Source: https://patents.google.com/patent/US10166370B2/en
Timestamp: 2019-04-23 03:02:31+00:00

Document:
2008-10-21 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=7972872&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US10166370(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2018-06-08 Assigned to B. BRAUN MELSUNGEN AG reassignment B. BRAUN MELSUNGEN AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: RAINES, KENNETH C.
Embodiments of a catheter insertion device are discussed comprising: an approximately hollow cylindrical catheter sleeve, at whose distal end a catheter is attached; a needle sleeve with a hollow needle, which is attached thereto and which, when ready for use, extends through the catheter sleeve and the catheter, and; a needle protective element that is arranged inside the catheter sleeve while being able to move on the needle. Said needle protective element has an engaging section that engages with an engaging device, which is formed in the vicinity of the needle tip, when the hollow needle is withdrawn from the catheter sleeve. A check valve is placed inside the catheter sleeve between the catheter and the needle protective element. The hollow needle, when ready for use, extends through said check valve, and the check valve automatically closes once the needle is withdrawn.
Device, system, and method for a catheter insertion device are generally discussed herein with specific reference to catheter device having a valve opener and a valve.
A device of this kind is known from EP 352 928, wherein in a hollow catheter hub a needle guard element is arranged. On withdrawal of the hollow needle from the catheter over an engaging means near the tip of the hollow needle, the needle guard element engages with the engaging means and covers the tip when the hollow needle is separated from the catheter. In this design, after withdrawal of the hollow needle from the catheter, through this catheter blood can issue with which the operating personnel can come into contact.
The invention is based on the object of designing a catheter insertion device of the type described above such that an outflow of blood from the catheter is prevented after removal of the hollow needle with the needle guard element.
This object is solved according to the invention by the features in the characterizing part of claim 1. In the ready position, a check valve is arranged in the catheter hub between the catheter and the needle guard element. Through this valve the hollow needle extends, so that after withdrawal of the hollow needle from the catheter the latter can be reliably closed such that an outflow of blood is prevented, while simultaneously the tip of the hollow needle is securely covered by the needle guard element so that the operating personnel cannot injure themselves on the needle tip.
FIG. 10 shows a longitudinal section through a further embodiment.
FIG. 1 shows a catheter insertion device 1 having a catheter hub 2 which has a two-part form in the embodiment. A distal hub element 3 of the catheter hub has a holding section 3 a in which a catheter 4 is press-fitted. The proximal end of the hub element 3 has an enlarged diameter with regard to the distal end and forms a connecting section with a hub element 5 whose distal end overlaps the proximal end of the hub element 3 and which is provided at its proximal end with a Luer thread 6. Between the two hub elements 3 and 5, a check valve in the form of a valve disc 7 is inserted and is fixed in place by the two hub elements 3 and 5.
In the ready position according to FIG. 1, there is inserted in the catheter hub 2 a needle hub 8 to which a hollow needle 9 is fixed which extends through the valve disc 7 and the catheter 4 so that the needle tip 9 a is exposed. Between needle hub 8 and valve disc 7 there is displaceably arranged in the proximal hub element 5 a valve actuating element 10 which has a nose section with a truncated cone-shaped locating section 10 a which serves to open the valve disc 7, as FIG. 3 shows. On the proximal side, a plunger section 10 b adjoins the locating section 10 a and has a hollow space or a gap for receiving a needle guard element 13. In the embodiment shown, the plunger section 10 b is formed by two spaced plungers between which the needle guard element in the form of a spring clip 13 is inserted, as shown in the cross-sectional view in FIG. 4.
On withdrawal of the hollow needle 9 from the catheter hub 2, an engaging means 9 b (FIG. 2), provided near the needle tip 9 a and having the form of a radial projection on the hollow needle which can be formed by light crimping, engages with the outer circumference of a bore in the rear wall 13 c of the spring clip 13, so that the spring clip 13 is removed from the catheter hub with the needle 9, while simultaneously resilient portions or the spring arms 13 a and 13 b of the spring clip cover the needle tip, completely protecting and blocking it in a needle guarded position. In this separated position shown in FIG. 2, the valve disc 7, due to its elasticity, closes the through-hole for the hollow needle 9 so that no blood can flow out through the catheter 4. As FIG. 6 shows, the valve disc is provided for example with three slits 7 a starting from the middle and extending radially over a short section X, forming elastic flaps 7 b therebetween which can be expanded by the hollow needle.
