# Patent

## Title
IV-catheter insertion device

## Abstract

The present disclosure is directed to a catheter insertion device, which has a catheter hub at the proximal end of a catheter, a tubular needle hub, at which a hollow needle is fixed and extends through the catheter hub and the catheter in a ready position such that the needle tip projects over the distal end of the catheter, a protective barrel which is received in the tubular needle hub in the ready position and is releasably connected to the catheter hub, and a pressure spring arranged between the needle hub and the protective barrel and which displaces the needle hub and the protective barrel apart from each other in an axial direction, wherein a manually operable holding member is provided between the needle hub and the protective barrel, and holds the needle hub in the ready position at the protective barrel against the bias of the pressure spring, so that after the holding member is released, the pressure spring moves the needle hub into a protective position in relation to the protective barrel, in which position the needle is positioned in the protective barrel.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a national phase application under 35 U.S.C. §371 of PCT Application No. PCT/EP2010/006909 filed Nov. 12, 2010, which claims the benefit of German application No. 10 2009 052 962.4 filed Nov. 12, 2009, the contents of each of which are expressly incorporated herein by reference.
FIELD OF ART
The present disclosure relates to a IV-catheter insertion device, comprising a protective barrel attached releasably to the catheter hub of an IV-catheter including a catheter hub, a catheter tube and a hollow needle extending through the lumen of the catheter tube in a ready position, whereby the hollow needle is received into the protective barrel in a protective position after the protective barrel is released from the catheter hub.
SUMMARY
In accordance with the first preferred embodiment of the IV-catheter insertion device of the present disclosure a tubular needle holder surrounds the protective barrel and a spring is provided between the protective barrel and needle holder. The tension of the spring is released by triggering a holding member, so that the hollow needle is automatically retracted into the protective barrel. This leads to simple handling combined with a reliable protection against needle-stick injuries
In a further preferred embodiment of the IV-catheter insertion device according to the present method, system and device, a spring clip is held at the distal end of the protective barrel. In the protective position, the hollow needle is retracted into the protective barrel and the needle tip is additionally covered by the spring clip.
Furthermore, a preferred embodiment of the IV-catheter insertion device according to the method, system and device has a self-closing valve, by means of which leakage of blood from the catheter hub after the removal of the hollow needle can be prevented.
Further aims, advantages, features and possible applications of the present method, system and device become apparent from the following description of the embodiments with reference to the drawings. Hereby, all the features described and/or shown diagrammatically form the subject matter of the present method, system and device, whether in themselves or in any meaningful combination, and independently of their summary in the claims and of the back-referencing of the claims.



BRIEF DESCRIPTION OF THE FIGURES
Examples of the present method, system and device are explained in more detail below with reference to the drawing, in which:
FIG. 1 shows a longitudinal section through the IV-catheter insertion device in a ready position,
FIG. 2 shows a detailed view of the catheter hub,
FIG. 3 shows a longitudinal section through the protective position of the protective barrel,
FIG. 4 shows another embodiment of the catheter hub,
FIG. 5 shows a side view of the IV-catheter insertion device in the ready position,
FIG. 6 shows a view of the IV-catheter insertion device in the protective position, and
FIG. 7 shows the protective barrel released from the catheter hub.



