CN115350381A

CN115350381A - Valve assembly, valve actuator and conduit assembly

Info

Publication number: CN115350381A
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: 2022-11-18
Also published as: CN112190817A; CN112190817B; ES2834969T3; CN107613891A; CN107614046B; CN107613891B; CN107614046A

Abstract

A valve assembly, valve actuator and conduit assembly, the valve assembly including 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 includes a step.

Description

Valve assembly, valve actuator and conduit assembly

The present application is a divisional application of the chinese patent application No. 201680030890.8 entitled "multipurpose blood control safety catheter assembly", filed 2016, 15/4/2016, international application number PCT/US2016/027955, to chinese national stage.

RELATED APPLICATIONS

This application claims the benefit of international patent application No. pct/US2015/026534 filed on day 4-month 17-2015, international patent application No. pct/US2015/026536 filed on day 4-month 17-2015 and international patent application No. pct/US2015/026542 filed on day 4-month 17-2015 and 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 a catheter assembly.

Background

Catheter assemblies are used to properly place a catheter into the vascular system of a patient. Once in place, a catheter, such as an intravenous catheter, may be used to infuse a liquid including conventional saline, medical compositions, and/or nutritional components into a patient in need of such treatment. Catheters additionally make it possible to remove fluids from the blood circulation system and to monitor conditions within the vascular system of a patient.

Disclosure of Invention

An aspect of the invention provides a catheter assembly wherein the valve actuator comprises a plurality of windows that are specifically sized and arranged to enhance saline flush 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 plurality of materials to reduce the magnetic 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 can be achieved by providing a valve actuator that moves 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 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 further achieved by providing a valve actuator that moves 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, wherein the plurality of windows are disposed outside of the reduced diameter region.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly including: a conduit; a needle having a sharp distal tip located within a catheter; a catheter seat connected to a catheter so as to pass a needle therethrough, the catheter seat including a valve that selectively allows or blocks fluid flow through the catheter; a valve actuator movable between a first position and a second position; and a return member that returns the valve actuator from the second position to the first position; and a needle protection component that encapsulates a sharp distal tip of a 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 can also be achieved by providing a catheter assembly including: a conduit; a needle having a sharp distal tip located within a catheter; a catheter seat connected to a catheter so as to pass a needle therethrough, the catheter seat including a valve that selectively allows or blocks fluid flow through the catheter; a valve actuator movable between a first position and a second position; a return member that returns the valve actuator from the second position to the first position; and a needle protection component enclosing the 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 arranged outside the reduced diameter region.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly including: a conduit; a needle having a sharp distal tip located within a catheter; a catheter seat connected to a catheter so as to pass a needle therethrough, the catheter seat comprising an inner diameter; a valve that selectively allows or blocks fluid flow through the conduit; a valve actuator movable 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 can also be achieved by providing a catheter assembly including a catheter; a needle having a sharp distal tip located within a catheter; a catheter hub connected to a catheter so 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 movable between a first position and a second position; and a return member that returns 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 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 and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above aspects and features of the invention will become more apparent from the description of exemplary embodiments of the invention with reference to the attached 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 seat and actuator;

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

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

FIG. 4 is a cross-sectional side view of the catheter seat 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 inserted;

FIG. 6 is a cross-sectional side view of the catheter seat 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 fitting removed;

FIG. 8 is a cross-sectional side view of the catheter hub of FIG. 7 with the luer fitting 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 shows 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 shows 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 pushed through the 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 shows a cross-sectional side view of another exemplary embodiment of a catheter having an actuator and a biasing member and a luer inserted therein;

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

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

figure 22 is a perspective view of a side-ported catheter;

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

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

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

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

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

FIG. 32 is a bottom perspective view of the inner sleeve of FIG. 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 the closed position;

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

FIG. 39A illustrates 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 base assembly of FIG. 39A as it penetrates the septum;

FIG. 39C illustrates a left side perspective cross-sectional 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 base assembly;

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

FIG. 40C illustrates a left side perspective cross-sectional 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 the 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 illustrates a cross-sectional view of the catheter hub assembly and hub assembly of FIG. 46 in a needle retracted position;

FIG. 48 illustrates a bottom plan view of the catheter hub 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 illustrates 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, in accordance with yet another embodiment;

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

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

FIG. 55 shows a side perspective view of a valve actuator including a window in a reduced diameter region in accordance with yet another embodiment;

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

FIG. 57 depicts 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 the catheter hub with the valve actuator of the embodiment 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 and needle hub portion of the embodiment of FIG. 62;

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

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

FIG. 66 shows 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 shows 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, the 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, 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 follows needle 12 into the vein. After insertion of the catheter tube 18, the needle 12 is removed from the patient's vein and catheter hub 14, leaving the catheter tube 18 in the patient and the needle 12 discarded.

According to various exemplary embodiments, the catheter seat 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 passage 28 that allows fluid to pass through the catheter hub 14. The outer surface 26 includes one or more protrusions 30 to secure a luer fitting 32 (fig. 4) to the catheter hub 14. The lug 30 and the luer 31 may form a threaded connection or the lug may be connected to the luer 32 by a snap fit or other twist connection. An example of a standard connection is

And (4) connecting. Some types of luer fittings 32 utilize a slip fit into the 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 can be viewed by a user, or the catheter hub may be made of an opaque material.

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

A pre-slit elastomeric septum 38 is positioned in the passage 28 and functions as a valve that forms a fluid seal and selectively permits fluid flow into or out of the flexible catheter tubing 18. In other words, the valve selectively permits or blocks fluid flow through the flexible conduit tube 18. The diaphragm 38 may be seated against the diaphragm flange 40 to limit distal movement. The tabs or other internal structures may form an interference fit with the septum 38 to hold the septum in place or to limit proximal movement of the septum. As best shown in FIG. 2B, the partition 38 has one or more pre-formed openings or slots 42 designed to selectively prevent unwanted fluid flow through the partition 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. A fluid passage 39 is provided on the outer circumference of the partition 38. Eight fluid channels 39 are shown equally spaced from one another, although different numbers and locations are contemplated. The fluid channel 39 has a suitable width and depth so that when the septum 38 is not open, blood can enter and air can escape the space in the front of the catheter hub 14 distal to the septum. At the same time, the size of the fluid channel 39 is small enough to prevent blood from flowing out through the septum 38 (at least for a certain period of time). Such a configuration is possible because the intermolecular forces in blood are greater than those in air.

