WO2009054000A2

WO2009054000A2 - A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal

Info

Publication number: WO2009054000A2
Application number: PCT/IN2008/000552
Authority: WO
Inventors: Kalpesh Jayantkumar Gajiwala
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-09-12
Filing date: 2008-09-01
Publication date: 2009-04-30
Anticipated expiration: 2010-03-12
Also published as: WO2009054000A3

Abstract

The multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal consists substantially of a flat strip (1) with slots at one end, which is opposite the grip end. The slot (2) near the end is open at the edge partially and the design of this slot substantially corresponds to the outer design of a needle cover that needs to be parked or accommodates the needle cover effectively. Another slot (4) corresponds to the outer design of the needle hub to help disengage a tight fitting needle from the syringe. There is a third slot (6), which has a file at one end and or side to score a glass ampoule. The edges (3a) of the flat strip are raised to create a guard rail and the surface is optionally grooved (7). The other end (9), also called the grip end, is beveled to help open the metal seal of a rubber cap of a bottle or vial. This end may be optionally angulated or curved.

Description

TITLE OF THE INVENTION:

A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal.

Prior Application: 1745/MUM/2007, dated 12^th September, 2007; at The Patent Office, Mumbai, India. References Cited

U.S. Patent Apr., 1987 Nelson 604/192 Documents

4659330 4820277 Apr., 1989 Norelh 604/192. 4850976 JuI., 1989 Heinrich et al. 604/192. 4872552 Oct., 1989 Unger 206/365. 4880413 Nov., 1989 Giuffre 604/192. 4883469 Nov., 1989 Glazier 604/192. 4909791 Mar., 1990 Norelli 604/192. 4909792 Mar., 1990 Norelli 604/192. 4944731 JuI., 1990 Cole 604/192. 4955866 Sep., 1990 Corey 604/192. 5135508 Aug., 1992 Vernamonti 604/192 5135509 Aug., 1992 OUiffe 604/192. 5139489 Aug., 1992 Hollister 604/192. 5151089 Sep., 1992 Kirk, III et al. 604/192. 5188611 Feb., 1993 Orgain 604/192. 5232455 Aug., 1993 Hollister 604/192. 5242417 Sep., 1993 Paudler 604/192. 5312368 May., 1994 Haynes 604/192. 5342322 Aug., 1994 Nathan et al. 604/192. 5423765 Jun., 1995 Hollister 604/192. 5486163 Jan., 1996 Haynes 604/192. 5490841 Feb., 1996 Landis 604/110. 5603699 Feb., 1997 Shine 604/110. 5681295 Oct., 1997 Gyure et al. 604/263. 5807351 Sep., 1998 Kashmer 604/263. 5891103 Apr., 1999 Burns 604/192. 5919165 JuI., 1999 Benson 604/110. 6159184 Dec, 2000 Perez et al. 604/192. 6319233 Nov., 2001 Jansen et al. 604/192. 6648858 Nov., 2003 Asbaghi 604/192 7083600 Aug., 2006 Meloul

EP and WO Patent Documents

0352008 Jan., 1990 EP. 0566631 Oct., 1993 EP. 0 623 358 Nov., 1994 EP.

0 626 924 Dec, 1994 EP.

WO 98/11928 Mar., 1998 WO

Introduction:

Injuries are occupational hazards of the medical profession. Injuries caused by used needle sticks or while cutting a glass ampoule or while opening the metal seal of a vial are quite common. The injured finger is an opening for germs to enter. Infections like hepatitis and HIV could be transmitted from contaminated products or fomites during handling. To avoid such injuries it is best to adopt safe practices or devices, which will protect against or minimize these injuries. A simple, economical, easily available, ready to use, multi purpose safety device would thus have a higher usage. In an earlier patent the concept of a needle stick injury prevention device was introduced. Here an upgraded version of the safety device is being introduced with features that will protect against a variety of injuries.