FIG. 3 shows the insertion of a syringe 14 in the catheter hub 2, wherein the neck portion 14 a of the syringe comes to abut on the plunger section 10 b of the valve actuating element 10 and presses it against the valve disc 7, so that the truncated cone-shaped locating section 10 a outwardly displaces the flaps 7 b of the valve disc and thereby opens the valve, so that a liquid can be inserted from the syringe 14 into the catheter 4 by passing through a bore of the nose section and the gap of the plunger section.
The incline of the truncated cone on the locating section 10 a and the displacement path of the actuating element 10 relative to the valve disc 7 are designed such that due to the elasticity of the material of the valve disc 7, the flaps 7 b displace the locating section 10 a to the right in FIG. 3 when the syringe 14 is removed from the catheter hub 2. Hereby, the valve disc 7 is automatically closed, as the position in FIG. 2 shows.
In the hub element 5, there is formed by a shoulder 5 a a stop for the actuating element 10, to define the position of the actuating element in the separated position in FIG. 2. The shoulder 5 a can stop a projection that extends radially of the lengthwise axis of the valve actuator Hereby, the truncated cone-shaped locating section 10 a lies near the stop 5 a, while its distal end abuts on the valve disc 7 as shown in FIG. 2. The radial slits 7 a of the valve disc 7 are designed such that in the ready position in FIG. 1, the flaps 7 b are bent radially upwards less than in the open position by the locating section 10 a in FIG. 3.
As the cross-sectional view in FIG. 4 shows, the two plungers lob of the valve actuating element 10 are guided in longitudinal grooves 5 e of the hub element 5 and they project radially inwards into the bore 5 c of the hub element 5, so that they form an abutting surface for the neck portion 14 a of the syringe 14. The bore 5 c in the hub element 5 is formed slightly conically corresponding to the conical neck portion 14 a of a syringe.
On the inner circumference of the bore 5 c of the hub element 5, a further shoulder 5 b having a smaller diameter is formed, on which the radially outer areas of the spring arms 13 a and 13 b abut in the ready position in FIG. 1. Hereby, the spring clip 13 is fixed in its position in the hub element 5. When the needle hub 8 with the hollow needle 9 is removed from the catheter hub 2, first the spring clip 13 is held on the shoulder 5 b by abutting until the radial projection 9 b comes to abut on the rear wall 13 c of the spring clip. In this position, the two spring arms 13 a, 13 b can be released from the shoulder 5 b and spring back inwards so that surfaces on the two spring arms cover the needle tip, as FIG. 2 shows, whereupon the spring clip 13 with the hollow needle 9 can be removed from the catheter hub. As shown in FIG. 2, walls having surfaces at distal ends of the spring arms are moved distal of the needle tip to cover the needle tip.
In the embodiment according to FIGS. 1 to 3, the distal end section of the hub element 5 is shrunk, welded or bonded onto the proximal end section of the hub element 3 after the valve actuating element 10 and the valve disc 7 are inserted in the hub element 5. It is also possible to join the two hub elements 3 and 5 to one another, for example by a thread which is secured against loosening after assembly. The spring clip 13 is inserted together with the hollow needle 9 in the bore 5 c of the hub element 5 during assembly, wherein the radially outer areas of the spring arms 13 a, 13 b snap in at the shoulder 5 b under elastic deformation.
Preferably, in front of the shoulder 5 b a projection 5 b′ can be formed in the bore 5 c of the hub element, as shown in FIG. 2. Hereby the snap-in and holding effect of the spring clip 13 is increased.
FIG. 5 shows a modified embodiment of the connection of the two hub elements 3 and 5, in which two cylindrical sections 3 b and 5 d engage in one another. A thread can be provided between these two cylindrical sections. However, it is also possible to bond or weld these two sections.