The partition 38 shown in FIG. 2B may be used in any of the embodiments discussed herein. Other baffle configurations may also be used, as will be appreciated by those of ordinary skill in the art. When the catheter tube 18 is initially inserted into the patient and the introducer needle 12 is removed, the septum 38 prevents blood from flowing through the 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 non-elastic 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 internal passageway 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 fluid flushing.

The tapered section 48 forms a proximal end of the actuator 44. The conical section 48 is a substantially frustoconical member that tapers toward the actuator barrel 46 and has one or more proximal openings 48A to allow fluid flow. The tapered section 48 receives or engages or abuts an end of a luer fitting (not shown). One or more tabs 50 extend from the actuator 44 to engage a corresponding flange 52 or one or more shoulders on the inner surface 24 of the catheter hub 14. The interaction between the tab 50 and the flange 52 limits the proximal movement of the actuator 44. Proximal opening 48A and internal passageway 48B in communication with internal passageway 46A preferably allow fluid flow between the luer fitting and catheter tubing 18. The side openings 48C in the tapered section 48 allow 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 a metal.

When the male luer is inserted into the catheter seat 14, the end of the male luer slides toward the tapered 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 passageways 48B and 48D of actuator 44, and into flexible conduit 18, or vice versa. When the luer fitting 32 is removed, the actuator barrel 46 remains in the septum 38.

Fig. 3-8 depict embodiments of catheter assembly 10 that include, for example, return component 56 that provides 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 passage 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 openings 55 advantageously provide increased area for fluid movement within the catheter hub assembly. The increased area advantageously allows for fluid irrigation and prevents fluid from solidifying in the proximal and distal ends of the partition 38. In addition, the openings 55 advantageously minimize stagnation of the fluid and allow for better mixing.

The first end of the actuator barrel has a nose 58 with a chamfered outer surface to engage the diaphragm 38. A frusto-conical section 61A extends from the second end of the actuator cylinder 59A. The frusto-conical section 61A has one or more openings 61B to allow fluid to flow through the frusto-conical section. The cylindrical section 61C extends from the frusto-conical 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, 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, an 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. Even during loading, the interference fit may be sufficient to retain the spring, or the distal end 64 of the spring may abut the partition 38. The proximal end 66 of the spring is connected to the actuator 54, for example by fitting onto the hook 60 and into the slot 62.

In various other embodiments, the actuator 54 and the biasing member 56 are integrated 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, bumps, 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 a quick-connect engagement that need not include an interference fit or press-fit in diameter.

Fig. 3-7 depict operation of the catheter hub 14 with an actuator 54 and a return member such as a biasing member or spring 56. The return feature 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 engaging the diaphragm) to close the valve. Needle 12 initially extends through actuator 54, septum 38, wedge 34 and catheter tubing 18. After needle 12 and catheter tube 18 are inserted into the patient, needle 12 is retracted, closing septum 38.

There are two basic methods of opening the partition 38, each of which may 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 the slit 42 of the partition 38. When the partition 38 is opened in this manner, the actuator 44 does not extend through the partition 38. Instead, the end surfaces of the actuator 44 are located on the slots 42 of the partition 38. Either the resilient slot 42 or the flap of the partition 38, or the spring 56, or both, may cause the actuator 44 to retract when the operation is complete and when the axial pressure on the actuator 44 is removed. In a second method, 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 partition 38. In the penetrated state, the resilient slit 42 of the partition 38 cannot retract into the actuator 44 by itself. Both diaphragm states may open the diaphragm 38 and allow fluid exchange.

As shown in fig. 5 and 6, when the male luer 32 is inserted into the catheter hub 14, the luer 32 moves the actuator 54 in a distal direction, compressing the spring 56. Further insertion of the luer fitting 32 moves the actuator 54 through the septum 38, thereby opening the slit 42 and allowing fluid flow through the catheter hub 14. As best shown in fig. 7 and 8, when the luer 32 is removed, the spring 56 removes the actuator 54 from the septum 38, thereby closing the slit 42 and preventing fluid flow through the slit. This allows catheter assembly 10 to be reused with multiple luer connections, as opposed to a single use catheter (where the actuator would remain in septum 38 after the luer is removed). The features of the exemplary embodiments of fig. 3-8 may be combined as appropriate 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 of the embodiments disclosed herein, the invention is not so limited. The return means may be any element or assembly that returns the actuator from its second position to its first position upon removal of the luer fitting. When configured as a biasing member, return member 56 may be, but is not limited to, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer. As discussed above, the return member 56 may also be constructed from the resilient slot 42 or flap of the partition 38.

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 barrel 69A has a distal end 69D that engages and opens the partition 38. The distal end 69D includes a nose having a chamfered outer surface. The tapered section 71A extends from the proximal end 71B of the actuator barrel 69A. The tapered section 71A is a substantially frustoconical member that receives or engages the end of a 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 seat 14. The first interference fit may be sufficient to allow compression of the spring 70A without contact between the spring 70A and the partition 38. In an alternative embodiment, the partition 38 may help limit the axial movement of the spring 70A. The second inner diameter is sized to form a second interference fit with actuator 68, such as with 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 seat 14. The second interference fit may be sufficient to allow compression of the spring 70A without contact between the spring 70A and the catheter hub 14. 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 seat 14. The spring 70A retaining the actuator 68 in the catheter seat portion 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. The removal of the tab 50 and shoulder 52 reduces the complexity of the apparatus. 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 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 very close to the distal end in an unloaded state. The varying pitch of the spring 70A allows for a concentration of stiffness at the distal and proximal ends to help maintain the interference fit while also allowing for sufficient compression of 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 (not shown) is inserted into the catheter hub 14, the end of the luer abuts the tapered section of the actuator 68. Further movement of the luer fitting moves the actuator 68 axially toward and through the septum 38, the first end of the actuator barrel separating the one or more slits. Movement of the actuator 68 toward the diaphragm 38 compresses the spring 70A. After the partition 38 is opened, fluid is allowed to flow through the conduit seat 14. The 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 the actuator 68 is removed, the diaphragm 38 returns to the closed position, preventing fluid flow through the diaphragm. The features of the exemplary embodiment of fig. 9 may be combined with the features of other exemplary embodiments disclosed herein as appropriate.

