Safety device for a hollow medical needle
10293143 ยท 2019-05-21
Assignee
Inventors
Cpc classification
A61M25/0618
HUMAN NECESSITIES
A61M2005/325
HUMAN NECESSITIES
A61M5/3273
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
International classification
A61M5/32
HUMAN NECESSITIES
Abstract
Method, system and device involving a needle device with a needle safety element with improved stable structure. A frame can surround the needle safety element to provide added stiffening of the needle safety element. The frame can include stays extending laterally of the needle safety element. The needle safety element with the frame can be slidably located on a needle and in a catheter hub in a ready to use position and be removable from the catheter hub in a protective position.
Claims
1. A needle safety assembly comprising: a needle safety element slidably mounted on a needle shaft having a needle tip and a radial projection proximal of the needle tip; the needle safety element comprising: a proximal wall having a perimeter defining an opening; a distal wall comprising a surface to block the needle tip in a protective position; and two movable arms distal of the proximal wall; a frame surrounding, at least in part, the needle safety element, said frame comprising: a first stay and a second stay connected to a bracket; wherein a lug extends from at least one of the stays in a radial direction relative to the needle shaft at a location between the bracket and the proximal wall, wherein said lug comprises a free end opposite an end that attaches to the at least one of the stays.
2. The needle safety assembly according to claim 1, wherein each of the two movable arms are resilient and extend from the proximal wall in the distal direction.
3. The needle safety assembly according to claim 1, wherein the two movable arms intersect each other in a ready to use position in which the needle tip is exposed.
4. The needle safety device according to claim 3, wherein the lug is formed on the first stay and a second lug is formed on the second stay.
5. The needle safety assembly according to claim 1, wherein each of the two movable arms being provided with a distal end portion opposite each other, the movable distal wall being provided on the distal end portion of at least one movable arm.
6. The needle safety assembly according to claim 5, wherein the movable distal wall abuts the needle shaft in a ready to use position in which the needle tip is exposed and covers the needle tip in a protective position.
7. The needle safety assembly according to claim 1, wherein the stays of the frame are joined to each other at respective distal ends by the bracket.
8. The needle safety assembly according to claim 1, wherein the stays of the frame are joined at respective proximal ends.
9. The needle safety assembly according to claim 1, wherein at least one stay is integral with the proximal wall.
10. The needle safety assembly according to claim 1, wherein the bracket extends transversely to an axis of the needle shaft.
11. The needle safety assembly according to claim 1, wherein the bracket and the stays are unitarily formed.
12. The needle safety assembly according to claim 1, wherein the bracket has a bore through which the needle shaft extends in a ready to use position.
13. The needle safety assembly according to claim 1, wherein the radial projection on the needle shaft is a crimp or a bead.
14. The needle safety assembly according to claim 13, wherein the crimp or the bead has a radial dimension that is larger than a largest dimension of the opening on the proximal wall.
15. The needle safety assembly according to claim 1, wherein the stays are provided with stiffening ribs extending lengthwise.
16. The needle safety device according to claim 1, wherein the lug is a first lug and further comprising a second lug, and wherein each of the first lug and the second lug extend radially of the needle shaft into a free space between the proximal wall and the distal wall of the needle safety element.
17. The needle safety device according to claim 1, wherein the first stay has a lengthwise edge, the second stay has a lengthwise edge, and wherein the two lengthwise edges are spaced from one another.
18. A needle safety assembly comprising: a needle safety element slidably mounted on a needle shaft having a needle tip; the needle safety element comprising: a proximal wall having an opening; a moveable distal wall; and two movable arms that extend along opposite sides of the needle shaft and intersect one another when viewing a side of the needle shaft; a frame surrounding, at least in part, the needle safety element comprising: a first stay and a second stay connected to a bracket; and lugs formed on the stays and extending radially of the needle shaft, where the lugs are formed at a location between the bracket and the proximal wall.
19. The needle safety assembly according to claim 18, wherein the stays are joined to each other at the distal ends by the bracket.
20. The needle safety assembly according to claim 18, wherein the stays extend laterally from the two arms of the needle safety element approximately parallel to the needle shaft.
21. The needle safety assembly according to claim 20, wherein the bracket extends transversely to the needle axis and comprises an opening having the needle shaft passing thereto in a ready to use position in which the needle tip is exposed.
22. The needle safety assembly according to claim 18, wherein the stays are joined at respective proximal ends from movement.
23. The needle safety assembly according to claim 18, wherein the bracket and the stays are unitarily formed.
24. The needle safety assembly according to claim 18, wherein the stays are provided with stiffening ribs extending lengthwise.
