Blood collection kits and related systems and methods

Abstract

A blood collection set that is coupled to a catheter system and can include a needle assembly and / or a housing. The needle assembly can include a body, a sharp needle extending proximally from the body, and a sheath covering a proximal tip of the sharp needle. The housing can be coupled to a distal end of the needle assembly. The housing can be configured to establish a fluid path through a connector of the catheter system.

Description

Technical Field

[0001] This disclosure generally relates to a blood collection kit and related systems and methods. Background Technology

[0002] Catheters are commonly used for parenteral nutrition, intravenous fluid resuscitation, and the administration of analgesics and antibiotics. They are also used for blood draws. Catheters can be inserted at the bedside using aseptic techniques and can remain in place for several weeks.

[0003] The most common type of catheter is the needle-type catheter. As the name suggests, a "needle-type" catheter can be attached to a guide needle with a sharp distal tip. The sharp distal tip is used to puncture the patient's skin and vein. The catheter can be inserted into the vein after the guide needle has punctured it. The guide needle typically allows the sharp distal tip to puncture the patient's skin and vein with minimal resistance, minimizing pain for the patient.

[0004] The guide needle is typically positioned at a steep angle relative to the skin surface and the longitudinal dimension of the vein to be punctured to allow penetration of the skin and vein walls. The needle and catheter are usually inserted with the bevel of the guide needle facing away from the patient's skin. After the tip of the guide needle pierces the wall, the insertion angle is lowered, allowing the guide needle and catheter to slide a certain distance into the vein to securely position the catheter within it.

[0005] Once the guide needle placement in the vein has been confirmed, the guide needle can be withdrawn and removed, leaving the catheter in place for future fluid infusions and / or blood draws. After blood is drawn through the catheter, the catheter system, including the catheter, can be flushed to remove residual blood. The catheter system can then be used for infusion. However, this process can be both time-consuming and dangerous, as multiple steps are required for blood collection and infusion. The risk of contamination from residual blood is inherent in each step of the process. Moreover, the flushing process to remove residual blood from the catheter system is often both time-consuming and unreliable, as even after flushing, grooves and recesses in the various components of the catheter system tend to retain residual blood and / or fluid.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to a blood collection kit and related apparatus, systems, and methods. In some embodiments, the blood collection kit may be coupled to a catheter system. In some embodiments, the catheter system may include a catheter hub that may include a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends of the catheter hub. In some embodiments, the catheter system may include a catheter extending distally from the distal end of the catheter hub. In some embodiments, the catheter may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter.

[0008] In some embodiments, the catheter system may include a connector that can be coupled to a catheter hub. In some embodiments, the connector may include a diaphragm. In some embodiments, the diaphragm may include a slit. In other embodiments, the diaphragm may not include a slit.

[0009] In some embodiments, the blood collection kit may include a needle assembly and / or a housing. In some embodiments, the needle assembly may include a body, a needle extending proximally from the body, and a sheath covering the proximal end of the needle. In some embodiments, the housing may be coupled to a connector. In some embodiments, the housing may be configured to establish a fluid path through the connector.

[0010] In some embodiments, the housing may be directly and removably coupled to the needle assembly. In these and other embodiments, the blood collection kit can be used for infusion after blood has been collected through the needle assembly and the needle assembly has been removed from the housing. In some embodiments, the housing may be integral with the needle assembly. More specifically, the housing may be permanently coupled to the needle assembly or integrally formed as a single unit with the body of the needle assembly.

[0011] In some embodiments, the catheter system may include a side port disposed between the distal end and the proximal end of the catheter hub. In some embodiments, the catheter system may include an extension tube. In some embodiments, the catheter system may include an adapter, which may include a distal end and a port. In some embodiments, the adapter may include a Y-type adapter, a straight adapter, or another suitable adapter. In some embodiments, the extension tube may include a distal end integral with the side port of the catheter hub and / or a proximal end integral with the distal end of the adapter.

[0012] In some embodiments, the connector may include a pinless connector. In some embodiments, the housing may be disposed in a proximal position. In some embodiments, the housing may include a male Luer connector. In some embodiments, the male Luer connector may be configured to activate a diaphragm and establish a fluid path through the connector in response to the housing moving from a proximal position to a distal position. In some embodiments, the housing may be screwed from a proximal position to a distal position or pushed from a proximal position to a distal position.

[0013] In some embodiments, the housing may include a distal member and a proximal member that moves distally toward the distal member. In some embodiments, the distal member of the housing may include a male Luer connector. In some embodiments, the male Luer connector may be configured to activate a diaphragm and establish a fluid path through the connector in response to movement of the proximal member toward the distal member.

[0014] In some embodiments, the housing may include a cannula configured to penetrate the diaphragm of the connector to establish a fluid path through the connector. In some embodiments, the cannula may extend through the diaphragm. In some embodiments, the cannula may include one or more side holes in fluid communication with the lumen of the cannula. In some embodiments, the housing may be movable from a proximal position to a distal position. In some embodiments, in response to the housing moving from a proximal position to a distal position, the cannula may extend through the diaphragm and may establish a fluid path through the connector.

[0015] In some embodiments, the catheter system may include an extension kit that may include a distal end coupled to the proximal end of the catheter hub and / or a proximal end coupled to the connector. In these and other embodiments, the connector may include a needleless connector.

[0016] In some embodiments, a system may include an extension kit. In some embodiments, the distal end of the extension kit may be configured to engage with the proximal end of a catheter hub. In some embodiments, the system may include a needle assembly. In some embodiments, the needle assembly may be directly engaged with the proximal end of the extension kit. In some embodiments, the system may include a catheter system. In some embodiments, the system may include a catheter hub and a catheter extending distally from the distal end of the catheter hub. In some embodiments, the system may include a needleless connector that is directly engaged with the proximal end of the extension kit. In some embodiments, the system may include a housing that is directly engaged with the needleless connector and the needle assembly. In some embodiments, the housing may be configured to establish a fluid path through the needleless connector.