Fig. 10 depicts another alternative embodiment of the 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 passageway. 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. First end 75A includes a nose having a chamfered outer surface. A cylindrical section 75C extends from the second end 75B of the tubular portion. 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 an interference fit with the inner surface of the catheter hub 14 and the proximal end is an interference fit with the actuator 72. The inner surface may have a channel, groove, slot, or other recess 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, conical spring 74 supports the actuator end, thus allowing removal of actuator tab 50. Catheter 10 is designed for use with different sized luer fittings that penetrate the internal channel 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 best shown in the exemplary embodiment of FIG. 10, by removing the tab 50, the actuator 72 and the catheter hub 14 can be shortened, thereby reducing the size and cost of the apparatus. The features of the exemplary embodiment of fig. 10 may be combined with the features of the other exemplary embodiments disclosed herein as appropriate.

Fig. 11 depicts another alternative embodiment of the 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 that tapers from the proximal end to the distal end of the catheter hub. The actuator barrel has a first end that engages and opens the slit 42. The first end portion 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 frustoconical 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 an aperture that receives at least a portion of the actuator 78. The biasing member 80 may also be, but is not limited to, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer. According to an exemplary embodiment, the aperture 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 projection 82. The distal opening 88 has a substantially cylindrical shape and a diameter that is less than the diameters of the proximal and

intermediate openings

84, 86. In various exemplary embodiments, the size, shape, and configuration of the elastomeric spring and the opening 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 barrel extends through and protrudes from the elastomeric spring 80. Actuator tab 82 seats in medial opening 86 to hold actuator 78 in place and resist proximal movement of actuator 78. A second end of the actuator extends from the proximal opening 84 to receive or engage a male luer fitting (not shown). When the luer is inserted, actuator 78 moves in a distal direction against the bias of elastomeric spring 80, elastically deforming elastomeric spring 80. When the luer fitting is removed, the elastomeric spring 80 returns the actuator 78 to substantially 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 the 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 barrel has a substantially frusto-conical shape that tapers from the distal end to the proximal end of the catheter hub. The actuator barrel has one or more openings to allow fluid to flow through the actuator. The actuator 90 includes a second end for receiving or engaging a luer fitting. The second end has a substantially frusto-conical shape. The second end may also include an internal passageway and one or more openings. An 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 passage.

The biasing member 92 in fig. 12 is preferably a resilient washer. The washer 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 washer 92. Washer 92 has an inner diameter that receives intermediate portion 94 of actuator 90. The intermediate portion 94 may have a diameter less than the frustum of the second end and less than the base of the first end, thereby retaining 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 washer 92 may be varied to accommodate one another.

The actuator 90 is placed in the washer 92 such that a first end of the actuator 90 extends through the washer 92 and projects from one side of the washer to engage the partition 38. A second end of the actuator 90 extends from the washer 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 elastically stretching washer 92. Further insertion of the luer fitting 32 moves the actuator 90 through the septum 38, thereby opening the slit 42. When luer fitting 32 is removed, washer 92 returns actuator 90 to its original position. In various additional embodiments, the washer 92 may be, but is not limited to, rubber, silicone rubber, thermoplastic elastomer, spring washer, elastomeric washer, plurality of resilient bands, compression spring, extension spring, coil spring, or other suitable biasing member. The features of the example actuator 90 and the biasing member 92 depicted in FIG. 12 may be suitably combined with other example embodiments disclosed herein.

Fig. 13 depicts another alternative embodiment of the 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 barrel 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 resilient members 100, such as a circular or radially extending silicone member, a plurality of resilient bands, rubber, silicone rubber, thermoplastic or thermoplastic elastomer. In various exemplary embodiments, the elastic band is made of silicone or silicon rubber. The biasing member 100 is connected to a fixed support 102 that is attached to the inner surface of the catheter seat 14. The fixed support portion 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 is inserted, actuator 98 moves in a distal direction, thereby stretching biasing member 100. When the luer fitting is removed, biasing member 100 returns actuator 98 to its initial position. The features of the example actuator 98 and biasing member 100 depicted in FIG. 13 may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 14 depicts another alternative embodiment of the catheter hub 14 having an actuator 104 and a return or biasing member 106. Biasing members 106 are similar to those discussed above with respect to fig. 13. The actuator has an actuator barrel surrounding an internal passageway. The actuator barrel 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 barrel and catheter hub 14 are shorter than those described in the other embodiments. Although 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 members. 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 the biasing member 106 depicted in fig. 14 may be suitably combined with the features of other example embodiments disclosed herein.

Figures 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 barrel has a first end that engages and opens the slit 42. The first end portion includes a nose portion having a chamfered outer surface. The second end of the actuator barrel receives or engages the male luer fitting 32.

The biasing member is an elastic band or disc 112 attached 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. A first end of the elastic band 112 is connected to the catheter hub 14. A 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 or molded bond, such as an adhesive. The features of the example actuator 110 and the biasing member 112 depicted in fig. 15A-B may be suitably combined with the features of other example embodiments disclosed herein.