Description
BRIEF DESCRIPTION OF THE FIGURES
(1) The present method, system and device are explained in more detail below with reference to the drawing, in which:
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DETAILED DESCRIPTION
(14)
(15) On the needle shaft 1.1, there is arranged a needle safety element 2 formed from thin sheet metal, which has a proximal rear wall 2.1 having a bore 2.2, through which the needle shaft 1.1 extends displaceably. The diameter of the bore 2.2 is smaller than the outer diameter of the portion 1.3 on the needle shaft, so the needle safety element 2 cannot be displaced beyond the needle tip in the distal direction, because the edge of the bore 2.2 in the rear wall of the needle safety element retains the portion 1.3 with an enlarged diameter. Thus the bore 2.2 in the rear wall 2.1 of the needle safety element forms an engagement means with the needle shaft. Instead of a bore, a sleeve can also be provided at or in front of the proximal rear wall 2.1 of the needle safety element 2, through which sleeve the needle shaft 1.1 extends and whose inner diameter is smaller than the outer diameter of portion 1.3 having the enlarged diameter, so that by means of the sleeve, the place of engagement of needle 1 and safety element 2 in
(16) In the embodiment of the needle safety element 2 in
(17) Although the needle safety element 2 is shown formed from a single sheet of spring steel, it is also possible to assemble different parts of the needle safety element to give a needle safety element by welding, brazing or beading. Here, different materials can also be used for individual parts, for example plastic and metal.
(18)
(19) As
(20) As shown in
(21) In the proximal area of the needle safety element 2, lateral stays 3a and 3b (
(22) Thus the present method, system and device comprise a needle safety element having preferably two intersecting arms having two stays which are spaced apart from each other and are fixedly joined to the proximal end of the needle safety element. In one embodiment, the fixing location is distal of the proximal wall by means of lugs extending from the proximal wall in a distal direction. In another embodiment, the fixing at the proximal wall takes place by bending over the two proximal ends of the two stays and fixing the bent ends directly at the proximal wall.
(23) According to another embodiment, at least one of the stays 3a and 3b can be formed by means of punching of a sheet metal integral with the proximal rear wall of the safety element 2.
(24) The stays 3a, 3b likewise preferably consist of sheet metal, and they are joined to each other at the distal ends by a bracket 3c, which extends transverse to the needle 1 and is preferably provided with a throughbore 3c1 for receiving the needle 1. The stays 3a and 3b each have upper and lower edges 3.8a and 3.8b (
(25) The bracket 3c with the two lateral stays 3a and 3b, which can be denoted as a protective band or frame 3.9 in
(26) To stiffen the stays 3a, 3b formed from a metal strip, stiffening ribs 3a1 and 3b1 are formed along these in the wall areas. Alternatively or additionally to this, the metal strip of the stays can be formed from a thicker sheet material. In a cross-sectional view, the stays 3a, 3b themselves can be slightly bent or have edges bent inward so that the stiffness of these stays is improved. In the cross-sectional view, the flat extension of the stays 3a, 3b extends transverse to the flat extension of the arms 2.3 and 2.4, as shown in
(27) In a plan view of the embodiment in
(28)
(29) In the embodiment according to
(30)
(31) Depending on the type of cutting die, during production of the guard band or stiffening bracket forming a frame with the rear wall 2.1, the distal end portion of the enlargement 3.3 can extend into the proximal elongation 3.2 at the cap-shaped bracket. For example, the extension 3.2 can extend somewhat upwards such that at least a part of this extension 3.2 is covered by the enlargement 3.3 in a perspective view of
(32) Approximately in the area of the point of intersection of the two arms 2.3 and 2.4 of the needle safety element, on one side of each stay a lug 3.4a and 3.4b is formed extending in the peripheral direction, bent somewhat inwardly toward the needle and adapted to the curve of the elongation 3.2 in the cap portion. The lug 3.4b is formed on the side of the stay 3b on which the shorter arm 2.4 extends, as shown in the plan view in
(33) Thus an aspect of the present method, system and device is a protective element having two arms, wherein each arm comprises a portion extending along an associated side of the needle shaft. A band or a stay also extends on each side of the needle shaft and of the two arms. In one embodiment, a lug extending in the peripheral direction extends from each stay over an associated arm. According to a further aspect of the present method, system and device, a protective band or frame is provided which surrounds a safety element, wherein two spaced-apart lugs are provided which each extend from a stay, and wherein the two lugs extend in the clockwise direction in the view from the proximal to the distal end.
