Peripheral Venous Catheter Assembly for Blood Sampling and Related Methods

Abstract

A peripheral intravenous (IV) catheter assembly having blood sampling and cannulation capabilities can have a blood collection holder (106) that has a needle hub (106a) attached to a catheter hub (102). The combination of the catheter assembly and the blood sampling holder can be referred to as a catheter and holder assembly (85). After cannulation, blood sampling can be performed directly through the needle and the blood collection holder. After blood sampling, the blood collection holder (106) and the needle (108) can be removed, leaving the catheter hub (102) with the patient for IV infusion. The catheter hub (102) can be a straight catheter hub or can include a side fluid port (500) for use as an integral IVC.

Description

Technical Field

[0001] The disclosed devices, systems, and methods relate to blood collection holders and, in particular, to blood collection holders for peripheral intravenous ("IV") catheters. In particular, the devices, systems, and methods relate to a blood collection holder that serves as an insertion hub for catheterization of an IV catheter. Background Art

[0002] Catheters are commonly used in various infusion therapies. For example, catheters are used to inject fluids (such as saline, various drugs, and total parenteral nutrition) into a patient, draw blood from a patient, or monitor various parameters of a patient's vasculature. After a catheter is placed into a patient's vasculature, an IV fluid source can be connected to a catheter adapter or catheter hub, thereby opening a blood control valve. Once connected in this way, fluid from the IV source can begin to flow through the catheter into the patient.

[0003] For many patients who are hospitalized and undergo catheterization, they will also undergo a separate blood sampling procedure. Thus, the patient will experience two separate procedures, which include (a) blood sampling and (b) infusion therapy using an IV catheter. Depending on the devices used in the hospital, the two separate procedures may also require the patient to be pricked more than once.

[0004] Currently, some IV catheters can allow a separate syringe to be attached to the insertion hub of the IV catheter. The insertion hub can have a removable blood plug assembly at the proximal end of the insertion hub. The syringe can thus be attached to the proximal end of the insertion hub, and the syringe can be used to draw blood through the IV catheter. After the syringe is filled with blood, the syringe can then be detached from the insertion hub. The filled syringe can then be connected to a hypodermic needle, and the needle can be inserted into a vacuum tube, which is commonly referred to in the relevant industry as a vacuum blood collection tube, for injecting the blood into the vacuum blood collection tube for blood sampling. Summary of the Invention

[0005] For the two separate procedures of blood sampling and infusion therapy, there may be two sets of hazardous medical waste generated by the procedures. Additionally, in the case where blood sampling and infusion therapy are separate procedures performed on a patient, the patient may undergo at least two needle pricks. Some aspects of the present invention relate to a combined device. The combined device can be referred to as a catheter and holder assembly. The catheter and holder assembly can perform multiple medical procedures in only a single needle prick, which otherwise would require multiple needle pricks.

[0006] A catheter and retainer assembly can include a catheter hub having a catheter tube body attached to a blood collection retainer. The blood collection retainer has a housing sized and shaped to receive a vacuum blood collection tube. A needle having a sharp distal end and a sharp proximal end passes through both the catheter and the blood collection retainer such that the sharp distal end is distal to the opening of the catheter tube body and the sharp proximal end is within the internal space of the blood collection retainer.

[0007] Some aspects of the present invention include a catheter and retainer assembly comprising: a catheter hub having a catheter tube body with a distal opening attached to the catheter hub; a needle including a sharp distal needle end and a sharp proximal needle end, and wherein the sharp distal needle end projects beyond the distal opening of the catheter tube body; and a blood collection retainer having a hub and a housing, the hub having an aperture through which the needle passes, the housing having an internal space sized to receive a vacuum blood collection tube; wherein the catheter hub is in contact with the blood collection retainer and the sharp proximal needle end is within the internal space of the housing.

[0008] The needle can include a notch proximal to the sharp distal needle end.

[0009] The blood collection retainer can include an end wall and side walls defining the internal space, and the hub can be integral with the end wall.

[0010] When the catheter assembly is in the ready-to-use position, the sharp proximal needle end can be within the internal space of the blood collection retainer.

[0011] A deformable shield can be retained within the internal space of the blood collection retainer, and the deformable shield can cover the sharp proximal needle end.

[0012] The blood collection retainer can include a protrusion that projects into the catheter hub in the ready-to-use position.

[0013] The portion of the needle that extends distally from the blood collection retainer and has a sharp distal end for venipuncture can be longer than the portion of the needle that extends into the blood collection retainer.

[0014] The needle can be fixed to the blood collection retainer by an adhesive.

[0015] The blood collection retainer can include an internal support post protrusion that projects proximally from the end wall into the internal space. The internal support post can include a through-hole through which the needle is inserted.

[0016] A blood collection holder may include a distal protrusion extending distally from an end wall, which may be configured to fit within the interior of a catheter hub.

[0017] The blood collection holder may include a distal annular flange disposed radially outward of the distal protrusion.

[0018] The needle may include a curved or arcuate section corresponding to a curved or arcuate section in the blood collection holder for assembly.

[0019] The curved or arcuate section of the needle may include a lumen therethrough.

[0020] The needle may include a profile change located proximal to the sharp distal needle tip.

[0021] A needle guard may be incorporated with the catheter and holder assembly. The needle guard may include a surface located at the side of the needle in a ready-to-use position, and wherein the surface is movable distally beyond the sharp distal needle tip in a protective position to cover the sharp distal needle tip.

[0022] The catheter hub may include a side port and a tube attached to the side port.

[0023] A valve and valve opener may be located within the catheter hub.

[0024] Some aspects of the present invention may also include a catheter and holder assembly comprising: a catheter hub including a catheter body; a blood collection holder having a proximal opening sized and shaped to receive a vacuum blood collection tube; and a needle including a sharp distal needle tip and a sharp proximal needle tip, the needle being fixed to the blood collection holder; wherein the needle extends through the catheter hub and the catheter body, and the distal needle tip extends distally of the opening of the catheter body.

[0025] Another aspect of the present invention may include a method of assembling a catheter and holder assembly. The method may include: mounting a needle including a sharp distal needle tip and a sharp proximal needle tip to a blood collection holder; coupling the blood collection holder to a catheter hub including a catheter body such that the needle extends through the catheter hub and the catheter body, and the sharp distal needle tip is located distally of the end opening of the catheter body; and wherein the blood collection holder has a body defining an internal space sized to receive a vacuum blood collection tube, and the sharp proximal needle tip is located within the internal space.

[0026] Another aspect of the present invention includes a method of performing blood collection and peripheral IV access using a single needle and a single needle stick.

[0027] Another aspect of the present invention includes a method of using a catheter assembly, wherein the catheter assembly includes a needle passing through a catheter hub and a catheter body, and wherein the needle includes a sharp distal end and a sharp proximal end, the sharp distal end being distal to the distal opening of the catheter body, and the sharp proximal end being proximal to the proximal opening of the catheter hub.

[0028] A catheter and holder assembly according to other aspects of the present invention may include a blood collection holder or housing, a catheter hub attached to the blood collection holder and having a catheter body, and wherein a needle including a sharp proximal end and a sharp distal end is at least partially within the lumen of the catheter body and at least partially within the blood collection holder.

[0029] Aspects of the present invention are also understood to include a catheter and holder assembly comprising: a catheter hub having a catheter body with a distal opening attached to the catheter hub; a needle including a sharp distal needle end and a sharp proximal needle end, and wherein the sharp distal needle end projects beyond the distal opening of the catheter body; and a blood collection holder having a hub and a housing, the hub having a hole through which the needle passes, the housing having an internal space sized to receive a vacuum blood collection tube; wherein the catheter hub is in contact with the blood collection holder, and the sharp proximal needle end is within the internal space of the housing.

[0030] A needle that can be used with the catheter assembly of the present invention may include a notch proximal to the sharp distal needle end.

[0031] The blood collection holder may include an end wall and side walls defining an internal space, and the hub is integral with the end wall.

[0032] A needle that can be used with the catheter assembly of this embodiment may have two spaced-apart sharp ends. The two sharp ends may include a distal needle end and a proximal needle end. When the catheter assembly is in the ready-to-use position, the sharp proximal needle end may be within the internal space of the blood collection holder.

[0033] A deformable shield may be held within the internal space of the blood collection holder, and the deformable shield may cover the sharp proximal needle end.

[0034] The blood collection holder may have a protrusion that projects into the catheter hub in the ready-to-use position.

[0035] The protrusion of the blood collection holder may be distal to the body, and the size and shape of the body may be designed to receive a vacuum blood collection tube.

[0036] The portion of the needle extending distally from the blood collection holder can be longer than the portion of the needle extending into the blood collection holder.

[0037] The needle can be fixed to the blood collection holder by an adhesive.

[0038] The blood collection holder can include an internal support post that projects proximally from an end wall or a distal wall of the blood collection holder and into the internal space of the body. The internal support post can include a through hole through which the needle is inserted.

[0039] The blood collection holder can include a distal projection that extends distally from the end wall and is configured to fit into a proximal opening of a catheter hub. The proximal opening of the catheter hub can be a female Luer fitting, and its size and shape can be determined according to the ISO Luer standard.

[0040] The blood collection holder can include a distal annular flange disposed radially outside the distal projection.

[0041] The needle can have a bend between the proximal end and the distal end. The bend can correspond to a bend formed in the blood collection holder. The two bends of the needle and the blood collection holder can be combined for assembly. The bend on the needle can be positioned closer to the proximal end than the distal end.

[0042] The needle can include a profile change portion proximal to the sharp distal needle tip.

[0043] The catheter and holder assembly can further include a needle guard that includes a surface located on the side of the needle in the ready-to-use position, and wherein the surface can move distally beyond the sharp distal needle tip in the protected position to cover the sharp distal needle tip.

[0044] The catheter hub can include a side port and a tube attached to the side port.

[0045] A valve and a valve opener can be located within the catheter hub. After a successful venipuncture, the valve opener can be pushed into the valve, such as the end of a syringe or the end of an IV administration line, to open the valve. The valve can have a plurality of slits that define a plurality of deflectable flaps. In one example, there can be three slits and three flaps.

[0046] Another aspect of the present invention is a catheter and holder assembly, comprising: a catheter hub including a catheter body; a blood collection holder having a proximal opening sized and shaped to receive a vacuum blood collection tube; and a needle including a sharp distal needle tip and a sharp proximal needle tip, the needle being fixed to the blood collection holder; wherein the needle extends through the catheter hub and the catheter body, and the distal needle tip extends distally of the opening of the catheter body.

[0047] Another aspect of the present invention is a method of assembling a catheter and holder assembly, the method comprising: mounting a needle including a sharp distal needle tip and a sharp proximal needle tip to a blood collection holder; coupling the blood collection holder to a catheter hub including a catheter body such that the needle extends through the catheter hub and the catheter body, and the sharp distal needle tip is located distally of the end opening of the catheter body; and wherein the blood collection holder has a body defining an internal space sized to receive a vacuum blood collection tube, and the sharp proximal needle tip is located within the internal space.

[0048] The method may further comprise gripping a flange at the proximal end of the blood collection holder.

[0049] The method may further comprise bringing the blood collection holder into abutment with the catheter hub.

[0050] The needle may be fixed to the blood collection holder by an adhesive.

[0051] The method may further comprise projecting a distal protrusion extending distally from an end wall of the body of the blood collection holder into the interior of the catheter hub.

[0052] The blood collection holder may include a distal annular flange disposed radially outward of the distal protrusion.

[0053] Additionally, it is advantageous to minimize medical waste by reducing the number of medical devices or components used in different procedures. It is also advantageous to minimize the number of needle sticks a patient must undergo.

[0054] Embodiments of the present disclosure may allow for the use of a single needle, such that there will be one less needle for a healthcare professional to manipulate and one less syringe to discard. In terms of accidental needle sticks, the healthcare professional may also be exposed to a lower risk by reducing the number of components the healthcare professional must manipulate.

[0055] An IV catheter assembly (which may more generally be referred to as a needle assembly or needle device) can include a catheter body, a catheter hub, a needle, a rubber shield, and a blood collection holder. The catheter hub can have a female Luer fitting at the proximal end for receiving a male Luer fitting in a Luer fit, optionally with external threads.

[0056] The catheter body can be fixed to the catheter hub, for example, with a metal bushing or ferrule.

[0057] A needle having a profile change proximal to the distal needle tip can be inserted through the proximal opening of the catheter hub, with the distal needle tip protruding from the distal opening of the catheter body in the ready-to-use position. The needle can also have a proximal needle tip at the end of the needle opposite the distal needle tip. The profile change can be a crimp, a material buildup, or a sleeve, and can be configured to engage a needle guard and prevent the needle guard from shifting distally away from the needle. In some examples, the profile change can be omitted, and the needle guard can cover the needle tip without using a profile change.