Fig. 16 depicts another alternative embodiment of the catheter seat 14 having an actuator 114 and a return member comprising a first biasing member 116 and a second biasing member 118. The actuator 114 has an actuator cylinder surrounding an internal passageway. The actuator barrel has a first end that engages and opens the slit 42. The first end includes a nose portion having a chamfered outer surface. Extending from the second end of the actuator barrel is a cylindrical member for receiving or engaging a luer fitting (not shown). The compressible section 120 is positioned in the actuator barrel. 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 elastic material, radially extending members, or other suitable biasing members. In various additional 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 resilient bands, a compression spring, an extension spring, a coil spring, rubber, silicone rubber, thermoplastic elastomer, or other suitable biasing member. The first and

second biasing members

116, 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 male luer is inserted, it engages compressible insert 120 and moves actuator 114 in a distal direction against the bias of first and

second biasing members

116, 118. Further insertion of the luer fitting moves the actuator 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 can be advanced a certain distance until the resilient force of the biasing

members

116, 118 is greater than the force required to compress the insert 120. At this point, insert 120 deforms such that further insertion of the luer does not result in further distal movement of actuator 114. When the luer 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 initial position. The features of the example actuator 114 and the biasing

members

116, 118 depicted in FIG. 16 may be combined with the features of other example embodiments disclosed herein.

Fig. 17 depicts another alternative embodiment of the 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 barrel has a first end that engages and opens the slit 42. Extending from the second end of the actuator barrel is a means for receiving or engaging a luer fitting (not shown). One or more projections 126 extend from the actuator radially 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 partition 128. Biasing member 124 includes two or more arms 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. Various sizes, shapes and configurations of the central hub 132 may be used depending on the catheter hub 14 and actuator 122. The biasing member 124 is preferably made of an elastic material such as silicone rubber. The biasing member 124 may also be made of, but is not limited to, rubber, silicone rubber, thermoplastic, or thermoplastic elastomer. The partition 128 and the biasing member 124 may be integrally formed, or the partition 128 and/or the slit 42 may be formed separately from the biasing member.

In various exemplary embodiments, the partition 38 is configured to return the actuator to its initial position. When a male luer fitting (not shown) is inserted, actuator 122 moves in a distal direction, opening slit 42 and passing 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 partition 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 to substantially its initial 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 may vary, with the depth of penetration of the luer into the catheter hub 14 and the resulting movement of the actuator 122 varying according to the luer. When the actuator 122 travels a certain travel distance past 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 slot 42 may move the actuator 122 to a position that allows the partition 38 to close. If the luer penetration 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 fitting is removed, biasing member 124 moves actuator 122 in a proximal direction until 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 the 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 the catheter hub 14 having an actuator 134 and a return or biasing member 136. The actuator 134 has an actuator barrel surrounding an internal passageway. The actuator barrel has a first end that engages and opens the diaphragm 38. The first end portion includes a nose portion having a chamfered outer surface. The second end of the actuator barrel receives or engages a luer (not shown). The pins 138 extend radially from the side of the actuator barrel. 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 that extends substantially in an axial direction of catheter hub 14 and a second portion that extends 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, spring, leaf spring, elastic band, or other elastic member. 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 exerted 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 fitting 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 in only a radial direction, e.g., radially downward in the orientation shown, with a force sufficient to slide the pin 138 along the cam slot 140 to the initial position. The features of the example actuator 134 and the biasing member 136 depicted in FIG. 18 may be suitably combined with the features of the other example embodiments disclosed herein.

Figures 19A-19B depict another alternative embodiment of the catheter hub 14 in which the actuator and return or biasing member are constructed from 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 first ends that extend through the partition 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 the movement of the first and second series of

windings

144, 146.

As the male luer fitting is inserted, the first series of windings 144 moves in a 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 fitting is removed, the second series of windings 146 returns the first series of windings 144 to their original position. The features of the example actuator and biasing member 142 depicted in fig. 19A-19B may be suitably combined with the features of other example 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 barrel has a first end that engages and opens the slit 42. The first end includes a rounded nose. A flange 152 for engaging the male luer 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 the flange 152 with the 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 barrel. However, the biasing member may also 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 multi-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 a distal direction such that the elastomeric tubing 150 engages the septum 38. Further insertion of the luer fitting 32 causes the actuator barrel to pass through the slit in the elastomeric tube 150 and compress the elastomeric tube 150 as the actuator 148 moves through the septum 38. When the luer 32 is removed, the elastomeric tubing 150 returns the actuator 148 to its original position. In various exemplary embodiments, the partition 38 may facilitate movement of the actuator 148 in a proximal direction. The features of the example actuator 148 and the biasing member 150 depicted in fig. 20A-B may be suitably combined with the features of other example embodiments disclosed herein.

Figures 21A-21C depict another alternative embodiment of a 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 barrel 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 32. The actuator is made of a rigid or semi-rigid material.

The biasing member of fig. 21A-21C preferably comprises a compressible, resilient sleeve 154. However, the biasing member may also be, but is not limited to, rubber, silicone rubber, thermoplastic, or a hot-strand plastic elastomer. In various exemplary embodiments, the flexible 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 multi-molding process that over-molds the diaphragm 156 and biasing member 154 to the actuator. In other alternative embodiments, the diaphragm 156 and the biasing member 154 may be connected, wrapped, or held together by an interference fit, such as by virtue of a cylindrical member compressing a portion of the resilient sleeve 154 against the inner surface of the catheter seat 14. The diaphragm 156 and the elastomeric sleeve 154 comprise a silicone material, although other suitable materials may be used.

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

As luer 32 is inserted, the actuator moves in a distal direction, compressing sleeve 154. Further insertion of the luer fitting 32 moves the actuator 152 through the septum 156, thereby opening the slit 42. When the male luer 32 is removed, the sleeve 154 returns the actuator 152 to its original position. The partition 38 may also facilitate movement of the actuator 152 in the proximal direction. The features of the example actuator 152 and the 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-ported catheter seat 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-ported catheter seat 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 channel. 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 an elastic member, such as a length of silicone or rubber tubing. 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 side-ported catheters 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 barrel 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. The biasing member 166 is depicted as a metal spring. However, the biasing member 166 may also 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 seat 162 and the biasing member 166 is positioned proximally of the side valve 172 in the catheter seat 162. The biasing member 166 is connected at a first end to the inner surface of the conduit seat 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 the biasing member 166 are positioned distal of the side valve 172. The biasing member 166 is connected at a first end to the inner surface of the conduit seat 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 cylinder to receive or abut the second end of the biasing member 166.

