CN115350381B

CN115350381B - Valve assembly, valve actuator and conduit assembly

Info

Publication number: CN115350381B
Application number: CN202211149274.8A
Authority: CN
Inventors: W·哈丁; S·谢夫古尔; L·特雷纳; 马伊平; S·巴拉苏布拉马尼亚恩; P·唐尼; J·伯克霍尔茨; S·艾萨克森; J·奥布莱恩
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2014-04-18
Filing date: 2016-04-15
Publication date: 2024-08-23
Anticipated expiration: 2036-04-15
Also published as: CN112190817A; CN112190817B; CN107613891B; CN107614046B; ES2834969T3; CN107613891A; CN115350381A; CN107614046A

Abstract

A valve assembly, a valve actuator and a conduit assembly, the valve assembly comprising a valve and a valve actuator, the valve actuator moving in the conduit assembly between a first position in which the valve is closed and a second position in which the valve is open, the valve actuator comprising: a shaft portion at a distal end of the valve actuator, the shaft portion configured to open the valve; and a mating portion at a proximal end of the valve actuator, the mating portion configured to engage a luer device; wherein the shaft portion at the distal end of the valve actuator comprises a step.

Description

Valve assembly, valve actuator and conduit assembly

The application relates to a multipurpose blood control safety catheter component, which is a divisional application of China patent application number 201680030890.8 of which the international application number is PCT/US2016/027955 which enters the national stage of China.

RELATED APPLICATIONS

The present application claims the benefit of international patent application No. pct/US2015/026534 filed on month 5, month 17, year 2015, international patent application No. pct/US2015/026536 filed on month 4, month 17, and international patent application No. pct/US2015/026542 filed on month 4, 2015, and the present application is a continuation of these applications for the united states, all of which are incorporated herein by reference in their entirety.

Technical Field

Various exemplary embodiments of the present invention relate to catheter assemblies.

Background

The catheter assembly is used to properly place the catheter into the vascular system of a patient. Once in place, catheters, such as intravenous catheters, may be used to infuse fluids including conventional physiological saline, medical compounds, and/or nutritional ingredients into a patient in need of such treatment. The catheter also makes it possible to remove fluid from the blood circulation system and to monitor conditions within the vascular system of the patient.

Disclosure of Invention

An aspect of the invention provides a catheter assembly wherein the valve actuator includes a plurality of windows specifically sized and arranged to enhance saline flushing capability. In addition, the catheter hub includes a floating spring design that improves manufacturability and performance. Finally, the catheter hub also uses one of a variety of materials to reduce susceptibility in the spring, enabling the catheter assembly to be used with a patient during a Magnetic Resonance Imaging (MRI) procedure.

The foregoing and/or other aspects of the present invention may be achieved by providing a valve actuator for movement in a conduit assembly between a first position in which a valve is closed and a second position in which the valve is open, the valve actuator comprising: a shaft portion at a distal end of the valve actuator, the shaft portion configured to pierce the valve; a mating portion at a proximal end of the valve actuator, the mating portion configured to engage a luer device; a reduced diameter region connecting the shaft portion and the mating portion; and a plurality of windows extending through the valve actuator for flushing fluid, the plurality of windows disposed in the reduced diameter region, wherein each of the plurality of windows does not extend the full length of the reduced diameter region.

The foregoing and/or other aspects of the present invention are further achieved by providing a valve actuator for movement in a catheter assembly between a first position in which a valve is closed and a second position in which the valve is open, the valve actuator comprising: a shaft portion at a distal end of the valve actuator, the shaft portion configured to pierce the valve; a mating portion at a proximal end of the valve actuator, the mating portion configured to engage a luer device; a reduced diameter region connecting the shaft portion and the mating portion; and a plurality of windows extending through the valve actuator for flushing fluid, wherein the plurality of windows are disposed outside the reduced diameter region.

The foregoing and/or other aspects of the present invention are also achieved by providing a catheter assembly, comprising: a conduit; a needle having a sharp distal tip located within a catheter; a catheter hub connected to the catheter such that the needle passes through the catheter hub, the catheter hub including a valve that selectively allows or blocks fluid flow through the catheter; a valve actuator that moves between a first position and a second position; and a return member for returning the valve actuator from the second position to the first position; and a needle protection component that encapsulates the sharp distal tip of the needle, wherein the valve actuator comprises a reduced diameter region having a plurality of windows, and each window of the plurality of windows does not extend the full length of the reduced diameter region.

The foregoing and/or other aspects of the present invention are also achieved by providing a catheter assembly, comprising: a conduit; a needle having a sharp distal tip located within a catheter; a catheter hub connected to a catheter such that a needle passes through the catheter hub, the catheter hub including a valve that selectively allows or blocks fluid flow through the catheter; a valve actuator that moves between a first position and a second position; a return member for returning the valve actuator from the second position to the first position; and a needle protection component enveloping a sharp distal tip of the needle, wherein the valve actuator comprises a reduced diameter region and a plurality of windows extending through the valve actuator for flushing fluid, the plurality of windows being disposed outside the reduced diameter region.

The foregoing and/or other aspects of the present invention are also achieved by providing a catheter assembly, comprising: a conduit; a needle having a sharp distal tip located within a catheter; a catheter hub connected to a catheter such that a needle passes through the catheter hub, the catheter hub comprising an inner diameter; a valve that selectively permits or blocks fluid flow through the conduit; a valve actuator that moves between a first position and a second position; and a spring returning the valve actuator from the second position to the first position, wherein a clearance fit is provided between the spring and the inner diameter.

The foregoing and/or other aspects of the present invention are also achieved by providing a catheter assembly comprising a catheter; a needle having a sharp distal tip located within a catheter; a catheter hub connected to a catheter such that a needle passes through the catheter hub, the catheter hub including a valve that selectively allows or blocks fluid flow through the catheter; a valve actuator that moves between a first position and a second position; and a return member for returning the valve actuator from the second position to the first position; and a needle protection component enveloping the sharp distal tip of the needle, wherein the return component comprises a metal component having a relative magnetic permeability of less than 2.0.

Additional and/or other aspects and advantages of the invention will be set forth in the description which follows, or will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above aspects and features of the present invention will become more apparent from the description of exemplary embodiments thereof with reference to the accompanying drawings, in which:

FIG. 1A is a perspective view of an exemplary catheter assembly;

FIG. 1B is an exploded perspective view of the catheter assembly of FIG. 1A;

FIG. 2A is a cross-sectional side view of an exemplary catheter hub and actuator;

FIG. 2B is a perspective view of an exemplary spacer;

FIG. 3 is a cross-sectional side view of an exemplary catheter hub, actuator, and spring with an introducer needle inserted through the catheter hub;

FIG. 4 is a cross-sectional side view of the catheter hub of FIG. 3 with the introducer needle removed;

FIG. 5 is a cross-sectional side view of the catheter hub of FIG. 4 with a luer fitting inserted;

FIG. 6 is a cross-sectional side view of the catheter hub of FIG. 5 with the luer fitting pushing the actuator through the septum;

FIG. 7 is a cross-sectional side view of the catheter hub of FIG. 6 with the luer removed;

FIG. 8 is a cross-sectional side view of the catheter hub of FIG. 7 with the luer removed;

FIG. 9 is a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 10 is a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 11 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 12 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 13 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 14 illustrates a cross-sectional isometric view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 15A illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

Fig. 15B is a cross-sectional side view of the catheter of fig. 15A with a luer fitting inserted;

FIG. 16 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 17 illustrates a cross-sectional perspective view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 18 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 19A illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

FIG. 19B is a cross-sectional side view of the catheter of FIG. 19A being pushed through a septum;

FIG. 20A illustrates a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member;

fig. 20B is the catheter of fig. 20A with a luer fitting inserted;

FIG. 21A illustrates a cross-sectional side view of another exemplary embodiment of a catheter with an actuator and biasing member inserted with a luer fitting;

FIG. 21B is a front view depicting the separator of FIG. 21A;

FIG. 21C is a cross-sectional side view depicting the actuator of FIG. 21A with an elastomer molded to the end of the actuator;

FIG. 22 is a perspective view of a side-port catheter;

FIG. 23 illustrates a cross-sectional side view of an exemplary embodiment of a catheter having a biasing member and an actuator for a side-port catheter;

FIG. 24 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having a biasing member and an actuator for a side-port catheter;

FIG. 25 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having a biasing member and an actuator for a side-port catheter;

FIG. 26 illustrates a cross-sectional side view of another exemplary embodiment of a catheter having a biasing member and an actuator for a side-port catheter;

FIG. 27 is a cross-sectional side view of an exemplary catheter assembly with a needle tip shield;

FIG. 28 is a perspective view of an exemplary outer sleeve of the needle tip shield;

FIG. 29 is a side view of the outer sleeve of FIG. 28;

FIG. 30 is a top view of the outer sleeve of FIG. 28;

Figure 31 is a top perspective view of an exemplary inner sleeve of the needle tip shield;

figure 32 is a bottom perspective view of the inner sleeve of figure 31;

FIG. 33 is a top perspective view of the needle tip shield clip;

FIG. 34 is a side view of the clip of FIG. 33;

FIG. 35 is a cross-sectional side view of the needle tip shield of FIG. 27;

FIG. 36 is another cross-sectional side view of the needle tip shield of FIG. 27;

FIG. 37 is a cross-sectional side view of the needle tip shield with the clip in a closed position;

FIG. 38 illustrates a right side view of another exemplary embodiment of an actuator;

FIG. 39A shows a cross-sectional view of the actuator of FIG. 38 in a catheter hub assembly;

FIG. 39B illustrates a cross-sectional view of the catheter hub assembly of FIG. 39A as it penetrates the septum;

FIG. 39C shows a left side cross-sectional perspective view of the catheter hub assembly of FIG. 39A as it penetrates the septum;

FIG. 40A illustrates a cross-sectional view of another exemplary embodiment of a catheter hub assembly;

FIG. 40B illustrates a cross-sectional view of the catheter hub assembly of FIG. 40A as it penetrates the septum;

FIG. 40C shows a left side cross-sectional perspective view of the catheter hub assembly of FIG. 40A as it penetrates the septum;

FIG. 41 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly in a needle extended position;

FIG. 42 shows a cross-sectional view of the catheter assembly of FIG. 41 in a needle retracted position;

FIG. 43 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly in a needle extended position;

FIG. 44 shows a cross-sectional view of the catheter assembly of FIG. 43 in a needle retracted position;

fig. 45 illustrates a cross-sectional view of the catheter hub assembly and needle hub assembly of fig. 44;

FIG. 46 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly in a needle extended position;

Fig. 47 shows a cross-sectional view of the catheter seat assembly and hub assembly of fig. 46 in a needle retracted position;

Fig. 48 shows a bottom plan view of the catheter seat assembly and hub assembly of fig. 46 in a needle retracted position;

fig. 49 illustrates an exemplary embodiment of a blood flashback feature of a catheter assembly;

FIG. 50 shows a needle in the catheter assembly of FIG. 49;

FIG. 51 illustrates another exemplary embodiment of a blood flashback feature of a catheter assembly;

FIG. 52 illustrates a side perspective view of a valve actuator including a window in a reduced diameter region according to further embodiments;

FIG. 53 illustrates a side perspective view of a valve actuator including a window in a reduced diameter region according to yet another embodiment;

FIG. 54 illustrates a side perspective view of a valve actuator including a window in a reduced diameter region according to yet another embodiment;

FIG. 54A shows a cross-sectional view of the valve actuator in the embodiment of FIG. 54;

FIG. 55 illustrates a side perspective view of a valve actuator including a window in a reduced diameter region according to yet another embodiment;

FIG. 56 illustrates a side perspective view of a valve actuator including a window outside of a reduced diameter region according to yet another embodiment;

FIG. 57 illustrates a side perspective view of a valve actuator including a window outside of a reduced diameter region according to yet another embodiment;

fig. 58 shows a rear perspective view of the valve actuator in the embodiment of fig. 57.

