WO1990003198A1

WO1990003198A1 - Needle placer and needle assembly

Info

Publication number: WO1990003198A1
Application number: PCT/NL1989/000071
Authority: WO
Inventors: Ronald Theodor Boumans; Robert Hans Muller
Original assignee: Spruyt-Hillen B.V.
Priority date: 1988-09-23
Filing date: 1989-09-22
Publication date: 1990-04-05
Also published as: NL8802352A; AU4403989A

Abstract

Device comprising a needle assembly (4), consisting of a needle (15) and a needle carrier (6) coaxial thereto, as well as a needle placer (3) for mounting the needle assembly in operative connection onto the head (8) of e.g. an injection device. The needle placer comprises a first (1) and a second (2) sleeve for protectively and coaxially enveloping the needle assembly, and the first sleeve member is connected in a terminable manner to the needle assembly and is suitable to serve as a tool for mounting the needle assembly onto the head of the injection device. The first sleeve member (1) is at least partially displaceable within the second sleeve member (2) between a first, extracted position, in which the needle (5) is located entirely within the needle placer (3), and a second, retracted position, in which the needle protrudes from the outer end (7) of the second sleeve member, the outer end being remote from said first sleeve member, and the outer end (7) of the second sleeve member comprises means for positioning it onto means cooperating therewith and present on the head of the injection device.

Description

Needle placer and needle assembly

The invention relates to a device comprising a needle assembly- consisting of a needle and a needle carrier coaxial thereto, as well as a needle placer for mounting the needle assembly in oper¬ ative connection onto the head of e.g. an injection device, said head being destined for that purpose, said needle placer com¬ prising a first and a second sleeve member for protectively and coaxially enveloping the needle assembly, and said first sleeve member being connected in a terminable manner to the needle assem¬ bly and being suitable to serve as a tool for mounting the needle assembly onto the head of the injection device.

Such a device is known from US patent specification 3,073,307. In the device disclosed therein, the first sleeve member is connected to the needle assembly by means of a break-off connection. The second sleeve member fits over the needle carrier and connects to the first sleeve member in a releasable manner. Upon placing the needle assembly onto the head of an injection device, first the second sleeve member is removed, after which, by handling the first sleeve member, the needle carrier can be screwed onto the head of the injection device. After positioning has been com¬ pleted, the first sleeve portion can be broken off the needle carrier, thus exposing the administering section of the needle.

Upon positioning the needle carrier of the known device, it may occur that the needle portion that is initially protected by the second sleeve member, comes into contact with the head of the injection device. Thus it may become contaminated or it may even deteriorate.

An object of the invention is to improve a device of the type re¬ ferred to in the introduction, and for that purpose is character- ized in that said first sleeve member is at least partially dis¬ placeable within said second sleeve member between a first, ex¬ tracted position, in which the needle is located entirely within the needle placer, and a second, retracted position, in which the needle protrudes from the outer end of said second sleeve member, said outer end being remote from said first sleeve member, and in that said outer end of said second sleeve member comprises means for positioning it onto means cooperating therewith and present on the head of the injection device.

When mounting the needle assembly onto tne head of the injection device, the device according to the invention can be used to place the outer end of the second sleeve portion onto the head, during which action the needle is always surrounded by the two sleeve members. Thus the risk of contamination or deterioration of the needle is Minimized. As both sleeve portions are coaxial to the axis of the needle, the needle can also be kept centered with re¬ spect to the head of the injection device during this action, and as the outer end of the second sleeve member has been placed onto the head the needle can also be kept straight with respect to the head, during this action. For the subsequent actual positioning of the needle assembly onto the head of the injection device, the first sleeve member is moved within the second sleeve member to¬ wards the head, until positioning has been completed. The guiding of the first sleeve member by the second sleeve member ensures that the correctly centered and straight position of the needle is maintained during positioning. Mounting of the needle assembly is subsequently effected by moving the seconα sleeve member within the first sleeve member, until positioning has been completed.