DETAILED DESCRIPTION
In the Figures, reference numeral 1 refers to a catheter hub which, in the embodiment shown, comprises a distal part 1.1 and a proximal part 1.2, between which an automatically self-closing valve 2 in the form of a valve disc is held, the valve 2 being provided with a central slit or slits which extend preferably radially out from the centre of the valve 2 and which is or which are closed in the closed position of the valve. At the distal end of the catheter hub 1, a catheter tube 1a is held in the hub part 1.1, preferably by a metal bushing. At the proximal end of the catheter hub 1, a Luer thread 1.3 is formed at the catheter hub part 1.2. The two parts 1.1 and 1.2 of the catheter hub 1 are joined to each other by bonding or welding. However, it is also possible to provide a one-piece catheter hub 1.
In the ready position of FIGS. 1 and 5, a protective barrel 3 is joined to the catheter hub 1, and the collar-shaped distal end 3.1 of this protective barrel overlaps the Luer thread 1.3 of the catheter hub 1 and engages with the proximal end of the catheter hub 1 by means of a central hub 3.2.
The protective barrel 3 is received in a needle holder 4 in the ready position of FIGS. 1 and 5, and the outer housing 4.1 of this needle holder surrounds the outer circumference of the protective barrel 3 and is joined to a hollow central hub 4.2 at the proximal end via a radial transverse wall 4.3, wherein a hollow needle 5 is fixed in the distal end of this hub, for example by bonding, and in the ready position of FIGS. 1 and 5, this hollow needle extends through the valve 2 and the catheter 1a, so that the needle tip 5.1 (FIG. 5) protrudes at the distal end of the catheter tube 1a. In the embodiment shown, the hollow central hub 4.2 extends from the proximal transverse wall 4.3 essentially up to the front end of the outer housing 4.1 of the needle holder 4.
The proximal end 3.3 of the protective barrel 3 lies at a distance from the transverse wall 4.3 of the needle holder 4.A pressure spring 6 is arranged between the transverse wall 4.3 and the proximal end 3.3 of the protective barrel 3, whereby the proximal end acts as a support for the pressure spring 6.
At the distal end of the protective barrel 3, preferably in the area of the collar portion 3.1, a radially movable lever portion 3.4 is formed, which is joined to a retaining hook 3.5 which, in the ready position of FIG. 1, overlaps a radial projection or flange 4.4 at the distal end of the housing 4.1 of the needle holder 4. By depressing the lever portion 3.4 in FIG. 1, the hook 3.5 is pivoted radially outwards, so that the needle holder 4 is released and the pressure spring 6 moves the needle holder 4 proximally relative to the protective barrel 3, as FIGS. 3 and 6 show, the distal end of the needle holder 4 still being held at the proximal end of the protective barrel 3. In this protective position of FIGS. 3 and 7, the hollow needle 5 is retracted into the protective barrel 3 and covered by a needle guard element in the form of a spring clip 7 such that the needle tip is no longer exposed and cannot lead to an injury.
In this shown embodiment, the spring clip 7 is held by its proximal rear wall 7.1 at the distal end of the protective barrel 3, preferably by means of moulded-on hooks 3.7 (FIGS. 2 and 4), wherein the spring clip in the embodiment shown is formed as a two-armed spring clip with crossing arms. In the protective position of FIGS. 3 and 6, the needle tip 5.1 is covered by at least one of the distal wall portions 7.2 and 7.3 of the arms of the spring clip 7, so that the hollow needle 5 need not be fully retracted into the protective barrel 3. Alternatively, however, the distal end of the protective barrel 3 can also be formed somewhat longer, so that both the hollow needle and the needle tip are then positioned completely inside the protective barrel in the protective position.
The hooks 3.7 holding the spring clip 7 are formed at the front face of the central hub 3.2 of the protective barrel 3. The central hub 3.2 engages the catheter hub 1 in the ready position, as FIG. 2 shows.
In the ready position, elbow-shaped portions at the distal wall portions 7.2 and 7.3 of the arms of the spring clip 7 abut behind a shoulder 1.4 on the inner circumference of the catheter hub 1, so that the spring clip 7 is held in the catheter hub 1 until the needle tip 5.1 is positioned inside the spring clip 7 in the protective position (FIG. 3) and the needle shaft releases the radial spread of the distal wall portions 7.2 and 7.3 of the spring arms of the spring clip. In the protective position, the distal wall portions of the spring clip 7 spring radially inwards so that they are released from the shoulder 1.4 in the catheter hub 1, and the protective barrel 3 with the spring clip 7 held thereon can be released from the catheter hub 1. as FIG. 7 shows.