FIG. 59 shows the amount of blood remaining on the valve actuator of FIG. 3 after a saline flush;

FIG. 60 shows the amount of blood remaining in the catheter hub with the valve actuator of the embodiment of FIG. 52 after a saline flush;

FIG. 61 shows a graphical comparison of the amount of blood remaining in a catheter hub with a valve actuator in the embodiments of FIGS. 3 and 53 after a saline flush;

fig. 62 shows a left side cross-sectional perspective view of an alternative embodiment of a catheter assembly.

Fig. 63 shows a left side cross-sectional perspective view of the catheter hub portion and the hub portion in the embodiment of fig. 62;

FIG. 64 shows a cross-sectional view of the catheter hub in the embodiment of FIG. 62;

FIG. 65 shows a cross-sectional view of the valve actuator and spring of the embodiment of FIG. 62;

FIG. 66 illustrates a perspective view of another embodiment of a valve actuator;

FIG. 67 shows a cross-sectional view of the valve actuator of FIG. 66;

FIG. 68 shows an enlarged view of the distal end of the valve actuator of FIG. 67;

FIG. 69 illustrates a perspective view of another embodiment of a valve actuator;

FIG. 70 illustrates a cross-sectional view of the valve actuator of FIG. 69; and

Fig. 71 shows an enlarged view of the distal end of the valve actuator of fig. 70.

Detailed Description

As shown in fig. 1A and 1B, catheter assembly 10 includes a hollow introducer needle 12, a catheter hub 14, and a needle hub 16. The introducer needle 12 has a sharpened distal end and extends through the catheter hub 14. A flexible catheter tube 18 extends from the distal end of the catheter hub 14, and the needle 12 passes through the catheter tube 18. Initially, the needle 12 is inserted into a vein of a patient. Catheter tube 18 is pushed along needle 12 and follows needle 12 into the vein. After insertion of catheter tube 18, needle 12 is removed from the patient's vein and catheter hub 14, leaving catheter tube 18 in the patient, and needle 12 is discarded.

According to various exemplary embodiments, the catheter hub 14 has a distal end 20, a proximal end 22, an inner surface 24, and an outer surface 26. The distal end 20 includes a catheter opening and the proximal end includes a luer opening. The inner surface 24 surrounds a channel 28 that allows fluid to pass through the catheter hub 14. The outer surface 26 includes one or more projections 30 to secure a luer fitting 32 (fig. 4) to the catheter hub 14. The lugs 30 and luer 31 may form a threaded connection or the lugs may be connected to luer 32 by a snap fit or other twist connection. An example of a standard connection isAnd (5) connection. Some types of luer fitting 32 utilize a slip fit into catheter hub 14. The catheter hub 14 may be made of a transparent or translucent polymeric material so that fluid flowing through the catheter hub may be observed by a user, or the catheter hub may be made of an opaque material.

A flexible conduit tube 18 extends through the conduit opening. A metal wedge 34 may be positioned in the channel to secure the catheter tube 18 in the catheter opening. Wedge 34 has a first end engaged with catheter tube 18 and a second end engaged with inner surface 24 of catheter hub 14. The first end of wedge 34 has a tapered nose that allows the first end to be easily engaged with catheter tube 18. When wedge 34 is inserted into catheter tube 18, catheter tube 18 expands, creating an interference fit between catheter tube 18, wedge 34, and inner surface 24 of catheter hub 14. The second end of the wedge 34 has a substantially frustoconical portion with an outer edge that engages the inner surface 24 of the catheter hub 14. Wedge flange 36 may be formed on inner surface 24 to create a limit to distal movement of wedge 34. Similar shoulders, tabs or grooves may also limit distal movement of wedge 34.

A pre-slit elastomeric septum 38 is positioned in the channel 28 and functions as a valve to form a fluid tight seal and selectively permit fluid flow into or out of the flexible conduit member 18. In other words, the valve selectively allows or blocks fluid flow through flexible conduit fitting 18. The septum 38 may rest against the septum flange 40 to limit distal movement. The protrusions or other internal structures may form an interference fit with the septum 38 to hold the septum in place or limit proximal movement of the septum. As best shown in fig. 2B, the baffle 38 has one or more preformed openings or slits 42 designed to selectively block the flow of undesired fluid through the baffle 38. The diaphragm 38 preferably has three intersecting slits 42, thereby forming three flaps that open when engaged by a valve actuator or diaphragm actuator (hereinafter actuator).

The partition 38 further includes a plurality of axial fluid passages 39. The fluid passage 39 is provided on the outer circumference of the partition 38. Eight fluid passages 39 are shown equally spaced from one another, although different numbers and positions are contemplated. The fluid channel 39 has a suitable width and depth so that when the partition 38 is unopened, blood can enter and air can escape the space in the front of the catheter seat 14 distal to the partition. At the same time, the size of the fluid passage 39 is small enough to prevent blood from flowing out through the partition 38 (at least for a certain period of time). Such a configuration is possible because the intermolecular forces in the blood are greater than the intermolecular forces in the air.

The baffle 38 shown in fig. 2B may be used in any of the embodiments discussed herein. Other baffle configurations may be used as will be appreciated by those of ordinary skill in the art. When catheter tube 18 is initially inserted into a patient and introducer needle 12 is removed, septum 38 prevents blood from flowing through channel 28 and out the distal end. The diaphragm 38 is made of an elastic material such as silicone rubber to form a valve. Other elastic materials may be used and inelastic materials may be incorporated into the baffle 38 as desired.

Fig. 2A depicts an exemplary embodiment of an actuator 44 having an actuator cylinder 46 surrounding an interior passage 46A. An actuator like that of fig. 2A may be used in any of the embodiments described herein. An actuator 44 is positioned in the channel 28 and is axially movable in the channel 28 to engage and open the slit 42. The actuator cylinder 46 is a substantially tubular member and the internal passageway 46A is substantially cylindrical to allow fluid to flow through the actuator 44 and the diaphragm 38 when the diaphragm 38 is opened or penetrated by the actuator 44. The tubular member has a distal opening 46B, one or more side openings 46C, and a distal end 46D that engages and opens the slit 42. The side opening 46C of the actuator 44 allows for fluid flushing.

The tapered section 48 forms the proximal end of the actuator 44. The tapered section 48 is a substantially frustoconical member that tapers toward the actuator cylinder 46 and has one or more proximal openings 48A to allow fluid flow. The tapered section 48 receives or engages or abuts the end of a luer fitting (not shown). One or more tabs 50 extend from the actuator 44 to engage with corresponding flanges 52 or one or more shoulders on the inner surface 24 of the catheter hub 14. The interaction between tab 50 and flange 52 limits the proximal movement of actuator 44. Proximal opening 48A and internal passageway 48B, which communicates with internal passageway 46A, preferably allow fluid to flow between the luer fitting and catheter tube 18. The side opening 48C in the tapered section 48 allows for fluid flushing. The actuator 44 is preferably made in one piece from a rigid or semi-rigid material such as a rigid polymeric material or metal.

When a male luer fitting is inserted into the catheter seat 14, the end of the luer fitting slides towards the conical section 48 and abuts the actuator 44. Further movement of the luer causes the actuator 44 to move axially toward and through the septum 38, with the distal end 46D of the actuator barrel 46 separating the one or more slits 42 to engage and open the septum 38. After septum 38 is opened by actuator 44, fluid is allowed to flow from the luer fitting, through internal passages 48B and 48D of actuator 44, into flexible conduit 18, or vice versa. When luer fitting 32 is removed, actuator cylinder 46 remains in septum 38.

Fig. 3-8 depict an embodiment of catheter assembly 10 that includes a return component 56 that provides, for example, a multi-purpose function for blood control. The actuator 54 has an actuator cylinder 59A surrounding an internal passage 59B. The actuator cylinder 59A is a substantially tubular member and the internal passageway 59B is substantially cylindrical. The tubular member has one or more openings 55 to allow fluid to flow through and around the actuator cylinder 59A. The opening 55 advantageously provides an increased area for fluid movement within the catheter hub assembly. The increased area advantageously allows for fluid flushing and prevents fluid clotting in the proximal and distal ends of the septum 38. In addition, the openings 55 advantageously minimize stagnation of the fluid and allow for better mixing.

The first end of the actuator cylinder has a nose 58 with a chamfered outer surface to engage the bulkhead 38. A truncated conical section 61A extends from the second end of the actuator cylinder 59A. The frustoconical section 61A has one or more openings 61B to allow fluid flow through the frustoconical section. The cylindrical section 61C extends from the frustoconical section 61A to engage the male luer fitting 32. One or more hooks 60 having an angled front surface and a slot 62 extend from the actuator barrel 59A.

In the exemplary embodiment shown in fig. 3-8, the return member 56 is a biasing member such as a coil spring, for example, a coil compression spring having a distal end 64 and a proximal end 66. The spring may be, but is not limited to, rubber, silicone rubber, thermoplastic elastomer, metal, plastic, elastomeric component such as an elastomer, or other suitable elastomeric material. The distal end 64 of the spring forms an interference fit with the inner surface 24 of the catheter hub 14. The interference fit may be sufficient to hold the spring, or the distal end 64 of the spring may abut the diaphragm 38, even during loading. The proximal end 66 of the spring is connected to the actuator 54, such as by fitting onto the hook 60 and into the slot 62.

In other various embodiments, the actuator 54 and the biasing member 56 are combined into a unitary structure. In various exemplary embodiments, the inner surface 24 of the catheter hub 14 and/or the outer surface of the actuator 54 and/or the biasing member 56 include undercuts, ridges, protrusions, teeth, or other suitable structures to form a quick connection between the catheter hub 14 and the biasing member 56 and between the biasing member 56 and the actuator 54. In further various exemplary embodiments, the biasing member or spring 56 and the actuator 54 may be attached to one another by an engagement that does not require a quick-connect including an interference fit or a press fit over a diameter.

Fig. 3-7 depict the operation of catheter hub 14 with an actuator 54 and a return member such as a biasing member or spring 56. The return member functions by returning the actuator 54 from a second position engaging the diaphragm 38 to open the valve (e.g., opening or penetrating the diaphragm) to a first position at the proximal end of the diaphragm 38 (not engaged with the diaphragm) to close the valve. Needle 12 initially extends through actuator 54, septum 38, wedge 34, and catheter tube 18. After needle 12 and catheter tube 18 are inserted into the patient, needle 12 is retracted, thereby closing septum 38.

There are two basic ways of opening the partition 38, each of which can be used in the practice of the present invention. In a first method, the partition 38 may be in an open state when the actuator 44 contacts or pushes against the slit 42 of the partition 38. When the partition 38 is opened in this way, the actuator 44 does not extend through the partition 38. Instead, the end surface of the actuator 44 is located on the slit 42 of the partition 38. The resilient slit 42 or the flap of the diaphragm 38, or the spring 56, or both, may cause the actuator 44 to retract upon completion of the operation and upon removal of axial pressure on the actuator 44. In a second approach, the partition 38 may be in a penetrated state wherein the actuator 44 extends through the partition 38, causing the partition 38 to open. In this state, the actuator 44 requires an external force, such as a spring 56, to retract the actuator 44 and close the diaphragm 38. In the penetrated state, the elastic slit 42 of the partition 38 cannot retract the actuator 44 by itself. Both diaphragm states may open diaphragm 38 and allow fluid exchange.

