of ​​contact between the second wing 1442 and the grip 1452, thereby reducing the frictional resistance to sliding movement between the grip 1452 and the second wing 1442. Therefore, the central bump 1484 can reduce the force required to move the IV catheter system 1400 from the insertion configuration to the fluid delivery configuration, making the transition easier to be completed with just one hand.

[0207] like Figure 14C As shown, the central protrusion 1484 can optionally be aligned with the central groove 1485, which is formed in the surface of the second wing 1442 facing the grip portion 1452. The central groove 1485 can receive the central protrusion 1484. Therefore, the central protrusion 1484 and the central groove 1485 can serve as alignment features to maintain alignment between the second wing 1442 and the grip portion 1452, thereby reducing the possibility of constraint or other resistance to movement to the fluid delivery structure, which could otherwise be caused by misalignment between the conduit component 1402 and the needle component 1404.

[0208] Figure 14C The diagram shows the open state, in which the needle component 1404 is rotated relative to the catheter component 1402 in a manner that positions the grip 1452 substantially perpendicular to the fixed platform 1422. In this state, the IV catheter system 1400 can provide alternative ergonomics for inserting the cannula into the fluid delivery position and / or moving the IV catheter system 1400 into the fluid delivery configuration. In this state, the central bump 1484 may not be positioned within the central groove 1485. However, when the needle component 1404 and the catheter component 1402 are rotated relative to each other again to position the IV catheter system 1400 in the compact state, the central bump 1484 can enter the central groove 1485 to ensure proper alignment between the needle component 1404 and the catheter component 1402.

[0209] The flash flow element 1412 can indicate the proper placement of the cannula of the catheter assembly 1402. When the cannula is inserted into a blood vessel, the resulting blood flow can enter the catheter assembly 1402 and reach the flash flow element 1412 through the needle assembly 1404, which can be secured to the proximal end of the needle assembly 1404. Blood can enter the flash flow chamber 1414 of the flash flow element 1412, which is visible to the user through the transparent wall of the flash flow element 1412. The flash flow element 1412 may also have a vent 1416 that allows any air in the IV catheter system 1400 to escape as blood enters, ensuring that blood can fill the flash flow element 1412.

[0210] Figure 15A , 15B 15C and 15D are perspective views of an IV catheter system 1500 according to yet another alternative embodiment, respectively, in the compact state in the insertion configuration, of the separate catheter component 1502 and needle component 1504, in the open state in the insertion configuration, and of the flash flow component in the disassembled state. The IV catheter system 1500 may have components similar to those of the IV catheter system of the foregoing embodiment. Figure 15A The diagram illustrates catheter component 1502, needle component 1504, extension tube 1506, and flash flow component 1512. As in some of the foregoing embodiments, the IV catheter system 1500 can be an integrated system; therefore, the extension tube 1506 can be pre-attached to the catheter component 1502. Several components of the IV catheter system 1500 may be similar to those in the foregoing embodiments and will therefore not be explicitly described further; rather, the construction and operation of these components can be understood by referring to the description of the foregoing drawings.

[0211] As shown in the figure, the catheter component 1502 may have a fixing platform 1522 with a first wing 1540 and a second wing 1542. The first wing 1540 may be integral with an extension tube connection 1524, which connects the extension tube 1506 to the catheter component 1502. In the insertion configuration, the second wing 1542 may cover the grip portion 1552 of the needle component 1504, such that the distal ends of the grip portion 1552 and the second wing 1542 have substantially the same generally elliptical shape, but the grip portion 1552 may be slightly larger than the second wing 1542. Therefore, the grip portion 1552 may extend beyond the contour of the second wing 1542.

[0212] The fixation platform 1522 may optionally be "soft," i.e., formed of a more compliant material that readily conforms to the patient's skin. In some embodiments, the fixation platform 1522 may be formed of a soft plastic, elastomer (e.g., silicone rubber), and / or similar materials. The fixation platform 1522 and the grip portion 1552 may have one or more grip features 1570 that facilitate hand gripping and / or manipulation of the fixation platform 1522 and / or the grip portion 1552.

[0213] Furthermore, the fixing platform 1522 and / or the gripping portion 1552 may optionally have features that further facilitate the movement of the IV catheter system 1500 from the insertion configuration to the fluid delivery configuration. Specifically, the extension tube connection 1524 may have a recess 1580, which can serve as a pushing feature. The recess 1580 may be positioned such that fingers can easily access the extension tube connection 1524 and thus easily access the first wing 1540 to apply distal pressure on the first wing 1540. The second wing 1542 may have a stepped portion 1582, where the thickness of the second wing 1542 changes from a greater thickness toward the distal end of the second wing 1542 to a smaller thickness toward the proximal end of the second wing 1542. Therefore, the stepped portion 1582 can provide a proximal oriented surface, which can also serve as a pushing feature. The physician can place their fingers on the proximal-oriented surface of the second wing 1542 to help apply distal pressure on the second wing 1542. The stepdown ridge 1588 can be positioned close to the stepdown portion 1582 to widen the dimensions of the proximal-oriented surface provided by the stepdown portion 1582, thereby facilitating the use of the stepdown portion 1582 as a push feature.

