Source: https://patents.google.com/patent/WO2003011381A1/en
Timestamp: 2019-12-11 22:56:01
Document Index: 413046010

Matched Legal Cases: ['art 28', 'art 28', 'art 38', 'art 38', 'art 38', 'art 27', 'art 38', 'art 27']

WO2003011381A1 - Protective device for a needle - Google Patents
WO2003011381A1
WO2003011381A1 PCT/EP2002/008534 EP0208534W WO03011381A1 WO 2003011381 A1 WO2003011381 A1 WO 2003011381A1 EP 0208534 W EP0208534 W EP 0208534W WO 03011381 A1 WO03011381 A1 WO 03011381A1
PCT/EP2002/008534
2001-07-31 Priority to ITB02001AOOO497 priority Critical
2001-07-31 Priority to ITBO20010497 priority patent/ITBO20010497A1/en
2002-07-30 Application filed by Delta Med S.R.L. filed Critical Delta Med S.R.L.
2003-02-13 Publication of WO2003011381A1 publication Critical patent/WO2003011381A1/en
2007-08-29 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=11439542&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2003011381(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
230000001681 protective Effects 0 abstract claims description title 115
238000007790 scraping Methods 0 claims description 26
Protective device for a needle, more particularly for a catheter introducing needle or so-called cannula needle (2), whereby this protective device (1) comprises protective means (14) which slidably cooperate with the needle (5), characterized in that said protective means (14) comprise a combination of at least, on one hand, safety means (16) having at least one part which, upon retraction of the needle (5) through the protective means (14), is placed in front of the needle point (18) and prevents the re-use of the needle (5), and, on the other hand, blocking means (19) which cooperate with the safety means (16) and which, when the protective device (1) passes from a non-operative state (A) into an operative state (B), release said safety means (16) from a blocked position into an unblocked position.
Protective device for a needle,
The operation involving replacing the needle into a protective hood is equally dangerous for the operator replacing it, as numerous specialised studies have shown statistically . In order to avoid this problem and to guarantee the safety of health staff during their activity, various kinds of protection devices applicable to cannula needles have been developped.
The main disadvantage of these devices, which are already known to the profession, is the considerable volume of the protective element which may make it laborious and difficult for the operator to use these cannula reedles, resulting in that this known system is less practical and versatile .
A further disadvantage is that extra operations are necessary compared to unprotected devices, entailing the risk of omissions or wrongly executed operations by the operator. The profession is also acquainted with protective devices for cannula needles involving the use of a pair of rings linked by a flexible wire. The first ring is fixed to the base of the needle, while the second is fixed to the end of the cannula and is intended to guide extraction of the needle and to contain its point. The mechanism makes the needle slide, during its extraction, through the axial forum of the second ring until its further extraction is stopped by the fixed length of flexible wire. Hereby, the needle arrives with its needle point into one of the rings. The needle, fitted into the ring with its point protected, can be safely pulled out of the cannula with the entire device comprising the two rings and the wire.
The main disadvantage of this device is the considerable encum brance entailed by the two protective rings and above all by the flexible wire, which can make it laborious and difficult to use the cannula needle, reducing its functional scope.
A further disadvantage of these rings and in general of all the devices known to the profession, is that the patient's body fluids, and sometimes drugs, which may be deposited on the needle as drops or as an adhesive covering, are still accessible and/or that there still is a considerable risk that these fluids or drugs leave the protective device. Shocks may cause them to squirt on the bare skin or into the eyes of the operators or of others standing in the proximity thereof, entailing the risk of infection or contamination .
