US3364930A - Sterile venoclysis apparatus and recipient set for use therwith - Google Patents

Description

Jan. 23, 1968 RYAN 3,364,930

STERILE VENOCLYSIS APPARATUS AND RECIPIENT SET FOR USE THEREWITH Filed June 11, 1965 4 Sheets-Sheet l Inveni'or George Rgnrz.

Jan. 23, 1968 G. R. RYAN STERILE VENOCLYSIS APPARATUS AND RECIPIENT SET FOR USE THEREWITH 4 Sheets-Sheet 2 Filed June 11, 1965 Inventor rge R%an Geo 5% Jan. 23, G. R. RYAN STERILE VENOCLYSIS APPARATUS AND RECIPIENT SET FOR USE THEREWITH Filed June 11, 1965 4 SheetsSheet 5 Qeorge RWY);

Jan. 23, 1968 e. R. RYAN 3,364,930

STERILE VENOCLYSIS APPARATUS AND RECIPIENT SET FOR USE THEREWITH Filed June ll, 1965 4 Sheets-Sheet 4 lnvenito r 6620;" 96 Egan United States Patent 3,364,930 STERILE VENOCLYSIS APPARATUS AND RECIPIENT SET FOR USE THEREWITH George R. Ryan, Waukegan, Ill., assignor to Abbott Laboratories, Chicago, 111., a corporation of Illinois Filed June 11, 1965, Ser. No. 463,130 14 Claims. (Cl. 123-214) ABSTRACT OF THE DISCLGSURE Apparatus for the intravenous administration of fluids which provides a positive sterility seal through the use of an integrated construction wherein the port cap of the liquid container and the cannula cover of the recipient set form cooperating elements. The cannula cover has a socket on its free end which fits into a mating male end on the port cover cap so that when the cannula cover is placed over the port cap, torque can be applied to the port cap to break the sterility seal.

The present invention relates to an improved sterile venoclysis apparatus and to a recipient set for use therewith.

Apparatus for the intravenous administration of fluids such as nutrient solutions, blood, and the like must be sterile at the time of use. This requires not only that the apparatus be in sterile condition at the time of receipt by the user, but in addition, it requires that no contamina tion occur when the apparatus is handled by the doctor or nurse in placing it in use. It is possible to provide sterile packages and seals in various forms to protect the apparatus against contamination in shipment and storage. But problems have occurred with respect to setting up the apparatus for use. This is due, on the one hand, to the necessity of using sterile covers that are sufficiently well afiixed to the parts covered that they do not fall or break off and, on the other hand, to the fact that the covers must be removed by doctors and nurses having limited physical strength, limited manual dexterity, inexperience, and under conditions of darkness, urgency, etc.

It should be added that the requirement of sterility is coupled with the requirement that the apparatus be simple, convenient, and easy to use. Even the most effective seal arrangement from the standpoint of sterility, per se, becomes unsatisfactory and even dangerous if the doctor or nurse must cope with cumbersome, time consuming, and difficult techniques that demand attention and effort interfering with a proper performance of other tasks necessary to the well-being of the patient.

The'above difliculties arise in part from the need to provide a positive sterility seal that resists accidental removal. In the case of plastic containers for venoclysis fluids, ports are most conveniently and effectively provided in the form of protruding short plastic cannulae. An especially effective sterility seal for such a port is an imperforate cap that covers the end of the cannula and extends in a jacket to the container wall adjacent the port, where it is atfixed to the container in a full annular seal. Such seals, however, are by their nature diflicult to remove.

The present invention is directed to apparatus that minimizes these-problems through the use of an integrated construction wherein the port cap of the liquid container and the cannula cover of the administration set form cooperating elements facilitating the preparation of the unit for use. In the preferred form of the invention, the cannula cover on the administration set has ears, defining surfaces against which finger pressure can be exerted by the doctor or nurse to apply considerable torque. At its free end, the cannula cover forms a socket having a recess. The port cover of the liquid container has a mating male end adapted to be received in the socket of the cannula cover, so that with the cannula cover received over the port cap, torque can be applied to the port cap to twist the same and break the sterility seal. This seal preferably is in the form of a jacket that envelops the port and is sealed to the liquid container adjacent the base of the port. In manufacture, shipment, and storage, the liquid container and the recipient set may be handled together or separately as desired. In use, however, these two units are necessarily brought together for the administration of fluid, so that the doctor or nurse has both on hand at this time. When the two units are withdrawn from the shipping packages usually employed, the cannula cover and the port cap are, of course, both in place, and are hence fully effective to maintain the sterility of the parts. The doctor or nurse thereupon seats the cannula cover in mating relation to the port cap and with a simple twist force is applied to the ears.