In the exemplary configuration of fig. 25, the diaphragm 170 and the 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 conduit seat 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 conduit seat 162 and at a second end to the actuator 164, such as by a pair of interference fits. The biasing member 166 may also abut the 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 conjunction with the features depicted in fig. 27-37. Hub portion 14 extends around needle tip shield 176 and retains the proximal end of needle 12. The needle cover 178 initially covers the needle 12, the catheter tube 18, and at least a portion of the catheter hub 14. The needle cover 178 may be connected to the catheter hub portion 14 or the needle hub portion 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, 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 the catheter tube 18 is inserted, the needle 12 is removed from the patient's vein and through the catheter hub 14. The needle tip shield 176 provides protection from needle 12 puncture as the needle 12 is retracted from the catheter hub.

According to the exemplary embodiment depicted in fig. 27-36, 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 the 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 with the inner sleeve.

According to the exemplary embodiment depicted in fig. 28-30, outer sleeve 178 includes an outer surface 184, an inner surface 186, a channel bounded by inner surface 186, a proximal opening, and a distal opening. The outer surface 184 has an octagonal configuration with eight flat sides, although other curvilinear 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 outer sleeve 178.

The fasteners 190 extend from the outer surface to engage projections on the catheter hub 14. In an exemplary embodiment, the male portion of the catheter hub is a luer fitting receiving thread, e.g.

A pattern of threads. 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 and rear edges to receive the projection 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 projections, thereby allowing the fasteners 190 to engage the front, back and/or sides of the connection while minimizing the amount of material and space required. In various exemplary embodiments, the fasteners 190 are formed without openings. The fastener 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, inner sleeve 180 includes a base 192, a distal side 194, and a proximal side 196. Resilient arms 198 and tabs 200 extend from the outer surface of base 192. Resilient arms 198 and tabs 200 engage slots 188 in sleeve 184. One or more clip retention portions 202 extend from an inner surface of the base 192. The clip is positioned between the clip retention portion 202 and the proximal side 196. The counter part 204 extends from the distal side 194 in the distal direction. The opposing member 204 is tubular and configured to be inserted into the catheter seat 14. Proximal side 194, distal side 196, and opposing member 204 each have an opening for receiving needle 12.

According to the exemplary embodiment depicted in fig. 33 and 34, resilient metal clip 182 includes a base 206 having an opening for receiving needle 12, a second arm 210 extending from base 206, and a first arm 208. 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 the first arm 208 and a second tab 220 is formed in the second arm 210.

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

When the needle 12 is withdrawn from the catheter hub 14, the tip of the needle 12 clears the first and

second hooks

212, 214, causing the first and

second arms

208, 210 to approach and the first and

second hooks

212, 214 to wrap around the tip of the needle 12, as shown in fig. 37. Thus, clip 182 is in a closed position in which the distal tip of needle 12 is blocked. This needle protection mechanism operates passively (automatically) by the clip 182 when the needle 12 is removed from the catheter hub 14, as no user actuation is required to activate the needle protection.

As the needle 12 is pulled further, the shaft of the needle slides through the needle tip shield 176 until a deformation (e.g., a crimp or protrusion 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 so that the needle shaft passes through, but not the deformation. Thus, the sharp distal tip region (e.g., including the deformation and sharp distal tip of needle 12) is enclosed by clip 182.

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

FIG. 35 shows arms 198 and tabs 200 of inner sleeve 180 positioned in slot 188 of outer sleeve 178. After the tip of needle 12 passes first and

second hooks

212, 214 and first and

second arms

208, 210 move to the closed orientation, tab 200 may engage slot 188 to resist separation of inner and

outer sleeves

180, 178 and possible exposure of needle 12.

FIG. 36 shows the first tab 216 and the second tab 218 engaging a first shoulder 220 and a second shoulder 222 on the outer sleeve.

Tabs

220, 222 help prevent clip 182 and inner sleeve 180 from inadvertently sliding into 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 catheters discussed herein. For example, the spring may be coated with a uv curable antimicrobial adhesive coating. The coating may be applied by spraying, batch tumbling, or during formation of the spring coils. Suitable coatings are described in U.S. patent No. 8,691,887, the disclosure of which is incorporated by reference. The types of antimicrobial agents suitable for use herein include chlorhexidine gluconate, chlorhexidine acetate, chloroxylenol, triclosan, hexetidine, and may be included in the actuator lubricant used 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 the actuator 54. The 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 septum 38 of the catheter hub assembly. Actuator 54 further includes an opening 55 extending through actuator 54 in a direction perpendicular to the centerline of actuator 54. For example, the actuator 54 may include two rectangular openings 55, although more or fewer openings are contemplated.

Actuator 54 also includes a plurality of grooves 57 that extend axially along a distal portion of the outer surface of actuator 54 in a plane parallel to the centerline of actuator 54. For example, there may be four grooves 57 along the outer surface of the distal portion of the actuator 54 that are substantially equally radially spaced from one another, although more or fewer grooves 57 are contemplated. The recesses 57 may have different depths into the actuator 54. The groove 57 differs from the opening 55 in that the groove 57 does not extend completely through the thickness of the actuator 54.

The openings 55 and the grooves 57 advantageously provide an increased area for fluid to flow inside the catheter hub assembly. The enlarged area advantageously allows for fluid irrigation and prevents fluid from freezing in the proximal and distal ends of the septum. In addition, the opening 55 and the plurality of grooves 57 advantageously minimize stagnation of the fluid and allow for better mixing. The groove 57 also prevents 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 the groove 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 the recess 57 of the actuator 54 provide more area for fluid to flow within the conduit seat 14, thereby achieving the advantages described above.