[0214] The grip portion 1552 may have a peripheral ridge 1583 positioned at the outer edge of the grip portion 1552. The peripheral ridge 1583 may serve as a pull feature. The peripheral ridge 1583 may be positioned such that fingers can easily access the apex and / or distal side of the peripheral ridge 1583 to apply proximal pressure to the grip portion 1552. The peripheral ridge 1583 may optionally be positioned outside the outer edge of the second wing 1542 when the IV catheter system 1500 is in the insertion configuration, such that the peripheral ridge 1583 can be accessed by fingers even when the second wing 1542 is positioned over the grip portion 1552. The peripheral ridge 1583 may define the boundary of a distal recess 1586 of the grip portion 1552, within which the second wing 1542 may reside in the insertion configuration.

[0215] Furthermore, the grip portion 1552 may have a proximal recess 1584. The raised edge of the grip portion 1552 surrounding and defining the proximal recess 1584 may also serve as a pulling feature. The physician may place the fingers of the hand on any of these edges to apply proximal pressure to the grip portion 1552.

[0216] Alternatively, the fixing platform 1522 and / or the grip 1552 may have one or more friction-reducing features that facilitate movement from the insertion configuration to the fluid delivery configuration. Such friction-reducing features may optionally reduce the degree of friction between the grip 1552 and the second wing 1542, allowing the grip 1552 and the second wing 1542 to slide more easily past each other. One such friction-reducing feature may be a central ridge 1592 on the second wing 1542 that extends toward the grip 1552. In the insertion configuration, the central ridge 1592 may abut against the grip 1552 to reduce the surface area of ​​contact between the second wing 1542 and the grip 1552, thereby reducing the frictional resistance to sliding movement between the grip 1552 and the second wing 1542. Therefore, the central ridge 1592 may reduce the force required to move the IV catheter system 1500 from the insertion configuration to the fluid delivery configuration, making this transition easier to complete with just one hand.

[0217] like Figure 15C As shown, the central ridge 1590 can optionally be aligned with the central groove 1592, which is formed in the surface of the grip 1552 facing the second wing 1542. The central groove 1592 can receive the central ridge 1590. Therefore, the central ridge 1590 and the central groove 1592 can serve as alignment features to maintain alignment between the second wing 1542 and the grip 1552, thereby reducing the possibility of constraint or other resistance to movement to the fluid delivery structure, which could otherwise be caused by misalignment between the conduit member 1502 and the needle member 1504.

[0218] Figure 15CThe diagram shows the open state, in which the needle component 1504 is rotated relative to the catheter component 1502 in a manner that positions the grip 1552 substantially perpendicular to the fixed platform 1522. In this state, the IV catheter system 1500 can provide alternative ergonomics for inserting the cannula into the fluid delivery position and / or moving the IV catheter system 1500 into the fluid delivery configuration. In this state, the central ridge 1590 may not be positioned within the central groove 1592. However, when the needle component 1504 and the catheter component 1502 are rotated relative to each other again to position the IV catheter system 1500 in the compact state, the central ridge 1590 may enter the central groove 1592 to ensure proper alignment between the needle component 1504 and the catheter component 1502.

[0219] The flash flow element 1512 can indicate the proper placement of the cannula of the catheter assembly 1502. When the cannula is inserted into a blood vessel, the resulting blood flow can enter the catheter assembly 1502 and pass through the needle assembly 1504 to reach the flash flow element 1512, which can be secured to the proximal end of the needle assembly 1504. Blood can enter the flash flow chamber 1514 of the flash flow element 1512, which is visible to the user through the transparent wall of the flash flow element 1512.

[0220] Various embodiments of the invention (not shown) also include a safety mechanism configured to secure the sharp, distal tip of the guide needle after removal from and separation of the needle assembly from the catheter assembly. The safety mechanism may include any compatible device known in the art. In some cases, the safety mechanism is configured to interact with needle features (e.g., loops, notches, curls, or protrusions on the needle). Curls or protrusions formed in the needle create a slightly convex, rounded structure that can be used to activate the safety mechanism. In some cases, the safety mechanism includes an arm or lever actuated to capture the needle tip within the safety mechanism and prevent the tip from being exposed prior to safe disposal.

[0221] A safety mechanism is attached to the body of the needle and is capable of sliding along the length of the needle. In some cases, the initial or assembled position of the safety mechanism is located near the base or proximal end of the needle component before catheter insertion. For some configurations, the assembled position of the safety mechanism is located between the proximal end of the needle seat and the proximal end of the catheter seat or fixation platform, wherein the safety mechanism does not overlap with the catheter seat or fixation platform. In some cases, a portion of the safety mechanism is located within the catheter seat, and a balancing portion of the safety mechanism is located outside the catheter seat, for example, within the needle seat. In some embodiments, a portion of the catheter seat or fixation platform extends proximally to provide a receiving portion in which at least a portion of the safety mechanism is received. In some cases, the entire safety mechanism is received within the receiving portion of the catheter seat or fixation platform before catheter insertion.

[0222] In some embodiments, the assembly position of the safety mechanism positions the proximal end of the catheter hub between the distal end of the safety mechanism and the distal end of the needle component's grip. In some cases, the assembly position of the safety mechanism positions the proximal end of the catheter hub between the distal end of the safety mechanism and the proximal end of the needle component's grip. In some cases, a portion of the safety mechanism overlaps with a portion of the needle component's grip. In some embodiments, at least some portions of at least one of the catheter hub and the grip overlap with at least some portions of the safety mechanism. In some embodiments, neither the catheter hub nor the grip has any portion overlapping with any portion of the safety mechanism.

