CONTAINER FOR FILLING A SYRINGE WITH AN IRRIGATION SOLUTION

Description

TITLE CONTAINER FOR THE 1 FILL OF A SYRINGE WITH A SOLUTION OF. IS REGATION PRIORITIES UiS, A. SUNDAY.BRIEF.No. 620512 DEL' AUGUST 1977.”985 Rome, The THE DIRECTOR ν·…….Β04Θ1 Α / 78 MiNiSTiìiiii niù.r.'ìniiiiJSTniA, nor ciimiibkcio b Ι)ιϊι.ϊ.'λιιτκ; MINUTE OF FILING FOR PATENT OF INDUSTRIAL INVENTION They go 10 the day of the month of...............at hours· „„J.^...and minutes LiQ There the Society has all cookpanv ................................-•••••SoeleU-delle-St-ate-dol-Belew-ere··· di naslonaltt h -....,.0 * A * A* .„ ©05 ecde In VI» „ ^...Weet _jBtrtàt B mm0 mendnurio ........................................ ............................................ Eng. BARZANÒ& ZANARDO SpA, with domicile for the purposes of the law at ..........................-«............................-..,aà-v..VlA-4»-l€-M©-H-TE'·-""""'·· n.......... ......»............ at 00)87 ROME Via Ita... .......................please send it to MP a^^^ltlo: 1. · Application, In stamp dn lEHSHKU RREVETIO TER INVENZIONE INDUSTRIALE aranti par TITLE "Container for filling <J1 una siringe con una aolu............. Min 11 ,,, Il ,,, Η . . I MM»»» ..........1(11. 4W*..»·»».»*»..· »·»»»·*·»········»* »···***·'*»»»»**♦****“·*" irrigation system*· 1,^1 X · Description In duplicate of n...............................writing page. 9. · Drawings, tables n......?................in duplo. letter d%carlco,Mm^^Ìl^^Ìf^^ -S. * Priority document with Italian translation, attached. · Authorization or Deed of Assignment. (reservation) 8. · Alteration of veranmento (eul 11770, Intcent of the Office Government office of 9, stamp duty of LVlì fire 10. hl W ·»·.*·*·+. ·» ·«·« »e .. ihOH« WO >a>a«a... rlohladant»»^. · from me The application, the desorlslonl and the dlsognl aopraelencatl were signed by .................... signed and stamped with the Umbrian seal of office, Oopla of this report · been by ma »ott tose ritta · delivered to the interested party. n Depositor v . JL^^IAI . ι.Η.ΐΐ h IMi4. h H . ».. . hi, ι ίϊοο.ϊΤΪΪΤΐ*.. MINISTRY OF INDUSTRY, COMMERCE AND CRAFTS!' Central Patent Office ROME I signed it to the Company: rresmlaU THE KENDALL COMPANY jj θη; f Delaware State Corporation at 95 West Street, Walpole, Massachusetts, USA, UUA National Corporation. ? <;on record 60461 yn Represented in Italy by ING. BARZANO' & ZANARDO, p, A.», Technical and Legal Consulting Company, in Rome, |la Piemonte 26, application for PATENT CERTIFICATE for INDUSTRIAL INVENTION, entitled: "Container for filling a syringe with irrigation solution" The undersigned requests that the priority deriving from the application filed in the USA be recognized, in accordance with the International Convention. 4otto No. 820.512 dated 1 AUGUST 1977 LIST OF DOCUMENTS Letter of appointment 76,500 Description in duplicate, Drawings (Tables^) in duplicate, Money order for the tax paid of 5 Lire, A revenue stamp of 2,000 Lire. Foreign priority document and Italian translation Authorization (reservation) 4oma, on 25 JULY 1978 THE KENDALL COMPANY ikq. BARZANO' * ZANARDO SpA attach ..... ........... i...·. DESCRIBE ..... ...... accompanying a patent application for an invention entitled: ..................... - .. . "Container for filling a syringe with 3 Medical irrigation involves the injection of liquid into a body cavity, a tube inserted into a patient's body, a wound, or other area as needed. One of the most common is irrigation. ..... of a Poley catheter during catheterization . . i ' ί « for the purpose, for example, of removing blockage in the catheter lumen or injecting an irrigation solution through the catheter into a patient's bladder. , ................................ ........................-, j..... * . I . i The normal procedure for irrigation of a Poley catheter is as follows. A tube of ; ; , ' ' The drainage is first connected to the proximal end of the catheter. A syringe is then inserted. filled with a container holding a sterile irrigation solution, and the tip of the syringe is inserted into the lumen. The user holds the proximal end of the catheter against the tip of the syringe with the fingers of one hand, while - 2 c I !The other hand is used to pump the syringe and expel the fluid from the syringe into the catheter. It may be necessary to repeat this procedure a ; I ' ' · ί number of times in order to remove the blockage from the catheter lumen or pump a sufficient volume of fluid into the patient's bladder. The ^syringe is filled with the solution between opera- J I 1 ' 3 subsequent pumping sessions. Since the irrigation procedure is normally undertaken without the use of sterile gloves, it is not uncommon for the physician .......