The fact that, according to the invention, a combination is made of safety means with blocking means, which automatically release the safety means from a blocked into an unblocked position, offers the advantage that the device functions very efficiently, as will be clear from the following detailed description. According to a preferred embodiment, the safety means and the blocking means are configured in such a manner that, upon retraction of the needle, the safety means, more particularly the part or parts which are placed in front of the needle point, remain at a distance from the needle during the entire retraction thereof. In other words, during the complete retraction, there is no contact between, on the one hand, the safety means, more particularly said safety tongue or safety tongues, and, on the other hand, the needle. As a result thereof, the safety means, more particularly said tongues, will never urge fluids adhered to the needle towards the needle point and off the needle point. In this manner, it is avoided that fluids are scraped completely from the needle and can consequently leave the protective device.
In the most preferred embodiment, said blocking means are shiftable in respect to the safety means, such that, by means of a shifting movement of the blocking means, the safety means are released from a blocked position into an unblocked position, whereby said blocking means cooperate with the needle in such a manner that a displacement and retraction of the needle also causes the above shifting movement of the blocking means. In this way, with a minimum of constructive parts, a device is offered which can be actuated automatically, just by the retraction of the needle .
Figure 1 represents a cross-section lateral view of a cannula needle assembly provided with a protective device according to the invention, said protective device being in non-operative state; figure 2 represents an enlargement of the portion which is indicated by F2 in figure 1 ; figure 3 represents the portion shown in figure 2, during retraction of the needle; figure 4 represents a cross-section lateral view similar as in figure 1 , however, with the needle in retracted position and with the protective device being operative; figure 5 represents an enlargement of the portion which is indicated by F5 in figure 4; figure 6 represents a cross-section lateral view similar as in figure 4, however, after that the needle, together with the protective device, is separated from the cannula; figures 7 and 8 represent an alternative embodiment of the invention, for the non-operative and operative state respectively of the protection device; figures 9 and 10 represent a further alternative embodiment of the invention, for the non-operative and operative state respectively of the protection device; figures 11 and 12 represent a still further alternative embodiment of the invention, for the non-operative state and the state during retraction of the needle, respectively; figure 13 represents a perspective view of the part which in figure 11 is indicated by F13.
With reference to figures 1 to 6 , reference 1 in general indicates a protective device for a cannula needle 2, which cannula needle 2, together with the cannula 3, forms a complete cannula needle assembly 4.
As shown, the safety means 16 and the blocking means 19 are preferably incorporated in a hollow body or housing 20 having a side wall 21 and two opposed end walls 22-23, which are each provided with a passage opening 24-25 for the needle 5. The safety tongue 17 consists of an elastically bendable lip, which in this case forms one part with the end wall 22, and which is configured and arranged in such a manner that, in its free position, it extends through the path of the needle 5, preferably in an oblique manner, as shown in figures 4 to 6.
The ring 26 is configured such that, in the non-operative state A of the protection device 1 , in which the needle 5 is completely inserted into the cannula 3, the ring 26 cooperates with the safety tongue 17 such that the latter is bent outwardly, in an open position S, in which this tongue 17 is not interfering with the needle 5. Hereby, as shown in figures 1 and 2, the tongue 17 and the ring 26, more particularly the outer ring part 28, are slightly hooking behind each other, by means of a recess 29 in the free end of the tongue 17 and a collar 30 at the front outer end of said ring part 28.
The above mentioned stopping means 15 consist of abutment parts which are provided at the needle 5 and at the protective means 14, respectively. In the embodiment of figures 1 to 6, these abutment parts are formed by an annular groove 31 nearby the point of the needle 5 and retaining means consisting of strips or fins 32 directed towards the axis of the ring 26 and inclined in the direction opposite to the extraction direction of the needle 5.
As shown, the needle hub preferably comprises at least one part 38 which, in the most forward position of the needle 5, cooperates with the protective means 14, thereby preventing the blocking means 14 from carrying out a shifting movement from the non-operative position A to the operative position B. This is obtained in that this part 38 extends through the opening 25 into the hollow body 20, thereby forming an obstacle for the displacement of the blocking means 14. More particularly, as shown in figure 2, said shifting is prevented in that the free end of part 38 comes into contact with said inner ring part 27 and/or said fins 35.