[0223] In some embodiments, a detachable mechanical connection is provided between the safety mechanism and at least one other component of the IV catheter system. In some embodiments, the distal end of the safety mechanism is selectively coupled to the proximal end of the catheter hub. In one embodiment, the safety mechanism is internally interlocked to the proximal end of the catheter hub. In one embodiment, the safety mechanism is externally interlocked to the proximal end of the catheter hub. In some embodiments, the distal end of the safety mechanism is selectively coupled to the proximal end of the fixation platform. In some embodiments, a surface of the safety mechanism is selectively coupled to at least one surface of at least one of the catheter hub, the blood control valve, the extension tube, and the fixation platform. In some cases, the mechanical connection is disengaged when the needle tip is secured within the safety mechanism.

[0224] Figure 16 , 17 Tables 18A, 18B, 19A, and 19B depict various modifications that can be made to many of the aforementioned IV catheter systems. For illustrative purposes, reference will be made to… Figure 14A and 14B The IV catheter system 1400 shown describes these modifications. However, these modifications can be made equivalently to other IV catheter systems described herein.

[0225] Figure 16 An IV catheter system 1600 is shown, constructed in the same manner as IV catheter system 1400, except that the first wing 1440 extends only between the catheter component 1402 and the extension tube junction 1424. In other words, in Figure 16 In this embodiment, the first wing 1440 does not extend outward beyond the extension tube joint 1424. In such an embodiment, the first wing 1440 may extend between the conduit member 1402 and the extension tube joint 1424 to reinforce the extension tube joint 1424, thereby facilitating the use of the extension tube joint 1424 as a gripping surface during insertion. As noted above, in many other embodiments described, the portion of the first wing extending beyond the extension tube joint may also be removed.

[0226] Figure 17An IV catheter system 1700 is shown, which is constructed in the same manner as the IV catheter system 1400, except that the flashover component 1412 includes a side vent. Specifically, as... Figure 17 As shown, the flashover component 1412 may include the proximal vent 1416a as described above (in Figure 14A (Ref. 1416). Additionally, the flash chamber 1412 may include one or more side vents 1416b formed through the sidewall of the flash chamber 1412. These side vents may be positioned close to the venting membrane 1701 and provide alternative or additional ventilation pathways for air as air leaves the flash chamber 1412.

[0227] When a physician inserts an IV catheter system, they can place their thumb over the proximal ventilation section 1416a, thereby blocking airflow through the ventilation section and minimizing blood flow into the flash member 1412. Therefore, the IV catheter system 1700 may include a lateral ventilation section 1416b, which provides an alternative pathway for airflow in the event that the proximal ventilation section 1416a is blocked. The lateral ventilation section 1416b can be shaped in any suitable manner. In some embodiments, the flash member 1412 may be elongated to accommodate a suitably sized lateral ventilation section. Any of the other IV catheter systems described above that also employ a flash member may also be configured with a lateral ventilation section. In some embodiments, a portion of the proximal ventilation section 1416a extends onto the sidewall of the flash member 1412 to form the lateral ventilation section 1416b. Therefore, the user's thumb can block the portion of the proximal vent 1416a located on the proximal end of the flash member 1412 without contacting or blocking the portion of the proximal vent 1416b located on the side wall of the flash member.

[0228] Figure 18A and 18B Perspective and side views of an IV catheter system 1800 are shown, constructed in the same manner as IV catheter system 1400, except that catheter component 1402 includes a visual indicator 1801 at its proximal end. The visual indicator 1801 is positioned on catheter component 1402 such that it is covered by needle component 1404 before catheter insertion. During insertion, needle component 1404 can be slightly retracted relative to catheter component 1402, causing the tip of the needle to be retracted or "covered" within the catheter. Figure 18A The relative positions of the catheter component 1402 and the needle component 1404 are depicted when the needle is in the covered position.

[0229] Once a doctor has inserted a needle into a patient's vein, they often retract the needle tip into the hooded position before further catheter insertion. The catheter component 1402 may include a visual indicator 1801 as a device to notify the doctor when the needle tip is in the hooded position. In other words, during the initial insertion procedure, the needle component 1404 will be positioned above the visual indicator 1801 (e.g., similar to...). Figure 14A (As shown). Subsequently, as the physician slides the needle assembly 1404 backward away from the catheter assembly 1402, the visual indicator 1801 will... Figure 18A The image is displayed so that the doctor is notified when the tip of the needle reaches the cover position.

[0230] In some cases, the visual indicator 1801 is located on the catheter component 1402 in a position chosen to be visible when the catheter component 1402 has been removed or retracted a desired distance from the needle adapter. For example, in some embodiments, the needle tip is covered within the catheter when the catheter component 1402 has been removed 2 mm from the needle adapter. Therefore, in some embodiments, the visual indicator 1801 is positioned approximately 2 mm inside the needle adapter when the catheter component 1402 is fully seated at the distal end or opening of the needle adapter.

[0231] Figure 18B A side view of the catheter component 1402 of the separate IV catheter system 1800 is provided. As shown, the visual indicator 1801 is positioned near the proximal end of the catheter component 1402. As noted above, the precise position of the visual indicator 1801 will depend on how the needle component 1404 and the catheter component 1402 overlap. In particular, the visual indicator 1801 can be positioned such that the visual indicator is exposed as soon as the tip of the needle reaches the hood position and before the needle component 1404 disengages from the catheter component 1402. In some cases, exposure occurs after approximately 2 mm of translational movement. In this way, the physician can easily separate the needle component 1404 from the catheter component 1402 to reach the hood position while still maintaining sufficient connection between the two components to facilitate further catheter insertion.