[0058] A needle guard (which is understood to include structural features for guarding the needle tip against accidental needle sticks) can be configured to be removed with the needle after a successful venipuncture, and a valve and valve actuator can be configured to remain with the catheter hub for controlling fluid flow therethrough, such as allowing fluid communication between a male Luer fitting and the catheter body. The valve actuator is configured to be pushed distally into the valve by the male end of a medical instrument such as a syringe or IV connector to open the valve for fluid flow. The valve and valve actuator can be similar to those disclosed in U.S. Publication No. 2018 / 0214673, the content of which is hereby expressly incorporated by reference.

[0059] Further information regarding the needle guard is discussed in U.S. Patent No. 8,568,372, the content of which is hereby expressly incorporated by reference. Generally speaking, the needle guard has a surface that is located on the side of the needle shaft in the ready-to-use position for injection and is capable of moving distally of the needle tip in a protective position to block the needle tip from accidental needle sticks.

[0060] In an alternative embodiment, the needle guard can be embodied as multiple components that cooperate to block the needle tip from accidental needle sticks. For example, the needle guard can include a spring-loaded needle carrier having a needle attached thereto. After a successful venipuncture, a release tab can be depressed to release the spring, and then the needle carrier and needle can be moved within a protective barrel to block the needle tip from accidental needle sticks. Further information regarding various aspects of catheter assemblies with valves and their components is discussed in PCT Patent Applications PCT / EP2016 / 069619 and PCT / EP2016 / 069643 and U.S. Patent No. 9,114,231, the content of which is hereby expressly incorporated by reference.

[0061] A cannula hub or a needle hub can be coupled to the distal end of the blood collection holder to receive a needle. For example, the needle hub can be part of the body of the blood collection holder or can be integral with the body of the blood collection holder.

[0062] The needle can have a needle tip distal to the needle hub and a second needle tip located inside the needle holder for piercing the septum on the vacuum blood collection tube. In other words, the needle shaft can have double-sharpened needle tips. When assembled with the catheter hub, the assembly includes the catheter hub and the needle, the catheter hub having a catheter body, and the needle having two sharp needle tips at two opposite ends of the needle shaft. For example, the catheter hub provided herein can include a catheter body through which the needle projects, and wherein the needle has a first sharp needle tip extending beyond the distal opening of the catheter body. The needle can have a proximal section extending proximal to the proximal opening of the catheter hub, and wherein the proximal section of the needle has a second sharp needle tip.

[0063] In one embodiment, the needle hub is integrally formed with the body of the blood collection holder. For example, the needle hub can be molded together with the body of the holder. Additional details regarding Figure 2 、 Figure 3A and Figure 3B and elsewhere describe additional details related to the blood collection holder and the associated rubber sleeve (also known as the multi-sample luer adapter or MSLA). Additionally, the size and shape of the blood collection holder of this embodiment can be designed to receive a vacuum blood collection tube. For example and as further discussed below, the blood collection holder can include a body portion having a wall that defines an interior sized and shaped to receive a vacuum blood collection tube.

[0064] A rubber shield, a deformable seal, or a self-sealing needle sheath (also known as the MSLA) can be attached to the interior of the blood collection holder at the second end of the needle or at the proximal end of the needle. In the ready-to-use position, before inserting the vacuum blood collection tube into the blood collection holder, the rubber shield can axially surround the proximal end of the needle and cover the proximal needle tip. The rubber shield can have a body, a proximal end, and a distal end.

[0065] In an embodiment, the body of the rubber shield or the needle sheath can be generally cylindrical. The self-sealing needle sheath can be made of rubber or a polymeric material to allow deformation in the axial direction of the needle. The size and shape of the open distal end of the self-sealing needle sheath can be designed to snap-fit onto a base in the interior of the holder and be assembled therewith for use.

[0066] The body and distal end of the rubber shield can define an open interior space and an open end leading into the open interior space. The body can be defined by a sidewall having a thickness defined between its inner sidewall surface and its outer sidewall surface. The distal end can have a flange extending radially outward from the body. The distal end with the flange can have a radial thickness greater than the radial thickness of the body.

[0067] Alternatively, the body can be formed in different geometries, such as but not limited to conical, frustoconical, pyramidal, frustopyramidal, prismatic, square, or rectangular. In the case of different geometries, the orientation of the geometry can be such that the body can elastically deform in the axial direction of the needle.

[0068] The proximal end of the rubber shield can include a covering that covers the interior of the rubber shield. The proximal end can be considered the sealed end of the rubber shield. The proximal end can have a domed surface to seal the proximal end of the rubber shield. Alternative shapes, such as planar or conical surfaces, can also be used. A hole or slit can be pre-formed in the surface of the proximal end or dome so that the needle can pass through when the rubber shield elastically deforms in the axial direction.

[0069] If a hole is pre-formed, the size of the hole can be designed such that when the rubber shield is in the ready-to-use position and the needle is not extending through the surface of the proximal end, the surface tension of the blood from the patient prevents leakage or flow through the rubber shield. Alternatively, one or more slits can be pre-formed in the surface such that the slits define two flaps in the surface. When the needle is inserted through the surface of the proximal end, the needle can be inserted into the slit and cause the flaps to separate from each other. When the needle is not extending through the surface of the proximal end, the flaps can seal against each other.

[0070] As further described, the blood collection holder can carry an insertion hub at its distal end. The blood collection holder can have a generally cylindrical body. The blood collection holder can have a distal sidewall at one end of the body. In some embodiments, the distal sidewall or end wall can be joined to the body by a radius or fillet. A mating flange can extend from the distal sidewall in the distal axial direction.

[0071] The size and shape of the mating flange can be designed to project into the interior of the catheter hub when assembled in the ready-to-use position, similar to the nose end of the needle hub of a standard catheter assembly. The mating flange can be embodied as a cylindrical protrusion. In some cases, the mating flange and the internal support post can be molded as separate components that can be detached from the end wall. For example, the combination of the mating flange and the internal support post can be screwed onto the end wall, pushed off the end wall, etc. Optionally, the combination of the mating flange and the internal support post can be separated from the body before or after use.

[0072] The mating flange may have a mating flange opening defined by the inner surface of the cylindrical protrusion. In some embodiments, the mating flange may be a different geometry that mates with the corresponding internal shape of the catheter hub to prevent rotation of the blood collection holder relative to the catheter hub. In some embodiments, the cylindrical protrusion of the mating flange may further include a mating protrusion that extends further distally from the mating flange. The mating protrusion may have the same thickness as the thickness of the sidewall of the mating flange.

[0073] In an embodiment, the mating protrusion may have a surface configured to push the needle guard into engagement with an internal engagement protrusion formed with the catheter hub when the blood collection holder mates with the catheter hub. This allows the needle guard to remain in place during the ready-to-use position and during needle retraction after a successful venipuncture to prevent early activation.

[0074] At an opposite end, such as the proximal end of the body, there may be an opening for receiving a vacuum blood collection tube into the internal space of the blood collection holder. Near or at the proximal end of the body, a handle or a gripping pad may project radially outward from the body. The handle may be generally rectangular in shape. In some embodiments, the blood collection holder may have one handle extending radially outward from the body.

[0075] In other embodiments, the blood collection holder may have two or more handles extending radially outward from the body. In the case of two or more handles, the handles may be equally spaced around the body, or the handles may be spaced such that they are ergonomically comfortable for single-handed gripping of the blood collection holder.

[0076] The metal bushing may be configured to squeeze the proximal end of the catheter tube against the inner wall surface of the catheter hub to hold the catheter tube to the catheter hub. Inside the catheter hub, a septum or valve, an actuator or valve opener, and a needle guard, such as a safety shield or end protector, are provided. The catheter hub may be made of a single hub body as shown, or made of two or more hub bodies assembled together.

[0077] The septum or valve may include at least one slit that defines an elastically deformable flap of the valve. In one example, the valve has more than one slit and more than one flap, such as three slits and three flaps. A needle can be inserted through at least one slit such that the elastic flap can be expanded by the hollow needle and closed when the needle is removed. The size and shape of the valve can be designed for a variety of uses by cooperating with a valve opener to open one or more slits of the valve for fluid flow and closing when removing a male Luer tip placed in the catheter hub to push the valve opener in the distal direction. In some examples, the flap may remain open and engaged with the valve opener in a single-use activation configuration. The number of slits that define the number of flaps can vary from one slit to four or more slits.

[0078] The catheter hub may have a proximal end with an opening. The proximal end may also be provided with a female Luer fitting having external threads, forming a female threaded Luer. In some examples, the threads may be omitted and the proximal opening may be used as a female Luer slip.

[0079] The catheter hub provided herein may include a pair of wings. Embodiments of the catheter hub may also include embodiments without wings.

[0080] In the internal space of the blood collection holder, an internal support post may extend proximally from the distal wall into the internal space. The shape of the internal support post may be generally cylindrical or conical, extending from the axial center of the blood collection holder. The internal support post may include a distal section and a proximal section. The distal section, which is closer to the distal wall or end wall, may have a first outer diameter that is a larger diameter than the second outer diameter of the proximal section.

[0081] The transition of the outer diameter from the distal section to the proximal section may be stepped or tapered. The size of the first outer diameter of the distal section may be designed to correspond to the inner diameter of the rubber shield to fix the rubber shield to the distal section. Since the rubber shield may be elastically deformable and stretchable, the first outer diameter may be larger than the inner diameter of the rubber shield when the rubber shield is in its relaxed state. Thus, the rubber shield can be fitted onto the distal section to fix the rubber shield to the distal section.

[0082] In some embodiments, the proximal section may have a second outer diameter that is smaller than the smaller inner diameter of the rubber shield. When the rubber shield is compressed axially towards the distal wall, the smaller second outer diameter of the proximal section may allow space to accommodate the elastic deformation of the rubber shield.

[0083] A hole may extend through the internal support post and through to the mating flange opening. The size and shape of the hole may be designed to accommodate a needle. The size of the hole may be designed to interference press-fit with the needle and / or may include a clearance or glue well that is sufficient for an adhesive to fix the needle to the hole.

[0084] The blood collection holder can cooperate with a needle and a rubber shield. The rubber shield can cooperate with an internal support post that extends proximally into the internal space from the distal side wall or end wall. The internal support post can include a distal section and a proximal section. The distal section of the internal support post that is closer to the distal side wall can have a first outer diameter that is larger than the second outer diameter of the proximal section.

[0085] In some embodiments, the rubber shield can be elastically deformable and stretchable such that when the rubber shield is in its relaxed state, the first outer diameter of the distal section can be greater than the inner diameter of the rubber shield. Thus, the rubber shield can be fitted onto the distal section to secure the rubber shield to the distal section. In other embodiments, the rubber shield can have a rigid structure near its distal end and have an interference fit with the first outer diameter of the distal section.

[0086] The rubber shield can be fitted such that a flange of the rubber shield abuts the distal side wall. Additionally, the rubber shield can be secured to the distal section by a mechanical device such as a clip or by an adhesive. In some embodiments, the rubber shield can have a loose fit on the distal section and be secured by a clip or adhesive. This can facilitate easier assembly.

[0087] The transition of the outer diameter from the distal section to the proximal section can be stepped or tapered. Proximally of the distal section, the proximal section of the internal support post can have a second outer diameter that is smaller than the first outer diameter of the distal section. When the rubber shield is compressed axially toward the distal side wall due to the insertion of a vacuum blood collection tube into the blood collection holder, the smaller second outer diameter of the proximal section can allow space to accommodate the elastic deformation of the rubber shield.

[0088] The proximal needle tip can be located inside the rubber shield. Thus, the proximal needle tip is located at an intermediate position between the internal support post and the proximal end of the rubber shield. Thus, the rubber shield surrounds the proximal needle tip, thereby separating the proximal needle tip from the rest of the internal space of the blood collection holder.

[0089] Thus, in the ready-to-use position, the rubber shield can act as a sanitary shield to prevent contamination of the proximal needle tip during replacement of the vacuum blood collection tube with a new or different one and to seal the needle to prevent blood backflow. When the vacuum blood collection tube is inserted into the internal space of the blood collection holder, the proximal end of the rubber shield can be axially compressed toward the distal side wall and elastically deformed. The proximal end of the rubber shield can be elastically deformed beyond the proximal needle tip such that the proximal needle tip extends proximally of the proximal end of the rubber shield and into the vacuum blood collection tube.