In the beginning, in the non-operative state A, the part 38 is in contact with the inner ring part 27, resulting in that the blocking means 14 are prevented from being displaced, resulting in that the safety tongue 17 is kept in the position, as shown in figures 1 and 2.
When retracting the needle 5, first, this needle freely slides through the protective means 14. From the moment on that the annular groove 31 arrives at the height of the fins 32, these fins are elastically urged into the annular groove 31 , resulting in that the needle 5 cannot make any further sliding movement through the ring 26. As a consequence, the ring 26 is taken along with the movement of the needle 5, causing that the ring 26, in other words the blocking means 19, are freeing the tongue 17, which interposes itself between the passage opening 24 and the point 18 of the needle 5, corresponding to a state of release R.
Upon further retraction, the ring 26 will contact the end wall 23, as shown in figure 5, and, as a consequence thereof, any further extraction movement of the needle 5 from the protective means 14 is prevented. Hereafter, the cannula needle 2 can be disconnected from the cannula 3 by means of the releasable coupling means 34.
The protective means 14 are preferably configured in such a manner that any contact between the safety tongue 17 and the needle 5 is excluded for the complete retraction of the needle 5. In this way, it is excluded that the safety tongue 17 acts as a scraping element for the needle 5 and that, on the moment that the tongue 17 is released, blood or other fluids are projected through the passage opening 24 and possibly are contaminating this opening. In normal use, in the design of figures 1 to 6 there will be no contact between the tongue 17 and the needle point 18 on the moment that the tongue 17 bends back into its free position. However, in order to exclude any contact, the point 18 can be further shortened, as indicated in dashed line 39 in figure 3.
The geometrical form and the inclination of the fins 32 make it possible to transfer the needle 5 towards the cannula 3 during the phase of assembly of the cannula needle assembly 4. Also the blocking means 19 are advantageous during the assembly, as by means of these blocking means 19, the tongue 17 can be kept in an non-activated state, allowing the free passage of the needle 5 to the protective means 14. During the passage from the non-operative state A to the operative state B, the needle 5 slides through the scraping means 33 which dry it from the liquids that are adhered to this needle 5, thereby retaining these liquids in the hollow body 20. Hence, although the shaft of the needle 5 is no longer sterile, a decisive reduction of any infective or toxic products adhered at the needle 5 takes place, thereby reducing the risk for anyone who might have to touch the shaft of the needle 5 with bare hands. Furthermore, although the hollow body 20 is not completely closed, the fluids retained in it by the scraping means 33 are practically completely held inside, even if the needle 5 were to undergo shocks or vibrations .
In the embodiment of figures 1 to 6, the coupling means 34 and the end wall 22 are made in one piece and together form a separate part which acts as a cover which is connected to the side wall 21 in any manner.
Figures 7 and 8 show a second embodiment of the protective device 1 in which the safety means 16 consist of a pair of opposed elastically bendable safety tongues 40-41 , facing each other and fixed to the end wall 23. The tongues 40-41 have a different length and consist of an elastically bendable first portion 42 which substantially extends in lengthwise direction and, at the distal end of this first portion 42, a second portion 43 which is directed transversely or substantially transversely in respect to the first portion 42. The safety tongues 40-41 are configured such that by means of their elasticity, they are permanently urged towards a position in which the second portions 43 are located in the path followed by the needle 5.
In this embodiment, the blocking means 19 consist of a ring 45 which is located around the needle 5 and in between the tongues 40-41 , such that these tongues 40-41 by means of said ring 45 can be kept in an open state S, as shown in figure .
Similarly as in figures 1 to 6, the ring 45 is provided with fins 32.
It should be noted that in figure 7 the configuration is chosen such that the tongues 40-41 are in contact with the ring 45, as well as in contact with the needle 5. Hereby, the tongues 40-41 are only in slight contact with the needle 5, resulting in that, during the retraction of the needle 5, no important frictional forces have to be surmounted .