In this embodiment, the valve actuating element 10 is also modified in relation to the embodiment of FIGS. 1 to 3. FIG. 7A shows a side view of the approximately U-shaped actuating element 10 with the spring clip 13 inserted therein. As the side view rotated by 90° in FIG. 7B shows, the locating section 10 a is partly flattened on opposite sides so that the width of the plunger sections 10 b extends into the locating section 10 a. FIG. 7C is a front view from the left in FIG. 7B and shows the flattened structure of the locating section 10 a. FIG. 7D is a sectional view along the central line in FIG. 7B. FIG. 7E shows a section through the valve actuating element 10 along the line B-B in FIG. 7D.
FIG. 5 shows the lower half of the valve actuating element 10 corresponding to the view in FIG. 7A, and the upper half in a sectional view rotated by 90° corresponding to FIG. 7B. The shoulder 5 a for positioning the valve actuating element 10 in the hub element 5 is hereby formed on the ends of the diametrically opposite grooves 5 e (FIG. 4), so that the proximal ends of the plunger sections 10 b abut on the shoulders 5 a. Corresponding to the shoulder 5 b in FIGS. 1 to 3 in the embodiment in FIG. 5, there is formed on the hub element 5 a projection 5 f which projects inwards at diametrically opposite positions on the bore 5 c of the hub element 5 and fixes the spring clip 13 in the hub element 5 until the spring arms 13 a, 13 b spring inwards over the needle tip and the spring clip with the hollow needle 9 is removed from the catheter hub.
FIG. 8 shows a modified embodiment having a hollow cylindrical valve actuating element 10 on whose inner circumference a projection 10 f is formed for positioning the spring clip 13 inside the valve actuating element 10. FIG. 9A shows a front view of the valve actuating element 10 from the right and FIG. 9B shows a front view from the left in FIG. 8, wherein for locating the neck portion 14 a of a syringe 14, in this embodiment radially inwardly projecting ribs 10 e are formed which protrude radially into the bore 5 c of the hub element 5, as the upper half of the valve actuating element in FIG. 8 shows, in which the sectional view of the lower half of the valve actuating element 10 is shown rotated by 90° in relation to the upper half.
FIG. 10 shows a modified embodiment wherein between the two hub elements 3 and 5 a check valve 17 is inserted, which has a hollow cylindrical section 17 b starting from a flange section 17 a and abutting on the inner circumference of the hub element 3. From the inner circumference near the flange section 17 a there start two opposite flaps 17 c, which abut on the outer circumference of the hollow needle 9 in the ready position in FIG. 10. When the needle 9 is removed from the catheter hub 2, the elastically deformed flaps 17 c move inwards and close the valve. In this embodiment, an actuating element for opening the valve 17 is not necessary, because the pressure of the fluid from the syringe 14 displaces the flaps 17 c radially outwards so that the liquid can flow out through the valve 17. In this embodiment of a check valve, a so-called duck-bill valve is concerned, whose construction is in itself known.
In FIG. 10, in order to allow the spring clip 13 to be held in the catheter hub during withdrawal of the hollow needle 9 from the catheter hub 2 until the radial projection 9 b on the hollow needle engages with the rear wall 13 c to cover the needle tip, in this embodiment there is formed on the inner circumference of the proximal hub element 5 a projection 5 f which extends radially inwards and on which the radially outer areas of the spring arms 13 a and 13 b come to abut and hold the spring clip until the spring arms spring back radially inwards to cover the needle tip. The inner diameter of the projection 5 f is designed only slightly smaller than the maximum radial dimension at the spring arms 13 a and 13 b, so that during assembly the spring clip 13 can be inserted by slight pressure into the position in the catheter hub as shown in FIG. 10.
In the embodiment of a catheter insertion device according to FIGS. 1 to 9, in the position of the valve actuating element 10 in FIG. 2 the valve disc 7 can be opened by low pressure produced by the syringe 4 for drawing off liquid from the catheter, wherein the elastic flaps 7 b are bent upward by the low pressure. In the embodiment of FIG. 10, a drawing-off of liquid from the catheter is not possible, because the duck-bill valve does not open when there is low pressure on the proximal side.