[0090] At the distal end of the bore, the mating flange may extend distally of the distal wall of the blood collection holder. The cylindrical projection of the mating flange may further include a mating projection extending further distally from the mating flange in the distal direction. The mating projection may include a main proximal portion, an arcuate section extending further distally from the cylindrical projection which is the mating flange in the distal direction.

[0091] The mating projection may have a distal key portion extending distally from the main proximal portion. The distal key portion may have an outer arcuate shape similar to the main proximal portion and the mating flange. The distal key portion may have a radially inner flat portion to set the needle guard in the catheter hub.

[0092] In the assembled, ready-to-use position of the attachment structure of a perpheral venous catheter assembly or a catheter and holder assembly that can collect blood, the catheter hub abuts the distally facing surface of the distal wall of the blood collection holder. The needle extends through the catheter hub and the catheter body, and the needle tip extends distally of the opening of the catheter body.

[0093] In the ready-to-use position, the catheter hub abuts the distally facing surface of the distal wall of the blood collection holder, and the mating projection and the mating flange of the blood collection holder project into the interior of the catheter hub.

[0094] The needle extends through the catheter hub and the catheter body, and thus extends through a valve and a valve opener located inside the catheter hub. Since the needle provides a through connection from the distal needle tip to the proximal needle tip, the needle provides a through connection from the distal needle tip to the space between the proximal needle tip and the rubber shield in the interior space of the blood collection holder.

[0095] In the ready-to-use position, the needle guard is positioned along the needle. For example, the needle may project through an opening in the proximal wall of the needle guard. When the needle is retracted, a wrinkled portion or a contour change portion formed together with the needle may move proximally of the two distal walls at the ends of the two arms of the needle guard. When the needle moves further proximally, the wrinkled portion or the contour change portion may engage the opening in the proximal wall so as to hold the needle guard on the needle and not fall off distally of the needle tip.

[0096] The needle guard (which is understood to include structural features for protecting the needle tip from accidental needle sticks) is configured to be removed together with the needle after a successful venous puncture. The valve and the valve actuator are configured to remain together with the catheter hub, for example inside the catheter hub, for controlling the fluid flow therethrough.

[0097] In an exemplary embodiment, as further described in the incorporated reference of U.S. Patent No. 8,568,372, the profile change portion of the needle can be configured to engage an outer periphery that defines a proximal opening in the rear wall or proximal sidewall of the needle guard, such that the needle guard can be removed from the catheter hub together with the needle. The proximal sidewall of the needle guard can be slidably located between the position of the profile change portion and the proximal end of the needle. Thereby, the proximal sidewall of the needle guard can be prevented from crossing the profile change portion and being separated from the needle.

[0098] The assembly of the needle guard in the catheter hub can also be used to prevent rotation of the needle guard. The needle guard can be assembled in the catheter hub such that rotation of the needle guard relative to the catheter hub can be prevented or minimized.

[0099] The radially inner flat portion of the distal key portion of the blood collection holder can contact a portion of the needle guard. In an exemplary embodiment, the needle guard can have a corresponding proximal flat surface or edge for contacting the flat portion of the distal key portion.

[0100] The catheter hub can be spaced from the needle, and the needle guard covering the needle tip can be similar to the configuration that occurs after a successful venipuncture for activation and separation. After initially placing the catheter into a vein for blood sampling and then subsequently advancing for peripheral venous access, at the actuation position, the blood collection holder is separated from the catheter hub. After peripheral venous access, the needle is withdrawn proximally from the catheter body and the catheter hub.

[0101] When the needle is withdrawn from the catheter hub, the needle guard remains coupled to the needle and is withdrawn from the catheter hub together with the needle. The needle guard can cover the distal needle tip to prevent accidental needle sticks when the needle is withdrawn from the catheter hub, and a crimp or material accumulation near the distal needle tip on the needle prevents the needle guard from shifting distally away from the needle.

[0102] At least two procedures or methods of using the catheter and holder assembly of the present invention can be envisioned. Figures 6A-6D A first use procedure is shown, in which blood sampling is performed when the blood collection holder is mated to the catheter hub. Figures 7A-7C A second use procedure is shown, in which, before performing blood sampling, the catheter body is advanced into the patient's vein, thereby separating the blood collection holder from the catheter hub.

[0103] In the first use procedure of the catheter and holder assembly, blood sampling can be performed with the blood collection holder mated to the catheter hub such that the distal needle tip of the needle extends distally of the distal opening of the catheter body during blood sampling.

[0104] In the ready-to-use position, where the catheter and the holder assembly (which has a housing with a proximal opening sized and shaped to receive a vacuum blood collection tube) are mated to the catheter hub, as described elsewhere herein, the distal needle tip extends distally of the distal opening of the catheter body such that the distal needle tip can be used to access a vein, just like in a conventional blood collection procedure. Upon successful access to the vein, the distal needle tip and the distal end of the catheter body are located within the vein, thereby allowing the needle to provide fluid communication between the vein and the interior space of the blood collection holder, and in particular the proximal needle section of the needle having a second sharp needle tip, which second sharp needle tip is covered by a rubber sheath or shield to limit or prevent blood backflow into the interior space of the holder.

[0105] Then, the healthcare professional can hold the catheter assembly in a steady manner with one hand to avoid movement of the catheter assembly relative to the vein, thereby enabling blood collection. In some embodiments, the catheter hub may be provided with a pair of wings to facilitate securing the catheter hub to the patient after venipuncture. The pair of wings may be flanges that extend radially outward from the catheter hub and are flexible to contact the patient's skin.

[0106] When the blood collection holder, such as the distal end of the holder, is still in contact with the catheter hub, a vacuum blood collection tube can be inserted. Insertion of the vacuum blood collection tube can axially deform the rubber shield in the interior space of the blood collection holder such that the septum on the vacuum blood collection tube causes the rubber shield to deform distally past the proximal needle tip. When the vacuum blood collection tube is fully inserted, the proximal needle tip can pierce the septum of the vacuum blood collection tube and be inserted into the vacuum blood collection tube such that the interior of the vacuum blood collection tube can be in fluid communication with the needle lumen.

[0107] In the case where fluid connection is achieved through the needle, blood sampling can thus be performed using the vacuum blood collection tube while the blood collection holder remains mated to the catheter hub.

[0108] When removing the vacuum blood collection tube after successful blood sampling, the rubber shield can return to its ready-to-use position, thereby covering the proximal needle tip of the needle having two sharp ends and preventing blood from leaking through the proximal needle tip. The elastic deformation of the rubber shield allows repeated blood sampling by sequentially inserting additional vacuum blood collection tubes into the interior space of the holder, while also preventing blood leakage when each vacuum blood collection tube is removed from the blood collection holder.

[0109] After the last vacuum blood collection tube is removed from the retainer, the needle and the retainer can be retracted proximally away from the catheter hub. After successful blood sampling has been completed, a healthcare professional can advance the catheter hub and the catheter body to place the catheter body into a vein, as is typically done in accordance with a peripheral IV catheter (PIVC) procedure. In this way, the healthcare professional can maintain the position of the blood collection retainer relative to the vein and thereby maintain the position of the needle relative to the vein, and advance the catheter body into the vein by moving the catheter hub in the distal direction.

[0110] As the catheter hub and the catheter body are advanced, the healthcare professional can completely remove the blood collection retainer and the needle attached to the retainer from the catheter hub by retracting the blood collection retainer in the proximal direction relative to the catheter hub.

[0111] Optionally, the last vacuum blood collection tube used with the body of the blood collection retainer can remain with the blood collection retainer when the blood collection retainer is retracted from the catheter hub. Then, the last vacuum blood collection tube can be removed from the blood collection retainer before or after separating the retainer from the catheter hub.

[0112] After successful venipuncture, when the hollow needle is withdrawn from the catheter hub, a profile change portion (e.g., by pleating) disposed near the distal needle tip and having the form of a radially protruding portion on the hollow needle engages with the safety shield such that the safety shield can be removed from the catheter hub together with the needle. The safety shield can then act as a shield or cover the distal needle tip as the needle is withdrawn from the catheter hub.

[0113] In an exemplary embodiment, the safety shield can have two arms that can move to cover the distal needle tip. When the distal needle tip moves proximally past the distal sidewalls of the two arms, the two arms are no longer biased by the needle and can move, e.g., elastically move or deflect radially to disengage from the interior of the catheter hub. When the arms of the safety shield move radially, the distal sidewall or sidewalls of the arms can cover the needle tip to prevent accidental needlesticks. That is, the distal sidewall can move from a position lateral to the needle tip to a position distal to the needle tip to prevent accidental needlesticks.

[0114] In some examples, the needle shield can have only one arm and one distal sidewall at the end of the one arm. In other examples, the profile change portion can include a sleeve, notch, or material buildup on the shaft of the needle. Using a needle with a notch near the distal end allows visualization of blood return in the annular space between the needle and the catheter body. Further information regarding the safety shield is discussed in U.S. Patent No. 7,736,339, the content of which is hereby expressly incorporated by reference.

[0115] After the needle is removed following successful catheter insertion, one or more flaps of the valve located within the catheter hub close one or more slits through the depth of the valve disc or valve plate due to their elastic properties, such that blood cannot or substantially cannot flow from the catheter body into the proximal chamber of the catheter hub and out through the proximal opening of the catheter hub. In this way, the valve prevents further blood spillage or flow.

[0116] Accordingly, the process described herein can provide blood sampling and catheter insertion for IV infusion in only one needle puncture using the catheter and holder assembly of the present invention. In contrast, prior art procedures can involve a first needle puncture using a blood collection needle to collect blood, and then, after blood collection and after the blood collection needle is removed, the procedure can involve a second needle puncture for PIVC access for IV infusion. In this embodiment, the blood collection holder has an integral needle hub for securing the needle, the needle having two sharp needle tips, namely a distal needle tip and a proximal needle tip. The blood collection holder also includes a housing or body attached to the needle hub, or in other words, the needle hub is attached to the body of the blood collection holder. The housing is generally cylindrical and has an interior sized and shaped to receive a vacuum blood collection tube. The proximal needle tip can be positioned within the interior of the housing for piercing the septum on the vacuum blood collection tube to provide fluid communication between the distal needle tip, the needle lumen, the proximal needle tip, and the interior of the vacuum blood collection tube when the needle is not obscured by a rubber sheath or shield.

[0117] A second use process of the catheter and holder assembly of the present invention includes performing blood sampling after a healthcare professional has advanced the catheter body into the patient, similar to normal PIVC access, but before the needle is completely removed from the catheter body lumen. Thus, blood sampling can be performed after the blood collection holder has been separated from the catheter hub, but before the needle attached to the blood collection holder is completely removed from the catheter body.

[0118] In the use-ready position where the blood collection holder is mated to the catheter hub, the distal needle tip extends distally of the distal opening of the catheter body such that the distal needle tip can be used to access a vein. Then, as the catheter body is further advanced into the vein, the distal needle tip retracts proximally of the distal opening of the catheter body. At this time, first and second backflows can be confirmed. When the catheter body is further within the vein and the needle is retracted in the proximal direction but has not completely exited the lumen of the catheter body, the needle remains in fluid communication between the vein and the interior space of the blood collection holder, such as leading to the proximal needle tip.

[0119] Then, prior to blood sampling, a healthcare professional may advance the catheter body partially or fully into a patient's vein. Optionally, a tourniquet may be used with the catheter and holder assembly of the present invention, as is conventional practice. When not permitted, for example, under the restrictions of certain local regulations, the tourniquet may not be used, and if used when not permitted, the first bottle or evacuated blood collection tube may need to be discarded.

[0120] Then, a healthcare professional may hold the catheter assembly steady enough with one hand to prevent the catheter assembly from moving relative to the vein. In some embodiments, the catheter hub may be provided with a pair of wings to facilitate securing the catheter hub to the patient after venipuncture. The pair of wings may be flanges that extend radially outward from the catheter hub and are flexible to contact the patient's skin.

[0121] In the case where the catheter hub is advanced to advance the catheter body into the vein and the needle retracts proximally during advancement of the catheter body, the blood collection holder and the catheter hub may be separated or physically spaced apart along the axial direction of the needle while still being coupled through the lumen of the needle and the catheter body. In the preparation sampling position, the needle fixed to the blood collection holder may still be in the patient's vein, or may be recessed from the distal opening of the catheter body and located within the lumen of the catheter body such that the needle in fluid communication with the lumen of the catheter body provides a fluid connection between the vein and the proximal needle tip.

[0122] In practice, the advancement of the catheter hub in the case where the distal needle tip is recessed or retracted proximally from the distal opening of the catheter body may be used as a safeguard to prevent the accidental advancement of the needle within the patient.