During the passage from the non-operative state A to the operative state B, the fins 32 engage in the annular groove 31 of the needle 5 during the latter ' s axial sliding, thereby causing the ring 45 to slide towards the end wall 23. This sliding motion of the ring 45 permits the disengaging of the free ends of the tongues 40-41 , so as to reach the state of release R, in which these free ends are curved towards each other, thus placing the tongues 40-41 between the passage opening 24 and the needle point 18. The different lengths of the tongues 40-41 allow the respective free ends to overlap each other, preferably without causing any interference, thereby avoiding the possibility of the needle 5 coming out of the hollow body 20.
Figures 9 and 10 show a further variant of the invention, the only difference with the embodiment of figures 7-8 being that the ring 45 has no fins 32 and directly fits around the needle 5, whereas the stopping means 15 at the needle 5 consist of a ridge 46 or thickening nearby the needle point 18. In this way, the side 47 of the ring 45 forms an abutment for the ridge 46.
Figures 11 and 12 relate to a further embodiment. An important difference with the embodiment of figures 9 and - 1
10 consists in that the tongues 40-41 and the ring 45 are dimensioned such that in the non-operative state A of the protective device 1 there is no contact between the tongues 40-41 and the needle 5 and furthermore also during the entire retraction of the needle 5 no such contact takes place. Figure 12 shows an intermediate position, which demonstrates that the tongues 40-41 nicely close around the needle point 18, without touching the latter. As explained in respect to the embodiment of figures 1 to 6 , this offers the advantage that the tongues 40-41 are not acting as scraping elements, resulting in that no drops of blood or other fluids are collected at these tongues 40-41 , thereby avoiding that such drops are catapulted towards the passage opening 24.
In all embodiments the needle hub 6 may be provided of one or more prolongated parts which at least partially surround the actual protective means 14, in other words surround the hollow body or housing 20. Such needle hub 6 is applied in the embodiment of figures 11 and 12 and is shown on itself in figure 13. More particularly, this needle hub 6 comprises prolongations 48-49-50, respectively in the lateral and partially in the upper part thereof. This further improvement is intended to prevent the possibility that the operator can disconnect the cannula needle 2 without activating the protective device 1.
According to an important preferred aspect of the invention, which is mentioned in the introductory portion of the description, the scraping means comprise a scraping ring which cooperates with the needle 5, said scraping ring for all positions being located inside the housing at a distance from the rear side of the rear wall or end wall of said housing. In the previously described embodiments, this is demonstrated by means of the distance D which is indicated in the figures 5, 8 and 10.
Another advantage is that it provides a protective device that is simple to construct and assemble and is therefore economic .
1.- Protective device for a needle, more particularly for a catheter introducing needle or so-called cannula needle (2), whereby this protective device (1) comprises protective means (14) which slidably cooperate with the needle (5), characterized in that said protective means (14) comprise a combination of at least, on the one hand, safety means (16) having at least one part which, upon retraction of the needle (5) through the protective means (14), is placed in front of the needle point (18) and prevents the re-use of the needle (5), and, on the other hand, blocking means (19) which cooperate with the safety means (16) and which, when the protective device (1) passes from a non-operative state (A) into an operative state (B), release said safety means (16) from a blocked position into an unblocked position.
2.- Protective device according to claim 1, characterized in that the safety means (16) and the blocking means (19) are configured in such a manner that, upon retraction of the needle (5), the safety means (16), more particularly the part or parts which are placed in front of the needle point (18), remain at a distance from the needle (5) during the entire retraction thereof.
3.- Protective device according to claim 1 or 2, characterized in that the blocking means (19) are shiftable in respect to the safety means (16), such that, by means of a shifting movement of the blocking means (19), the safety means (16) are released from a blocked position into an unblocked position, whereby said blocking means (19) cooperate with the needle (5) in such a manner that a ! 1 -
displacement and retraction of the needle (5) also causes the above shifting movement of the blocking means (19).