[0232] A visual indicator similar to visual indicator 1801 can be added to any of the aforementioned IV catheter systems to provide indication when the needle has reached the hood position. Furthermore, in some embodiments, a tactile indicator may be used instead of a visual indicator, or as a supplement to a visual indicator. For example, needle component 1404 and / or catheter component 1402 may include one or more features (e.g., ridges or grooves) that provide tactile indication when the needle has reached the hood position.

[0233] Figure 19A and 19BPerspective and side views of an IV catheter system 1900 are shown, constructed in a manner similar to that of IV catheter system 1400, except that catheter component 1402 and needle component 1404 are configured to facilitate various types of insertion grip techniques. Figure 19A As shown, the flashover component 1412 is relative to Figure 14A The flashlight component depicted is elongated. Additionally, the flashlight component 1412 includes a side grip portion 1902, which forms a feature on opposite sides of the flashlight component 1412 that facilitates gripping the flashlight component 1412 between the thumb and middle finger. For example, the side grip portion 1902 may include a flat surface and / or other types of grip features (e.g., a ridge).

[0234] like Figure 19B As clearly shown, the catheter component 1402 may include a push tab 1901 extending upward from the top surface of the catheter component 1402. The push tab 1901 can serve as a surface that a physician's index finger can push while simultaneously gripping the side grip portion 1902 between the thumb and middle finger. The length of the flash flow component 1412 can be configured such that the push tab 1901 is spaced from the side grip portion 1902 by a distance corresponding to the average length of a physician's index finger. The additional length of the flash flow component 1412 can also allow for longer visibility of the flash flow. Other IV catheter systems that incorporate a flash flow component in the needle component, as described herein, can also be configured in a similar manner. Figure 19A and 19B The method shown includes a side grip and a push tab.

[0235] Figure 20 An IV catheter system 2000 is shown, constructed in a manner similar to that of IV catheter system 1400, except that it has several additional features. Like IV catheter system 1400, IV catheter system 2000 includes a catheter component with a fixing platform 1422, an extension tube, and a needle component with a flash flow component 1412. Figure 20 As shown, the IV catheter system 2000 also includes a flexible, integrated push tab 2001, a push tab incision 2002, and an integrated stress relief section 2003.

[0236] The push tab 2001 can be integrally molded from the same material as the fixation platform 1422. For example, the push tab 2001 may include a base 2001a positioned on top of the catheter adapter and facing the proximal end of the catheter adapter. The base 2001 can be connected to the fixation platform 1422 via connecting channels 2001b extending downward from the base 2001a on both sides of the catheter adapter. The connecting channels 2001b can reinforce the base 2001a and can facilitate the molding process. A plurality of ridges 2001c may extend upward from the base 2001a and can serve as surfaces that a physician can push during needle insertion and / or when separating the needle component from the catheter component, such as when covering the needle during catheter insertion. In some embodiments, textures and / or indentations may be used instead of ridges 2001c, or used in conjunction with ridges.

[0237] An incision 2002 may be formed in the top surface of the distal end of the needle component such that the incision 2002 will be substantially aligned with the base 2001a. Thus, the incision 2002 forms an area in which a physician can place his thumb or other fingers to more easily apply distal force to the actuating tab 2001.

[0238] The stress relief part 2003 can also be integrally molded from the same material as the fixed platform 1422. To facilitate the molding of the stress relief part 2003, a connecting channel 2003a can be formed between the fixed platform 1422 and the stress relief part 2003.

[0239] Although the push tab 2001 and stress relief portion 2003 are shown as including a connection channel, in some embodiments, each of these features may be molded separately from the fixing platform 1422 (i.e., molded without the connection channel). Furthermore, each of the push tab 2001, the notch 2002, and the stress relief portion 2003 may be included on any of the IV catheter systems described herein.

[0240] In some embodiments, the IV catheter system 2000 may include an anti-rotation feature. For example, such as... Figure 21 As shown, the anti-rotation feature can consist of a protrusion 2010 formed at the proximal end of the catheter component and a corresponding protrusion 2011 formed in the portion of the catheter component into which the needle component is inserted. The protrusions 2010 and 2011 can be positioned relative to each other to prevent the wing from rotating downward away from the fixed platform.

[0241] For example, refer to Figure 21The protrusion 2011 can be configured to contact the protrusion 2010 when the wing is directly oriented below the fixed platform, preventing further counterclockwise rotation of the wing relative to the catheter component. In this way, drooping of the wing is prevented. However, at the same time, the wing can still rotate clockwise to easily accommodate different gripping techniques. This anti-rotation feature can also be included in any other embodiment of the IV catheter system described herein.

[0242] In this regard, each IV catheter system described is a closed system (i.e., a system including an extension tube). However, it should be noted that many of the aforementioned features can be equivalently implemented in open IV catheter systems (i.e., systems excluding an extension tube). Figure 22A and 22B An example of an open IV catheter system 2200 is shown, which is otherwise substantially the same as IV catheter system 2000. As shown, IV catheter system 2200 includes a catheter component 1402a without an extension tube. Because it is an open system, catheter component 1402a can be configured to provide an intravascular inlet once the needle component has been removed. For example, catheter component 1402a may include a single-use or reusable internal blood control feature and a threaded Luer connection 2202 that allows other devices to be coupled to the catheter component. Alternatively, catheter component 1402a may not include the blood control feature.