(34) While
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(36) Thus the present method, system and device comprise an elongation or extension of the lug in a distal and/or proximal direction at the associated stay, to limit upward and downward displacement of the arm. In other words, the lugs can be configured in the axial direction such that they determine the displacement of the arms in the radial direction.
(37) To achieve this effect, the lugs formed at the opposite stays 3a and 3b can also be offset to each other in the longitudinal direction, so that for example in
(38) The lugs have rounded corners to avoid sharp edges. Preferably, an arc-shaped transition is formed between the enlargement 3.3 and the shoulder of the lug 3.4b, as
(39) Thus a further aspect of the present method, system and device is a safety means having a band-shaped guard having two lugs along a first side which are offset in the axial direction, and along a second side, which are also offset in the axial direction.
(40) The stiffening frame made from thin sheet metal by punching and bending and having the stays 3a, 3b, has an approximately U-shaped basic form with flattened shoulders corresponding to the stays, as can be seen from
(41) According to another embodiment, the lugs 3.4a and 3.4b in
(42) According to a further embodiment, the opposite lugs 3.4a and 3.4b can also be lengthened in the peripheral direction so far that their edges abut at each other on the upper and lower side or only on one side and thus overlap or cover the middle portion of the intersecting arms 2.3 and 2.4. In such an embodiment, the lugs 3.4a and 3.4b provide a closed or approximately closed cross section together with the stays 3a and 3b in a sectional view of the needle safety device. Hereby, the lugs surrounding the needle safety element 2 extend into the free space O (
(43) In the embodiment of
(44) According to a further modification, the needle safety element can also be formed with arms 2.3 and 2.4 extending approximately parallel to each other, wherein the two arms can be bent in the middle portion preferably somewhat inwardly toward the needle, so that in this area the lugs 3.4a and 3.4b can overlap the arms of the safety element further inwardly, while the elbow-shaped portions 2.7 provided for engagement with a catheter hub are exposed. In the embodiments shown, in the view according to
(45) The needle safety element 2 described is preferably formed by punching and bending of a thin metal strip so that altogether the smallest possible overall dimensions are achieved. In practice, the safety element 2 has for example a longitudinal dimension of approximately 8 mm and a radial dimension of approximately 3 mm. In a corresponding way, the frame around the two arms is formed by punching and bending of the sheet metal such that the overall dimensions of the needle safety device are not increased by a remarkable amount. It is clear that the same configuration can be achieved using a plurality of components or parts which are assembled to obtain a safety element having a band-shaped guard for improving stability. The plurality of single parts can be formed from different metals or materials or from a plastic-metal compound.
(46) According to a modification, the cap-shaped bracket 3c can also be joined to the stays 3a and 3b by adhesion or welding. The bracket can also be formed such that it extends under or over the needle shaft, wherein for example an approximately semicircular recess can be formed in the bracket for guiding the needle shaft in the ready position. A bracket having a bore for the passage of the needle as shown is preferred.
(47) When the elbow-shaped portions 2.7 have another function than engaging with a catheter hub, these arc-shaped portions 2.7 can also have another shape. For example, they can be bent sharply, to form an edge acting outwardly. It is also possible to form this arc-shaped portion 2.7 flattened, so that it does not protrude or hardly protrudes over the periphery of the cap-shaped bracket 3c.
(48) Instead of sheet metal, another material can also be used, which when having small dimensions is correspondingly formable to form a needle safety device having small dimensions in this way.
(49) The small dimensions of the needle safety device made of sheet metal also allow the needle safety device arranged in the ready position on a hollow medical needle in the proximal area of the needle shaft to be covered by a conventional needle safety cap 5, which cap is placed on a needle hub 1.4, as
(50) Preferably, grooves extending lengthwise are formed onto the needle safety cap 5 and distributed over its inner periphery, and by means of these grooves the needle safety cap is held on the needle hub 1.4 on which corresponding radially projecting ribs 1.5 are formed distributed over the periphery. Due to the small radial dimensions of the needle safety element 2 having the stiffening frame 3a to 3c, there is no risk that the needle safety cap 5 could contact the needle safety element 2, so the inner and/or outer surfaces of the needle safety cap 5 can also be formed corrugated.
(51) If the described needle safety device is made of plastic, it has larger dimensions, wherein a frame formed as described is provided in the same way around the resilient arms of the needle safety element.
(52) Instead of two bent distal end walls of the safety element 2, a safety element can also be provided wherein only one arm has a bent distal end wall, which overlaps the needle tip in the protective position.