ί ϊ· .....: ' '..... , 1 or nurse contaminate the syringe barrel ve; / '·; ' '......... ' '..... F nendo is contact with it with the ungloved hand. When the syringe is replaced in the .............. .............. j irrigation solution for the purpose of filling ì '7 "..... . ' ......ί of the same, the contaminated cylinder will contaminate ! '"7....... / ' 7'' ' .......7" . 7 ·....... " ! the solution so that contaminated solution ver-' ......... ' ' ....... .....' ' ..... ! will be drawn into the syringe. / The introduction of solution: Contaminated bladder from the catheter syringe into the patient's bladder can result in adverse effects for the patient. The same problem can occur in other irrigation procedures where the bladder is repeatedly filled with solution; I ction by immersing its cylinder in the solution. 1 With the intention of obviating this [- 3 drawback, the invention provides a container, for use in filling a syringe with sterile irrigation solution without contact of the solution with the barrel of the syringe, said container comprising a bottle to contain the solution, a barrier tube, which is removably mounted: / ￎﾪ * * XtQiￂﾷ . / ￃﾬj' in the bottle and extends down the bottle through its neck, the barrier tube having an open lower end and a . , - i ·. removable closure on its upper end and ! ....... i forming a seal with the neck of the bottle so that, when the barrier tube is inserted into the ! bottle, the solution in the bottle assumes a lower level adjacent to the bottom of the barrier tube. , ' . / ' ·».> : ' ' i riera in the area below the barrier tube and a higher level in the region outside the barrier tube, and constituting a barrier that prevents contact between the solution and the barrel of a syringe inserted, after removing the closure, into the barrier tube to position its tip in the solution below the barrier tube. In using the container, the bottle.......... is partially filled with sterile irrigation solution with the barrier tube removed from the bottle. glia. The barrier tube is then inserted into the ί body of the bottle with the closure in position ' i* - 4 - 1 · ! 1 ' Ί jfor the purpose of sealing the barrier tube relative to the bottle at the neck. This creates a partial vacuum inside the bottle at one location; ' ........... ' ' ' .....' ' [...... Action above the solution thereby preventing the passage of more than a minimum quantity of solution into the lower end of the barrier tube when the closure element is removed from it ............·.....'..............' " ' :.....................'...... ' :........ ! so. After removing the closure element, the syringe barrel can be inserted into the barrier tube to fill the syringe through its tip without contact of the solution with the syringe barrel. The II syringe cylinder can be placed !.................... ....... ì in the barrier tube for repeated filling, while the level of the part of the solution below ' the barrier tube remains at the lower end* jof the barrier tube. ! fc. In one embodiment, a resilient hollow cap on the upper end of the tube The barrier provides support for the cylinder of the 1..................· 11 ' syringe while positioned in the barrier tube. This cap may be such as to form a seal with' an enlargement of the syringe barrel in order to permit prolonged storage of the syringe in the container between uses. A A} y - 5 - : Some embodiments of the invention will now be described in detail, by way of example, with reference to the attached drawings in which: j ,· ' · . | ......................'....................:..............................................'.................................................' / ' : Figure 1 is a perspective view of the 'V' and 'i'. ι illustrates the use of a syringe for irrigation of a catheter, ...... .................................