The port cover seal is thereupon broken and the cannula cover and the port cover can readily be removed.

It is therefore, a general object of the present invention to provide an improved sterile venoclysis apparatus, and administration unit for use therewith, in which the cannula cover of the administration unit and the sterility cap on the port of the liquid container cooperate to facilitate setting up the apparatus for use.

A more specific object of the present invention is to provide the above apparatus in a form wherein the cannula cover of the administration set serves as a tool to apply seal-breaking force to the port cap of the liquid container with a mechanical advantage that permits ready removal of the port cap.

A more specific object of the present invention is to provide the above apparatus in which the outlet port cap of the liquid container telescopes within a socket on the free end of the cannula cover of the administration set whereby twist applied to the cannula cover serves the outlet ort cap in torsion to break the same for removal.

Still another object of the present invention is to provide an improved venoclysis apparatus and liquid container and administration set therefor in which sterile port cap can be readily removed and yet the unit is suitable for inexpensive and practical manufacture from plastic component parts essentially similar to the parts otherwise required in the apparatus and therefore, do not contribute substantial additional cost, weight, complexity or other undesirable attributes to the apparatus.

The novel features which I believe to be characteristic of my invention are set forth with particularity in the appended claims. My invention itself, however, both as to its organization and method of operation, together with further objects and advantages thereof, will best be understood by reference to the accompanying drawings, taken in connection with the following description in which:

FIGURE 1 is a view of a venoclysis liquid container and administration set in assembled condition for use;

FIGURE 2 is an enlarged fragmentary view of the liquid container showing an outlet port and cap thereover and the administration set with a cannula cover thereon, all in exploded relation preparatory to removal of the outlet port cover of the liquid container and in accordance with the preferred form of the present invention;

FIGURE 3 is a fragmentary view like FIGURE 2 but showing the cannula cover received over the outlet port cover for application of finger twist force for removal of the outlet port cap with the indicated directional force to be applied to break the outlet port cap seal;

FIGURE 4 is a view like FIGURE 3 but showing the condition of the parts after the cannula cover has been twisted to break the seal on the outlet port cap;

FIGURE 5 is a fragmentary exploded view showing the cannula cover withdrawn and carrying with it the outlet port cap to expose the outlet port to receive the cannula to assembly the apparatus to the form shown in FIGURE 1;

FIGURE 6 is an enlarged fragmentary view, partially in axial cross-section, of the outlet port structure and cap thereon and the cannula and cover thereon in the spaced positions just prior to removal of the outlet port cover;

FIGURE 7 is a fragmentary view with parts in crosssection of the cannula partially inserted in the outlet P FIGURE 8 is a fragmentary view with parts in crosssection showing the cannula fully inserted;

FIGURES 9 and 10 are fragmentary views in perspective of alternative embodiments of the cooperating outlet port cap and cannula cover constructions;

FIGURES 11 and 12 are views in perspective and end elevation views of a modified form of the outlet port structure wherein the outlet port cover, when broken free, is removably retained by the cannula cover;

FIGURE 13 is a fragmentary view in cross-section of a further embodiment of the outlet port assembly construction;

FIGURE 14 is a perspective view of the embodiment of FIGURE 13 showing the outlet port cover broken free and partially removed; and

FIGURE 15 is a fragmentary view, partly in crosssection of the embodiment of FIGURE 13, with the outlet port cover removed and the cannula inserted in the outlet port.

Referring now to FIGURE 1, there is shown at 10 a container for venoclysis fluid, such as nutrient solution, salt solution, blood or the like. In the form shown, the container is of plastic material, such as a vinyl plastic, which is folded about itself to define edge 10a and sealed along the three edges to define a bag. At its upper edge 12 the container forms a supporting web, which may be of the same material as the bag itself or in the alternative may include a relatively rigid reinforcing material, such as cardboard. The bag is supported by suitable means (not shown) through the medium of the hook 14 which fits within a suitable opening 12a in the upper end 12 as shown.