[0123] After the blood collection holder is retracted from the catheter hub, an evacuated blood collection tube may be inserted into the blood collection holder, but wherein the needle remains in fluid communication with the catheter body. Insertion of the evacuated blood collection tube may axially deform a rubber shield or MSLA within the internal space of the blood collection holder such that the rubber shield deforms distally past the proximal needle tip to expose the needle tip. When the evacuated blood collection tube is fully inserted, the proximal needle tip may pierce the septum and be inserted into the evacuated blood collection tube such that the evacuated blood collection tube may be in fluid connection with the proximal needle tip.

[0124] Using the fluid connection between the evacuated blood collection tube and the needle, blood sampling may thus be performed via the needle while the blood collection holder remains mated to the catheter hub.

[0125] After a successful blood draw, when removing the evacuated blood collection tube, the rubber shield can return to its ready-to-use position, covering the proximal needle tip and preventing blood from leaking through the needle and out of the proximal opening of the catheter hub. The elastic deformation of the rubber shield allows repeated blood draws with multiple evacuated blood collection tubes while also preventing blood leakage when each evacuated blood collection tube is removed from the blood collection holder.

[0126] After a successful blood draw has been completed, the healthcare professional can then remove the blood collection holder and attached needle from the catheter hub. The healthcare professional can also completely remove the blood collection holder and needle from the catheter hub by axially retracting the blood collection holder in a proximal direction relative to the catheter hub.

[0127] When withdrawing the hollow needle from the catheter hub after a successful venipuncture, a profile change portion (e.g., by pleating) disposed near the distal needle tip and having the form of a radially projecting portion on the hollow needle engages the safety shield such that the safety shield can be removed from the catheter hub with the needle, as previously described elsewhere herein. The safety shield can then act as a shield or cover the distal needle tip of the needle as the needle is withdrawn from the catheter hub.

[0128] After removing the needle following a successful catheter insertion, one or more flaps of the valve close one or more slits through the depth of the valve disk or valve disc due to their elastic properties such that blood cannot or substantially cannot flow out through the proximal opening of the catheter hub. Thus, the catheter hub can prevent further blood loss or flow.

[0129] Accordingly, using the catheter and holder assembly of the present invention, the described process can provide blood sampling and catheter insertion with only one needle stick. In contrast, prior art devices require a first needle stick with a blood sampling device to obtain a blood sample via an evacuated blood collection tube. After the desired number of samples (e.g., tubes) have been obtained, the blood sampling device is then removed from the patient. A second needle stick is then performed with a catheter assembly to obtain peripheral IV access.

[0130] After a successful venipuncture, the catheter hub can then be connected to an infusion line. However, the catheter and holder according to some aspects of the present invention can perform the blood sampling function and peripheral IV access with only a single needle stick. Accordingly, this assembly reduces waste by using fewer components and at least one less needle and reduces the number of needle sticks to one, which can minimize needle stick injuries and potential patient stress due to potentially receiving more than one needle stick.

[0131] In an alternative embodiment, a raised cap may be included that surrounds the mating flange, with a gap or space therebetween. As previously described, the mating flange is configured to project into the catheter hub. A stop projection may be provided on the inner surface of the raised cap. The size and shape of the raised cap may be designed to project around the outside of the catheter hub at the proximal end of the catheter hub, and the mating flange is configured to project into the proximal opening of the catheter hub. The raised cap may prevent the catheter hub from being accidentally or prematurely detached from the blood collection holder during cannulation and blood sampling. An accidental detachment of the catheter hub and the blood collection holder may be unpleasant for the healthcare professional and create a risk of unintentional needle movement when the healthcare professional adjusts the relative movement of the catheter hub.

[0132] To prevent accidental movement, the blood collection holder may have a raised cap that may be a cylindrical projection extending distally from the distal wall of the blood collection holder. The cylindrical projection may have a wall structure that is radially outwardly spaced from the mating flange such that the raised cap and the mating flange are concentric with each other, and the raised cap extends distally from the distal wall to cover the proximal portion of the catheter hub when mated with the blood collection holder.

[0133] In an example, the outer surface of the raised cap may also be shaped, for example, to include claws, engagement features, interference surfaces, to engage a protective sheath placed on the catheter assembly during encapsulation and transportation in cases where the catheter assembly and the blood collection holder are encapsulated as a single assembly.

[0134] On the inner surface of the raised cap, the stop projection may extend radially inwardly from the inner surface. The stop projection may be a single convex lip or ridge or annular projection formed around the inner circumference of the raised cap. Optionally, the stop projection may be discontinuous and formed around the inner circumference by providing a plurality of spaced-apart individual ridges. The stop projection is configured to contact a rear external feature or surface of the catheter hub (such as the external threads of the catheter hub) to limit relative movement.

[0135] In another alternative embodiment of the blood collection holder, a raised cover is formed around a mating flange and has two stop protrusions disposed on the inner surface with a space or gap between the two stop protrusions. The cover protrusion of this embodiment may include a second stop protrusion located axially further away from the distal wall of the blood collection holder, or spaced distally from the distal wall of the blood collection holder, and spaced from the first stop protrusion. Similar to the first stop protrusion, the second stop protrusion may be a single lip or ridge or annular protrusion formed around the inner circumference of the raised cover. Alternatively, the second stop protrusion may be discontinuous and formed around the inner circumference by providing a plurality of spaced-apart individual protrusions. The second stop protrusion may be radially aligned with the first stop protrusion. Alternatively, the second stop protrusion may be radially offset along the circumference of the interior of the cover protrusion.

[0136] By using the second stop protrusion, even if the catheter hub accidentally moves over the first stop protrusion, the catheter hub can be held by the second stop protrusion. The second stop protrusion can be regarded as a backup of the first stop protrusion. This embodiment can be regarded as a blood collection holder having two separate stoppers or one stopper with a backup stopper.

[0137] The first stop protrusion and the second stop protrusion can have the same size and the same shape. Alternatively, the first stop protrusion and the second stop protrusion can have different sizes so that different levels of force can be applied to the catheter hub so that different levels of force are required to overcome the two stop protrusions. For example, by including a surface structure or lip that is further inward from the inner surface of the raised cover than the first stop protrusion, the second stop protrusion can require a higher separation force than the first stop protrusion.

[0138] Additional stop tabs, such as more than two rows of stop tabs, may be provided to provide additional resistance to the catheter hub from separating from the blood collection holder. Additionally, alternative forms of stop tabs may be used. Although the exemplary embodiment uses a dome-shaped, annular lip, raised or ridged stop tab, the stop tab may alternatively have other geometric shapes, such as rectangular, different shapes, claws, relatively sharp gripping structures such as barbs, etc., or may be an arcuate flange on the interior of the cover protrusion. The stop tabs may have different shapes from one another.

[0139] In yet another alternative embodiment, the body of the catheter hub is provided with side fluid ports and tubing, also referred to as an integrated catheter hub.The integrated catheter hub may include side fluid ports extending obliquely from the generally cylindrical body of the catheter hub.

[0140] The tubing can be connected to a side fluid port at its first end, and the opposite end of the tubing can be connected to a fluid adapter (such as a male or female needleless valve). A syringe without a needle can be attached to the fluid adapter and infuse a fluid such as a drug. The tubing can have a lumen for fluid flow and provide a fluid connection between the catheter hub 102 through the side fluid port and an external adapter.

[0141] The external adapter can be any type of conventionally known adapter, such as a Luer connector, a needleless connector, or a conventional vent plug. Blood flow can be blocked by a seal or diaphragm located at the proximal end of the catheter hub, where proximally, the side fluid port leads to the catheter hub, so as not to interfere with fluid flow through the side fluid port. IV fluid or other medicaments can flow into the catheter hub via the connection from the external fluid adapter through the tubing and through the side fluid port.

[0142] Additionally, the catheter hub of the present embodiment can have a pair of wings protruding from the body of the catheter hub to assist in fixation to a patient, such as an adhesive dressing.

[0143] An alternative blood collection holder can include a cap protrusion or a stop protrusion for use with an integral catheter hub. The side fluid port and the tubing can be arranged such that they do not interfere with the assembly of the raised cap when the blood collection holder mates with the integral catheter hub.

[0144] The operating procedure of a catheter assembly using an integral catheter hub can be the same as that described elsewhere herein.

[0145] In another alternative needle, the shaft of the needle can have a bending feature or a bending section for mating with a correspondingly shaped groove in the blood collection holder. The needle can have a bending feature or a bend at an intermediate position between the distal needle tip and the proximal needle tip. The bending feature can be a simple C-shaped bend such that the distal needle tip and the distal section of the needle shaft are axially aligned with the proximal needle tip and the proximal section of the needle shaft. Alternatively, the bend can be of a different shape, such as an S-shape or a complex shape.

[0146] The hole of the blood collection holder can similarly have a corresponding groove or shape for receiving or accommodating the bending section or the bend of the needle. The needle can be assembled and snapped into the corresponding groove or the corresponding bending feature of the blood collection holder. In some embodiments, the needle can be pushed into the corresponding groove by axial insertion.

[0147] In some embodiments, the blood collection holder can be a two-piece construction separated along the hole at least at the needle hub section of the holder such that the needle can be snapped into the corresponding groove before assembling the blood collection holder. The corresponding groove can have a profile corresponding to the bending section of the needle and a slight undercut feature, thus requiring a slight force to push the needle into the groove.

[0148] The combination of corresponding slots and bending features can sufficiently mechanically secure the cannula without the need for additional adhesives. Alternatively, even when using bending features and slots of corresponding shapes, an adhesive can be used or other bonding techniques (such as ultrasonic welding) can be used to bond the needle to the blood collection holder.

[0149] Methods of manufacturing and using the needle device and its components and parts are understood to be within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0150] These and other features and advantages of the present device, system, and method will become apparent as they are better understood with reference to the specification, claims, and drawings, in which:

[0151] Figure 1A is an exploded view of a catheter assembly with a valve and a blood collection holder.

[0152] Figure 1B Shows a cross-sectional view of the catheter hub taken along the axial direction, having a catheter body and a bushing and other components.

[0153] Figure 2 Shows a cross-sectional view of an embodiment of the blood collection holder.

[0154] Figure 3A and 3B Shows the needle and the blood collection holder in an attached or assembled configuration and their cross-sectional views.

[0155] Figure 4A and 4B Shows the catheter hub, the needle, and the blood collection holder in an attached or assembled configuration.

[0156] Figure 5 Shows an exploded cross-sectional view of an exemplary embodiment of the catheter assembly and a vacuum blood collection tube.

[0157] Figures 6A-6D Shows different stages of an embodiment of the catheter assembly for blood sampling and catheter insertion.

[0158] Figures 7A-7D Shows a second use process, in which blood sampling is performed after a medical professional has advanced the catheter into the patient's body

[0159] Figure 8A and 8B Shows an alternative embodiment of the blood collection holder with a cap protrusion and a stop protrusion.

[0160] Figure 9A and 9BShows another alternative embodiment of a blood collection holder having a lid projection and two stop projections.

[0161] Figure 10A And 10B Shows an alternative embodiment of a catheter hub, wherein the catheter hub is an integral catheter hub.

[0162] Figure 11A And 11B Shows an embodiment of a curved needle for attachment to a blood collection holder. Detailed Description

[0163] The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of the blood collection holder and IV catheter provided in accordance with some aspects of the present apparatus, system, and method, and is not intended to represent the only forms in which the present apparatus, system, and method may be constructed or utilized. The description sets forth the features and steps for constructing and using embodiments of the present apparatus, system, and method in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numerals are intended to indicate like or similar elements or features.

[0164] For two separate procedures of blood sampling and infusion therapy, there may be two sets of hazardous medical waste generated by the procedures. Additionally, in cases where blood sampling and infusion therapy are separate procedures performed on a patient, the patient may be subjected to at least two needle sticks.

[0165] Even in the case of using a syringe attached to the cannula hub of a PIVC, this requires the operator to attach and detach components. The need to add a hypodermic needle to the syringe to fill a vacuum blood collection tube further increases the likelihood of an accidental needle stick when connecting the hypodermic needle to the syringe filled with blood and manipulating the syringe with a needle at the end. It is important for healthcare professionals to minimize the risk of accidental needle sticks because of the prevalence of potentially fatal infectious diseases such as acquired immunodeficiency syndrome (AIDS) and hepatitis, which can be transmitted via body fluid exchange through accidental needle stick injuries caused by handling used needles.

[0166] Additionally, it is advantageous to minimize medical waste by reducing the number of medical devices or components used in different procedures. It is also advantageous to minimize the number of needle sticks a patient must undergo.