[0243] IV catheter system 2200 is shown as including a flash chamber 1412, which includes a path-defining structure 2800. Whether open or closed, any of the above-described IV catheter systems can employ the path-defining structure 2800 within the flash chamber to enhance visualization of proper catheter placement. More specifically, the path-defining structure allows blood to flow through the flash chamber at a more controlled rate, which aids in identification when the catheter is properly positioned within the vascular system.

[0244] Figure 23 A separate path-defining structure 2800 is shown. The path-defining structure 2800 includes a distal portion 2800a and a proximal portion 2800b. In some embodiments, the proximal portion 2800b may have external dimensions that substantially match the internal dimensions of the proximal end of the flash member 1412, such that a fluid-impermeable seal is formed between the two members. The proximal portion 2800b may include a vent groove 2802, which is sized to allow air but not fluid to escape from the flash member 1412. In other words, the proximal portion 2800b can function as a vent plug.

[0245] Compared to the external dimensions of the proximal portion 2800b, the distal portion 2800a can have a reduced external dimension. The internal dimensions of the chamber 3210b of the flashover component 1412 (see...) Figure 24A The external dimensions of the distal portion 2800a can also be configured such that a gap or channel exists only along the top of the flashover member 1412 between the distal portion 2800a and the inner wall of the chamber 3210b. For example, as Figure 24A As shown, when the path defining structure 2800 is inserted into the chamber 3210b, a channel will exist above the path defining structure 2800. However, the outer surface of the distal portion 2800a can contact the inner wall of the chamber 3210b surrounding the rest of the path defining structure 2800. In this way, only blood / fluid will be allowed to flow along the outer surface of the distal portion 2800a within the channel. Because this channel is formed along the top of the flash flow member 1412, it will be oriented toward the physician during insertion, allowing the physician to see the rate of blood flow.

[0246] To allow blood to flow from the proximal end of the needle 3202a into the channel, an opening 2801 can be formed in the distal end 2800a1 of the distal portion 2800a, as... Figure 24A As clearly shown. Opening 2801 may include a central portion 2801a that extends further into the distal portion 2800a than the rest of opening 2801. The proximal end (or at least the proximal opening) of needle 3202a may be located within this central portion 2801a. A plurality of leakage channels 2801a1 may be symmetrically spaced around the inner surface of opening 2801 and may extend from the distal end 2800a1 to the central portion 2801a. Any leakage channel 2801a1 may serve as a fluid passage through which blood escaping from the proximal end of needle 3202a can flow from the central portion 2801a toward a channel formed above the path defining structure 2800.

[0247] Leakage channels 2801a1 may be symmetrically spaced around opening 2801, thereby allowing path-defining structures 2800 to be inserted into chamber 3210b in any orientation. In other words, regardless of the orientation of path-defining structures 2800, at least one leakage channel 2801a1 will be positioned in an upward orientation and will intersect with the channel, thereby providing a pathway to the channel. Figure 24A As shown, the shape of the inner surface of chamber 3210b can be designed such that the channel will wrap around the distal end 2800a1 at the top of chamber 3210b (i.e., a gap will exist between the top portion of the distal end 2800a1 and the inner surface of chamber 3210b). Therefore, as Figure 24BAs indicated by the arrow, blood can flow out of needle 3202a through opening 3202a1 and into central portion 2801a. Subsequently, although blood can flow into each leak channel 2801a1, a fluid passage will only be provided between upward-oriented leak channels, caused by the distal end 2800a1 contacting the inner wall of the chamber 3210b where the other leak channels are located. Therefore, as blood fills central portion 2801a and leak channels 2801a1, the blood will eventually flow around the top portion of distal end 2800a1, and then flow proximally within the channels.

[0248] Various techniques can be employed to secure the needle 3202a and ensure that the opening 3202a1 remains positioned within the central portion 2801a. For example, in Figure 24C In this embodiment, needle 3202a is shown having a proximal portion 3202a2 that extends proximally beyond opening 3202a1 and through the proximal wall of central portion 2801a. In this embodiment, path defining structure 2800 includes a proximal chamber 2810 opposite central portion 2801a, in which proximal portion 3202a2 of needle 3202a is positioned. Proximal portion 3202a2 may be coiled or otherwise modified to prevent it from being pulled distally through the passage between central portion 2801a and proximal chamber 2810. Furthermore, in some embodiments, a potting adhesive may be deposited around proximal portion 3202a2 within proximal chamber 2810 to further secure proximal portion 3202a2. In such embodiments, the potting adhesive may additionally seal the passage to prevent blood from flowing into proximal chamber 2810. Alternatively, the size of the passage can be designed such that the proximal portion 3202a2 independently blocks fluid flow into the proximal chamber 2810.

[0249] Figure 24D An alternative embodiment for securing the needle 3202a in a suitable position is shown. As shown, the needle 3202a may include a raised region 3202a3, the outer dimensions of which are sufficient to prevent the needle 3202a from being pulled through the needle holding portion 3202c. The raised region 3202a3 may be positioned relative to the opening 3202a1 such that the opening 3202a1 remains positioned within the central portion 2801a. In some embodiments, the needle holding portion 3202c may include a recessed section into which the raised region 3202a3 may be positioned to further prevent movement of the region 3202a in a proximal or distal direction.