Prior Art and Background: hi prior art there are many patents which describes ways to avoid needle stick injuries. The simplest is certainly the needle cover itself, but reintroducing the needle back into the cover has caused many injuries, with many hospitals banning such a practice. Apart from wasting a precious resource like the needle cover, the needle remains open unless some other mechanism is made available. This has led to many inventions to get the needle covered and locked after a single use. This precludes the reuse of the needle in the same patient at interval of few seconds or minutes, wasting precious medicines and time required to refill another syringe and increasing the cost, especially during an operative procedure, unless one keeps the needle exposed. Many of the inventions available are too complex for manufacturing as well as the use. And they focus only on protecting the user from needle stick injuries. One can also note that as each new invention brings out the short comings of the preceding inventions, it is obvious that we are still in search for a simple and economical solution for the problem.

Indian patent number 203913 describes one such safety device for prevention of needle stick injuries. However, the said device does not have the safety features for protecting against injuries that can happen while opening the metal seal of a vial or cutting a glass ampoule. The new device has improved upon the previous version, by introducing an open rimmed slot at one end of the device, where the needle cover can be pushed in sideways. Further the new device introduces features of safety for opening a metal seal of a vial and cutting a glass ampoule.

Usually a glass vial has a rubber cap, which is fixed to the mouth of the vial by an aluminum seal with a flip-top which covers the central rubber portion of the cap. The aluminum seal makes the vial air tight and leak proof. At the top a central circular part of the aluminum seal covers the centre of the rubber cap and protects it from contamination. It can be flipped open when required. To access the contents of the vial, a needle is introduced through the central portion of the rubber cap after flipping open the central aluminum top. Often in the absence of a proper device, the doctor or a nurse will use finger nail to flip the aluminum cover, resulting in an injury caused by the sharp edge of the cut aluminum cover. At times it does not open completely, there by increasing the chances of the needle coming in contact with the unopened part of the flip-top and getting contaminated. The new invention also provides for safe and proper opening of the aluminum flip-top part of the seal. And it also helps in safe and complete removal of the metal seal of the vial and in uncovering of the rubber cap of the vial.

Generally to break open a glass ampoule, the neck of the ampoule is scored with a metal file with a serrated edge. At times a nurse uses her own bare thumb and finger to break off the top portion, frequently injuring herself. Alternatively, a blunt instrument is struck to the top part of the ampoule to break it. This causes glass pieces to fly or fall into the ampoule, either injuring someone or contaminating the medicine. The added advantage of the new invention is that it allows the safe breaking of the glass ampoule preventing injuries and contamination Objective of the invention:

The objective of this invention is to upgrade the previous patent with the addition of safety features for opening the metal seal of a vial and cutting a glass ampoule in a manner that will protect the user's hand from accidental injuries, in addition to improve the ease of parking of the needle cap or cover. And to make all this possible keeping in mind that the design is simple, flat and compact, economical, easy to package with needle - needle cover - syringe assembly, easy to sterilize, transport, use and dispose off. The design should be versatile, from the point of view that it can accommodate various different designs of the needle cover, and is not dedicated to a particular design, thereby allowing the manufacturers the freedom to manufacture or continue to manufacture their own particular designs of the needle covers. Further the aim is to allow the reuse of a precious resource, the needle cover, which protected the user from the accidental injury till before the uncapping of the needle for the use, while keeping the user's fingers and hand away from the potentially contaminated needle tip. And also to keep the needle-syringe assembly free of any encumbrances, so that the free and proper use of the needle - syringe assembly is not hampered.

The Statement of Invention:

The present invention consists substantially of a flat strip with slots at one end. The slot near the end is open at the edge partially and the design of this slot substantially corresponds to the outer design of a needle cover that needs to be parked or accommodates the needle cover effectively. Another slot corresponds to the outer design of the needle hub to help disengage a tight fitting needle from the syringe. There is a third slot, which has a file at one end and or side to score a glass ampoule. The edges of the flat strip are raised to create a guard rail and the surface is optionally grooved. The other end, also called the grip end, is beveled to help open the metal seal of a rubber cap of a bottle or vial. This end may be optionally angulated or curved.