At its bottom end 10a, the bag 10 has one or more ports, indicated generally at 16 and 16a (shown as two in number for purposes of illustration). Each of these port units includes a sheet 18 of the plastic material (here shown as circular) which is welded "or adhesively afiixed to the surface of the bag 10 at the bottom end 10a and extends on both sides of the bottom end. As is described in further detail hereafter, each of the plastic sheets has integrally attached to it an outwardly extending port-defining tube. One such tube is indicated at 20, FIGURE 1. As further described hereafter, each of these tubes 20 prior to use is covered by an enveloping port cap 22 which serves to maintain the sterile integrity of the port and is aflixed to the container so as to resist accidental removal. One of these port caps is shown in place over port unit 16a.

In the use condition as shown in FIGURE 1, at least one of the ports of the bag 10 has the cap 22 removed to expose the tube 20 and receive the relatively rigid cannula of theadministration set. The port 16, FIGURE 1, is shown in this cannula-receiving condition, the cannula being indicated at 24. A transparent sight chamber 26 is connected to the cannula 24 and at its bottom end receives the administration tube 28. Flow control clamp 30 adjustably pinches the tube 28 to control the rate of fluid flow. The needle 32 at the free end of the tube 28 is adapted to puncture the vein of the patient, thereby defining the complete fluid flow path from the bag 10 through the port 16 to cannula 20 and thence through sight chamber 26 and tube 28 to the needle 32 and into the vein.

The needle 32 preferably is of stainless steel or other suitable material. The other portions of the administration set and the bag preferably are of suitable plastic material. With the exception of the cannula 24 and cap 22, these are preferably of relatively soft pliable material, such as well-plasticized vinyl resins or solt polyethylene. The cannula 24 is relatively hard and tough for reasons discussed hereafter. It may be made of a thermo plastic compound such as a relatively unplasticized vinyl plastic material, a relatively hard thermo-setting resin such as a phenolformaldehyde resin, or even of metal. The cap 22 may be made of a thermo-plastic composition such as a relatively unplasticized vinyl plastic or other plastics that will meet the requirements later discussed. v

The flow control device 30 may be any one of the numerous types well known to the art. In the particular form shown, it consists of a plastic frame forming a vertical anvil against which the administration tube 28 rests. A member movable in the horizontal direction bears against the tube opposite the anvil and adjustably pinches the tube against the anvil as the threaded member 3011 is rotated.

Prior to use, the cannula 24 is covered by a cannula cover indicated generally at 34, FIGURE 2. This cover is shown in perspective in FIGURES 2 to 5, inclusive and in side elevation and in part axial cross-section in FIGURE 6. At one end, the cannula cover defines a cylindrical opening 36 into which the cannula is snugly received. As shown, this opening is closed at its bottom end 36a, thus defining a complete sheath about the end of the cannula 24 and serving to protect the sterility thereof. As also shown, the cannula cover 34 has a pair of diametrically opposed ears 38 and 38a which are of suitable size to receive the fingers of the nurse or doctor setting up the equipment. At the end remote from the opening 36, the cannula cover 34 has a socket-defining recess indicated at 40. In the form shown, this recess is prismatic in shape and, specifically is cubical.

Cannula cover 34 is of relatively hard material, such as a relatively unplasticized vinyl resin. Alternatively, a thermo-setting plastic such as a phenol-formaldehyde resin may be used. The bore 3-6 into which the cannula 24 is received is slightly tapered, as is the cannula 24, thus permitting the cannula cover to be force fitted onto the cannula in tight sterility maintaining seal.

The port unit 22 is shown in perspective in FIGURES 2-5 and in enlarged cross-section in FIGURES 68. In FIGURES 2 and 6 the cap 22 is shown in the affixed position for storage and shipment of the container 10. As seen best in FIGURE 6, the port unit 20 includes an outwardly extending tube 44 which at its base defines an annular flange 44a. Portion 44a is affixed by welding or by adhesive to the circular sheet 18, as also shown in FIGURES 2 to 8. Preferably the annular base portion 44a feathers toward its periphery, as shown. The tube 44 thus forms a unit sealed at the portions of attachment to the sheet 18 which, in turn, is sealed to the wall of container 10.