[0167] Embodiments of the present disclosure may allow for the use of a single needle, such that there will be one less needle for a healthcare professional to manipulate and one less syringe to discard. In terms of accidental needlesticks, by reducing the number of components that a healthcare professional must manipulate, the healthcare professional can also be exposed to a smaller risk.

[0168] Now referring to Figure 1A and 1B , components of a valved catheter assembly 100 with a blood collection holder 106 are shown. The IV catheter assembly 100 (which may more generally be referred to as a needle assembly or needle device) is shown to include a catheter body 104, a catheter hub 102, a needle 108, a rubber shield 252, and a blood collection holder 106. The catheter hub 102 may have a female Luer fitting at the proximal end for receiving a male Luer fitting in a Luer fit and optionally have external threads.

[0169] The catheter body 104 may be fixed to the catheter hub 102, for example, with a bushing or ferrule. Further description of the catheter hub 102 and the catheter hub 104 will be made with reference to Figure 1B below.

[0170] The needle 108 having a profile change portion 144 proximal to the distal needle tip 110 may be inserted through the proximal opening of the catheter hub 102, and the distal needle tip 110 projects from the distal opening 112 of the catheter body 104 in a ready-to-use position. The needle 108 may also have a proximal needle tip 200 at the end of the needle 108 opposite the distal needle tip 110. The profile change portion 144 may be a crimped portion, a material buildup portion, or a sleeve, configured to engage a needle guard and prevent the needle guard from shifting distally away from the needle. In some examples, the profile change portion may be omitted, and the needle guard may cover the needle tip without using the profile change portion.

[0171] The needle guard 132 ( Figure 1B) (which is understood to include structural features for shielding the needle tip from accidental needle sticks) is configured to be removed with the needle 108 after a successful venipuncture, while the valve 136 and valve actuator 134 are configured to remain with the catheter hub 102 for controlling fluid flow therethrough. The actuator 134 is configured to be pushed distally into the valve 136 by the male end of a medical implement, such as a syringe or IV connector, to open the valve for fluid flow. Further information regarding the needle guard 132 is discussed in U.S. Patent No. 8,568,372, the contents of which are expressly incorporated herein by reference. In alternative embodiments, the needle guard 132 may be embodied as a plurality of components that cooperate to block the needle tip from accidental needle sticks. For example, the needle guard may include a spring-loaded needle carrier having a needle attached thereto. After a successful venipuncture, the release tab may be pressed to release the spring, and then the needle carrier and needle are moved within the protective barrel to block the needle tip from accidental needle sticks. Further information regarding various aspects of the valved catheter assembly and components thereof are discussed in PCT patent applications PCT / EP2016 / 069619 and PCT / EP2016 / 069643 and U.S. Patent No. 9,114,231, the contents of which are expressly incorporated herein by reference.

[0172] A cannula hub or needle hub 106a may be incorporated at the distal end of the blood collection holder 106 to receive a needle 108, which may have a needle tip located distal to the needle hub and a second needle tip located inside the needle holder, the second needle tip being used to pierce the septum on the evacuated blood collection tube. Thus, when assembled with the catheter hub 102, the present assembly includes a catheter hub having a catheter tube body and a needle having two sharp needle tips at two opposing ends of the needle shaft. For example, the catheter hub may be provided with a catheter tube body, through which the needle may protrude and have a first sharp needle tip extending beyond a distal opening of the catheter tube body. The needle may have a proximal section extending proximally of a proximal opening of the catheter hub, and wherein the proximal section of the needle has a second sharp needle tip.

[0173] In this embodiment, the needle hub 106a is integrally formed with the body of the blood collection holder 106. For example, the needle hub may be molded together with the body of the holder. Figure 2 , Figure 3A and Figure 3BAdditional details related to the blood collection holder 106 and an associated rubber sleeve 252 (also referred to as a multi-sample luer adapter or MSLA) are described. In addition to the implementation structure for fixing the needle to the nose of the needle hub as described in the incorporated references, the size and shape of the blood collection holder 106 of this embodiment can be designed to receive a vacuum blood collection tube therein. For example and as further discussed below, the blood collection holder 106 can include a body section having an interior sized and shaped to receive a vacuum blood collection tube.

[0174] A rubber shield, deformable seal, or self-sealing needle sheath 252 (also referred to as MSLA) can be attached to the interior of the blood collection holder 106 at the second end of the needle ( Figure 3B ). In the ready-to-use position, prior to inserting the vacuum blood collection tube into the blood collection holder 106, the rubber shield 252 can axially surround the proximal end of the needle 108 and cover the proximal needle tip 200 of the needle 108. The rubber shield 252 ( Figure 1A ) can have a body 254, a proximal end 256, and a distal end 258. In an embodiment, the body 254 can be generally cylindrical. The self-sealing needle sheath 252 can be made of a rubber or polymeric material to allow deformation in the axial direction of the needle 108. The open distal end 258 of the self-sealing needle sheath 252 can be sized and shaped to snap-fit onto and be assembled with a base in the interior of the holder for use.

[0175] The body 254 and the distal end 258 of the rubber shield 252 can define an open interior space 260 and an open end leading into the open interior space. The body 254 can be defined by a sidewall having a thickness defined between its inner sidewall surface and its outer sidewall surface. The distal end 258 can have a flange 262 extending radially outward from the body. The distal end 258 having the flange 262 can have a radial thickness greater than the radial thickness of the body 254.

[0176] Alternatively, the body 254 can be formed into different geometries, such as but not limited to conical, frustoconical, pyramidal, frustopyramidal, prismatic, square, or rectangular. In the case of different geometries, the orientation of the geometry can be such that the body can elastically deform in the axial direction of the needle 108.

[0177] The proximal end 256 of the rubber shield 252 may include a covering that covers the interior 260 of the rubber shield 252. The proximal end 256 may be considered the sealed end of the rubber shield 252. The proximal end 256 may have a dome surface 264 to seal the proximal end of the rubber shield 252. Alternative shapes, such as a flat or conical surface, may also be used. A hole or slit may be pre-formed in the surface 264 of the proximal end 256 so that the needle 108 passes through when the rubber shield 252 is elastically deformed in the axial direction. If a hole is pre-formed, the size of the hole may be designed such that when the rubber shield is in the ready-to-use position and the needle 108 does not extend through the surface 264 of the proximal end 256, the surface tension of the blood from the patient prevents leakage or flow through the rubber shield 252. Alternatively, one or more slits may be pre-formed in the surface 264 such that the slits define two flaps in the surface 264. When the needle 108 is inserted through the surface 264 of the proximal end 256, the needle may be inserted into the slit and cause the flaps to separate from each other. When the needle 108 does not extend through the surface 264 of the proximal end 256, the flaps may seal against each other.

[0178] As further described below Figures 2-4B The blood collection holder 106 may carry a cannula hub 106a at its distal end. The blood collection holder 106 may have a generally cylindrical body 600. The blood collection holder 106 may have a distal wall 604 at one end of the body 600 and a side wall 607 that defines an interior space 620. In some embodiments, the distal wall or end wall 604 may be joined to the body 600 with a radius or rounded corner 606. A mating flange 610 may extend from the distal wall 604 in the distal axial direction. When assembled in the ready-to-use position, the size and shape of the mating flange 610 may be designed to project into the interior of the catheter hub 102, similar to the nose end of the needle hub of a standard catheter assembly. The mating flange 610 may be embodied as a cylindrical projection. In some cases, the mating flange 610 and the internal support post 630 may be molded as separate components that are removable from the end wall. For example, the combination of the mating flange 610 and the internal support post 630 may be screwed onto the end wall 604, pushed away from the end wall 604, etc. Optionally, the combination of the mating flange 610 and the internal support post 630 may be separated from the body 600 before or after use.

[0179] The mating flange 610 can have a mating flange opening 614 defined by the inner surface of the cylindrical protrusion. In some embodiments, the mating flange 610 can be a different geometry that keys to the corresponding internal shape of the catheter hub 102 to prevent the blood collection holder 106 from rotating relative to the catheter hub 102. In some embodiments, the cylindrical protrusion of the mating flange 610 can further include a mating protrusion or distal protrusion 612 that extends further distally from the mating flange 610. The mating protrusion 612 can have the same thickness as the thickness of the sidewall of the mating flange 610. In an embodiment, the mating protrusion 612 can have a surface configured to push the needle guard 132 into engagement with an internal engagement protrusion formed with the catheter hub when the blood collection holder 106 mates with the catheter hub 102. This allows the needle guard to remain in place during the needle retraction after the ready-to-use position and successful venipuncture to prevent early activation.

[0180] At an opposite end, such as the proximal end of the body 600, there can be an opening for receiving a vacuum blood collection tube into the internal space 620 of the blood collection holder 106. Near or at the proximal end of the body, a handle, flange, or gripping pad 602( Figure 1A ) can project radially outward from the body 600. The handle or flange 602 can be generally rectangular in shape. In some embodiments, the blood collection holder 106 can have one handle 602 that extends radially outward from the body 600. In other embodiments, the blood collection holder 106 can have two or more handles 602 that extend radially outward from the body 600. In the case of two or more handles 602, the handles can be equally spaced around the body 600 or can be spaced so as to be ergonomically comfortable for single-handed gripping of the blood collection holder 106.

[0181] Figure 1B A cross-sectional view of the catheter hub 102 taken along the axial direction is shown, having a catheter 104 and a bushing 138. The bushing 138 can be configured to squeeze the proximal end of the catheter body 104 against the inner wall surface of the catheter hub 102 to hold the catheter body 104 to the catheter hub 102. Inside the catheter hub 102, a septum or valve 136, an actuator or valve opener 134, and a needle guard 132, such as a safety shield or end protector, are provided. The catheter hub 102 can be made of a single hub body as shown, or of two or more hub bodies assembled together.

[0182] The septum or valve 136 may include at least one slit that defines an elastically deformable flap of the valve. The needle 108 may be inserted through the at least one slit such that the elastic flap can be expanded by the hollow needle and closed when the needle is removed. The size and shape of the valve may be designed for various uses by cooperating with a valve opener to open one or more slits of the valve for fluid flow and closing when removing a male Luer tip that is placed in the catheter hub to push the valve opener in the distal direction. In some examples, the flap may remain open and engage with the valve opener 134 in a single-use activation configuration. The number of slits that define the number of flaps may vary, from one slit to four or more slits that define two or more flaps (e.g., three or more flaps).

[0183] The catheter hub 102 may have a proximal end with an opening. The proximal end may also be provided with a female Luer fitting having external threads 103, forming a female threaded Luer. In some examples, the threads may be omitted and the proximal opening may be used as a female Luer slider.

[0184] Figure 1A The catheter hub 102 with a pair of wings is shown. Embodiments of the catheter hub may also include embodiments without wings.

[0185] Figure 2 is a cross-sectional view of an embodiment of a blood collection holder along Figure 1A line A-A therein. In the internal space 620 of the blood collection holder 106, an internal support post 630 extends proximally from the distal wall 604 into the internal space 620. The shape of the internal support post 630 may be generally cylindrical or conical, extending from the axial center of the blood collection holder 106. The internal support post 630 may include a distal section 630a and a proximal section 630b. The distal section 630a, which is closer to the distal wall or end wall 604, may have a first outer diameter that is a larger diameter than the second outer diameter of the proximal section 630b. The transition of the outer diameter from the distal section 630a to the proximal section 630b may be stepped or tapered. The size of the first outer diameter of the distal section 630a may be designed to correspond to the inner diameter of the rubber shield 252 to fix the rubber shield 252 to the distal section 630a. Since the rubber shield 252 may be elastically deformable and stretchable, the first outer diameter may be larger than the inner diameter of the rubber shield 252 when the rubber shield is in its relaxed state. Thus, the rubber shield 252 can be fitted onto the distal section 630a to fix the rubber shield 252 to the distal section 630a. In some embodiments, the proximal section 630b may have a second outer diameter that is smaller than the smaller inner diameter of the rubber shield 252. When the rubber shield 252 is compressed axially towards the distal wall 604, the smaller second outer diameter of the proximal section 630b may allow space to accommodate the elastic deformation of the rubber shield 252.

[0186] The hole 632 can extend through the inner support post 630 and into the mating flange opening 614. The size and shape of the hole 632 can be designed to accommodate the needle 108. The size of the hole 632 can be designed to have an interference press fit with the needle 108 and / or can include a clearance or glue well sufficient for an adhesive to secure the needle 108 to the hole 632. The hole 632 extends through the needle hub 106a and the inner support post 630.