Brief Descriptions of the accompanying drawings:

Fig.l describes the top view of the flat surface of the device.

Fig.2 describes the top view of the flat surface of the device.

Fig 3 A describes the oblique view of the device and the usage of the device to disengage the needle from the syringe tip.

Fig.3B describes the oblique view of the device, with the angulated beveled end.

Fig.3C describes the grip end with various bevel options.

Fig.4 describes a possible option for the opposite surface of the device.

Fig.5 and 5 A show the device attached to the cover of a needle with a connector and its use and a curved cross section of the device.

Fig.6 and 6A show the device attached to the cover of a needle with a connector and its use with a flat cross section of the device.

Fig.7 shows the use of the device in parking the needle cover.

Fig.7 A shows the use of parking the needle into the needle cover parked in the device.

Fig. 8, 8 A and 8B show the use of the device to open the flip-top seal of a vial.

Fig. 9, 9 A and 9B show the use of the device to break an ampoule. Fig.10 shows the use of the device to remove the metal seal of a vial and to expose the rubber cap completely.

Fig.l 1 shows some more of the variations of the beveled grip end.

Fig.12 shows the variation of the end of the device with a slot for the needle cover, where the end makes a funnel shape or end is slanting.

Description of the Invention:

The multipurpose safety device is a flat strip 1, fig.l. At the end opposite the grip end there is a slot 2, which substantially corresponds to the outer design of a needle cover or accommodates it effectively. Here it is shown circular only for the purpose of illustration, assuming the needle cover is circular in cross section. The slot is partly open at the edge, as shown in fig.l, in such a way that more than half of the slot is still on the strip. The slot is of such dimensions that it allows for a snug fitting at the broad open end of the needle cover. Following this there is another slot 4, as shown in fig.l, the design of which corresponds to the outer design of the hub of a needle. Following this there is another long straight slot with rounded ends 6, which is wide enough to allow an ampoule to be inserted. At one end of this slot there is a file 5 with a serrated edge, which can score or scratch a glass ampoule. The slot 6 can be rectangular, square, oval, round, a tear drop or any geometric pattern so long as it serves the purpose of allowing the ampoule to be inserted, scratched and broken. Further the strip has a guard rail 3 and 3a on either edges or the borders. Guard rail 3a and 3 meet to form guard rail 3b which separates the grip end from the working area. Within the area of the guard rail there are parallel grooves 7, which extend from one edge to the other i.e. from 3 to 3a and are preferably at right angles to the edge of the flat strip, as seen in fig.l The grooves preferably start near the slot end and continue till the boundary of the guard rail 3b, which separates the grip end. The grip area 8 is sufficiently long to allow a firm grip to the user and may be optionally scored or roughened to prevent slippage. The end 9 near the grip area is beveled. In another version, as shown in fig. 2, a variation is shown to indicate the adaptability of the design. Here a flat strip 16 has a slot 10 which is a hexagon, corresponding to the hexagonal outer design of a needle cover with one side open and is situated at the end that is opposite to the grip end. This is followed by a slot 11 which corresponds to the outer design of the hub of a needle. This is followed by another long rectangular slot 14 wide enough to allow the ampoule to be inserted, where a file 12 is situated on the side of this long slot. The purpose of this drawing is to show that one can adapt this device to the need of the user. Indeed the needle cover slot 10 can be any polygonal or geometric design corresponding to the outer design of the needle cover. The file too may be placed suitably at the end/ends and or the side or sides of the long slot. 13,13a and 13b are guard rails which are along the edge starting from slot end and going around and isolating the grip end. There are parallel deep grooves extending from one edge to the other edge and starting from the slot end up to the end of the guard rail 13a which separates the grip end from working area. 15 are deep parallel grooves extending from edge 13 to 13b and starting from the slot end till 13a. 14x is the cross section of the long slot 14 showing the raised edges i.e. guard rail, the space for the slot, the tooth of a file which scratches the glass. 16x and 16y are two examples of a cross section at 16. In 16x the guard rails are on both sides of the device and in 16y guard rail is on one side of the device. 17 is the grip end and 18 is the rounded corners of the beveled end 19.