Preferably the needle assembly is retained by the first sleeve member ny means of a terminable clamping connetion, acting at least in the direction parallel to the axis of the needle. Here, the clamping action is sufficiently strong to ensure that the needle assembly stays in its position in the first sleeve member during the preparatory actions, but at the same time sufficiently weak for it to be terminable intentionally. This way, after posi¬ tioning the needle assembly onto the head of the injection device, the needle placer can easily be removed from the head of the in¬ jection device by exerting a force on the needle placer in the direction away from the head, parallel to the needle. During this process, the needle placer remains intact and can be used again in orαer to again remove, if necessary, the needle assembly from the head of the injection device, by applying the actions performed when mounting the needle assembly in reversed order. After again extracting the first sleeve member out of the second sleeve member to the greatest possible extent, the needle is again enveloped by the two sleeve members. If a needle placer would be thrown away together with the needle assembly, then there is only the slight¬ est chance that people such as garbage collectors and nurses would inadvertently be pricked by the needle.

According to a preferred embodiment, the first sleeve member is rotatable with respect to the second sleeve member and said needle carrier comprises a head portion, being formed so on its exterior that it interengages with a complementary shaped portion of said first sleeve member, in order to be co-rotated with said first sleeve member. Thus e.g. the possibility is created to screw the needle carrier onto or into the head of the injection device, while the second sleeve member meanwhile remains stationary on the head.

The head portion can be conical and may taper towards the outer end or said second sleeve member, said head portion comprising wings at its circumference that extend radially with respect to said needle, each of said wings lying in respective planes with said needle, and fitting into grooves provided at the inner cir¬ cumference of said first sleeve member and establishing the terminable clamping connection therewith.

The head portion may also comprise a disc, lying in a plane per¬ pendicular to the axis of said needle, said disc being polygonal or being provided with a radial toothing, said first sleeve member being provided with a receiving space complementary to the disc circumference, wherein the space of the first sleeve member, destined for the accommodation ot the needle, has a cross-section of such dimensions that the neeαle forms a terminable clamping connection therewith. The clamping ot the neeαle in the first sleeve member is provided here in order to compensate tor possible insufficient clamping action between the head portion, particu¬ larly the disc, and the first sleeve member.

According to a preferreα emboαiment, one of the sleeve members comprises a radially extending cam which can travel in a groove provided in said other sleeve member upon rotation of said first sleeve member, wherein said groove comprises a helical wall, which limits the freedom of displacement for the cam in a direction parallel to the axis of the needle when said first sleeve member is moved towards the retracted position, ana wherein said groove comprises a first and a second end. By rotating the tirst sleeve member and simultaneously pressing t into a direction parallel to the axis of the needle, herewith the needle assembly can be both rotated and moved in the direction towards the head of the injec¬ tion device in a controlled manner. Mere, the helical wall of the groove is preferably interrupted at the first end of the groove, for forming a passage for the cam in a direction parallel to the axis of the needle, so that a possibility is provided to shift the first sleeve member, without rotating it, inside the second sleeve portion. According to a further preferred embodiment, the cam forms a part of a finger, which itself forms part of the second sleeve member and is resilient in radial direction with respect to the axis of the needle. On account of the resilient finger it is possible, after manufacturing the two sleeve members, to oin these in a simple manner, by outwardly bending the finger and sub- sequently inserting the first sleeve member into the second sleeve member, until tne cam is received in the groove.

It the needle placer, as stated before in the preceding text, is also used tor again removing the needle assembly from the head of the injection device, then it could be favourable if a provision were present to prevent the two sleeve members, when they are in their extracted positions with respect to one another and envelope the released needle assembly, from being inadvertently pressed into each other, so that the persons referred to above might be pricked by the neeαle. This can be attained in various ways, e.g. in that the groove is narrowed down at its second end so as to enable the clamping of the cam there, or in that the groove end comprises at its second enα a snap lock for the cam. Here, it is not absolutely necessary that the cam forms part of a finger, as described hereabove.