[0187] Figure 3A and 3B The needle 108 and the blood collection holder 106 are shown in an attached configuration. Figure 3A A perspective view of the needle 108 and the blood collection holder 106 in an attached configuration is shown. Figure 3B Shown is Figure 3A A cross-sectional view taken along the axis of the needle assembly of an embodiment of. The blood collection holder 106 can cooperate with the needle 108 and the rubber shield 252. The rubber shield 252 can cooperate with the inner support post 630 and extend proximally from the distal wall or end wall 604 into the inner space 620. The inner support post 630 can include a distal section 630a and a proximal section 630b. The distal section 630a of the inner support post 630 that is closer to the distal wall 604 can have a first outer diameter that is a larger diameter than the second outer diameter of the proximal section 630b.

[0188] In some embodiments, the rubber shield 252 can be elastically deformable and stretchable such that when the rubber shield is in its relaxed state, the first outer diameter of the distal section 630a can be greater than the inner diameter of the rubber shield 252. Thus, the rubber shield 252 can be fitted over the distal section 630a to secure the rubber shield 252 to the distal section 630a. In other embodiments, the rubber shield 252 can have a rigid structure near its distal end 258 and have an interference fit with the first outer diameter of the distal section 630a.

[0189] The rubber shield 252 can be assembled such that the flange 262 of the rubber shield 252 abuts the distal wall 604. Additionally, the rubber shield 252 can be secured to the distal section 630a by a mechanical means such as a clip, barb, claw or by an adhesive. In some embodiments, the rubber shield 252 can have a loose fit on the distal section 630a and be secured by a clip, barb, claw or adhesive. This can facilitate easier assembly.

[0190] The transition of the outer diameter from the distal section 630a to the proximal section 630b can be stepped or tapered. Proximally of the distal section 630a, the proximal section 630b of the inner support post can have a second outer diameter that is smaller than the first outer diameter of the distal section 630a. When the rubber shroud 252 is compressed axially towards the distal wall 604 due to the insertion of the vacuum blood collection tube into the blood collection holder 106, the smaller second outer diameter of the proximal section 630b can allow room to accommodate the elastic deformation of the rubber shroud 252.

[0191] The proximal needle tip 200 can be located inside the rubber shroud 252. Thus, the proximal needle tip 200 is located at an intermediate position between the inner support post 630 and the proximal end 256 of the rubber shroud 252. Thus, the rubber shroud 252 surrounds the proximal needle tip 200, separating the proximal needle tip 200 from the rest of the internal space 620 of the blood collection holder 106.

[0192] Thus, in the ready-to-use position, the rubber shroud 252 can serve as a sanitary shield to prevent contamination of the proximal needle tip 200 and to seal the needle during replacement of the vacuum blood collection tube with a new or different vacuum blood collection tube, preventing blood backflow. When the vacuum blood collection tube is inserted into the internal space 620 of the blood collection holder, the vacuum blood collection tube (e.g., the diaphragm on the vacuum blood collection tube) can axially compress and elastically deform the proximal end 256 of the rubber shroud 252 towards the distal wall 604. The proximal end 256 of the rubber shroud 252 can elastically deform past the proximal needle tip 200 such that the proximal needle tip 200 extends proximally of the proximal end 256 of the rubber shroud 252 and into the vacuum blood collection tube, e.g., through the diaphragm of the vacuum blood collection tube.

[0193] At the distal end of the aperture 632, the mating flange 610 extends distally of the distal wall 604 of the blood collection holder. The cylindrical protrusion of the mating flange 610 can also include a mating protrusion or distal protrusion 612 that extends further distally from the mating flange 610. The mating protrusion 612 can include a main proximal portion 612a, an arcuate section that extends further distally from the cylindrical protrusion of the mating flange 610. The mating protrusion 612 can have a distal key portion 612b that extends distally from the main proximal portion 612a. The distal key portion 612b can have an outer arcuate shape similar to the main proximal portion 612a and the mating flange 610. The distal key portion 612b can have a radially inner flat portion to set the needle guard 132 in the catheter hub, as described below with reference to Figure 4B as described.

[0194] Figure 4A and 4BShown is the catheter hub 102, the needle 108, and the blood collection holder 106 in an attached or assembled configuration, which may be referred to as a peripheral intravenous catheter assembly 85 capable of collecting blood or a catheter and holder assembly 85. Figure 4A A perspective view is shown of the catheter hub 102, the needle 108, and the blood collection holder 106 in an attached or assembled configuration. In the assembled, ready-to-use position of the attached configuration, the catheter hub 102 abuts the distally facing surface of the distal wall 604 of the blood collection holder 106. The needle 108 extends through the catheter hub 102 and the catheter body 104, with the needle tip 110 extending distally of the catheter body opening.

[0195] Figure 4B Shown is Figure 4A a cross-sectional view of an embodiment taken along a plane extending in the longitudinal direction of the needle assembly.

[0196] Figure 4B A cross-sectional view is shown of the needle assembly in an assembled, ready-to-use position. In the ready-to-use position, the catheter hub 102 abuts the distally facing surface of the distal wall 604 of the blood collection holder 106, and the mating protrusion 612 and the mating flange 610 of the blood collection holder 106 project into the interior of the catheter hub 102.

[0197] The needle 108 extends through the catheter hub 102 and the catheter body 104, and thus through the valve 136 and the valve opener 134 located within the catheter hub 102. Since the needle 108 provides a through connection, a flow lumen, from the distal needle tip 110 to the proximal needle tip 200, the needle 108 provides a through connection from the distal needle tip 110 to the space between the proximal needle tip 200 and the rubber shield 252 within the interior space 620 of the blood collection holder.

[0198] In the ready-to-use position, the needle guard 132 is positioned along the needle 108. For example, the needle may project through an opening in the proximal wall of the needle guard. When the needle is retracted, a wrinkled portion or profile change 144 formed with the needle 108 may move proximally of the two distal walls at the ends of the two arms of the needle guard. When the needle moves further proximally, the wrinkled portion or profile change may engage the opening in the proximal wall to hold the needle guard 132 on the needle and prevent it from falling off distally of the needle tip.

[0199] The needle guard 132 (which is understood to include structural features for protecting the needle tip from accidental needlesticks) is configured to be removed with the needle 108 after a successful venous puncture. The valve 136 and the valve actuator 134 are configured to remain with the catheter hub 102, for example, within the interior of the catheter hub, for controlling fluid flow therethrough.

[0200] In an exemplary embodiment, as further described in the incorporated reference of U.S. Patent No. 8,568,372, the profile-changing portion 144 of the needle 108 can be configured to engage the outer periphery defining the proximal opening on the rear wall or the proximal side wall of the needle guard 132, such that the needle guard 132 can be removed from the catheter hub 102 together with the needle 108. The proximal side wall of the needle guard 132 is slidably positioned between the location of the profile-changing portion 144 and the proximal end of the needle 108. Thus, the proximal side wall of the needle guard 132 can be prevented from passing over the profile-changing portion 144 and from separating from the needle 108.

[0201] The assembly of the needle guard 132 in the catheter hub 102 can also be used to prevent rotation of the needle guard 132. The needle guard 132 can be assembled in the catheter hub 102 such that rotation of the needle guard 132 relative to the catheter hub 102 can be prevented or minimized.

[0202] The radially inner flat portion of the distal key portion 612b of the blood collection holder 106 can contact a portion of the needle guard 132. In an exemplary embodiment, the needle guard 132 can have a corresponding proximal flat surface or edge for contacting the flat portion of the distal key portion 612b.

[0203] Figure 5 An exploded cross-sectional view of an exemplary embodiment of the catheter assembly 100 and the vacuum blood collection tube 900 having a septum 902 is shown. The catheter hub spaced from the needle and the needle guard covering the needle tip are similar to the configuration that occurs upon activation and separation after a successful venipuncture. Further description of the operation of the catheter assembly 100 and the actuation position when the needle 108 is withdrawn from the catheter hub 102 can be found below with reference to Figure 6D and 7C found.

[0204] After initially placing the catheter into a vein for blood sampling and then subsequently advancing for peripheral vein access, at the actuation position, the blood collection holder 106 is separated from the catheter hub 102. After peripheral vein access and after blood sampling, the needle is withdrawn proximally from the catheter body 104 and the catheter hub 102. When the needle 108 is withdrawn from the catheter hub 102, the needle guard 132 remains coupled to the needle 108 and is withdrawn from the catheter hub 102 together with the needle. The needle guard 132 can cover the distal needle tip 110 to prevent accidental needle sticks when the needle 108 is withdrawn from the catheter hub 102, and the crimped portion or material buildup near the distal needle tip on the needle prevents the needle guard from shifting distally away from the needle.

[0205] At least two processes or methods of using the catheter and holder assembly 85 can be envisioned. Figures 6A-6DIllustrates a first use process, in which blood sampling is performed when the blood collection holder 106 is mated with and in contact with the catheter hub 102. Figures 7A-7C Illustrates a second use process, in which, before blood sampling, the catheter body 104 is advanced into the patient's vein, so that the blood collection holder 106 is separated from the catheter hub 102, spacing the holder apart from the catheter hub 102.

[0206] First, referring to Figures 6A-6D , illustrates a first use process of the catheter and holder assembly 85, which shows different stages of the assembly, configured for blood sampling and catheter insertion. In the illustrated configuration, blood sampling can be performed with the blood collection holder 106 mated to the catheter hub 102, such that the distal needle tip 110 of the needle extends distally of the distal opening of the catheter body 104 during blood sampling.

[0207] Figure 6A Illustrates the catheter and holder assembly 85 in a ready-for-use position, with the blood collection holder 106 mated to the catheter hub 102, the blood collection holder 106 having a housing with a proximal opening sized and shaped to receive a vacuum blood collection tube. In the ready-for-use position, as described with respect to FIGS. 1 - 5, the distal needle tip 110 extends distally of the distal opening of the catheter body 104, such that the distal needle tip 110 can be used to access a vein, as in a conventional blood collection procedure. After successfully accessing the vein, the distal needle tip 110 and the distal end of the catheter body 104 are within the vein, allowing the needle 108 to provide fluid communication between the vein and the interior space 620 of the blood collection holder 106, and in particular the proximal needle section of the needle having a second sharp needle tip 200, which is covered by a rubber sheath or shield 252 to limit or prevent blood from flowing back into the interior space of the holder 106( Figure 4B ).

[0208] Then, a healthcare professional can hold the catheter assembly 100 in a steady manner with one hand to avoid movement of the catheter assembly 100 relative to the vein, enabling blood collection. In some embodiments, the catheter hub 102 may be provided with a pair of wings 120 to facilitate securing the catheter hub 102 to the patient after venipuncture. The pair of wings may be flanges extending radially outward from the catheter hub 102 and are flexible to contact the patient's skin.

[0209] Figure 6B Illustrates blood sampling by inserting a vacuum blood collection tube 900 into the interior space 620 of the blood collection holder 106. The vacuum blood collection tube 900 is inserted while the blood collection holder 106 (e.g., the distal end of the holder) remains in contact with the catheter hub 102. As with respect to Figure 3BAs described, the insertion of the vacuum blood collection tube 900 can axially deform the rubber shield 252 ( Figure 4B ) in the internal space 620 of the blood collection holder 106, causing the diaphragm 902 on the vacuum blood collection tube 900 to deform the rubber shield 252 distally beyond the proximal needle tip 200. When the vacuum blood collection tube 900 is fully inserted, the proximal needle tip 200 can pierce the diaphragm 902 of the vacuum blood collection tube 900 and insert into the vacuum blood collection tube 900, such that the interior of the vacuum blood collection tube 900 can be in fluid communication with the needle lumen.

[0210] In the case of achieving fluid connection through the needle 108, blood sampling can thus be performed using the vacuum blood collection tube 900 while the blood collection holder 106 remains engaged and in contact with the catheter hub 102.

[0211] When the vacuum blood collection tube 900 is removed after successful blood sampling, the rubber shield 252 can return to its ready-to-use position, thereby covering the proximal needle tip 200 of the needle with two sharp ends and preventing blood from leaking through the proximal needle tip 200. The elastic deformation of the rubber shield 252 allows repeated blood sampling by sequentially inserting additional vacuum blood collection tubes 900 into the internal space 630 of the holder 106, while also preventing blood leakage when each vacuum blood collection tube is removed from the blood collection holder 106.

[0212] After the last vacuum blood collection tube 900 is removed from the holder 106, the needle 108 and the holder 106 can be retracted proximally away from the catheter hub 102. Figure 6C Shows the position after blood sampling when a healthcare professional advances the catheter body into a vein for catheter insertion. After successful blood sampling has been completed, the healthcare professional can advance the catheter hub 102 and the catheter body 104 to place the catheter body into the vein, as is typically done according to the peripheral IV catheter (PIVC) procedure. In this way, the healthcare professional can maintain the position of the blood collection holder 106 relative to the vein and thereby maintain the position of the needle 108 relative to the vein, and advance the catheter body into the vein by moving the catheter hub in the distal direction.