Fig. 39B and 39C illustrate the catheter hub assembly when 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. However, the groove 57 of the actuator 54 penetrates the partition 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 partition 38 through the groove 57. After the operation of the catheter assembly is complete, the actuator 54 is retracted from the septum 38 by the force exerted by the biasing member 56. The catheter assembly is configured for multiple uses under depression of the actuator. Features described in this embodiment, such as actuators, may be used in combination with features described throughout this application.

Fig. 40A illustrates another embodiment of an actuator 164 in the catheter hub assembly. The catheter hub assembly includes a catheter hub 162 having a side opening 168. The side opening 168 provides an auxiliary port to fluid flow in the conduit seat 162. The intersection of the main bore of the catheter hub 162 with 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 the sleeve 172 allows fluid to enter the catheter hub 162. The catheter hub assembly further includes a spacer plate 170 and a biasing member 166 that provides tension to the actuator 164.

Actuator 164 includes a plurality of openings 165 that extend through 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 septum 170 and compresses the biasing member 166. The conduit seat is configured such that the opening 165 of the actuator 164 optionally penetrates the septum 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 at the proximal end of the partition 38 and the catheter hub 162. Increased fluid mixing also occurs at the distal end of the septum 38 if the opening 165 in the actuator 164 penetrates the septum 170.

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

Fig. 41 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly 300 having a different type of needle protection mechanism, in this case, the needle protection mechanism receives the entire needle within a protection tube or cartridge, rather than just the needle tip. Catheter assembly 300 utilizes active (rather than passive or automatic) needle protection because activation by the user is required (by depressing activation button 308) to activate needle protection. However, both active and passive needle protection fall within the scope of the present invention.

The operation of catheter assembly 300 is as follows. The catheter 302 and needle 304 are inserted into a vein of a patient. When the needle 304 and catheter 302 are fixedly positioned, the activation button 308 is depressed. When the activation button 308 is depressed, as shown in FIG. 42, the inner hub portion 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, needle 304 is now in a retracted position in which the entire needle 304 (including its sharp distal tip) is retained within outer needle housing 314. The inner needle housing 312, which holds 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, the outer needle housing 314 and the spring 310 is an exemplary needle protection component.

More information regarding active needle protection mechanisms used in this embodiment may be found in U.S. Pat. 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 feature, 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 only protecting the needle tip, as in fig. 27-37. Because no user actuation is required to activate 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 the catheter assembly 400 is as follows. The catheter 404 and needle 402 are inserted into a vein of a patient. When the needle 402 and catheter 404 are fixedly positioned, the needle 402 is retracted by the user.

When the user pulls on the outer needle housing or outer needle hub portion 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 the inner needle housing 408. Before the distal tip of the needle 402 enters 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 fully 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, the clip 412 is no longer biased, it enters the closed position in which the distal tip of the needle 402 is blocked.

The needle 402 further includes a deformation 403 adjacent 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 back 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. The 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 on the outer needle housing 414, the inner needle housing 408 and the catheter hub 406 disengage and separate. In particular, the boss 410 of the inner needle housing 408 is disengaged from the hole in the catheter hub 406.

After the needle 402 is used, the inner and

outer needle housings

408, 414 that enclose the tip of the needle 402 are discarded. The catheter hub assembly may then be used. In particular, the user may engage the luer 416 and the catheter hub 406 to cause the actuator to open or penetrate the septum and establish fluid communication.

More information regarding the needle tip protection mechanism used in this embodiment can be found in U.S. Pat. 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 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly 500 having a needle tip shield. Because no user actuation is required to activate 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, the needle 512 extends through the actuator 528, which pierces the septum 526 in the catheter seat 514, similar to that described in the above embodiment. V-clip 540, located in needle end shield 520, is biased by needle 512 to an open position (V-clip 540 is compressed) to allow needle 512 to pass beyond V-clip 540. The V-shaped clip 540 comprises a resilient metal clip. After catheter assembly 500 is operated, biasing member 530 retracts actuator 528 into catheter seat 514.

FIG. 47 illustrates a cross-sectional view of catheter assembly 500 with needle 512 in a retracted position. When the distal tip of needle 512 enters needle tip shield 520 and is positioned over the proximal end of V-clip 540, V-clip 540 is no longer biased. Rather, V-clip 540 expands into the closed position in needle tip shield 520 (the V-clip is expanded) to prevent needle 512 from traveling past V-clip 540. The expansion of V-clip 540 within needle tip shield 520 forms one or more barriers (described below) that prevent the distal tip of needle 512 from exiting 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. In at least one radial direction, the diameter of the deformation is larger than the diameter of the rest of the needle 512. In at least one radial direction, the diameter of the deformation 596 is greater 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 encapsulated by the barrier of the washer 542 and the V-clip 540.

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

On the other hand, when the needle 512 is in the retracted position and no longer biases the V-clip 540, 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 be disengaged from the needle tip shield 520.

Additionally, a 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 scoop (spade) 566, both configured to attach the V-clip 540 to the outer wall of the needle tip shield 520. The outer wall of needle tip shield 520 includes a tab 589 that secures V-clip 540 by creating friction between V-clip 540 and needle tip shield 520. This configuration advantageously secures V-clip 540 to 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.

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

More information regarding the needle tip mechanism used in this embodiment may be found in U.S. Pat. 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. Features described in this embodiment, including passive needle protection features, may be used in combination with features described throughout this application.

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

Fig. 49-51 illustrate various exemplary embodiments of blood flashback in a catheter assembly. Flashback is the visualization of blood, which confirms the entry of the needle tip into the vein. A first flashback 600 is observed through the catheter tubing 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 tubing. A second flashback 604 is observed in the hub/grip as it exits the rear of the needle 612 and enters the flash chamber in the hub/grip. Through the porous membrane or micro-groove, air is vented by the plug in the back of the hub/grip. The third flashback 606 can be seen in the catheter seat 614 when blood from the first flashback 600 flows into the catheter seat and stops at the blood control septum. Air is vented through micro-grooves in the periphery of the blood control septum. Features described in these embodiments, including the blood flashback feature, can be used in combination with features described throughout this application.