It the cam is indeed, as described above, part of a resilient finger ot the second sleeve member, then the groove can be devised so, that towards its second end it is upwardly inclineα, so as to torm a transition tor tne cam of the groove to the outer enα of said seconα sleeve member. By rotation of the first sleeve member in the final stage of the series of actions requireα for again re¬ moving the neeαle assembly from the heaα of the injection αevice, the cam comes out of the groove automatically, an by the resil¬ ient property of the finger it will press against the exterior of the first sleeve member, thereby securing both sleeve members with respect to one another to some extent. For a more positive locking of the two sleeve member with respect to one another, the first sleeve member may be provided for that purpose on its exterior with a receiving space for the cam, in the vicinity of the groove.

The invention will now be further described on the basis of a num¬ ber of exemplary embodiments represented in the drawing, in which:

πgures 1 A-1 U show the device in (partial) longitudinal section in various subsequent stages during the mounting of a needle assembly onto the head of an injection device;

figure 1E shows the needle assembly in partical longitudinal sec- tion after the mounting thereof onto the head of the injection de¬ vice has been completed;

figures 2-5 show several embodiments of constructions of the needle placer with which in the extracted state the two sleeve members can be fixed to a greater or lesser extent;

figure 6 is a longitudinal section of a portion of the first sleeve member, with an embodiment of the head portion of the needle carrier that differs from that of figure 1;

figure 7 is a section of the first sleeve member with the needle carrier present therein, in which the section has been taken along the line VII-VII in figure 6;

figure 8 is a section that corresponds by its nature to that of figure 7, but with another embodiment of the head portion of the needle carrier.

In figure 1 , the device according to the invention is shown just before the start of the positioning of the needle assembly 4 onto the head 8 of an injection device, which has not been further shown here. The head 8 comprises a bore 20, destined to receive the needle carrier 6. The device is composed of a needle assembly 4, comprising a needle 5 and a needle carrier 6, as well as a needle placer 3, comprising a first sleeve member 1 and second sleeve member 2. The needle 5, as regarded in the direction of the axis of the needle, is on the one side of the needle carrier 6 protectively enveloped by the first sleeve member 1 and on the other side of the needle carrier 6 protectively enveloped by the second sleeve member 2. The outer end 7 of the second sleeve mem¬ ber 2, which end is faced towards the head 8 of the injection device, is devised so that it can be placed onto means on the head of the injection device cooperating therewith, as e.g. can be seen in figure 1B. Other ways of cooperation between the head 8 of the injection device and the second sleeve member 2 are of course also conceivable. The needle carrier 6 comprises a head portion 10 and a body 9, destined to be mounted into the head 8. In this example, the body 9 comprises external threading, which can cooperate with an internal threading provided in the bore 20. Other connections between body 9 and the head 8 are also possible, e.g. a snap con- nection or a Luer-connection.

The head portion 10 has a conical shape, the tip of the cone, through which also the needle 5 protrudes, being directed away from the outer end 7. The head portion 10 comprises on its ex- terior a number of wings 11 , each extending radially with respect to the axis of the needle 5 and each also lying in respective planes with the needle 5. The wings 11 fit into complementary formed slits 12, provided at the inner circumference of the first sleeve member 1. The wing end edges axial with respect to the di- rection of the axis of the needle 5 are, at the location where they fit into grooves 12, at an angle with respect to the axis of the needle 5 that is larger than the angle of the generatrix of the cone of the head portion 10 with respect to the axis of the needle. The reason for this will be elucidated hereinafter. The wings 11 have such dimensions in the directions radial with re¬ spect to the needle, that they form a terminable clamping connec¬ tion with the respective bottoms of the slits 12 in the first sleeve member 1. This clamping is sufficiently strong to minimize the risk that the needle assembly 4 might drop from the needle placer, which should be prevented in the period between removing the device from its commercial packaging and its actual position¬ ing onto the head 8 of the injection device.