[0017] In some embodiments, a method may include inserting a catheter of a catheter system into a patient's vascular system. In some embodiments, the method may include coupling a blood collection kit to the catheter system. In some embodiments, the housing may include a male Luer connector. In some embodiments, the housing may be positioned in a proximal position, and the method may include moving the housing from the proximal position to a distal position. In some embodiments, in response to the housing being moved from the proximal position to the distal position, the male Luer connector may activate a diaphragm and establish a fluid path through the connector. In some embodiments, the housing may be screwed from the proximal position to the distal position or pushed from the proximal position to the distal position. In some embodiments, the method may further include collecting blood from the patient after moving the housing from the proximal position to the distal position.

[0018] In some embodiments, the housing may include a distal member and a proximal member that moves distally toward the distal member. In some embodiments, the distal member of the housing may include a male Luer connector. In some embodiments, the method may include moving the proximal member distally toward the distal member. In some embodiments, the male Luer connector may activate a diaphragm and establish a fluid path through the connector in response to the proximal member moving distally toward the distal member. In some embodiments, the method may further include collecting blood from the patient after moving the proximal member distally.

[0019] In some embodiments, the housing may include a cannula, which may extend through a diaphragm in response to coupling the blood collection kit to the catheter system. In some embodiments, the method may include collecting blood from a patient using the blood collection kit.

[0020] In some embodiments, the housing may include a cannula, and the method may include moving the housing from a proximal position to a distal position. In some embodiments, in response to the housing being moved from the proximal position to the distal position, the cannula may extend through a diaphragm and may establish a fluid path through the connector. In some embodiments, the method may further include collecting blood from the patient after moving the housing from the proximal position to the distal position.

[0021] In some embodiments, a method may include coupling an extension kit to the proximal end of a catheter hub. In some embodiments, the extension kit may include a distal end and a proximal end. In some embodiments, the method may include coupling the distal end of the extension kit to the proximal end of the catheter hub. In some embodiments, the method may include coupling a needle assembly to the proximal end of the extension kit and drawing blood from a patient. In some embodiments, the method may include coupling a connector to the proximal end of the extension kit and / or coupling a blood collection kit to the connector. In some embodiments, the method may further include collecting blood through the extension kit.

[0022] In some embodiments, the method may include removing a needle assembly from a blood collection kit coupled to a catheter system, and flushing the catheter system or infusing fluid through the catheter system after removing the needle assembly from the blood collection kit.

[0023] As used in this disclosure, the term "connection" may include, but is not limited to, a direct connection. It should be understood that the above general description and the following detailed description are exemplary and explanatory, and do not limit this disclosure. It should be understood that the various embodiments are not limited to the configurations and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of this disclosure, unless such requirement exists. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0024] Exemplary embodiments are described and explained with additional features and details using the accompanying drawings, wherein:

[0025] Figure 1A This is a top perspective view of an exemplary catheter system according to some embodiments;

[0026] Figure 1B This is a top perspective view of an exemplary blood collection kit according to some embodiments;

[0027] Figure 1C This is a cross-sectional view of a blood collection kit according to some embodiments;

[0028] Figure 1D This is another cross-sectional view of a blood collection kit according to some embodiments;

[0029] Figure 2A This is a top perspective view of a catheter system according to some embodiments, showing the connection of an exemplary blood collection tube to the catheter system;

[0030] Figure 2B This is a cross-sectional view of a blood collection kit coupled to an exemplary connector according to some embodiments;

[0031] Figure 3 This is a top perspective view of a catheter system according to some embodiments, showing an exemplary clamping fixture engaged, with an exemplary needle assembly of the blood collection kit removed.

[0032] Figure 4 This is a top perspective view of an exemplary adapter connected to a connector and an exemplary housing of a blood collection kit according to some embodiments;

[0033] Figure 5 This is a top perspective view of a catheter system connected to an example syringe according to some embodiments;

[0034] Figure 6A This is a side view of a connector according to some embodiments;

[0035] Figure 6B This is a cross-sectional view of a connector according to some embodiments;

[0036] Figure 7 This is a cross-sectional view of a portion of a catheter system coupled to a syringe according to some embodiments;

[0037] Figure 8 This is a top perspective view of a catheter system coupled to an exemplary infusion kit according to some embodiments;

[0038] Figure 9 This is a top perspective view of a catheter system according to some embodiments, showing the removal of the housing;

[0039] Figure 10 This is an enlarged perspective view of the housing of a blood collection kit according to some embodiments;

[0040] Figure 11 This is a top perspective view of a portion of a catheter system according to some embodiments, showing the removal of another exemplary needle assembly and an exemplary blood control diaphragm;

[0041] Figure 12A This is an enlarged perspective view of a portion of a catheter system according to some embodiments, showing a blood collection kit arranged in an exemplary proximal position;

[0042] Figure 12B This is an enlarged perspective view of a catheter system according to some embodiments, showing a blood collection kit arranged in an exemplary distal position;

[0043] Figure 13A This is a top perspective view of an exemplary pinless connector according to some embodiments;

[0044] Figure 13B This is a top perspective view of another exemplary pinless connector according to some embodiments;

[0045] Figure 13C This is a top perspective view of another example blood collection kit according to some embodiments, the blood collection kit being configured to connect to a needleless connector;

[0046] Figure 13D According to some embodiments Figure 13C A cross-sectional view of the blood collection kit;

[0047] Figure 13E According to some embodiments Figure 13CThe upper perspective view of the blood collection kit shows another exemplary housing removed from the needle assembly;

[0048] Figure 14A According to some embodiments Figure 13C A side view of another exemplary housing of the blood collection kit, showing a Luer lock;

[0049] Figure 14B It is a connection to the pin assembly according to some embodiments. Figure 14A A side view of the housing, showing the Luer slider;

[0050] Figure 14C This is an enlarged perspective view of a Luer slider connected to a pinless connector according to some embodiments;