As shown in fig. 5 and 6, when the male luer fitting 32 is inserted into the catheter seat 14, the luer fitting 32 moves the actuator 54 in the distal direction, compressing the spring 56. Further insertion of luer fitting 32 moves actuator 54 through septum 38, thereby opening slit 42 and allowing fluid flow through catheter hub 14. As best shown in fig. 7 and 8, when luer fitting 32 is removed, spring 56 removes actuator 54 from septum 38, thereby closing slit 42 and preventing fluid flow through the slit. This allows the catheter assembly 10 to be reused with multiple luer connections, as opposed to a single use catheter (where the actuator would remain in the septum 38 after luer removal). The features of the exemplary embodiments of fig. 3-8 may be suitably combined with other exemplary embodiments disclosed herein.

Although return member 56 is shown as a biasing member (e.g., a spring or other resilient member) in all embodiments disclosed herein, the invention is not so limited. The return member may be any element or assembly that returns the actuator from its second position to its first position when the luer is removed. When configured as a biasing member, the return member 56 may be, but is not limited to, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer. The return member 56 may also be constructed from the resilient slit 42 or flap of the partition 38, as discussed above.

Fig. 9 depicts an alternative embodiment of the actuator 68 and biasing member 70A. The actuator 68 has an actuator cylinder 69A surrounding an internal passage 69B. The actuator cylinder 69A is a substantially tubular member and the internal passage 69B is substantially cylindrical. A series of openings 69C are formed in the actuator cylinder 69A to allow fluid to flow through and around the actuator 68. The actuator cylinder 69A has a distal end 69D that engages and opens the partition 38. The distal end 69D includes a nose with a chamfered outer surface. A tapered section 71A extends from a proximal end 71B of the actuator cylinder 69A. The tapered section 71A is a substantially frustoconical member that receives or engages the end of the luer fitting.

The biasing member is a coiled metal compression spring 70A having a distal end 70B and a proximal end 70C. The distal end 70B of the spring 70A has a first outer diameter and a first inner diameter. The proximal end 71B of the spring 70A has a second outer diameter and a second inner diameter. The second outer diameter may be different from the first outer diameter and the second inner diameter may be different from the first inner diameter. The spring 70A may have a substantially conical shape.

In various exemplary embodiments, the first outer diameter is sized to form a first interference fit with the inner surface of the catheter hub 14. The first interference fit may be sufficient to allow compression of the spring 70A without contact between the spring 70A and the spacer 38. In alternative embodiments, the spacer 38 may help limit the axial movement of the spring 70A. The second inner diameter is sized to form a second interference fit with the actuator 68, such as with the actuator cylinder 69A. The second interference fit is sufficient to hold and support the actuator 68 in place in an unstressed condition both axially and radially relative to the catheter hub 14. The second interference fit may be sufficient to allow compression of the spring 70A without the spring 70A and catheter hub 14 contacting. Because of the support provided by the spring 70A, the actuator 68 is held, as shown, substantially self-centered and does not contact the inner wall of the catheter hub 14. The spring 70A holding the actuator 68 in the catheter seat 14 provides an advantage over the catheter shown in fig. 2 in that the actuator tab 50 and corresponding shoulder 52 extending from the inner surface are removed. Removal of tab 50 and shoulder 52 reduces the complexity of the device. In various alternative embodiments, the tab 50 is used to retain the actuator, and the spring 70A is freely positioned in the catheter hub 14 without an interference fit with the catheter hub 14 or the actuator 68.

According to the illustrated embodiment, the first outer diameter and the first inner diameter of the spring are larger than the second outer diameter and the second inner diameter. The pitch of the spring 70A also varies from the distal end to the proximal end. The spring 70A may have one or more coils that contact or are located at or near the distal end in the unloaded state. The varying pitch of the spring 70A allows the stiffness to be concentrated at the distal and proximal ends to help maintain an interference fit while also allowing adequate compression through the middle of the spring 70A. The features of the example actuator 68 and biasing member 70A depicted in fig. 10 may be suitably combined with the features of other example embodiments disclosed herein.

When a luer fitting (not shown) is inserted into catheter hub 14, the end of the luer fitting abuts the tapered section of actuator 68. Further movement of the luer causes the actuator 68 to move axially toward and through the septum 38 with the first end portion of the actuator barrel exiting the one or more slits. Movement of actuator 68 toward diaphragm 38 compresses spring 70A. After the partition 38 is opened, fluid is allowed to flow through the catheter hub 14. Compression of the spring 70A is maintained by the luer fitting. When the luer is removed, the spring 70A returns the actuator to its original position, thereby removing the actuator 68 from the septum 38. After actuator 68 is removed, diaphragm 38 returns to the closed position, preventing fluid flow through the diaphragm. The features of the exemplary embodiment of fig. 9 may be suitably combined with the features of other exemplary embodiments disclosed herein.

Fig. 10 depicts another alternative embodiment of catheter hub 14 having an actuator 72 and a return or biasing member 74. The actuator 72 has an actuator cylinder 73A surrounding an internal passage. The actuator cylinder 73A is a tubular member surrounding a cylindrical internal passage. A series of openings 73B are formed in the tubular member to allow fluid to flow through and around the actuator 72. The actuator cylinder 73A has a first end 75A that engages and opens the slit of the partition 38. The first end 75A includes a nose portion having a chamfered outer surface. A cylindrical section 75C extends from the second end 75B of the tubular portion. The cylindrical section 75C may have a tapered bore for receiving a luer fitting, or the bore may be a continuation of the cylindrical internal passageway.

The return or biasing member of fig. 10 is a coiled metal compression spring 74 having a distal end and a proximal end. The distal end is interference fit with the inner surface of the catheter hub 14 and the proximal end is interference fit with the actuator 72. The inner surface may have a channel, groove, slot or other depression 76 to receive the distal end of the spring 74. The spring 74 depicted in fig. 10 may be similar or identical to the spring 70A depicted in fig. 9.

As discussed above, the conical spring 74 supports the actuator end, thus allowing removal of the actuator tab 50. Catheter 10 is designed for use with different sized luer connectors that penetrate the internal passage at different lengths. Because the tab 50 of the example actuator 44 depicted in fig. 2 cannot travel through the septum 38, the length of the tubular portion is increased to accommodate different sized luer fittings. As clearly shown in the exemplary embodiment of fig. 10, by removing tab 50, actuator 72 and catheter hub 14 may be shortened, thereby reducing the size and cost of the device. The features of the exemplary embodiment of fig. 10 may be suitably combined with the features of other exemplary embodiments disclosed herein.

Fig. 11 depicts another alternative embodiment of catheter hub 14 having an actuator 78 and a return or biasing member 80. The actuator 78 has an actuator cylinder surrounding an internal passageway. The actuator barrel and the internal passageway have a tapered shape tapering from a proximal end to a distal end of the catheter hub. The actuator cylinder has a first end that engages and opens the slit 42. The first end includes a nose portion having a chamfered outer surface. One or more projections 82 extend radially from the barrel to engage the biasing member 80. The projection 82 may be a single truncated conical flange extending around the outer surface of the barrel, one or more tabs extending from the barrel, or other similar structure.

The biasing member 80 in fig. 11 is preferably an elastomeric spring having an outer surface that engages the inner surface of the catheter hub 14 and a bore that receives at least a portion of the actuator 78. Biasing member 80 may also be, but is not limited to, rubber, silicone rubber, thermoplastic or thermoplastic elastomer. According to an exemplary embodiment, the bore includes a proximal opening 84, a medial opening 86, and a distal opening 88. The proximal opening 84 has a substantially cylindrical shape with a first diameter. The intermediate opening 86 has a second diameter that is greater than the first diameter. The intermediate opening 86 may be cylindrical or may be defined by one or more angled walls to have a substantially frustoconical shape. For example, the intermediate opening 86 may be defined by a wall having an angle corresponding to the angle of the actuator tab 82. Distal opening 88 has a substantially cylindrical shape and a diameter that is less than the diameters of proximal opening 84 and intermediate opening 86. In various exemplary embodiments, the size, shape, and configuration of the elastomeric springs and openings may vary depending on the catheter hub 14 and the actuator 78.

The actuator 78 is placed into the elastomeric spring 80 such that at least a portion of the first end of the actuator cylinder extends through and protrudes from the elastomeric spring 80. The actuator tab 82 seats in the intermediate opening 86 to hold the actuator 78 in place and resist proximal movement of the actuator 78. The second end of the actuator extends from the proximal opening 84 to receive or engage a male luer fitting (not shown). When the luer fitting is inserted, the actuator 78 moves in the distal direction against the bias of the elastomeric spring 80, elastically deforming the elastomeric spring 80. When the luer is removed, the elastomeric spring 80 returns the actuator 78 substantially to its original position. The features of the example actuator and biasing member depicted in fig. 11 may be combined with other example embodiments disclosed herein.

Fig. 12 depicts another alternative embodiment of catheter hub 14 having an actuator 90 and a return or biasing member 92. The first end of the actuator 90 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a substantially frustoconical shape tapering from the distal end to the proximal end of the catheter hub. The actuator cylinder has one or more openings to allow fluid flow through the actuator. The actuator 90 includes a second end for receiving or engaging a luer fitting. The second end has a substantially frustoconical shape. The second end may also include an internal passageway and one or more openings. The intermediate portion 94 connects the first and second ends of the actuator 90. The intermediate portion 94 has a substantially cylindrical shape surrounding the internal passageway.

Biasing member 92 in fig. 12 is preferably a resilient washer. The gasket 92 has an outer surface that engages the inner surface of the catheter hub 14. The inner surface of the catheter hub may include a slot or groove 96 to receive and retain the gasket 92. The washer 92 has an inner diameter that receives a middle portion 94 of the actuator 90. The intermediate portion 94 may have a diameter that is smaller than the truncated portion of the second end and smaller than the base of the first end, thereby holding the gasket against the first flange formed by the first end and the second flange formed by the second end. The shape, size, and configuration of the actuator 90 and the gasket 92 may be varied to accommodate each other.

The actuator 90 is placed in the washer 92 such that a first end of the actuator 90 extends through the washer 92 and protrudes from one side of the washer to engage the spacer 38. The second end of the actuator 90 extends from the gasket 92 to receive or engage the male luer fitting 32. When luer fitting 32 is inserted, actuator 90 moves in a distal direction against the bias of washer 92, thereby resiliently stretching washer 92. Further insertion of luer fitting 32 moves actuator 90 through septum 38, thereby opening slit 42. When luer fitting 32 is removed, washer 92 returns actuator 90 to its original position. In various further embodiments, the gasket 92 may be, but is not limited to, rubber, silicone rubber, thermoplastic elastomer, spring gasket, elastomeric gasket, a plurality of elastic bands, compression springs, extension springs, coil springs, or other suitable biasing members. The features of the example actuator 90 and biasing member 92 depicted in fig. 12 may be suitably combined with other example embodiments disclosed herein.

Fig. 13 depicts another alternative embodiment of catheter hub 14 having an actuator 98 and a return or biasing member 100. The actuator 98 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. The actuator 98 includes a second end for receiving or engaging a male luer fitting (not shown).