Reverting to figures 1 en 1B, in front view a finger 19 can be seen, forming a part of the second sleeve member 2 and i.a. being defined by two radial slits in the second sleeve member 2. From the outer end of the finger 19 a cam 15 protrudes radially inwards with respect to the axis of the needle 5. The cam 15 fits into a groove 16 provided on the exterior of the first sleeve member 1. The wall located on the side of the outer end 7 of the second sleeve member 2 of the groove is entirely disposed in a plane per¬ pendicular to the axis of the needle 5. The opposite wall 17 of the groove 16, on the other hand, is helical, as further illus¬ trated in figures 6 and 8. Here, the groove 16 has an open end, as the wall 17 has been interrupted to provide a passage for the cam 15, in a direction parallel to the axis of the needle 5.

On the basis of figure 1B through figure 1E, now the procedure for placing the needle assembly 4 onto the head 8 of the injection de¬ vice, as such can be performed by means of the device according to the invention, -will be elucidated.

After the outer end 7, which e.g. may comprise a toothing, of the second sleeve member 2 has been placed onto the head 8 of the in¬ jection device, and the bore 20 is also coaxial to the axis of the needle 5, the first sleeve member 1 is rotated in the direction of the arrow B and simultaneously also pressed into a direction to¬ wards the head 8, the cam running against and along the wall 17 until the passage in axial direction has been reached. The shape of the groove 16, which widens as it extends, also makes it poss- ible that the first sleeve member 1 is rotated first about the axis of the needle 5, and only afterwards pushed towards the head 8 in order to displace the cam 15 through the passage in wall 17 (relatively) in a direction opposite to the axial direction A. After the cam 15 is brought out of the groove 16, the cam 15, in a relative sense, can be slid over a reduced portion of the first sleeve member 1 , in a direction opposite to that of the direction A. By this axial displacement of the first sleeve member 1, the threading of the body 9 can be brought properly before the thread¬ ing of the head 8, after which by rotation of the first sleeve member 1, in the direction of the arrow B, the body 9 can be screwed into the head 8. Upon rotation of the first sleeve member 1 , the needle carrier 6 and thus also the body 9 are co-rotated therewith by the cooperation of the wings 11 and the slits 12. At a certain moment during rotation and displacement of the first sleeve member 1 in the directions of the arrows B and A, respect- ively, the outer end of the first sleeve member 1 located at the side of the head 8 of the injection device, will contact the head 8. By continuing the rotation of the first sleeve member 1 in the direction of the arrow B, the body 9 will be rotated further into the bore 20, wherein the radial outer ends of the wings 22 are permitted to slide in direction A along the bottoms of the slits. As the angle of the axial end edges of the wings 11 with respect to the axis of the needle 5 exceeds that of the generatrix of the conical shape of the head portion 10, sufficient force required for rotation can be exerted on the needle carrier 6 during the last stage of positioning it onto the head 8 thereof. This is re¬ lated to the circumstance that in this example, prior to position¬ ing, the head portion 10 is found to be sunken into the first sleeve member 1 to a corresponding extent as shown in figures 1A-1C.

When the basis of the conical head portion 10 touches upon the head 8, as is the case in figure 1D, the needle placer 3 can be removed from the head 8 and from the now placed needle carrier 6, by exerting a force on the needle placer 3 in the direction of the arrow C. The clamping action between the radial edges of the wings 11 and the bottoms of the slits 12 is sufficiently slight for this purpose. After this, a situation as shown in figure 1E has been established.