The cap 22 of the port unit 20 is telescoped over the tube 44 as is shown best in FIGURE 6. This portion, identified as 22a, forms an outer jacket. At its base the jacket 22a flares out in annular conformation at 22b, where it overlays the annular base 44a of tube 44. Jacket 22a is aflixed at its edges in an annular welded or adhesive seal to the annular portion 44a of the tube 44.

Cap 22 also has an inner cylindrical solid plug portion 220 telescopically received in the tube 44. It will be noted from FIGURE 6 that the portion 22:: substantially fills the tube 44, leaving no substantial unfilled air space. This is desirable for purposes of sterilization, storage and shipment. The inner cylindrical portion 220 and the outer jacket 22a of the cap are joined at the end of the tube 22 by the annular web 22d as shown. Upstandingfrom the portion 22d, the cap 22 has the prismatic head 222, shown for illustration as cubical, which receives the socket 40 in the cannula cover 34. This head is shown in perspective in FIGURE 2.

As above described, the portion 22a of the cap 22 is afiixed to member 18 by the annular portion 22b. When the cap 22 is to be removed, it is twisted in relation to the member 18 thus subjecting the jacket 22a and at least part of the annular portion 22b to torsion. By application of suflicient torque the jacket 22a or portion 22b is twisted beyond the rupturing point and breakage occurs along a line encircling the tube 44. The cap 22 then can be removed to expose the tube 44 to receive the cannula 24 for administration of fluid from the container to the patient.

The operation of the apparatus above described can best be understood by reference to FIGURES 2-8 inclusive. Initially the recipient set is positioned with the cannula cover 34 located above and in spaced relation with the head 22:: of the cap 22. This position is shown in perspective in FIGURE 2, and in cross section in FIG- URE 6. Normally the container 10 is held in one hand of the doctor or nurse and the recipient set is held in the other hand. From the position of FIGURES l2 and 6, the two units are brought together to mate the head 222 and the socket 40. This position is shown in fragmentary view in FIGURE 3. At this time the cannula cover 34 is twisted by the application of finger pressure to the ears 38 and 38a, as indicated by the arrows F, FIGURE 3. This twisting moment is resisted by the bag 10, which is held in the other hand of the doctor or nurse as mentioned above. Thus, the tubular section defined by the jacket 22a is subjected to torsion that extends along its length, and through at least part of annular flange 22b.

The user continues to apply finger pressure to the ears 38 and 38a as above described until the jacket 22a or the annular portion 22b ruptures. This is shown in FIG- URE 4, where the line of rupture is indicated at R and is located in the annular portion 22b. It will be noted that in FIGURE 4, the ears 38 and 33a (and the cannula cover 34) are shown rotated from the positions of FIGURE 3 as required to achieve the break. When breakage has taken place, and the cap 22 has been thus freed of the bag 10, the cannula cover 34 is withdrawn as shown in FIG- URE 5. This withdrawal may remove the cap 22 as the cannula cover is withdrawn or, in the alternative, may leave the cap 22 in place for removal by hand. For illustrative purposes in FIGURE 5, the cap 22 is shown as being withdrawn with the cannula cover 34. If the grip between the prismatic head 222 of the cap and the socket 40 of the cannula cover is less than the force of plu-g 22c and jacket 22a in holding the cap, it can be subsequently removed by hand through a simple pulling action when desired.

In any event, the cap 22 and the cannula cover 34 are removed in unison or separately from the tube 44 and from the cannula 24. The cannula 24 is then inserted within the port tube 44, as shown in FIGURE 7. The cannula 24 is then forced inwardly until the point thereon punctures the sheet 18 and extends beyond wall 10. The cannula 24 is then pushed to the position of FIGURE 8 where a passage is defined from the interior of the bag 10 through the opening 16 and the cannula. This is the position the parts have in FIGURE 1, where they are ready for use.