The biasing member in fig. 13 may be, but is not limited to, one or more elastic members 100, such as a circular or radially extending silicone member, a plurality of elastic bands, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer. In various exemplary embodiments, the elastic band is made of silicone or silicone rubber. The biasing member 100 is connected to a fixed support 102 that is attached to the inner surface of the catheter hub 14. The fixed support may be a single component extending radially around the inner surface, or it may be one or more separate pieces depending on the type of biasing member.

The biasing member 100 receives and/or is coupled to the actuator 98 to maintain the actuator 98 in an unstressed position. When the male luer fitting is inserted, the actuator 98 is moved in the distal direction, stretching the biasing member 100. When the luer is removed, the biasing member 100 returns the actuator 98 to its original position. The features of the example actuator 98 and biasing member 100 depicted in fig. 13 may be suitably combined with features of other example embodiments disclosed herein.

Fig. 14 depicts another alternative embodiment of a catheter hub 14 having an actuator 104 and a return or biasing member 106. The biasing members 106 are similar to those discussed above with respect to fig. 13. The actuator has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. The actuator includes a second end for receiving or engaging a luer fitting (not shown). The actuator cylinder and catheter hub 14 are shorter than those described in other embodiments. Any actuator or any catheter hub described herein may be used in this embodiment. The biasing member 106 may be, but is not limited to, rubber, silicone rubber, thermoplastic elastomer, one or more strips, radially extending members, or other suitable biasing member. The biasing member 106 includes a flange 108 that fits into a groove or slot in the catheter hub 14. The features of the example actuator 104 and biasing member 106 depicted in fig. 14 may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 15A-15B depict another alternative embodiment of a catheter hub 14 having an actuator 110 and a return or biasing member 112. The actuator 110 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. The first end includes a nose portion having a chamfered outer surface. The second end of the actuator cylinder receives or engages the male luer fitting 32.

The biasing member is a resilient band or disc 112 connected near the second end of the actuator 110. The elastic band 112 may be, but is not limited to being made of latex, rubber, silicone rubber, thermoplastic elastomer, or other suitable elastic material. The first end of the elastic band 112 is connected to the catheter hub 14. The second end of the elastic band 112 is connected to the actuator 110, such as by an interference fit or other mechanical connection, or by a chemical bond or a molded bond, such as an adhesive. 15A-B, features of the example actuator 110 and biasing member 112 may be suitably combined with features of other example embodiments disclosed herein.

Fig. 16 depicts another alternative embodiment of catheter hub 14 having an actuator 114 and a return member including a first biasing member 116 and a second biasing member 118. The actuator 114 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. The first end includes a nose portion having a chamfered outer surface. A cylindrical member for receiving or engaging a luer fitting (not shown) extends from the second end of the actuator barrel. The compressible section 120 is positioned in the actuator cylinder. The compressible section 120 is made of a suitable compressible material, such as an elastomer or polymer.

Similar to the biasing members depicted in fig. 13-15B, the first biasing member 116 and the second biasing member 118 of fig. 16 may be one or more strips of resilient material, radially extending members, or other suitable biasing members. In various further embodiments, the biasing member depicted in fig. 13-16 may be, but is not limited to, a spring washer, an elastomeric washer, a plurality of elastic bands, a compression spring, an extension spring, a coil spring, rubber, silicone rubber, thermoplastic elastomer, or other suitable biasing member. The first biasing member 116 and the second biasing member 118 are connected to the catheter hub 14 by one or more support blocks 122. In various exemplary embodiments, only a single biasing member may be used.

When the luer is inserted, the luer engages the compressible insert 120 and moves the actuator 114 in the distal direction against the bias of the first and second biasing members 116, 118. Further insertion of the luer causes the actuator to move through the septum (not shown), thereby opening the slit 42. The first and second biasing members 116, 118 and the compressible insert 120 are configured such that the actuator 114 may be advanced a certain distance until the elastic force of the biasing members 116, 118 is greater than the force required to compress the insert 120. At this point, the insertion portion 120 is deformed such that further insertion of the luer does not result in further distal movement of the actuator 114. When the luer fitting is removed, the insert 120 expands to its normal volume and the first and second biasing members 116, 118 return the actuator 114 to its original position. The features of the example actuator 114 and biasing members 116, 118 depicted in fig. 16 may be combined with features of other example embodiments disclosed herein.

Fig. 17 depicts another alternative embodiment of catheter hub 14 having an actuator 122 and a return or biasing member 124. The actuator 122 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. A means (not shown) for receiving or engaging a luer fitting extends from the second end of the actuator barrel. One or more projections 126 extend radially from the actuator toward the inner surface of the catheter hub 14. Similar to the embodiment depicted in fig. 2, the projection 126 engages a tab (not shown) on the catheter hub 14 to limit axial movement of the actuator 122.

Biasing member 124 of fig. 17 extends in a distal direction from spacer 128. Biasing member 124 includes two or more arm portions 130 connected to a central hub 132. The central hub 132 is shown as a cylindrical member having an opening. The central hub 132 is configured to engage at least a portion of the front end of the actuator 122. A central hub 132 of various sizes, shapes, and configurations may be used depending on the catheter hub 14 and the actuator 122. The biasing member 124 is preferably made of an elastic material such as silicone rubber. Biasing member 124 may also be, but is not limited to being, made of rubber, silicone rubber, thermoplastic or thermoplastic elastomer. The spacer 128 and biasing member 124 may be integrally formed or the spacer 128 and/or slit 42 may be formed separately from the biasing member.

In various exemplary embodiments, the diaphragm 38 is configured to return the actuator to its original position. When a male luer fitting (not shown) is inserted, the actuator 122 is moved in a distal direction, thereby opening the slit 42 and passing through the septum 128. The partition 38 includes one or more slits 134, the slits 134 defining two or more flaps. In the exemplary embodiment shown in fig. 17, the baffle 38 has three slits 134 defining three triangular flaps. When the actuator 122 is inserted into the partition 38, the flap moves in a distal direction to receive the actuator 122. The flap is resilient and applies a biasing force to the actuator 122 that may be sufficient to return the actuator 122 substantially to its original position or at least to a position that allows the slit 42 to close, depending on the depth of insertion of the actuator 122.

As mentioned above, the length of the luer fitting may vary, and the depth of penetration of the luer fitting into the catheter hub 14 and the resulting movement of the actuator 122 varies depending on the luer fitting. When the actuator 122 travels a certain distance through the partition 38, the partition 38 is unable to return the actuator 122 to a position that allows the slit 42 to close. According to an exemplary embodiment, the biasing member 124 is configured to bias the actuator 122 to at least a position in which the slit 42 may move the actuator 122 to a position that allows the diaphragm 38 to close. If penetration of the luer fitting is long enough, the first end of actuator 122 moves through septum 38 and engages biasing member 124, such as central hub 132. Further movement of the actuator 122 stretches the arm 130. When the luer is removed, the biasing member 124 moves the actuator 122 in the proximal direction until the biasing member 124 is in an unstressed state. At this point, the diaphragm 38 moves the actuator 122 in the proximal direction a sufficient distance to allow the slit 42 to close. The features of the example actuator 122 and biasing member 124 depicted in fig. 17 may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 18 depicts another alternative embodiment of catheter hub 14 having an actuator 134 and a return or biasing member 136. The actuator 134 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the diaphragm 38. The first end includes a nose portion having a chamfered outer surface. The second end of the actuator barrel receives or engages a luer fitting (not shown). Pins 138 extend radially from the side of the actuator cylinder. The pin 138 mates with a slot 140 formed in the catheter hub 14. In the exemplary embodiment, slot 140 is a cam slot having a first portion extending substantially in an axial direction of catheter hub 14 and a second portion extending obliquely, axially, and radially upward from the first portion in a distal direction.

The biasing member 136 of fig. 18 may be, but is not limited to, rubber, silicone rubber, thermoplastic elastomer, springs, leaf springs, elastomeric bands, or other resilient members. The biasing member 136 may apply a force to the actuator 134 in both the axial and radial directions or in only the radial direction. In the exemplary embodiment, a majority of the force applied by biasing member 136 is in a radial direction. When the luer is inserted into the catheter hub 14, the luer moves the actuator 134 in the distal direction. Movement of the actuator 134 slides the pin 138 in the cam slot 140 forcing the actuator 134 to move radially and axially. When the luer is removed, the biasing member 136 forces the actuator back, moving the pin 138 along the cam slot 140 to its initial position. In various exemplary embodiments, the biasing member 136 may act only in a radial direction, such as radially downward in the orientation shown, with a force sufficient to slide the pin 138 along the cam slot 140 to an initial position. The features of the example actuator 134 and biasing member 136 depicted in fig. 18 may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 19A-19B depict another alternative embodiment of catheter hub 14 wherein the actuator and return or biasing member are comprised of a single spring 142. The spring 142 has a first series of windings 144 extending in an axial direction. The first series of windings 144 have a first end that extends through the bulkhead 38. The first series of windings 144 may have a first inner diameter at the distal end and a second inner diameter at the proximal end that is greater than the first inner diameter. The second series of windings 146 extends around at least a portion of the first series of windings 144. The second series of windings 146 may be coaxial with the first series of windings 144 and have a first inner diameter at the proximal end and a second inner diameter at the distal end that is greater than the first inner diameter. The second series of windings 146 has at least one coil that forms an interference fit with the catheter hub 14. The second series of windings 146 may have a shoulder extending around the inner surface to limit movement of the first series of windings 144 and the second series of windings 146.

When the male luer fitting is inserted, the first series of windings 144 moves in the distal direction, compressing the second series of windings 146. Further insertion of the luer causes the first series of windings 144 to move through the septum 38, thereby opening the slit 42. When the luer is removed, the second series of windings 146 returns the first series of windings 144 to their original position. 19A-19B, features of the exemplary actuator and biasing member 142 may be suitably combined with features of other exemplary embodiments disclosed herein.

Fig. 20A-20B depict another alternative embodiment of the catheter hub 14 having an actuator 148 and a return or biasing member 150. The actuator 148 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. The first end includes a rounded nose. A flange 152 for engaging luer fitting 32 extends from the second end of the actuator barrel. The flange 152 is positioned in a slot 154 formed in the catheter hub. Engagement of flange 152 with slot 154 limits axial movement of the actuator.

The biasing member in fig. 20A-20B is preferably an elastomeric tube 150 positioned around the actuator cylinder. The biasing member may be, but is not limited to, rubber, silicone rubber, thermoplastic or thermoplastic elastomer. In various exemplary embodiments, the elastomeric tube 150 is molded to the actuator 148, such as in a multiple molding process, although other suitable mechanical and chemical connections may be used. The elastomeric tube 150 has one or more slits 151 that open to allow the actuator to pass through the slits.

When the male luer fitting 32 is inserted, the actuator 148 is moved in the distal direction such that the elastomeric tube 150 engages the septum 38. Further insertion of luer fitting 32 causes the actuator cylinder to pass through the slit in elastomeric tube 150 and compress elastomeric tube 150 as actuator 148 moves through septum 38. When luer fitting 32 is removed, elastomeric tube 150 returns actuator 148 to its original position. In various exemplary embodiments, the diaphragm 38 may facilitate movement of the actuator 148 in the proximal direction. Features of the example actuator 148 and biasing member 150 depicted in fig. 20A-B may be suitably combined with features of other example embodiments disclosed herein.

Fig. 21A-21C depict another alternative embodiment of catheter hub 14 having an actuator 152 and a return or biasing member 154. The actuator 152 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slit 42. Extending from the second end of the actuator barrel is a cylindrical member for engaging the male luer fitting 32. The actuator is made of a rigid or semi-rigid material.