On account of the fact that the two sleeve members 1 and 2 and the needle carrier 6 are coaxial to the needle 5, the needle remains in its track during displacement of the first sleeve member 1 in the second sleeve member 2. The head 8 of the injection device is shaped so, that the outer end 7 of the second sleeve member 2 can be positioned thereon in such a manner, that the bore 20 present in the head 8 for the body 9 of the needle carrier 6 is coaxial to the needle 5, so that the needle 5 can be mounted into the head of the injection device in a reliable, straight and centric manner. This is particularly favourable if the membrane of a cartridge already present therein needs to be pierced upon the positioning of the needle onto the injection device. In existing devices, a needle inserted obliquely or off-center in a cartridge was cor¬ rected by e.g. further screwing the neeαle assembly onto the heaα. However, this coulα lead to bending (breakage) of the needle and stretching of the hole in the membrane, resulting in leakage, or, in those cases were suction was required, .suction of false air ana risk ot contamination. These risks are minimized by the device according to the invention. The guiding by the second sleeve mem¬ ber 2 of the first sleeve member 1 ensures that the neeαle can be introαuced into the head in a straight manner.

The needle placer 3 can also be used for removing the needle assembly 4 again from the heaα 8 of the injection device. For this purpose, the needle placer is positioned onto the head in the same condition as it was in when positioning of the needle assembly 4 onto the head 8 was completed. Subsequently the first sleeve mem¬ ber 1 is rotated with respect to the second sleeve member 2 in a direction opposite to that of the arrow B, wherein by engagement of the slits 12 onto the wings 11 the needle carrier is turned out of the heaα 8. In the shown example, at a certain moment a press- ure force has to be exerted on the first sleeve member 1 towards the head 8, in order to eftect that the axial end edges of the wings come to abut against the complementary portions of the slits 12. Subsequently, the rotation of the first sleeve member 1 is continued, until the body 9 has gone out of the bore 20 ana the head 8. Then the first sleeve member 1 can be pulleα over a cer¬ tain distance out of the second sleeve member 2, until the cam 15 is brought into the groove 16 through the axial passage in wall 17. After that the first sleeve member is further rotated in a di¬ rection opposite to that of the arrow B, until, e.g. by one of the construction of figures 5-8, the cam 15 is secured to a greater or lesser extent, and thus also the two sleeve members with respect to one another. By the use of the needle placer 3 for again re¬ moving the needle assembly, the chance that the patient would be pricked is thus minimized.

Figure 5 shows that the groove 16 is gradually made less deep, so that the cam 15, as a consequence of the resilience of the finger 19, can move outwards. Finally a certain amount of clamping action between the cam 15 and the exterior of the first sleeve member 1 s obtained. Figure ,4 also shows a receiving space 21 for the cam 15, said space being provided in the first sleeve member. The cam 15 is positively retained hereby, and with it also the second sleeve member 2 with respect to tne first sleeve member 1. Other options are shown in figures 3 and 5. In figure 3 the groove 1b is αeviseα so, that with sufficient rotation of the first sleeve mem- ber 1 with respect to the second sleeve member 2, the cam 15 is clampeα between the two walls of the groove 16. In figure 5 the enα of the groove 16 is αevised as a snap lock for the cam 15. In these figures 3 and 5, the second sleeve portion 2, apart from the cam 15, has been omitted for clarity's sake.

Figures 6-8 relate to special shapes of the head portion of the needle carrier 6. Figures 6 an 7 show a head portion 13 that may be tapered, and that comprises a disc 22 at the side facing to¬ wards the outer end 7, said disc having a quadrangular shape. The inner periphery of the first sleeve member 1 is shaped according¬ ly. In order to establish sufficient holding power between the needle assembly and the second sleeve member 1 , now the first sleeve member 1 is devised so, that the needle, or at least the part tnereof that extends inside the first sleeve member 1 , is presently clamped to the same effect as the embodiment described hereaoove. Finally, figure 8 shows a head portion 24 with a disc 23 that comprises a toothing. In this case too, the needle is re- taineα insiαe the first sleeve member by clamping.

The described device is not only applicable in injection αevices, but also in vacuum blood collecting systems and systems in which separate componenrs of^• the substance to be injecteα are mixed in the syringe prior to injecting.