[0213] When the catheter hub 102 and the catheter body 104 are advanced, the healthcare professional can completely remove the blood collection holder 106 and the needle 108 attached to the holder from the catheter hub 102 by retracting the blood collection holder 106 proximally relative to the catheter hub 102.

[0214] Figure 6DFigure 100 shows the catheter assembly 100 after successful catheter insertion and separation of the blood collection holder 106 from the catheter hub 102. Additionally, the filled vacuum blood collection tube 900 from a previous blood sampling procedure is not shown. Optionally, the last vacuum blood collection tube 900 may remain attached to the blood collection holder 106 as the blood collection holder 106 is retracted from the catheter hub 102. The last vacuum blood collection tube may then be removed from the blood collection holder 106. In other words, with the vacuum blood collection tube 900 either in or out of the holder, the needle 108 and the holder 106 may be removed from the catheter body and the catheter hub.

[0215] After successful venipuncture, when the hollow needle 108 is withdrawn from the catheter hub 102, a profile change portion 144 (e.g., by pleating) disposed near the distal needle tip 110 and having the form of a radially projecting portion on the hollow needle engages the safety shield 132 such that the safety shield 132 can be removed from the catheter hub 102 together with the needle 108. The safety shield 132 can then act as a shield or cover the distal needle tip 110 of the needle 108 as the needle 108 is withdrawn from the catheter hub 102.

[0216] In an exemplary embodiment, the safety shield 132 may have two arms that can move to cover the distal needle tip 110. When the distal needle tip 110 moves proximal to the distal sidewalls of the two arms, the two arms are no longer biased by the needle and can move, e.g., radially elastically move or deflect to disengage from the interior of the catheter hub 102. When the arms of the safety shield 132 move radially, the arm or the distal sidewalls of the arms can cover the needle tip 110 to prevent accidental needlesticks. That is, the distal sidewalls can move from a position lateral to the needle tip to a position distal to the needle tip to prevent accidental needlesticks. In some examples, the needle shield 132 may have only one arm and one distal sidewall at the end of the one arm. In other examples, the profile change portion may include a sleeve, a notch, or a material buildup on the shaft of the needle. Using a needle with a notch near the distal end allows visualization of blood return in the annular space between the needle and the catheter body. Further information regarding the safety shield 132 is discussed in U.S. Patent No. 7,736,339, the content of which is expressly incorporated herein by reference.

[0217] After removing the needle 108 following successful catheter insertion, one or more flaps of the valve 136 located inside the catheter hub 102 close one or more slits through the depth of the valve disk or valve plate due to their elastic properties such that blood cannot or substantially cannot flow from the catheter body 104 into the proximal chamber of the catheter hub 102 and out through the proximal opening of the catheter hub 102. Thus, the valve 136 prevents further blood spillage or flow.

[0218] Therefore,Figures 6A-6D The process described in Figures 6A-6D can provide blood sampling and catheter insertion for IV infusion with only one needle puncture using the catheter and holder assembly 85 of the present invention. In contrast, prior art procedures can involve a first needle puncture using a blood collection needle to collect blood, and then, after blood collection and after the blood collection needle is removed, the procedure can involve a second needle puncture for PIVC access for IV infusion. In this embodiment, as previously described, the blood collection holder 106 has an integral needle hub 106a ( Figure 1A ) for securing the needle 108, which has two sharp needle tips, namely a distal needle tip 110 and a proximal needle tip 200. The blood collection holder 106 also includes a housing or body 600 attached to the needle hub 106a, or in other words, the needle hub 106a is attached to the body of the blood collection holder 106. The housing is generally cylindrical and has an interior sized and shaped to receive a vacuum blood collection tube. The proximal needle tip 200 can be positioned inside the housing 600 for piercing the septum 902 on the vacuum blood collection tube to provide fluid communication between the distal needle tip 110, the needle lumen, the proximal needle tip 200, and the interior of the vacuum blood collection tube 900 when the needle is not covered by a rubber sheath or shield.

[0219] Figures 7A-7D A second use process of the catheter and holder assembly 85 is shown, in which blood sampling is performed after the healthcare professional has advanced the catheter tube body 108 into the patient's body, similar to normal PIVC access, but before the needle is completely removed from the catheter tube lumen. Thus, blood collection can be performed after the blood collection holder 106 has been separated from the catheter hub 102, but before the needle 108 attached to the blood collection holder 106 is completely removed from the catheter tube body.

[0220] Figure 7A The catheter and holder assembly 85 is shown in the ready-to-use position, with the blood collection holder 106 fitted into the catheter hub 102. In the ready-to-use position, as described with respect to FIGS. 1-5, the distal needle tip 110 extends distally of the distal opening 112 of the catheter tube body 104 such that the distal needle tip 110 can be used to access a vein. Then, as the catheter tube body is further advanced into the vein, the distal needle tip 110 retracts proximally of the distal opening 112 of the catheter tube body 104. At this time, primary and secondary blood returns can be confirmed. When the catheter is further within the vein and the needle is retracted in the proximal direction but has not completely exited the lumen of the catheter tube body 104, the needle 108 remains in fluid communication between the vein and the internal space 620 of the blood collection holder 106, such as through to the proximal needle tip 200.

[0221] Then, prior to blood sampling, a healthcare professional may advance the catheter body 104 partially or fully into the patient's vein. Optionally, for Figures 6A-6D the procedures of Figures 6A-6D or 7A - 7D, a tourniquet may be used with the catheter and holder assembly 85 of the present invention as is conventional practice. When not permitted, for example, due to certain local regulations, the tourniquet may not be used, and if used when not permitted, the first bottle or vacuum blood collection tube may need to be discarded.

[0222] Then, the healthcare professional may hold the catheter assembly 100 steadily enough with one hand to prevent the catheter assembly 100 from moving relative to the vein. In some embodiments, the catheter hub 102 may be provided with a pair of wings 120 to facilitate fixing the catheter hub 102 to the patient after venipuncture. The pair of wings may be flanges that extend radially outward from the catheter hub 102 and are flexible to contact the patient's skin.

[0223] Figure 7B The ready - to - sample position of the catheter and holder assembly is shown after the catheter body 104 has been advanced partially or normally fully into the vein. In the case where the catheter hub 102 is advanced to advance the catheter body 104 and the needle retracts proximally during the advancement of the catheter body, the blood collection holder 106 and the catheter hub 102 may be separated or physically spaced apart along the axial direction of the needle while still being connected through the lumen of the needle 108 and the catheter body. In the ready - to - sample position, the needle 108 fixed to the blood collection holder 106 may still be in the patient's vein or may be recessed from the distal opening of the catheter body and located within the lumen of the catheter body such that the needle in fluid communication with the lumen of the catheter body provides a fluid connection between the vein and the proximal needle tip 200.

[0224] In practice, the advancement of the catheter hub 102 in the case where the distal needle tip 110 is recessed or retracted proximally from the distal opening of the catheter body can be used as a safeguard to prevent the accidental advancement of the needle 108 within the patient.

[0225] Figure 7C Blood sampling is shown by inserting the vacuum blood collection tube 900 into the internal space 620 of the blood collection holder 106 such that the proximal needle tip 200 pierces the septum on the vacuum blood collection tube to open fluid communication with the interior of the vacuum blood collection tube. After the blood collection holder 106 is retracted from the catheter hub 102, the vacuum blood collection tube 900 is inserted into the blood collection holder 106, but where the needle remains in fluid communication with the catheter body. As referred to Figure 3BAs described above, the insertion of the vacuum blood collection tube 900 can axially deform the rubber shield 252 in the internal space 620 of the blood collection holder 106, causing the rubber shield 252 to deform distally past the proximal needle tip 200 to expose the needle tip 200. When the vacuum blood collection tube 900 is fully inserted, the proximal needle tip 200 can pierce the septum and insert into the vacuum blood collection tube 900, enabling the vacuum blood collection tube 900 to be in fluid communication with the proximal needle tip 200.

[0226] Using the fluid connection between the vacuum blood collection tube 900 and the needle 108, blood sampling can thus be performed via the needle 108 while the blood collection holder 106 remains engaged with the catheter hub 102.

[0227] When the vacuum blood collection tube 900 is removed after successful blood sampling, the rubber shield 252 can return to its ready-to-use position, thereby covering the proximal needle tip 200 and preventing blood from leaking through the needle and exiting through the proximal opening of the catheter hub, as shown and described above. Figure 3B The elastic deformation of the rubber shield 252 allows repeated blood sampling with multiple vacuum blood collection tubes, while also preventing blood leakage when each vacuum blood collection tube is removed from the blood collection holder 106.

[0228] After successful blood sampling has been completed, the medical professional can then remove the blood collection holder 106 and the attached needle 108 from the catheter hub 102. The medical professional can also completely remove the blood collection holder 106 and the needle 108 from the catheter hub 102 by axially retracting the blood collection holder 106 in the proximal direction relative to the catheter hub 102. With the vacuum blood collection tube 900 either in or out of the holder, the needle 108 and the holder 106 can be removed from the catheter body and the catheter hub.

[0229] Figure 7D The catheter assembly 100 is shown after successful catheter insertion and separation of the blood collection holder 106 from the catheter hub 102, including complete removal of the needle from the catheter body and the catheter hub. There may be additional filled vacuum blood collection tubes not shown.

[0230] When the hollow needle 108 is withdrawn from the catheter hub 102 after successful venipuncture, a profile change portion 144 (e.g., by pleating) disposed near the distal needle tip 110 and having the form of a radial protrusion of the hollow needle engages the safety shield 132, enabling the safety shield 132 to be removed from the catheter hub 102 together with the needle 108, as previously described elsewhere herein. The safety shield 132 can then act as a shield or cover the distal needle tip 110 of the needle 108 as the needle 108 is withdrawn from the catheter hub 102.

[0231] After removal of the needle 108 following successful catheter insertion, one or more flaps of the valve 136 ( Figure 1B and 4B ) close one or more slits through the depth of the valve disk or valve plate due to their elastic properties such that blood cannot or substantially cannot flow out through the proximal opening of the catheter hub 102. In this way, the catheter hub 102 prevents further blood loss or flow.

[0232] Thus, using the catheter and retainer assembly 85 of the present invention, Figures 7A-7D the process described in can provide blood sampling and catheter insertion with only one needle puncture. In contrast, prior art devices require a first needle puncture with a blood sampling device to obtain a blood sample via a vacuum blood collection tube. After the desired number of samples (e.g., tubes) have been obtained, the blood sampling device is then removed from the patient. A second needle puncture is then performed with a catheter assembly to obtain peripheral IV access. After successful venipuncture, the catheter hub can then be connected to an infusion line. However, the catheter and retainer 85 according to some aspects of the present invention can perform the blood sampling function and peripheral IV access with only a single needle puncture. Thus, the present assembly reduces waste by using fewer components and at least one less needle, and reduces the number of needle punctures to one, which can minimize needle stick injuries and potential stress to the patient due to potentially receiving more than one needle puncture.

[0233] Figure 8A and 8B show an alternative embodiment of the blood collection retainer 106. This alternative embodiment provides a raised cap 170 around the mating flange 610, with a gap or space therebetween. As previously described, the mating flange 610 is configured to project into the catheter hub. A stop projection 172, which may also be referred to as a distal annular flange, may be provided on the inner surface of the raised cap 170. The size and shape of the raised cap 170 can be designed to project around the outside of the catheter hub at the proximal end of the catheter hub, and the mating flange 610 is configured to project into the proximal opening of the catheter hub. The raised cap can prevent the catheter hub 102 from being accidentally or prematurely separated from the blood collection retainer 106 during intubation and blood sampling. An accidental separation of the catheter hub 102 and the blood collection retainer 106 can be unpleasant for the healthcare professional and create a risk of inadvertent needle movement when the healthcare professional adjusts the relative movement of the catheter hub 102.

[0234] To prevent accidental movement, the blood collection holder 106 may have a raised cap 170, which may be a cylindrical protrusion extending distally from the distal wall 604 of the blood collection holder 106. The cylindrical protrusion may have a wall structure that is radially outwardly spaced from the mating flange 610 such that the raised cap 170 and the mating flange 610 are concentric with each other, and the raised cap extends distally from the distal wall 604 to cover the proximal portion of the catheter hub 102 when mating with the blood collection holder 106. In an example, the outer surface of the raised cap 170 may also be contoured, such as including claws, engagement features, interference surfaces, to engage a protective sheath placed on the catheter assembly during encapsulation and transportation in cases where the catheter assembly and the blood collection holder are encapsulated as a single assembly.