FIGURE 9 is a fragmentary view in perspective of an alternative form of the present invention. In this construction the head 122e of the cap 22 is of generally cylindrical construction with a hole or bore extending cross-wise of its axis (xx, FIGURE 9). The cannula cover 34 has a cylindrical extension 134a adapted to be received in this hole. The hole or bore and the extension 134a define mating conformations of the cap and the cannula cover to enable the convenient application of torsion to the 6 jacket 22a and annular base 22b of the cap 22. This is done with the parts in the position shown in FIGURE 9. The cannula cover thus provides lever action giving a mechanical advantage by which application of relatively small hand force twists the jacket and base until break takes place.

FIGURE 10 shows a partially cross-sectional view of still another form of the present invention. In this instance the head 222:; on the cap 22 has a narrowed cylindrical portion 222 defining upper beveled annular shoulder 222g and lower beveled annular shoulder 222k. The cannula cover 34 has an extending portion 234a with a circular opening 234b of size to be received over the end of the head portion 222e of the cap 22. The cannula cover also defines spaced surfaces 234s and 234d that bear against the upper and lower annular shoulders 222g and 222k of the cap head. By the application of lifting force to the cannula cover 34, the same is urged in the counterclockwise direction as seen in FIGURE 10. The jacket 22 of the cap accordingly is subjected to tension along the right hand side as seen in FIGURE 10. Suificient lifting force will ultimately cause the jacket 22 to rupture in tension and permit the same readily to be removed. If necessary, the cannula cover 34 can be rotated in relation to the cap after the rupture begins to tear the jacket 22 at a different point and the action continued until the jacket is torn completely around its periphery.

FIGURES 11 and 12 are enlarged in perspective and side elevation views, respectively, of an alternative construction of the prismatic head 22e as modified to provide spring resistance to the insertion of the same in the cannula cover 34. In this case the head has beveled faces 322a and 322b spaced by a slit 3220. The 'head is larger than the socket 40, FIGURE 2, when in the relaxed condition of FIGURE 11. However, when the socket 40 is placed on the head and forced down, the head flexes inwardly as shown in the dotted lines of FIGURE 12. This flexure causes the sides of the head to grip the sides of the socket 40 with sufficient force to cause the cap to come off with the cannula cover 34 when the same is withdrawn as in FIGURE 5.

In the embodiment of FIGURES 13 to 15, wall 410 of the fluid container is unbroken in the vicinity of port assembly 416. The flange 444a of port member 420 is sealed directly to the outer face of Wall 410. Closure cap 422 fits over the port tube 444, and closure flange 42212 is sealed to the upper face of port flange 444a. Closure flange 422]) diminishes in height in an axial direction from closure cap 422. A circular recess 422 is provided at the base of cap 422 to form a thin wall section 422g in the cap proximate flange 4221). Cap 444 is provided with an inner cylindrical solid plug 4440 which is received in tube 444 and the lower end of which bears against wall 410. As in the embodiment of FIGURES 2 to 8, closure cap 422 has a prismatic head 422e upstanding from the upper end 422d of cap 422. When the cap member 422 is to be removed, cannula cover 34 is ap plied to the cap member 422 such that prismatic head 422e lockingly engages the mating socket 40 of cannula cover 34, in the manner shown in FIGURE 4. The cars 38 and 38a are then twisted until cap 422 ruptures at thin wall section 422g, as seen in FIGURE 14. The cannula cover and ruptured upper portion of cap 422 are lifted to expose port 444. After rem-oval of the cannula cover from the cannula 24, the cannula 24 is inserted in the port and the point of the cannula pierces bag wall 410 to provide fluid communication between the bag and the transfer set 26, 28, 32.

While I have shown and described specific embodiments of the present invention it will, of course, be understood that many alternative embodiments may be used without departing from the true spirit and scope thereof. For example, while in FIGURE 2 the head 22:; and the socket 44) are cubical in shape, any prismatic shape will provide the necessary key action here desired. Indeed, any

non-circular shape that permits the parts to mate and requires that they rotate in unison when in the mated condition will suflice. Moreover, While the jacket 22 is shown in a single specific form, it will be evident that its purpose is to provide a sterile seal and in that other jacket forms may be used, including alternative jacket forms that can be torn by the application of torque or force in a different direction than those above specifically described. The cannula cover, also, may be in other forms providing a wrench, prying, or other action on the jacket and a mechanical advantage with respect to its breakage and removal.