In another embodiment similar to the embodiment shown in fig. 3-8, the assembly 10 does not include a return member 56. Rather, as previously described, the flap defined by the slit 42 of the resilient diaphragm 38 acts as the return member 56. Before operation, the actuator 44 is in a free state and does not contact the partition 38 (first position of the actuator 44). In operation, the partition 38 is in an open state in which the actuator 44 contacts the partition 38 and pushes against the slit 42 of the partition (the second position of the actuator 44). 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 the axial pressure on the actuator 44, the resilient flap defined by the open slit 42 of the partition 38 causes the actuator 44 to retract to the first position.

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

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. The shaft portion 750 is configured to penetrate a septum of a 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 for the passage of fluid out of the hollow interior passageway 746a.

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

The reduced diameter region 752 is a ramped feature disposed near a proximal end of the inner diameter of the valve actuator 744. Reduced diameter region 752 is disposed between shaft portion 750 and mating portion 754 to connect shaft portion 750 and mating portion 754 and provide a continuous outer surface of valve actuator 744. Reduced diameter region 752 includes a plurality of protrusions 758 on the outer diameter as shown in fig. 52-57 and on the inner diameter as shown in fig. 58. The protrusion 758 advantageously facilitates 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 full height) of the reduced diameter region of fig. 3-8 may be, for example, 0.035-0.040 inches. In fig. 52-55, however, the window 756 extends only a portion of the reduced diameter region 752.

In particular, fig. 52-55 show that for actuators having the noted overall dimensions, the windows 756 can extend approximately 0.005 inches, 0.010 inches, 0.015 inches, and 0.020 inches, respectively, from the distal end of the reduced diameter region 752. Other embodiments include a window 756 that extends any length less than the full length of the reduced diameter region 752. Alternatively, the window 756 may extend about 1/2 or 1/3 of the length of the reduced diameter region 752. Fig. 56 and 57 show the window 756 adjacent the distal end of the reduced diameter region 752, but outside the 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 window 756 of fig. 56 and 57 can extend at a length of about 0.010 inches and 0.020 inches, respectively. The 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 saline flushing, blood or fluid deposits may remain. The window 756 is reduced in size and 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. Saline flow 748 of figure 54A is representative of each window 756 of figures 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 in fig. 3-8. The window 756 is sized such that fluid traveling in a longitudinal direction (axial direction) through the internal passageway 746a is diverted to a perpendicular direction (radial direction) away from the valve actuator 744. For actuators having the total dimensions mentioned, the preferred optimal dimension (length or height) is about 0.0125 ± 0.005 inches. The closer the size of the window 756 is to this preferred size, the more radial will be the direction of flow of fluid exiting the window 756. Higher velocity radial flow will optimize the flushing performance.

The velocity of the flush fluid traveling through the window 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 when compared to the embodiment of fig. 52-58. Thus, a small portion of the reduced irrigation may remain near the corner between the inner diameter of the adapter and the proximal end of the irrigation window.

By arranging the window 756 at the distal end of the reduced diameter region 752, the flow speed and direction is 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 internal passageway 746a travels shorter as it reaches 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 the window 756 in the 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 changes the flushing performance of window 756. As mentioned above, the optimal size (length or height) of the window is about 0.0125 ± 0.005 inches for an actuator with 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 marked by a number indicates the amount of blood remaining in the catheter hub after the saline flush. The remaining blood was measured by the ratio of blood mass to 3 ml of saline, with 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, and 764 having a ratio of 0. As shown in fig. 59 and the windowed portion of fig. 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 saline flush in various sizes of window 756 in the valve actuator 744 of fig. 52-55 and in the window of the valve actuator of fig. 3-8. Specifically, with a window height of 0.0125 inches, the amount of blood remaining is about 2.2%. With the 0.0375 inch window height of fig. 3-8, the amount of blood remaining is about 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, hub portion 816 operates in a similar manner to the embodiment of fig. 46-48. Catheter seat 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, the stopper 820 includes a porous membrane or micro-groove disposed at the proximal end of the hub portion 816 to vent air while containing blood.

Fig. 63 shows the catheter hub 814 and the needle hub 816 of the catheter assembly 810. In particular, catheter seat 814 comprises 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 condition. The 302 and 304 stainless steels have very low magnetic susceptibility in the annealed state, which is advantageous when the catheter assembly remains on the patient during a Magnetic Resonance Imaging (MRI) procedure.

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

The catheter hub 814 also includes a septum 838. The septum 838 is secured to the inner diameter 815 of the catheter hub 814 by an interference fit to ensure proper operation of the septum 838. The septum 838 contacts the interior wall of the catheter seat 814 for proper positioning. When assembled from the proximal end of the catheter hub 814, the septum 838 passes through the undercut 813.

The valve actuator 844 is configured to penetrate the septum 838 during operation of the catheter assembly 810. When the valve actuator 844 penetrates the septum 838, the spring 856 is compressed. Subsequently, the spring 856 retracts the valve actuator 844 after piercing the septum 838. The spring 856 includes a center coil 857 and two or more end coils 858. The end coils 858 have a larger outer diameter than the center 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. Both 302 stainless steel and 304 stainless steel are conventional materials for springs because they contain higher carbon content and are easier to manufacture. However, catheter assemblies including springs constructed of 302 or 304 stainless steel have very high magnetic properties when hardened to the level required by the spring. In particular, the metal of the spring must be cold worked to elastically temper in order to have a higher shear strength, which thus makes the metal more magnetizable.

Accordingly, springs constructed of 302 or 304 stainless steel in catheter assemblies may not be compatible for use in Magnetic Resonance Imaging (MRI) procedures. This is because the magnets of the MRI apparatus may cause sensitive metal pulls, twists and heating in the catheter assembly. Therefore, 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 machining. However, 316 stainless steel is the preferred material for the spring 856, and it advantageously increases strength as the material is tempered. In this example, the temper of 316 stainless steel is increased to meet ASTM F138-08 material strength standards for stainless steel surgical implant devices. Preferably, the strength requirements of the spring 856 exceed those specified in ASTM F138.