Near the needle tip 5.1, a crimp (not shown), formed by crimping the needle shaft proximal of the needle tip, or a radial projection (not shown), is formed, which in the protective position in FIG. 3 abuts at the proximal rear wall 7.1 of the spring clip 7 and thereby also holds the needle holder 4 via the needle 5 on the protective barrel 3 in the position as shown in FIG. 3.
In alternative embodiments (not shown) without a needle guard element, the distal end of the protective barrel is somewhat longer, or the hollow needle is somewhat shorter than represented in FIGS. 3 and 7, so that both the hollow needle and the needle tip are then positioned completely inside the protective barrel in the protective position. In the embodiments according to the present method, system and device without a needle guard element, the needle can have a needle crimp to hold the needle holder via the hollow needle on the protective barrel. Alternatively, in the case of a hollow needle without a needle crimp, the proximal end of the protective barrel can lock with the distal end of the needle holder.
Thus, in addition to the protective function in relation to the needle tip, the needle guard element in the form of the spring clip 7 fixed to the protective barrel 3 also fulfils two holding functions the first between the catheter hub 1 and the protective barrel 3 and the second between the protective barrel 3 and the needle holder 4 In the ready position of FIG. 1, the spring clip 7 holds the protective barrel 3 abutting the catheter hub 1 as long as the elbows at the distal wall portions 7.2 and 7.3 engage behind the shoulder 1.4 in the catheter hub. This engagement prevents the axial disconnection of the catheter hub 1 from the protective barrel 3 in the ready position, so that the catheter hub 1 and the protective barrel 3, together with the needle holder 4 form a unit in FIGS. 1 and 5. In the protective position of FIG. 3, the spring clip 7 holds the needle holder 4 at the protective barrel 3 against the force of the pressure spring 6 by engagement of the edge of the bore in the proximal rear wall 7.1 of the spring clip with a projection on the needle shaft, so that no further holding means are required between the proximal end of the protective barrel 3 and the distal end of the needle holder 4 in FIGS. 3 and 7 in order for the protective barrel 3 and the needle holder 4 to form a unit on disposal.
In the embodiment of FIGS. 1 and 2, a valve-actuation element 8 is displaceably guided in the catheter hub 1 and has diametrally opposite stays 8.1, between which the spring clip 7 is arranged in the ready position. After the protective barrel 3 is released from the catheter hub 1 (FIG. 7), a syringe or an infusion line can be connected to the catheter hub, wherein a hub formed at the infusion hose or the syringe, corresponding to the central hub 3.2 of the protective barrel 3, displaces the valve actuation element 8 in the distal direction to open the valve 7.
In the embodiment of FIG. 4, no valve-actuation element 8 is provided. The valve 2 in the form of a valve disc opens or closes automatically when a liquid is introduced or when blood is collected. Reference numeral 10 of FIG. 4 shows a protective cap attached to the catheter hub 1, preferably covering the lever or press-button 3.4 at the protective barrel so that this lever or press-button can only be actuated after the removal of the protective cap 10.
Further embodiments according to the present method, system and device can also be formed without any valve whatsoever or without any valve with valve actuation element respectively.
The needle holder 4 can be formed with a closed proximal end. In the embodiment according to FIG. 1, the hollow middle hub 4.2 of the needle holder 4 is open at the proximal end and is closed by a blood-stopper 9.
Several modifications of the described embodiments are possible. For example, a holding member can be formed at the distal end of the outer housing 4.1 of the needle holder 4, wherein this holding member releases the connection with the distal end of the protective barrel 3, so that a relative displacement between the needle holder 4 and the protective barrel 3 by the pressure spring 6 is possible.
Instead of a needle guard element in the form of a spring clip with crossing arms, a needle guard element can also be provided, whose two arms extend from the proximal rear wall approximately parallel to each other, whereby the arms of such a spring clip also hold the spring clip in the catheter hub in the ready position as long as the arms of the spring clip are spread apart from each other by the needle shaft.
Further the spring clip 4 can be embodied as another kind of needle guard element. Needle guard elements as shown in WO 99/08742 can be used. Further it is also possible that a sleeve having a rear wall can be used as needle guard element wherein the distal end of the sleeve has radial elasticity by slits which extend parallel to the axis of the sleeve on the distal end which can be provided by an engagement means on the outer circumference for engaging the inner circumference of the catheter hub.
The needle guard element can be made of metal and/or plastic material and can comprise several parts.