It will be understood that the present claims are intended to cover all modifications and alternative constructions as wall within their true spirit and scope.

What I claim as new and desire to secure by Letters Patent of the United States is:

1. A recipient set suitable for use in removing the port cap of a venoclysis liquid container having an outlet port defining structure and a sterility maintaining cap thereover, the cap being affixed to the liquid container in sterility maintaining relation to the outlet port and being held thereon by break portions breakable upon predetermined movement of the cap in relation to the container, said portions being sufficiently strong to withstand substantial applied force and thus securely retain the cap in sterility maintaining position; the recipient set comprising a relatively rigid cannula having a free end adapted to be received in said outlet port defining structure to conduct -=fluid from the container, said cannula having a removable sterility maintaining cover telescoped over the free end thereof, the free end of said sterility maintaining cover and said cap having interengaging conformations efiective when engaged to to apply force from the cover to the cap in direction to break said break portions through force applied to the cover.

2. A recipient set suitable for use in removing the port cap of a venoclysis liquid container having an outlet port defining structure and a sterility maintaining cap thereover, the cap being aflixed to the liquid container in sterility maintaining relation to the outlet port and being held thereon by break portions breakable upon predetermined movement of the cap in relation to the container, said portions being sufficiently strong to withstand substantial applied force and thus securely retain the cap in sterility maintaining position; the recipient set comprising a relatively rigid cannula having a free end adapted to be received in said outlet port defining structure to conduct fluid from the container, said cannula having a removable sterility maintaining cover telescoped over the free end thereof, the free end of said sterility maintaining cover and said cap having interengaging conformations effective when engaged to apply force from the cover to the cap in direction to break said break portions through force applied to the cover, said cover having portions against which finger force may be applied to exert said force with mechanical advantage.

3. A recipient set suitable for use in removing the port cap of a venoclysis fluid container having a protruding port structure and a port-protecting cap secured in position thereover, said cap having a section breakable upon application of force and at least one conformation against which said force may be applied, the recipient set comprising: a rigid cannula adapted to fit in said port structure when the cap is removed to define an outlet flow path for said fluid container; a sterile cover encompassing said cannula to define a sterile protection therefor and having a free end defining a conformation adapted to lockingly mate with said conformation of the port-protecting cap of the fluid container, whereby finger force applied to the cover exerts said force on the cap; and administration tubing connected to said cannula to transmit fluid from the fluid container to the recipient.

4. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cap enveloping said structure, said cap having an outboard end and anchored along a line encircling the outlet port defining structure and spaced from said outboard end, the cap being removable from the fluid container by torque applied to the cap in relation to the container, the outboard end of the cap defining a non-circular head; the recipient set comprising: a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover having a free end, the free end of the cover defining a socket adapted to be received on the head of the cap, whereby the cannula cover may be positioned in mating position on the cap and turned to apply tearing torque to the cap for removal of the same.

5. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure and spaced from said outboard end, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a non-circular head, the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover and having a free end, the free end of the cap defining a socket adapted to be received on the head of the cap, the cannula cover further having finger-receiving ears against which the fingers may be applied to exert torque thereon, whereby the cannula cover may be positioned in mating position on the cap and turned to apply tearing torque to the cap for removal of the same.

6. A recipient set suitable for use in removing the port cap of a venoclysis sterlie fluid container having a protruding outlet defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure and spaced from said outboard end, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a prismatic head; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the voutlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having a free end defining a socket conformation adapted to be received on the head of the cap whereby the cannula cover may be telescoped over the head of the cap and turned to apply tearing torque to the cap for removal of the same.

7. A receipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure and spaced from said outboard end, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a prismatic head; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container said cannula-defining part having a sterility maintaining cover thereover, the cover having a free end defining a socket of prismatic conformation adapted to be received on the head of the cap whereby the cannula cover may be telescoped over the head of the cap and turned to apply tearing torque to the cap for removal of the same, the cannula cover having a pair of extending ears against which the fingers may be applied to exert turning force thereon.

8. A receipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure and spaced from said outboard end, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a prismatic head; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having a free end defining a socket of prismatic conformation adapted to be received on the head of the cap, the head and the socket in the relaxed condition being mutually interfering and being capable of flexing to define a force fit when assembled, whereby the cannula cover may be telescoped over the head of the cap and turned to apply tearing torque to the cap for removal of the same and withdrawal of the cap and cannula cover as a unitary body.