4.- Protective device according to claim 3, characterized in that the blocking means (19) substantially consist of a sliding ring (26-45) located around the needle (5).
5.- Protective device according to claim 3 or 4, characterized in that the needle (5), at its proximal end, is attached in a needle hub (6), and in that this needle hub (6) comprises at least one part (38) which, in the most forward position of the needle (5), cooperates with the protective means (14), more particularly is inserted in the protective means (14), thereby preventing the blocking means (19) from carrying out the above-mentioned shifting movement .
6.- Protective device according to any of the preceding claims, characterized in that said part of the safety means (16) is elastically bendable, such that it is urged into the path of the needle (5), respectively said parts are elastically bendable, such that they are urged into the path of the needle (5), whereby said part, parts, respectively, in their blocked position, are kept at least substantially out of the path of the needle (5) by means of said blocking means (19).
7.- Protective device according to any of the preceding claims, characterized in that said part, parts, respectively, of the safety means (16) consist of safety tongues (17-40-41 ) .
8.- Protective device according to claim 7, characterized in that the safety means (16) consist of a pair of safety tongues (40-41), which, from opposite sides of the needle (5), can be brought into the path of this needle (5).
9.- Protective device according to any of the preceding claims, characterized in that the protective means (14) and the needle (5) comprise stopping means (15), acting as abutment means between the protective means (14) and the needle (5), which define an end position when retracting the needle ( 5 ) .
10.- Protective device according to claim 9, characterized in that the stopping means (15) at the needle (5) comprise an annular groove (31) or a ridge (46) or thickening or the like on the outside of the needle (5) and in that the stopping means (15) at the protective means (14) are formed by said blocking means (19) or by parts cooperating with said blocking means (19),
11.- Protective device according to any of the preceding claims, characterized in that the safety means (16) and the blocking means (19) are housed in a hollow body (20), said hollow body (20) being provided with passage openings (24-25) for the needle (5).
12.- Protective device according to any of the preceding claims, characterized in that the protective means (14) are realized as an extension piece for a catheter hub, whereby this extension piece is provided with coupling means (34) for releasably coupling it to said catheter hub.
13.- Protective device according to any of the preceding claims, characterized in that it is provided with scraping means (33) to dry the needle (5) when the device (1) itself passes from the non-operative state (A) to the operative state (B) .
14.- Protective device according to claim 13, characterized in that the scraping means (33) are formed by and/or fixed at the blocking means (19).
15.- Protective device according to claim 13 or 14, characterized in that the scraping means (33) comprise a ring or the like, more particularly a plastic O-ring, which is provided around the needle (5).
16.- Protective device according to any of the preceding claims, characterized in that the needle (5) is attached in a needle hub (6) and that said needle hub (6) is provided with one or more prolongations (48-49-50) which at least partially surround the protective means (16).
17.- Protective device for a needle, more particularly for a catheter introducing needle, whereby this protective device comprises protective means (14) which slidably cooperate with the needle (5), characterized in that said protective means (14) comprise one or more safety tongues (17-40-41) which upon retraction of the needle (5) are automatically positioned in front of the needle point (18), thereby preventing the needle (5) from being re-used, whereby these tongues (17-40-41) upon the complete retraction movement of the needle (5) remain at a distance from the needle ( 5 ) .
18.- Protective device for a needle, more particularly for a catheter introducing needle, whereby this protective device (1) comprises a hollow' body (20) forming a housing, which body (20) slidably cooperates with the needle (5) such that the needle (5) can be retracted into a position in which the needle point (18) is located in said hollow body (20), characterized in that said protective device (1) comprises a scraping ring which cooperates with the needle (5), whereby this scraping ring is located inside the housing, at a distance (D) from the rear side of the rear wall of said housing.