[0250] In some embodiments, the needle 3202a can be modified to reduce the rate at which blood flows through the needle. For example, in Figure 24EIn the diagram, needle 3202a is shown with a coiled portion 3202a4 extending towards its proximal end. The coiled portion 3202a4 reduces the internal dimensions of needle 3202a, thereby slowing the rate at which blood flows into the central portion 2801a. This reduced rate of blood flow into the central portion 2801a will similarly reduce the rate of blood flow along the channel formed above the path-defining structure 2800, thus aiding in identification once needle 3202a is properly positioned within the patient's body.

[0251] Figure 25A and 25B Another embodiment of the path defining structure 2900 is shown, which can function in a similar manner to the path defining structure 2800. In particular, the path defining structure 2900 can be configured to allow blood to flow along a visible channel formed at the top of the flash flow member 1412.

[0252] The path defining structure 2900 may include a distal portion 2900a and a proximal portion 2900b. The proximal portion 2900b may include a venting recess 2902 that allows air to be discharged from the proximal end of the flash flow member 1412 without discharging blood. Unlike the distal portion 2800a of the path defining structure 2800, the distal portion 2900a of the path defining structure 2900 is not configured to be oriented at any location within the flash flow member 1412. Instead, the distal portion 2900a may include a visualization channel 2903 and a plurality of alignment ridges 2904 configured for a specific orientation. The inner surface of the chamber 3210b may be configured to receive the alignment ridges 2904 such that the path defining structure 2900 will be oriented with the visualization channel 2903 facing upwards. For example, the chamber 3210b may include a longitudinally oriented groove or tab that intersects with the alignment ridges 2904 to require the path defining structure 2900 to be inserted in the correct orientation and prevent rotation.

[0253] The distal portion 2900a of the path-defining structure 2900 may include a distal end 2900a1 having an opening 2901. A leakage channel 2901a may extend between the opening 2901 and the visualization channel 2903. In a manner similar to that described above, blood can flow from the opening 3202a1 and enter the opening 2901 and the visualization channel 2903 through the leakage channel 2901a, as... Figure 25C The arrows in the diagram indicate this. Although not shown in this embodiment, however... Figure 24C-24E The various configurations of the needle 3202a shown can also be used with the path-limiting structure 2900.

[0254] Figure 26An embodiment of the flashover component 1412 is shown, in which a vent plug 3000 is used instead of the proximal portion 2900b. Furthermore, although not shown, the vent plug 3000 can similarly replace the distal portion 2800b. Figure 26 As shown, the vent plug 3000 is separated from and positioned close to the path-limiting structure 2900. The vent plug 3000 primarily serves to release air but obstruct fluid flow. However, in some embodiments, the vent plug 3000 may also be configured to secure the path-limiting structures 2800 / 2900 in place. For example, the flashover component 1412 may include a protrusion 3010 positioned close to the vent plug 3000 when it is inserted into the chamber 3210b. The protrusion 3010 prevents the vent plug 3000, and thus the path-limiting structures 2800 / 2900, from moving proximally within the chamber 3210b.

[0255] Figures 27A-27C These all indicate different ways in which path-limiting structures 2800 or 2900 can be fixed within chamber 3210b. Figure 27A In the diagram, opening 2901 is shown to have internal dimensions that closely correspond to the external dimensions of the needle holding portion 3202c, thus forming a press-fit interface. Opening 2801 can also be constructed in this manner. Alternatively, openings 2801 / 2901 can be molded above the needle holding portion 3202c.

[0256] exist Figure 27B and 27C In this configuration, the path-defining structures 2800 / 2900 can be held within chamber 3210b by means of the mating between the proximal portions 2800b / 2900b and the inner surface of chamber 3210b. Figure 27B In the middle, chamber 3210b may include an inclined retaining protrusion 3101. The inclination of the retaining protrusion 3101 allows for the formation of a distally facing flange, against which the proximal end of the proximal portion 2800b or 2900b abuts. This inclination facilitates the insertion of the path-defining structure 2800 or 2900, but prevents the path-defining structure from being retracted later.

[0257] Figure 27C An example is shown in which the proximal portion 2800b or 2900b includes a retaining rib 3102a that inserts into a retaining groove 3102b formed on the inner surface of the chamber 3210b. During assembly, the path-defining structure 2800 or 2900 can be inserted into the chamber 3210b until the retaining rib 3102a is inserted into the retaining groove 3102b. Here, the retaining rib 3102a prevents the path-defining structure from being retracted proximally.

[0258] In some embodiments, porous materials may be employed within the channels created by the path-defined structure. For example, in Figure 28A In this process, porous material 3200 can be incorporated into the visualization passage 2903 and extend through the portion of the proximal portion 2900b including the ventilation groove 2902. Porous material 3200 can function to expel air while simultaneously wicking blood at an easily observable rate. Alternatively, porous material 3200 can be positioned only in... Figure 28B Within the proximal portion 2900b shown.

[0259] Figure 29 and 30 Additional variations that can be made to embodiments employing either path-defined structure 2800 or 2900 are described. Figure 29 In the diagram, opening 2901 is shown as having a greater depth. Due to this greater depth, a larger fluid volume would be required before blood can flow through the channel. Therefore, the depth of opening 2801 or 2901 can be selected to substantially control the time required to provide visual feedback for proper venous confirmation. Figure 30 In this configuration, the sealing cap 3400 is positioned above the proximal opening of the flash flow component 1412. The sealing cap 3400 blocks airflow until it is removed. Therefore, the sealing cap 3400 can be used when the extension tube is pre-filled with saline solution to prevent saline solution from flowing proximally into the flash flow component 1412. More specifically, with the sealing cap 3400 properly positioned, saline solution will only be allowed to flow distally within the needle 3202a. After needle insertion, the sealing cap 3400 can be removed to allow the flash flow component 1412 to be used as described above.