[0051] Figure 14D It is a connection according to some embodiments to Figure 13A Pinless connectors Figure 13C A cross-sectional view of the blood collection kit, showing the blood collection kit in an exemplary proximal position;

[0052] Figure 14E It is a connection according to some embodiments to Figure 13A Pinless connectors Figure 13C A cross-sectional view of the blood collection kit, showing the blood collection kit in an exemplary distal position;

[0053] Figure 15A This is a top perspective view of a catheter system according to some embodiments, showing another exemplary blood collection kit;

[0054] Figure 15B According to some embodiments Figure 15A A perspective view of the blood collection kit, showing an exemplary distal component in a first position;

[0055] Figure 15C It is a connection to an exemplary pinless connector according to some embodiments. Figure 15A A cross-sectional view of the blood collection kit, showing the distal component in an exemplary first position;

[0056] Figure 15D According to some embodiments Figure 15A A perspective view of the blood collection kit, showing the distal component in an exemplary second position;

[0057] Figure 15E According to some embodiments Figure 15A A cross-sectional view of the blood collection kit, showing the distal component in the second position;

[0058] Figure 16This is a top perspective view of a catheter system according to some embodiments, showing an exemplary adapter with an example injection port.

[0059] Figure 17A yes Figure 16 An enlarged perspective view of the injection port shows an exemplary cap according to some embodiments;

[0060] Figure 17B According to some embodiments Figure 16 An enlarged perspective view of the injection port shows the cap open;

[0061] Figure 18 This is a top perspective view of a catheter system according to some embodiments, showing an exemplary straight adapter.

[0062] Figure 19 This is an enlarged perspective view of an exemplary elongated end cap connected to an exemplary adapter according to some embodiments;

[0063] Figure 20 This is a top perspective view of a catheter system according to some embodiments, showing an exemplary flashback chamber;

[0064] Figure 21A This is an enlarged top view of an exemplary cannula tip according to some embodiments;

[0065] Figure 21B According to some embodiments Figure 21A An enlarged top perspective view of the cannula tip;

[0066] Figure 22A This is an enlarged top view of another exemplary cannula tip according to some embodiments;

[0067] Figure 22B According to some embodiments Figure 22A An enlarged top perspective view of the cannula tip;

[0068] Figure 23A This is a top perspective view of a catheter system according to some embodiments, showing an exemplary extension kit coupled to a blood collection kit;

[0069] Figure 23B This is a top perspective view of a catheter system according to some embodiments, showing the connection to... Figure 13C An extension kit for the blood collection kit;

[0070] Figure 23C This is a top perspective view of a catheter system according to some embodiments, showing the connection to... Figure 15A Extension kits for blood collection kits; and

[0071] Figure 24This is a top perspective view of a catheter system according to some embodiments, showing an extension kit coupled to the proximal end of an exemplary catheter hub. Detailed Implementation

[0072] Referring now to Figure 1, in some embodiments, the catheter system 100 may include a catheter hub 102, which may include a proximal end 104, a distal end 106, and an inner lumen 108 extending between the proximal and distal ends. In some embodiments, a side port 110 may be disposed between the distal end 106 and the proximal end 104 of the catheter hub 102. In these and other embodiments, a catheter 112 may extend distally from the distal end 106 of the catheter hub 102.

[0073] In some embodiments, catheter 112 may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, needle hub 134 may be removably coupled to the proximal end 104 of catheter hub 102. In some embodiments, catheter 112 may include a sheath-type catheter such that guide needle 132 extends from needle hub 134 through catheter 112 to insert catheter system 100 into a patient's vascular system. In some embodiments, catheter 112 and guide needle 132 may be assembled such that the sharp proximal end of guide needle 132 extends beyond the distal end of catheter 112, with the bevel of guide needle 132 facing upwards and away from the patient's skin.

[0074] In some embodiments, the guide needle 132 and catheter 112 can be inserted into the patient's vascular system through the skin at a shallow angle. In some embodiments, in response to the insertion of the guide needle 132 and catheter 112 into the patient's vascular system, blood can flow through the guide needle 132 and into the needle hub 134, and blood can be seen within the needle hub 134 to indicate to the user that the guide needle 132 is located within the patient's vascular system.

[0075] In some embodiments, the catheter system 100 may include an adapter 114. In some embodiments, the adapter 114 may include a Y-type adapter, a straight adapter, or another suitable adapter. In some embodiments, the adapter 114 may include one or more of a distal end 116, a first port 118, and a second port 120. In some embodiments, the adapter 114 may include a reduced volume and / or reduced size relative to a standard adapter to avoid blood contamination. In some embodiments, in response to insertion of the catheter 112 into a patient's vascular system, blood may flow through the catheter 112, at least a portion of the catheter hub 102, the extension tube 122, and into the adapter 114.

[0076] In some embodiments, the ports of adapter 114 may be coupled to connector 128. In some embodiments, a first port 118 and / or a second port 120 of adapter 114 may be coupled to connector 128. More specifically, in some embodiments, connector 128 may be integrally formed with the first port 118 and / or the second port 120 as a single unit. In other embodiments, the first port 118 and / or the second port 120 of adapter 114 may be coupled to connector 128 via Luer connectors. In these embodiments, connector 128 may include Luer connectors, such as female or male Luer connectors. In some embodiments, the Luer connector may be threaded or slidably engaged with adapter 114.

[0077] In some embodiments, the catheter system 100 may include an extension tube 122, which may include a distal end 124 integral with a side port 110 and a proximal end 126 integral with a distal end 116 of an adapter 114. In some embodiments, a clamp, such as a pinch clamp 136 or another suitable clamp, may be provided on the extension tube 122, and the clamp is configured to selectively clamp the extension tube 122 to close a fluid path through the extension tube 122. In some embodiments, any suitable clamp may be used instead of the pinch clamp 136.