The biasing member of fig. 21A-21C preferably includes a compressible resilient sleeve 154. The biasing member may be, but is not limited to, rubber, silicone rubber, thermoplastic, or a hot-stock plastic elastomer. In various exemplary embodiments, the elastomeric sleeve 154 is integrally formed with the baffle 156. In further embodiments, the diaphragm 156 and biasing member 154 are integrally formed with the actuator 152, such as by a multiple molding process that over-molds the diaphragm 156 and biasing member 154 to the actuator. In other alternative embodiments, the diaphragm 156 and biasing member 154 may be connected, wrapped or held together by an interference fit, such as by a cylindrical member pressing a portion of the resilient sleeve 154 against the inner surface of the catheter hub 14. The diaphragm 156 and the elastic sleeve 154 comprise a silicone material, although other suitable materials may be used.

As best shown in fig. 21B, the partition 156 has an oval configuration and is formed with a single slit 158. The slit 158 may be formed during molding or cut the partition 156 after the molding operation. The diaphragm 156 is configured such that the slit is in an open orientation and unstressed condition. The baffle 156 is fitted into a slot or groove in the inner surface of the catheter hub 14. The groove is sized to compress the slit to the closed orientation, thereby forming a fluid-tight seal. As best shown in fig. 21C, the elastomer 160 may be overmolded or assembled onto the front edge of the conductor.

When luer fitting 32 is inserted, the actuator moves in a distal direction, compressing sleeve 154. Further insertion of luer fitting 32 moves actuator 152 through septum 156, thereby opening slit 42. When luer fitting 32 is removed, sleeve 154 returns actuator 152 to its original position. The diaphragm 38 may also facilitate movement of the actuator 152 in the proximal direction. The features of the example actuator 152 and biasing member 154 depicted in fig. 21A-21C may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 22 depicts a side opening catheter hub 162, and fig. 23-26 depict various exemplary embodiments of an actuator 164 and a return or biasing member 166 for use with the side opening catheter hub 162. The catheter hub 162 includes a channel and a side opening 168 extending substantially orthogonal to the channel. A diaphragm 170 forming a first valve is positioned in the passageway. A side valve, such as valve sleeve 172, is also positioned in the channel to form a second valve for side opening 168. The valve sleeve is a resilient member, such as a piece of silicone or rubber tubing. The valve sleeve 172 is press fit into the catheter hub. When fluid is introduced into the side opening 168, the valve 172 deforms in a radial direction, allowing fluid to flow around the valve sleeve 172 and into the channel. For a side-port catheter having a valve sleeve of the type described herein, reference is made to U.S. Pat. No. 4,231,367, which is incorporated herein by reference.

Fig. 23-26 depict an actuator 164 having an actuator cylinder surrounding an internal passage. The actuator cylinder has a first end that engages and opens the valve. A cylindrical or frustoconical member extends from the second end of the actuator barrel to engage the male luer fitting. Biasing member 166 is depicted as a metal spring. Biasing member 166 may be, but is not limited to, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer.

In the exemplary configuration of fig. 23, the diaphragm 170 is positioned distally of the side valve 172 in the catheter hub 162 and the biasing member 166 is positioned proximally of the side valve 172 in the catheter hub 162. The biasing member 166 is connected at a first end to the inner surface of the catheter hub 162 and at a second end to the actuator 164, such as by a pair of interference fits. The biasing member 160 may also abut the side valve 172 to limit distal movement.

In the exemplary configuration of fig. 24, the diaphragm 170 and biasing member 166 are positioned distally of the side valve 172. The biasing member 166 is connected at a first end to the inner surface of the catheter hub 162 and at a second end to the actuator 164, such as by a pair of interference fits. The actuator 164 includes a flange 174 or one or more tabs extending radially from the actuator barrel to receive or abut the second end of the biasing member 166.

In the exemplary configuration of fig. 25, the diaphragm 170 and biasing member 166 are positioned proximal to the side valve 172. The biasing member 166 is connected at a first end to the inner surface of the catheter hub 162 and at a second end to the actuator 164, such as by a pair of interference fits. The biasing member may also abut the diaphragm 170 to limit distal movement.

In the exemplary configuration of fig. 26, the diaphragm 170 and the side valve 172 are integrally formed. The biasing member 166 is connected at a first end to the inner surface of the catheter hub 162 and at a second end to the actuator 164, such as by a pair of interference fits. Biasing member 166 may also abut side valve 172 to limit distal movement. The features of the example actuators and biasing members depicted in fig. 22-26 may be suitably combined with the features of other example embodiments disclosed herein.

Any of the catheters described herein may be used in combination with the features depicted in fig. 27-37. The needle hub 14 extends around the needle tip shield 176 and retains the proximal end of the needle 12. Needle cover 178 initially covers needle 12, catheter tube 18, and at least a portion of catheter hub 14. The needle cap 178 may be connected to either the catheter hub 14 or the needle hub 16. The needle 12 initially extends through the needle tip shield 176 and the catheter hub 14. A flexible catheter tube 18 extends from the distal end of the catheter hub 14, with the needle 12 passing through the catheter tube 18. Initially, the needle 12 is inserted into a vein of a patient. Catheter tube 18 is pushed along needle 12 and into the vein following needle 12. When catheter tube 18 is inserted, needle 12 is removed from the patient's vein and through catheter hub 14. The needle tip shield 176 provides protection from puncture by the needle 12 as the needle 12 is retracted from the catheter hub.

According to the exemplary embodiment depicted in fig. 27-36, the needle tip shield 176 includes an outer sleeve 178, an inner sleeve 180, and a resilient metal clip 182. The outer sleeve 178 is connected to the catheter hub 14 and surrounds the inner sleeve 180 and clip 182. An inner sleeve 180 is positioned within the outer sleeve 178 and is movable in an axial direction. The clip 182 is connected to the inner sleeve 180 and is axially movable therewith.

According to the exemplary embodiment depicted in fig. 28-30, the outer sleeve 178 includes an outer surface 184, an inner surface 186, a channel defined by the inner surface 186, a proximal opening, and a distal opening. The outer surface 184 has an octagonal configuration with eight flat sides, although other curved and/or rectilinear shapes may be used. The inner surface 186 has a flat top wall and a flat bottom wall connected by a pair of curved sides. A slot 188 extends through the wall of the outer sleeve 178.

A catch 190 extends from the outer surface to engage a projection on the catheter hub 14. In an exemplary embodiment, the protrusion of the catheter hub is a luer receiving thread, e.gA thread of the type. The fastener 190 has a front edge, a rear edge, and a pair of side edges. An opening or recess is formed between the front edge and the rear edge to receive the protrusion of the catheter hub. The openings allow the fasteners 190 to be formed with a gap approximately equal to or slightly greater than the height of the protrusions, thereby allowing the fasteners 190 to engage the front, rear and/or sides of the connection while minimizing the amount of material and space required. In various exemplary embodiments, a clip 190 is formed without an opening. The catch 190 resists premature release of the needle tip shield 176 from the catheter hub 14.

According to the exemplary embodiment depicted in fig. 31 and 32, the inner sleeve 180 includes a base 192, a distal side 194, and a proximal side 196. Extending from the outer surface of the base 192 are resilient arms 198 and tabs 200. Resilient arms 198 and tabs 200 engage slots 188 in sleeve 184. One or more clip retention 202 extend from an inner surface of the base 192. The clip is positioned between the clip retention 202 and the proximal side 196. The opposing member 204 extends in a distal direction from the distal side 194. The opposing member 204 is tubular and is configured to be inserted into the catheter hub 14. The proximal side 194, distal side 196 and opposing member 204 each have an opening for receiving the needle 12.

According to the exemplary embodiment depicted in fig. 33 and 34, the resilient metal clip 182 includes a base 206 having an opening for receiving the needle 12, a second arm 210 and a first arm 208 extending from the base 206. The first arm 208 extends further in the axial direction than the second arm 210. The first arm 208 has a first hook 212 and the second arm 210 has a second hook 214. A first tab 218 is formed in first arm 208 and a second tab 220 is formed in second arm 210.

Initially, the needle 12 passes through the outer sleeve 178, the inner sleeve 178, and the clip 182. The needle 12 biases the clip 182 into the open position such that the first and second hooks 212, 214 rest along the needle shaft. In the assembled position, the fastener 190 engages with luer threads on the outer surface of the catheter hub 14, with the opposing member 204 extending into the proximal opening of the catheter hub 14. To remove the catch 190 from the catheter hub 14, the outer sleeve 178 of the needle tip shield 176 must be lifted so that the catch 190 can slide over the luer threads. But lifting of the needle tip shield 176 relative to the catheter hub 14 is initially prevented by the opposing members 204 extending into the catheter 14.

When the needle 12 is withdrawn from the catheter hub 14, the distal end of the needle 12 leaves the first and second hooks 212, 214, as shown in fig. 37, causing the first and second arms 208, 210 to approach and the first and second hooks 212, 214 to surround the distal end of the needle 12. Thus, clip 182 is in a closed position in which the distal tip of needle 12 is blocked. Such needle protection mechanisms operate passively (automatically) by the clip 182 when the needle 12 is removed from the catheter hub 14, as no actuation by the user is required to initiate needle protection.

As the needle 12 is pulled further, the needle shaft slides through the needle tip guard 176 until the deformation (e.g., a crimp or projection 250 formed near the distal end of the needle 12 to increase its diameter in at least one direction) engages the base 206 of the clip. The opening in the base 206 of the clip is sized to interact with the deformation such that the needle shaft passes but the deformation does not. Thus, the sharp distal tip region (e.g., including the deformation of the needle 12 and the sharp distal tip) is enclosed by the clip 182.

Further movement of the needle 12 causes the inner sleeve 180 to be pulled further into the outer sleeve 178, thereby removing the opposing member 204 from the catheter hub 14. When the opposing member 204 is withdrawn from the catheter hub 14, the catch 190 may be removed from the luer threaded projection and the needle tip shield 176, needle 12, and hub 16 may be separated from the catheter 10.

Figure 35 shows the arms 198 and tabs 200 of the inner sleeve 180 positioned in the slots 188 of the outer sleeve 178. After the tip of the needle 12 passes the first and second hooks 212, 214 and the first and second arms 208, 210 move to the closed orientation, the tab 200 may engage the slot 188 to resist separation of the inner sleeve 180 and the outer sleeve 178 and possible exposure of the needle 12.

Fig. 36 shows the first tab 216 and the second tab 218 engaged with the first shoulder 220 and the second shoulder 222 on the outer sleeve. The tabs 220, 222 help prevent the clip 182 and inner sleeve 180 from inadvertently sliding into the outer sleeve 178, such as during shipping. Needle 12 biases first arm 208 and second arm 210 to the open position such that tabs 216, 218 engage outer sleeve 178.

Any of the various exemplary embodiments discussed herein may include an antimicrobial system such that one or more antimicrobial agents or antimicrobial coatings may be incorporated or applied to any of the components of the catheter discussed herein. For example, the spring may be coated with a uv curable antimicrobial adhesive coating. The coating may be applied by spraying, batch rolling, or during formation of the spring wire. Suitable coatings are described in U.S. patent No. 8,691,887, the disclosure of which is incorporated by reference. Types of applications for the antimicrobial agent suitable for use herein include chlorhexidine gluconate, chlorhexidine acetate, chloroxylenol, triclosan, hexetidine, and may be included in an actuator lubricant that is employed to facilitate easy penetration and opening of the septum and to facilitate easy return of the actuator to the closed position after luer disconnection.