[0260] Various embodiments of the invention also include a safety mechanism configured to secure the sharp, distal tip of the guide needle after removal from the catheter adapter and separation of the needle hub. The safety mechanism may include any compatible device known in the art. In some cases, the safety mechanism is configured to interact with needle features (e.g., loops, notches, coils, or protrusions on the cannula). Coils or protrusions formed in the cannula create a slightly convex, rounded configuration that can be used to activate the safety mechanism. In some cases, the safety mechanism includes an arm or lever actuated to capture the needle tip within the safety mechanism and prevent the tip from being exposed prior to safe handling.

[0261] A safety mechanism is attached to the body of the needle and is capable of sliding along the length of the needle. In some cases, the initial or assembled position of the safety mechanism is located near the base or proximal end of the catheter adapter before catheter insertion. For some configurations, the assembled position of the safety mechanism is located between the proximal end of the needle hub and the proximal end of the catheter adapter or stabilizing platform, wherein the safety mechanism does not overlap with the catheter adapter or stabilizing platform. In some cases, a portion of the safety mechanism is located within the catheter adapter, and a balancing portion of the safety mechanism is located externally to the catheter adapter, such as within the needle hub. In some embodiments, a portion of the catheter adapter or stabilizing platform extends proximally to provide a receiving portion in which at least a portion of the safety mechanism is received. In some cases, the entire safety mechanism is received within the receiving portion of the catheter adapter or stabilizing platform before catheter insertion.

[0262] In some embodiments, the assembly position of the safety mechanism positions the proximal end of the catheter adapter between the distal end of the safety mechanism and the distal end of the paddle-shaped grip of the needle hub. In some cases, the assembly position of the safety mechanism positions the proximal end of the catheter adapter between the distal end of the safety mechanism and the proximal end of the paddle-shaped grip of the needle hub. In some cases, a portion of the safety mechanism overlaps with a portion of the paddle-shaped grip of the needle hub. In some embodiments, at least some portions of at least one of the catheter adapter and the paddle-shaped grip overlap with at least some portions of the safety mechanism. In some embodiments, neither the catheter adapter nor the paddle-shaped grip has any portion overlapping with any part of the safety mechanism.

[0263] In some embodiments, a detachable mechanical connection is provided between the safety mechanism and at least one other component of the access device. In some embodiments, the distal end of the safety mechanism is selectively coupled to the proximal end of the catheter adapter. In one embodiment, the safety mechanism is internally interlocked to the proximal end of the catheter adapter. In one embodiment, the safety mechanism is externally interlocked to the proximal end of the catheter adapter. In some embodiments, the distal end of the safety mechanism is selectively coupled to the proximal end of the stabilization platform. In some embodiments, a surface of the fixation platform is selectively coupled to at least one surface of at least one of the catheter adapter, the blood control valve, the extension tube, and the stabilization platform. In some cases, the mechanical connection is disengaged when the needle tip is secured within the safety mechanism.

[0264] In some embodiments, a specific catheter device (e.g., Figure 1-30 The catheter device in any of the figures may include a needle safety mechanism. The safety mechanism may include any safety mechanism configured to secure the sharp distal end of the guide needle as the needle is withdrawn from the catheter of the particular catheter device.

[0265] Safety mechanisms can be coupled to a particular catheter device in any number of ways. In some embodiments, the safety mechanism may include an internal interlock, wherein the safety mechanism engages with the inner surface of the catheter adapter. The engagement may include threaded, mating, snap-fit, connection, attachment, fastening, clamping, hooking, or any other suitable engagement method. Non-limiting examples of safety mechanisms including internal interlocks are provided in 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," the entire contents of which are incorporated herein by reference. In some embodiments, the safety mechanism may include a clamp 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 SAFETYIV CATHETER," the entire contents of which are incorporated herein by reference.

[0266] 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. In some embodiments, the safety mechanism may be coupled to the outer surface of the catheter adapter and the inner and / or outer surface of the needle hub. The coupling may include threads, mating, snap-fit, 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," the entire contents of which are incorporated herein by reference. 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 IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOODCONTROL SEPTUM," the entire contents of which are incorporated herein by reference. The V-clamp can selectively hold a portion of a catheter adapter.

[0267] In some embodiments, a detachable mechanical connection is provided between the safety mechanism and at least one other component of the IV catheter system. In some cases, this mechanical connection is disengaged when the distal end of the needle 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 components: a catheter adapter, a blood control valve, an extension tube, and one or more paddle-shaped grips.

[0268] In some embodiments, the safety mechanism may include a safety cylinder, which may be spring-loaded. For example, the safety cylinder may be as described in BD. TM Autoguard TM The safety mechanism is spring-loaded, similar to that in a BC shielded IV catheter. In some embodiments, the safety mechanism may be passively and / or actively activated. In some embodiments, the safety mechanism is configured to interact with needle features (e.g., loops, notches, coils, or protrusions on the needle). In some embodiments, the safety mechanism may include an arm or lever that can be actuated to capture the distal end within the safety mechanism and prevent the end from being exposed before safe handling. In some embodiments, the safety mechanism may be attached to the body of the needle and may be capable of sliding along the length of the needle.