Claims

C L A I M S

1. Device comprising a needle assembly, consisting of a needle and a needle carrier coaxial thereto, as well as a neeαle placer for mounting the needle assembly in operative connection onto the heaα of e.g. an injection device, said head being destined for that purpose, said needle placer comprising a first and a second sleeve member for protectively and coaxially enveloping the needle assem¬ bly, and said first sleeve member being connected in a terminable manner to the needle assembly an being suitable to serve as a tool for mounting the needle assembly onto the heaα of the injec- tion device, characterized in that said first sleeve member ' 1 ) is at least partially displaceable within said second sleeve member (2) between a first, extracted position, in which the needle (5) is located entirely within the needle placer (3), and a second, retracted position, in which the needle protrudes from the outer end (7) ot said second sleeve member, said outer end being remote from said first sleeve member, and in that said outer enα (7) of said second sleeve member comprises means^* for positioning it onto means cooperating therewith and present on the heaα of the injection device.

2. Device according to claim 1 , characterized in that saiα needle assembly (4) is retained by saiα tirst sleeve member (1 ) by means of a terminable clamping connection, acting at least in a αirection parallel to the axis of the neeαle.

3. Device according to claim 2, characterized in that said first sleeve member (1 ) is rotatable with respect to the seconα sleeve member (2) and in that said needle carrier (6) comprises a head portion (10; 13, 14), being formed so on its exterior that it interengages with a complementary shaped portion of said first sleeve member, in orαer to be co-rotateα with said first sleeve member.

4. Device according to claim 3, characterized in that the head portion (10) is conical and tapers towarαs the outer enα (7) of saiα second sleeve member (2), said heaα portion comprising wings (11) at its circumference that extenα radially with respect to said neeαle, each of said wings being αisposeα in respective planes with saiα neeαle (5), fitting into grooves provided at the inner circumference of said first sleeve member (1) and establish¬ ing the terminable clamping connection therewith.

5. Device accorαing to claim 3, characterized in that, said head portion (13; 14) comprises a disc (22, 23) lying in a plane perpendicular to the axis of said needle, saiα disc being poly¬ gonal or being proviαeα with a raαial toothing, saiα first sleeve member (1) being provided with a receiving space complementary to the αisc circumference, wherein the space of the first sleeve mem¬ ber, αestineα for the accommoαation of the neeαle (5), has a cross-section of such dimensions that the neeαle forms a termin¬ able clamping connection therewith.

6. Device according to one of claims 3-5, characterized, in that one of the sleeve members (1; 2) comprises a radially extending cam (15) which can travel in a groove (16) provided in said other sleeve member (2; 1 ) upon rotation of said first sleeve member, wherein said groove comprises a helical wall (17), which limits the freeαo of αisplace ent for the cam (15) in a direction parallel to the axis of the needle (5) when said first sleeve mem¬ ber is moved towards the retracted position and wherein said groove comprises a first and a second end.

7. Device according to claim 6, characterized in that saiα helical wall (17) of the groove is interrupteα at the first enα of the groove (16) for forming a passage for the cam (15) in a direc- tion parallel to the axis ot the neeαle (5).

8. Device accorαing to claim 6 or 7, characterized in that that saiα cam (15) forms a part of the outer enα of a finger (19), which forms a part ,of the second sleeve member (2) ana is resi¬ lient in radial direction with respect to the axis of the neeαle (5).

9. Device accorαing to claims 6, 7 or 8, characterized in that saiα groove (16) is narroweα down at its second end so as to en¬ able the clamping of the cam (15) there.

10. Device according to claim 6, 7 or 8, characterized in that said groove (16) end comprises at its second end a snap lock (18) tor the cam (15).

11. Device according to claim 8, characterized in that said groove (1b) is upwardly inclineα towards its seconα enα n the raαial direction, so as to form a transition tor the cam (15) of the groove to the outer end of said second sleeve member (2).

12. Device according to claim 11, characterized in that, in the vicinity of the groove (16), said first sleeve member (1 ) is pro¬ vided on its exterior with a receiving space (21 ) for the cam (15).