Fig. 3 A and 3B show oblique views of the device 29, where 23a and 23b are examples of circular and hexagonal slots at the end opposite the grip end. 24, 24a and 24b denote the elevated border or a guard rail, 25 is the slot for the needle hub. The needle 22 with its needle hub 21 mounted on a syringe 20 is shown as it is inserted into the slot 25. Once the hub gets engaged into the slot the needle can be easily disengaged from the syringe. Following this slot is straight long slot 27 with a file 26 at one end of the slot. 28 point to the grooves and 29 is the grip end. 'x' is the angle of the bevel 30 and the magnitude of angle 'x' is such that 0° < x < 90°. The 'x' represents the angle of bevel in all different designs. In fig. 3 B the flat end is angulated 31 and then beveled, so as to create a fulcrum 'f at the angle. In fig. 3C, A, B, C and D are different examples of the grip end. In A the flat grip end 32 is angulated and then beveled with the corners 33 well rounded. In B the grip end has depression 36 for the thumb or a finger, and the flat surface 37 is curved and beveled such that zone 37a provides the fulcrum. In fig. C there is a bevel between two curved borders 34 and 35. D is another version where end 39 shows angulated bevel. These are mere examples and many such modifications are possible by any one conversant with the art.

Fig.4 shows a possible variation of the other surface of the device 45 where 40 is the slot for the needle cover, 41 is the slot for the needle hub 42 is the straight slot, 43 is the file on the border of the device, 44 are the vertical ribs to strengthen the device and 46 is the bevel.

Fig. 5, 5 A and 6, 6 A show a variation where the device 62 has all the features of the previous design i.e. it has slot 55 and 55a at the end opposite the grip end corresponding to the outer design of a needle cover, slot 57, which corresponds to the outer design of the needle hub, followed by a straight slot 59 with a file 58 to score a glass ampoule, a guard rail 60, the grooves are omitted as an option, 61 represents the clamps which can clamp the device to a syringe, 54 is the grip end and 63 is the beveled end. The variation here is that, as shown in Fig. 5 and 6, a flexible connector 56 joins the rim of the slot 55 to the rim 50 of the needle cover 49 having needle 47 with its needle hub 48 attached to the syringe 52. 51 and 53 are the two ends of the piston. In Fig.5A and 6A the needle cover 49a is seen parked in the slot 55a with the flexible connector 56a seen connecting the rim 50a of the needle cover 49a to the rim of the slot 55a. Here one can note that the curve of the slot 55a acts like a clamp on the needle cover. In fig. 5 A, 64x is the cross section of the device at 64 which is curved so as to accommodate the curve of the syringe and 58a is a variation of arrangement of the file in the slot 59. In fig. 6A, 64y at 64 is the cross section of the device which is flat. In another variation as shown in fig. 9 A the slot 110 for the needle cover parking has vertical grooves or serrations or fine ribs which corresponds to the fine ribs or grooves on the outer surface of the needle cover for a better grip.

Fig.11 and 12 shows some of the possible variations, though all possible variations conceivable by those skilled in the art are beyond anyone's scope to describe. Fig.l lA shows a beveled end 128 with a slight upraised wall, 129 is an optional horizontal bar or an elevation on the undersurface which can act as a pivot; B shows the bevel with a curved indent 131 in the edge; C shows the bevel with a variation of the curved indent in the edge 130; while D shows that the same indent appears like a deep grove 132 and this may be claimed to engage a thin aluminum seal giving a better grip. Fig. 12 shows the variations of the slot end of the device, where 133 is the runnel shaped end of the device 135 with 134 being the slot for the needle cover at the tapering aspect of the funnel shaped end, which may help guide the needle cover into the slot. In another variation the device 138 has a slanting end 136 for the slot 137.