[0078] In some embodiments, connector 128 may include a proximal end configured to receive blood collection kit 200. Some embodiments of blood collection kit 200 may include needle assembly 202 and housing 204 configured to engage connector 128. In some embodiments, housing 204 may be cylindrical. In some embodiments, blood collection kit 200 may be used for one or more of the following: collecting blood from a patient, flushing, and infusion.

[0079] Now refer to Figure 1A-1C In some embodiments, the needle assembly 202 of the blood collection kit 200 may include a body 212, a needle 214 extending proximally from the body 212, and a sheath 216 covering the sharp proximal end 218 of the needle 214. In some embodiments, the sheath 216 may be elastic. In some embodiments, the sheath 216 may be plastic or another suitable material. In some embodiments, the needle 214 may be secured within the body 212 by press-fit, adhesive, mechanical means, or another suitable mechanism. In some embodiments, the needle 214 may extend proximally beyond the body 212.

[0080] In some embodiments, the sheath 216 may be coupled to the body 212 of the needle assembly 202. In some embodiments, the sharp proximal end 218 of the needle 214 may be enclosed within the sheath 216. The sheath 216 may include an open distal end and a closed proximal end.

[0081] Now refer to Figure 1C In some embodiments, the housing 204 and the body 212 may be removably coupled together and are detachable. In these and other embodiments, the blood collection device 200 can be used for infusion after blood has been collected via the needle assembly 202 and removed from the housing 204. Referring now to... Figure 1D The housing 204 and the main body 212 of the needle assembly 202 can be integrated or formed as a single unit.

[0082] Now refer to Figure 2A In some embodiments, the housing 204 and the blood collection kit 200 may be pre-attached to the connector 128 and the catheter system 100. In some embodiments, the catheter system 100 may be assembled and provided with the housing 204 pre-attached to the connector 128. In other embodiments, a user may couple the blood collection kit 200 to the connector 128. In some embodiments, the blood collection kit 200 may be configured to receive a blood collection device 306, such as a blood collection tube. In some embodiments, in response to the blood collection device 306 pushing the sheath 216 distally toward the body 212, a needle 214 may pierce the sheath 216, and the sharp proximal end 218 of the needle assembly 202 may be inserted into the blood collection device 306.

[0083] In some embodiments, inserting a sharp proximal end 218 into a blood collection device 306 can connect the blood collection device 306 to a blood collection kit 200. In some embodiments, the blood collection device 306 can be connected to the blood collection kit 200 after the catheter 112 has been positioned within the vascular system. In some embodiments, when the blood collection device 306 is penetrated by the sharp proximal end 218, blood can flow into the blood collection device 306 due to the pressure difference between the vascular system and the blood collection device 306. In some embodiments, the needle assembly 202 may include a thread 308 that can be engaged with a corresponding thread of a cylindrical retainer (not shown) for the blood collection device 306.

[0084] Now refer to Figure 2B In some embodiments, the proximal end of connector 128 may include a diaphragm 206 that may be coupled to the body 207 of connector 128. In some embodiments, the body 207 may be rigid or semi-rigid. In some embodiments, the diaphragm 206 may be made of an elastomer and / or an elastic material. In these and other embodiments, the diaphragm 206 may include a slit or may not include a slit.

[0085] In some embodiments, housing 204 may include a cannula 210 configured to penetrate or extend through diaphragm 206 to provide a fluid path through connector 128. In these and other embodiments, the tip of cannula 210 may be disposed within housing 204, which may reduce the risk of injury to the user. In some embodiments, the tip of cannula 210 may be blunt, which may reduce the risk of damage to connector 128, or may be sharp, which may facilitate penetration of diaphragm 206. In some embodiments, cannula 210 may extend distally from housing 204, and the proximal end of cannula 210 may be secured within housing 204 by press-fit, adhesive, mechanical means, or other suitable mechanisms.

[0086] In some embodiments, the cannula 210 may be made of metal or another suitable material. In some embodiments, the outer diameter of the cannula 210 may be uniform in all or part of its length. In some embodiments, a portion of the housing 204 extending from the cannula 204 may be made of plastic or another suitable material. In some embodiments, the proximal end 220 and / or the cylindrical portion surrounding the housing 204 of the cannula 210 may be made of plastic or another suitable material.

[0087] In some embodiments, the proximal end 220 of the housing 204 may include a Luer connector 302 configured to engage with a corresponding Luer connector of the needle assembly 202. Some embodiments of the Luer connector 302 may include, for example, a female Luer connector or a male Luer connector. In some embodiments, the Luer connector 302 may be threaded or sliding-fit.

[0088] Now refer to Figure 3 In some embodiments, before removing the cannula 210 from the diaphragm 206 and the needle assembly from the catheter system 100, the user may first engage the clamping device 136 disposed on the extension tube 122 to stop the fluid flow path through the catheter system 100, which extends from the cannula 112 through the extension tube 122, through the adapter 114, through the connector 128, through the cannula 210 and into the needle assembly 202. In some embodiments, the needle assembly 202 may be removed from the catheter system 100 after blood has been collected in the blood collection device 306 and / or after the clamping device 136 has been engaged. In these and other embodiments, the housing 204 and the blood collection kit 200 may be pre-attached to the connector 128 and the catheter system 100. In some embodiments, the catheter system 100 may be assembled and provided with the housing 204 pre-attached to the connector 128.

[0089] Now refer to Figure 4According to some embodiments, a Luer connector 302 is shown at the proximal end 220 of the housing 204. In some embodiments, the needle assembly 202 (e.g., see...) Figure 3 It may include a Luer connector, such as a male Luer connector, to be coupled to Luer connector 302.