## Claims

1. An IV-catheter insertion device, comprising:
a catheter hub comprising an interior at a proximal end of a catheter tube;
a tubular needle holder with an attached hollow needle having a needle tip, the hollow needle extending through the catheter hub and the catheter tube in a ready position such that the needle tip projects distally of a distal end of the catheter tube;
a protective barrel is received in the tubular needle holder in the ready position and releasably connected to the catheter hub;
a pressure spring arranged between the tubular needle holder and the protective barrel and to displace the tubular needle holder and the protective barrel axially away from each other when released; and
wherein a manually operable holding member is provided between the tubular needle holder and the protective barrel and holds the tubular needle holder in the ready position on the protective barrel against a bias force of the pressure spring so that after the holding member is released, the pressure spring moves the tubular needle holder into a protective position in relation to the protective barrel, in which the hollow needle is positioned in the protective barrel.

2. The IV-catheter insertion device according to claim 1, wherein a radially moveable release lever or press-button is formed at a collar-shaped distal end portion of the protective barrel and is joined to a hook, which overlaps a radially projecting lug or flange of the tubular needle holder in the ready position.

3. The IV-catheter insertion device according to claim 1, wherein an automatically-closing valve is arranged in the interior of the catheter hub, and the hollow needle extends through the automatically-closing valve in the ready position.

4. The IV-catheter insertion device according to claim 3, wherein a valve-actuation element is displaceably guided in the catheter hub and is distally displaceable to open the automatically-closing valve.

5. The IV-catheter insertion device according to claim 1, wherein the tubular needle holder has an outer housing and a hollow central hub in which the hollow needle is held, wherein the outer housing and the hollow central hub are joined to each other by a distal transverse wall.

6. The IV-catheter insertion device according to claim 5, wherein the hollow central huh of the tubular needle holder comprises a blood stopper at a distal end.

7. The IV-catheter insertion device according to claim 1, wherein a needle guard element is mounted at the distal end of the protective barrel and is held in the interior of the catheter hub in the ready position until the needle tip is retracted into the needle guard element, and the needle guard element holds the tubular needle holder on the protective barrel in the protective position against the force of the spring by engagement with a projection on the hollow needle shaft.

8. The IV-catheter insertion device according to claim 7, wherein the needle guard element has two arms extending from a proximal rear wall, and the rear wall of the needle guard element is provided with a throughhole for the hollow needle and is fixed to a distal front wall of the protective barrel by hooks.

9. The IV-catheter insertion device according to claim 7 wherein the needle guard element is a spring clip.

10. An IV-catheter insertion device, comprising:
a catheter hub having a catheter tube;
a tubular needle holder with a hollow needle and a needle tip, the hollow needle extending through the catheter hub and the catheter tube in a ready position;
a protective barrel projecting, at least in part, into the catheter hub and received in the tubular needle holder in the ready position;
a pressure spring compressed in between the tubular needle holder and the protective barrel in the ready position; and
when the tubular needle holder and the protective barrel axially move away from one other when the pressure spring is released so that the hollow needle is positioned in the protective barrel.

11. The IV-catheter insertion device according to claim 10, further comprising a needle guard element mounted at a distal end of the protective barrel and held in the catheter hub in the ready position.

12. The IV-catheter insertion device according to claim 10, further comprising a valve located inside the catheter hub for limiting fluid flow.

13. The IV-catheter insertion device according to claim 12, wherein the hollow needle extends through the valve in the ready position.

14. The IV-catheter insertion device according to claim 10, further comprising a manually operable holding member positioned between the tubular needle holder and the protective barrel and holding the tubular needle holder in the ready position on the protective barrel against a bias force of the pressure spring.

15. The IV-catheter insertion device according to claim 14, wherein the manually operable holding member is radially moveable to release the pressure spring.

16. An IV-catheter insertion device, comprising:
a catheter hub having a catheter tube attached thereto;
a tubular needle holder with a hollow needle having a needle tip attached thereto, the hollow needle extending through the catheter hub and the catheter tube in a ready position such that the needle tip projects distally of a distal end of the catheter tube;
a protective barrel releasably connected to the catheter hub, said protective barrel being received in the tubular needle holder in the ready position;
a pressure spring being compressed and arranged between the tubular needle holder and the protective barrel to displace the tubular needle holder and the protective barrel axially away from each other when expanded; and
wherein a manually operable holding member for releasing the spring is formed at a distal end portion of the protective barrel and is joined to a hook, which overlaps a radially projecting element on the tubular needle holder in the ready position.

17. The IV-catheter insertion device according to claim 16, wherein an automatically-closing valve is arranged in the catheter hub.

18. The IV-catheter insertion device according to claim 16, wherein the manually operable holding member is either a release lever or a press-button.

19. The IV-catheter insertion device according to claim 16, further comprising a needle guard element mounted at a distal end of the protective barrel and held in the catheter hub in the ready position.

20. The IV-catheter insertion device according to claim 19, wherein the needle guard element has two arms extending from a proximal rear wall, and the rear wall of the needle guard element is provided with a throughhole for the hollow needle and is fixed to a distal front wall of the protective barrel by hooks.