·...... _.................. t Figure 2 is an elevation, partly in section, of one embodiment of an irrigation solution container, · | I Figure 3 is a corresponding sectional view,....................,....................7........................................ 1 Figure 4 is another corresponding sectional view showing the removal of a closure member from a barrier tube in the container,! Figure 5 is a cross-sectional view of the silk; illustrates the use of the container for filling the sy........ri n ga, ........j............... ;......; 2 · , ......'......'........................................... ...................................., Figure 6 is an end view of a barrier tube for use in another form of rea-.......... containerization for irrigation solution,......... : _, ; _ . _ ; ; .... . !......... Figure 7 is a section along line ; *7—7 of Figure 6 showing the barrier tube in the ^container, < .......7 ...................................................... 7 ;.............. ' [ Figure 8 is a sectional view of that embodiment of the container illustrating its use for filling the syringe, and | Figure 9 is a sectional view of that container illustrating its use for storing the syringe. j Equal numerical references indicate parts, equal from one end of the figures to the other. Figure 1 shows a syringe 20 connected to a Poley catheter 22. Syringe 20 has a barrel 24 containing a chamber 26, a plunger 28, and a tip 30 that communicates with chamber 26. In use, tip 30 is inserted into the proximal end 34 of the discharge lumen 32 in catheter 22, and the tip is then pumped to eject fluid from chamber 26 into the lumen 32 and flush catheter 22. As an alternative to providing the syringe with a plunger, it may be pumped by compressing a bulb on the proximal end. I z Ί simale of the cylinder. As explained above, this procedure is normally performed without the use of sterile gloves so that the cylinder 24 pro-| The product can be easily contaminated by the user's hands following contact with the cylinder, | To avoid contact between the cylinder and the cylinder, please note! ......... . .· . ·. mined and the irrigation solution, this solutionA - 7 - : jj· , , < ' ί ί" . ·· ,' fine is dispensed from a special container. j In the embodiment shown in FIGS. 2 through 4, the container 36 consists of a bottle 38 containing a removable barrier tube 40. The bottle 38 has side walls 42 and a bottom wall 44 enclosing a solution receiving chamber 46 and an open neck 48 at its upper end. The barrier tube 40 has a cross-section 40. 1........ .. cylindrical lower section 50 and a sval.li ' . ( ί ...... sata upper section 52. The inside of the barrier tube forms a ca-, i ' ; ''fi ' , , A . · ' ' ' . ί ' 1 ' ' J 1 ' |........A needle 54 of sufficient width and length to receive substantially the entire length of the syringe cylinder .A' a ì , - , | ;,·...................;.......... , dro 24, as shown in figure 5.. j........ .................... ;; The barrier tube 40 has an opening 58 on the. ........ , j its lower end which provides communication: ì between channel 54 and chamber 46 when the bar tubeA 'A ..... AAA . i ..........riera 40 is inserted into bottle 38 and another; j............... . between opening 60 on its upper end. In the | embodiment shown, the inner end J 'ΆΑ"· .. A—, ,x J * · · ' · A . i | 56 of the barrier tube 40 is slightly spaced , .. ........, from the bottom wall 44 of the bottle 38 when the barrier tube 40 is inserted into the chamber t ? A........·...........' ' < ! 46; Alternatively, the inner end 56 of the tu* 'X ' ' ' ' ί < - ; . ; bo a barrier 40 can come into contact with the wall ,[ϊ :ι ' 0 (' J · ” . I — 8 — j bottom 44 when barrier tube 40 is inserted into the bottle and may have one or more openings in the side to provide communication between channel 54 and chamber 46. Barrier tube 40 has a removable closure member 62 that extends through and covers the opening 60 at its upper end and consists of a sheet of flexible material adhered to the outer end 52 of barrier tube 40. Alternatively, the closure member may be a removable plug. The ! .......................; ' ..........τ.........'......... ...... , ;.............. ' ".....