[0090] Now refer to Figure 5 In some embodiments, the needle assembly 202 can be disengaged from the housing 204, and then the syringe 802 can be coupled to the housing 204. In operation, in some embodiments, the clamping clamp 136 can disengage the syringe 802 from the extension tube 122 to open a fluid path through the catheter system 100. In some embodiments, the syringe 802 can be coupled to the connector 128 via a threaded Luer connector, Luer slide, press fit, etc. In some embodiments, the syringe 802 can be used for flushing or infusion after blood collection and removal of the needle assembly 202. In these and other embodiments, the housing 204 and the blood collection kit 200 can be pre-attached to the connector 128 and the catheter system 100. In some embodiments, the catheter system 100 can be assembled and provided with the housing 204 pre-attached to the connector 128.

[0091] In some embodiments, syringe 802 may be filled with fluid 702, such as saline or another suitable fluid, to remove residual blood after blood collection. In some embodiments, syringe 802 may be actuated by pressing the plunger 706 of syringe 802 to release fluid from syringe 802 and flush catheter system 100.

[0092] Now refer to Figures 6A-6B The proximal end of connector 128 may include a diaphragm 206, which may be coupled to the body 207 of connector 128. In some embodiments, the body 207 may be rigid or semi-rigid. In some embodiments, the diaphragm 206 may be made of an elastomer and / or an elastic material. In these and other embodiments, the diaphragm 206 may include a slit or may not include a slit. In some embodiments, a cannula 210 (e.g., see Figures 1-5) may penetrate or extend through the diaphragm 206 to provide a fluid path through connector 128.

[0093] Now refer to Figure 7In some embodiments, connector 128 may include a diaphragm 206 configured to receive cannula 210 of housing 204. In some embodiments, diaphragm 206 and / or slits may include dimensions that allow cannula 210 to extend through diaphragm 206. In some embodiments, the distal end 714 of cannula 210 may be positioned near the distal end 138 of connector 128. In some embodiments, this positioning of distal end 714 may facilitate an efficient flushing process by reducing the space within connector 128. In some embodiments, distal end 714 may include a bevel 226 angled to increase fluid flow through distal end 714.

[0094] Now refer to Figure 8 In some embodiments, the needle assembly 202 may be disengaged from the housing 204, and the extension kit 900 may be coupled to the housing 204. In some embodiments, the extension kit 900 may include an infusion chamber and / or an intravenous bag. In some embodiments, the extension kit 900 may be used for flushing or infusion. As previously described, in some embodiments, the housing 204 may include a Luer connector 302, such as a sliding or threaded male Luer connector or a sliding or threaded female Luer connector. In some embodiments, the Luer connector 302 may be coupled to a corresponding Luer connector 902 of the extension kit 900.

[0095] Now refer to Figure 9 and Figure 10 Following the flushing and / or infusion procedure, in some embodiments, the housing 204 can be removed from the connector 128. For this purpose, in some embodiments, a clamping clamp 136 can be engaged to clamp the extension tube 122, thereby closing the fluid path. In some embodiments, the needle assembly 202 can be removed by applying force to the needle assembly 202 in a proximal direction 1100 relative to the connector 128. In other embodiments, the needle assembly 202 can be removed by disengaging the threads or other engagement features from the connector 128.

[0096] like Figure 10 As shown, in some embodiments, the distal end 714 of the cannula 210 is surrounded by or otherwise blocked by the housing 204 to increase user safety. In some embodiments, the housing 204 may be cylindrical and may be substantially rigid. In some embodiments, the distal edge 1200 of the housing 204 may extend beyond the distal end 714 of the cannula 210 to prevent accidental needlestick injuries.

[0097] Now refer to Figure 11In some embodiments, connector 128 may include a blood control valve 502 or other suitable blood control technology. In some embodiments, the blood control valve 502 may be disposed within housing 204, such that in some embodiments, clamping clamp 136 may not be required. Indeed, in some embodiments, the blood control valve 502 can make blood collection, flushing, and / or infusion processes more efficient by automatically preventing blood exposure when removing needle assembly 202, for example, as... Figure 11 As shown. In these and other embodiments, cannula 211 may extend distally from the body 212 of needle assembly 202 and may be part of needle assembly 202. In some embodiments, cannula 211 may be configured to extend through blood control valve 502 in response to coupling needle assembly 202 to housing 204. In some embodiments, cannula 211 may include or correspond to cannula 210 (see, for example, Figures 1-10) in one or more features and / or operational aspects. In some embodiments, cannula 211 may extend through diaphragm 206. In some embodiments, cannula 211 may extend through blood control valve 502 and / or cannula 210 may extend through diaphragm 206.

[0098] Now refer to Figure 12A-12B In some embodiments, the housing 204 may be coupled to the connector 128 in a proximal position, in which the distal end 714 of the cannula 210 abuts or contacts the connector 128 but does not extend through or pierce the connector 128 or the diaphragm 206, for example, as Figure 12A As shown. In these and other embodiments, the distal end 714 may be proximal to the diaphragm 206. In this way, some embodiments of the catheter system 100 can reduce the risk of leakage by maintaining a closed fluid path throughout the shelf life of the catheter system 100. In some embodiments, the housing 204 may be pre-attached to the connector 128 in a proximal position. In other embodiments, the housing 204 may be pre-attached to the connector 128 with the cannula 210 extending through the diaphragm 206 of the connector 128.

[0099] In some embodiments, the housing 204 may be moved from a proximal position to a distal position, for example, as Figure 12B As shown. In some embodiments, in response to the housing 204 being in the distal position, the fluid path through the diaphragm 206 can be opened. In some embodiments, for example, a user can move the housing 204 from the proximal position to the distal position before blood collection to push the cannula 210 into and / or through the diaphragm 206. In other embodiments, the blood collection kit 200 may be packaged with the catheter system 100, but may not be assembled or attached until ready for use.

[0100] Now refer to Figures 13A-13BIn some embodiments, connector 128 may include a pinless connector. In some embodiments, connector 128 may include, for example, MAXPLUS. TM Pinless connector, MAXZERO TM Pinless connector, BD Q-SYTE TM Luer joint activated split diaphragm (available from Becton, Dickinson and Company, Franklin Lake, New Jersey), SMARTSITE TM A needleless connector (available from Becton, Dickinson and Company, Franklin Lake, New Jersey) or another suitable connector. In some embodiments, the needleless connector within the catheter system 100 may not be penetrated by the cannula 210, but may be opened via a male Luer connector or another suitable mechanism.