As tempering of the 316 stainless steel increases, the magnetic attraction also increases. However, 316 stainless steel is less magnetic than 302 or 304 stainless steel due to the lower carbon content. In particular, the composition of the 316 series stainless steels or their equivalents, and in particular the ratio of the chromium and nickel contents and the Cr/Ni content in these alloys, help to stabilize the austenite phase 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 an elastic temper, the spring 856 in the catheter assembly 810 is compatible for use in MRI procedures.

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

These material and process choices allow the spring 856 in the catheter assembly 810 to achieve a relative magnetic permeability of less than 2.0, preferably less than 1.1. Relative permeability is a dimensionless value as generally understood by those of ordinary skill in the art. The material and associated processing options for the spring 856 advantageously allow the catheter assembly 810 to remain attached to the patient during the MRI procedure. In other words, the correct alloy and metal temper are used in the catheter assembly 810 to keep the magnetic susceptibility sufficiently low so 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, the end coil 858 is movably captured between the diaphragm 838 and the undercut 813. The end coils 858 of the spring 856 advantageously do not have to be arranged at precise locations. The outer diameter of the end coil 858 is larger than the diameter of the undercut 813 to movably retain the spring 856. Thus, the spring 856 and the catheter seat 814 advantageously prevent accidental removal of the valve actuator 844. Moreover, the improved assembly advantageously results in less variation in the functionality of catheter assembly 810.

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

There is a clearance fit between the inner diameter 815 of the catheter seat 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 the end coil 858 passes the undercut 813 during assembly, the spring 856 is properly positioned. The other end coil 858 is non-movably secured to the valve actuator 844. Thus, when no luer fitting is present, the spring 856 and valve actuator 844 may move or "float" (within limits) axially within the catheter seat 814. The actuator does not contact the inner diameter 815 of the catheter seat 814.

When there is an interference fit between the spring and the inner diameter of the catheter as described in the embodiments 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 septum rests penetrates 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 tight, 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 inner diameter of the catheter hub, with the diaphragm moving with the spring, can cause seizure. The higher force in the interference fit can overcome the friction of the diaphragm and cause the diaphragm to move with the spring. Additionally, the interference fit may cause undue stress on the valve actuator 844 during retraction. Also, if the spring 856 is compressed too far distally such that the septum 838 is compressed, the interference fit may not allow the septum 838 to retract or relax. As a result, septum 838 may leak over time due to excessive and sustained compression.

On the other hand, with a clearance fit between the spring 856 and the inner diameter 815 of the catheter hub 814, the spring 856 can move axially when no luer is present, and the spring can apply pressure to the proximal face of the septum 838 only when a luer is inserted. Thus, the combination of the clearance fit and the undercut 813 advantageously improves handling, the 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. When engaged to a septum in a catheter, the

openings

902, 905 provide for fluid flushing and flow through the valve actuator 900. The

openings

902, 905 operate in a similar manner as described in the above embodiments.

The 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, a radius 908 is disposed on either end surface of step 906. In particular, radius 908 is disposed at the interface between step 906 and distal end 904 and at the interface between step 906 and 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 embodiments. The rounded portion 908 advantageously allows for ease of manufacturing during injection molding.

Fig. 69-71 illustrate a valve actuator 950 with a two-step distal end termination 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 suitable rounding 958 on each end surface. Similarly, the radius 908 advantageously allows for ease of manufacturing during injection molding.

The foregoing detailed description of certain exemplary embodiments has been provided for the purpose of illustrating the principles of the present invention and its practical application, thereby enabling others skilled in the art to understand the present invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any embodiments and/or elements disclosed herein may be combined with each other to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and are intended to be included within the scope of the description and the invention. The specification describes specific examples to achieve a more general objective that may be achieved in other ways.

The terms "front," "back," "upper," "lower," "upward," "downward," and other directional descriptors used in this application are intended to facilitate the description of exemplary embodiments of the invention, and are not intended to limit the structure of exemplary embodiments of the invention in any particular position or orientation. Terms of degree, such as "substantially" or "approximately" should be understood by one of ordinary skill to refer to a reasonable range outside of the given value, e.g., general tolerances associated with 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 includes a step.

2. A 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 step comprises a radius.

4. The valve actuator of claim 3, wherein the radiused portion comprises:

a first radius at an interface between the step and a distal surface of the valve actuator; and

a second radius at an interface between the step and an outer diameter of the valve actuator.

5. The valve actuator of claim 2, wherein:

the steps comprise a first step and a second step; and the number of the first and second electrodes,

the first step and the second step each include a rounded portion.

6. The valve actuator of claim 5, wherein the first and second steps are adjacent to each other.

7. The valve actuator of claim 5, wherein the first step is adjacent a distal surface of the valve actuator.

8. 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 allows or blocks fluid flow through the conduit;

a valve actuator movable between a first position and a second position; and

a return component that returns the valve actuator from the second position to the first position; and

a needle protection component that encloses the distal tip of the needle, wherein,

the return member includes a metal member having a relative magnetic permeability of less than 2.0.

9. The catheter assembly of claim 8, wherein the return member comprises a spring.

10. The catheter assembly of claim 8, wherein the return member is made of a material selected from the group consisting of 316L stainless steel, 316Lvm stainless steel, titanium, beryllium, copper, magnesium, and magnesium alloys.

11. The catheter assembly of claim 8, wherein the return member comprises a magnesium alloy.

12. The catheter assembly of claim 8,

the relative magnetic permeability is less than 2.0; and is

The return component comprises Elgiloy.

13. The catheter assembly of claim 8, wherein the relative magnetic permeability is less than 1.1.

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

15. The catheter assembly of claim 14, wherein the diamagnetic material comprises palladium.

16. The catheter assembly of claim 8, wherein the catheter assembly is configured to remain attached to a patient during a magnetic resonance imaging procedure.