[0235] On the inner surface 171 of the raised cap 170, a stop protrusion 172 may extend radially inwardly from the inner surface 171. The stop protrusion 172 may be a single lip or ridge or annular protrusion formed around the inner circumference of the raised cap 170. Optionally, the stop protrusion 172 may be discontinuous and formed around the inner circumference by providing a plurality of spaced-apart individual ridges. The stop protrusion 172 is configured to contact a rear external feature or surface of the catheter hub (such as the external threads of the catheter hub) to limit relative movement.

[0236] Figure 9A and 9B Another alternative embodiment of the blood collection holder 106 is shown. This alternative embodiment provides a raised cap 170 that is formed around the mating flange 610 and has two stop protrusions 172, 174 provided on the inner surface, with a space or gap between the two stop protrusions. In addition to Figure 8A and 8B the cap protrusion 170 and the stop protrusion 172 described therein, the cap protrusion 170 of this embodiment may include a second stop protrusion 174 that is located axially further away from the distal wall 604 of the blood collection holder 106, or at a position distally spaced from the distal wall 604 of the blood collection holder 106 and spaced apart from the first stop protrusion 172. Similar to the first stop protrusion 172, the second stop protrusion 174 may be a single lip or ridge or annular protrusion formed around the inner circumference of the raised cap 170. Optionally, the second stop protrusion 174 may be discontinuous and formed around the inner circumference by providing a plurality of spaced-apart individual ridges. The second stop protrusion 174 may be radially aligned with the first stop protrusion 172. Alternatively, the second stop protrusion 174 may be radially offset along the circumference inside the cap protrusion. As shown, the second stop protrusion 174 is located distally of the first stop protrusion 172.

[0237] Using the second stop projection 174, even if the catheter hub accidentally moves past the first stop projection 172, the catheter hub can be retained by the second stop projection 174. The second stop projection 174 can be regarded as a backup for the first stop projection 172. This embodiment can be regarded as a blood collection retainer 106 having two separate stops or a stop with a backup stop.

[0238] The first stop projection 172 and the second stop projection 174 can have the same size and the same shape. Alternatively, the first stop projection 172 and the second stop projection 174 can have different sizes such that different levels of force can be applied to the catheter hub so that different levels of force are required to overcome the two stop projections. For example, by including a surface structure or lip that is more inward from the inner surface 171 of the raised cap 170 compared to the first stop projection, the second stop projection 174 can require a higher separation force than the first stop projection 172.

[0239] As can be understood from Figures 8A-9B the embodiments, additional stop projections can be provided, such as more than two rows of stop projections, to provide additional blocking to prevent the catheter hub 102 from separating from the blood collection retainer 106. Additionally, alternative forms of stop projections can be used. Although the exemplary embodiments use dome-shaped, annular lip, raised or bulging stop projections, the stop projections can alternatively have other geometric shapes, such as rectangular, different shapes, claws, relatively sharp gripping structures such as barbs, etc., or can be an arcuate flange on the inside of the cap raised. The stop projections can have different shapes from each other.

[0240] Figure 10A and 10B shows an alternative embodiment of the catheter hub 102, wherein the body of the catheter hub is provided with side fluid ports and fittings, also referred to as an integrated catheter hub. Figure 10A A perspective view shows an alternative embodiment of the catheter hub 102, wherein the catheter hub 102 is an integrated catheter hub, and Figure 10B shows having Figure 10A a perspective view of a catheter and retainer assembly 85 of a catheter hub and a blood collection retainer 106, and the blood collection retainer 106 can be one of the retainers discussed elsewhere herein.

[0241] The one-piece catheter hub 102 may include a side fluid port 500 that extends obliquely from the generally cylindrical body of the catheter hub 102. A fitting 540 may be connected to the side fluid port 500 at its first end, and the opposite end of the fitting may be connected to a fluid adapter (such as a male or female needleless valve) to which a syringe without a needle may be attached and fluids such as medications may be infused. The fitting 540 may have a lumen for fluid flow and provide a fluid connection between the catheter hub 102 through the side fluid port 500 and an external adapter. The external adapter may be any type of conventionally known adapter, such as a Luer connector or a conventional vent plug. Blood flow may be blocked by a seal or diaphragm located at the proximal end of the catheter hub 102, where proximally, the side fluid port 500 leads into the catheter hub so as not to interfere with fluid flow through the side fluid port 500. IV fluids or other medications may flow into the catheter hub 102 via the connection from the external fluid adapter through the fitting 540 and through the side fluid port 500.

[0242] Additionally, the catheter hub 102 of the present embodiment may have a pair of wings protruding from the body of the catheter hub to assist in securing to a patient, such as a sticky dressing.

[0243] Figure 10B A perspective view of the one-piece catheter hub 102 in cooperation with a blood collection holder 106 is shown, and the blood collection holder 106 may be one of the holders 106 described above.

[0244] Additionally, although Figure 10B shown in cooperation with a blood collection holder 106 without a cap protrusion or stop protrusion, alternative blood collection holders may include a cap protrusion or stop protrusion for use with the one-piece catheter hub 102. The side fluid port 500 and the fitting 540 may be arranged such that they do not interfere with the assembly of the raised cap when the blood collection holder 106 is in cooperation with the one-piece catheter hub 102.

[0245] The operating procedure of the catheter assembly 102 using the one-piece catheter hub 102 may be the same as that shown for the exemplary straight catheter with respect to Figures 6A-7D .

[0246] Figure 11A and 11BAn alternative needle 108 is shown, wherein the shaft of the needle has a bend feature or bend section 109 for mating with a correspondingly shaped groove in the blood collection holder 106. The needle 108 may have a bend feature 109 at an intermediate position between the distal needle tip 110 and the proximal needle tip 200. The bend feature may be a simple C-shaped bend such that the distal needle tip 110 and the distal section 111 of the needle shaft are axially aligned with the proximal needle tip 200 and the proximal section 201 of the needle shaft. Alternatively, the bend 109 may be a different shape, such as an S-shape or a complex shape.

[0247] The bore 632 of the blood collection holder 106 may similarly have a corresponding slot or shape 633 for receiving or accommodating the bend section 109 of the needle 108. The needle 108 may be assembled and snapped into the corresponding slot or corresponding bend feature 633 of the blood collection holder 106. In some embodiments, the needle 108 may be pushed into the corresponding slot 633 by axial insertion. In some embodiments, the blood collection holder may be a two-piece construction separated along the bore at least at the needle hub section of the holder such that the needle 108 may be snapped into the corresponding slot 633 prior to assembling the blood collection holder 106. The corresponding slot 633 may have a profile corresponding to the bend section 109 of the needle 108 and a slight undercut feature such that a slight force is required to push the needle into the slot. Figure 11A

[0248] The combination of the corresponding slot 633 and bend feature 633 may sufficiently mechanically secure the cannula without the need for additional adhesive. Alternatively, even when using the bend feature 109 and correspondingly shaped slot 633, an adhesive may be used or other bonding techniques (such as ultrasonic welding) may be used to bond the needle 108 to the blood collection holder 106.

[0249] As described above, embodiments of components from the incorporated references may be used for various components of the catheter assemblies of the present invention and are discussed herein. For example, with respect to the catheter hub, the body of the hub may be a wingless catheter hub, a winged catheter hub, a catheter hub with a port, or a catheter adapter with a lumen, which has a valve or a permanent diaphragm.

[0250] Methods of manufacturing and using the catheters and holder assemblies and their components described herein are within the scope of the present invention. The method is understood to include using a blood collection holder as an intubation hub with an IV catheter in a straight IV catheter assembly and an integral IV catheter, the integral IV catheter having a side fluid port extending from the body of the catheter hub and having a fitting attached thereto, the fitting then having a fluid adapter at the end of the fitting.

[0251] ​Although limited embodiments of the catheter and holder assembly, their components, and their use for blood sampling and peripheral IV access have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, various features of the double-pointed needle, rubber shield, and blood collection holder may include alternative materials and the like. Additionally, it can be understood and expected that features specifically discussed for one blood collection holder embodiment may be employed to be included in another blood collection holder embodiment, so long as the functions are compatible. Accordingly, it should be understood that the blood collection holder and its use in a catheter assembly constructed in accordance with the principles of the disclosed devices, systems, and methods may be embodied in ways different from those specifically described herein. The present disclosure is also defined in the appended claims.

Claims

1. A catheter and holder assembly (85) comprising: A catheter hub (102) having a catheter body (104) with a distal opening (112), attached to the catheter hub (102); A needle (108) including a sharp distal needle tip (110) and a sharp proximal needle tip (200), and wherein the sharp distal needle tip (110) projects beyond the distal opening (112) of the catheter body (104); and A blood collection holder (106) having a needle hub (106a) with a bore (632) through which the needle (108) passes, and a housing (600) having an internal space (620) sized to receive a vacuum blood collection tube; Wherein, in a ready-to-use position, the catheter hub (102) is in contact with the blood collection holder (106), and the sharp proximal needle tip (200) is located within the internal space (620) of the housing (600).

2. The catheter and retainer assembly (85) according to claim 1, wherein, The needle (108) includes a notch, a crimp, a cannula, or a stack proximal to the sharp distal needle tip (110).

3. The catheter and retainer assembly (85) according to claim 1 or 2, wherein, The blood collection holder (106) includes an end wall (604) and side walls (607) defining the internal space (620), and the needle hub (106a) is integral with the end wall (604).

4. The catheter and retainer assembly (85) according to claim 1 or 2, wherein, When the catheter and holder assembly is in the ready-to-use position, the sharp proximal needle tip (200) is within the internal space (620) of the blood collection holder (106).

5. The catheter and retainer assembly (85) according to claim 1 or 2, wherein The blood collection holder (106) has a distal projection (612) that projects into the catheter hub (102) in the ready-to-use position.

6. The catheter and retainer assembly (85) according to claim 1 or 2, wherein, The portion of the needle (108) extending distally of the blood collection holder (106) is longer than the portion of the needle (108) extending into the blood collection holder (106).

7. The catheter and retainer assembly (85) according to claim 1 or 2, wherein, The blood collection holder (106) includes an internal support post (630) projecting proximally from the end wall (604) into the internal space (620), the internal support post (630) having a bore (632) therethrough through which the needle is inserted.

8. The catheter and retainer assembly (85) according to claim 5, wherein, The blood collection holder (106) includes a mating flange (610) extending distally from the end wall (604), and the distal projection (612) extends distally of the mating flange (610).

9. The catheter and retainer assembly (85) according to claim 1 or 2, wherein, The needle (108) has a bending feature (109) that corresponds to a bending feature (633) in the blood collection holder (106) for assembly.

10. The catheter and retainer assembly (85) according to claim 1 or 2, further comprising a needle guard (132), the needle guard (132) including a surface located at the side of the needle in the ready-to-use position, and wherein, The surface is movable distally of the sharp distal needle tip (110) in a protected position to cover the sharp distal needle tip (110).

11. The catheter and retainer assembly according to claim 1 or 2 further includes a side fluid port (500) and a fitting (540) attached to the side fluid port (500) or a valve (136) having a valve opener (134) located within the catheter hub (102).

12. A method of assembling a catheter and retainer assembly (85), the method comprising: mounting a needle (108) including a sharp distal needle tip (110) and a sharp proximal needle tip (200) to a blood collection retainer (106); coupling the blood collection retainer (106) to a catheter hub (102) including a catheter body (104) such that the needle (108) extends through the catheter hub (102) and the catheter body (104) and the sharp distal needle tip (110) is distal to the distal opening (112) of the catheter body (104); and wherein the blood collection retainer (106) has a housing (600) defining an internal space (620) sized to receive a vacuum blood collection tube, and the sharp proximal needle tip (200) is located within the internal space (620).

13. The method according to claim 12, wherein, The blood collection retainer (106) includes an end wall (604) and side walls (607) defining the internal space (620) and a proximal opening.

14. The method according to claim 12 or 13 further includes a flange (602) at the proximal end of the blood collection retainer (106), the flange (602) including a surface for gripping.

15. The method according to claim 12 or 13 further includes: coupling a deformable shield within the internal space (620) of the blood collection retainer (106), the deformable shield covering the sharp proximal needle tip (200).

16. The method according to claim 13, wherein, The blood collection retainer (106) includes a distal projection (612) extending distally from the end wall (604), the distal projection (612) projecting into the interior of the catheter hub (102).

17. The method according to claim 16, wherein, The blood collection retainer (106) includes a distal annular flange disposed radially outward of the distal projection (612).

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