[0101] In some embodiments, connector 128 may facilitate the flushing process by including a proximal end surface 806, which may be substantially flat and / or smooth to avoid collecting residual blood and fluid. In some embodiments, a diaphragm 206 may be disposed within the body 207 of connector 128. In some embodiments, the proximal end surface 806 may abut or contact syringe 802. In some embodiments, connector 128 may include a proximal end 130 and a distal end 138.

[0102] Now refer to Figure 13C-13E The diagram illustrates a blood collection kit 200 according to some embodiments. In some embodiments, the blood collection kit 200 may be similar to or identical to the blood collection kit 200 described, for example, with respect to Figures 1-12, in one or more features and / or operations. In some embodiments, the blood collection kit 200 may include a housing 204. In some embodiments, the housing 204 may include a male Luer connector 205, which may be configured to engage with the proximal end 130 of a needleless connector, for example, as shown in Figure 1-12. Figures 13A-13B As shown. In some embodiments, the male Luer connector 205 may be tapered and / or integrally formed as a single unit with the rest of the housing 203. In some embodiments, the housing 203 may be removably coupled to the needle assembly 202 or integrally formed as a single unit with the needle assembly 202.

[0103] Now refer to Figures 14A-14B In some embodiments, housing 204 may include Luer connector 302 (e.g., see...). Figure 2BA male Luer connector 205 may be disposed on the inner surface of the housing 204. The male Luer connector 205 may include a Luer lock 402 or a Luer slider 404. In some embodiments, the protrusion of the male Luer connector 205 may extend beyond the cylindrical portion of the housing 204, for example, as shown in the figure. Figure 13C-13E As shown. In other embodiments, the protrusion of the male Luer connector 205 may not extend beyond the cylindrical portion of the housing 204, and the protrusion may be disposed within the cylindrical portion. In some embodiments, the male Luer connector 205 may be configured to engage the Luer connector 209 at the proximal end 130 of the pinless connector (e.g., see...). Figures 13A-13B ).

[0104] Now refer to Figure 14C-14E In some embodiments, the housing 204 may be disposed in a proximal position, for example, as shown in the image. Figure 14D As shown. In these embodiments, connector 128 can be coupled to the male Luer connector 205 of housing 204, such that the male Luer connector 205 remains adjacent to connector 128 but is not inserted into the connector. Figure 14C As shown, in some embodiments, the male Luer connector 205 and the connector 128 may be spaced apart.

[0105] In some embodiments, the housing 204 and / or the needle assembly 202 can be moved from a proximal position to a distal position, for example, as Figure 14E As shown. In some embodiments, in response to the housing 204 being in the distal position, the male Luer connector 205 can be fully inserted into the connector 128. In some embodiments, the user can move the housing 204 from the proximal position to the distal position before performing the blood collection procedure.

[0106] Now refer to Figures 15A-15E In some embodiments, housing 204 may include a distal member 213 and a proximal member 215 that moves distally toward distal member 213. In some embodiments, distal member 213 of housing 204 may include a male Luer connector 205. For example, as Figure 15D-15E As shown, in some embodiments, the proximal member 215 can be moved distally toward the distal member 213. In some embodiments, the male Luer connector 205 can activate the diaphragm 206 and establish a fluid path through the connector 128 in response to the movement of the proximal member 215 distally toward the distal member 213. In some embodiments, the outer surface of the distal member 213 may include one or more protrusions 217 that can facilitate the proximal member in a proximal position (e.g., as shown in the diagram). Figure 15C (as shown) and / or distal locations (e.g., as shown) Figure 15E(as shown in the diagram). In some embodiments, the inner surface of the housing 204 may include one or more protrusions 219 configured to slide over protrusions 217 and engage the proximal member 215 to snap into the distal member 213. In some embodiments, the protrusions 219 may be provided on the inner surface of the arm 221 of the proximal member 215 of the housing 204, the arm being detachable from the remainder of the proximal member 215 along opposite edges and the end of the arm 221 to provide flexibility.

[0107] Now refer to Figure 16 , 17A In some embodiments, and 17B, adapter 114 may include injection port 408 configured to receive syringe 802 (e.g., see 17B). Figure 5 Alternatively, the adapter 114 may be straight, as shown, or may include a Y-type adapter or another suitable shape. In some embodiments, the connector 128 may be needleless or configured to receive the cannula 210. In some embodiments, the adapter 114 may include a blood control valve 409 disposed within the lumen 222 of the adapter 114 and capable of sealing the injection port 408.

[0108] In some embodiments, the injection port cap 410 may be coupled to the injection port 408 to prevent contamination of the injection port 408 and / or the blood control valve 409. Some embodiments of the injection port cap 410 may include a hinge 411 or other suitable connecting means to hold the injection port cap 410 abutting the injection port 408. Some embodiments of the injection port cap 410 may include sizing and fixing features to facilitate easy opening and secure closure of the injection port 408. In some embodiments, the injection port cap 410 may be press-fitted to the injection port 408 to selectively close access to the adapter 114. Referring now to Figure 18 According to some embodiments, adapter 114 is shown in a straight construction and does not have injection port 408.

[0109] Now refer to Figure 19 In some embodiments, a particular port of adapter 114 (e.g., the second port 120 of adapter 114) may include an elongated end cap 500. In some embodiments, the elongated end cap 500 may even extend along or distal to the inner wall 501 of the cavity 504 forming the first port 118. In this way, some embodiments of adapter 114 may reduce blood contamination of the second port 120. In some embodiments, the elongated end cap 500 may be disposed within the cavity 506 of the second port 120. In some embodiments, connector 128 may be pinless or configured to receive cannula 210.