19.- Needle or safety cannula needle assembly, characterized in that it is provided with a protective device (1) according to any of the preceding claims.
PCT/EP2002/008534 2001-07-31 2002-07-30 Protective device for a needle WO2003011381A1 (en)
ITB02001AOOO497 2001-07-31
ITBO20010497 ITBO20010497A1 (en) 2001-07-31 2001-07-31 Protection device for cannula needle
US10/485,242 US7530965B2 (en) 2001-07-31 2002-07-30 Protective device for a needle
DE2002616467 DE60216467T2 (en) 2001-07-31 2002-07-30 Protection device for a needle
EP20020764822 EP1412006B1 (en) 2001-07-31 2002-07-30 Protective device for a needle
JP2003516611A JP3790247B2 (en) 2001-07-31 2002-07-30 Protector for needle
DK02764822T DK1412006T3 (en) 2001-07-31 2002-07-30 Protective device for a needle
HK04108470A HK1067321A1 (en) 2001-07-31 2004-10-28 Protective device for a needle
WO2003011381A1 true WO2003011381A1 (en) 2003-02-13
JP (1) JP3790247B2 (en)
AT (1) AT346632T (en)
DE (1) DE60216467T2 (en)
HK (1) HK1067321A1 (en)
IT (1) ITBO20010497A1 (en)
PL (1) PL204005B1 (en)
PT (1) PT1412006E (en)
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2001-07-31 IT ITBO20010497 patent/ITBO20010497A1/en unknown
2002-07-30 PL PL368457A patent/PL204005B1/en not_active IP Right Cessation
2002-07-30 RU RU2004105941/14A patent/RU2276611C2/en active
2002-07-30 ES ES02764822T patent/ES2276954T3/en active Active
2002-07-30 DE DE2002616467 patent/DE60216467T2/en active Active
2002-07-30 CN CN 02816742 patent/CN100371036C/en active IP Right Grant
2002-07-30 PT PT02764822T patent/PT1412006E/en unknown
2002-07-30 JP JP2003516611A patent/JP3790247B2/en active Active
2002-07-30 AT AT02764822T patent/AT346632T/en unknown
2002-07-30 US US10/485,242 patent/US7530965B2/en active Active
2002-07-30 WO PCT/EP2002/008534 patent/WO2003011381A1/en active IP Right Grant
2002-07-30 DK DK02764822T patent/DK1412006T3/en active
2002-07-30 EP EP20020764822 patent/EP1412006B1/en active Active
2004-10-28 HK HK04108470A patent/HK1067321A1/en unknown
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DK1412006T3 (en) 2007-04-02
CN1547493A (en) 2004-11-17
PL204005B1 (en) 2009-12-31
EP1412006B1 (en) 2006-11-29
DE60216467D1 (en) 2007-01-11
HK1067321A1 (en) 2007-08-24
RU2004105941A (en) 2005-03-27
ITBO20010497D0 (en) 2001-07-31
AT346632T (en) 2006-12-15
EP1412006A1 (en) 2004-04-28
JP2004535905A (en) 2004-12-02
JP3790247B2 (en) 2006-06-28
US20040225260A1 (en) 2004-11-11
ITBO20010497A1 (en) 2003-01-31
CN100371036C (en) 2008-02-27
US7530965B2 (en) 2009-05-12
PL368457A1 (en) 2005-03-21
ES2276954T3 (en) 2007-07-01
DE60216467T2 (en) 2007-09-27
PT1412006E (en) 2007-03-30
RU2276611C2 (en) 2006-05-20
KR100424964B1 (en) 2004-06-23 The catheter apparatus having a cannula protective interlock type continuous guard member
ES2454199T3 (en) 2014-04-09 Needle protection device
JP4969642B2 (en) 2012-07-04 Passive latching safety shield for injection devices
US20130060197A1 (en) 2013-03-07 Catheter assembly and components thereof
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