Fig. 38 shows an exemplary embodiment of an actuator 54. Actuator 54 may be used in any of the embodiments disclosed herein. The actuator 54 includes a nose 58 that reduces friction after the actuator 54 penetrates into the bulkhead 38 of the catheter hub assembly. The actuator 54 further includes an opening 55 extending through the actuator 54 in a direction perpendicular to a centerline of the actuator 54. For example, the actuator 54 may include two rectangular openings 55, although more or fewer openings are contemplated.

The actuator 54 further comprises a plurality of grooves 57 extending axially along a distal portion of the outer surface of the actuator 54 in a plane parallel to the centerline of the actuator 54. For example, there may be four grooves 57 spaced substantially equidistant from each other in the radial direction along the outer surface of the distal portion of the actuator 54, although more or fewer grooves 57 are contemplated. The grooves 57 may have different depths into the actuator 54. The recess 57 differs from the opening 55 in that the recess 57 does not extend completely through the thickness of the actuator 54.

The openings 55 and grooves 57 advantageously provide an increased area for fluid to flow inside the catheter hub assembly. This enlarged area advantageously allows for fluid flushing and prevents fluid from solidifying in the proximal and distal ends of the septum. In addition, the openings 55 and the plurality of grooves 57 advantageously minimize stagnation of the fluid and allow for better mixing. The grooves 57 also prevent the diaphragm from sealing against the outer surface of the actuator during operation. By not forming a sealing interface, fluid is allowed to leak through the diaphragm via grooves 57 and provide additional flushing.

Fig. 39A shows the actuator 54 of fig. 38 in a catheter hub assembly. Similar to the embodiments described above, the catheter hub assembly further includes the catheter hub 14, the spacer 38, and the biasing member 56. As shown, the opening 55 and recess 57 of the actuator 54 provide more area for fluid to flow within the catheter hub 14, thereby achieving the advantages described above.

39B and 39C illustrate the catheter hub assembly as the biasing member 56 is compressed and the actuator 54 penetrates the septum 38. The catheter hub assembly may be configured such that the opening 55 and/or the groove 57 of the actuator 54 optionally penetrate the septum 38. In this embodiment, the opening 55 in the actuator 54 does not penetrate the partition 38. But the recess 57 of the actuator 54 penetrates the diaphragm 38. In addition to the advantages described above, this configuration allows for increased fluid flow from the proximal end to the distal end of the septum 38 through the groove 57. After the operation of the catheter assembly is completed, the actuator 54 is retracted from the diaphragm 38 by the force applied by the biasing member 56. The catheter assembly is configured for multiple uses under depression of the actuator. The features described in this embodiment, such as an actuator, may be used in combination with the features described throughout this application.

Fig. 40A shows another embodiment of an actuator 164 in a catheter hub assembly. The catheter hub assembly includes a catheter hub 162 having a side opening 168. The side openings 168 provide secondary ports to fluid flow in the catheter hub 162. The intersection of the main bore of the catheter hub 162 and the side opening 168 includes a sleeve 172. The sleeve 172 provides selective fluid communication between the side opening 168 and the catheter hub 162. In particular, when sufficient fluid pressure is applied through the side opening 168, the sleeve 172 compresses. Compression of sleeve 172 allows fluid to enter catheter hub 162. The catheter hub assembly further includes a diaphragm 170 and a biasing member 166 that provides tension to the actuator 164.

The actuator 164 includes a plurality of openings 165 that extend through the actuator 164 in a similar manner as described above. The actuator 164 includes two rows of four openings 165 having different sizes and spacings, although different numbers, sizes and spacings of the openings 165 are contemplated. As shown, the openings 165 provide more area for fluid to flow inside the catheter hub 14, thus achieving similar advantages as described above with respect to fig. 38-39C.

Fig. 40B and 40C illustrate the catheter hub assembly as the actuator 164 penetrates the diaphragm 170 and compresses the biasing member 166. The catheter hub is configured such that the opening 165 of the actuator 164 optionally penetrates the diaphragm 170. In this embodiment, the opening 165 in the actuator 164 does not penetrate the diaphragm 170. In addition to the advantages described above, this configuration allows for increased fluid flow between the side opening 168 and the catheter hub 162 at the proximal end of the septum 38. If the opening 165 in the actuator 164 penetrates the septum 170, improved fluid mixing may also occur at the distal end of the septum 38.

When operation of the catheter assembly is completed, the actuator 164 is retracted from the diaphragm 170 by the force applied by the biasing member 166. The catheter assembly is configured for multiple uses under depression of the actuator 164. The features described in this embodiment, such as an actuator, may be used in combination with the features described throughout this application.

Fig. 41 shows a cross-sectional view of another exemplary embodiment of a catheter assembly 300 having a different type of needle protection mechanism, in which case the needle protection mechanism receives the entire needle within a protective tube or cartridge, rather than protecting only the needle tip. Because user activation (by depressing the activation button 308) is required to initiate needle protection, the catheter assembly 300 employs active (rather than passive or automatic) needle protection. Both active and passive needle protection fall within the scope of the present invention.

The operation of catheter assembly 300 is as follows. Catheter 302 and needle 304 are inserted into a vein of a patient. When the needle 304 and catheter 302 are fixedly placed, the activation button 308 is depressed. When the activation button 308 is depressed, as shown in fig. 42, the inner needle seat or inner needle housing 312 disengages from the wall (not shown) of the activation button 308. The needle 304 is then retracted into the catheter hub 306. The spring 310 surrounding the inner needle housing 312 is released by the activation button 308, which causes the inner needle housing 312 to travel to the opposite end of the outer needle housing 314. Thus, the needle 304 is now in a retracted position in which the entire needle 304 (including its sharp distal tip) is held in the outer needle housing 314. The inner needle housing 312 holding the needle 304 is held in the outer needle housing 314 by the force exerted by the spring 310. Thus, the combination of the inner needle housing 312, outer needle housing 314, and spring 310 is an exemplary needle protection component.

More information about the active needle protection mechanism used in this embodiment can be found in U.S. patent nos. 4,747,831、5,501,675、5,575,777、5,700,250、5,702,367、5,830,190、5,911,705、8,361,038、8,388,583、8,469,928、8,864,715 and 8,932,259, the contents of which are incorporated herein by reference. The features described in this embodiment, including the active needle protection features, may be used in conjunction with the catheter assemblies described throughout this application.

Fig. 43 shows a cross-sectional view of another exemplary embodiment of a catheter assembly 400 having a different type of needle protection mechanism, in this case, which only protects the needle tip as in fig. 27-37. Because user actuation is not required to initiate needle protection, the needle protection mechanism disclosed in catheter assembly 400 operates passively (automatically) when needle 402 is removed from catheter hub 406. The operation of catheter assembly 400 is as follows. Catheter 404 and needle 402 are inserted into a vein of a patient. When the needle 402 and catheter 404 are fixedly placed, the needle 402 is retracted by the user.

When the user pulls on the outer needle housing or outer needle hub 414, the needle 402 is withdrawn from the catheter 404. The needle 402 is then retracted into the catheter hub 406, with the sharp distal tip of the needle 402 eventually entering into the inner needle housing 408. Prior to the distal tip of the needle 402 entering the inner needle housing 408, the needle 402 contacts and biases the longitudinal metal clip 412 into the open position. The longitudinal clip 412 may be, for example, a leaf spring that extends and compresses in a longitudinal direction. When the distal tip of the needle 402 is sufficiently advanced into the inner needle housing 408, as shown in fig. 44, the clip 412 extends into the inner needle housing 408 toward the centerline of the needle 402. Thus, clip 412 is no longer biased into a closed position in which the distal tip of needle 402 is blocked.

The needle 402 further comprises a deformation 403 adjacent to the distal tip of the needle. In at least one direction, the diameter of the deformation 403 is larger than the diameter of the rest of the needle 402. The deformation 403 prevents the needle 402 from exiting the inner needle housing 408 during retraction of the needle 402. In particular, when the distal tip of the needle 402 is located in the inner needle housing 408, the deformation 403 contacts the rear wall of the inner needle housing 408 and prevents the needle 402 from exiting the inner needle housing 408. Thus, the distal tip of the needle 402 and the deformation 403 are enclosed in the inner needle housing 408. Clip 412, needle 402, inner needle housing 408, and outer needle housing 414 are exemplary needle protection components.

As shown in FIG. 45, as the user continues to pull the outer needle housing 414, the inner needle housing 408 and catheter hub 406 disengage and disengage. In particular, boss 410 of inner needle housing 408 is disengaged from the hole in catheter hub 406.

After the needle 402 is used, the inner needle housing 408 and the outer needle housing 414, which enclose the distal end of the needle 402, are discarded. The catheter hub assembly may then be used. In particular, the user may engage the luer fitting 416 and catheter hub 406 to cause the actuator to open or penetrate the septum and establish fluid communication.

More information about the needle tip protection mechanism used in this embodiment can be found in U.S. patent nos. 5,215,528 and 5,558,651, the contents of which are incorporated herein by reference. The features described in this embodiment, including passive needle protection, may be used in conjunction with the catheters described throughout this application.

Fig. 46 shows a cross-sectional view of another exemplary embodiment of a catheter assembly 500 having a needle tip shield. Because user actuation is not required to initiate needle protection, the needle protection mechanism disclosed in catheter assembly 500 operates passively (automatically) when needle 512 is removed from catheter hub 514. The operation of catheter assembly 500 is as follows. During operation, similar to that described in the above embodiments, the needle 512 extends through an actuator 528 that pierces a septum 526 in the catheter hub 514. The V-clip 540 located in the needle tip shield 520 is biased by the needle 512 to an open position (the V-clip 540 is compressed) to allow the needle 512 to pass beyond the V-clip 540. The V-clip 540 comprises a resilient metal clip. After operation of the catheter assembly 500, the biasing member 530 retracts the actuator 528 into the catheter hub 514.

Fig. 47 shows a cross-sectional view of catheter assembly 500 with needle 512 in the retracted position. When the distal tip of the needle 512 enters the needle tip shield 520 and is positioned on the proximal end of the V-clip 540, the V-clip 540 is no longer biased. Instead, the V-clip 540 expands into a closed position (the V-clip is expanded) in the needle tip shield 520 to prevent the needle 512 from traveling beyond the V-clip 540. The expansion of the V-clip 540 in the needle tip shield 520 forms one or more barriers (described below) that prevent the distal tip of the needle 512 from exiting the needle tip shield 520.

The needle tip shield 520 includes a metal washer 542 and the needle 512 includes a deformation 596 adjacent the distal tip of the needle 512. The diameter of the deformation is greater than the diameter of the remainder of the needle 512 in at least one radial direction. In at least one radial direction, the diameter of the deformation 596 is larger than the through hole in the washer 542, in which the needle 512 travels. Thus, during retraction of the needle 512, the deformation 596 prevents the needle 512 from exiting the washer 542. Thus, when the needle 512 is in the retracted position, the distal tip of the needle 512 and the deformation 596 are enclosed by the washer 542 and the barrier of the V-clip 540.

Fig. 48 shows a bottom plan view of the catheter hub assembly and the needle hub assembly as the needle is retracted. Catheter hub 514 includes a collar 534 having a collar opening 536 and luer threads 532. When the needle 512 biases the V-clip 540 to the open position as described above, the latch 584, which is connected to the foot 582 of the V-clip 540, engages the collar 534. The V-clip 540, which engages the collar 534, maintains the catheter hub 514 connected to the tip shield 520.