[0110] Now refer to Figure 20 In some embodiments, the catheter system 100 may include a secondary flashback chamber 600 disposed at the proximal end 104 of the catheter hub 102. In operation, in some embodiments, placement of the catheter 112 within the vascular system can be confirmed by visible blood or an "instaflash" within the catheter 112 and / or within the primary flashback chamber of the catheter hub 102. In some embodiments, the secondary flashback chamber 600 may facilitate observation of blood within the secondary flashback chamber 600 to enhance initial venous confirmation and to allow the catheter 112 to remain in place within the vein during blood collection, flushing, or infusion.

[0111] In some embodiments, in response to confirmation of proper placement of catheter 112 within a vein, the needle assembly 202 and / or housing 204 of the blood collection kit 200 may engage with connector 128 to open a fluid path for blood collection. After blood collection, in some embodiments, needle assembly 202 may be removed, and syringe 802 may be coupled to housing 204 for flushing catheter system 100 or for infusion of medications, saline, or the like. In some embodiments, connector 128 may be needleless or configured to receive cannula 210.

[0112] Now refer to Figures 21A-21B and Figures 22A-22B In some embodiments, the cannula 210 may include one or more side holes 700, which, together with the opening 701 in the distal end 714, provide multiple fluid paths through the distal end 714. In some embodiments, the side holes 700 may be located near the distal end 714. In some embodiments, the side holes 700 and / or the opening 701 may be in fluid communication with the lumen of the cannula 210, which may extend through the cannula 210. In some embodiments, the diaphragm 206 (e.g., see...) Figure 2B It can be spaced apart from the side hole 700 to avoid blocking the side hole 700 in response to the extension of the cannula 210 through the diaphragm 206.

[0113] In some embodiments, such as Figures 21A-21B As shown, the side holes 700 may be substantially annular and may be disposed in one or more sides of the cannula 210. In some embodiments, the side holes 700 may be disposed on opposite sides of the cannula 210. In some embodiments, one or more side holes 700 may be formed to extend through the side of the cannula 210 at an angle. In some embodiments, each side hole 700 may be substantially uniform or non-uniform relative to each other. In these and other embodiments, the cannula 210 may include any number of side holes 700, and each side hole 700 may include any suitable size, shape, and / or orientation.

[0114] like Figures 22A-22B As shown, for example, one or more side holes in side holes 700 may include substantially orthogonal shapes. In some embodiments, at least one side hole in side holes 700 may be formed as a slit extending through the side surface 707 of cannula 210 to provide multiple paths of fluid communication between the lumen 704 of cannula 210 and the external environment, together with the distal end 714.

[0115] Now refer to Figure 23A In some embodiments, connector 128 may be coupled to adapter 114, and blood collection kit 200 may be coupled to connector 128. In some embodiments, for example, as shown in FIG23, connector 128 may be coupled to the proximal end of extension kit 716. In some embodiments, extension kit 716 may include extension tube 718, which may include a distal end integrated within distal Luer connector 720 and / or a proximal end integrated within proximal Luer connector 722. In some embodiments, blood collection kit 200 may be coupled to connector 128. Referring now to... Figures 23B-23C In some embodiments, various configurations of the blood collection kit 200 described with respect to one or more of the figures 1-23 may be provided at the proximal end of the extension kit 716.

[0116] Now refer to Figure 24 In some embodiments, the extension kit 716 may be coupled to the proximal end 104 of the catheter hub 102, and the needle assembly 202 may be coupled to the proximal end of the extension tube 718. In some embodiments, the proximal end of the extension tube 718 may be integrated within the needle assembly 202. In other embodiments, the needle assembly 202 may be removably coupled to the proximal Luer connector 722. In some embodiments, various configurations of the blood collection kit 200 described with respect to one or more of Figures 1-23 may be located at the proximal end of the extension kit 716.

[0117] In some embodiments, catheter hub 102 may include an open catheter hub, which may not include an integral extension tube. In some embodiments, extension kit 716 may be coupled to the proximal end 104 of catheter hub 102. In some embodiments, needle assembly 202 may be pre-attached to extension kit 716 or coupled to extension kit 716 before coupling extension kit 716 to the proximal end 104 of catheter hub 102.

[0118] In some embodiments, after the catheter 112 is placed within the patient's vascular system, the blood collection device 306 (which may include a blood collection tube) can be coupled to the needle assembly 202, and blood can be collected within the blood collection device 306. In some embodiments, in response to the blood collection device 306 pushing the sheath 216 distally toward the body 212, the needle 214 can pierce the sheath 216, and the sharp proximal end 218 of the needle assembly 202 can be inserted into the blood collection device 306 to collect blood.

[0119] In some embodiments, after blood collection, the clamp 136 may be engaged to prevent fluid from flowing through a fluid path in the catheter system 100 that extends from the catheter 112 through the catheter hub 102, through the extension kit 716, and into the needle assembly 202. In some embodiments, after engaging the clamp 136, the needle assembly 202 may be disengaged from the extension kit 176 and removed from the catheter system 100. In some embodiments, after removing the needle assembly 202, the proximal end of the extension kit 716 may then be coupled to a flushing or infusion device. In some embodiments, after coupling the proximal end of the extension kit 716 to a flushing or infusion device, the clamp 136 may be disengaged, and the fluid path may be opened, allowing flushing or infusion into the patient's vascular system via the extension kit 716 and the catheter hub 102 coupled to the extension kit 716.

[0120] In some embodiments, after flushing or infusion, the clamping clamp 136 may be engaged to stop flow through the extension kit 176 and / or the needle assembly 202 may then be coupled to a connector, such as connector 128 (see one or more in Figures 1-20). In some embodiments, connector 128 may be coupled to the proximal end of extension kit 176 and / or housing 204 (see one or more in Figures 1-20) may be coupled to connector 128. In these and other embodiments, after flushing or infusion via a flushing or infusion device connected to housing 204, housing 204 may be disconnected from connector 128 and housing removed from catheter system 100.