·...... '..........' barrier tube 40 carries a resillen sealing ring: I ·· · - · ' - · i ' . te 64 which is secured thereto adjacent to the upper section 52 and forms a seal with the neck 48 when the barrier tube 40 is inserted into the chamber 46 to prevent passage of air between the chamber 46 and the atmosphere through the neck 48. Alternative-...................' ' ' \ ........ . I........ . I' mind, the sealing ring can be fixed inside the neck 48. The sealing ring 64 can be Made of any suitable material such as rubber. i: Container 36 is supplied in a sterile condition to the hospital or other place of use. To use it, the barrier tube 40 j * s . ' J is removed from bottle 38 and a solution ί •'i / ί " ί * ί - 9 ι 1 [ Sterile irrigation fluid S is poured into chamber 46 through neck 48 until it reaches a level 1 below neck 48 as shown in FIG. 2. Barrier tube 40, which is still closed by closure member 62, is then inserted through neck 48 into chamber 46 until sealing ring 64 makes a head-to-head engagement. 1; - - ' . I J. sealed with the neck 48 of the bottle thereby isolating the chamber 46 from the atmosphere as illustrated in FIG. 3 and establishing a lower level L* of the solution S at the lower end 56 of the barrier tube 40. Then, as shown in FIG. 4, the closure member 62 is removed from the barrier tube 40 in order to provide access to the channel 54. i. and to the solution. The partial vacuum created in chamber 46 above the upper level L of solution S prevents solution S from rising more than a minimum distance in channel 54 when closure member 62 is removed so that the lower level L' of solution S remains adjacent to opening 58. As shown in figure 5, the syringe ! ....... " ' ' '·' ' ' " ' ............ ' .....Γ 7; 20 can be filled by inserting its cylinder 24 I in channel 54 until its tip 30 is positioned ' : ' ' . \ '7 . jnata in the solution S below the opening 58 < k , j'* i jj.*: 5'*.^± ΗΙ < 7.;·;.-: / ί, / , / / . ,,. :. / ',u... 7.7^.-7.7 ,.7 7I — 10 — Ϊ ' and withdrawing the plunger 28 from the cylinder 24 to draw sterile irrigation solution S into the chamber 26 of the syringe. During this operation, air passes from the atmosphere down between the cylinder 24 and the wall of the barrier tube 40 and forms bubbles B which A / ,"·" they pass upwards through the solution in order to partially discharge the vacuum above the level!" the upper L of the solution S, as this level decreases following the passage of the solution in the syringe as indicated by the arrows in figure 5. After filling, syringe 20 is removed from barrier tube 40, its tip 30 is placed in catheter 22 as shown in FIG. 1, and irrigation solution is pumped into lumen 32 of catheter 22. After the solution has been pumped from syringe 20, its tip 30 is withdrawn from catheter 22, and the syringe can be replaced in barrier tube 40 and refilled, as previously described in connection with FIG. 5. During subsequent filling, the lower level of solution S remains at the lower end of channel 54 near opening 58, so that there is no contact of the sterile irrigation solution S with the container cylinder. •4 ? ί 'ΐ :.ι 1' - 11 mined 24. The syringe 20 can therefore be repeatedly filled without contact of its cylinder with - ? the Bterile irrigation solution S, allowing . . ί In this way the irrigation of the catheter 22 in an aseptic manner and minimizing the possibility of \ ..................... ' ' ' "7 ' 7 ejection of contaminated solution through the catheter into the patient's bladder, ί '........ ...............7!,>7" , " · 7 After watering is completed. ,, / / 7 1 7"' of the catheter, the closure member 62 may be placed in position on the barrier tube 40 to retain the sterile irrigation solution for subsequent use. Alternatively, the container 36 may be discarded. In the embodiment illustrated in FIGS. 6 through 9, barrier tube 40 includes a passage 70, the inner end 72 of which communicates with channel 54 at a location slightly above opening 58 and the upper end 74 of which communicates with chamber 46 above the upper level L' of solution S when barrier tube is positioned in the bottle. Solution S assumes a lower level L' in channel 54 adjacent to lower end 72 of passage 70 and, during filling of the syringe, air passes from channel 54 through passage 70 to the upper end of chamber 46. ϊ In this embodiment, the barrier tube 40 consists of a cylindrical part 50 which carries on its upper end a hollow plug I J ' ' j resilient 75 of rubber or other material, which forms ' I / ' 'a seal in the neck 48 when the barrier tube 40 is inserted into the chamber 46. The plug 75 has an annular slot 76 on its lower end to receive the upper end of the cylindrical wall 50 of the barrier tube 40. As best shown in FIGS. 6 and 7, the cap 75 has a shoulder 78 formed by a plurality of circumferentially arranged projections separated by openings 82, which provide communication between the portions 84 and 85 of the interior of the cap 75. <* As shown in figures 8 and 9, the syringe has an annular enlargement 88. 