On the other hand, when the needle 512 is in the retracted position and the V-clip 540 is no longer biased, the V-clip 540 moves to the closed position. In the closed position, the latch 584 and the foot 582 of the V-clip 540 are moved into axial alignment with the collar opening 536. The collar opening 536 thus allows the catheter hub 514 to disengage from the tip shield 520.

Additionally, the barrier 578 in the V-clip 540 prevents the distal tip of the needle 512 from exiting the needle tip shield 520 when the V-clip 520 is moved to the closed position. Preferably, the barrier 578 includes two barriers, although more or fewer barriers are contemplated. The combination of the V-clip 540 and the washer 542 is an exemplary needle protection component.

The V-clip 540 further includes an outer wall 570 and a spade (spade) 566 configured to attach the V-clip 540 to the outer wall of the needle tip shield 520. The outer wall of the needle tip shield 520 includes protrusions 589 that secure the V-clip 540 by creating friction between the V-clip 540 and the needle tip shield 520. This configuration advantageously secures the V-clip 540 to the needle tip shield 520 and avoids the use of an outer housing for installation. Thus, the width of the needle tip shield 520 is advantageously reduced.

The catheter hub assembly may then be used as a multipurpose blood control device when the catheter hub assembly and needle tip shield 520 are separated. In particular, the actuator 528 may be engaged multiple times using the luer threads 532 in a similar manner as described in the embodiments above.

More information about the needle tip mechanism used in this embodiment can be found in U.S. patent nos. 6,749,588, 7,604,616 and U.S. patent application publication No. 2014/0364809, the contents of which are incorporated herein by reference. The features described in this embodiment, including the passive needle protection features, may be used in combination with the features described throughout this application.

Needle protection members other than those disclosed herein may also be used in the present invention. These needle protecting components may be needle tip shields as exemplified by the embodiments of FIGS. 27-37, 43-45 and 46-48, may be needle enveloping tubing as exemplified by the embodiments of FIGS. 41-42, or may be other arrangements. When the needles are removed from the catheter hub, they may be operated passively (automatically) as in the embodiments of fig. 27-37, 43-45 and 46-48, or they may require active actuation by the user as in the embodiments of fig. 41-42.

Fig. 49-51 illustrate various exemplary embodiments of blood flashback in a catheter assembly. Flashback is the visualization of blood, which confirms entry of the needle tip into the vein. The first flashback 600 is observed through the catheter tube as blood travels to the open distal end of the hollow needle 612, out of the notch or opening 602 of the needle 612 near the needle tip, and up through the interior annular space between the needle 612 and the interior of the catheter tube. A second flashback 604 is observed in the hub/grip as it exits the rear of the needle 612 and enters the flashback chamber in the hub/grip. Through the porous membrane or micro-groove, air is expelled by the stopper in the rear of the hub/grip. The third flashback 606 is visible in the catheter hub 614 when blood from the first flashback 600 flows into the catheter hub and stops at the blood control septum. Air is expelled through the micro-grooves in the outer periphery of the blood control septum. The features described in these embodiments, including the blood flashback feature, may be used in combination with the features described throughout the application.

In another embodiment similar to the embodiment shown in fig. 3-8, the assembly 10 does not include the return member 56. Instead, as previously described, the flap defined by the slit 42 of the elastomeric septum 38 acts as the return member 56. Before operation, the actuator 44 is in a free state and does not contact the diaphragm 38 (the first position of the actuator 44). In operation, the diaphragm 38 is in an open state in which the actuator 44 contacts the diaphragm 38 and urges the slit 42 (the second position of the actuator 44) against the diaphragm. The open state of the partition 38 allows fluid communication. In the open state of the partition 38, the actuator 44 does not extend through the partition 38. In other words, the actuator 44 does not penetrate the partition 38. As a result, when the operation is complete and upon removal of axial pressure on the actuator 44, the resilient flap defined by the open slit 42 of the diaphragm 38 causes the actuator 44 to retract to the first position.

In another embodiment, as shown in fig. 52-55, the valve actuator 744 functions in a similar manner to the valve actuator of the catheter assembly described in the embodiment of fig. 3-8. However, for reasons described below, the valve actuator 744 of the following embodiments improves the flushing ability of the catheter assembly during saline flushing.

Similar to the embodiment of fig. 3-8, the valve actuator 744 includes a shaft portion 750, a reduced diameter region 752, and a mating portion 754. The valve actuator 744 may be about 0.529 inches in length. Shaft portion 750 is configured to penetrate the septum of the catheter assembly. In particular, the shaft portion 750 includes a distal opening 746b that provides access to a hollow interior passageway 746a that extends through the length of the valve actuator 744. When the valve actuator 744 penetrates the septum, a fluid, such as blood or saline, travels through the hollow interior passageway 746a. The valve actuator 744 also includes a plurality of openings 746c that provide a passageway for fluid to leave the hollow interior passageway 746a.

The mating portion 754 is disposed at the distal end of the valve actuator 744. The mating portion 754 may have an outer diameter of about 0.138 inches. The outer diameter of the mating portion 754 is greater than the outer diameter of the shaft portion 750 so that the mating portion 754 can be engaged with and disengaged from a luer fitting.

The reduced diameter region 752 is a sloped member disposed near the proximal end of the inner diameter of the valve actuator 744. The reduced diameter region 752 is disposed between the shaft portion 750 and the mating portion 754 to connect the shaft portion 750 and the mating portion 754 and provide a continuous outer surface of the valve actuator 744. The reduced diameter region 752 includes a plurality of projections 758 on the outer diameter as shown in fig. 52-57 and on the inner diameter as shown in fig. 58. The protrusions 758 advantageously facilitate assembly of the spring and securing the spring in the catheter assembly during operation.

The reduced diameter region 752 also includes a plurality of windows 756. As shown in fig. 3-8, the window may extend the full length of the reduced diameter region of the valve actuator. In a valve actuator 744 having a length of about 0.529 inches and a maximum outer diameter of about 0.138 inches, the full length (or height) of the reduced diameter region of fig. 3-8 can be, for example, 0.035-0.040 inches. 52-55, however, the window 756 extends only a portion of the reduced diameter region 752.

In particular, fig. 52-55 illustrate that for an actuator having the noted overall dimensions, the windows 756 may extend approximately 0.005 inch, 0.010 inch, 0.015 inch, and 0.020 inch, respectively, from the distal end of the reduced diameter region 752. Other embodiments include windows 756 that extend any length less than the full length of the reduced diameter region 752. Alternatively, the window 756 may extend approximately 1/2 or 1/3 of the length of the reduced diameter region 752. Fig. 56 and 57 illustrate window 756 adjacent the distal end of reduced diameter region 752, but outside of reduced diameter region 752. The window 756 of fig. 56 and 57 is located in the mating portion 754 of the valve actuator 756. The windows 756 of figures 56 and 57 may extend at lengths of approximately 0.010 inches and 0.020 inches, respectively. Advantages of window 756 are provided below.

During use, valve actuator 756 is typically flushed with saline, for example, to remove any remaining blood or fluid. However, even after a physiological saline flush, blood or fluid deposits may still remain. The window 756 is reduced in size and is placed at the proximal end of the reduced diameter region 752 to advantageously improve saline flushing.

In particular, the size (length or height) of the window 756 increases the velocity of the saline flow. The saline flow 748 of fig. 54A represents each window 756 of fig. 52-55. As shown in fig. 54A, the fluid flush rate of the saline flow is almost entirely in the radial direction when exiting the window 756. This is because the window 756 is smaller in size than the window of the valve actuator of fig. 3-8. The window 756 is sized such that fluid traveling in a longitudinal direction (axial direction) through the internal passageway 746a transitions to a vertical direction (radial direction) away from the valve actuator 744. For actuators having the total dimensions mentioned, the preferred optimal dimensions (length or height) are about 0.0125±0.005 inches. The closer the size of the window 756 is to this preferred size, the more radial the direction of flow the fluid will exit the window 756. Higher velocity radial flow will optimize flushing performance.

When compared to the embodiment of fig. 52-58, the flushing fluid velocity traveling through the windows of the valve actuator in fig. 3-8 has a higher axial component and travels at a lower velocity due to the larger window size. Thus, a small portion of the reduced flush may remain near the corner between the inner diameter of the adapter and the proximal end of the flush window.

By disposing windows 756 at the distal end of the reduced diameter region 752, the flow velocity and direction are improved. The windows 756 outside the reduced diameter portion 752 cause the fluid flow in the internal passageway 746a to change direction more abruptly than the windows in the valve actuator of fig. 3-8. This is because fluid flowing through the internal passageway 746a travels shorter as the flow reaches the window 756. Thus, the window 756 outside the proximal end of the reduced diameter portion 750 forces the flow to change to a more radial direction as it exits the window 756.

Fluid traveling through windows 756 in reduced diameter region 752 responds similarly. In these embodiments, the distance of the window 756 from the centerline of the valve actuator 744 is variable between the distal and proximal ends of the reduced diameter region 752. This variable flow travel length slightly alters the flushing performance of the window 756. As noted above, the optimal size (length or height) of the window is about 0.0125±0.005 inches for an actuator having the mentioned overall dimensions. The combination of radial flow direction and increased velocity advantageously enhances flushing.

Fig. 59 and 60 are graphical illustrations of improved flushing performance of the valve actuator. Fig. 59 shows a valve actuator having the window of fig. 3-8, and fig. 60 shows a valve actuator having the window 756 of fig. 53. The dashed line identified by the number represents the amount of blood remaining in the catheter hub after the physiological saline flush. The remaining blood was measured by a ratio of blood mass to 3 ml of physiological saline, 760 having a ratio of 1.0, 762 having a ratio of 0.9, 764 having a ratio of 0.8, 766 having a ratio of 0.7, 764 having a ratio of 0. As shown in the window portions of fig. 59 and 60, the amount of blood remaining in the reduced window design of fig. 60 is significantly less than the amount of blood remaining in the normal window design of fig. 59.

FIG. 61 shows another graphical representation of the amount of blood remaining after a 0.3 ml saline flush. The data points show the amount of blood remaining after the physiological saline flush in various sized windows 756 in the valve actuator 744 of fig. 52-55 and in the windows of the valve actuators of fig. 3-8. In particular, at a window height of 0.0125 inches, the amount of blood remaining is about 2.2%. With a window height of 0.0375 inches of fig. 3-8, the amount of blood remaining is approximately 4.3%. Thus, as shown, the fluid flushing performance is improved by about 50% when the window is about 0.0125 inches, as compared to the window in the valve actuator of fig. 3-8.

Fig. 62-65 illustrate an alternative embodiment of a catheter assembly 810 having various components that function in a similar manner to the embodiments described above. In particular, needle seat 816 operates in a similar manner to the embodiment of FIGS. 46-48. Catheter hub 814 operates in a similar manner to the embodiment of fig. 4-8, except for the differences detailed below.

When not in use, the needle and catheter tubing of catheter assembly 810 are enclosed by needle cover 878. Needle cover 878 is removed to begin operation of catheter assembly 810. Catheter assembly 810 also includes a flow control plug 820 similarly depicted in fig. 51. In particular, plug 820 includes a porous membrane or micro-groove disposed at the proximal end of hub 816 to vent air while containing blood.

Fig. 63 shows catheter hub 814 and needle hub 816 of catheter assembly 810. In particular, catheter hub 814 includes a metal wedge 834 made of, for example, 302, 304, or 305 stainless steel in an annealed state. Alternatively, the metal wedge 834 may be 302 or 304 stainless steel in or near an annealed state. 302 and 304 stainless steels have very low magnetic susceptibility in the annealed state, which is advantageous when the catheter assembly is left on the patient during a Magnetic Resonance Imaging (MRI) procedure.