9. A recipient set for venoclysis apparatus suitable for use in removing the port cap of a venoclysis fluid container having a protruding port cap secured in position thereover by a section breakable upon application of twist and having a prismatic head, the recipient set comprising: a rigid cannula adapted to fit in said port structure when the cap is removed to define an outlet flow path for said fluid container; a sterile cover for said cannula, said cover telescoping over said cannula to define a sterile protection therefor, and having a free end in said telescoped portion and a socket defined by said end adapted to be received upon and mate with the prismatic head of the cap, said cover further having ears against which finger pressure may be applied to exert torque, whereby force applied to the cover when positioned on the cap twists the portprotecting cap in finger to break the breakable section thereof; and, in administration tubing connected to said cannula to transmit fluid from the fluid container to the recipient.

10. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure and spaced from said outboard end, the cap having an axis and being removable from the fluid container by torque about said axis applied to the cap in relation to the container; the outboard end of the cap defining a head having an opening transverse to said axis; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having an extension adapted to fit in said opening, whereby the extension may be inserted in said opening and turned to apply rupturing force to the cap for removal of the same.

11. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line of adhesion encircling the outlet port defining structure and spaced from the protruding end thereof and being removable from the fluid container by tension applied to the cap in relation to the container; the outboard end of the cap defining a head with a reduced portion forming spaced shoulders; the recipient set com prising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having an extension With an opening adapted to be received over said head and defining spaced surfaces adapted to bear against said shoulders when the cover is tilted with the opening in alignment with the reduced portion of the cap, whereby prying force exerts tension on portions of said cap in relation to the container to remove the same.

12. A recipient set suitable for use in removing the port cap of a venoclysis fluid container having a protruding part structure and a port-protecting cap secured in position thereover by a section breakable upon application of force and having conformations against which said force may be applied, the recipient set comprising: a rigid cannula adapted to fit in said port structure when the cap is removed to define an outlet flow path for said fluid container; a sterile cover for said cannula, said cover telescoping over said cannula to define a sterile protection therefor and having a free end in said telescoped position, said cover having conformations of the port-protecting cap of the fluid container, whereby finger force applied to the cover exerts, with mechanical advantage, said force on the cap; and administration tubing connected to said cannula to transmit fluid from the fluid container to the recipient.

13. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container having a protruding outlet port defining structure and an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and being anchored to the container along a line encircling the outlet port defining structure, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a first locking means; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having a free end defining a second locking means adapted to lockingly engage said first locking means whereby the cannula cover may lockingly engage the head of said cap and be turned to apply tearing torque to the cap for removal of said cap.

14. A recipient set suitable for use in removing the port cap of a venoclysis sterile fluid container, a cylindrical outlet port defining structure having a port flange secured to said container, an imperforate cylindrical cap enveloping said structure, said cap having an outboard end and a cap flange sealingly secured to said port flange, the cap being removable from the fluid container by torque applied to the cap in relation to the container; the outboard end of the cap defining a prismatic head; the recipient set comprising a fluid conducting tube terminating in a relatively rigid cannula-defining part adapted to be received in the outlet port defining structure to conduct fluid from the container, said cannula-defining part having a sterility maintaining cover thereover, the cover having a free end defining a socket of prismatic conformation adapted to be received on the head of the cap whereby the cannula cover may be telescoped over the head of the cap and turned to apply tearing torque to the cap for removal of said cap, the cannula cover having a pair of extending ears against which the fingers may be applied to exert turning force thereon.

(References on following page) 1 1 12 References Cited 7 3,205,889 9/ 1965 Alder et a1 128-272 UNITED STATES PATENTS 3,211,144 965 Nehring -2 128-214 4 1 3 1.1 9! 5 9 ,089 12/1966 Brookfield 128221 11/1903 Daniels 81-2 4/1945 B erg 222 83 5 DALTON L. TRULUCK, Pnmary Examzner.

7/ 1957 Tasciotti 81-3 34 RICHARD A. GAUD ET, Examiner.

7/ 1959 Bellamy 128-272

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