It is convenient to fabricate the check valve in the form of a valve disc 7 or of the flap valve 17 from elastic silicon, while a correspondingly rigid plastic material is used for the hub elements 3 and 5 and for the valve actuating element 10.
a needle guard comprising a surface for guarding the needle tip from unintended needle sticks when the needle tip is removed from the catheter hub, said surface of the needle guard being located to a side of the needle shaft in the ready position and being located distal of the needle tip in the needle guarded position to guard the needle tip.
2. The catheter insertion device of claim 1, wherein the bore of the valve actuator extends through the nose section and the needle shaft is located in the bore that extends through the nose section in the ready position.
3. The catheter insertion device of claim 2, wherein the valve actuator and the needle are slidable relative to one another.
4. The catheter insertion device of claim 3, wherein the needle guard and the needle are slidable relative to one another.
5. The catheter insertion device of claim 1, wherein the needle guard is biased by the side of the needle shaft in the ready position.
6. The catheter insertion device of claim 1, wherein the needle comprises a lateral projection for engaging a perimeter defining an opening on a proximal wall of the needle guard.
7. The catheter insertion device of claim 1, wherein the catheter hub comprises a first hub section attached to a second hub section.
8. The catheter insertion device of claim 1, wherein the valve comprises the at least one slit comprising three slits defining three flaps.
wherein the nose section of the valve actuator is slidable into the valve to open the at least one slit when a male Luer tip is located in said bore of said catheter hub and pushing distally against an abutting surface at a proximal end of the valve actuator.
10. The method of claim 9, wherein the catheter hub comprises a push tab on an exterior of the body.
11. The method of claim 9, wherein the plunger section comprises two spaced apart plunger components.
12. The method of claim 9, wherein the surface of the needle guard is located to a side of the needle in the ready position.
13. The method of claim 12, wherein the needle and the needle guard are movable relative to one another so that the surface is distal of the needle tip in the needle guarded position to guard the needle tip.
14. The method of claim 9, wherein the bore of the catheter hub comprises a groove and wherein the valve actuator is positioned at least in part in the groove.
15. The method of claim 9, wherein the needle guard is located distally of the proximal opening of the catheter hub.
16. The method of claim 9, further comprising moving the nose section of the valve actuator into the valve by positioning a male Luer tip in the proximal opening of the bore of the catheter hub.
17. The method of claim 16, further comprising removing the male Luer tip from the proximal opening of the bore of the catheter hub for allowing the valve to close.
wherein the plunger section comprises an actuating surface that is exposed for abutting by a male Luer tip after the needle guard is removed with the needle from the catheter hub.
19. The catheter insertion device of claim 18, wherein the needle guard is located at least in part inside the bore of the catheter hub.
20. The catheter insertion device of claim 19, wherein the needle guard comprises two resilient arms.
21. The catheter insertion device of claim 20, wherein the needle guard is located between the spaced apart plunger components.
22. The catheter insertion device of claim 20, further comprising a radial projection on the needle for engaging a proximal wall on the needle guard when the needle is removed from the catheter hub.
23. The catheter insertion device of claim 18, wherein the nose section of the valve actuator has an exterior surface and a projection projects radially of the valve actuator and abuts the internal shoulder in the bore of the catheter hub.
24. The catheter insertion device of claim 18, wherein the valve actuator is slidable distally when pushed by a male Luer tip and is slidable proximally when the male Luer tip is removed.
25. The catheter insertion device of claim 18, further comprising a groove and wherein the valve actuator is disposed at least in part in the groove.
wherein the plunger section is guided distally within the groove when a male Luer tip is positioned in the bore of the catheter hub and pushing against an abutting surface at a proximal end of the valve actuator.
27. The catheter insertion device of claim 26, wherein the needle guard is located at least in part inside the bore of the catheter hub.
28. The catheter insertion device of claim 27, wherein the needle guard comprises an arm that is movable relative to the needle.
29. The catheter insertion device of claim 28, wherein a projection on the valve actuator is located distally of the shoulder in the bore of the catheter hub.
30. The catheter insertion device of claim 26, wherein the needle guard is located between the spaced apart plunger components.
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