The device is made up of suitable material which may be synthetic, metal or natural which can be easily sterilized and preferably of suitable color which may assist in easy identification in the presence of blood and tissues and preferably radio opaque.

One wishes to reiterate that the foregoing descriptions and examples have been set forth merely to illustrate the invention and are not intended to be limiting. Since modifications of the described embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art, the invention should be construed broadly to include all variations within the scope of the appended claims and equivalents thereof.

Working of the Invention:

Fig 7 and 7A shows the use of the slot 67 where one can push the needle cover into the slot by pressing the open aspect of the slot 67a over the needle cover 68. This can be done with one hand and due to flexibility as well as the tapering shape of the cover it is easy to find an appropriate point of introducing the needle cover into the slot. The dimension and the design of the slot allow the needle cover to fit well into the slot, with the expanded rim usually found in the cover being larger in dimension than the dimension of the slot 72 is the needle being inserted into the needle cover for a safe parking. The grip end 71 or 77 keeps the user's hand away from the needle tip preventing an accidental injury by it. The transverse grooves 75 and the guard rail 65, 76 can further arrest the needle from reaching the user's hand. The second slot 66 or 73 corresponding to the needle hub can be used to disengage a tightly fitting needle over the syringe tip. After introducing the needle hub into the slot the device is rotated to disengage the needle from the syringe tip as shown in fig. 3A. After disengaging the needle, the needle can now be held from the hub end and put into the needle cover while the user's fingers are always away from the needle tip. Also many a times during the surgery, a doctor requires to gently bend a needle, this can be achieved easily with the help of any of these slots, without touching the needle tip. The file 70 of slot 69 or file 74 can be used to score or scratch the neck of the ampoule.

Fig. 8, 8A and 8B show how to safely open the seal of a medicine vial. A glass vial 85 has rubber cap, which is fixed to the mouth by an aluminum seal 83 with a central flip-top 80 which covers the central rubber portion of the cap. To have an access for the needle this flip-top has to be pried open. Here the beveled grip end 82 with an angulated bevel 84 is used first to press the outer rim 81 downwards to create a level discrepancy between the outer rim of the seal and the central flip-top. Then, as shown in the fig. 8A, the bevel edge 87 of the grip end 88 is pushed below the flip-top rim 86. Then using angle of the beveled end 89 as a fulcrum the flip- top portion is flipped open. 90 is the aluminum seal and 91 is the glass bottle in the same figure. In fig. 8B one can see that the grip end 94 has flipped open the flip-top seal 92 with the bevel 93 using angle 95 as a fulcrum exposing the central rubber cap 96 under the seal 97 of the bottle 98. Fig. 9 and 9A shows the use of the device for safely breaking an ampoule. In fig. 9 the top 101 of a glass ampoule 108 is introduced through slot 102. A file 100 placed at one end of the slot 102 is brought in contact with the neck of the ampoule at 107 to score the ampoule. 103 is the grip end with the bevel 104 and 105 is the slot for the needle cover and 106 is for the needle hub. In fig. 9 A one can see when the grip end 113 is tilted upwards the slot end 114 creates pressure on the top portion of the ampoule 115 while lower end of the slot 111 engages the body portion of the ampoule creating second class lever, which causes the ampoule to break at the neck that is scored 112 and weakened, breaking the ampoule in a more gentle and precise manner. 109 are inner serrations in slot 110 which may correspond to the outer serrations of the needle cover giving a better grip. Fig. 9B shows a neat circular break 117 of the ampoule 118 with the top 116 separated well. There are no jagged edges or loose glass pieces.

Fig 10 shows how to use the device 120 to completely remove the aluminum seal 119 of a vial. Here a part of the device is shown. The edge 122 of the long rectangular or straight slot engages the top of the seal covering the rubber cap of the vial. The serrated file edge 121 is then inserted at the lower end of the seal 124. The device is then twisted upwards in the direction shown by 123. This removes the aluminum seal completely exposing the rubber cap 125 covering the mouth 126 of the bottle 127.