[0269] In some embodiments, in the pre-insertion assembly position, a safety mechanism may be disposed between the catheter adapter and the needle hub. In some embodiments, in the pre-insertion assembly position, the catheter adapter and the needle hub may be spaced apart by at least a portion of the safety mechanism. In some embodiments, in the pre-insertion assembly position, the proximal end of the catheter adapter may be disposed between the distal end of the safety mechanism and the distal end of the grip portion (e.g., a paddle grip) of the needle hub. In some embodiments, in the pre-insertion assembly position, the proximal end of the catheter adapter body may be disposed between the distal end of the safety mechanism and the proximal end of the grip portion of the needle hub. In some embodiments, a portion of the safety mechanism may overlap with a portion of the grip portion of the needle hub. In some embodiments, at least a portion of at least one of the catheter adapter and the grip portion overlaps with at least some portions of the safety mechanism. In some embodiments, neither the catheter adapter body nor the grip portion overlaps with any portion of the safety mechanism.

[0270] In any of the above embodiments of an IV catheter system including a catheter component with one or more wings, the wings may be configured such that they can pivot about an axis defined along the longitudinal length of the catheter component. For example, see reference to Figure 14A The second wing 1442 may be formed of a flexible material and / or may be configured with a hinge (e.g., by forming a thinned portion along the length of the catheter seat), which allows the wing to pivot upward and downward about a longitudinal axis. One advantage of this type of pivoting is that it allows the second wing 1442 to be angled upward away from the patient's skin during insertion. This upward angle accommodates the physician's thumb or other fingers below the second wing 1442, thereby facilitating shallower insertion. The flexible and / or pivotable wing can then be moved downward to a flat position for fixation to the patient's skin. U.S. Provisional Patent Application No. 62 / 247,621, filed October 28, 2015 and incorporated herein by reference, discloses several techniques for allowing the wing to pivot at an angle, which are suitable for use with the above-described embodiments of many IV catheter systems.

[0271] In any of the above embodiments, the components of the fixation platform can be formed from the same material by injection molding or other processes. This material can be an elastomer or other low-hardness material that is gentle on the patient's skin and / or a dressing used to hold the catheter components in place during fluid delivery. For example, some embodiments of the invention include a low-hardness material with a durometer hardness from about 30 Shore A to about 90 Shore D. In some embodiments, the low-hardness material has a durometer hardness from about 50 Shore A to about 90 Shore D. In some embodiments, the components of the fixation platform can be formed from a thermoplastic elastomer (TPE) or a similar material.

[0272] Furthermore, in any of the above embodiments, the grip portion and / or other elements of the needle component may be formed of a transparent or white material, while some or all of the components of the fixing platform may be formed of a colored material (e.g., green, pink, blue, yellow, purple, etc.) specifically designed for the catheter specification. Color contrast can help physicians identify the components of the catheter system that are separated from each other during insertion of the catheter system into a patient's vein (e.g., including covering the catheter).

[0273] This invention may be embodied in other specific forms without departing from the structures, methods, or other essential characteristics broadly described herein and claimed below. In all respects, the described embodiments should be considered illustrative rather than restrictive. Therefore, the scope of the invention is defined by the appended claims, rather than by the foregoing description. All modifications within the equivalent meaning and scope of the claims are included within the scope of the claims.

Claims

1. An IV catheter system, the IV catheter system comprising: catheter components, including: The catheter seat includes a distal end and a proximal end, the catheter seat being shaped to define a chamber extending between the distal end and the proximal end and a needle port at the proximal end, the needle port providing an inlet to the chamber; A cannula extending distally from the distal end of the catheter seat; The push tab located at the proximal end of the catheter seat; and A fixing platform extending outward from the catheter seat; and The needle component includes: The needle seat portion includes a distal end and a proximal end, the distal end of the needle seat portion including a cut that aligns with the push tab formed at the proximal end of the catheter seat portion; and The needle extending distally along the axis from the distal end of the needle seat portion, Both the catheter component and the needle component include protrusions, which are configured to intersect each other to restrict rotation of the needle component relative to the catheter component; and The protrusions of the catheter component and the needle component prevent the wings of the catheter component from rotating downwards below the fixed platform.

2. The IV catheter system according to claim 1, wherein, The pushing tab and the fixing platform are connected via one or more connection channels.

3. The IV catheter system according to claim 1 or 2, wherein, The catheter component includes a stress relief section, which is positioned around the sleeve at the distal end of the catheter seat and is connected to the fixed platform via a connecting channel.

4. The IV catheter system according to claim 1 or 2, wherein, The IV catheter system also includes: A flash flow component, the flash flow component including a path defining structure for controlling blood flow within the flash flow component.

5. The IV catheter system according to claim 1, wherein, The fixed platform includes a first wing extending from the guide tube seat.

6. The IV catheter system according to claim 5, wherein, The conduit component further includes a second wing extending in the opposite direction to the first wing, the second wing joining but not extending beyond the extension tube joining portion of the conduit component.

7. The IV catheter system according to claim 5 or 6, wherein, The first wing is configured to pivot relative to the conduit seat.

8. The IV catheter system according to claim 7, wherein, The first wing includes a hinge that enables pivoting.

9. The IV catheter system according to claim 7, wherein, The first wing is formed of a flexible material capable of pivoting.

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