11 diameter "H........ ;..... · .......' ....... ....................... : " Ί........ - :inside of the part 84 of the channel in the cap is slightly larger than, while the internal diameter of the - part 85 of the channel in the cap 75 is slightly smaller than the external diameter of the enlargement 88. Consequently, as shown in figure 8, when the syringe is placed in the channel 54, the enlargement 88 already normally rests on the stop 78 of the cap 75. In this case, 13 ~ j ; age position, the cylinder 24 and the enlargement.88 ; ι ' ' ! 'they are spaced from the openings 82 so that air Air from the atmosphere may pass through openings 82 into channel 54 during filling of the syringe. When the plunger 28 is withdrawn from the cylinder 24, air passes from the atmosphere through openings 82 into channel 54 and thence through passage 70 into the upper part of chamber 46 in order to permit filling of the syringe without contact of the irrigation solution S with the cylinder 24. j Once the irrigation procedure has been completed, the syringe 20 may be placed in the bottle in the position illustrated in FIG. 9. In this position, the enlargement 88 has been forced downward in the cap 75 to form a seal with the inner surface of the cap 75 in the portion 85 of the channel in the cap, thereby preventing the passage of air through the openings 82 and excluding the channel 54 from the atmosphere.This prevents contamination of the sterile irrigation solution S in chamber 46 and allows storage of the container 3f> for an extended period of time without it being required for use again. ί · . ' i

Claims

1. CLAIMS 1. A container for use in filling a ί -μ - 14 ί L syringe with sterile irrigation solution without contact of the solution with the barrel of the syringe, said container comprising a bottle for containing the solution, a barrier tube, which is removably mounted in the bottle and extends down the bottle through its neck, the barrier tube having an open lower end and a removable closure member at its upper end and forming a seal with the neck of the bottle so that, upon insertion of the barrier tube into the bottle, the solution in the bottle assumes a lower level adjacent to the neck of the bottle.7 at the bottom of the barrier tube in the lower region of the barrier tube and a higher level in the outer region of the barrier tube, and constituting a barrier that prevents contact between the solution and the barrel of a syringe inserted, after removal of the closure element, into the barrier tube to position its tip in the solution below the barrier tube.

2. A container according to claim [ ................................. 7 .....! '......... ..... ................' ί wherein the seal consists of a resilient sealing ring disposed between the upper end of the barrier tube and the neck of the bottle. 7 3. A container according to claim 1 wherein the barrier tube comprises at its upper end a resilient hollow cap which provides a seal with the neck of the bottle. I . ·' 4. The container of claim 1 wherein the cap includes a ledge for supporting an enlargement of the syringe barrel, the ledge having openings for air access to the interior of the bottle to replace solution withdrawn from the syringe........ ........... ........·... .,7|.

5. A container according to claim 1 wherein the cap has a portion below the neck of reduced diameter wherein the enlargement can be forced downward to form a seal.

6. A container according to claim 1 substantially as herein described with reference to figures 2 to 5 of the accompanying drawings.

7. A container according to claim 4 substantially as herein described with reference to figures 6 to 9 of the accompanying drawings.