Thus it can be seen from the above descriptions and the workings of the invention that here is a new invention which is compact, simple, economical, easy to package, sterilize, transport, and providing easy on site availability. The design is easy to use, without in any way hampering the free use of the needle-syringe assembly as it is totally independent of the needle and the syringe, and versatile in adapting to the needle cover designs. Therefore it avoids any burden on the manufactures for adapting to a new design and allows them to manufacture needle cover design of their choice. The design allows the user to reuse a precious resource, a needle cover, for the protection from accidental injury, as it keeps the user's hand far away from the contaminated needle tip. Over and above this, it provides a tool to open the central top portion of the vial covering the rubber cap with ease, preventing any injury and keeping the vial cap free of contaminants. Further, it also has a mechanism to assist in complete removal of the seal to help in uncovering the rubber cap. There is also a mechanism which assists in safely breaking of a glass ampoule. A version, where the needle cover is attached to the rim of the slot for the needle cover through a flexible connector, gives an extra advantage of keeping the needle cover safely parked and easily available, to avoid wastage of time in searching an accidentally misplaced needle cover.

Claims

I therefore claim:

(1) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, where the device is a fiat strip with slots at one extremity, where one of the slot is at the edge of the extremity and the slot corresponds to or accommodates the outer design of the needle cover and the part of the rim of the slot is open at the edge, and this slot is followed by another slot which accommodates or corresponds to the outer design of the needle hub, and is followed by a linear slot which has a file at one end or side; and the borders of the said strip are elevated, beginning at the slot end and extending towards the other extremity till the area beyond all the slots, and the elevated borders are joined with each other by a transverse elevation which separates the grip area of the device from the slot area, and optionally there are transverse grooves extending from one elevated border to the other, beginning near the slot end and recurring till the elevated transverse bar, and the end near the grip area, called grip end, is optionally beveled.

(2) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in claim 1, wherein the slot near the end of the strip may be circular or polygonal or geometrical and or corresponding to the outer design of the needle cover and may have serrations on the inner rim of such width and dimension so as to fit well with the grooves and serrations on the outer surface of the needle cover, and the slot is of such dimension that it allows the narrow end of the needle cover to pass through but is smaller than the broad end of the needle cover; and the opening in the rim of the slot is such that it allows the needle cover to slip into the slot sideways, as shown in fig.7, and yet sufficiently smaller than the diameter of the needle cover so as to retain it snugly, and or wherein the end may be slanting or funnel shaped with the slot placed near the tapering aspect, as shown in fig. 12.

(3) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in claim 1, wherein the linear or long slot may be rectangular or rectangular with rounded ends or elliptical or tear drop or dumb-bell or key hole shaped or of any geometric pattern or irregular pattern and the file may be placed at one end or side or both the ends or both the sides or ends and sides of the slot, or it is on the outer border of the device with or without the linear slot.

(4) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in claim 1, wherein the angle 'x' of the bevel of the grip end is such that 0 < x < 90°.

(5) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in claim 1, wherein the grip end near the bevel or the bevel itself is angulated or curved, and the beveled end may be straight, or slanting or curved and or of various shapes, for example as shown in fig.3C and fig.l 1.

(6) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in above claims, wherein there is a connector between the rim of the needle cover and the slot for the needle cover, which may be partially or completely flexible.

(7) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in above claims, wherein the flat strip is curved in transverse cross section and the curvature may correspond to the curvature of a syringe and there may be a clasp to fix the device to the syringe.

(8) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in above claims, wherein the flat strip is of a shape other than a long rectangle within the spirit of the invention.

(9) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in above claims, wherein the device may be made up of natural, metallic or synthetic material and or of suitable color or colors and or transparent or semi transparent and or sterilizable and or radio-opaque material.

(10) A multipurpose safety device to prevent needle stick injury and to prevent injuries while cutting an ampoule or opening a vial seal, as claimed in above claims, substantially as herein before described with reference to the accompanying drawings.