Fig. 64 shows the catheter hub 814 and fig. 65 shows the valve actuator 844 of the catheter hub 814 prior to operation. In particular, catheter hub 814 includes an inner diameter 815 and undercut 813. The inner diameter 815 is larger than the undercut 813. Undercut 813 is used to secure spring 856 as described further below.

Catheter hub 814 also includes a septum 838. Baffle 838 is secured to the inner diameter 815 of catheter hub 814 by an interference fit to ensure proper operation of baffle 838. Baffle 838 contacts the inner wall of catheter hub 814 for proper positioning. Septum 838 passes through undercut 813 when assembled from the proximal end of catheter hub 814.

Valve actuator 844 is configured to penetrate septum 838 during operation of catheter assembly 810. When the valve actuator 844 penetrates the partition 838, the spring 856 is compressed. Subsequently, the spring 856 retracts the valve actuator 844 after piercing the septum 838. Spring 856 includes a central coil 857 and two or more end coils 858. End coil 858 has a larger outer diameter than central coil 857.

Tests have shown that the material of the metal wedge 834 does not cause magnetic problems during the MRI procedure, but this is not necessarily the case for the spring 856. Either 302 stainless steel or 304 stainless steel is a conventional material for springs because of its higher carbon content and ease of manufacture. However, the catheter assembly including the springs composed of 302 or 304 stainless steel has very high magnetic properties when hardened to the level required for the springs. In particular, the metal of the spring must be cold worked to elasto-tempering in order to have a higher shear strength, which thus makes the metal more susceptible to magnetization.

Thus, springs constructed of 302 or 304 stainless steel in the catheter assembly may not be compatible for use in Magnetic Resonance Imaging (MRI) procedures. This is because the magnets of the MRI device may cause sensitive metals in the catheter assembly to pull, twist, and heat. Thus, the catheter assembly with the spring constructed of 302 or 304 stainless steel should be removed from the patient prior to performing the MRI procedure.

316 Stainless steel is not commonly used as a spring material due to its low strength, high cost, and difficult processing. But 316 stainless steel is the preferred material for the spring 856 and advantageously increases in strength as the tempering of the material changes. In this example, the tempering of the 316 stainless steel was increased to meet the ASTM F138-08 material strength standard for stainless steel surgical implant devices. Preferably, the strength requirements of the spring 856 exceed the strength requirements specified in ASTM F138.

As the tempering of 316 stainless steel increases, so does the magnetic attraction force. However, due to the lower carbon content, 316 stainless steel has a lower magnetic property than 302 or 304 stainless steel. In particular, the composition of the 316 series stainless steel or its equivalent, particularly the chromium and nickel content and the ratio of the Cr/Ni content in these alloys, helps the austenitic phase to remain stable and resist transformation to martensite throughout the cold working process. The low carbon content of the "L" grade 316 stainless steel also contributes to alloy stability. Thus, when the 316 stainless steel reaches spring temper, the spring 856 in the catheter assembly 810 can be compatibly used in MRI procedures.

In particular, the spring 856 is advantageously made of 316 stainless steel cold worked to elastomehc. Other preferred materials for the spring 856 include 316L stainless steel, 316LVM stainless steel (bare wire without nickel coating, minimum tensile strength 240 ksi), titanium, beryllium, copper, magnesium, and magnesium alloys such as Elgiloy (R). Alternatively or additionally, the spring 856 is plated with a diamagnetic material, such as palladium, to achieve a desired permeability. The spring 856 may be magnetizable but plated with a diamagnetic material to substantially counteract the overall magnetic properties of the material. Thus, the diamagnetic material may help to achieve zero net attraction of the metal.

These material and process choices allow the springs 856 in the catheter assembly 810 to achieve a relative magnetic permeability of less than 2.0, preferably less than 1.1. The relative permeability is a dimensionless value as is generally understood by those of ordinary skill in the art. The choice of materials and associated processing for the spring 856 advantageously allows the catheter assembly 810 to remain attached to the patient during the MRI procedure. In other words, proper alloy and metal tempering is used in the catheter assembly 810 to keep the susceptibility low enough that there are no compatibility issues with the catheter assembly 810 during the MRI procedure.

During assembly, one of the end coils 858 of the spring 856 travels through the undercut 813 and is snapped into place. In particular, end coil 858 is movably captured between baffle 838 and undercut 813. The end coils 858 of the springs 856 advantageously do not have to be arranged at precise locations. The outer diameter of end coil 858 is greater than the diameter of undercut 813 to movably retain spring 856. Thus, the spring 856 and the catheter hub 814 advantageously prevent accidental removal of the valve actuator 844. Moreover, the improved assembly advantageously results in less variation in the functionality of the catheter assembly 810.

The outer diameter of the central coil 857 is smaller than the diameter of the undercut 813. This advantageously prevents interference and allows the spring 856 to move axially in the catheter hub 814 a limited amount until a luer fitting is attached.

There is a clearance fit between the inner diameter 815 of the catheter hub 814 and the outer diameter of the end coil 858 of the spring 856. The clearance fit advantageously facilitates assembly and operation of the spring 856. In particular, once end coil 858 passes undercut 813 during assembly, spring 856 is properly positioned. The other end coil 858 is immovably fixed to the valve actuator 844. Thus, when no luer is present, the spring 856 and valve actuator 844 may move axially or "float" (within limits) inside the catheter hub 814. The actuator does not contact the inner diameter 815 of the catheter hub 814.

When there is an interference fit between the spring and the inner diameter of the catheter as described in the embodiment of fig. 3-8, it may be difficult to place the spring in the correct position. In particular, due to the length of the inner diameter in the catheter hub, it may be difficult to set the exact position of the spring. Moreover, the shoulder on which the diaphragm rests goes deep inside the length of the inner diameter of the duct seat.

Furthermore, the interference fit requires very tight tolerances on the outer diameter of the spring and on the inner diameter of the catheter hub. If the interference fit is too severe, the life of the spring may be compromised. If the interface between the spring and the inner diameter of the catheter hub becomes loose, the spring and valve actuator may be inadvertently removed.

An interference fit may also present operational problems because the diaphragm may move with the spring during retraction. This is because the interference fit between the spring and the inside diameter of the catheter hub may cause a jam, where the diaphragm moves with the spring. The higher force in the interference fit overcomes the friction of the diaphragm and causes the diaphragm to move with the spring. Additionally, the interference fit may cause undue pressure on the valve actuator 844 during retraction. Moreover, if spring 856 is compressed too far distally such that septum 838 is compressed, the interference fit may not allow septum 838 to retract or relax. As a result, the baffle 838 may leak over time due to excessive and sustained compression.

On the other hand, in the event that there is a clearance fit between the spring 856 and the inner diameter 815 of the catheter hub 814, the spring 856 may move axially when no luer fitting is present, and the spring may apply pressure to the proximal face of the septum 838 only when the luer fitting is inserted. Thus, the combination of clearance fit and undercut 813 advantageously improves handling, ability to position the spring 856, and manufacturability of the catheter assembly.

According to another embodiment, as shown in fig. 66-68, a valve actuator 900 with a single stepped distal tip includes a side opening 902, a distal end 904, a distal end opening 905, a step 906, a radius 908, and an outer diameter 910. The openings 902, 905 provide for fluid flushing and flow through the valve actuator 900 when engaged to a septum in a conduit. The openings 902, 905 operate in a similar manner as described in the above embodiments.

A step 906 is disposed between the distal end 904 and the outer diameter 910 of the valve actuator 900. Since the valve actuator 900 is injection molded, no sharp edges are formed on its outer surface. Instead, the rounded portions 908 are disposed on either end surface of the step 906. In particular, the rounded portion 908 is disposed at the interface between the step 906 and the distal end 904 and at the interface between the step 906 and the outer diameter 910. The step 906 at the distal end 904 of the valve actuator 900 replaces the taper at the distal end of the valve actuator of the above-described embodiments. The rounded portion 908 advantageously allows for ease of manufacture during injection molding.

Fig. 69-71 illustrate a valve actuator 950 with a dual stepped distal end tip according to another embodiment. In this embodiment, the valve actuator 950 includes an opening 952, a distal end 954, a distal end opening 955, a radius 958, and an outer diameter 960 in a manner similar to that described in the embodiment of fig. 66-68. However, the valve actuator 950 has two steps 956 between the outer diameter 960 and the distal end 954. The two steps 956 have two different diameters with a suitable radius 958 on each end surface. Similarly, the rounded portion 908 advantageously allows for ease of manufacture during injection molding.

The foregoing detailed description of certain exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application so as to enable others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and are intended to be within the scope of the description and the invention. The specification describes specific examples to achieve more general objectives, which may be achieved in other ways.

The terms "front", "rear", "upper", "lower", "upward", "downward" and other directional descriptors used in the present application are all intended to facilitate description of the exemplary embodiments of the present application, and are not intended to limit the structure of the exemplary embodiments of the present application in any particular location or orientation. Terms of degree, such as "substantially" or "about" should be understood by one of ordinary skill to refer to a reasonable range outside of the given values, such as, for example, general tolerances associated with the manufacture, assembly, and use of the described embodiments.

Claims

1. A valve assembly comprising a valve and a valve actuator that moves in a conduit assembly between a first position in which the valve is closed and a second position in which the valve is open, the valve actuator comprising:

A shaft portion at a distal end of the valve actuator, the shaft portion configured to open the valve; and

A mating portion at a proximal end of the valve actuator, the mating portion configured to engage a luer device;

Wherein the shaft portion at the distal end of the valve actuator comprises a first step having an outer diameter smaller than an outer diameter of the shaft portion and a second step having an outer diameter smaller than an outer diameter of the first step,

The first step includes a first rounded portion, the second step includes a second rounded portion,

Wherein the first rounded portion is disposed adjacent to the first step and at an interface between the first step and the second step of the valve actuator, and

The second rounded portion is disposed adjacent to the outer diameter of the valve actuator and at an interface between the first step and the outer diameter of the valve actuator.

2. A valve actuator, the valve actuator comprising:

A shaft portion at a distal end of the valve actuator, the shaft portion configured to open a valve; and

3. The valve actuator of claim 2, wherein the first and second steps are adjacent to each other.

4. The valve actuator of claim 2, wherein the first step is adjacent to a distal surface of the valve actuator.

5. A catheter assembly, comprising:

A conduit;

a needle having a distal tip and disposed within the catheter;

a catheter hub connected to the catheter such that the needle passes through the catheter hub, the catheter hub comprising:

a valve that selectively permits or blocks fluid flow through the conduit;

The valve actuator of claim 2, the valve actuator moving between a first position and a second position; and

A return member for returning the valve actuator from the second position to the first position; and

A needle protection component enveloping the distal tip of the needle, wherein,

The return member comprises a metal member having a relative permeability of less than 2.0; and

The return member comprises one of 316L stainless steel and 316Lvm stainless steel.

6. The catheter assembly of claim 5, wherein the return member comprises a spring.

7. The catheter assembly of claim 5, wherein the relative permeability is less than 1.1.

8. The catheter assembly of claim 5, wherein the return member is plated with a diamagnetic material.

9. The catheter assembly of claim 8, wherein the diamagnetic material comprises palladium.

10. The catheter assembly of claim 5, wherein the catheter assembly is capable of remaining attached to a patient during a magnetic resonance imaging procedure.