[0121] All examples and conditional language described herein are intended for illustrative purposes to aid the reader's understanding of this disclosure and the inventors' concepts for the purpose of advancing the art, and should be construed as not being limited to such specific examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims

1. A catheter system, comprising: A catheter hub, the catheter hub including a distal end, a proximal end, and an inner lumen extending through the distal end and the proximal end of the catheter hub; A catheter extending distally from the distal end of the catheter seat; A connector, which is coupled to the catheter seat and includes a proximal end, the proximal end of which includes a diaphragm; and A blood collection kit, comprising a needle assembly and a housing, wherein the housing is coupled to a connector, and wherein the housing is configured to establish a fluid path through the connector. Wherein, when the housing is connected to the connector, the proximal end of the connector and the diaphragm are located within the housing. The housing is directly and removably connected to the needle assembly via a proximal Luer connector on the housing. When the needle assembly is connected to the housing, the blood collection kit is in a first configuration; when the needle assembly is removed from the housing, the blood collection kit is in a second configuration. The needle assembly of the blood collection kit is configured to receive a blood collection device when the blood collection kit is in the first configuration, and the proximal Luer connector is configured to connect to an infusion device when the blood collection kit is in the second configuration.

2. The catheter system according to claim 1, further comprising: A side port is disposed between the distal end of the catheter seat and the proximal end of the catheter seat; An extension tube, the extension tube including a distal end integral with a side port of the catheter seat and a proximal end integral with the distal end of the catheter seat; and An adapter, the adapter including a distal end and a port, wherein the connector is coupled to the port of the adapter.

3. The catheter system according to claim 2, wherein, The adapter includes a Y-type adapter or a straight adapter.

4. The catheter system according to claim 1, wherein, The connector is a pinless connector.

5. The catheter system according to claim 4, wherein, The housing is disposed in a proximal position, the housing including a male Luer connector configured to activate the diaphragm and establish a fluid path through the connector in response to the housing moving from the proximal position to the distal position, the housing being screwed from the proximal position to the distal position or pushed from the proximal position to the distal position.

6. The catheter system according to claim 4, wherein, The housing includes a distal member and a proximal member movable distally toward the distal member. The distal member of the housing includes a male Luer connector configured to activate the diaphragm and establish a fluid path through the connector in response to the proximal member moving distally toward the distal member.

7. The catheter system according to claim 1, wherein, The housing includes a cannula configured to penetrate the diaphragm of the connector to establish a fluid path through the connector.

8. The catheter system according to claim 7, wherein, The cannula includes a side port that is in fluid communication with the inner lumen of the cannula.

9. The catheter system according to claim 7, wherein, The housing is movable from a proximal position to a distal position, and in response to the housing moving from the proximal position to the distal position, the cannula extends through the diaphragm and establishes the fluid path through the connector.

10. The catheter system according to claim 7, wherein, The cannula extends through the diaphragm.

11. The catheter system of claim 1, further comprising an extension kit including a distal end coupled to the proximal end of the catheter hub and a proximal end coupled to the connector, the connector being a needleless connector.

12. The catheter system according to claim 1, wherein, The needle assembly includes a body, a needle extending proximally from the body, and a sheath covering the proximal end of the needle.

13. A method comprising: Connect the blood collection kit to the catheter system, wherein the catheter system includes: A catheter hub, the catheter hub including a distal end, a proximal end, and an inner lumen extending through the distal end and the proximal end of the catheter hub; A catheter extending distally from the distal end of the catheter hub; and A connector, which is coupled to the catheter seat and includes a proximal end, the proximal end of which includes a diaphragm; The blood collection kit includes a needle assembly and a housing, wherein the housing is coupled to the connector, and wherein the housing is configured to establish a fluid path through the connector. Wherein, when the housing is connected to the connector, the proximal end of the connector and the diaphragm are located within the housing. The housing is directly and removably connected to the needle assembly via a proximal Luer connector on the housing. When the needle assembly is connected to the housing, the blood collection kit is in a first configuration; when the needle assembly is removed from the housing, the blood collection kit is in a second configuration. The needle assembly of the blood collection kit is configured to receive a blood collection device when the blood collection kit is in the first configuration, and the proximal Luer connector is configured to connect to an infusion device when the blood collection kit is in the second configuration.

14. The method according to claim 13, wherein, The catheter system also includes: A side port is disposed between the distal end of the catheter seat and the proximal end of the catheter seat; An extension tube, the extension tube including a distal end integral with a side port of the catheter hub and a proximal end integral with the distal end of the catheter hub; and An adapter, the adapter including a distal end and a port, wherein the connector is coupled to the port of the adapter.

15. The method according to claim 13, wherein, The connector is a pinless connector.

16. The method according to claim 15, wherein, The housing is disposed in a proximal position, the housing includes a male Luer connector, the method further includes moving the housing from the proximal position to a distal position, the male Luer connector activating the diaphragm and establishing a fluid path through the connector in response to the housing moving from the proximal position to the distal position, the housing being screwed from the proximal position to the distal position or pushed from the proximal position to the distal position.

17. The method according to claim 15, wherein, The housing includes a distal member and a proximal member movable distally toward the distal member, the distal member of the housing including a male Luer connector, the method further including moving the proximal member distally toward the distal member, the male Luer connector activating the diaphragm and establishing a fluid path through the connector in response to the distal member moving distally toward the distal member.

18. The method according to claim 13, wherein, The housing includes a cannula, and the method further includes moving the housing from a proximal position to a distal position, wherein, in response to the housing moving from the proximal position to the distal position, the cannula extends through the diaphragm and establishes a fluid path through the connector.

19. The method according to claim 18, wherein, The cannula extends through the diaphragm in response to connecting the blood collection kit to the catheter system.

20. The method according to claim 13, wherein, The catheter system also includes an extension kit comprising a distal end connected to the proximal end of the catheter hub and a proximal end connected to the connector, which is a needleless connector.

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